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Ascent_DOTmed_Stryker_Bridge_June_Full_Pg.indd 1 5/9/11 10:59 AM contents June 2011

features

19 AAMI – Exclusive interview with AAMI President 46 and CEO Mary Logan 22 SNM – Exclusive interview with SNM President Dr. Dominique Delbeke

37 Nanomedicine – Big news on a microscopic scale

46 Kinecting With the Dead – Motion-sensing game controller helps doctors perform virtual autopsies

50 A Cardiac Controversy – Sudden deaths of student athletes fuel the heart screening debate

Visit DOTmed.com/news for breaking news daily, to comment on stories in this issue, to participate in surveys and more. industry sector reports

26 PET/CT – New drugs may give molecular imaging a boost 54

34 SPECT – Is the supply chain at the breaking point?

39 Nuclear Medicine – The latest from the field

54 Stress Tests – Legal & connectivity woes

PUBLISHER DOTmed.com, Inc. contents PRESIDENT Philip F. Jacobus

editorial

EDITOR-IN-CHIEF Sean Ruck 212-742-1200 Ext. 218 departments [email protected]

ASSISTANT EDITOR Brendon Nafziger 6 Letter from the Editor – The new Godzilla generation STAFF WRITER Olga Deshchenko

16 Health Care Chronicles – Provider Credentialing: CONTRIBUTING WRITERS Matt Haddad, Learn now or pay later Thomas V. Vorpahl, Sruthi Valluri, David Willis 21 Show and Conference Spotlight – SNM Exhibitor sneak peak design DESIGN DIRECTOR Stephanie Biddle 24 Money Health – Making your next purchase a Lindsay Grystar profitable one DESIGN COORDINATOR sales 36 In Memoriam – DOTmed News honors industry legend SALES DIRECTOR David Blumenthal Lawrence Shack 212-742-1200 Ext. 224 [email protected]

44 Diagnostic Directions – Ultrasound at the point of KEY ACCOUNT Don Hurtikant MANAGERS 212-742-1200 Ext. 275 care: Who’s in charge? [email protected]

Susan Minotillo 212-742-1200 ext. 261 [email protected]

ACCOUNT EXECUTIVES Sean Collins 212-742-1200 Ext. 288 in every issue [email protected] Daniel Gaspar 212-742-1200 Ext. 203 8 Upcoming Events Calendar [email protected] 8 This month’s exclusive online content Dustin Sewnauth 212-742-1200 Ext. 289 8 Top Stories from Our Daily Online News [email protected] Rigo Smith 11 In the Next Issue 212-742-1200 Ext. 207 12 New Product Showcase [email protected] 14 Hospital Spotlight Press Releases 58 This Month’s Featured Auctions If you have news regarding your company submit it to: [email protected] 60 Marketplace & Classifieds Article and Story Consideration 64 Blue Book Price Guide If you have an article or feature story you would like the editor of DOTmed Business News to consider publishing, submit it to: [email protected]

Letters to the Editor Submit letters to the editor to: [email protected]

Auctions DOTmedSM provides the DOTmed Business NewsSM to its registered users free of charge. If you want information about auctioning equipment on DOTmedSM makes no warranty, representation or guarantee as to the accuracy or timeliness DOTmed.com, please call: 212-742-1200 Ext. 296, of its content. DOTmedSM may suspend or cancel this service at any time and for any reason or email us at [email protected] without liability or obligation to any party. All trade names, trademarks and trade dress contained herein belong to their respective owners and are used herein with the intent to DOTmed Business News is published by DOTmed.com Inc., represent the goods and services of their respective owners. If you think your trade name, 29 Broadway, Suite 2500, New York, NY 10006 trademark or trade dress is not properly represented, please contact DOTmed.com, Inc. Copyright 2011 DOTmed.com, Inc. All rights reserved. Letter from the Editor

A new Godzilla generation Recently, I was speaking with a new acquaintance about the lack of a viable domestic source of molybdenum-99. We discussed some of the hurdles one might face in trying to build a nuclear reactor in the United States. One of the major obstacles now, he pointed out, is “the new Godzilla generation.” He explained it as a description of the public perception that anything nuclear is bad. So how does Godzilla fit in? Although many people never saw beyond the cheesy special affects and rubber-suited actor who portrayed the giant dinosaur, the film is not without social commentary. Godzilla was “born” a little more than a decade after the bombings of Hiroshima and Nagasaki and was a symbol of the public fear surrounding nuclear energy. In that respect, the fear was well–justified, with so many lives lost and so many more witnessing the effect of the most powerful man-made weapons ever used. The new fears surrounding all things nuclear again have roots in Japan, following the power plant catastrophe there (which I discussed in last month’s letter). I can only imagine the stiff opposition governments or private industry will face when attempting to build any new plants. However, it may be we can’t afford not to build those plants. Even the biggest nuclear plant disasters — Three Mile Island, Fukushima Daiichi and Chernobyl — have resulted in relatively few deaths regardless of their notoriety. And although debate will rage on as to how many additional deaths have or will occur from the radiation introduced by those disasters, nuclear energy is still a cleaner energy source than coal or oil. Even though major oil spills and coal mine collapses and fires are more common, I think the fact that the hazards are visible — oil covered beaches, billowing smoke — make them less frightening to the public. The invisible hazards of radiation can’t be sidestepped. But in reality, the benefits provided by nuclear plants has so far, signifi- cantly outweighed the risks. The challenge is to educate the public and provide solid facts and figures to prove it. Whether that’s providing a side-by-side environmental impact comparison, or updates on how many lives are saved through the use of radio- isotopes in medicine, the public needs the education.

Until next issue! Sean Ruck Editor-in-Chief DOTmed Business News

Please outline the content of the article Call for and provide a brief description of your qualifications as an authority Submissions and in your field. White Papers SM By email to: DOTmed Business News [email protected] invites all medical industry professionals who have unique By mail to: experience or knowledge in The Editor, DOTmed Business News any clinical or business area of 29 Broadway, Suite 2500 health care to submit an article New York, NY 10006 for publication.

6 DOTmedbusiness news I j u n e 2011 www.dotmed.com systems, and discover the ANDA Medical difference. Upcoming Events Exclusively Online This Month

Health Freedom Expo PET vs. SPECT in CAD detection: Jun 10 – Jun 12, Chicago, Ill. Lantheus shares full results of its Phase 2 clinical trial An exclusive Q & A with Dr. Jamshid Maddahi The Endocrine Society’s 91st Annual Meeting DM16096 Jun 14 – Jun 17, Boston, Mass. This month in medical history: We honor the “American OMTEC Exposition & Conference Noble” Jun 16 – Jun 17, Rosemont, Ill. DM16164

AANP Annual National Conference Jun 22 – Jun 26, Las Vegas, Nev. Corrections: Dave Stopak of Advanced Imaging Solutions was inad- vertently left off the ultrasound sales and service directory World Vaccine Congress Asia 2011 in last month’s issue. Jun 22 – June 24, Singapore Chris Cone of Unisyn Medical Technologies was inadver- AAMI Conference & Expo tently left off the mammography sales and service direc- Jun 25 – Jun 27, San Antonio, Texas tory in last month’s issue. In last month’s mammography ISR, Dr. Sara Fredrickson’s AWHONN 2011 Convention name was misspelled. Jun 25 – Jun 29, Denver, Colo.

School Nutrition Association National Conference 2011 Top Stories from Our Daily News Jul 10 – Jul 13, Nashville, Tenn. Read www.dotmed.com/news Online

At some NYC public hospitals, women have long wait for mammograms New York City women at one public hospital have to wait near- ly five months to undergo routine screening mammograms, according to a city audit released last month. The audit, un- dertaken by City Comptroller John C. Liu, found what it called “dangerously long waits” for screening and diagnostic mam- mograms at some of the nine public hospitals it reviewed in fiscal 2009. Jc[dghM^·aZVY^c\egdYjXi^k^in The comptroller’s office said three of the nine hospitals had waiting times for screening mammograms far longer than the The Unfors Xi, now in its Platinum Edition, is a complete two-week maximum required by the public system’s policy. system for diagnostic x-ray multi-parameter measurements For three hospitals, Elmhurst Hospital and Queens Hospital on all modalities. This includes Radiography, Fluoroscopy, Mammography, Dental and CT. Added options include separate in Queens, and Woodhull Hospital in Brooklyn, wait times detectors for luminance and illuminance measurements and ranged from 41 to 148 calendar days. radiation scatter or leakage measurements, both of which can be quickly attached to the Unfors Xi. For reporting purposes, And although the public hospitals don’t have guidelines specify- the new Unfors QA View software is now available. ing how fast a woman should receive a diagnostic mammogram -- given to women showing possible breast cancer symptoms, such as a lump -- women at five of the audited hospitals had All designed to increase your Flexible reporting software average wait times between 17 and 50 working days. accuracy and productivity! One meter – all applications But the Health and Hospitals Corporation, which runs the Truly easy to use city’s 11 acute care public hospitals, disputed the comptrol- ler’s findings, arguing his office cited out-of-date data and that wait times had improved. HHC said that now patients with The Unfors Concept symptoms can receive a diagnostic mammogram within 24 to 72 hours. And for screening mammograms, seven of the 11

Accurate result 10s to learn Pocket sized Unfors Instruments, Inc. Phone: (866) 4UNFORS public hospitals have a waiting time of one day or less. 48 Anderson Avenue, Suite 1 +1 (860) 355-2588 www.unfors.com New Milford, CT 06776, USA Fax: +1 (860) 350-2664 E-mail: [email protected] • Online: dotmed.com/dm16015

8 DOTmedbusiness news I j u n e 2011 www.dotmed.com

AAMI: Biomed field gets ment might be called “clinical engineer- tions for the company across the entire ing,” but at another, “medical technology Siemens portfolio of health care products new name services.” And the group thought some and solutions. He will be based at the At a two-day meeting in late April hosted naming uniformity could help the profes- company’s U.S. headquarters in Malvern, by the Association for the Advancement sion as it grows by giving people outside Penn. of Medical Instrumentation, more than two the industry a unified term that would be dozen industry leaders picked a new name Sorensen is the co-director of the A.A. instantly recognizable. for the profession responsible for maintain- Martinos Center for Biomedical Imaging ing and servicing medical equipment. But AAMI, half of whose 6,000 members at Massachusetts General Hospital in are biomeds, did stress that no one has Boston. He also currently serves as the It’s “healthcare technology management.” been asked to change any business professor of Radiology and Health Sci-

cards yet, as the new name applies only ences & Technology at Harvard Medical “We felt that this name was accurate, to the field or profession as a whole. At School and is a faculty member at the easily understood by the public and oth- the conference, the matter of individual Harvard-MIT Division of Health Sciences er health care workers, and allowed for job titles was not addressed. and Technology. expansion of the field in the future,” Pat Lynch, a biomedical support specialist Online: dotmed.com/dm16006 According to his faculty profile at HST, with Global Medical Imaging, said in a • Sorensen’s primary areas of research are statement. Harvard professor to head using functional magnetic resonance im- aging to help understand brain diseases The meeting, which ran from April 28-29 Siemens Healthcare and using other radiologic technologies to at AAMI’s Arlington, Va. headquarters, Siemens Healthcare appointed neuroradi- evaluate new therapies. His techniques was attended by 30 engineers, techni- ologist Dr. Gregory Sorensen as its chief have been used at 56 centers around the cians, educators and corporate leaders. executive officer last month. Sorensen will replace Randy Hill, the interim CEO, start- world for phase II and phase III cancer AAMI convened the meeting, dubbed the ing June 1. He will also be responsible for drug research, the profile said. Future Forum on Technology Manage- Siemens’ operations in Canada. Online: dotmed.com/dm ment, because the nomenclature for the • 16074 biomed department varies from hospital As the new CEO, Sorensen will lead mar- to hospital: at one hospital the depart- keting, sales, service and support func-

10 DOTmedbusiness news I j u n e 2011 www.dotmed.com For nervous patients, MRI played with a certified therapy dog for 15 minutes half an hour before their MRI Coming in July: goes to the dogs was scheduled. Another six patients had For the 15 percent of patients so nervous no doggy time before their scan. Ruch- about MRI exams they can’t undergo man said after the exam, self-reported The Biomed Issue them without first taking a tranquilizer, anxiety fell an average of nearly 14 units scientists might have found a safe, furry on the Spielberger State-Trait Anxiety alternative to drugs. At a presentation Inventory for Adults, a standard 40-item last month at American Roentgen Ray test used by psychologists to gauge Society’s meeting in Chicago, Dr. Rich- anxiety. But anxiety scores remained ard Ruchman said playing with therapy essentially the same for the patients dogs before getting a scan could signifi- without doggy time. cantly ease self-reported anxiety. In his study, which he conducted with his teen- Online: dotmed.com/dm16026 age daughter at a New Jersey teaching • hospital, 28 patients spent time with or Industry Sector Reports: Patient monitors DOTmed monitors the market from ECG to oximeters in our annual report.

Infusion pumps Increased FDA scrutiny and regulatory measures have honed in on infusion pumps. Find out what the impact has been and what manufacturers are doing to address the changes.

Testing equipment Biomeds keep hospitals running and they depend on this equipment to do their jobs. We take a look at the tools of the trade.

• Service/Maintenance Agreements • Turn-key Projects (De-Install, Rig, Move, and Re-Install) Defibrillators • MR & CT Inspections This equipment is cropping up • Oxford Magnet Services everywhere, from hospitals to high • Technical Support (Onsite and Remote) schools. Manufacturers are taking note and planning accordingly.

Features: Critical access hospitals/rural health What strategies are hospitals using to survive?

DOTmedbusiness news I j u n e 2011 11 To see more NEW products, visit www.DOTmed.com. Have a new product? PRODUCT Send your press release to SHOWCASE [email protected].

Canon U.S.A. adds to digital radiography portfolio Canon U.S.A., Inc., introduced four general flat panel digital radiography systems, the CXDI- 401C, CXDI-401C COMPACT, CXDI-401G and CXDI-401G COMPACT DR Systems. The 510(k) cleared, lightweight systems offer an approximately 17-inch by 17-inch imaging area, making them ideal for diagnostic imaging areas and radiology rooms. These four new gen- eral flat panel detectors are highly sensitive and offer high signal-to-noise performance. All four feature pixel pitch of 125 microns with approximately 11.3 million megapixels on an approximate 17-inch by 17-inch imaging area. Coupled with a quick image preview and processed image display of approximately three to five seconds, the four new models provide a quick, high-resolution DR solution. Additionally, the CXDI-401C and CXDI-401C COMPACT DR systems incorporate a Cesium Iodide (CsI) scintillator. The CXDI-401C COMPACT and CXDI-401G COMPACT DR Systems fit into most universal Bucky systems. Boasting the same resolution and high-sensitivity as the larger models, these two COMPACT DR models weigh approximately 15 pounds and features a sleeker, minimal housing unit for improved ease-of-use and simple inclusion into existing radiology departments. • Online: dotmed.com/dm16028

FDA clears MR Instruments’ 16-channel head coil MR Instruments Inc. received U.S. Food and Drug Administra- tion 510(k) clearance for a 16-channel head coil that works with G.E. Healthcare’s 1.5- and 3-Tesla MRI systems. The company said it was also seeking CE marking to sell the coil in Europe. • Online: dotmed.com/dm15730

Toshiba Vantage Titan MR knee coil Toshiba America Medical Systems, Inc., has announced FDA clear- ance for the extra-large knee Array coil for the Vantage TitanTM MR system. Toshiba is the first diagnostic imaging vendor to offer an extra-large knee coil with a 22 cm interior diameter for MR imaging. The wide diameter of the extra-large knee Array coil can accom- modate most bariatric patients. The extra-large knee Array coil can be used when imaging non-bariatric patients as well; its wide diameter is ideal for imaging a flexed or bent knee. Toshiba’s extra-large knee Array coil can be used for most routine and advanced MR knee studies, including assessing car- tilage, fractures or knee replacement. It is available to current and new Vantage Titan customers. • Online: dotmed.com/dm16050

12 DOTmedbusiness news I j u n e 2011 Expect biopsy needle Boston Scientific Corporation’s aspiration needle, dubbed Expect, features an “echogenic” pattern, meaning it bounces off sound waves so it’s highly vis- ible on ultrasound. This lets doctors better guide the needle to collect tissue samples from targeted organs. The Expect Needle received both Food and Drug Administration clear- ance and CE Mark approval earlier this year, the Natick, Mass.-based com- pany said. It’s now available in both markets. “Combining EUS with [fine needle aspiration] offers powerful diagnostic ca- pabilities that can help optimize malignancy management in the GI tract and inform appropriate treatment paths for the patient, including surgery, chemother- apy, radiation or palliation,” said Dr. Robert H. Hawes, a professor of medicine with the Medical University of South Carolina in Charleston, in a statement. • Online: dotmed.com/dm16041

Perceptive Pixel’s multi-touch desktop display Perceptive Pixel, recently unveiled the world’s first professional multi-touch, high-resolution, optically-bonded, projected capacitive 27” LCD desktop display This is the first and only solution with performance and a form factor appropriate for professional users in fields such as geo-intel- ligence, digital content creation, computer-aided design (CAD), en- ergy exploration, medical imaging and other visualization-intensive sectors. The new 27” display empowers users to work directly on screen to access and manipulate complex data and workflows. “This is literally the most advanced desktop display in the world,” said Jeff Han, founder, CEO and chief scientist at Percep- tive Pixel. EndoChoice releases • Online: dotmed.com/dm16113 giDash and giComply EndoChoice’s giDash provides physician metrics in real time and trending formats to help monitor and drive practice profitability. The giDash program incorporates a dashboard populated with key metrics visually displayed for at-a-glance review. Physicians can also view data that includes financial-payer mix, collections, aging, referrals and productivity. The company also debuted giComply, a software program that automates the traditional pathology logbook and generates fast, accurate requisitions and labels. With giComply, the nurse selects a patient from the practice management system; enters specimen information us- ing intuitive, onscreen anatomic graphics and drop-down menus; then prints the requisition and labels. All informa- tion is automatically entered into the electronic logbook, which includes a searchable database and the ability to color-code entries for faster, easier reference. • Online: dotmed.com/dm16057 DOTmedbusiness news I j u n e 2011 13 Hospital Spotlight Cooper University Hospital, Camden, New Jersey

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1: Hospital interior 2: Leksell Gamma Knife Perfexion 3: President and CEO John P. Sheridan, Jr. 4: Control room monitors 5: Rendering of the Cooper Medical School of Rowan University 6: Hospital Exterior

14 DOTmedbusiness news I j u n e 2011 www.dotmed.com Stat Snapshot: Year Founded: 1887 President & CEO: John P. Sheridan, Jr. Number of beds: 600 Number of Employees: 5,488 Specialties: Critical Care Medicine; Level 1 Trauma Center; Vascular Surgery, includ- ing minimally invasive repair of aneurysms and aortic diseases; Cooper Heart Institute; Cooper Neurological Institute with Leksell Gamma Knife Perfexion; Cooper Cancer Institute with Cooper Cyberknife Center; Cooper Digestive Health Institute. 2 Recent Development: The hospital has a new, 10-story 312,000 square foot patient pa- vilion with 60 private medical/surgical patient rooms, 30 state-of-the-art critical care beds, an expanded Emergency Department, 12 operating room suites, and new laboratory. In 2009, Cooper partnered with Rowan University to establish a new four-year allopathic medical school in Camden, NJ -- Cooper Medical School of Rowan Univer- sity. The first class is anticipated to enter in fall of 2012. Noteworthy distinctions: Winner of Con- sumer Choice Award from the National Re- search Corporation for six consecutive years; Named Blue Distinction Center for knee and hip replacement and spine surgery by Blue Cross/Blue Shield; Earned Major Clinical Research Affiliate (MCRA) designation from The Cancer Institute of New Jersey.

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DOTmedbusiness news I j u n e 2011 15 Health Care Chronicles Provider Credentialing: Learn now or pay later By Matt Haddad

hese days, it seems that ev- innocuous changes in demographics to eryone is being “creden- more problematic changes in profes- tialed.” Americans are pain- sional and legal status. Failure to detect fully aware of the need to even minor changes can result in higher produce credible, current administrative costs, patient safety is- identification each and every time they sues and an increased likelihood of boardT a flight. Banks and consumer medical errors and corresponding credit companies use increasingly so- medical malpractice claims. Hospitals phisticated techniques to ascertain iden- may also bear further financial burdens tity and eliminate fraud. The health through the retroactive denial of claims — hospitals can ensure patient safety, care industry relies upon the process of for services performed by providers decrease liability and protect their insti- credentialing to identify providers and who have lapsed licenses or other inad- tutions from financial harm. Continu- qualify them for practice. equate, flawed credentials. ous monitoring of provider credentials Unfortunately, technology so- Traditionally, hospital leadership is not simply a good extra step, it is a lutions have made little headway has viewed credentialing as a “check serious, fiscal responsibility that must in truly improving the health care the box” regulatory burden largely be a part of hospital operations. credentialing process, which is still overlooked from an efficiency stand- largely manual in nature and reliant point. As a result, credentialing pro- Evolving credentialing on the paper file. Provider credential- cesses are antiquated and time-con- ing as the principal source of provider suming. However, with the advent of standards information for the organization, as a Web services and other software in- For almost 80 years, hospital creden- whole, is a source of massive errors novations, this area is poised for dra- tialing standards hardly changed. and inefficiency. matic change. Credentialing was a process of peer Aside from the human error in- With real-time information — oversight, which relied more on a local volved with manual, paper-based pro- rather than updates which can arrive network of providers who knew each cesses, provider information changes months or even years following chang- other. As the United States grew in constantly and without warning—from es to a provider’s credentials or profile population and became more mobile, health care delivery systems needed to expand and become more complex. To this day, while personal knowledge of physician abilities and character are factors for smaller community hospi- tals, organizations largely rely upon an expanding list of third-party sources for certification, historical and general capability information. Strict controls on the definition of reliable sources of information and the use of those sources have been mandated by federal and state gov- ernments, as well as The Joint Com- mission, National Committee for Quality Assurance, Utilization Re- view Accreditation Commission and other accreditation bodies. One area of credentialing im- provement recently addressed is the frequency of information updating. This recognition of the need for more frequent credentialing activities was

16 DOTmedbusiness news I j u n e 2011 www.dotmed.com heralded by the 2007 TJC standards. In a radical departure plaintiff, whose subsequent treatment after discharge includ- from credentialing principles based on a policy of “What ed six corrective surgeries, claimed that St. Mark’s Hospital you don’t know can’t hurt you,” TJC deemed credentialing was negligent – or guilty of culpable conduct – in credential- to be a significant organizational duty in the provision of ing the surgeon. St. Mark’s argued that Utah did not recog- quality patient care. According to these new standards, the nize a cause of action for negligent credentialing. goal of credentialing was to identify provider issues by col- Rejecting the hospital’s contention that the woman’s lecting data on an ongoing basis. claim was barred by the immunity afforded to health care Though it’s been four years since this came out, many providers for discharging duties under the state’s peer re- facilities still have not been able to comply with these stan- view, the court maintained that St. Mark’s held the ultimate dards due to inadequate resources, technology and exper- responsibility for medical staff decisions. The court went tise. The basic framework of credentialing is still only the on to recognize negligent credentialing as a viable common initial and reappointment cycle. Yet in the not-too-distant law claim. future, such periodic credentialing may become as antiquat- In the landmark 1998 case, Romero vs. Columbia, a ed as the horse and buggy. hospital paid $23.2 million in damages after a routine her- Technology is enabling a convergence of point-of-ser- nia operation resulted in extreme loss of blood and conse- vice need with real-time access to provider information. If quent heart attack. The court found the hospital liable in the the trend continues, the requirement to credential at any screening process of the offending physician, who had been specific date will be unnecessary as complete credentialing sued 11 times and had privileges suspended from another will be continuously performed. For this to happen, insur- state prior to the malpractice incident. Due to a restraining ance data, affiliations, peer references and other manually order the surgeon had placed on his former hospital, the sus- available information must be converted into electronic da- pensions never surfaced. The hospital argued due diligence tabases for constant, automated and secure access. These in the screening process, but could not arbitrate against the databases will need to be continuously updated and new overwhelming undocumented evidence that had escaped requirements may have to be put into place for the sources them during their credentialing of the provider. of such information. In the end, incomplete and inefficient credentialing led Though these changes are still to come, today there is to massive financial loss on the part of the hospital, further still an abundance of provider information that can be elec- damage to the hospital’s reputation and most importantly, tronically accessed and monitored in real time, thereby pro- unacceptable harm to a patient. viding immediate and tangible improvement in risk man- agement and efficiency.

Legal consequences Prior to 1965, hospitals were considered charitable organi- zations and immune from being sued for negligence. Much has changed since that time and hospitals are now a natural litigation target as they have deeper pockets than individual providers and can be easily exposed to direct liability. Plain- tiffs’ attorneys are even now drawing a causal link between provider errors occurring in as many as one-third of hospi- tal admissions, as reported in the journal Health Affairs, and negligent credentialing, thereby laying the legal responsibil- ity at the feet of the organization. Hospitals and other health care facilities are also expe- riencing growing levels of risk exposure through increased accountability for physician liability. In most states, if a clinician has behavioral issues or oth- er problems with their qualifications that should have been revealed by proper and effective credentialing, the facility can be held responsible for any harm caused to patients by that provider. Injured patients may also have legal recourse against the hospital for malpractice if the credentialing process was incomplete, inadequate or non-existent. These growing levels of risk responsibility on the part of the hospi- tal are increasingly supported by courts across the nation. Consider the Utah Supreme Court, which recently re- versed an earlier decision against a woman who had brought several claims of malpractice against the physician who mis- handled her abdominal surgery at St. Mark’s Hospital in Salt Lake City, where the original operation was performed. The

DOTmedbusiness news I j u n e 2011 17 State courts across the country have concluded hospi- nial rate based on provider issues can mean a major finan- tals have legal duties to patients to increase patient safety cial problem for a facility. and reduce malpractice cases and a responsibility to stake- holders to keep their operations financially viable. Hospi- Should hospitals do their own credentialing tals not aware of changes in provider credentials are simply at all? laying the foundation for liability issues in the future. Even The task of having individual hospitals acquire and suc- when the hospital is able to successfully defend against cessfully implement technology to produce a continuous such cases, the cost of litigation and damage to its reputa- credentialing process is understandably daunting. Even tion may be irreparable. with automation and reduced labor, there are significant challenges to assuring that technology will deliver the ben- A new trouble spot: reimbursement and efits being sought. credentialing Perhaps the key issue is in the inefficiency of most hos- While ineffective credentialing can lead to loss of accredita- pitals performing their own credentialing at all. Across the tion status, licensure and Medicare certification, there is now U.S., hospitals and other organizations are performing the a further significant financial liability: recovery audits. same credentialing processes in isolation. There are no effi- For many years, recovery audit firms have been en- ciencies to credentialing in silos. Processes that specialized gaged by payers to identify and collect overpayments due service organizations can provide for less cost and greater to billing and coding errors. Recently, some of these firms quality should be accessed to meet this challenge. have looked to provider issues as another potential source Credentialing Verification Organizations equipped of recovery. Consequentially, any claim or reimbursement with continuous verification technology are the best solu- submitted must be screened for provider credentialing is- tion for hospitals that should primarily focus on delivering sues at the time of service. For instance, if a provider had quality care. a lapsed license at the time care was provided, that claim These CVOs specialize in finding lapsed or expired could be justifiably denied. Claims screening activities are licenses, sanctions, de-certifications and other issues that quickly uncovering that anywhere from 2 to 7 percent of might affect patient care and provider services and flag- claims are at risk or justify denial due to provider creden- ging that information to offer a more complete credential- tialing issues. This may seem small, but even 1 percent de- ing picture of each provider. This type of outsourced tech- nology approach is becoming increasingly efficient and cost-effective for hospitals forced to reduce resources, but still comply with quality measures in today’s competitive health care market. Of course, hospitals cannot delegate the ultimate decision to appoint a physician, but obtaining the information necessary to make that decision may be a needlessly expensive and error-prone exercise that should be outsourced.

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)FBMUIDBSF fense in protecting patients, staff and a hospital’s reputa- *OEVTUSZ tion. The more rigorous the process, the higher the quality of the resulting doctors, patient care and industry standing. Hospitals and health care facilities are coming to terms with the importance of understanding their providers past, pres- ent, and future. Avoiding knowledge of provider issues is a perilous path, so remember: “Who you know, what you know and when you know it” is the new normal. • Online: dotmed.com/dm16086 Matthew Haddad is president and CEO of Medversant, a Web- based data management provider. As a health care industry con- sultant, Mr. Haddad has arranged financing and provided interim management to acute care facilities, skilled nursing facilities, psy- chiatric care facilities and assisted living centers. He serves on the Board of the American Association of Preferred Provider Organiza- tions and has published numerous articles on credentialing, tech- nology and healthcare-related issues. Mr. Haddad received a B.S. in Business Administration from the State University of New York at Albany and his JD from Boston University. He maintains state bar licensure in New York, California and Massachusetts.

18 DOTmedbusiness news I j u n e 2011 www.dotmed.com AAMI advances its message to the health care world

he Association for the Advancement of Medical A lawyer by training, Logan practiced for 20 years with a fo- Instrumentation (AAMI) has had a busy couple cus on health care regulatory concerns before moving into of years. As is the case with many organizations, association leadership. She served as general counsel for policy shifts and new initiatives by the federal gov- the American Dental Association, and also spent seven years ernment pose challenges for the association. Cur- as its chief operating officer, before being tapped for the po- rentT President and CEO Mary Logan, came in at just the right sition with AAMI in April 2009. Logan set aside some time in time, getting a chance to settle into her role before tackling her busy schedule to speak with DOTmed News about some those challenges. of the progress AAMI has made under her watch.

DOTmedbusiness news I j u n e 2011 19 DMBN: It seems like you joined AAMI just in time. There’s I would say although most people in the outside world been a lot of movement in the health care arena during the won’t really notice the change, it’s really important in how past two years. What kind of challenges is your member- we represent ourselves to the world. For the first time, we ship facing? have a tagline, “Advancing safety in medical technology.” We also moved last year to much more inviting office space, Logan: I would say the biggest challenge right now is the with great meeting rooms for members. convergence of technologies, most notably medical devices with IT. There are new drug/device combinations and new DMBN: What are some of your personal goals as president device/device combinations all providing a lot to consider. and CEO? There are also more products utilizing wireless capabilities than ever before, taking the functions that historically bigger Logan: One of the charges the board gave me when I first and bulkier devices did individually and combining them all joined was to build bridges with the external world and I into one device – patient monitor- have worked really hard on that. Last year alone, I met with ing is a good example. about 50 organizations. A second challenge has emerged Society Snapshot We are so busy with so many op- due to the increased scrutiny hos- portunities. One of my challenges AAMI provides global leadership and programs is helping to make sure we have pitals face in regards to patient to support the health care community in the the capacity to do all the things safety and cost control. That has, development, management and use of safe and possible. We’ve opened the doors, in turn, created tremendous op- effective medical technology. portunity and pressure across the shaken the rugs out the window entire health care system, includ- Association Fast Facts and announced to the world ing health care associations. we’re ready to do work. Now, we Year started: 1967 need to make sure we’re ready to DMBN: What have been some of Number of members: 438 companies and do a really good job with what the highlights during your time 6,294 individuals we have on our plates. with the association? Area of operation: National and international DMBN: And that will be seen at Logan: I would say last year, Leadership: Volunteer with paid support staff your conference? AAMI’s defining moment was a historic summit co-hosted with Conference Fast Facts Logan: Certainly. I’m looking the FDA, which focused on the forward to many highlights. 45 safety of infusion devices and sys- Years in existence: Standout examples include our tems. What was magical about the Average attendance: More than 1,500 Harken Lecture, where a nuclear event was that we had 350 diverse energy expert will share lessons Exhibitors: More than 150 stakeholders in a room together we can apply in health care, the and they worked as a whole to Date: June 25-27, 2011 Joint Commission’s EVP as a agree on 13 priorities for improv- general session speaker, and an Location: Henry B. Gonzalez Convention FDA expert who will speak on ing infusion safety. We now have Center, San Antonio, Texas working groups in the AAMI the new MDDS [medical device Foundation Medical Device Safety Tagline: The Premier Conference for data system] regulations. Healthcare Technology Management. Council set up just for the purpose DMBN: What do you most look of working on these priorities and forward to about the show? making the safety goals a reality. Logan: To me, the most important thing about the conference DMBN: Are there other plans like that for the future? is being in one place with a community of 1,500 committed Logan: We’re actually repeating the process twice this Octo- technology experts who care a lot about patient safety and ber, first on alarm safety and then on reprocessing reusable advancing clinical technology. It’s fun and energizing to be medical devices. The alarm safety summit will be co-hosted with them in a great learning and networking environment. with the ECRI Institute and the American College of Engi- DMBN: If someone wanted to get involved with a commit- neering. The summit on reprocessing reusable medical de- tee, what should they know? vices will be co-hosted with the FDA, since that topic is one of the FDA’s new efforts. Logan: There’s a place for professionals with many level of involvement. We have the standards-setting side of AAMI DMBN: Has the Association’s direction or goals changed where our committees are open and readily welcome sub- under your leadership? ject experts and hospital-based individuals. We also have Logan: Some things have definitely changed, and I think the Technology Management Council, editorial board, an- they’ve been welcome changes. For example, last Novem- nual conference program planning committee, and more. ber our board adopted a new strategic plan for the asso- Beyond that, if someone’s looking to get involved, visit our ciation. This four-page plan replaces the old 50-page plan. web site or give me a call! Online: dotmed.com/dm16095 We also recently went through a rebranding initiative and •

20 DOTmedbusiness news I j u n e 2011 www.dotmed.com Show and Conference Spotlight SNM 2011 – Exhibitor Sneak Peak

Here’s a look at some of the exhibitors that will be at the SNM annual meeting. To find out more, visit their booth at the show and tell them DOTmed News sent you!

tion to refurbished SPECT cameras clinical cases that show image qual- and cardiac PET. AIS can offer same- ity improvements using iterative recon- day parts delivery to maximize custom- struction for both SPECT and CT stud- er uptime. Our highly trained sales and ies. The high resolution of the flat panel technical staff coupled with advanced allows for true isotropic voxels and pro- quality control measures ensures your vides high-quality images when viewed refurbished system will run like new. at any angle. Co-planar SPECT and CT capabilities eliminate the need to index the bed between the two acquisitions, Bracco Diagnostics, Inc. which for many studies provides greater confidence in image registration. Booth 5069 Diagnostic confidence with low radia- tion exposure, optimal efficiency, and GE Healthcare excellent image quality are the hall- MEDX, Inc. Booth 1051 marks of CardioGen-82® (Rubidium Rb Booth 8017 Recently awarded the ‘Price Perfor- 82 Generator) from Bracco Diagnostics MEDX has been a leading provider of mance Value’ Leadership in PET/CT Inc. Indicated for cardiac PET imaging high quality new, remanufactured and for North America 2011 by Frost & Sul- under rest and pharmacologic stress, refurbished molecular imaging equip- livan, GE Healthcare’s Optima PET/CT CardioGen-82 is setting a new standard ment, service and parts since 1973. 560 combines superb image quality, of care in the detection and manage- The company will introduce the next high productivity and a patient friendly ment of coronary artery disease. generation T-Quest compact gamma experience. The system offers efficien- camera. The FDA-cleared T-Quest in- cy and investment protection with the cludes enhanced thyroid imaging and capability to grow with the needs of the Siemens Healthcare now features expanded imaging capa- bilities to perform parathyroid, sentinel practice. From the uninterrupted full Booth 6033 node, MUGA, gastric emptying, hepa- head to toe exam to the dose reduction Highlighted products include the work- tobiliary, bone spots and other small features, the Optima PET/CT 560 was in-progress Biograph mMR, the world’s organ studies. designed to help physicians put pa- first integrated whole-body molecu- tients’ needs first. It includes advanced lar magnetic resonance (MR) system Delivering over 3,000 nuclear imaging VUE Point HD intelligent 3D iterative with simultaneous data acquisition systems and upgrades to facilities all reconstruction technique enhancing technology; IQ·SPECT, Siemens’ field- over the world, MEDX continues to of- resolution that helps enable clinicians upgradeable combination of hardware fer complete SPECT and PET cover- to confidently detect small lesions and and software; the Biograph mCT 20 age including accreditation assistance, increase quantitative accuracy. Excel, the 20-slice molecular computed multi-vendor field service and certified tomography (CT) scanner designed to parts, 24/7/365 technical phone sup- deliver optimum performance for cost- port, professional applications training Absolute Imaging conscious customers; and the entire and 24-hour U.S. service response. line of Biograph mCT scanners, which Solutions combine HD·PET and time-of-flight, Booth 4083 and advanced CT capabilities with up AIS specializes in Nuclear Medicine, to 128 slices. X-ray, Ultrasound/Echo, CT and Car- diac PET. With nearly 200 years of combined field service experience, AIS maintains, repairs, relocates and installs Philips Healthcare nuclear medicine cameras throughout Booth 6069 the Southeast region of the U.S. Full Iterative Technology (FIT) avail- able on Philips BrightView XCT uses AIS also offers the new C! Photon dual advanced algorithms for the truest pic- head cardiac SPECT camera in addi- ture possible. Philips will showcase new

DOTmedbusiness news I j u n e 2011 21 SNM: This year, the society has cause for celebration

The SNM has been around for a long time – more than half a century. But this is a particularly good year to be lead- ing the society with some long-planned initiatives seeing the light of day. Dr. Dominique Delbeke, the 2010-2011 president, shared some information about the latest from SNM, including the big news about the initiatives.

DMBN: Serving as president of SNM the position was available, I realized proposes names according to set crite- is an impressive accomplishment. How I liked what I was doing and stayed ria of accomplishments, and then there did you get to where you are today? with it. Since 1990, I’ve been on the is an election process by membership. faculty at Vanderbilt University where So it’s a question of being known for Delbeke: I’m a nuclear physician I’m now a professor of Radiology and your scientific accomplishments and by training. It’s not a specialty that Radiological Sciences and Director of involvement with the society. medical students think of when it Nuclear Medicine and Positron Emis- comes time to decide about a spe- sion Tomography. DMBN: How do you make yourself cialty because nuclear medicine is not known? addressed much in medical school. DMBN: And when did you get in- Medical students are usually exposed volved with the society? Delbeke: You have to be engaged, to nuclear medicine if they choose to one way is to develop SNM educa- do an elective radiology or nuclear Delbeke: I’ve been an SNM mem- tional programs, whether live at SNM medicine rotation. Actually, I started ber since 1986, when I was training scientific meetings or web-based. In in pathology but I had an opportu- in nuclear medicine as a resident. I my own experience, I also wrote sev- nity to work in nuclear medicine for began to be more involved with the eral books in a popular teaching file two years while waiting for a pathol- governance of the society about seven format on nuclear medicine, nuclear ogy position to open up. By the time or eight years ago. As for becoming cardiology and positron emission to- president, a nomination committee mography. Through that authorship,

22 DOTmedbusiness news I j u n e 2011 www.dotmed.com my national and international visibil- cal medical diagnostic tests and high ity increased and I was invited to give quality care. Meeting Fast Facts lectures at major meetings throughout Years in existence: 58 the world. Nuclear medicine and molecular im- aging are not only an essential compo- Average attendance: 5,000 DMBN: As the 2010-2011 SNM presi- nent for the diagnosis and treatment dent, what were your main goals? of diseases, but can contribute to more Exhibitors: 474 efficient and cost effective health care Delbeke: Overall, the mission of the Location: San Antonio Convention by guiding to the most appropriate Center, San Antonio, Texas society is to improve health care by therapies and sparing patients from advancing molecular imaging and unnecessary treatment, especially “Must see” events: The SNM and therapy. I was planning to continue unnecessary and expensive invasive SNMTS Opening Plenary Sessions to support the SNM long-term initia- procedures. will be held on Sunday, June 5. tives, such as bringing new biomark- On Monday, June 6 there will be ers to the bedside, that are critical to I believed that the best way to achieve a Special Plenary Session. The the future of our field. this goal was through sustainable de- exhibit hall and poster hall with the livery of radioisotopes, well designed latest advances in technologies However with the current economic multicenter clinical trials, comparative and research will be open Sunday challenges, I also wanted to focus effectiveness research and evidenced- through Tuesday. on the more immediate needs of the based multidisciplinary practice Additional information: This year membership. I perceived these as be- guidelines. I believe that during my ing concerns related to the shortage of SNM is offering a Virtual Meeting for presidency, all these SNM initiatives those unable to attend the Annual radioisotopes, decreasing reimburse- have moved forward. ment and health care reform. Meeting. The Virtual Meeting will make 70 courses available online DMBN: What do you believe are the within 24 hours of the live session. The goal of the health care reform is to biggest challenges facing the imaging This will include 35 CE sessions, provide health care to more individuals sector today? and to control its cost. The number and 20 technologist sessions and cost of advanced imaging procedures Delbeke: I believe there are two huge 15 scientific sessions. has grown disproportionally compared challenges. The first impacts imag- to the overall growth rate of health care. ing in general – the economy and the In addition, the public concern about problem the government is facing in membership, SNM was able to move radiation exposure is rising. trying to provide more care to more forward a number of initiatives At people while simultaneously decreas- this year’s SNM Annual Meeting Laboratory accreditation and physi- ing costs. cian’s adherence to evidenced-based held in San Antonio, Texas on June practice guidelines and appropriateness The second is more specific to nuclear 4-8, 2011, SNM will celebrate the end use criteria are increasingly important medicine. The public is becoming very of the molecular imaging campaign. as a condition for reimbursement. concerned about radiation exposure I have the privilege to summarize its related to medical imaging. accomplishments and thank the do- The goal of SNM is to ensure that pa- nors, both individuals through the tients continue to have access to criti- To address the public’s concern, SNM Educational and Research Foun- there’s a two-fold solution. Recom- dation and corporate sponsors. As the mendations need to be put in place to results of their sponsorship, SNM has Society Snapshot ensure radiation exposure is as low as now integrated fully molecular imag- possible, while still providing the im- ing throughout its programs. Mission statement: To improve aging quality needed. The public also human health by advancing needs to be educated about the rela- DMBN: Would you consider the an- molecular imaging and therapy tively low risk of radiation exposure nouncement of those initiatives your proudest moment as SNM president? Founded: 1954 compared to the risk of not diagnos- ing or not treating appropriately a dis- Delbeke: There’s no particular mo- Number of members: Over 17,000 ease they might have. ment, but I have really enjoyed the Area of operation (national, DMBN: Are there any big announce- privilege of serving the membership international): SNM’s members ments coming from SNM this year? and bringing people together to ac- are worldwide; many of the soci- complish these initiatives. I’ve also ety’s activities are focused in the Delbeke: Absolutely. Five years ago enjoyed building the bridges for col- Unites States SNM started a molecular imaging laborations and contributions to par- campaign under the leadership of Pe- ticular goals. Leadership: Volunteer, elected ter Conti, then SNM president. With leadership the funds raised – from industry and • Online: dotmed.com/dm16146

DOTmedbusiness news I j u n e 2011 23 Money Health Making your next purchase a profitable one By Thomas V. Vorpahl t’s a common scenario: Hospital Meanwhile, new technology begets buyers carefully select equip- new challenges as technology tends ment they believe will give the to evolve incrementally, as opposed to organization the most bang for sudden, major breakthroughs. its buck, only to find it’s a mon- As you may guess, OEMs aren’t your time and resources. The payback, ey pit as downtime, patient diversion motivated to be completely transparent as many of your peers will tell you, is a andI maintenance costs mount. with service performance metrics, so much healthier bottom line. Speaking of Having been on the original equip- we can expect self-reported data to have peers, that’s also the route to finding the ment manufacturer side of the industry undergone some level of PR treatment, right partner: a credible, evidence-driv- for 35 years, I’ve witnessed the harmful clouding the buyer’s judgment. What’s en advisor will bring with it a strong repercussions of basing purchasing de- more, not only is an understanding of cadre of satisfied customers and the doc- cisions for expensive clinical technol- the fair market value needed upfront, umented savings to match it. Take the ogy on incomplete data. It’s not unusu- but also a true apple-to-apple compari- Texas-based Seton Family of Hospitals. al, for example, for a hospital to spend son between equipment platforms, as Within the past year, Seton buyers were as much on service and parts over the well as the optimal set of terms and con- able to slash nearly $370,000 in equip- first five years as it did on the initial ditions for that specific modality. ment management costs by uncovering purchase of the device. Wise purchas- So what’s a hospital buyer to do? better alternatives for upgrades, repair, ing decisions hinge on the complete- Though some might try to uncover re- purchases and replacement. That’s the ness and accuracy of the information liable data on their own, many have power of good data. available to decision-makers. found value in skipping the process • Online: dotmed.com/dm16141 Where do hospital buyers get their of wading through questionable data information? In my experience, most and instead joining forces with an un- Following 30+ years of OEM executive lead- CFOs get it from their supply chain and biased advisor who can provide fac- ership in medical equipment manufacturing, service line officers, who do their home- tual data on all attributes mentioned Tom Vorpahl now serves as chief operating work and then make a recommenda- above. Put simply, the ideal partner officer at TriMedx, a medical equipment and tion. The staff, in turn, typically gets its would be a “Consumer Reports” of asset management firm, delivering nearly information from a group purchasing health care equipment: vendor-neu- $150 million in customer savings. TriMedx organization or third-party consultant. tral, data-rich and evidence-based. is a subsidiary of Ascension Health, the na- Of course, physicians have traditionally Yes, it does take an investment of tion’s largest nonprofit health network. had a say in equipment purchases too, but that influence has declined as insti- tutions have been forced to make deci- sions based on the pro-forma invoice. That’s where it gets interesting. As you’re likely aware, the true cost of a new purchase isn’t just the technology itself; it’s the cost of the equipment plus its maintenance over the course of its entire life cycle. Un- fortunately, complete, factual data aren’t readily available in the current pro-forma model—not in a way that assists the buyer in truly understand- ing the total cost of ownership. In order to grasp that TCO, buy- ers need access to downtime data over the lifetime of the equipment, performance forecasts and metrics for newer models, meantime to failure, cost and availability of replacement parts, possible trade value and more.

24 DOTmedbusiness news I j u n e 2011 www.dotmed.com HOSPITAL O.R. & SURGERY CENTER CONFERENCE 2011 "VHVTU




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UNTIL 6/30/11, DOTMED READERS CAN REGISTER FOR $1,695/EACH BY USING COUPON CODE DOTOR615 WHEN REGISTERING ONLINE: www.HLTHCP.com 26 DOTmedbusiness news I j u n e 2011 www.dotmed.com AGENTS OF CHANGE Despite regulatory hurdles, PET drugs may give molecular imaging a boost By Olga Deshchenko

hen the Food and Drug Administration order to continue manufacturing agents for clinical use. held a public meeting on positron emis- One PET drug producer got a jumpstart on the require- sion tomography drugs in early March, ments. In early February, PETNET Solutions, Inc., a wholly its organizers were pleasantly surprised owned subsidiary of Siemens Medical Solutions USA Inc., by the number of participants. became the first commercial entity to file an application Once the meeting reconvened after lunch, Jane Axelrad, and receive FDA approval for a PET agent as mandated by Wthe associate director with the Office of Regulatory Policy at FDAMA. the Center for Drug Evaluation and Research, announced PETNET received FDA approval for its ANDA for Flu- that more than 200 people were taking part in the event, deoxyglucose F 18 injection, or FDG, a popular oncology a significant jump from the previous PET meeting which agent. The company submitted the application more than hosted about 50. three years ago, says Edward Plut, vice president, product Axelrad credited the attendance boost to “either chang- management and marketing, with PETNET. “To date, we’re es in the industry or just the fact that now we’re really get- the only commercial manufacturer to even submit an appli- ting serious, people are paying more attention.” cation, let alone to be approved by the FDA,” he says. Whatever the reason, it shows radiopharmaceutical de- More than a decade seems like a long time for estab- velopers are set to launch new PET drugs and doctors are lishing the regulations, but in many aspects, PET drugs eager to put them into practice. were uncharted territory for the FDA. “Throughout these To date, few agents have received a nod from the FDA, but industry experts predict that will change within the next few years. Not only is the FDA now keen on closely working with manufacturers of imaging agents on the approval process, but the country’s PET infrastructure is also mature and strong -- encouraging factors for drug innovation. “It may well be that the timing is finally right,” says Jonathan Allis, general manager of PET business with GE Healthcare.

Regulatory changes Originally developed as research tools, PET radiopharma- ceuticals only began to gain traction in clinical practice in the 1980s. The imaging agents caught FDA’s attention about a de- cade later and the agency began to consider regulating them. In 1997, Congress enacted the FDA Modernization Act, which gave the agency the power to regulate PET drug manufacturing. But Congress said the agency couldn’t require manufac- turers to submit a New Drug Application or an Abbreviated New Drug Application for an agent for a period of two years after the law was enacted or two years after the completion of special approval procedures and current good manufac- turing practices for PET drugs -- whichever took longer. “They didn’t need to worry that we were going to be moving very speedily,” Axelrad joked at the meeting. It took the FDA more than 12 years to provide the final rule and guidance on cGMP for PET radiopharmaceuticals, which were officially published in December 2009. By the end of 2011, all PET drug manufacturers will have to comply with the cGMP and submit an NDA or ANDA in

DOTmedbusiness news I j u n e 2011 27 proceedings, we’ve tried to be sensi- “This is a significant milestone for decisions and therefore better out- tive to the fact that we are bringing Lantheus because it provides a very comes for patients,” says Washburn. under regulatory control an industry clear path towards the final approval Just last month, Lantheus pre- that had been largely unregulated and of the agent and it gives us great clarity sented data on the full results from its an industry with special characteris- on what exactly we need to do to get Phase 2 clinical trial of Flurpiridaz at tics,” Axelrad said at the meeting. there,” says Dr. Daniel Washburn, the the International Conference of Non- With more clarity from the FDA, company’s vice president, clinical de- Invasive Cardiovascular Imaging in industry experts hope to see novel velopment and medical affairs. “From Amsterdam. PET agents glide through the regu- a development perspective, it lowers And later this year, the company latory process in the near future and the overall risk to the program because plans to launch the first part of its pave the way for PET radiopharma- we know exactly what we need to do Phase 3 trial for the agent, which will ceuticals currently in development. as we proceed into Phase 3.” be global and involve about 100 sites. Currently, SPECT is the dominant There are currently no similar car- PET meets CAD modality for noninvasive detection of diac PET imaging agents at the same Lantheus Medical Imaging Inc., a CAD but the approval of Flurpiridaz advanced stages of development as North Billerica, Mass.-based diagnos- can turn PET into a worthy competitor. Flurpiridaz. tic imaging company, is hoping to add According to Washburn, PET has a new PET cardiac imaging agent to higher image quality than SPECT and A focus on a neurodegen- the list of approved drugs. Lantheus offers some unique technical features, erative disease such as attenuation correction, which is developing Flurpiridaz F 18, a myo- Another PET agent aims to change the reduces artifacts prevalent in other cardial perfusion agent for imaging of grim statistics around the only cause imaging modalities. PET also holds a patients with coronary artery disease. of death among the top 10 in the Unit- lot of potential for novel applications, In early March, the company ed States that at this point cannot be such as the ability to measure absolute reached an agreement with the FDA prevented, cured or slowed in its pro- quantitative blood flow in the heart. “I on a Special Protocol Assessment on gression. think the hope is that all of these char- the design and planned analysis of the Nationwide, 5.4 million people acteristics lead to better diagnostics Phase 3 clinical trial for the drug. are living with Alzheimer’s disease

28 DOTmedbusiness news I j u n e 2011 www.dotmed.com

and the care for those who are sick will cost Americans about $183 billion in 2011, according to the Alzheimer’s As- sociation. Avid Radiopharmaceuticals, Inc., bought by pharma giant Eli Lilly and Company last year, is looking to bring its agent Amyvid (a Florbetapir F 18 injection) to market. Amyvid is currently under investigation for PET imag- ing of beta-amyloid plaque in the brain. The drug’s value is rooted in the amyloid hypothesis, which argues that ac- cumulated levels of beta-amyloid in the brain lead to Al- zheimer’s disease. If approved, Amyvid will be the first drug to measure amyloid deposits in the brains of living patients, potentially providing clinicians with the means for early diagnosis and intervention. The drug got its start in 1999 at the University of Penn- sylvania, where Avid founder and CEO Dr. Daniel Skov- ronsky began working on its development. Skovronsky and his team first looked at dyes that were used to stain cadaver tissue to see the amyloid plaque. They then worked on a way to translate the dyes into an imaging test. After years of medicinal chemistry research, the scien- tists got to Florbetapir, “a small molecule that binds very avidly to the target of amyloid plaques,” says Skovronsky. It’s no secret that drug development is a time-consum- a unique challenge – the absence of a readily available truth ing, expensive and complex process but Amyvid also faced standard to validate the newly developed test. After a lot of discussion and work with the FDA, the researchers came up with a solution. They would image volunteers who are near the end of life and who had agreed to donate their brains to research upon death. “We would compare the amyloid actually found postmortem to the got rubidium? amyloid that we found in the scan, and thus develop a pa- thology truth standard,” says Skovronsky. In the Phase 3 trial, about 150 people volunteered to Cardiac PET Stress Testing Made Easy! be imaged. Not all of them died, but the first 35 who did formed the key data set for Amyvid. “We sometimes think STARK Law Compliant – Easy Lease Model of those 35 as pioneers, the individuals who made it pos- Simple Terms allow you to Grow your Business sible to get to this point in the field,” Skovronsky says. So how close is Amyvid to approval? In December, the and Be Profitable from Day One! FDA assigned priority review designation to the drug’s ap- YOUR LEASE FEE INCLUDES: plication. Then in January, an FDA advisory panel voted • ACLS Certified Nuclear Medicine 3-13 against approval because of concerns around reader variability of the scans and a lack of a substantial training Technologist and Medical Assistant framework for clinicians. • GE PET Scanner, Control and Prep But the panel also unanimously voted to approve Rooms Amyvid if the company created a rigorous program to train WE... readers. • Hold contract for Rb-82 Generator “The FDA asked us to establish a reader training pro- • Provide for Medical Physics gram for market interpretation to help ensure reader accu- • Handle Maintenance Agreement racy and consistency of our scans,” Skovronsky explains. • Manage ICANL accreditation “And they asked us to validate the reader training program using the existing Amyvid scans which were obtained in • Maintain RAM License Phase 2 and Phase 3 of our clinical trials.” Call TODAY for Details: 352.327.1000 If approved, physicians will be able to use Amyvid to www.mobilenuclear.com rule out Alzheimer’s disease. But the agent is far from be- AMI coming a screening tool. Anti Matter, Inc It’s established that if there is no amyloid in the brain, the patient doesn’t have Alzheimer’s disease. However, the presence of amyloid doesn’t necessarily mean that the

30 DOTmedbusiness news I j u n e 2011 www.dotmed.com patient has the disease. “That is why drugs that can halt the progression of project that’s in its early stages. The it’s not a completely accurate diagnos- the disease make it to the market. And companies hope to develop a blood- tic for Alzheimer’s disease but it is a according to Carrillo, several promis- based test that can help determine true representation of amyloid in the ing drugs are currently in Phase 3 tri- who should be specifically tested with brain,” says Maria Carrillo, senior di- als, and many more are in Phase 2. a more complex imaging test for the rector, medical and scientific relations, The most exciting thing about such disease, Allis says. with the Alzheimer’s Association. pharmaceuticals is the potential to use As for Amyvid, Skovronsky re- “Maybe in the future, there will them earlier in the progress of the dis- frains from speculating on a timeline be definite proof that patients with ease. “That’s the shift in the therapeu- for the agent’s approval, only saying amyloid in the brain are going to get tic world that we’re probably going to that Avid and Lilly are working with Alzheimer’s, and drugs could be used see this decade,” says Carrillo. the FDA to complete the training pro- to remove amyloid out of the brain,” Another company working on a gram “as quickly as possible.” Skovronsky says. “But we’re just not PET imaging drug to detect amyloid just there yet.” plaque is GE Healthcare. Its flute- In development for oncology Nonetheless, the potential ap- metamol agent is close to finishing the In addition to neurodegeneration, GE proval of Amyvid is generating quite Phase 3 program and the company is also working on several PET agents a buzz. This spring, for the first time plans to file an application with the for imaging cancer. One of its drugs, in 27 years, three expert workgroups FDA later this year. fluciclatide, could be used for imag- published new criteria and guidelines According to Allis, GE is look- ing angiogenesis, and is currently in for the diagnosis of Alzheimer’s dis- ing at an integrated approach to Al- Phase 2 trials. ease. The new guidelines emphasize zheimer’s disease. “We’re particularly There is a huge class of anti-angio- the importance of biomarkers, such interested in how PET and MRI will be genic drugs, says Allis, worth about $8 as Amyvid, in the early diagnosis and used together in both the diagnosis of billion. If and when GE’s angiogenesis research into the progression and in- Alzheimer’s disease and also in thera- agent gains approval, it can be used to tervention of Alzheimer’s. py monitoring of the disease,” he says. track changes in response to a specific Of course, Amyvid will be con- GE is also collaborating with therapy. sidered a particularly useful tool in Johnson & Johnson in developing Instead of having a patient take a diagnosing Alzheimer’s if pharma a biosignature for Alzheimer’s, a

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DOTmedbusiness news I j u n e 2011 31 particular drug for months only to find it’s not effective, a PET exam with the agent can determine the response with- PET vs. SPECT in weeks, explains Allis, thus reducing both the potential of in CAD detection: unpleasant side effects for the patients and the associated Lantheus shares full costs. results of its Phase 2 GE plans to progress fluciclatide into Phase 3 next year. clinical trial Researchers within Siemens’ Molecular Imaging Bio- An exclusive Q & A with marker Research facility are also developing a number of Dr. Jamshid Maddahi novel oncology PET biomarkers “that image the key hall- marks of cancer,” says PETNET’s Plut. Several Siemens’ www.dotmed.com/news/16096 agents are currently in Phase 1 or 2 clinical trials, with a cel- lular proliferation agent preparing to start Phase 3 trials. pany, and that’s before the Eli Lilly deal enabled access to A class of their own? additional resources. Although many PET drugs are currently on track to FDA And yet, compared to a pharma product, bringing a approval, the journey is complicated and, increasingly, PET drug to market is relatively inexpensive and quick. costly. “But because there are so few precedents, the challenge Dr. Mark Hibberd, senior medical director, global med- with an imaging drug is that it’s more difficult to under- ical affairs and pharmacovigilance with Lantheus, has been stand what the market outlook is for it and how it will be in the clinical trial research industry for about 20 years. He used by doctors,” says Skovronsky. says drug development costs have gone up and are likely Plut also says that although it’s somewhat cheaper to keep climbing. to develop an imaging agent compared to a therapeutic “Some of the drivers for the increasing costs have been drug, the volume of utilization for most therapeutic prod- increased regulatory standards for the demonstration of ucts would far exceed that of a PET drug once approved. safety and the efficacy of new products,” he explains, which “When compared to therapeutic drug products, there’s a call for additional partnerships and longer, larger trials. mismatch between the development costs for an imaging To bring Amyvid to where it is today, Avid raised $70 agent and the potential volume or procedures that will be million from venture capital investors as a startup com- performed in the marketplace with that imaging product

32 DOTmedbusiness news I j u n e 2011 www.dotmed.com once approved,” he says. an improvement in overall survival, “A lot of the hope for personal- The fact that imaging agents are are quite challenging with diagnostic ized medicine and molecular imag- held to the nearly same standard as imaging, explains Plut. But an imag- ing biomarker development is to use classic therapeutic products drives ing agent can be shown to improve molecular imaging to help stratify this mismatch between development diagnostic accuracy, stratify patients patients, to help determine which pa- costs and potential procedure vol- and influence change in patient man- tients might benefit from particular umes. agement. types of therapy, rather than one size For instance, classic outcome That’s why there should be an fits all treatment,” says Plut. studies performed with traditional “equitable development pathway” To turn that hope into reality will pharmaceutical products, measuring specific for imaging agents, “that require developers of biomarkers and takes the unique properties of molec- pharma products to collaborate on Agent Update: ular imaging biomarkers and the dis- R&D initiatives, a growing trend in tributed manufacturing requirements the market. Sodium Fluoride F 18 of PET into account,” says Plut. And the industry has no inten- Sodium fluoride F 18, the PET agent “There are molecular imaging tions of slowing down. “We’ve only for bone imaging, has been deemed agents which are very close to approv- seen the tip of the iceberg of what mo- safe and effective by the FDA, but its al and we’re eagerly looking to them lecular imaging can accomplish for utilization has been relatively limited as precedents,” he adds. patients,” says Avid’s Skovronsky. for a long time. • Online: dotmed.com/dm16102 What’s standing in its way? Accord- Making it personal Olga Deshchenko can be reached via email ing to Edward Plut, vice president, One of the biggest promises of molec- at [email protected] product management & marketing ular imaging is its ability to drive the with PETNET Solutions, it’s a lack of care model towards personalized med- See the nuclear medicine sales reimbursement. icine. Experts say that additional PET and services directory starting drugs will aid clinicians in identifying on page 42. However, the company is collaborat- the right patients for particular thera- ing with the imaging community to pies, and do so early and accurately. change that. To satisfy Medicare’s requirement for a large clinical trial in order to support reimbursement, PETNET is working with the Acad- emy of Molecular Imaging to carry out a trial that compares sodium fluo- ride to traditional bone imaging tests. (To date, the trial is about halfway through.) In 2010, the Centers for Medicare and Medicaid Services decided to cover PET with sodium fluoride un- der the CMS Coverage with Evidence Development program. The National Oncology PET Registry then estab- lished a registry for the agent, cre- ating a pathway for clinicians to get reimbursed for using sodium fluoride for PET. “Since that time, we’ve seen a pretty significant growth in utilization for sodium fluoride and there’s a lot of excitement in the community around PET bone imaging,” says Plut. The next step is to use the combined results of the CED program through NOPR and the AMI clinical trial to pe- tition CMS for a broad coverage deci- sion on the agent, which the imaging community hopes to do in the next year or two, according to Plut. • Online: dotmed.com/dm16103

DOTmedbusiness news I j u n e 2011 33 Is the SPECT supply chain at the breaking point?

he parallels between the U.S. gas crisis and the emission computed tomography equipment has gotten one affecting nuclear medicine are uncanny. more efficient. Doctors have also started turning to hybrids In 1973, the United States was faced with an like SPECT/CT, which allow for ultrafast cardiac imaging, unprecedented gas shortage. During the gas cri- translating to less isotope use. Some facilities have even ex- sis, drivers were lined up at the pump for hours. perimented with reducing the dose used during scans to Rationing meant drivers were only able to fuel on even or see if they could provide the same quality of care. Todd days of the month, depending on whether their license plate ended with an even or odd number. A fragile chain For last summer’s medical imaging isotope shortage, The fragility of the isotope supply chain gained worldwide thousands of patients were backlogged as they awaited attention less than two years ago, when an inspection of needed procedures, in some cases for months at a time. the National Reactor Universal in Chalk River, Ontario un- “We saw wait time increasing and patients being turned covered a leaky reactor vessel. In mid-May, 2009, the nearly down,” says Sergio Calvo, marketing director of molecu- 60-year-old reactor, which supplies half the United States’ lar imaging with Siemens Healthcare. “Some patients who supply of molybdenum-99, the isotope from which techne- couldn’t wait went to other studies – so nuclear cardio went tium-99m is derived, was taken offline for repairs. Initially to echo-cardio for example, so that was a problem.” estimated to take as long as eight months to complete, re- Both shortages raised the awareness of our depen- pairs actually took nearly twice that long, with the reactor dency on foreign supplies and prompted conversations finally reopening last August. about self-sufficiency as a nation, either by developing our During the shutdown, the domestic nuclear medicine own supplies or by improving technology to reduce our community turned to overseas reactors to alleviate the needs. For the gas crisis, economy cars were introduced to shortage. However, the condition of the Chalk River reac- the market, while after the isotope shortage, single-photon tor spurred concerns about the remaining reactors and a

34 DOTmedbusiness news I j u n e 2011 www.dotmed.com Shortages in An aging fleet And that’s a problem, because the current crop of reactors is radioisotopes have nearing the end of their working lives. The HFR reactor in increased the strain Petten is currently slated to be decommissioned in 2015, with the NRU reactor to be shuttered the following year. Building a on the nuclear plant in the U.S. requires a lengthy approval process between medicine community. state and federal government and the Nuclear Regulatory Committee. In fact, the process has proven so daunting that it has been more than three decades since any new plant has By Sean Ruck been built. Still, isotope suppliers are exploring their options. For in- stance, some progress is being made in the effort to create Mo- 99 with smaller reactors utilizing a liquid core of low-enriched uranium. Lantheus Medical Imaging Inc., a radiopharmaceu- tical company, is working with NTP Radioisotopes Ltd., a Private offices feel the pain subsidiary of the South African Nuclear Energy Corporation, Of the 18,000 nuclear cameras in the U.S., to commercially produce the first Mo-99 sourced from LEU. more than a third are dedicated to nuclear But even if they succeed, the U.S. is unlikely to see a simi- cardiology. This means more than 6,000 lar plant within the next few years, which means it’s a game cameras rely on a steady supply of tech- of wait and see to determine not if, but when, lives and live- netium-99m to keep them running. And lihoods will again be facing a supply chain stretched to the nuclear cardiology is largely a service pro- limit. Online: dotmed.com/dm16156 vided by private cardiology offices. • Those private offices, already hammered Sean Ruck may be reached via email at [email protected] by 36 percent cuts in reimbursement and a required utilization rate increase from 50 See the nuclear medicine sales and services percent to 90 percent, really took the brunt directory starting on page 42. of the damage from the shortage.

thorough inspection was conducted for the High Flux Re- actor in Petten, Netherlands, the second-largest supplier of Mo-99 for the U.S. Inspectors found corroded pipes in im- mediate need of repair, and that reactor was also taken of- fline for six months. Of the three remaining reactors in the world capable of supply moly at that time, two were used largely for research needs and not configured to produce radioisotopes year-round, and the Safari-1 in Pelindaba, South Africa, the only functioning major supplier of Mo- 99, was also undergoing intermittent repairs.

The supply chain is only as strong as . . . At the time of this writing, the NRU is offline for repairs yet again, in this case, routine maintenance, but rather than the typical five-day shutdown, this shutdown will span nearly five weeks. Still, it’s not the catastrophe of 2009, since this was not a forced shutdown and it’s also (at least current- ly) not coinciding with a long shutdown of any of the five plants that produce most of the world’s Mo-99. But the fact remains, whether the shutdown is five days or five weeks, the NRU is ancient in terms of a nuclear plant. Even optimists must feel shaky with a growing de- mand draining a supply that can’t be stockpiled, since Mo-99 decays in hours. Advocates for a domestic plant can point out that they’re generally safer than nuclear power plants, but with the Fukushima Daiichi nuclear plant di- saster in Japan unlikely to come to a close until early 2012 at best, few people are opening their arms in welcome over plans to build any new nuclear plants.

DOTmedbusiness news I j u n e 2011 35 In Memoriam Lawrence Shack, longtime GE salesman, dies Industry legend dies at 68. awrence Shack, a longtime salesman for GE Health- would be at the top of the list”. care and a fixture in the nuclear medicine industry, Persistence also paid off when he was briefly one of the died May 18, according to a notice from his family. only people on GE’s nuclear medicine sales force. In the ear- LShack, 68, had heart problems, his wife, Sue, said. ly 1990s, going through a rough patch and looking to trim Born to a Jewish family in Great Britain, Shack immi- the budget, GE decided to slash its nuclear medicine sales grated to the United States in his teens, and went on to be- division and combine whatever employees remained with come one of the country’s top nuclear medicine equipment the rest of the medical sales staff. The company approached salesmen, selling for GE Medical Systems from 1981 until he Shack with an offer to move to the new team and to sell the retired in 2008, Don Bogutski, a friend, said. company’s whole line, but he refused. In most years, Shack was the number one nuclear med- “He said, ‘Absolutely not. I sell nuclear medicine, and icine salesman in the country, and almost never less than I’m your number one guy. You’re going to keep me selling number three, his friends said. [it],’” Bogutski recalls. “To do that once in your career is a great thing, but to Shack was kept on as GE’s only nuclear medicine sales- do that over and over and over again is almost impossible,” man in the East Coast from 1994 to 1996, when the company Bogutski said. decided to relaunch the nuclear medicine sales group. Shack’s success was credited to his great personal Shack was also a member of GE’s field advisory board, charm, his understanding of the industry and his persis- where he was a sought-out authority on the market, and where tence. If customers had a problem and considered switch- the company would get his opinion on new products or mar- ing vendors, he would bring their demands to GE and get keting strategies. “Everyone wanted get Larry’s point of view,” something worked out. Dorn said. “He had this brain – he could dissect anything and “He was the consummate salesman,” said Bill Dorn, a everything, to find the good things and bad things.” salesman at GE, who considers Shack a mentor, and knew In 1999, Shack considered moving to Florida, then a him since 1986. “Regardless of what Larry had to sell, he weak territory for GE. The company helped re-locate him, and even bought his house from him – something GE would usually only do for top executives, Dorn said. Once there, Shack helped revive sales. He also settled into a golfing community, where, within a few years, he was elected president, even though he didn’t play golf, Dorn noted. “Larry Shack was a remarkable individual who did more than sell equipment to his customers,” Dr. Stanley J. Goldsmith, director of nuclear medicine and molecular im- aging with New York-Presbyterian Hospital-Weill Cornell Medical Center, said in an e-mail. “He became a part of their efforts and in many ways, a part of their lives. His presence and personality enriched any activity or group with which he was associated and he made everyday experiences more exciting. He will be missed and he will be remembered.” Shack’s charm was evident to Bogutski the first time they met in 1981. Bogutski was walking down a hallway in Morristown Memorial Hospital in New Jersey, when he saw a man with a big grin on his face, sauntering in his direction. Both knew the other was in nuclear medicine, and at the same hospital on business, Bogutski said. But the other man immediately disarmed him with what would become known as his tagline. “Hello, love,” the man said, in a British accent. “How are you doing today?” Shack is survived by his wife Sue Shack; his daughters Stephanie and Stacy Shack; and his siblings Rozzie Asch and Betsy Felsenberg. The funeral was held May 23, at Sol Levinson & Bros. Inc. in Pikesville, Md. • Online: dotmed.com/dm16162

36 DOTmedbusiness news I j u n e 2011 www.dotmed.com Big news on a microscopic scale

Nanomedicine may be the next frontier in health care

By Sruthi Valluri

ecent budget talks on Capi- program director of the NIH’s Na- tiatives have now entered clinical trials. tol Hill have focused na- tional Cancer Institute’s Nanotechnol- If previous drug development timelines tional attention on divisive ogy program, says nanotechnology is are any indication, nanopharmaceutical ideological issues. But while poised to make a significant difference products could be entering the market- Republicans and Demo- in the field of medicine. place within the next five to ten years. crats nearly shut down the government “There’s quite a bit of potential,” This shift towards the microscopic Rduring their extended standoff, both says Grodzinski. “You can entertain is not new. Nanotechnology has been sides agreed—almost unanimously— possibilities, you have indications of in existence since the 1800s. Yet, it has on one thing: nanotechnology. what nanotechnology can bring.” largely been confined to electronics Tucked away in the 2012 federal Although fast growing, nanotech- and materials engineering. Nanotech- budget is $2.1 billion earmarked for the nology is concerned with the smallest nologies most consumers are familiar National Nanotechnology Initiative, of units—the nanometer. As a unit of with include the computer and the which coordinates nanotechnological measurement, the nanometer is a bil- black filler in rubber tires. Medical ap- research and development across sev- lionth of a meter and is no wider than plications, on the other hand, have so eral federal agencies. The budget sig- ten atoms in a row. The Food and Drug far been confined to laboratories. nifies an increased investment by Con- Administration defines nanotechnol- But in recent years, Grodzinski says, gress, marking a 16 percent increase ogy as anything that operates between nanomedicine has been moving from for the NNI from the last year. 1 and 100 nanometers in length. At this laboratories to the marketplace. In his six Launched in 2000, the NNI began scale, an ant is a million times as large years as program director, Grodzinski with eight agencies and a paltry bud- as a single nanoparticle. says he’s noticed a considerable change get of $464 million. Now, the NNI is a in the volume and focus of research. collective of 25 federal agencies. And History a long time in the “The field is more mature,” says as the NNI has grown, so too has its making Grodzinski. “More people are working funding—by nearly 300 percent in the In recent years, there has been a flurry on it, and there are more companies past decade. of research in nanomedicine, especially being spun off from universities to The federal government’s sup- in cancer therapies and, to a lesser ex- commercialize this technology. Trans- port and investment could not come tent, vaccine development. Several ini- lational efforts are starting to move at a better time. Dr. Piotr Grodzinski, forward.”

DOTmedbusiness news I j u n e 2011 37 Nanomedicine’s debut and potential many of the side effects associated with chemotherapies. One of the earliest success stories of nanomedicine has been The medical nanoengineering platform that Bind Biosci- Abraxane, a breast cancer drug that entered the market in ences is currently testing involves nano-sized doses of can- March 2005. At the time of its introduction, nanomedicine cer drugs. was still a negligible segment of the pharmaceutical indus- But Langer’s technique coats the drug with plastic to con- try. At only $8.5 billion of the world’s market, nano-biotech- trol the rate of the drug’s release into the system. A secondary nology was still a nascent field, characterized more by its coat of water protects the drug from the body’s immune sys- idealism and media hype than its marketability. tem. Finally, markers are added to direct the drug to its target. Today, Abraxane, now a product of Celgene Corpora- The end result, Langer says, is target-specific, controlled re- tion, has more than $400 million in annual sales. The prod- lease of cancer therapies that can be anywhere between 1,000 uct’s success has paralleled the growth of the industry as a and 100,000 times more powerful than traditional treatments. whole. This year, nanobiotechnology is predicted to reach a The scale of nanoparticles also makes them attractive global marketshare of $20.8 billion. for other areas of medical research. NanoBio Corporation, As the literature in nanotechnological research expands, an Ann Arbor, Mich.- based company, is currently in clinical so do the possibilities for drug makers. Other researchers trials for a topical herpes labialis treatment for cold sores and companies are seeking to mimic Abraxane’s success, at the site of infection. The company, originally a spin-off perhaps even surpass it. of research at the University of Michigan, entered an agree- Dr. Larry Tamarken, president and CEO of CytImmune ment with GlaxoSmithKline in December 2009. Sciences Inc., a Rockville, Md.-based nanomedicine compa- Their product uses emulsions--composed of nanome- ny, sees cancer therapies as the next logical step for nano- ter-sized droplets, each a combination of two detergents, technological research. According to Tamarken, the reason oil, and water—to treat infections. At 200 nanometers, the for the industry’s focus on cancer therapies is two-fold: the emulsions are small enough to easily permeate the skin and growing medical need for more successful cancer treatment treat the virus, but big enough to avoid absorption into the options, and the nature of nanoparticles themselves. blood stream. Unlike traditional antibiotic and antifungal “On average, you have a one in 10 chance that any treatments, nanoparticles would eliminate the need for sys- chemotherapy protocol will be successful,” says Tamarken. temic-wide treatment of many localized infections. “The question we ask is, why can’t we do better?” Tamarken says the more realistic goal,is not to cure A little problem cancer, but rather to treat it like a chronic disease, not unlike Dave Peralta, NanoBio’s chief operating and financial of- diabetes. CytImmune Sciences’ product, a drug called Au- ficer, agrees that the size of nanodroplets makes them an rimune, uses gold nanoparticles to deliver tumor necrosis ideal solution for the pharmaceutical industry. But Peralta factor (TNF) to cancer cells. It enters clinical trials this year. also points out that nanotechnology’s strength might also Traditional treatment of solid tumors like breast can- be its weakness. cer has been a combination of chemotherapy and surgery. In the spring of 2004, researchers reported brain dam- Aurimune bypasses these methods entirely. Tumors need age in largemouth bass that had been exposed to bucky- blood vessels to sustain their growth, but these blood ves- balls, a commonly used carbon-based nanoparticle. Later sels are poorly constructed and leaky, with holes ranging reports found that nanoparticles could accumulate in the from 200 to 400 nanometers in diameter. environment. The findings ignited what continues to be a At 27 nanometers, Aurimune’s gold nanoparticle can lingering concern regarding nanoparticles. easily exit the blood stream at these cancer-specific sites “There’s been more scrutiny for very small nanopar- and deliver TNF. The drug then binds to the tumor’s blood ticles,” says Peralta.“There are concerns about toxicity, and vessels and causes them to die off. about their ability to get into the bloodstream and into dis- The size of nanoparticles is what makes them such at- tant organs.” tractive candidates for cancer therapy. Conventional che- But these concerns are specific to the smallest of nano- motherapy relies on high doses of drugs and indiscriminate particles, those smaller than 10 nanometers, Peralta points targeting. Both healthy and cancerous cells are exposed to out. “In nanomedicine, there’s a wide range within which toxic chemicals that may or may not have the intended ef- people operate,” he says. “Because concerns are raised re- fect. “In the world of nanomedicine, cancer is the lowest garding those specifics, the whole nano space gets painted hanging fruit, the easiest target,” says Tamarken. with broad strokes.” Dr. Bob Langer, an Institute Professor at the Massachu- Despite these concerns, the FDA decided in 2007 not to setts Institute of Technology, has also harnessed nanopar- require any additional safety trials for nanomedical initia- ticles to treat cancer. Langer has been on the frontline of tives. Grodzinski sees the FDA’s decision as a vote of confi- nanotechnological research for the past twenty years and dence for the relatively new field. operates the world’s largest academic bioengineering lab. “It’s the nature of medicine and medical sciences to be One of Langer’s nanoparticles is currently in clinical trials cautious,” says Grodzinski. “There is also some hesitation through Bind Biosciences, a Cambridge, Mass.-based com- to adopt new concepts. This perception will be a major bar- pany that Langer co-founded. rier, but there is a strong body of knowledge that nanopar- According to Langer, nanotechnology lends itself to ticles will make a difference.” the field of cancer therapies because of its ability to deliver Online: dotmed.com/dm16114 high concentrations of drugs at specific targets but without •

38 DOTmedbusiness news I j u n e 2011 www.dotmed.com Siemens Medical Solutions’ Biograph mMR

Nuclear Medicine – the latest from the field By Sean Ruck

elcome to the yearly round-up of the 2010, Siemens Medical Solutions introduced the world’s top topics in nuclear medicine imag- first PET-MR, the Biograph mMR. The system still requires ing. The last 12 months have provided 510(k) review by the Food and Drug Administration. a lot to talk about, from the first glimpse While Siemens had the big reveal, Philips Healthcare of new modalities, to the end of an iso- was the first to make it to market with its own PET-MRI tope shortage, to market shifts and developments in system, which has receive CE marking for sale in Europe. Wradiopharmaceuticals(see story on page 27). The Ingenuity TF PET/MR is the first new imaging modal- ity introduced by the company in a decade. Hybrids are a hit The high desirability of PET has led to a number of hybrid The case for SPECT offshoots. PET/CT has been around for a decade but some PET hybrids may be cutting into the SPECT pie, but the new combinations may not be far off. For example, at RSNA SPECT is still a workhorse used in about 7 million proce-

DOTmedbusiness news I j u n e 2011 39 dures each year and will likely hold that position for some of hoops at any time. Of course, Medicare, the largest health time. In part, the large install base in the United States care insurer in the country has had the most impact being provides security as the devices work off their debt to the directly tied to rules and regulations passed down from the facilities utilizing them. Few facilities will readily discard federal level. a machine performing the required imaging, to pay a sig- nificantly higher price for PET especially with the fast and furious rate new hybrids and radiopharmaceuticals are be- Another dilemma in the ing developed. A second point in SPECT’s favor is what may be anti- quated insurance regulations. “If you have a patient with refurbished market is the a high BMI and they’re going to need a PET scan, why not go straight to it?” says Joe Mathews, director of sales and scarcity of the latest operations for Nuclear Medicine Professionals Inc. “The only reason preventing that direct move to PET is that an technologies. insurance company is mandating a certain sequence of testing.” However, the SPECT story isn’t all good news. Short- After Diagnosis Related Groups, first introduced in ages of certain radioisotopes (see story on page 34) may New Jersey in 1980, went national, it became lucrative to darken its future. establish freestanding imaging clinics that could get rea- sonable reimbursements from Medicare. The situation also The give and take of Medicare increased the client pool for dealers of refurbished equip- According to Mathews, certain steps must be taken to meet ment. “It was a good time for the refurb market,” says Don mandated insurance requirements, like a non-nuclear stress Bogutski, president of Diagnostix Plus, Inc., a supplier of test, followed by a nuclear stress test, and then a PET exam. new and refurbished nuclear medicine equipment and ser- That means a lot of hoops to jump through and health care vices. “These freestanding clinics were owned by entrepre- insurance providers may add or subtract from the number neurs, not doctors, and one thing they had in common was the ability to assess the benefits of going with used, as op- posed to new, equipment. “ Healthy reimbursement rates coupled with actively seeking the best buys on equipment – whether new or used, meant these facilities were working with a good profit and loss model. But all good things come to an end and the pendulum swung the other way in 2009. That year, Medicare took another look at the situation and reset the clock – deciding it would be cost-effective to bring scans back to hospitals, so reimbursements to private centers were slashed. The blow staggered the industry. It was followed by the current recession and the lending market tightened its purse strings and began to aggressively call in outstanding debts. Once-thriving freestanding imag- ing clinics were forced to quickly develop new business strategies to remain solvent.

Strategies for survival Private practices faced challenges few had experienced. Many patients had come to expect a full-spectrum of care which included nuclear medical imaging services. But in- dependent doctors found it difficult to rationalize the pur- chase of expensive imaging devices when new reimburse- ment and utilization rules might at best, allow them to break even. That’s why business has been humming for Mathew’s company, which supplies SPECT cameras via a lease pro- gram. “We wheel them in, the exams are done, we wheel them back out,” he explains. “It’s nice for doctors who don’t have high volume, but want to provide a service that will help them retain patients.” Getting the benefits without the burden is a good way for health care providers to stay afloat. By utilizing a lease service, there’s no need for a hot lab or a technologist, a

40 DOTmedbusiness news I j u n e 2011 www.dotmed.com service contract for machine maintenance or pharmaceutical contracts. But Mathews does point out, the solution Nucle- ar Medicine Professionals provides doesn’t make sense for everyone. If the service is needed more than twice a week, it’s probably more cost-effective to purchase a system. A second strategy of the freestanding imaging centers has been to become a little less freestanding. According to Diagnostix Plus’ Bogutski, many of the larger prac- tices have entered into relationships with hospitals. “So instead of the SPECT cardiology clinic of Dr. Jones, it’s now The Outpatient Treatment Center for Our Lady of Leisure,” he says.

A market in flux Equipment sales for nuclear medicine have also been hit hard by the turmoil. According to a November 2010 report by health care research firm, Bio-Tech Systems Inc., while PET unit orders increased dramatically in 2004 and 2005, they plummeted from 2006 to 2009, with the main cause be- ing reimbursement issues. However, that same report has forecasted growth of nine percent from 2010 through 2017. Whether that will be good news for the refurbished side remains to be seen. For now, it too is adapting to a strange market. Where before, freestanding imaging facilities were the key buyers for many, they are now approaching hospi- tals, a much different situation. “That’s because an admin- istrator who saves money by buying used equipment won’t get much of a reward for the decision,” says Bogutski. “But if something goes wrong with the machine and it was pur- chased from a questionable source — that may mean he’s getting fired.” Another dilemma in the refurbished market is the scar- city of the latest technologies. By nature, the used market’s supply will always be a little behind what OEMs are offering as the next big thing. So there’s a lag as the market waits for the new to become old.”Very few PET systems come onto the market,” says Jeremy Basterash, marketing manager for MEDX Inc., a provider of remanufactured and refurbished molecular imaging equipment. And once a unit does hit the market, enough buyers have it on their wish lists that bidding wars erupt and by the time the dust settles, there’s little profit to be made. But newer, more efficient machines are on many wish lists since they enable a faster throughput of patients, mak- ing up in volume what has been lost in reimbursement for individual procedures. And although the profit margin may be small, it’s still profit and delivering what the customer wants is still a good business decision. Glen Witherbee, regional sales manager for Med-En- gineering, a company providing service to the molecular imaging community, has seen another troubling trend. “We’re seeing facilities cutting service contracts, either not renewing or renegotiating to cuts costs. Some are to- tally going without, gambling on saving by just having to pay time and materials,” he says. “They’re looking at it like car insurance, if you don’t have an accident, you don’t need it.” • Online: dotmed.com/dm16172 Sean Ruck may be contacted via email at [email protected].

DOTmedbusiness news I j u n e 2011 41 DOTmed Registered Nuclear Medicine Sales & Service Companies For convenient links to these companies’ DOTmed Services Directory listings, go to www.dotmed.com and enter [DM 16172] Names in boldface are Premium Listings.

Name Company - Domestic City State Certified DM100 David Stopak A. Imaging Solutions Birmingham AL Chuck Coco Chuck Coco San Diego CA • • Phil Lonbeck DB Medical Electronics Diamond Bar CA Kenn Matayor Jaken Medical Inc. Chino CA Ted Huss Medical Imaging Resources Colfax CA • Debbie Wong Spectrum Dynamics Danville CA • • William Carroll Eclipse Systems Inc. Durham CT Stewart Farber Farber Medical Solutions, LLC Bridgeport CT Christine Holland Parker Medical, Inc. Bridgewater CT Erin Diaz Faes AlmA Imaging Palm City FL Moshe Alkalay Hi Tech Int’l Group Boca Raton FL • Rick Staab InterMed Biomedical Services Inc Alachua FL • Joe Mathews NMPI Gainsville FL Larry Sprague Imaging Resources Martinez GA Paul Eaton Southeast Nuclear Electronics Canton GA Steve Basterash Technological Horizons Enterprises Dalton GA • David Askew Scandia Corporation Urbandale IA • Eric Ellingson MEDX, Inc. Arlington Heights IL Greg Kramer C&G Technologies, Inc. Jeffersonville IN Grant Norris Associated Imaging Services Wichita KS • • Joseph Sciarra Marquis Medical Denham Springs LA • David Pac American Radiology Source Timonium MD • • JOHN GEBHARDT HEALTHCARE SYSTEMS INC ANNAPOLIS MD • • Steve Rentz Block Imaging International Lansing MI Jeff Rogers Medical Imaging Resources Inc. Ann Arbor MI • Richard Allen R.A. Services Macomb MI • Justen Harness Universal Medical Resources Washington MO •

42 DOTmedbusiness news I j u n e 2011 www.dotmed.com Name Company - Domestic City State Certified DM100 Shanna Flanagan DMS Health Technologies Fargo ND Lisa Wiggs Absolute Imaging Solutions Stokesdale NC • Kevin Larcher Larcher Medical Sherrills Ford NC Don Bogutski Diagnostix Plus, Inc. Teaneck NJ Marcus Carter M5 MEDICAL Princeton NJ • Edward Zingman EGro LLC Valley Stream NY Leon Gugel Metropolis International Long Island City NY Ian Alpert Tandem Medical Equipment, Inc. Smithtown NY • • Allison Mitchell MIMSoftware Cleveland OH • • Michael Lies Medical Advantages Inc. Pittsburgh PA Chris Reilly CER MEDICAL Summerville SC • Roger Rae Mobile Resources, Inc. Sioux Falls SD • Rick Rippin ABT Molecular Imaging Knoxville TN Bart Browning Molecular Imaging Solutions Knoxville TN Jack Barker Rowe Transfer Inc. Knoxville TN Richard Armijo Advanced Nuclear Consultants Houston TX • Aaron Ortiz Infinity Medical Imaging Houston TX • Stephan Anderson Radiology Equipment Sales & Service, LLC New Braunfels TX Dan Pakuszewski Southwestern Imaging Spring TX • Kenneth Smith BC Technical West Jordan UT Tom Luque ECS Nuclear Camas WA • •

Name Company-International City Country Certified DM 100 Derradji Youcef Sarl Dtm BBA Algeria Tom McGhie TSG Instrumentation Inc Burlington Canada BAOQIANG DING Beijing Nuclear Medicine Repair Center Beijing China Carlos Duran INGENIERIA CLINICA Bogota Colombia Sami Samir Mohamed Salh ELECTRONIC MEDICAL EQUIPMENT EME Mohandssin Giza Egypt Gerd Stockmann Inter Medical Luebbecke Germany Sajid Farooq Babar Precision Technologies Lahore Pakistan Gilberto Mangual ImageTek Canovanas Puerto Rico

DOTmedbusiness news I j u n e 2011 43 Diagnostic Directions

Ultrasound at the point of care: who’s in charge?

By David Willis

ne in three hospital- radiologists. Instead, the concept of a ized patients may suffer limited, or focused, examination plays medical errors or other an important role in use of ultrasound adverse events, a rate ten at the point of care, the researchers from times higher than previ- Yale reported. “Clinicians from diverse ous estimates, according to a study specialties can become very adept at Opublished in the April issue of Health using ultrasonography to examine a Affairs. Another study in the same is- particular organ, disease or procedure sue reported medical errors cost the that is relevant to their area of exper- U.S. health care system $17.1 billion tise, whereas imaging specialists typi- in 2008. Taken together, these findings cally perform a more comprehensive show we need to work harder to im- examination,” they wrote. prove the safety of health care. One technology that might help is Ultrasound accuracy ultrasound at the point of care. Yet as Let’s examine the facts about ultra- the use of ultrasound becomes more sound at the point of care. Advances integrated into medical specialties, it in ultrasound equipment have made also becomes more of a flashpoint in it possible to use this powerful, safe the long-simmering turf war between technology around the world – and radiologists and non-radiologists. beyond--from the International Space Station (where astronauts were trained, in trauma patients is 90 to 98 percent. Turf wars with expert medical guidance, to per- What’s more, the FAST exam has been According to an August 2010 special form ultrasound examinations) to the shown to decrease the need for CT and report in Emergency Medicine News, Mount Everest base camp (where ultra- to speed up treatment, thus resulting in ”Radiologists and Emergency Physi- sound has been used to diagnose high- shorter hospital stays, lower costs, and cians Still Debating Who Should Hold altitude pulmonary edema) and Mid- reduced mortality. the Ultrasound Probe.” A driving force dle East battlefields (where portable A study presented at American seems to be the evolving applications ultrasound devices can be employed College of Emergency Physicians Re- of the technology that have lead to mis- to rapidly check wounded soldiers for search Forum last year also found that understandings on the part of some ra- internal bleeding and other potentially ultrasound at the point of care, utilized diologists, who perceive an encroach- life-threatening conditions). by ER physicians, was 85 percent accu- ment on their traditional domain. In The FAST (Focused Assessment rate for evaluating acute appendicitis actuality, there is an opportunity for with Sonography for Trauma) ex- in children, one of the most common radiologists and non-radiologists to amination is a perfect example of abdominal surgical emergencies in work together in new ways to improve this important distinction. This use children, with about 80,000 such cases health care. The report pointed out that of ultrasound at the point of care en- in the United States each year. Ultra- better understanding of the benefits of ables emergency medicine physicians sound is the preferred modality for emergency ultrasound, for example, a safer way to assess trauma patients this age group, due to mounting public would be “a win-win for the hospital for potentially life-threatening prob- health concerns over the risks of radia- system.” lems, by checking for fluid, including tion exposure. However, a February New England hemorrhaging, with a sensitivity of 73 Emergency physicians and the Journal of Medicine review offers a key to 99 percent, according to the NEJM other principal physician specialties insight: Non-radiologists are not en- review. The overall accuracy for clini- that use ultrasound in their practices croaching on the traditional domain of cally significant intra-abdominal injury are trained in residency and fellow-

44 DOTmedbusiness news I j u n e 2011 www.dotmed.com ship and have clinical experience in integrating their find- Adverse events resulting from blind insertions of cen- ings into the patient’s entire treatment plan. In addition, the tral lines also pose another financial hazard: expensive American College of Emergency Medicine (ACEP) updated litigation. An analysis by the American Society of Anes- its evidence-based emergency ultrasound guidelines in thesiology found that the median malpractice payment for 2009, reporting that the technology is widely used at bed- central venous catheter-related claims was $105,500, with side to diagnose acute, life-threatening disorders, guide in- multi-million dollar payments reported for certain catheter vasive procedures and aid emergency medicine physicians injuries, such as cardiac tamponade, hemothorax and blood in developing a treatment plan. Not only does the ACEP vessel injury. deem the ability to perform and interpret emergency ultra- Over the past five years, use of ultrasound guidance sound to be a fundamental skill for emergency physicians, has expanded significantly in anesthesiology, where even but it also endorses having dedicated ultrasound equip- for experienced anesthesiologists, injecting regional anes- ment at bedsides in the ED. thesia blindly is challenging, creating a risk of injuries to Ultrasound at the point of care also improves patient adjacent structures. While nerve stimulation offers a reli- safety, a crucial goal for both physicians and adminis- able method of locating the correct nerve, it can be a time- trators, given the high rate of medical errors that have consuming process of trial and error, as various nerves are recently been reported. The NEJM found that, “With tested. Ultrasound offers a safe, cost-efficient and speedier appropriate use, point-of-care ultrasonography can de- solution. crease medical errors [and] provide more efficient real- Here is a case where seeing truly is believing—in the time diagnosis.” power of ultrasound at the point of care to save time and Physicians often employ ultrasound at the point of money, while powerfully enhancing patient safety, no mat- care as a safe way to guide certain invasive procedures, ter which practitioner is holding the ultrasound probe. such as nerve block injections, central-line placement • Online: dotmed.com/dm16124 and fluid drainage, including thoracentesis and para- centesis. Ultrasound guidance of catheterization of the David Willis is vice president, Innovation and Competitive Strat- internal jugular vein reduces the rate of catheter-related egy at SonoSite, Inc. in Bothell, Washington. He was also a sonog- bloodstream infections by 35 percent, offering significant rapher at the Health Sciences Center in Winnipeg, Canada and is a cost savings. The Centers for Disease Control and Pre- registered medical sonographer (RDMS, RDCS). He completed the vention estimate that the marginal costs to the healthcare Executive Education Program at the Wharton School of Business. system of a single catheter-related bloodstream infection is $25,000. For placing central lines, the Agency for Healthcare Re- search and Quality (AHRQ) identifies ultrasound guidance as one of 11 patient safety practices warranting widespread adoption. AHRQ found that “real-time ultrasound guid- ance for CVC insertion…improves catheter insertion suc- cess rates, reduces the number of venipuncture attempts +RZPXFKFDQ7UL0HG[ prior to successful placement and reduces the number of complications associated with catheter placement.” Com- VDYH\RX" plications, including pneumothorax, are reduced substan- tially, with a relative risk reduction of 78 percent. PLOOLRQLQ A NICE guideline In the United Kingdom, the National Institute of Clinical FXVWRPHUVDYLQJV Excellence (NICE) has issued national guidelines recom- mending ultrasound guidance as the preferred method to lower the risk of such serious complications as collapsed LQFUHDVH GHFUHDVH lung, arterial puncture, nerve injury and arteriovenous fis- tula. It’s now become the standard of care. In the U.S., many LQKRXVH H[WHUQDO top medical centers have adopted an institution-wide poli- H[SHUWLVH VHUYLFH cy requiring ultrasound guidance for all central-line place- FRQWUDFWV ments. The 2011 CDC Guidelines for the Prevention of In- travascular Infections list the use of ultrasound for central venous catheter placement to reduce the number of cannu- lation attempts and mechanical complications. The rationale is simple: It’s safer to place a central line when physicians can see the jugular vein under ultrasound, instead of working blindly. Since patients’ anatomy can 7UL0HG[ vary, landmark methods are also more likely to result in ZZZWULPHG[FRP  multiple insertion attempts, with initial failure rates of up to 35 percent reported in medical literature.

DOTmedbusiness news I j u n e 2011 45 Kinecting with the dead Microsoft’s motion-sensing game controller helps doctors perform virtual autopsies

By Brendon Nafziger

he Radiological Society of North America’s an- it, and to implement it as a standard procedure, and make a nual tradeshow is the world’s biggest radiolo- scientific approach with bigger numbers of cases.” gist convention and one of the largest medical conferences around. But it’s not the sort of place Autopsies go virtual you’d expect to see autopsy photos. The roots of the Virtopsy project stretch back to 2000. Yet, last year, attendees saw images from an autopsy – Around that time, researchers made a surface scan of atT least, a virtual one. a child run over by a car, to match the impressions on the On the show floor, the Swedish diagnostic imaging skin with tire tracks from the vehicle. This was among a company Sectra was demonstrating its “virtual autopsy” handful of cases that prompted the researchers to wonder if table – a touch-screen display hooked up to a PACS system. the process could move from an occasional, one-off tool to a About the size of a small pool table, it’s what one might “black box system” for routine autopsies. expect to see on an episode of CSI. “You put in body on one side, it comes out other side, At the show, the table’s screen showed images of a rath- and the system gives you an idea about the injuries and er flabby, middle-aged man, who was apparently stabbed documents everything,” Ebert said. to death in his apartment. After he was found, the medical Virtopsy, in essence, was born. By 2006, the team, then examiner put him through a CT scanner, creating a three- based in Bern, got its own CT scanner. Later, the research- dimensional X-ray portrait of his corpse. ers also picked up a surface scanner and a 1.5-T MRI unit. With the CT reconstruction of the body, doctors could By the time they moved to Zurich, they had been running then examine the cadaver inside and out. around 300-400 cases a year (and they also upgraded to a 3T First, they could look at the skin surface, and see the small, MRI). In Zurich, they expect to do slightly more – though straw-hole gashes left by the knife. Peeling away the skin and not, perhaps, much more. viscera, they could examine the ribs smashed by the force of “Switzerland is not the U.S.,” Ebert wryly noted. the attack. And they could also find something not revealed during a normal autopsy: the pockets of air trapped inside Helpful, but expensive body, formed where the flesh closed around the blade. The main advantage of the virtopsy approach is its com- Although the table is brand-new, virtual autopsies, prehensiveness, Ebert said. A pathologist dissecting a ca- technically, are not. CT scans on corpses have been going daver takes notes about what he sees, but he doesn’t write on since at least the 1990s. down everything. If you take a CT or MRI scan, you have But only in the last decade has a formal process arisen the complete body regardless of what you’re looking for, for managing caseloads. The leader in this field, a Swiss Ebert said. If new questions arise, you can always go back group, calls that process “virtopsy.” to re-examine the slides. “We’re not the first to perform CT scans on a dead Yet Ebert cautioned that a virtual autopsy is not a substi- body,” Dr. Lars Ebert, a computer scientist with the Virtop- tute for a normal autopsy, as medical examiners cannot iden- sy group, based out of the University of Zurich, told DOT- tify all pathologies and diseases just using MRI and CT scans. med News. “But we’re the first to generate a workflow for “A CT scan can be a good adjunct to an autopsy,” Dr.

46 DOTmedbusiness news I j u n e 2011 www.dotmed.com Stephen Cina, deputy chief medical ing in a medial examiner system on a the computer for them. This takes time. examiner of Broward County, Fla., county or state budget,” he said. And But the Virtopsy group thinks the Ki- professor of pathology at the Uni- with ongoing financial crises, it’s hard nect might be able to simplify this. versity of Miami and president of the to ask for funding for CT or MRI ma- Released last fall by Microsoft for Florida Association of Medical Exam- chines, which cost millions of dollars. the Xbox 360 video game console, the iners, told DOTmed News. “But an In fact, the Virtopsy group esti- Kinect is, in essence, a camera system autopsy is still the gold standard.” mates a full-body CT scan adds about with a microphone that lets players Currently, Cina said the recom- 1,000-1,500 Swiss francs per exam manipulate on-screen images using mended use for CT scans is to help ($1,134 - $1,701). MRI, which gener- just body movements, gestures and guide the autopsy, by identifying inju- ally carries $100,000 in yearly mainte- voice commands. It was designed to ries or pathological conditions in areas nance costs, probably also adds 1,500 compete with Nintendo’s massively not routinely dissected by examiners. Swiss francs. popular Wii, and was launched with For instance, examiners often respect Another snag for adoption is the family wishes to hold open-casket need for specialists to interpret the im- funerals. This means they rarely cut ages. In general, the Virtopsy group Scanning the fallen In the United States, the technology deep inside the facial bones, so a CT says doctors with some training in an that forms the backbone of the virtual scan could be useful to get prelimi- emerging discipline, forensic radiol- autopsy process has caught on with nary information about the face. ogy, are preferred for image interpreta- the Department of Defense. Over the It’s also helpful in high-profile tion. “A normal radiologist is not the past decade, most fallen soldiers com- cases where a lot evidence is needed, person you need,” Ebert said. “Some of ing back from the wars in the Middle or if the family has strong religious the changes you see postmortem could East undergo CT scans in the autopsy objections to autopsies, such as among be mistaken [for another pathology]. suite over in Dover Air Force Base. Orthodox Jews. You need to read images differently.” But with the exception of the mili- In fact, Dr. Michael Thali, managing director of the Institute of Forensic tary, where nearly all soldiers killed in Hands-free PACS Medicine at the University Zurich and combat are scanned when their bodies manipulation one of the founders of the Virtopsy return home, virtual autopsy technol- Whether it becomes a standard tool project in Switzerland, worked at the ogy is not routinely used by medical in the United States or not, the Swiss Armed Forces Institute of Pathology examiners in the United States [See team is still working to make virtop- as a researcher earlier in his career. Sidebar]. Fewer than 10 of the big sies as efficient as possible. And re- U.S. examiner offices either have the cently, they found a $140 entertain- Paul Stone, an Army spokesman, said the CT scans help the doctors technology or are planning to buy it in ment device that might give virtopsy examining the soldiers map bullet the near future, Cina said. examiners’ workflow a boost. The main problem with adopting trajectories and help them find shrap- The device is Microsoft’s Kinect, nel in, say, the back, which might be the technology is the one afflicting near- and the problem it solves is a gory one. ignored in a normal autopsy. ly every aspect of health care: cost. The autopsy hall is, after all, a In his recent survey of 100 medical messy place. Medical examiners get “We’re not doing virtual autopsies,” examiners, nearly one-fifth of all prac- their hands dirty with body fluids and he told DOTmed News. “We’re us- ticing, board-certified examiners in the other contaminants. If they want to ing the CT scanner to augment or country, Cina said he found the major- browse through CT slides or look at enhance the autopsy process.” ity would use virtual autopsy technol- other imaging data on a PACS system, The scans also help the military’s ogy if it were accessible and affordable. they have to remove their gloves and data-gathering efforts to better un- “The trouble is, you’re also work- wash up, or ask someone to operate derstand how our soldiers are killed, information that can be useful in protecting them. Because the CT scans can be done on soldiers still kitted out in their full-body armor, re- searchers can see exactly where the armor failed to save them. While this information is shared with the teams who develop the armor, Stone suggested it’s too simplistic to say armor improvements come directly from their efforts. “It’s very complex, the data they use to Virtopsy suite with autopsy improve or redesign things,” Stone said. dummy. (Courtesy Virtopsy) “But we support that effort, we provide data, here and from the folks fighting the wars in Afghanistan and Iraq.”

DOTmedbusiness news I j u n e 2011 47 a slew of family-friendly titles like “Kinectimals” – where how complicated it was to [get] these hack drivers,” he said, players interact with adorable baby animals. so nothing was done. But sometime later, the colleague went But many people saw it had potential beyond play- out and bought a Kinect anyway. Before leaving for a confer- ing with cartoon tiger cubs. Shortly after its Nov. 4 launch, ence in the United States, he left it in Ebert’s office. Ebert got open-source enthusiasts Adafruit Industries put up a $3,000 his hands on an open-source hack driver, and started to tin- bounty on the first person to come up with an open-source ker around with it. A few weeks later, it was working. driver for the device. By Nov. 10, hacker Hector Martin The Kinect isn’t the first time someone has tried to create claimed the prize. Soon, artists, scientists and entrepre- a no-touch PACS interface. An earlier piece of software, called neurs were finding new uses for it. One team developed a Gestix, could be set up to remotely operate a PACS system – program so a performer could strum an “air guitar” that ac- through gestures – using a Web cam. But Ebert said because it tually creates music. Others figured out how to use gestures relied on a basic Web cam, it was hard to program. The Web to control robots and computer-rendered puppets. cam would have to be calibrated to recognize a physician’s At first, Microsoft’s response was, as expected, rather specific gestures and even the color of the glove used. ham-fisted. The company threatened to “work closely with The ease with which the team got Kinect working comes law enforcement” to keep the Kinect “tamper-resistant.” from its real strength: it’s a depth-sensing camera. The device is But the Redmond, Wash.-based software giant eventually actually a two-part system: a light source shoots out infrared accepted the Kinect was more than a toy, and decided to beams to map the room, which get reflected back and picked embrace the new uses. This spring, Microsoft is even sched- up by the camera. The system can then tell how far into the uled to release its own basic programming toolkit. room something is by how long it takes for the light to bounce The potential for the Kinect wasn’t lost on the Virtopsy back. It can then separate the foreground – say, a doctor’s team. Around the time the Kinect hacks made news, Ebert hand– from the background. It can use this “knowledge” to said Dr. Steffen Ross, a gadget-crazy colleague, approached only interpret the nearer object’s movements: in this case, the him with an idea. What if the Kinect could be used for the doctor’s hands. Programmers can even ensure the Kinect isn’t hands-free control of the PACS system in the autopsy hall? confused by someone walking in front of the doctor, by telling This way, the doctor could just wave his arms around to it to ignore near, big objects that suddenly appear. scroll through the slides. No washing up needed. “You have depth, not just color, so it makes it quite easy Ebert, at first, was skeptical. He wasn’t sure if he could to program and get results quickly,” Ebert said. get the Kinect and the PACS to work together. “I had no idea Nonetheless, the team’s Kinect-PACS control system is just a proof-of-concept prototype. It hasn’t been used in a real virtopsy case yet. “Basically, we wanted to publish [the results] first before we continue development. Even though my colleagues already were like, ‘When can we use it?’” Ebert said they’ve submitted their findings to the jour- nal Surgical Innovation, and are awaiting a response. But they already know some of the challenges ahead, such as perfecting the device’s voice-control. The system doesn’t pick up Swiss-German accented English very well, the accent of most of the Virtopsy examiners. And the team still would prefer to have finger recognition, which is being Medical Cooling Solutions worked out by computer experts at MIT. Naturally, the Virtopsy team isn’t alone. As with the iPad, Current chiller provider for: other doctors are busy trying to find a place for the Kinect in GE OptimaTM MR450w Systems GE DiscoveryTM MR450 & MR750 Systems medicine. Doctors at Sunnybrook Hospital in Toronto, for in- stance, have done something similar to the Virtopsy team, rig- t


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50 DOTmedbusiness news I j u n e 2011 www.dotmed.com Sudden deaths of young athletes fuel the heart screening debate

n a Thursday night in this year found the rate of sudden car- also how in-depth it should be. March, Wes Leonard, a diac death among National Collegiate Across the U.S., a personal and 16-year-old basketball Athletic Association student athletes family history questionnaire and a star, led his Fennville, is one for every 43,770. standard physical exam are the usual Mich., high school team But no national and systematic precursors to participation in team to victory, scoring a lay-up shot in registry exists for sudden death cases sports. Many parents and cardiolo- Oovertime. in youth and many studies gather gists also believe electrocardiograms Leonard’s teammates picked him their estimates from published news and echocardiograms should be regu- up and carried him through the gym. articles about the incidents. lar aspects of screening. Just moments into the celebration, the “Various reports carry different But when it comes to the effec- teen collapsed. numbers — everything from a few tiveness, feasibility and cost of a na- Hours after being rushed to a lo- hundred a year to 14,000 a year,” says tionwide cardiac screening approach, cal hospital, he was pronounced dead. Michele Snyder, executive director of experts remain divided. Leonard suffered a cardiac arrest due Parent Heart Watch, an organization to dilated cardiomyopathy — an en- that advocates for thorough cardiac ECG concerns larged heart. screening in youth. “And we truly An electrocardiogram is a quick and The Fennville Blackhawks are far don’t know.” painless test that can catch some of the from alone in losing a teammate and Many medical professionals agree. common abnormalities that may lead a friend to sudden death. And when Dr. Stephen Daniels, the pediatrician- to a sudden death. “Research shows a young athlete dies during a sporting in-chief at The Children’s Hospital in that a well-read ECG can catch be- event, the tragedy makes headlines Aurora, Colo., and a spokesman for tween 40 and 60 percent of the condi- nationwide. the American Heart Association, says tions that happen,” says Snyder. “The whole issue of athletes and while sudden death is not a minor is- And yet, the American College of sudden death is emotionally charged,” sue, it’s also not a very common oc- Pediatrics, the American College of says Dr. Douglas P. Zipes, a distin- currence. “But we don’t have national Cardiology and the AHA do not rec- guished professor emeritus of medicine registries or ways of combining data ommend ECGs to be a formal part of with the Indiana University School of across jurisdictions in a way that we the screening process. Medicine. “You have a youngster who really have a firm handle on what that “The current position is that the is supposed to represent the epitome of number is,” he says. screening really should focus on per- health, and all of the sudden, he’s es- There is more clarity on the condi- sonal and family history and the physi- sentially struck by lightning.” tions that trigger sudden cardiac arrests. cal examination, as a way of identifying Both parents and medical profes- In the United States, the most prevalent athletes who should then get further sionals share a common aim to reduce cause of sudden death among young evaluation,” says AHA’s Daniels. and ideally prevent sudden deaths in athletes is hypertophic cardiomyopa- Many experts believe that an student athletes. thy, an abnormal thickening of the heart ECG is not an efficient screening tool But when it comes to formulating muscle that’s often an inherited condi- because it may miss some disease is- a strategy to achieve that goal, opinion tion. According to a 2003 article in the sues and indicate there’s a problem and practice diverge, with rifts even New England Journal of Medicine, it ac- when there isn’t one. “Screening with within the cardiology community. counts for about a quarter of all deaths an electrocardiogram is pretty contro- among student athletes. versial,” says Dr. Aaron Berman, chief The heart of the issue Other leading causes include con- of cardiovascular disease at Beaumont There are plenty of estimates but little genital coronary abnormalities and Hospital, Royal Oak in Michigan. concrete data regarding deaths among arrhythmogenic right ventricular car- It’s not uncommon for athletes to student athletes. diomyopathy (ARVD), a rare inher- have unusual ECGs due to changes Some researchers say the rate is ited heart muscle condition. in their heart because of intense lev- as low as one in 300,000 youngsters. When the media reports on a els of training, explains Berman, who Others estimate that it’s less than 100 new sudden death incident, the news also runs the hospital’s Healthy Heart students a year from among the 10 to reignites the debate not only about Check Program for student athletes. 12 million participants. And a study whether all students should take part “The fear is, that as many as 15 per- published in the journal Circulation in a mandatory cardiac screening but cent of kids who undergo a screening

DOTmedbusiness news I j u n e 2011 51 lar health through research and com- munity initiatives, knows a thing or two about the test. As the founder and medical direc- tor of the foundation’s Young Hearts for Life (YH4L) Cardiac Screening Program, Marek and his team have screened more than 60,000 active stu- dents using ECGs. According to Marek, as embar- rassing as it is for the medical com- munity to admit, few physicians ac- tually know how to calculate a false positive rate and no specific data on the false positive rate of ECGs is cur- rently available. Some previous research has con- cluded ECGs produce an abnormal rate of 10 to 40 percent. But that’s be- cause the abnormal rate included “a lot of findings that are normal vari- ance in these young adult athletes and clearly are not indications of the dis- are going to be found with some kind ern Medical Center, who took part in ease we’re looking for,” says Marek. of abnormality and then will be re- the study. “When we tried to break “When you narrow the criteria to ferred for additional testing,” he says. it down into what it costs to do the just the conditions that we’re looking “There will be a lot of anxiety and ex- study, it came out to what we thought for, you get a very acceptable abnor- pense associated with that.” was fairly reasonable.” mal rate,” he says. “It’s not something To counter some of the potential Scott and colleagues found that that’s going to overwhelm the com- false positives, Berman’s screening pro- an ECG and a screening echo cost munity with extensive testing.” gram performs a “quick look echocar- about $60 per student. The cost per Marek also says screening pro- diogram” test on students whose ECGs student when an echo was only done grams for diseases such as breast and look suspicious. Since starting the pro- if a student had a suspicious ECG was prostate cancer have much higher gram in 2007, Beaumont has screened around $42. false positive rates – why hold this more than 5,500 kids. Scott points out that the goal of screening to a different standard? On top of the false positive and this particular study was to find out In a study of 32,000 students false negative rates of ECGs, cost is whether or not it was feasible to of- screened through the YH4L program, a common argument against the test. fer the same quality cardiac screening Marek says his team found the ab- The screening program at Beaumont for student athletes throughout the normal rate of ECGs to be in the low is funded through philanthropy, with state, regardless of location. “There’s single digits. (The results will be pub- physicians volunteering their time. “If no question that you can find [heart lished in September.) people actually had to pay for this, it abnormalities],” he says. “Whether “Just because there is no data that would be expensive,” says Berman. or not this is the best way to do it, we clearly shows it is beneficial, doesn’t don’t know.” mean it shouldn’t be done,” he says. Yet, Scott points out that nothing Exactly how expensive? “We do hundreds of things in medicine in the research data contradicts the In a recent study, researchers in Texas where there is no definitive data.” current screening recommendations screened 2,506 students from 70 school Another benefit of comprehensive maintained by medical societies. districts using two different models. In screening is that it may catch health The researchers plan to publish one model, students got an ECG exam, issues unrelated to sudden death risk the complete results of their study in and if the test results looked suspicious conditions. a cardiology journal soon. for hypertrophic cardiomyopathy, ath- At Beaumont Hospital, the screen- letes also got an echocardiogram. In ing program identified many students the other model, all students got both In defense of ECGs with beginnings of hypertension. “I’d an ECG and an echo exam. Supporters of ECG screenings for ath- say probably somewhere around 10 “Because it was a research study, a letes say opposition to the test because percent of our kids were allowed to lot of the costs were involved in doing of its false positive rate is flawed. continue in sports but were recom- the research,” says Dr. William Scott, Dr. Joseph Marek, a cardiologist mended to follow up with their own chief of cardiology at Children’s Med- who leads the Midwest Heart Foun- physicians,” says Berman. “I think the ical Center and professor of pediatrics dation, an Illinois-based nonprofit earlier you light people up to that sort at the University of Texas Southwest- dedicated to improving cardiovascu- of problem, the better off they’re go-

52 DOTmedbusiness news I j u n e 2011 www.dotmed.com an outpatient cardiology department. (The team will publish these findings soon.) Because parents and cardiologists volunteer their time, the students are screened free of charge. But if the cost were to be calculated, ECGs would run about $10 per student, according to Marek. Although Marek doesn’t believe extensive cardiac screening should be mandatory, he does think that physi- cians have a responsibility to inform parents of the sudden cardiac arrest risks and the available testing options. Not only is there no national registry to gather sudden cardiac arrest numbers, but many studies are also flawed because they use a very rigid definition of “athlete,” says Marek. “If some young adult dies at home from one of these Image courtesy of Beaumont Hospital conditions while he’s playing basketball in the driveway, it doesn’t hit the news,” he says. “But is his death any less important than if he were making a winning basket?” For many cardiologists, those reasons are enough to continue inspecting students’ electrocardiograms for ab- normalities. ing to be.” “I’ve thought a lot about this. I don’t want to waste my For many, it becomes harder to argue the value ECGs free time doing and reading ECGs and make parents do- based on cost — is there a price too high when a child’s life nate their free time,” says Marek. “I’m looking for a reason hangs in the balance? not to do this and quite frankly, I haven’t found one.” ECG proponents say the cost of the tests is miniscule • Online: dotmed.com/dm16077 compared to the country’s significant health care spending and innovative approaches can help lower the price tag. Olga Deshchenko may be reached via email at [email protected]. “I believe there are ways we could make this work and I believe it’s our responsibility to do that,” says Snyder, who lost a 17-year-old daughter to sudden cardiac arrest. “While we’re debating whether we can afford this, kids are dying. And we don’t know how many.”

A screening community model Advocates of broad cardiac screening using ECGs often cite community programs as solutions to keeping the cost to a minimum while still screening a large percentage of active youths. Marek’s YH4L program is an example of a community initiative that strives to be large scale, cost-effective and ef- ficient. Because of the program’s design, the organization can go into a high school and do about 1,200 ECGs in one day. To perform the ECGs, YH4L trains community volun- teers. Parents take part in a 90-minute training program that discusses sudden cardiac death and teaches them to do an ECG. “We’ve trained about 6,000 community volunteers so far,” says Marek. A common criticism of the volunteers performing the tests is that they are not medically trained professionals. But Marek says “that’s nonsense.” “When I was a medical student, I learned how to do an ECG in about five minutes,” he says. “Nowadays, if people can figure out how to use their darn cell phone, they can certainly do an ECG.” Marek’s team has also carried out an internal study that shows the quality assurance rate of ECGs done by commu- nity volunteers is the same or better than that of tests done at

DOTmedbusiness news I j u n e 2011 53 ISR: Stress Test

Image courtesy of Nasiff Associates

Stress test industry update: legal & connectivity woes By Olga Deshchenko Insurer that denied stress tests violated state law

lue Cross Blue Shield of Delaware caught a lot According to the report, MedSolutions denied nearly 30 of heat recently for denying what may have percent of the requests to cover nuclear stress tests. The in- been medically necessary diagnostic cardiac surer’s preauthorization program also required physicians stress tests, prompting investigations by both the to prove the tests were necessary before paying for them. state’s insurance commissioner and the U.S. Sen- And Avi E. Soffer, CEO of University Nuclear and Diag- ate Committee on Commerce, Science and Transportation. nostics, says Delaware isn’t the only state with troubling de- BThis April, Delaware’s Department of Insurance re- nials of critical diagnostic tests -- it’s happening nationwide. leased its report, which found that BCBSD violated state law According to Soffer, many payers use the health care re- by signing a contract with MedSolutions, a company that form’s goal of trimming the “excess” and controlling costs guaranteed the insurer would slash costs through denials of across system to underpay or completely deny coverage for high-tech imaging tests. procedures like nuclear stress tests.

54 DOTmedbusiness news I j u n e 2011 www.dotmed.com At the same time as the Department of Insurance re- Prompted by the investigations, BCBSD said in April it leased its findings, the Senate shared its summary report on would modify its policies -- doctors no longer need to obtain preauthorization in Delaware. It pointed the finger at payers preauthorization for nuclear stress tests for the members of and clinicians, scolding them for not putting patients first. the insurance plan. The Senate’s investigation was triggered by a patient According to Soffer, a diagnostic stress test is one of the named Michael Fields, who was denied nuclear stress tests most vital tools in the hands of cardiologists. “It is arguably twice in January of 2010. He was eventually admitted to their most important diagnostic [exam] and certainly the a hospital and received bypass surgery. The Senate report number one contributor to the decrease in cardiovascular found that Fields’ preauthorization procedure “unnecessar- disease and detection of ischemia,” he says. ily delayed care for his life-threatening medical condition.” • Online: dotmed.com/dm16130

The quest for painless integration

n the transition to electronic pany,” he explains. fort to standardize an HL7 format medical records, providers On the other hand, the compat- across the industry, Moore doesn’t aren’t the only ones who need to ibility option has no annual fee and anticipate it will happen for several deal with changes -- equipment requires no integration with the EMR years. For now, manufacturers are fo- manufacturers must also recon- vendor – it seamlessly runs parallel to cused on ensuring EMR connectivity, figure their offerings to meet the new the electronic health record. (The Nas- without the burden of additional costs requirementsI for their customers. iff CardioCard software is compatible for providers. And stress test systems are no with 98 percent of the EMR compa- And the emphasis on improving exception. Since the advent of EMRs, nies, according to Moore.) the workflow in light of EMRs, says there has been a bigger focus on in- If working and coordinating with Moore, has created a shift in the in- formation retrieval and sharing that’s numerous EMR vendors wasn’t chal- dustry. Manufacturers are not only fast and easy. lenging enough, stress test equipment providing stress test products but Currently, a major challenge in companies must also function in a broader, customized solutions for the stress test industry is workflow realm that lacks a waveforms stan- their customers. and connectivity to an EMR, says Mi- dard. Test results can widely vary in • Online: dotmed.com/dm16131 chael Moore, vice president of sales file formats, including XML, JPEG, with Nasiff Associates. PDF and TIFF. Olga Deshchenko can be reached via According to Moore, analogue sys- Although there is an ongoing ef- email at [email protected] tems are being phased out in favor of PC-based systems in today’s test mar- ket but many physicians are yet to catch up with the latest PC-based units. For customers who have older diagnostic systems, the transition to a paperless system can be an expensive process. For manufacturers to offer provid- ers a system that best fits their evolv- ing needs, companies must work with EMR vendors, which is not always easy. “There are approximately 250 different EMR companies and there is no standard in the industry in which one device will communicate with a software company,” says Moore. When it comes to connecting a stress test unit to an EMR, Moore says customers have two options: in- terface and compatibility. “The inter- face will save a couple of clicks and generally comes with an annual fee to the customer from an EMR com-

DOTmedbusiness news I j u n e 2011 55 DOTmed Registered Stress Test Sales & Service Companies For convenient links to these companies’ DOTmed Services Directory listings, go to www.dotmed.com and enter [DM 16130] Names in boldface are Premium Listings.

Name Company - Domestic City State Certified DM100 Doug Rabkin Buckeye Medical Colton CA • Chris Portugues Cardiac Direct Ventura CA Phil Lonbeck DB Medical Electronics Diamond Bar CA Jesus Aguilera JFA Biomedical Services Palmdale CA Lisa Vanasco Ready Medical Paramount CA Ramon Manalo Requests International Stevenson Ranch CA Kevin McMahon Unfors Instruments Inc. New Milford CT Oswaldo Guio Let Medical Miami Lakes FL • • Lamar Gale Gale Medical Savannah GA • Joe Murray Medeco Boise ID • • Monte Montain Alternative Source Medical Buffalo Grove IL • • Robert Gaw Jr. Physiciansi ResourceService Network Fall River MA • Alda Clemmey Saffire Medical Taunton MA • • John Gladstein Medical Device Depot EllicottMRI City MD • Alison Fortin Global Inventory Management Dover NH • • Marc Fessler IndependenceQuality Cryogenic MRI Engineering service Little –Egg the Harbor coolNJ choice Abe Sokol Absolute Medical Equipment Wesley Hills NY • • Anita Bourdeau Nasiff Associates, Inc. Central Square NY Bulent Buyukoglu USmedevice, LLC Cumberland RI Shannon Moore SPBS Lubbock TX • Keith Castelamare B&K BIOMEDICAL SERVICES Chester VA •

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56 DOTmedbusiness news I j u n e 2011 www.dotmed.com …To Your Phone And Call Us Today!

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CT SCANNERS SPECIAL PROCEDURE PORTABLE X-RAY

SIEMENS Volume Zoom CT Scanner PHILIPS Integris 3000 GE AMX IV Plus Portable X-Ray Auction 21752A Cath Angio Lab Auction 21724A Current Bid: $66,752 Auction 15886A Current Bid: $9,000 DOM: 2000 Starting Bid: $1,000 Bids: 1 Siemens 4-Slice Volume Zoom CT You are bidding on a Phillips Integris DOM: 1997 Scanner currently installed and 3000 Cath lab. This unit was removed in working operational. order. The battery has been tested and is working. MRI SCANNERS LASERS GE AMX 700 Portable X-Ray CUTERA TitanXL Laser – Yag Auction 15851A TOSHIBA Opart MRI Scanner $55,000 Auction 20734 A Current Bid: Auction 21910A Model#-46-270954G2 Current Bid: $26,000 Starting Bid: $3,000 Bids: 4 S/N-S1740036 DOM: 1999 A LOADED 2007 Cutera XEO with DOM-11/2006 A TOSHIBA Opart .35T Open MRI nearly new Pearl for skin resurfacing, Scanner. Magnet is located in a 1064 NdYag with Hair Removal and single story with floor to ceiling Laser Genesis functionality enabled. windows that are removable. MAMMO

LUMENIS LumeOne Laser – IP GE DMR Plus Mammo Unit PHILIPS Intera NT ACS 1.5 MRI Auction 21503A Auction 18928A Scanner Starting Bid: $10,000 Current Bid: $5,700 Auction 22139A Like new! This unit has only been DOM: 2003 Current Bid: $25,000 used for 3 training sessions. A GE DMR Plus Mammo Unit. This MRI is in good working condi- The unit is not in clinical use. tion and is in storage under power near London in England. C-ARMS FISCHER SenoScan 25/50 Digital Mammo Unit

MRI PARTS OEC 9600 C-Arm Auction 21906A $20,000 Auction 21836A Current Bid: DOM: 2003 Current Bid: $25,000 SUMITOMO F70 MRI Compressor This machine was 100% functioning Auction 6257A DOM: 1998 This unit was removed from when when last used approx. 1 year Current Bid: $12,088 ago and decommissioned. Brand New Sumitomo F70 MRI service in working order. Compressor. Sumitomo F70 Com- pressor available with exchange. OEC 9400 C-Arm BONE DENSITOMETERS Auction 21133A Current Bid: $9,001 CONTRAST INJECTORS This unit is in working condition GE Lunar Prodigy Bone and has a 9” Image Intensifier. Densitometer Auction 20818A MEDRAD Contrast Injector CT Current Bid: $8,000 Auction 20974 OEC 9000 C-Arm : $5,000 DOM: 2007 Starting Bid Auction 21478A DOM: 2001 This GE LUNAR Prodigy Dexa Current Bid: $4,000 Densitometer is staged and opera- Acquired by the hospital in August This unit was removed from service tional but not in clinical use. 2001, removed from service by the in working order but is currently in cath lab clinician, still functional and storage. 12” Image Intensifier. last inspected October 2010.

58 DOTmedbusiness news I j u n e 2011 www.dotmed.com All auctions were running at time of publication. Questions? Interested in posting an auction? Call the DOTmed Online Auction Help Desk at 212-742-1200 x 252

RAD - RAD/FLUORO ATL Philips HDI 5000 Cardiac - FRIGITRONICS CE-82 Vascular Ultrasound Cryosurgical Unit ROOMS Auction 21101A Auction 22079A Starting Bid: $5,000 Starting Bid: $350 GE Proteus Rad Room Ultrasound Machine ATL HDI5000 This equipment is in great physical Auction 21997A w/DICOM and DVD burner Cardiac and working condition. Unit comes Current Bid: $9,000 and Vascular probes. Echo P4-2; complete with foot switch, hand DOM: 2003 Vascular L7-4 piece, gas lines and gas cylinders. This system is currently being maintained by GE. OAKWORKS CFPM 400 Pain READING Management Table CONTINENTAL TM50 Rad Room Auction 22068A $4,250 Auction 20816A KODAK DirectView CR800 s CR Current Bid: The table is in excellent condition Starting Bid: $1,000 Auction 22154A with minimal use for 1 yr. There is DOM: 1997 Starting Bid: $3,000 A CONTINENTAL Trex TM50 Rad DOM: 2003 3 yr warranty remaining. Room. Kodak DirectView CR800 CR Reader. This unit was in good WYEAST MEDICAL Totalift II SIEMENS Iconos R200 Rad/Fluoro working condition when recently Stretcher Room de-commissioned. Auction 22081A Auction 21992A Starting Bid: $1,000 Starting Bid: $1,500 It is in excellent physical and work- DOM: 2000 ALL OTHER ing condition. As a stretcher, it ad- A SIEMENS Iconos R200 justs to bed height and remains flat Fluoroscopy Room. while the patient is transferred. CATERPILLAR D-349 Backup Generator SIEMENS Siregraph D40 Rad/ Auction 21450 A DUPONT Riboprinter Fluoro Room Current Bid: $16,000 Microbiology Auction 20821A Caterpillar D-349 Back up generator Auction 6181A Starting Bid: $1,000 Starting Bid: $3,500 DOM: 1996 These are high end precision instru- This room is in clinical use and TRACKMASTER TMX425 ments that provide absolute analysis good working condition. Treadmill cost effectively. These are a must for Auction 20651A all quality applications and provide a Current Bid: $1,000 complement to other lower technol- Like NEW condition used twice for ogy instruments, such as the Vitek. ULTRASOUND demonstration purposes. This sys- tem is designed to be used during GE Logiq Book XP Ultrasound Stress Testing and will connect to a OB / GYN Stress EKG unit. Auction 21874A Current Bid: $7,000 HILL-ROM 850 Beds Electric DOM: 2005 Auction 22043A This unit was recently de-commis- Starting Bid: $250 sioned in working condition. A LOT of (5) HILL-ROM Model 850 Electric Beds. There are currently 10 ACUSON Aspen Advanced lots with 5 beds each for a total of OB / GYN - Vascular Ultrasound 50 beds. Auction 22143A Current Bid: $2,600 Date of Manufacture -2003; Probes: L7 ; V4

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(877) 904-1904 [email protected] [email protected] (86)20-85541373 www.BluestoneDiagnostics.com www.dododomed.com

62 DOTmedbusiness news I j u n e 2011 www.dotmed.com PROTON EMPLOYMENT OPPORTUNITIES SERVICES INCORPORATED 776 Jernee Mill Road, Suite 120 Sayreville, NJ 08872 1 800 793-0190 Fax 732 238-1225 www.prosvcs.com [email protected] Association of Medical 9GYCPVVQVJCPMCNNQWTUCVKUſGF Service Providers customers for choosing Proton Our mission is to provide superior products and services to our customers through a network We install, sell and service all types of whole of local Independent Service Organizations. body diagnostic imaging scanners in We provide AMSP members the support of one New Jersey, New York, Connecticut, of the largest and most technically competent Florida, and Eastern Pennsylvania. national service organizations in the country.

We now directly repair and asset manage FSE Employment Opportunities the following modalities: Looking to employ MRI, CT and X-ray field MRI service engineers. Benefits include: CT X-Ray ‡([FHOOHQWSD\ R&F ‡)XOOKHDOWKFDUHEHQHILWV Bone Densitometry ‡&RPSDQ\YHKLFOH Mammography ‡JDVDOORZDQFH Ultrasound ‡.EHQHILWV ‡(PSOR\PHQWRSSRUWXQLWLHVLQHYHU\ (we cover most manufacturers, please call for details) region of the country

We also service: Please upload your resume on the Chillers, Cameras, Processors, AMSP web site and MRI Coils www.amsp.net We correct chronic and intermittant imaging hardware problems, software problems, application problems, and assist with ACR Accreditations. Classifieds Rate Card 4 lines: $100 • 8 lines: $175 16 lines: $325

ADVERTISER INDEX ADVERTISER PAGE ADVERTISER PAGE ADVERTISER PAGE Absolute Imaging Solutions, LLC 41 Health Care Exports, Inc. 35 Molecular Imaging Solutions, Inc. 43 www.ais-nuclear.com www.ahce.com www.molecularsolutions.net Altima Diagnostic Imaging Solutions 11 Hitachi Medical Systems Inside back cover Nationwide Imaging Services, Inc. 29 www.altimadis.com www.hitachimed.com www.nationwideimaging.com Amber Diagnostics 53 IDN 49 Nuclear Medicine Professionals, Inc. 30 www.amberusa.com www.idnsummit.com www.mobilenuclear.com Ampronix Imaging Technology 4 Integrity Medical Systems, Inc. 40 Owen Kane Holdings, Inc. 57 www.ampronix.com www.integritymed.com www.owenkane.com ANDA Medical 7 Johnson Thermal Systems 48 Oxford Instruments 56 www.andamedical.com www.johnsonthermal.com www.oxford-instruments.com/mri C&G Technologies 27 Life Systems, Inc. 55 Radiological Imaging Services 9 www.cgtscan.com www.lifesystemsinc.com Stryker Sustainability Solutions Complete Medical Services 36 Logical Solutions Services, Inc. 24 (formerly Ascent) 2 www.completemedicalservices.com www.solutionservices.us sustainability.stryker.com DMS Topline Medical 31 Marquis Medical 28 Tesseract 10 www.toplinemedical.com www.marquismedical.net www.tesseractusa.com Drand Medical 1 Medical Imaging Resources, Inc. 32 TriMedx Healthcare Equipment Services 45 www.drandmedical.com www.medimagingsales.com www.trimedx.com Dunlee, Inc. Inside front cover Medicall 18 Unfors Instruments, Inc. 8 www.dunlee.com www.medicall.in www.unfors.com Government Liquidation 16 MEDX, Inc. 42 Varian Medical Systems, Inc. Back cover www.govliquidation.com www.medx-inc.com www.varian.com/interay HCP 25 Metropolis International 33 Viable Med Services, Inc. 17 www.hlthcp.com www.metropolismedical.com www.viablemed.net

DOTmedbusiness news I j u n e 2011 63

Blue Book Price Guide Recent equipment and parts auctions on DOTmed with actual sale prices.

SURGICAL -Hand-held control pendant -Computer Screen 12-Nov 7 HH11BEX Probe and Vacuum Set WELLS JOHNSON Liposuction Unit HK Power -Mouse -Motion Control Box -Keyboard -Cables C4E40V 11-Apr 1 C1540 MicroMark II 8G Mark- lAspirator to connect to the control computer outside the ers D4JV30 12-Oct 5 G08LF Probe Guides 8G HK Power Surgical Aspirator in excellent work- treatment room. Auction #17140 – sold for a D4JY74 12-Nov 16 G011LF Probe Guides 11G ing condition. This machine has been babied. hospital in UT, $5,000. D4JW58 12-Nov 25 MVAC Vacuum Set 07A518 It has been used sparingly in a private medical 12-Sep 12 MVAC Vacuum Set Auction #17738 office as adjunct to daily medical care. Auc- UNIVERSAL Chest X-Ray Eureka Linear – sold for a broker in Fla., $2,600. tion 17278 – sold for a medical office in Calif. MC-15 This auction is for a Linear MC-150 $1,500. X-Ray Room. This Room has a Gendex model SIEMENS Mammo Unit 3000 5000 Table. The Generator is a Universal LOT of four Mammo Units. The following HANAULUX O/R Light Heraeus CP7000. The room was manufactured in 1996. units are included in this lot: 1999 Siemens Hanalux 2000 O/R light set. This unit has three Auction #16887 – sold for a medical office in 3000 Mammo; model no. 6134707x014e, S/N lights on each of its two heads. Auction #17258 NY, $1,900. 05810S11, 18x24, 24x30, lead glass, face – sold for a hospital in Tenn, $2,000. shield, compression paddles, spot compression GE MRI Scanner Signa MRI Highspeed This paddles, manuals.1995 Siemens 3000 Mammo GYRUS Electrosurgical Unit 744000 auction is for a GE Signa MRI Highspeed 1.0T with 2008 tube: 18x24, 24x30, dual buckys, Gyrus PK superpulse generator with footswitch MRI Scanner. (DOM 2000) The unit has Octane lead glass face shield, compression paddles, and cable. Great working condition.. Auction I, Software Version: 9.1.0723d. SGD Gradient. spot compression paddles, manuals pictures, #17082 – sold for a dealer in Calif., $7,000. The unit Magnet: LCC 1.0T The unit options: model no.6134709x041e, s/n: 02052s11. 2001 TOF, FAST GRAD, FSE&FLAIR, SS-FSE, EPI. Siemens Nova: model no. 6134709x041e, s/n ENDOSCOPY The unit coils include: Head, CTL,Body Flex, 08123 s11, complete system, 18x24, 24x30, NV Head, Wrist, Knee, Mammo, Shoulder dual buckys, lead glass, face shield, compres- STORZ Video Endoscopy Karl Storz Array, 3 INCH GP There are several manuals sion paddles, spot paddles, manuals. 2004 Sie- Karl Storz Endoscopy System. This system included as well. The cold head was replaced mens 1000 Mammo: complete system, model includes the following: Light Source, Xenon, in February 2010. Helium Level was 83% in no.312 20509, s/n 405 301, 18x24, 24x30, dual Recorder, Video Image Processor, Insufflator on June 11 2010. Unit is being serviced by the buckys, lead glass, face shield, compression 264305-20, 19” Monitor SCSX19A1A11, Printer OEM. Auction #16849 – sold for a medical of- paddles, spot compression paddles. Auction UP-51MD. Auction #17303 – sold for a hospital fice in Austria, $36,000. #17725 – sold for an exporter in Calif., $10,000. in NY, $5,000. PERKIN ELMER Gamma Counter Wizard 1470 PHILIPS MRI Scanner Proview/Panorama 0.2 IMAGING This auction is for a PERKIN ELMER Wizard This auction is for a Philips Proview/Panorama PICKER Rad/Fluoro Room Clinx RF This auc- 1470 Gamma Counter. Unit is in excellent 0.23T MRI system. Installation date October tion is for a 1998 PICKER Rad/Fluoro Room In condition, never used at the department where 2001, in Switzerland. System comes with a good condition. -Generator: Picker-MT3100RF, it was purchased originally. Physician who comprehensive set of coils and was continu- - high frequency 100kw output - high speed ordered it left hospital so it was put into storage. ously under manufacturers full service contract. rotor drive - automatic exposure control - foot- 220V/50Hz system. Auction #16441 – sold for a Deinstallation has to be mid July 2010. HF switch - three tube capability -Pulsed Fluoros- hospital in Austria, $2,900. shielding is included in price and has to be copy capability - Continuous flouro, plus 30, 15, deinstalled as well. VIA 2.1, all available options 7.5 pulse/sec -Table: Picker ClinxRFD 90 with GE CT Scanner CTi This auction is for a GE are listed in attached image Please see list of floating top. (all digital) -90/90 angulation -Fully CTi manufactuered in 1996: There was a new coils attached as image. Auction #17615 – sold enclosed table base -Dual position fluoro foot- tube installed on 3/24/2009 and currently has for a manufacturer in Switzerland, $40,000. switch -400 lb patient weight capacity -Original a slice count of 39,300. Tube Serial Number: Clinx Over Table X-ray Tube -0.6-1.2mm focal 43368. Tube Type: DU3506. THA Type DA165. HOLOGIC Bone Densitometer Discovery/QDR spots -400.000 heat units - Universal Bucky This unit is a Single Slice CT. Unit is a CT Heli- Hologic Discovery Bone Densitometer QDR Se- - Three-Field AEC Pickup - Interconnecting cial. The unit has a Gantry Serial # 205931CN9 ries Serial Number/83788 Manufactured 2008. Cables -FlouroPro RF Digital Imaging System The unit Gantry Model # 2119732-2 The unit . Like new condition. Operating Platform/XP -AutoStore automatic spot image storage to is located on the first floor of the facility and 12.7 Scanning Sites/Lumbar Spine, Dual Hips, disk for data protection -Instantaneous online can be moved to a back door where a ramp is Forearms Computer/Hologic Model ASY01333 image review -Digital Processor -Intel Chipset located. The ramp would have to be removed Serial#/83788 Level/Apex Includes: All Manu- -19” LCD Medical Desktop Monitor -High Reso- and the unit lifted from the door using a forklift. als DXA Phantom Auction #17604 – sold for a lution CCD camera operating at 1024x1024x12 This unit is in working condition and is only be- medical office in NY, $21,000. bits 30FPs -Direct couple lens -Motorized iris ing auctioned because the seller is upgrading to -Fluoro save- up to 300 frames -Multi level a newer CT Scanner. Auction #17823 – sold for temporal filtering -Image review -Workstation a broker in TX, $12,000. Included -Equipment -one 20” procedure room DOTmed Auctions monitor with mobile monitor pedestal cart -one ETHICON Mammo Accessories Ethicon Mam- separate 20” control room monitor -keyboard, motome Want to auction mouse, glide pad, -compact 25” electronics More than $11,000 worth of Mammotome cabinet. Auction #17340 – sold for a hospital in supplies. The breakdown is as follows: REF equipment on NJ, $2,100. DESCRIPTION LOT # EXP DATE UNITS MST11 Stereotactic Probe C4D49U 10-Dec 3 dotmed.com? CMS Waterphantom This auction is for a CMS MST11B Stereotactic Probe D4JX7U 12-Nov Contact an auction Waterphantom. This device is a three-dimen- 8 MST11B Stereotactic Probe C4EK3Y 11-Jun sional, computer-controlled, scanning water 3 MST11B Stereotactic Probe C4ER6N 11-Jun specialist. phantom to measure radiation field profiles in 5 HH8BEX Probe and Vacuum Set D4JX01 a water tank (dimensions 24” x 27 1/2” x 24” 12-Nov 8 MST8 Stereotactic Probe C4EA05 212.742.1200, ext. 296 deep) Probe transit is 24”. The system consists 11-May 1 MST8 Stereotactic Probe D4K02A 12- of the following: -Water tank -2 PTW Scanning Nov 3 MST8 Stereotactic Probe E4L36Z 13-Apr or [email protected]. Ion Chambers -CMS Dual Integrating Preamps 5 HH11BEX Probe and Vacuum Set D4JZ6J

64 DOTmedbusiness news I j u n e 2011 www.dotmed.com you deserve

Can you afford system downtime? Are you concerned about optimized image quality? Are you getting factory-certified replacement parts? EGJ= Service Hitachi Your Service Flexible Coverage/Pricing Alternatives D Quarterly Uptime Guarantee D OEM-certified & Tested Parts D 30-minute Guaranteed Phone Response D 2-hour Guaranteed Onsite Response D Unlimited Coil Replacements D OEM-trained Service Engineers D OEM-trained Technical Phone Support D Site Accreditation Assistance D Unlimited Onsite Applications Visits D Applications Helpline Support D Market Assessment Tools D Advertising Campaign Assistance D

Hitachi makes it easy to keep your system up-to-date and running smooth, in addition to advancing your facility with its site accredita- tion and marketing support.

DOTmed Auctions Compare and Call! Want to auction equipment on dotmed.com? Contact an auction specialist. 212.742.1200, ext. 296 Call 800.800.3106, ext. 2902 or email [email protected] or [email protected].

^^^OP[HJOPTLKJVT New from Varian Interay: Replacement for your Performix 6.3 mHU CT tube MCS-6074 GE Lightspeed Plus

Designed as a replacement for: GE Lightspeed family of CT scanners

s6ARIANS-#3REPLACES $4 "ACKWARDSCOMPATIBLEWITH $4 $4 $4 sM(5MMTARGET s3UPPORTSSECONDFULLSCANS s#ALIBRATESLIKETHEORIGINAL

For more information go online for a data sheet or contact us for the dealer nearest you.

USA Contact Information Europe Contact Information Varian Interay Varian X-ray Products Germany 1-800-INTERAY TEL 49-2154-924-980 TEL 843.767.3005 FAX 49-2154-924-994 FAX 843.760.0079 www.varian.com/interay [email protected] E-mail [email protected] “All trademarked terms are property of the respective manufacturer.”