February 4, 2016 Hand hygiene compliance industry group formed to lead change for patient safety To create meaningful awareness of the patient safety risks and the economic burden to the US healthcare system of outdated hand hygiene compliance measurement, eight US-based hand-hygiene compliance solution providers have formed an alliance. EHCO, the Electronic Hand-hygiene Compliance Organization, aims to lead and influence changes in hand-hygiene measurement policy and guidelines at accreditation organizations, government agencies, health insurers, and hospitals. EHCO's focus is to improve hand hygiene compliance and, in turn, increase safety and reduce avoidable harm to patients and hospital staff. While proper hand hygiene is critical to preventing the transmission of many infections, compliance with hand hygiene guidelines is less than 50% globally. Until recently, the only way to measure how well healthcare workers performed hand hygiene was manual direct observation. With direct observation, individuals know they are being observed and adjust their behavior, a phenomenon known as the Hawthorne Effect, inflating a hospital's true compliance rate. A hospital may think its hand hygiene compliance rate is 90%; but direct observation only accounts for 1.2% to 3.5% of all hand-hygiene events, leaving more than 96% of hand hygiene events undocumented and compliance rates highly overstated. "Patient health and lives are being put at risk by outdated compliance measurement methods which often inflate actual hand hygiene rates by up to 300%," said Paul Alper, Chairman of EHCO and VP of Patient Safety Strategy, DebMed. "Patients are subjected to extended lengths of stay and unnecessary suffering as a result of HAIs, many of which could be prevented with proper hand hygiene. That is why the members of EHCO are uniting to drive change in US healthcare policy," Alper continued. Only within the past few years has evidence-based electronic measurement of hand hygiene become widely available to accurately and continuously measure hand hygiene compliance in real-time and enable meaningful feedback to healthcare workers. While capturing 100% of hand hygiene behavior electronically gives hospital leaders in quality, patient safety, and infection control visibility to accurate and reliable rates, no policy guidelines or mandates exist. EHCO member companies believe that it is their responsibility to lead the change in the acceptable standard of care to improve public health and patient safety. Connie Steed, Director of Infection Prevention at the Greenville Health System in Greenville, SC has been working with one electronic hand hygiene company for the past six years to help them develop and perfect their system. "We have seen consistent double digit increases in hand hygiene compliance and reductions in healthcare-associated infections," continued Steed. "These benefits have come with cost savings that can justify the cost of the system." The companies engaged in EHCO include Airista, BioVigil, CenTrak, Clean Hands-Safe Hands, DebMed, Hill-Rom, Inc., SwipeSense, and Versus Technology. "We have come together with a common goal, to lead the change in how hospitals measure this key performance indicator of patient safety and quality," said Alper. "Just as every other area of healthcare is adopting advanced technologies for improved efficiencies and care, there is now innovative technology to help drive true improvement in hand hygiene compliance that is linked to the reduction of avoidable infections and their associated costs," continued Alper. Visit ECHO for more information. Drug shortage guidelines: Sign of an ongoing problem? Last week's publication of ethical guidelines for distributing pediatric oncology drugs during a shortage appeared to be a sign that the shortage issue isn't going away any time soon. "Over the past decade, drug shortages, defined as a supply of a marketed drug inadequate to meet current or projected demand, have become increasingly common," wrote Yoram Unguru, MD, a pediatric hematologist/oncologist at the Herman and Walter Samuelson Children's Hospital at Sinai in Baltimore, and colleagues online in the Journal of the National Cancer Institute. "Although there have been fewer new drug shortages in the United States since 2012, the number of active drug shortages has steadily increased, reaching an all-time high of 320 as of September 30, 2014, with 265 drugs currently in shortage," they noted. The authors' ethical guidelines include considerations of "'curability,' prognosis, and the incremental importance of a particular drug to a given patient's outcome." And in the end, they concluded, "Solving the drug shortage problem will ultimately require a major policy shift, one that is grounded in coordination and cooperation." The shortage problem continues to be the result of a number of factors, Joseph Famulare, chairman of the International Society for Pharmaceutical Engineering, said. "The majority of shortages are attributed to manufacturing and quality problems," he said. "Pharmaceuticals, especially sterile ones, are made to very exacting standards with very high technologies. With some of these older drugs, the manufacturing capacity has diminished over time, and actions [have been] taken involving removal of products due to manufacturing defects." The FDA has attempted to address the shortage problem: In 2012, it instituted a rule requiring manufacturers to notify the agency of any impending drug shortages. The FDA, in turn, would work with the drugmaker to lessen the shortage. However, these efforts haven't eliminated the problem, although the number of new shortages has dropped from 117 in 2012 to 44 in both 2013 and 2014, according to the FDA. The problem won't go away until a market-based solution is implemented, according to Joel Zivot, MD, former president of Physicians Against Drug Shortages (PADS), a grassroots group of doctors concerned about the issue. "A drug company decides to make a drug because it anticipates a reasonable return on investment," said Zivot, an associate professor of anesthesiology and surgery at Emory University in Atlanta, who was speaking for himself. "If there's no market for a drug, the vendor won't make the drug, unless the government decides it's going to supplement the difference or loss to make it economically worthwhile," he said in a phone interview. "In our desire to get a better and better price, we forced vendors out of the market." Zivot and other members of PADS blame the problem in large part on group purchasing organizations. "If you fail to get that contract ... you may leave the market, and say you are not going to make the drug any more," Zivot continued. The purchasing group may then be left with only one or two vendors for that drug, and if one of them stops production due to a manufacturing problem, "because of the way modern manufacturing is in the style of 'just in time,' no one has anything on the shelf and no other vendor can nimbly enter the market." PADS supports getting rid of a safe-harbor exemption in the federal anti-kickback law that allows group purchasers to extract a fee from drug companies who sign contracts with them. "Purchasing groups can demand an extra price to make the deal -- you're saying to the vendor, 'You have to pay me a fee to make this deal; it's a kickback." "A repeal of the anti-kickback statute safe harbor exemption would go a long way toward solving this problem," he said. However, the group has not had much success selling the idea on Capitol Hill. "We asked then-Rep. Ed Markey (D-MA) -- now Sen. Markey -- for a [Government Accountability Office] investigation -- so far, nothing. That was in 2012." Visit MedPage Today for the story. DETECTO's new medical carts offer features for mobile storage DETECTO’s new Rescue and Whisper series medical carts come in multiple color options with five or six drawers and 360-degree rotation for tight corners. The Whisper series offers features in the clinical mobile storage market, including drawer facades that quickly snap off and back on and completely-sealed drawer rails without any exposed seams for hygienic wipe-down cleaning. As the name implies, the Whisper series offers the ultimate in whisper-quiet rolling convenience with its insulated interior walls. The soft-close drawers glide shut for convenience. The carts’ balanced design will not topple over when full drawers are extended. The carts are manufactured from quality aluminum cart body construction that is powder-coat painted for durability with easy-to-clean ABS countertops. The keyed or EMG breakaway central lock secures all drawers at the same time for added convenience. The carts’ 5-inch-diameter wheels feature two parking locks and one steering lock. ABS bumpers protect all four corners of the medical carts. The push handle offers a user-friendly design. Multiple optional accessories are available to customize your cart or you may purchase a fully-loaded cart pre-stocked with typical accessories needed for ER or Anesthesiology departments. For more info visit DETECTO. Crosstex acquires NAMSA’s Sterility Assurance Products division Crosstex has entered into a definitive agreement with North American Science Associates, Inc. (NAMSA) to acquire their Sterility Assurance Monitoring Products division. This division manufactures a broad suite of high-quality biological and chemical indicators which are used to accurately monitor the effectiveness of sterilization processes. These indicators are designed primarily for the industrial segment serving medical device, life science and other manufacturers, representing a new end-market for Crosstex. Crosstex is a Cantel Medical Company. Subject to customary closing conditions, the transaction is expected to close in the 3rd quarter of our Fiscal Year 2016. Visit BusinessWire for the full release. MedAssets named category leader in “2015/2016 Best in KLAS” report MedAssets ranked #1 in claims management and revenue cycle outsourcing in the newly published “2015/2016 Best in KLAS” report, which is based on industry feedback. The report recognizes MedAssets leadership in software and services for end-to-end revenue cycle management capabilities, addressing cost and quality pressures facing the U.S. healthcare industry. On January 27, Pamplona Capital Management completed its acquisition of MedAssets. It intends to combine MedAssets’ Revenue Cycle Management (RCM) segment, which currently serves more than 2,700 hospital clients and touches more than $450 billion in gross patient revenue annually, with Precyse, a Pamplona-owned health information management (HIM) services, technology, and education company. “Moving forward, as we combine our capabilities with Precyse, we look forward to creating a national leader in the end- to-end outsourced revenue cycle services, technology and education market,” said Amy Amick, president of Revenue Cycle Management (RCM) of the new MedAssets-Precyse enterprise. Produced by the KLAS research firm, results reported in the “2015/2016 Best in KLAS” report are based on industry feedback from thousands of healthcare executives and clinicians, with data gathered on software, services, and medical equipment. Visit Yahoo for the release. Separately, Pamplona has entered into an agreement with Vizient, Inc. (formerly VHA-UHC Alliance NewCo, Inc.) to divest MedAssets’ Spend and Clinical Resource Management (SCM) segment to Vizient. That transaction is expected to be completed in mid-February 2016. Visit BusinessWire for the article. DNA in healthy breast tissue may indicate cancer risk DNA in normal breast tissue can indicate a woman's risk for developing breast cancer, according to a new study at University College London. Previous research has shown risk factors such as family history, starting periods early, and entering menopause late are linked to an increased risk for breast cancer. These factors change the genetic program in breast cells, which the researchers said can be detected in DNA. The potential to find these changes could allow doctors to more accurately predict women's risk for breast cancer. "These new findings are important in supporting further research into women's cancer development and prevention," said Martin Widschwendter, head of the department of women's cancer at University College London, in a press release. "We are working hard to understand the risk factors associated with epigenetic changes in normal breast tissue and how these predispose a woman to cancer. The application of these altered epigenetic signatures hold the key developing new interventions that could 'switch off' this epigenetic defect and hold the key to preventing cancer development." "These new data show how epigenetic alterations, if detected early enough, could be used to identify women at higher risk of developing breast cancer," said Andrew Teschendorff, a researcher at University College London. "Since epigenetic alterations are reversible, it offers the potential to design preventive strategies. Our work further highlights the importance of inter-disciplinary work, combining clinical, biological and statistical expertise to make these findings possible." Visit UPI for the study. Unnecessary blood tests common before low-risk surgeries Depending on which hospital you go to for your low-risk surgical procedure, you may be 2.4 times more or less likely to be sent for unnecessary blood tests. This is among the findings of a study conducted by researchers from the Institute of Clinical Evaluative Sciences (ICES) and the Women's College Hospital Institute for Health Systems Solutions and Virtual Care (WIHV). Published in the journal Anesthesiology, the study reviewed patient records for nearly 1 million Ontario adults who underwent ophthalmologic surgery or low-risk surgical procedures in the five years between 2008 and 2013. Researchers found that overall, preoperative laboratory tests (including complete blood count, blood clotting tests or basic metabolic panel) were conducted prior to roughly 30 percent of these procedures. In addition, they found high variability in rates amongst the 119 institutions studied. Previous studies have shown that for patients undergoing low-risk surgery, routine preoperative blood tests do not improve outcomes and can lead to surgical delays and negative impacts on patient care. As part of the Choosing Wisely campaign, multiple Canadian and American specialty societies, including the Canadian and American Society of Anesthesiologists, the American Society for Clinical Pathology and the American and Canadian surgical societies have each published recommendations stating that unless a patient has clinical indications, preoperative lab tests should be avoided prior to low-risk surgeries. The most common preoperative blood tests were the basic metabolic panel and complete blood count, each performed before 25 percent of procedures. Additionally, blood clotting tests were conducted prior to 5 percent of the procedures. This study is the first to examine preoperative lab rates for a broad range of low-risk procedures in multiple institutions across a large patient population and district, and over a period of multiple years. Visit Science Newsline for the study. FDA Draft Guidance on UDI: Enforcement policy on national health related item code and national drug code numbers assigned to devices The Food and Drug Administration (FDA) released a draft guidance document, “Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance for Industry and Food and Drug Administration Staff.” Medical devices currently available through a pharmacy and potentially eligible for reimbursement from payers are generally labeled with an 11-digit reimbursement number. This is typically a National Health Related Item Code (NHRIC) or National Drug Code (NDC) number. The Unique Device Identification System final rule (UDI Rule) includes a provision (21 CFR 801.57) that rescinds any NHRIC or NDC number assigned to a medical device. If a device is required to bear a UDI on its label, any NHRIC or NDC number assigned to that device is rescinded and may no longer be on the device label or on any device package on the compliance date established by the FDA in conjunction with the UDI Rule. The compliance date for when a device is required to bear a UDI on its label can be found on the Agency’s UDI Compliance Dates webpage. If a device is not required to bear a UDI on its label, any NHRIC or NDC number assigned to that device is rescinded as of September 24, 2018, and may no longer be on the device label or on any device package. When finalized, this draft guidance will describe the Agency’s intent not to enforce before September 24, 2021, the prohibition against providing NHRIC or NDC numbers on device labels and packages, with respect to class III devices, devices licensed under the Public Health Services (PHS) Act, class II devices, and implantable, life-supporting or life- sustaining devices, manufactured and labeled prior to September 24, 2018. In the draft guidance, the Agency is also proposing to extend the deadline to request use of FDA-issued labeler codes under a system for the issuance of unique device identifiers (UDIs) to September 24, 2018 (an extension from the 2014 deadline). While implementing UDI requirements according to the scheduled UDI compliance dates is important to achieving the UDI Rule objectives in a timely manner, it is not the FDA’s intent to disrupt existing reimbursement, supply chain, and procurement processes, or to potentially interfere with patients’ access to treatment. Additional time is appropriate for stakeholders to make changes to ensure that these processes will not depend on NHRIC and NDC numbers. Visit FDA for the guidance.