F-D-C REPORTS — FOUNDED 1939 $665 A YEAR ® www.TheSilverSheet.com“The Silver Sheet” MEDICAL DEVICE QUALITY CONTROL Vol. 13, No. 2 February 2009 THE NEWS THIS ISSUE • RECALLS SOARED TO THEIR HIGHEST POINT EVER IN 2008, with companies recalling a total of 845 devices. Many of the recalls were related to software problems and tainted heparin. “The goal is to try and decrease those recalls,” says Tim Ulatowski, director of CDRH’s Office of Compliance. “So we’re trying to push that number down through effective enforcement actions and industry training.” There is good news, however: The number of Class I recalls fell from 23 in 2007 to only 17 in 2008 – industry’s best Class I showing since 2003. Also, the recall manager for a Virginia hospital chain tells what companies should do to make their recall letters clearer and easier to comply with. “We get some recall letters and we truly don’t know what to do with them,” Bea Haupt says................................................Below • COMPLETE TABLE OF RECALLS FROM 2008 includes 17 Class I (2%), 726 Class II (86%) and 107 Class III (12%) medical device events ............................................................................................................12 • WARNING LETTERS: I-Flow cited for QS and MDR reg violations in relation to its infusion pumps.........66 • IN BRIEF: New GHTF guidance instructs firms on the control of products and services obtained from suppliers; former OSEL Director Larry Kessler is concerned that CDRH doesn’t always follow scientific principles and practices .......................................................................................................Back page Problems Related To Software, Heparin Help Push Recalls To All-Time High Also, FDA And Industry Experts Give Tips For Composing Recall Letters The number of recalled medical devices counting methods are typically negligible; the skyrocketed last year to its highest point ever, agency counted 831 total recalls in FY 2008 and spurred on by a large volume of Class II recalls 664 in FY 2007. related to product software and devices containing tainted heparin. “The goal is to try and decrease those recalls,” Ulatowski says. “So we’re trying to push that “Software is an area where we’re seeing ... an number down through effective enforcement actions uptick in the reason for problems with products,” and industry training.” says Tim Ulatowski, director of CDRH’s Office of Compliance. “As the products become more There were 726 recalls designated as Class II last intricate and software-driven, we want to make sure year, accounting for the bulk of the recalls. That is a we’re ahead of the problems.” 49 percent increase over 2007, when 487 Class II recalls were reported. Manufacturers initiated a total of 845 device recalls in calendar year 2008, up 43 percent from 2007, According to a “Silver Sheet” analysis, software when 591 recalls were logged. (See chart, p. 3.) problems accounted for 71 of the Class II recalls. For its 2008 figures, “The Silver Sheet” counted Software anomalies were noted as the reason for recalls issued during the calendar year, while FDA one Class I recall: Physio-Control’s LifePak CR tallies recalls according to fiscal year (Oct. 1- Plus automated external defibrillator was Sept. 30). The differences between those two configured with incorrect software. Contents copyrighted © F-D-C Reports, Inc. 2009 protected by U.S. Copyright Law. Reproduction, photocopying, storage or transmission by magnetic or electronic means is strictly prohibited by law. 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F-D-C REPORTS “The Silver Sheet” Page 2 Class I is FDA’s most serious recall category, you, because he or she is going to show you reserved for situations where the agency believes shortcuts that your labeling doesn’t take into patients face a reasonable probability of serious account,” he says. “And then you need to figure out injury or death from use of the defective products. how to prevent that from happening.” Nine Class III recalls also were attributed to software FDA also is warning manufacturers not to put off problems. recalling bad software while they wait for appropriate fixes to be developed. “We’re looking at software recalls in more detail. Software is subject to [an agency] analysis that’s “A lot of time in the device industry I’ll hear, ‘You going on,” Ulatowski says. know Mike, we’ll recall that about six years from now when we get the software update,’” says Mike FDA is trying to determine “software’s contribution Verdi, also a senior recall coordinator for FDA. to the total recall package,” he notes. “And then as “No, no, no. Recall it now.” we drill down, what are the specific areas that created the software recalls? We’re trying not to be Software Problematic For Diagnostics, Too superficial. We’re trying to get down to the exact problem areas that generated the problems so we FDA’s Office of In Vitro Diagnostic Device can target solutions.” Evaluation and Safety (OIVD) also is trying to determine the best way to curb software recalls tied Ulatowski also says there is a continuing need to to in vitro diagnostic (IVD) products. train FDA investigators on the intricacies of devices that contain software. “We’re trying to figure out how much we should be concerned about software recalls,” says Ian Pilcher, FDA Senior Recall Coordinator Melvin Szymanski an OIVD consumer safety officer. blames poor software development for the spike. “Software is pretty complicated when it’s put in “Software development is being done quickly in the these instruments,” he says. “So what we’re trying beginning, and then firms are marketing the product to get a handle on is, how we should review this before fixing the software glitches that should be stuff and how we should look for problems. It’s tested-out during product development,” he says. kind of a newer field for us, and we don’t see all the [software] code. We’re more familiar with looking Many of the software problems could be avoided if at testing data and clinical data – that sort of thing – companies performed proper real-world testing, but software is a little bit of a black box.” Szymanski told “The Silver Sheet.” Pilcher told “The Silver Sheet” that problems “Let’s say it’s a device used in a hospital. You with software are the third most-common IVD better have a nurse come and test that device for recall issue. Executive Editor: Director, Device Publications & Databases: Mary Houghton Sean Smith “The Silver Sheet” 240-221-4410 [email protected] Creative Director: FOUNDED 1997 Managing Editor: Louise Koenig www.TheSilverSheet.com www.fdcreports.com Shawn M. Schmitt Commericial Sales Director: 240-221-4419 [email protected] F-D-C REPORTS, INC. 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URL: www.elsevierjapan.com. Telephone: 03-3589-6370. Fax: 03-3589-6371. “The Silver Sheet” 3 “The devices are becoming more and more complex,” The software review process is difficult for OIVD, he says. “Although we don’t regulate them in the pre- Pilcher says, because there is an overwhelming market sense, you have things like lab information amount of software in some IVDs. systems, hospital information systems, and things like “You can imagine the amount of software for some that, so we also get some recalls with those.” of these complex analyzers. And we don’t look at Further, “glucose meters are starting to do more the code; we don’t thoroughly review it,” he says. things in terms of tracking and downloading data, so “For most IVDs ... we’re reviewing their it’s just kind of a broader field of devices that are verification and validation, and design controls and coming under scrutiny,” Pilcher notes. specifications – that’s it.” Because the review of IVD software is relatively Pilcher says he isn’t aware of an effort to hire new to OIVD, the office is relying on the honesty of software engineers or developers for OIVD. Rather, manufacturers when it comes to recalls. the office is working with FDA’s Office of Science and Engineering Laboratories (OSEL) to determine “One of the trickier things is, the only information the best approach for reviewing and weeding out we get from the firms is that it’s a software recall,” bad IVD software.