MDDI_Medical Device & Diagnostic Industry

MDDI, July 2016

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This article explores the specific recalls, hazardous situations, trends, and possible mitigations related to each of the three root causes FDA directly correlated to a five-year upward trend in medi- cal device recalls (Figure 2). Device Design Since 2010, issues with device design have accounted for nearly 35% of all recall root causes determined upon firm or FDA investigation. Included in this analysis are root causes determined to be directly correlated to subcategories of device design, such as component design, labeling design, packaging design, process design, and soft- ware design. While the five-year analysis of design-related recalls does not necessarily demonstrate a consistent upward trend, the mean number of recalls per year documented in this investigation hovers well above 900, indicating continued recall problems across multiple medical device companies and platforms. In addition to being the most prevalent cause of medical device recalls, recalls related to device design are also the most likely to cause serious health problems or death to the end user. Recalls correlated to device design encapsulate close to 46% of the five- year total of Class I recalls, with a 303% increase between FY 2013 and FY 2014, according to analysis by Blue Lynx Consulting. (Note: 2015 data provided by FDA is incomplete, therefore growth be- tween 2013 and 2014 was the latest information available at time of press.) Despite the proliferation of more complex guidance documents such as the agency's 2002 General Principles of Software Validation, the upswing of death and serious injuries related to design issues continues. As evidenced by the upward trend of recalls and the multiplicity among those companies that experience recalls for the same reasons annually, it is clear that device companies still strug- gle to identify proper mitigations for the reoccurrence of these haz- ards. Information collected from the agency's database by Blue Lynx Consulting shows that 30% of device companies that instituted a recall for device designs in 2010 were once again opening recalls in 2014 for similar reasons. Why Do Design-Related issues Reoccur? As demonstrated by Figure 3, companies have struggled immensely over the past five years in their attempts to mitigate recalls derived from elements of device design. Specifically, manufacturers strug- gled most profoundly in the areas of labeling design, packaging de- sign, and process design. Although each of these subcomponents can be tied back to device design, their unique complications should be viewed as im- pediments for the mitigation of the remaining failures and hazard- ous situations. While each of these areas of device design comes with associated regulations, guidance, and standards, the current reactive state of medical device companies does not allow for con- tinuous growth over a wide variety of situations where the issues are both unique and complex. It is logical to attribute the fluctuation of these recall issues to com- panies that are unable to mitigate every known issue at once. When a company focuses on curbing growth of one type of recall, they are sim- ply "launching the seeds" for the next upward trend in another area. software controls Much like the Cooper Committee legislation of 1970, both FDA's Safe Medical Devices Act of 1990 and the 1996 Quality System Re- quirements were prompted into legislation by a set of tragic events related to the use of medical devices. Between 1985 and 1987, can- cer patients undergoing radiation treatment via the Therac 25 Ac- celerator device were given massive overdoses of radiation due to a concurrent programming error in the device's software. 2 The inci- dent, thought of as the worst series of radiation accidents in the 35- year history of the technology, resulted in six adverse events, includ- ing multiple instances of severe burns, irreversible limb paralysis, and, catastrophically, the death of two patients. While the Therac 25 tragedy brought to light the dangers of soft- ware-controlled medical devices and prompted health authorities to establish more stringent regulatory controls regarding the design, validation, and manufacture of software, the continuing advance- ment of technology coupled with a reactive industry model has led to a vicious cycle of exciting progress followed by an equal and even more frustrating regression. Between January 2010 and December 2015, there were an average of approximately 225 software-related recalls annually, accounting for nearly 8% of the total recalls during that time, according to Blue Lynx Consulting. There was also a progressive yearly occurrence rate, with trending indicating an upward swing in the following root causes as identified by the agency: software change control, soft- ware manufacturing process design, and software design. MD + DI MEDICAL DEVICE AND DIAGNOSTIC INDUSTRY July 2016 | 21 Figure 2. Device design, production controls, and software controls are the leading causes of medical device recalls. Yearly Recall Average 3000 2250 1500 750 0 Medical Device Recalls: Leading Causes 2010–2016 Device Design 2641 665 225 Production Controls Software Controls 800 1000 600 400 200 0 –50 Recall Growth Rate by Percent 2010–2014 2% 70% –51% 326% 361% 761% 872% Growth Rate Component Design Device Design Software Design Process Design Packaging Design Labeling Design Software Design MFG. Process Figure 3. Process design, packaging design, and labeling design have proved challenging for medical device manufacturers.

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