MDDI_Medical Device & Diagnostic Industry

MDDI, July 2016

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22 | July 2016 Recalls Software-related recalls are also rising steadily, accounting for a 111% cumulative increase since 2010. Unlike other root causes of device issues, software-related recalls are unique in the sense that each of the three subcategories has also shown a steep and steady growth. As demonstrated in Figure 4, software design, software change control, and software process design have each shown an implausible upward trend over the past five years. Even after the industry has had ample time to digest guidance documents such as FDA's 2002 General Principles of Software Vali- dation, the upswing in death and serious injuries related to design issues continues. As evidenced by the upward trend of recalls and the multiplicity of companies that experience recalls for the same reasons annually, it is clear device companies still struggle to identify proper mitigations for the reoccurrence of these hazards. Why Do issues Related to software controls Reoccur? While software-controlled devices predate the 1976 Food, Drug, and Cosmetic Act that officially expanded FDA's scope of jurisdiction to cover medical devices, the ever-escalating complexity of software technology continues to be a challenge for health authorities. As ev- idenced by the release of both the 2002 General Principles of Software Validation and 2005 Content of Pre-Market Submission for Software Controlled Medical Devices guidance documents, FDA has initiated "ongoing efforts to state their recommendations more clearly and ensure they remain current as technology advances." In addition, 11% of FDA's planned draft guidance documents for 2016 are spe- cific to the topic of software. Despite FDA's best efforts to stay ahead of technological compli- cations posed by an influx of intricate software-controlled devices, analytics of recall trends related to software continue to demon- strate a disconnect between the availability of guidance and risk in- formation to manufacturers, and the ability of those manufacturers to actually mitigate issues. It is apparent that FDA is investing considerable time and ef- fort in trying to reduce device problems and recalls; it is also clear that regulations for manufacturers incorporating risk management have been in place for several years. What is not clear is how device manufacturers are implementing these requirements. Therefore, we must again ask whether the information provided in this article in- dicates a problem that is more behavioral than technological. production controls When you take into consideration that elements of the manufacture and servicing of medical devices make up nearly a quarter of the con- trols set in place by FDA's 21 CFR 820 Quality System Requirements, it comes as no surprise that recalls related to these same controls make up 24% of all recalls since 2010, according to Blue Lynx Consulting. While the controls set forth by FDA in the 1978 Food, Drug, and Cosmetic Act (amended in 1990 to include design controls) were aimed at providing consumers with safer and more effective products, recalls related to production controls have accounted for an average of 665 recalls per year since 2010, with an annual growth rate of 11% per- cent over the same five-year span, according to Blue Lynx Consulting. In comparison with the astronomical growth rates of the other two leading causes of medical device recalls, those related to pro- duction controls are growing at a much slower rate, according to Blue Lynx Consulting's analysis. But while some members of indus- try may view this as a positive, production controls continue to be the second leading cause of medical device recalls on a yearly basis. Furthermore, the year-to-year fluctuations of both production control recalls and their subcategories demonstrates the inability of industry to adequately control these recalls and set into place the proper mitigations to prevent their growth. Specifically, the giant swings in areas of production controls like errors in labeling and packaging (Figure 5) exhibit industry's inability to control adverse events in areas of business that should be easy wins. Why Do issues Related to production controls Reoccur? While the fluctuations in yearly growth percentages related to production control recalls may be vast, three failure modes consis- tently account from more than 65% of all manufacturers' recalls of the same category. Specifically, recalls related to process controls, packaging, and packaging controls made up an average of 68% of all production control recalls from 2010 to 2015, with bookend highs coming in 2010 (77%) and 2015 (76%). As a result, any hope the medical device industry has of stem- ming future issues related to production controls must begin with a tactical plan aimed at reducing the hazards associated with these specific failure modes and working outward throughout the year without losing focus on other known issues that are potentially harmful to both the business and end user. 400 500 300 200 100 0 Software Recall Growth Rate by Percent 2010–2015 Cumulative Growth Software Design 96% 214% 460% Software Change Control Software Process Design 160 120 80 40 0 Ð40 Labeling/Packaging Recalls: Percent Growth 2010–2014 86% Ð23% 144% % Growth 2010Ð2011 2011Ð2012 2013Ð2014 2012Ð2013 Ð31% Figure 4. Recalls related to software design, software change control, and software process design have been on the rise. Figure 5. There have been huge swings in areas of production controls such as errors in labeling and packaging.

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