MDDI_Medical Device & Diagnostic Industry

MDDI, July 2016

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MD + DI MEDICAL DEVICE AND DIAGNOSTIC INDUSTRY July 2016 | 23 conclusion Throughout this article, the statistical evidence has demonstrated that issues that result in medical device recalls do not only reoccur; the existence of the reoccurrence points to a more severe and altogether disconcerting problem. When more granular analysis is applied to the reoccurrence of these adverse events, evidence unveils industry's in- ability to demonstrate year-to-year control over its products. Sadly, the history of the medical device industry parallels New- ton's Third Law of Physics. For every Cooper Committee, there is a Therac 25 tragedy; for every 21 CFR 820, there is a Super Bug out- break. The question remains: Does it have to be this way? It has been more than 75 years since U.S. lawmakers explicitly recognized the safety challenges posed by medical devices and included them as a distinct category of products regulated by the Food, Drug, and Cosmetic Act of 1938. Since the establishment of this early legislation, the risks related to medical devices and their ever-expanding technologies have come to fruition despite FDA's efforts to provide industry with a set of proactive tools for mitiga- tion. Despite the availability of information and legislation born from FDA-sanctioned committees like 1970's Cooper Committee and an influx of device regulations promulgated by the agency in the 1990s, medical device recalls reached an all-time high in 2014 (2823 recalls). While it is apparent that FDA is investing considerable time and effort to reduce device issues and recalls, the upward trend related to recalls appears to point to a disconnect between the efforts of the health authority and manufacturers' ultimate understanding of mitigation strategies. To fully understand this disconnect, consider the following: Between January 1, 2010, and December 31, 2015, FDA released 183 draft and final guidance documents related to the life cycle management of medical devices. In that same time period, Class I recalls grew at an annual rate of 29%, topping out in 2014 with 543 total recalls. Given the plethora of information health authorities provide medical device manufacturers, it seems unfathomable that those same manufacturers would have multiple recalls in a five-year span. However, as our research demonstrates, 30% of manufacturers ex- periencing field actions in 2010 were once again opening recalls for similar product issues within the next five years. With first-quarter 2016 recall numbers peaking above the industry horizon, early av- erages show a recall epidemic that has the ability to grow another 2% over final returns from 2015. These returns, coupled with the five-year upward trend of adverse events, beg the question: Why do these problems keep reoccurring? In response to this confounding query, global health authorities have spent the past five years placing a greater emphasis on the use of risk management in the medical device total product life cycle. With the institution of safety assurance cases from FDA for infu- sion pumps and the more recent revision to ISO 13485, health au- thorities and standards associations alike have provided industry a foundation aimed at integrating risk management throughout the product's life cycle, including playing a larger role in quality manage- ment system processes. Still, the efforts surrounding a more mature and holistic version of risk management have done little to stem the tide of this recall epidemic. As such, research conducted regarding industry's view of risk management points to a problem more rooted in culture. A 2011 survey of risk management professionals reported that many in- dividuals involved with risk management had a relatively shallow understanding of the tools and techniques available to aid in their risk management initiatives. 3 It also found that risk management was viewed as a necessary evil; one group of participants (16 out of 46) suggested that organizations do not know how to tie risk man- agement into the elements of a quality system. This information, when coupled with health authorities' proliferation of guidance to aid manufacturers in their fight against adverse events, uncovers a more viable truth: The reactive behavior of manufacturers is a mas- sive contributor to their unmitigated failures. In a February 29, 2016, article for the Harvard Business Review, Francisco Poliodoro tackled a similar question in response to business failures at U.S. space agency NASA and global oil and gas company BP. While each organization had experienced cata- strophic events leading to the deaths of employees and the loss of millions of dollars, they were unable to introduce the proper controls to prevent reoccurrences. BP, for example, experienced two large oil disasters within five years of each other, leading to the death of 26 workers. The second of the two events, 2010's ex- plosion of the Deepwater Horizon oil rig, caused an oil spill of epic proportions, leading to severe long-term environmental effects in the Gulf of Mexico. The company also suffered huge losses, includ- ing multiple public protests by consumers and an $8 billion loss of funds in a court settlement. Analogous to what is happening in the medical device industry regarding reoccurring recalls, both NASA and BP were provided with the foresight to produce a proactive culture to ensure safer and more effective business practices. However, as Poliodoro pointed out, "safety-related behaviors fade over time and other motivating forces come to the fore, gradually launching the seeds of the next error." If you consider the current issues facing medical device manu- facturers in parallel with Poliodoro's theory regarding the reoccur- rence of adverse events being tied to behavioral issues—or, in this case, a company's inability to disengage from the reactive cycle and learn from both the knowledge afforded it by health authorities and its own past failures—it is clear that the main impediments to the reduction of adverse events are the companies themselves. References 1. J.A. Johnson, FDA Regulation of Medical Devices, [online] (Congressional Research Service, 25 June 2012); available from Internet: crs/misc/R42130.pdf. 2. B.A. Rose, Fatal Dose, [online] (Canadian Coalition for Nuclear Responsibility, June 1994); available from Internet: 3. T.C. Chan, Implementation of Risk Management in Medical Device Companies: A Survey Analysis of Current Practices, [online] (University of Southern Cali- fornia, Los Angeles, 2012); available from Internet: http://search.proquest. com/docview/1288414340. Joshua R. Dix is a regulatory affairs specialist. You can reach him at Suraj Ramachandran is a regulatory affairs manager. Reach him at Darin S. Oppenheimer is a director of regulatory CMC and combination products. Reach him at 2

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