Medical device recalls reached an all-time high in 2014 despite FDA's best efforts to curb the problem.
Joshua R. Dix, Suraj Ramachandran, Darin S. Oppenheimer
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 mitigation. 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 1990's, medical device recalls reached an all-time high in 2014 (2823 recalls).
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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, one must 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, defined by FDA as recalls in which "dangerous or defective products could predictably cause serious health problems or death" 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 experiencing field actions in 2010 were once again opening recalls for similar product issues within the next five years. As first-quarter 2016 recall numbers start to peak above the industry horizon, early averages 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 begs the question: Why do these issue keep reoccurring?
In response to this confounding query, global health authorities have spent the last five years placing a greater emphasis on the use of risk management in the medical device total product lifecycle. With the institution of safety assurances cases from FDA for infusion pumps and the more recent revision to ISO 13485, health authorities 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 management system processes. Still, the efforts surrounding a more mature and holistic version of risk management has done little to stem the tide of this recall epidemic.
As such, research conducted in 2011 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 individuals involved with risk management had a relatively shallow understanding of the tools and techniques available to aid in their risk management initiatives. It also found that risk management was viewed as a necessary evil; one group of participants (16/46) suggested that organizations do not know how to tie risk management into the elements of a quality system. This information, when partnered 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 massive contributor to their unmitigated failures.
In his February 29th, 2016 article for the Harvard Business Review, Francisco Polidoro tackled a similar question in response to business failures at NASA and BP. While each organization had experienced catastrophic events leading to death of employees and the loss of millions of dollars, they were unable to introduce the proper controls to prevent the 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 explosion of the Deepwater Horizon Oil Rig caused an oil spill of epic proportions causing severe long-term environmental issues in the Gulf of Mexico. The company suffered from huge loses, including multiple public protests by consumers and an 8 billion dollar loss of funds to a court settlement.
Analogous to reoccurring medical device 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 points out, "safety related behaviors fade over time and other motivating forces come to the fore, gradually launching the seeds of the next error." When paralleled with the current issues facing medical device manufacturers, Polidoro's theory regarding the reoccurrence 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 them by health authorities and their own past failures--it is clear the main impediments to the reduction of adverse events are the companies themselves.
Disclaimer: The perspectives shared in this article represent the personal opinions and insights of the individual authors and are not associated with the authors' respective employers.
Note: All supporting statistical information garnered from the FDA Recall Database in support of this article was compiled and provided by Blue Lynx Consulting.
Joshua R. Dix is a regulatory affairs specialist. Based in the Western New York area, he is the global regulatory lead for multiple product platforms with responsibilities including regulatory strategy, submissions, product CAPA, and audits. With extensive experience in both regulatory affairs and quality systems, Dix has worked to bring multiple medical devices to market in more than 20 different countries. He holds a bachelor's degree in English from the State University of New York.
Suraj Ramachandran, MS, is a regulatory affairs manager. Based in the Chicago area, he is involved primarily with managing the infusion pump platform and supporting all new product development and life cycle maintenance activities, including regulatory submissions, design control, audits, and CAPAs. Ramachandran has also led many development efforts regarding medical device software intended for both domestic and international markets. He holds an undergraduate degree in biomedical engineering as well as a master's degree in biomedical engineering from the University of Michigan. In addition, he holds a RAC certification from the Regulatory Affairs Professional Society.
Darin Oppenheimer, MS, is a director of regulatory affairs. He is involved in many facets of the product development life cycle, including regulatory submissions, due diligence, and active participation on industry trade organizations and standards committees. Oppenheimer leads a team of regulatory professionals focusing on electromechanical devices and software. His prior background as a research and development scientist focused on pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery. His undergraduate degree is in molecular biology from the University of Tampa. He also holds two master's degrees from Johns Hopkins University in biotechnology and regulatory science, as well as a graduate certificate in biotechnology enterprise.
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