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W-34: Risk Management and Recalls





Poster Presenter

      Darin Oppenheimer

      • Director, Regulatory Affairs CMC
      • Merck & Co., Inc.
        United States

Objectives

This study surveys the risk managers of U.S. medical device enterprises to identify their views regarding current practices of risk management and its effectiveness at mitigating quality problems and recalls.

Method

Invitations to participate in the survey were sent in mid-August, 2016, to an initial cohort of 224 potential participants who appeared to meet established inclusion criteria. Of this group, 50% (112/224) responded with expressions of interest.

Results

Results suggest that most organizations invest insufficient resources to support risk management activities, and these resources are focused predominately at early stages of product management. It further suggests that risk management teams and participants could profit from deeper education with regard to different types of tools and a wider appreciation of enterprise risk management approaches. Most respondents appeared to believe that their organization had an adequate risk management system in place, but this belief is challenged by the repeated problems seen with industry recalls.

Conclusion

Medical device manufacturers must anticipate product failures that could pose safety risks for patients through the use of systematized risk management methods. However, product recalls and safety problems continue to increase, so that the effectiveness of risk management implementation is brought into question. In a 2011 survey, Chan (2012) reported that many individuals involved with risk management had a relatively shallow understanding of the tools and techniques that might help to improve their risk management initiatives and were in companies that viewed risk management as a “necessary evil”. Since that time, much has happened to increase the scrutiny on risk management, but it is not clear whether these efforts have improved the state of risk management.