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Top 5 Causes of Medical Device Recalls

From cardiac devices to knee implants, millions of Americans rely on medical equipment to improve their health and overall quality of life. As the medical device market continues to grow and reach more patients in more countries, recalls in this sector are also growing more complex. With this growing complexity, it becomes more important than ever for manufacturers to be prepared and maintain regulatory compliance. As we’ve seen in recent recall events, there are a variety of reasons that can cause a recall to occur and manufacturers should be keenly aware that a recall could take place at any time.

The Stericycle ExpertSOLUTIONS Quarterly Index looks at FDA recall numbers and highlights the key recall trends in the medical device industry. When we look at recent data, the top causes of medical device recalls since Q1 2014 include:

  • Packaging Issues – Leaking/Labeling – 101MM Units – 53%
  • Fault Device Connection – 19MM units – 10%
  • Particulate Matter – 17MM units – 9%
  • Med Device Component Change – 14MM units – 7%
  • Fault Device – Leakage – 14 MM units 7%

The top driver of medical device recalls since Q1 2014 was packaging issues with 53 percent due to leaking and/or labeling errors. Some of these issues include age or weight specific usage information not provided on the packaging or non-sterile outer package issues.

Fault device connection was also a leading cause of recalls. As technology continues to advance, it is likely that connection and software errors will continue to increase complexity and could lead to further recalls. In fact, a recent report from Transparency Market Research values the global medical device connectivity market at $33.5 billion by 2019.

No matter the cause, executing a medical device recall is no easy feat and requires preparation. With increasingly complex domestic and international distribution requirements as well as strict FDA regulations, it is critical manufacturers have best practices in place to address the challenges of recall execution. For instance, documentation and traceability are two key areas manufacturers should be focused on for regulatory compliance reasons and staying prepared ahead of a potential recall event. This should be a major component of a product recall plan designed to streamline recall response and ensure the organization is prepared for the eventuality of an issue.

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