FDA Hosting Public Workshop on Device Risk in Postmarket Setting

Posted March 20, 2015

The U.S. Food and Drug Administration (FDA) is hosting a public workshop next month on the clinical considerations of risk with a medical device that is already on the market and in use.

The agency says it wants to hear from all stakeholders about what to do when hazards develop in the postmarket setting—hazards that were either not known at the time the device was originally cleared for market or hazards that “were anticipated, but harm occurs at an unexpected rate or in unexpected populations or use environments.”
Furthermore, the FDA says it wants to work with the medical device industry to “harmonize” practices related to postmarket risk assessment, so that there is a better understanding of what actions may be needed when problems arise.

At the April 21 workshop—to be held at the agency’s White Oak campus in Silver Spring, MD—FDA officials will seek input on a draft list of risk principles and factors to consider when analyzing postmarket risk. A 15-page paper listing these principles was developed in cooperation with an AAMI working group and is intended to articulate “a shared view of risk.”  The draft paper is available online.

Interested parties may submit comments on the paper by e-mail to AAMI President Mary Logan at mlogan@aami.org and Lauren Clauser at lclauser@aami.org, by May 20, 2015.

The workshop will cover the following topics: what factors are important to consider when conducting risk assessments of marketed devices; are there improvements that the agency and industry can make to enhance risk assessments during medical device recalls and shortages; what conflicting practices are used by the FDA and industry that cause confusion or delay appropriate public health actions; and what potential policies or guidance would prove useful for industry to ensure postmarket quality, compliance, and safety, according to a March 19 Federal Register announcement.

The agency emphasized that the goal of the workshop is not to eliminate risk, saying that risk will always be a factor. “The medical device industry, FDA, doctors, and patients recognize that medical devices cleared or approved for market may pose some inherent risk, even when used appropriately according to labeling,” the agency said in its public notice.

The agency is seeking comments on the workshop topics from medical device manufacturers, standards organizations, healthcare providers, academia, patients, and other interested parties.

AAMI has a number of resources dedicated to risk management, including the spring edition of Horizons, a supplement to AAMI’s peer-reviewed journal BI&T (Biomedical Instrumentation & Technology). The publication features best practices in applying risk management terminology and an article on the use of safety assurance cases.

Additionally, AAMI University offers a course for medical device manufacturers on integrating risk management into the quality system.  

In late September, AAMI and the FDA will hold a two-day summit on risk management. The two organizations have joined forces before to organize summits on issues of interest to the healthcare technology community.