Properly Manage a Medical Device Recall [5 steps]

Medical device recalls have been on the rise for over a decade, with 51.2% of the recalls contributing to quality issues in the first quarter of 2019. Whereas for the first time since the third quarter of 2016, quality issues were the leading cause of medical device recalls. The average recall size in the first quarter of 2019 was 823,126; the highest since 2006.

While nobody likes to think about the possibility of a recall, having a well-documented remediation plan can mean the difference between a streamlined recall and widespread public panic.

What is your objective when a medical device recall occurs?

For the FDA, reducing risk to consumer safety should be considered the primary objective. Unfortunately, removing the product from the market is not always ideal, however, it may be necessary based on the risk to public health.

What is your organization’s plan to restore trust?

Customers and distributors may question your organization’s efforts and communications after a recall. How you execute the recall will be a significant factor in how soon your organization can restore its reputation and gain back public trust.

This article will discuss five steps an organization can take to better manage possible future recalls.