A postmarket surveillance benchmarking exercise.

Abstract

Monitoring device performance after a product has been launched is a critical aspect of maintaining product safety. Not only is it the right thing to do, but our regulators expect that it’s done. • FDA 21 CFR 822 discusses monitoring and evaluation of product performance data. • The medical device risk management standard ISO 14971 requires that manufacturers establish, document, and maintain a system to collect post-production quality information and act on that information. • MEDDEV 2.12-1 specifically discusses the guideline that product incidents shall be monitored against established trigger levels based on risk documentation, and expects a manufacturer to submit a report to the competent authorities when those expected thresholds are exceeded. A good postmarket surveillance system can inform a company of emerging issues before they lead to patient harm, or even prevent exposure of potentially brand-damaging problems. In an effort to benchmark practices at several medical device companies, a survey was sent out in September 2013 asking questions regarding their systems to monitor and act upon postmarket data. This article summarizes those findings.