FDA Looks to Boost Hospital-Based Surveillance of Device-Related Adverse Events — Physician’s First Watch

Medical News |
October 26, 2016

FDA Looks to Boost Hospital-Based Surveillance of Device-Related Adverse Events

By Kelly Young

Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM

The FDA says that hospitals are underreporting injuries and deaths related to medical devices.

The agency inspected 17 hospitals that had reports of either uterine cancer spread by power morcellators or infections tied to use of contaminated duodenoscopes. Hospitals often did not properly report adverse events to the FDA or to the device manufacturer. In some instances, hospitals had no procedures or training in place to do so.

"We believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals," Dr. Jeffrey Shuren, Director of the FDA's Center for Devices and Radiological Health, wrote in a blog post.

In December, the agency will host a workshop to gather ideas and advice for how to improve hospital-based surveillance of device problems.

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