Medical Device Safety and Monitoring Issues

Safety checks play a vital role in the security and confidence the consumer presumably has in a medical device or apparatus. The U.S. Food and Drug Administration (FDA) is the authority the public counts on for verification of a medical product or device. Despite the approval, or lack of it, there are approximately 3,000 deaths a year resulting from medical device problems, according to the Brookings Institute, reports The New York Times.

Prescription drugs have a data base that is made public by Medicare for medical claims and is readily accessible. Medical devices, however, have a “passive system” of notification which means hospitals, nursing homes, medical device manufacturers and importers are required to notify the FDA of problems or adverse effects as they arise. Doctors, nurses, and other health care professionals are not held to the same requirement, reports the Times. The FDA categorizes this sort of voluntary data collected as potentially “incomplete, inaccurate, untimely, unverified, or biased.”

As a reflection of this, a Senate report released in 2016 accused the Japanese manufacturer Olympus of hospitals’ conducting a “lethargic investigation” involving allegedly contaminated duodenoscopes. Another example, the birth control Esssure, has come under scrutiny for not properly collecting data that involved serious health risks, reports the Times.

A suggested solution is for the FDA to do for medical devices what has been done for drugs, which is to utilize a database to “confirm or clear” problematic drugs. The ongoing progress in technology with increased standardized methods of data-gathering will undoubtedly lead to strides and improvement in medical device safety.

This entry was posted in Defective Medical Devices. Bookmark the permalink.


© 2005-2018 Parker Waichman LLP ®. All Rights Reserved.