Medical Device Safety

Medical devices are any materials, hardware or equipment implanted or used on a patient’s body.  They include knee, hip, spine, heart and breast implants, heart pacemakers, and many others.  They also include devices used by healthcare professionals to monitor, test or treat you in the hospital (Intravenous pumps, insulin pumps, scoping instruments used for things like colonoscopies, etc.).

There is no doubt that knee and hip replacements have improved the quality of life for many, many patients. Pacemakers can keep hearts beating in a healthy rhythm. Many, many patients go on to lead more productive lives after implant surgery. 

Medical device safety is monitored by the Food and Drug Administration through safety reports entered into an FDA database (called MedWatch) by the manufacturer, doctors, surgeons and patients or families.  Unfortunately, as you can see from some of the news articles below, the FDA’s performance in monitoring and following up on the safety events reported to them has been called into serious question recently.  This has resulted in many patients being harmed from some devices.  The FDA is working to improve the transparency of medical device safety incidents as a result, as well as labeling of medical devices with special indentifiers.

If you are having a device implanted in your body, you can discuss the device safety record and ask your surgeon for a copy of the medical device manufacturer’s product sheet to keep with your medical files in case you have any future issues. The name of the device, model or ID number, manufacturing date, and company name are all good things to keep on file. 

You can also look up the device on the FDA website and do a search for any reported safety issues for further discussion with your surgeon (see links below)

Read More

Resources

Track My Solutions
Whether you have a knee, hip or other orthopedic implant, a pacemaker or other implanted device, this is a free service that alerts you directly if there is a recall on your specific medical device. They have an app that you can download called 'Track My Implant'. You register your 'UDI' number (Unique Device Identification) and if you don't know it,  you can get assistance finding your UDI.

From the FDA


MedWatch: Report a Medical Device or Drug Safety Issue

FDA Medical Device Safety Page

Public Health & Safety Communications by Year
Risks associated with use of medical devices and
recommendations to avoid or reduce risk.

Medical Device Recalls

Medical Device Bans

 

 

 

 News Articles

Leading the Call for Reform of Medical Device Safety Surveillance, 
The Journal of The American Medical Association Editorial - James Salazar, MD and Rita Redberg, MD, 2019.

Hidden FDA Reports Detail Harm Caused by Scores of Medical Devices
Kaiser Health News by Kristina Jewett, March 7, 2019

Documentary Movies

Kicking the Hornet's Nest Movie Trailer
A movie coming out soon about a medical device called a morcellator,used on many women to remove uterine fibroids. Riveting testimony from patients, families & the medical community about how the device caused undiagnosed cancer to spread, tragically shortening the lives of many women. 

The Bleeding Edge
This Time Magazine article does an in-depth story about the movie & provides a link to the Netflix viewing platform.  The film addresses the dangers and patient harm from common medical devices and the Food & Drug Administration's (FDA) process for reviewing and approving the safety of these, and other devices.

 

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