About Medical Device Safety Reports (MDSR)

Medical devices sustain life, alleviate pain, and overcome disability. They also, on occasion, fail to operate properly or are misused in ways that cause injuries and deaths. Since 1968, ECRI Institute, a nonprofit health services research agency, has investigated thousands of such problems--more than any other organization or government agency. It does so on behalf of healthcare facilities, regulatory agencies, insurance companies, medical examiners, patients, and attorneys.

In addition, ECRI Institute has operated an international medical device problem reporting system since 1971. Through this system, we encourage readers, healthcare providers, patients, and manufacturers to report all medical device related incidents and deficiencies to us so that we can determine whether a report reflects a random failure or one that is likely to recur and cause harm. Concerned parties can submit problem reports to us in a letter, by phone or fax, or by using our Problem Reporting Form.

ECRI Institute has written more than 1,300 original case reports containing recommendations for prevention or remediation of medical device hazards. Some of these cases--usually the most critical or severe--are then published in the form of Hazard Reports or User Experience Network™ Reports in ECRI Institute's journal, Health Devices, which is widely known as the Consumer Reports of medical devices. ECRI Institute also publishes information to help healthcare professionals avoid medical device injury and manage medical devices properly through Guidance Articles, Frequently Asked Questions (FAQs), posters, and checklists in Health Devices.

Medical Devices Safety Reports (MDSR) provide free access to a carefully selected and edited selection of more than 200 documents and case studies. In their original form, many of these reports contained specific reference to certain makes and models of medical devices, many of which are no longer in use. This identifying information has been removed, but the citation to the original published Health Devices report is given. The incident described, type of device involved, lessons learned, and ECRI Institute's safety recommendations remain relevant and timeless.

MDSR is not an alerting service, but a collective look at the types of problems that have occurred with medical devices over the last 30 years. ECRI Institute does provide weekly alerts of medical device hazards and recalls through membership in its Health Devices System.

For more information on the various report classifications, click here.

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