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.