Medical Device Problem Reporting
ECRI Institute encourages the reporting of medical
device problems and hazards. This can be done using ECRI Institute's Problem Reporting Form.
The link below will open a new browser window and load
ECRI Institute's Problem Reporting Form. When you have submitted your information,
simply close the window to return here.
Click here to access ECRI Institute's Problem Reporting Form.
For nearly 30 years, ECRI Institute has gathered and investigated reports
of incidents involving medical devices from healthcare providers, patients, and
manufacturers from around the world. As a result, thousands of devices have been
recalled or modified by their manufacturers. We encourage healthcare providers, patients, and
manufacturers to report medical device related incidents and deficiencies to
us so we can determine whether a report reflects a random failure or one that is likely to
recur and cause harm. Reports can also be submitted to us by letter, telephone, or fax.
ECRI Institute acknowledges receipt of the report and informs the reporting party of our finding and
opinions in cases for which we can provide guidance; otherwise, we log the report in our
system and monitor the situation for developing trends of similar problems. As soon as
members of ECRI Institute's staff--clinical engineers and other technical specialists who have
expertise in biomedical, electronic, chemical, radiologic, and computer
technologies--determine that specific device hazards and problems may exist, ECRI Institute informs
the manufacturers and encourages them to respond constructively and correct the problem.
The name of the reporting institution and of the person making the report is never
revealed without permission.