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.

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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.

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