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ECRI Institute > Patient Safety Center > Medical Device Problem Reporting

Medical Device Problem Reporting

Reporting a Problem to ECRI Institute

You may report suspected problems to us using our online Problem Reporting Network (PRN) form.

We strongly encourage healthcare providers, patients, and manufacturers to report medical-device-related incidents and deficiencies to us. For 40 years, ECRI Institute has gathered and investigated reports of incidents involving medical devices (including capital equipment, reusable and disposable instruments, and reagents).

In cases where we can provide guidance related to the report, we inform the reporting party of our findings and opinions. Otherwise, we monitor the situation for developing trends of similar problems.

As soon as we determine that specific device hazards and problems may exist, we inform the manufacturers and encourage them to correct the problem. (The reporter's identity is never revealed without permission.)

We publish many device-related reports as Hazard Reports and User Experience Network™ articles in Health Devices and as Hazard Bulletins, Urgent Bulletins, and Action Items in Health Devices Alerts.

You may also report problems by downloading and completing our PRN Form.

Fax or mail your report to:

ECRI Institute
5200 Butler Pike
Plymouth Meeting PA, 19462-1298, USA
Fax: (610) 834-1275

Report to FDA
In cases where a death or serious injury results, facilities may be required to report the incident to the U.S. Food and Drug Administration (FDA) or to the device manufacturer. Healthcare facilities can download FDA MedWatch forms and instructions directly from FDA's Web site.

As of December 31, 2007, ECRI Institute discontinued its Computerized Problem Reporting System for submitting a report to FDA and/or a device manufacturer. Please click here for more information.

Members of ECRI Institute's Continuing Care Risk Management System, Healthcare Risk Control System, Health Devices System, Health Devices Gold, and SELECTplus™ program may still access our Computerized Problem Reporting System (special password required) for their archived reports.