Ask HRC: Handling Third-Party Medical Devices Involved in Adverse Events

December 23, 2008 | Healthcare Risk, Quality, & Safety Guidance


An HRC member recently asked ECRI Institute for recommendations for handling medical devices owned by a patient or other third party, such as a physician, when the device is known or suspected to have malfunctioned while being used on a patient. For instance, the member asked, should the device be sequestered pending further analysis as if it was owned by the hospital?

In consultation with ECRI Institute’s Accident and Forensic Investigation (AFI) Group, HRC recommended to the member that the equipment be sequestered and not be cleaned or tested, and that, if the involved device or equipment stores data electronically, no data should be downloaded pending an appropriate investigation. The facility should only permit electronic data to be downloaded from the device or equipment, if applicable, in the course of an appropriate investigation, and only by an individual employed or retained by an interested party who is competent and skilled to perform this task. In the event of a lawsuit, lost or compromised data...

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