Investigating medical device incidents do's and don'ts

by John R. Fischer, Senior Reporter | November 23, 2021
HTM Parts And Service Risk Management
From the November 2021 issue of HealthCare Business News magazine


Among his recommendations are that clinical engineers receive automatic notifications of when events occur and be aware of policies for appropriately responding to serious injuries and death. Retrieving error codes and data logs before the device is used on patients or unplugged is also a must, as is the impounding of equipment for safety testing before being used again. “You want to make sure a device involved in an event does not get recycled back into the general patient flow until it has been eliminated as a possible source of injury,” he said.

Any investigation should include the manufacturer of the device in question, as it knows its technology the best and may be aware of similar incidents. In addition, clinical engineers must work with risk managers to conduct interviews appropriately with clinical staff on what led to the incident.

All investigations must be documented and written up in reports submitted to the FDA, Joint Commission, hospital safety boards, risk management and other appropriate entities. Reports should not include opinions or conclusions but only facts. A follow-up process should then be used to ensure all information has been collected and is accurate.

“Once you have all this information you have to establish a line of communication as appropriate, depending on the nature of the incident, depending on what clinical area of the hospital is affected,” said Subhan, chief biomedical engineer of VA Greater Los Angeles Healthcare System.

He says the aftermath of an investigation should be treated as an opportunity to learn from mistakes and take corrective actions, such as removing devices from service, upgrading in-service education programs and reviewing training and protocols. Corrective actions must be continually monitored.

He adds that the best way to help prevent similar incidents in the future is to make people both in and outside your institution aware of it. “One of the suggestions we have is maybe you can put together an article and publish it in one of the HTM publications so people can learn through your incident investigation.”

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