Investigating medical device incidents do's and don'ts

by John R. Fischer, Senior Reporter | November 23, 2021
HTM Parts And Service Risk Management
Investigating a medical device-related incident properly can save providers money and avoid lawsuits
From the November 2021 issue of HealthCare Business News magazine

All providers have experienced medical device-related incidents. How they investigate and address these events, however, makes all the difference in the repercussions they face.

In a session at the 2021 virtual AAMI eXchange REWIRED event, Arif Subhan and his colleagues, Alan Lipschultz and Frank Painter, discussed a number of ways that clinical engineers in healthcare organizations can prepare and conduct an investigation into such incidents to avoid consequences like unwanted lawsuits, prevent future incidents from occurring and save on time and money. Their session was titled, "How to Handle a Medical Device Incident—HTM Perspective".

“We want to learn from our mistakes. We want to benefit from the problems we’ve had in the past so we don’t have them in the future,” said Painter, an adjunct professor in biomedical engineering at the University of Connecticut.

Any investigation into a medical device incident according to Painter starts with being ready for an investigation. The better the preparation, the more likely providers can answer patient questions and calm them. This decreases the chance of a lawsuit.

To do this, clinical engineers should establish relationships with chains of authority to know whom to report incidents to when they occur. They should especially become close to risk managers, who manage all accidents, keep records of them and lead the way in addressing them.

Clinicians should also be trained on policies for properly documenting hospital incidents. When an actual case does occur, a grab and go toolkit with items such as a digital camera should be ready for clinical engineers to use to evaluate and document the scene. Any disposables should be bagged and labeled, and no cleaning or movement of equipment should occur as this can contaminate evidence. In addition, equipment settings should be preserved. “If the clinicians know about that, they won’t deserve those device settings and they’ll have this information available in the end,” said Painter.

Lipschultz, president of HealthCare Technology Consulting, says how effectively these events are investigated and communicated comes down to policy. Any organization should address all types of incidents in their protocols, from near misses to adverse patients events to adverse device events, especially ones involving serious injuries or deaths. “It’s also key to look at in your institutions how easy it is for clinicians to report adverse patient events. If it’s not easy then the clinicians will not report them.”

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