Investigating a medical device-related incident properly can save providers money and avoid lawsuits

Investigating medical device incidents do's and don'ts

November 23, 2021
by John R. Fischer, Senior Reporter
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.”

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.”