Eighty percent of 150 hospital representatives participating in a recent webinar hosted by ECRI Institute said they've had to perform a medical device accident investigation in the last two years, making them a common issue hospitals have to deal with, and an equally important one, since protecting patient safety is a top priority.

But medical device accident protocol is more complicated than it would appear, since health care environments are made up of a series of interconnected devices, according to Mark Bruley, vice president of accident and forensic investigation at ECRI Institute.

"It's important to understand that in all accidents, almost 100 percent of what you're dealing with is a system of medical devices," he said.
Diagnosing and fixing the device that caused the problem is more than a technical review, it's an investigation that involves a series of interfaces, and a team effort.

Step one: Take action

"It's important that risk managers be notified immediately when an incident happens," said Bruce Hansel, executive director of accident and forensic investigation at ECRI Institute. "We hear over and over that the risk manager didn't know until later."

Once the ball is rolling, a team consisting of biomeds, clinicians, safety committee members, and possibly legal counsel should put together an action plan. They will also be part of the investigation and testimony later on if necessary.

An initial step in the investigation should be figuring out the root cause of the problem. Since it's more complicated than testing the device — a task normally performed by the hospital's biomed department — Bruley urged them to instead examine the different device interfaces: the link between the user and the device, the patient and the device, the accessories/disposables and the capital equipment, and the device and the environment in which it's used, for instance, the hospital or home setting.

The investigation would also include figuring out which factors led to the accident. These could range from external factors, labeling and other sorts of errors from the manufacturers, to a person actually tampering with the device.

"In our experience, sabotage is actually something you need to consider," said Bruley.

But overall, he said, device failures happen because of user errors. For example, hospital staff misconnecting the device, or not monitoring the patient properly.

Since user error is such a large percent of medical device-related accidents, investigations should involve a thorough comparison of the cause of the user error and the device malfunction.

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