"So examine the instructions, the familiarity of the user with the device and if the device design invited error," said Bruley.

Clearly, part of the process will also include staff and even patient interviews about the incident. All of this information would most likely go into an oral or written report as well.


Whether based on guidelines, medical records, equipment testing or interviews, evidence must always support the conclusion, according to Bruley.

Preserving evidence

Since evidence is clearly needed, preserving it properly requires a thought-out process, according to Hansel.

He would even go as far as to say it should be part of the training for new hires.

One of the first questions Hansel asks a hospital during an investigation is whether they still have the evidence, or the device. "And the answer is usually no, it's been thrown away."

He said keeping the evidence is important not only for the investigation, but for preventing recurrences as well. In fact, ECRI Institute has guidance documents with various suggestions on what to save, how long it should be saved and how to decontaminate and label a device for storage. The document is also meant to be on hand in various hospital departments in the immediate aftermath of an event for personnel to refer to.

However, Hansel said becoming overly concerned with evidence shouldn't lead to forgetting about what's really important in medical device accident investigations.

"Patients come first. So don't preserve [the evidence]it if it's going to hurt the patient."

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