Speaking at the North Carolina Biomedical Association’s annual symposium on September 3, Alan Lipschultz of HealthCare Technology Consulting urged his audience of biomeds to be vigilant about identifying and reporting incidents involving medical devices. Collaborating with other hospital departments and manufacturers is key to the process, he said.
Lipschultz began his session by defining four types of medical device events:
- Adverse patient event (APE), an unanticipated event that causes harm to a patient.
- Device-related event, an APE that involves a medical device.
- Near-miss event, a precursor of an adverse event that points to specific individual or system failure. This type of event is “much more common” than an APE and “represents greater opportunity to improve safety,” Lipschultz said.
- Close call, a Joint Commission term used to describe a process variation that did not affect outcome.
Evidence from the Department of Health & Human Services (HHS) suggests that hospitals to date are not doing well in reporting events, as required by CMS. A 2012 report from HHS found that “hospital reporting systems only captured 14% of incidents in October 2008,” Lipschultz said.
Compounding this lack of reporting, Lipschultz said, will be the pending implementation of electronic medical reporting. Studies have shown, he said, that “facilities instituting EMRs are seeing big increases in APEs reported.” As a result, he continued, biomeds “need to be prepared to deal with such events increasing suddenly.”
When confronted with an incident, Lipschultz said, one’s “natural instinct is to figure out what went wrong ASAP,” but it may be wiser to take some time to “consider the best approach to the investigation.” Delay may allow better understanding of what happened, he said. In addition, it may be appropriate to have others, such as the manufacturer or neutral parties, to be involved. And finally, it is possible that the clinical engineering department may have a conflict of interest in the investigation if maintenance is involved in the incident.
Biomedical departments should also have close cooperation with risk managers within their facilities, Lipschultz said. There should be a formal agreement between the two groups about when to involve each other in an investigation.
Documentation of maintenance is especially important, Lipschultz added. If a legal action develops as a result of an event, he said, it could involve maintenance performed months or years earlier. Good documentation may be essential to determining whether maintenance was involved in the event.