Healthcare Device Adverse Event Recognition and Investigation

​Any general discussion related to investigation of healthcare device accidents must be limited due to the vast diversity of technologies and devices. Chapters or entire texts could be dedicated to the techniques and subtleties of investigating technologies (e.g., infusion pumps, wheelchairs, resident lifts, specialty beds) as well as disposable devices (e.g., catheters, breathing circuits, electrodes, tubing sets).

This guidance article covers basic areas of healthcare device accident investigation, including general causes of healthcare device accidents, device interfaces, investigation guidelines, information collection, equipment inspection and testing, and interviewing.

Information on the tracking and analysis of general problems related to individual technologies, to device-related techniques, or to manufacturer product lines is not included.

Most serious or fatal healthcare-device-related accidents occur in the healthcare facility, although accidents in the home setting with devices that are provided and maintained by the healthcare facility (or possibly a durable medical equipment DME supplier) are becoming more common. Healthcare facilities and other user facilities are usually the first to become aware of an accident and have the best access to the relevant device(s); equipment purchasing, maintenance, and repair records; personnel; and resident records. Both healthcare facilities and their contracted independent investigators are then in the best position to quickly and fully investigatemost aspects of an accident.

The goals of an internal accident investigation are to determine what happened, why it happened, and which corrective actions and preventive measures can be taken. The goal is not to assign blame. Accident investigations are performed soon after the event and typically include a review of event reports, resident charts, equipment-related documentation, and healthcare facility procedures. Involved personnel are interviewed. Equipment is examined and tested, frequently under conditions similar or identical...