Risk Management Tips for Device-Related Events

As risk managers know, clinical staff sometimes do not preserve all equipment involved in an event, especially disposable devices and associated packaging. Staff may not understand the need to preserve the equipment or they are concerned about time constraints. In addition, staff often do not record all relevant device-related information in the event report, such as the device's manufacturer and model number, date of application, placement, lot and/or serial number, and date used on or removed from the patient. This means that information necessary to an investigation of an event that may involve patient injury or death is often lost or unavailable to the risk manager and investigators when it is needed.

This Risk Analysis describes procedures for handling medical devices involved in events or accidents, including documentation and impounding of devices, and maintaining a chain of custody. A sample letter to send to manufacturers to secure their cooperation in preserving devices when they must be returned is also included inSample Letter: Manufacturer Inspection of Incident-Related Device.

Ideally, all device-identifying information should be recorded in the patient's chart so that it is readily available. It is unrealistic, however, to assume that healthcare facilities can accomplish this rather burdensome record-keeping task. Therefore, we recommend that identifying information (serial, control, or lot number) be recorded for life-support devices, both equipment and accessories, which may or may not be disposable. Such devices...