Risk Management Tips for Device-Related Events

May 1, 2004 | Healthcare Risk, Quality, & Safety Guidance


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 in Sample Letter: Manufacturer Inspection of Incident-Related Device.

Healthcare facilities should also consider recording information about devices that, though not necessarily involved in life support, are commonly involved in recalls or incidents. Such devices include the following (detailed information on...

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