Ask HRC: Using Unapproved Accessories to Modify Medical Devices
August 6, 2007 | Healthcare Risk, Quality, & Safety Guidance
An HRC member recently inquired about how to handle the modification of a medical device with accessories not approved by the manufacturer, noting that a medical staff member wanted to customize a piece of equipment for use in the facility. In our response, we address user-modified equipment by recommending against implementing all but the simplest device modifications requested by clinicians. We define modificationas the replacing, remounting, adjusting, or adding of components or subsystems to a device to improve safety, reliability, or performance.
Modifications recommended by the manufacturer or other recognized sources should usually be implemented at once. Modifications by a healthcare facility to meet its special needs, on the other hand, should be discussed and approved by the clinical engineering department, administration, risk management, and clinical staff. Whenever such modifications are contemplated, consideration must be given to the possible technical and clinical effects, as well as liability risks and regulatory agency requirements. A healthcare facility should document a well-reasoned need for a device to be modified, including the fact that an equivalent device is not commercially available. It should also document considerations taken and testing performed to ensure the safety and efficacy of the modified device. After modification, the device should be inventoried, and the facility must remain vigilant for any recalls affecting the original device. In addition, it may be necessary to modify the inspection and preventive maintenance activities...