Produced by Galveston Shriners Burn Hospital and
The University of Texas
Medical Branch Blocker Burn Unit.
Contributors: Sally Abston MD, Patricia Blakeney
PhD, Manubhai Desai MD,
Patricia Edgar RN, CIC, John P Heggers PhD, David N Herndon MD,
Marsha Hildreth RD,
Ray J Nichols Jr. MD
SAFE MEDICAL DEVICES
Medical device - any implement used to assess,
treat, or rehabilitate a patient, with the exception of drugs.
The federal "Safe Medical Devices Act" requires that
medical devices that injure patients or employees, be reported and
Medical Devices Reportable Incident (MDR) - any event in which a
medical device causes serious illness, serious injury, or death.
When an MDR occurs:
1. The patient or injured party comes first. Notify the in-house
physician in all cases.
2. Attend to the physical and emotional needs of the injured person.
3. Remove and impound the medical device.
- Label the device.
- Save all materials and packaging related to the device.
- Leave the device intact. Do not disassemble, clean or otherwise
- Protect yourself and others by using universal precautions and biohazard
4. Report the incident to your supervisor AND notify the Risk Manager.
5. The Risk Manager will give instructions for handling of impounded
equipment for evaluation and repair.
6. You may be instructed by your supervisor to complete the Shriners
Galveston Hospital occurrence report form. Do not complete this form
until instructed to do so by your manager.
7. A physician must examine the patient or injured party. They
will evaluate the severity of the injury, document their findings, and state
what treatment was initiated. There are no exceptions, no matter how
small a patient injury seems to be.
If medical equipment malfunctions or is
involved in a patient injury, first take care of the patient and
immediately notify the in-house physician.
√ Impound the equipment and any disposable parts that connect, and
√ Notify Risk Management (#6675 or pager 645-5670) where the equipment
is and what has happened STAT.
√ Await instructions from your supervisor on completing occurrence