March

2. So who has operational responsibility for maintaining and repairing clinical equipment? The Bio-Medical Department

3. Why? To reduce the risk of injury to the patient and staff user from the use of clinical equipment. How? Clinical equipment rented or owned by University Hospitals is checked before being used. All equipment? Yes, all equipment is checked prior to being put into service and after repairs are completed.

4. How is the risk factor determined? By how the equipment will be used (Function) For example, life support in ICU, to monitor, or diagnose, etc. By how dangerous the equipment may be to the patient or user ( Clinical Risk). For example, patient death, patient or user injury, capable of misdiagnosing. By how much maintenance the equipment requires. For example, extensive, average, minimal or none.

5. Equipment requiring high maintenance or being used for life support is inspected every 6 months. Equipment not included in the Plan will have an electrical safety check prior to being placed in service or after it is repaired. T HE STICKER SYSTEM: A label placed on clinical equipment to show it has passed an electrical safety inspection by the Bio-Medical department.

8. Safe Medical Device Reporting By law, University Hospitals are required to report any device, instrument, object or equipment used in diagnosing, treating or caring for a patient that has or may have caused or contributed to a death, or serious injury, or serious illness as a result of failure, malfunction, or inadequate design or labeling.