MEDICAL EQUIPMENT <ul><li>The Scope of the Medical Equipment Management Plan is to: </li></ul><ul><li>repair, maintain, and keep an inventory of clinical equipment. </li></ul><ul><li>respond to Hazard Notices and Safe Medical Device Reporting and Recall of Products. </li></ul>
So who has operational responsibility for maintaining and repairing clinical equipment? The Bio-Medical Department
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.
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.
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.
But wait… you’re not off the hook yet! You too have an important role in medical equipment safety. <ul><li>You should be trained in basic operating and safety procedures before using medical equipment. </li></ul><ul><li>You should know what to do if and when equipment malfunctions. </li></ul>
What to do if medical equipment is defective: <ul><li>Remove it from service. </li></ul><ul><li>Tag it by placing a sign on the equipment stating it is Broken and Not to be used and identify the problem. </li></ul><ul><li>Notify Bio-Med at extension 51746 at University Hospital St Paul, and 54129 at University Hospital Zale Lipshy. </li></ul>
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.
How to Report <ul><li>Notify the physician . </li></ul><ul><li>Notify the Risk Manager (RM) who will notify the Clinical Safety Officer. </li></ul><ul><li>Complete an on line Event Report Form </li></ul><ul><li>If the RM determines the device has or may have caused the injury, the RM reports the incident to the Food and Drug Administration (FDA). </li></ul>
Hazard Notice or Recall Notice <ul><li>Recall Notice or Hazard Notice may be sent by the FDA or a Product Manufacturer alerting us to a product malfunction or problem. </li></ul><ul><li>When we receive a Notice, the department(s) who may be using the product will be notified immediately by the Risk Manager or person receiving the notice. </li></ul><ul><li>The affected department(s) is required to respond to the Recall or Hazard Notice. </li></ul>