Page 1 of 3 Title: Policy on Medical Equipment Inventory Effective Date: Reviewed : Revised: Function: Environment of Care POLICY The Facility Name maintains either a written inventory of all medical equipment or an inventory of selected medical equipment for conducting maintenance, testing, and inspection activities. All new medical equipment will be evaluated before initial use to determine whether to include this equipment in the inventory. RISK CRITERIA Written criteria are used to identify risks associated with medical equipment. Medical Equipment is defined as all electrical and non-electrical equipment used for the treatment, diagnosis, monitoring and care of patients. The risks include, physical risks associated with use and equipment incident history. The risks identified are used to assist in determining the strategies for maintenance, testing, and inspection of medical equipment. In addition, the identified risks are used to guide the development of training and education programs for staff that use or maintain equipment. INVENTORY Equipment requiring planned maintenance is listed as part of an inventory. The list includes equipment maintained by the <<Biomedical Engineering Department>> as well as equipment maintained by vendors. Medical equipment in clinics of the Facility Name will be evaluated to for the inventory as well. The clinical manager and << Biomedical Engineering Director>> will evaluate orientation and training requirements at the time the equipment is purchased. Detailed orientation for operators and <<Biomedical Engineering Staff>> will be provided as necessary. The <<Engineering Department>> evaluates new types of equipment before initial use to determine whether to include this equipment in the inventory PROCEDURE 1. The <<Identify Department (e.g. Biomedical Engineering Department)>> maintains either a written inventory of all medical equipment or an inventory of selected medical equipment. 2. Based on the Risk Factor Threshold, the <<Biomedical Engineering Director>> will determine to include or exclude the equipment from the inventory. The Risk Factor, along with information from manufacturers and resources, will also be used to determine the frequency of these activities. 308870308 Page 2 of 3 Title: Policy on Medical Equipment Inventory Effective Date: Reviewed : Revised: Function: Environment of Care 3. All new and existing equipment that is part of the medical equipment inventory program is assigned a permanent equipment identification control number. This identification number will remain with the equipment for the duration of the equipment use in the facilities. This number will be retired and removed from the Maintenance Management System (MMS) when the equipment has been replaced. Equipment rented or borrowed will be assigned a temporary unique identifier, which is used while that equipment is used by the organization. 4. The identification number will also be the preventive maintenance file number for the hard copy records. All new and existing equipment are assigned relevant preventive maintenance task code or codes. 5. Criteria for determining inclusion on the medical equipment inventory will be developed by the <<Biomedical Engineering Director>>. Information from manufactures recommendations, ECRI, FDA, and other authorities on medical equipment will be used. The criteria will be: Equipment Function (E) Therapeutic – Life Support Therapeutic – Surgical or Intensive Care Therapeutic – Physical Therapy or Treat Diagnostic – Surgical or ICU Monitoring Risk Value 10 9 8 7 Diagnostic – Other Physiological Mont Analytical – Laboratory Analytical – Laboratory Accessories Analytical – Computer and Related Equipment Miscellaneous – Patient Related Miscellaneous – Non-Patient Related 6 5 4 3 2 1 – Physical Risk (P) Potential Patient Death Potential Patient Injury Inappropriate Therapy or Misdiagnosis Equipment Damage No Significant Identified Risks History of Medical Equipment (H) Poor Moderate Adequate Good Excellent Risk Value 5 4 3 2 1 Risk Value 5 4 3 2 1 6. Each piece of medical equipment will be evaluate by the above criteria and 308870308 Page 3 of 3 Title: Policy on Medical Equipment Inventory Effective Date: Reviewed : Revised: Function: Environment of Care added to the inventory. The risk values for the criteria will be added to determine the risk factor for each piece of equipment: (Risk Factor or Maintenance Value = E + P + H) 7. The Risk Factor will be used to determine the inspection, testing, and maintenance activities. The Risk Factor, along with information from manufacturers and resources, will also be used to determine the frequency of these activities. Based on the Risk Factor Threshold, <<Biomedical Engineering Director>> will determine to include or exclude the equipment from the inventory (Attachment I). 8. Equipment included in the medical equipment management inventory program is assigned an individual control number in which all work orders and preventive maintenance forms are referenced. 9. Equipment determined not to be in the medical equipment management inventory program will require an initial safety inspection and be released for use. Repairs will be performed as necessary. 10.Leased equipment will be evaluated utilizing the medical equipment inventory system and included into the medical equipment management inventory program as appropriate. 11. If the lease includes preventive maintenance and service, the leasing department will inform the clinical engineering director when any maintenance has been performed or the equipment is returned. The leasing department will be responsible for administering the manufacturer or leasing agent’s maintenance documentation on site through the term of the lease. 12.Medical equipment will randomly evaluated during periodic Environmental Tours and adverse findings (e. g., outdated stickers, broken equipment, missing stickers) will be reported to biomedical engineering and the Environment of Care® (EC) Committee. ATTACHMENT: Attachment I- Medical Equipment Inclusion Assessment Form (ME-EC.02.04.01EP2 c) 308870308