MEDICAL EQUIPMENT MANAGEMENT PLAN

EQUIPMENT MANAGEMENT PLANPage 6 of 6THE UNIVERSITY OF MICHIGAN HOSPITAL AND HEALTH CENTERSEQUIPMENT MANAGEMENT PLANPURPOSE The purpose of this plan is to outline an Equipment Management Program that provides for the safe and reliable operation of medical equipment used in the treatment of patients throughout the University of Michigan Hospitals and Health Centers (UMHHC). The Equipment Management Program will ensure that the equipment provides accurate, reliable information to the clinicians, that the equipment is safe for the patients and operators, and that the equipment is utilized to its fullest capacity in order to optimize patient care.ORGANIZATION ROLES AND RESPONSIBILITIESThe Equipment Management Committee oversees the Equipment Management Program as part of the UMHHC Environment of Care Program. The committee is responsible for designing, implementing, and monitoring an Equipment Management Program that is based upon manufacturer recommended practice, organizational experience, as well as policies, standards, regulations and applicable laws that govern the UMHHC. The committee reports to the Environment of Care Committee, however, the committee has the authority to expand the program as necessary to ensure the highest level of safety and participation by all UMHHC staff. The committee is comprised of representatives from Biomedical Engineering, Capital Equipment, Maintenance, Medical Center Risk Management, Pathology, Patient Equipment, Purchasing, Radiation Oncology, and Radiology Engineering Services.The Equipment Management Committee monitors six branches of the Equipment Management Program. Each branch is responsible for the technical and engineering support of certain medical equipment at the UMHHC. Technical support of medical equipment includes, but is not limited to, incoming inspection, installation, monitoring, preventive maintenance, troubleshooting, repairs, modification for improvement, reliability, and safety. Engineering support of medical equipment includes, but is not limited to, modification for improvement, reliability, safety, hazard alert/recall monitoring and notification, incident investigation, and research development.1) Biomedical Engineering - The Biomedical Engineering department is responsible for the technical and engineering support of the majority of the medical equipment at the UMHHC, with the exception of that which is covered by the other five branches. The Biomedical Engineering department is comprised of medical engineers, biomedical engineering technicians, industrial electricians, and maintenance mechanics who together directly support the medical equipment, or coordinate the support of the medical equipment by an outside source.2) Maintenance - The Maintenance department is responsible for the technical and engineering support for the sterilizers, instrument washers, and reverse osmosis systems at the UMHHC. The Maintenance department is comprised of an electrical service group, an HVAC service group, a plumbing service group, and maintenance mechanics. These service groups and maintenance mechanics together directly support the equipment or coordinate the support of the equipment by an outside source.3) Pathology - The Pathology department is responsible for the technical and engineering support for the laboratory equipment at the UMHHC. The Pathology department staff coordinate the support of the laboratory equipment by an outside source, either via US Counseling or directly with the vendor/manufacturer.4) Patient Equipment - The Patient Equipment department is responsible for the technical and engineering support for the rental patient equipment (e.g. infusion pumps, syringe pumps, etc.) at the UMHHC. The Patient Equipment department staff coordinate the support of the rental patient equipment by the company from whom the equipment was rented from.5) Radiation Oncology - The Radiation Oncology department is responsible for the technical and engineering support for the radiation therapy equipment at the UMHHC. The Radiation Oncology department staff coordinate the support of the radiation therapy equipment by an outside source, either via US Counseling or directly with the vendor/manufacturer.6) Radiology Engineering Services - The Radiology Engineering Services department is responsible for the technical and engineering support for the diagnostic radiology equipment at the UMHHC. The Radiology Engineering Services department is comprised of medical engineers and biomedical engineering technicians who together directly support the diagnostic radiology equipment, or coordinate the support of the diagnostic radiology equipment by an outside source.All UMHHC staff are responsible for adhering to the policies and procedures developed in support of the Equipment Management Program. Responsibilities include, but are not limited to, ensuring all equipment used within the patient care vicinity has been inspected prior to use, immediately reporting problems with medical equipment, and requesting education on the operation of unfamiliar medical equipment.EQUIPMENT MANAGEMENT PLAN ACTIVITIESSelection and acquisition of equipment: Each of the six branches of the Equipment Management Program actively participates in the selection and acquisition of equipment. Activities revolving around the identification of the need for equipment replacement include, but are not limited to, submitting planned capital equipment requests based on depreciation schedules, monitoring approved capital equipment and construction projects, monitoring hazard alerts/product recalls, and reactively replacing equipment based on inability to further maintain. Assistance provided during the selection process includes, but is not limited to, identifying technical specifications, writing Requests For Proposals, reviewing bids, verifying performance specifications, coordinating clinical trials, benchmarking with similar institutions, consulting external agencies that focus on equipment safety (e.g. AAMI, ECRI, FDA, etc.), performing site visits, and negotiating with vendors. Assistance provided during the acquisition process includes, but is not limited to, coordinating construction activities to prepare the site for the equipment, coordinating installation efforts, performing acceptance testing, and coordinating training of clinical staff/service personnel.Evaluation of equipment for inclusion into the Equipment Management Program: All equipment that directly supports patient care, or that is located within the patient care setting, regardless of ownership, is assessed for inclusion into the Equipment Management Program. Two different methods are utilized by the six branches of the Equipment Management Program. The first method, which is utilized by all branches except Maintenance, incorporates a modified American Hospital Association method that factors in equipment function, clinical application, manufacturer recommended preventive maintenance, impact of preventive maintenance, and customer impact if failure were to occur. Based on the scoring outcome, equipment is assigned a risk category of 1LS (high risk/life support), 1 (high risk), 2 (less risk) or 3 (no risk). All category 1LS, 1 and 2 equipment is included in the Equipment Management Program. The second method, which is utilized solely by Maintenance, is the same scoring methodology that is utilized for the Utilities Management Program that factors in area of utility/equipment support, physical risk if the utility/equipment were to fail, maintenance requirements of the utility/equipment, and incident history of the utility/equipment. Based on the scoring outcome, the utility/equipment is assigned an APMI number. Any utility/equipment with an APMI score of 12 and above are included in the Utilities Management Program, and subsequently the Equipment Management Program.Incoming inspections (Hospital owned equipment): All hospital owned equipment that directly supports patient care, or that is located within the patient care setting, regardless of acquisition method, is inspected prior to initial use. Equipment is inspected to assure physical condition, functionality, accuracy, patient/operator safety, electrical safety, and proper documentation. If appropriate, as is the case for radiographic and nuclear imaging systems, equipment is also inspected by certified physicists and State of Michigan inspectors. All equipment has a universal asset tag identification label attached, and is included in the computerized maintenance management system inventory. An appropriate inspection label is also attached, based on the risk category of the device. Operator and service manuals are maintained on file in the department that will be responsible for the technical and engineering support of the equipment.Incoming inspections (Rental equipment): Material Services and Purchasing Services have certified certain vendors as preferred vendors for supplying rental patient equipment. These vendors conduct electrical safety inspections on their devices before delivering them to the hospital and are responsible for all maintenance and repair of their devices. These vendors will provide written service history reports to UMHHC upon request. Rental equipment provided by non-preferred vendors is inspected by Biomedical Engineering prior to initial use. Rental equipment in the patient care setting has (a) a brown label that indicates that the equipment is non-hospital owned, (b) an appropriate risk category label that indicates that Biomedical Engineering has accepted the equipment prior to patient use, and (c) an asset tag identification label if the equipment is anticipated to remain in the facility for three months or longer.Incoming inspections (Other non-hospital owned equipment): Equipment that is used in the patient care setting which has been brought into the hospital for evaluation, trial use, etc. is inspected by Biomedical Engineering prior to initial use. Non-hospital owned equipment in the patient care setting has (a) a brown label that indicates that the equipment is non-hospital owned, (b) an appropriate risk category label that indicates that Biomedical Engineering has accepted the equipment prior to patient use, and (c) an asset tag identification label if the equipment is anticipated to remain in the facility for three months or longer. The manufacturer/vendor who brought the device into the hospital for evaluation, trial use, etc. is responsible for all maintenance and repair of their devices.Incoming inspections (Research equipment): Equipment that is used in the patient care setting which has been brought into the hospital for research purposes is inspected by Biomedical Engineering prior to initial use. Research equipment in the patient care setting has (a) a brown label that indicates that the equipment is non-hospital owned, (b) an appropriate risk category label that indicates that Biomedical Engineering has accepted the equipment prior to patient use, and (c) an asset tag identification label if the equipment is anticipated to remain in the facility for three months or longer. The research department who brought the device into the hospital for research purposes is responsible for coordinating all maintenance and repair of their devices.Incoming inspections (Patient owned equipment): Use of patient owned electrically powered equipment or appliances, especially in critical care areas, is highly discouraged but is not prohibited. The clinical staff providing direct patient care to the patient in question is responsible for determining whether a device should be used by the patient, taking patient condition and any special environmental circumstances into consideration. If the patient is not electrically susceptible (e.g. no penetrations through the skin), the clinical staff conducts a visual inspection of the device for obvious defects (e.g. intact cases and covers, power cord integrity, etc.) prior to patient use. Biomedical Engineering is available to train clinical staff in conducting these device inspections. If the patient is electrically susceptible, and the clinical staff recommends use of the device, Biomedical Engineering conducts an electrical safety inspection of the device prior to patient use. Patient owned equipment in the patient care setting has (a) a brown label that indicates that the equipment is non-hospital owned and (b) an appropriate risk category label that indicates that Biomedical Engineering has accepted the equipment prior to patient use.Preventive maintenance inspections: In conjunction with the evaluation of equipment for inclusion in the Equipment Management Program, each classification of device is assigned a preventive maintenance inspection strategy and schedule. The preventive maintenance inspections for most equipment included in the Equipment Management Program are interval-based, however some are meter-based (note, interval-based preventive maintenance inspections are still assigned to meter-based devices to ensure that the devices meter is checked). The frequency for interval-based preventive maintenance inspections is determined based upon manufacturer recommendations, risk levels, and past organizational experience. Preventive maintenance work orders are generated on a monthly basis, with expectations that the work orders be completed in a timely manner. Additional preventive maintenance work orders may be generated for those devices that have missed their previous preventive maintenance inspections (e.g. device could not be located, device was in use, etc.), or that came due for preventive maintenance off-cycle (e.g. meter-based inspections).Repairs: All repairs are prioritized and performed in a timely manner. To assure the continuation of patient care in the event of equipment failure, backup devices are available for most critical devices (e.g. anesthesia units, physiologic monitors, defibrillators, ventilators, infusion pumps, etc.). Backup devices may be located either within the using department, in Biomedical Engineering, or in Patient Equipment, depending on the criticality of reduction in downtime. These backup devices are also available for use in expanding the facilitys capacity to provide patient care in the event of internal/external disasters. In addition, departments maintain individualized emergency procedure plans for critical equipment and/or systems (e.g. physiologic monitoring, nurse call system, etc.) to ensure continuity of patient care in the event of equipment and/or system failures. Review of hazard alerts and product recalls: Notification of hazard alerts and product recalls come from a variety of sources (e.g. manufacturers, vendors, ECRI, FDA, etc.). In conjunction with hospital policy 05-02-007 “Product Recall / Hazard Warning Control Program,” all hazard alerts and product recalls are promptly reviewed, acted upon, and documented, regardless of their origination. To aid this process, an e-mail group has been established to promote the rapid dissemination of hazard alerts and product recalls throughout the facility. Members of this e-mail group have been identified as representatives for their department to receive hazard alerts, review the alerts, identify any hazards that may impact their department, disseminate the notice and its corrective action to all appropriate department personnel, and submit a Product Recall Summary form to Safety Management Services for any alerts that impacted their department. Ultimately, Safety Management Services is the central point within UMHHC to maintain records of hazard alerts and product recalls that impact the facility, however further detailed records (e.g. specific work orders for every effected device) may be maintained at the individual department level.Incident investigations: In conjunction with hospital policy 05-02-006 “Safe Medical Device Act (SMDA) Policy,” all incidents involving medical devices are reported via the hospital incident reporting system. In addition, all explanted devices suspected of possible failure are reported via the hospital explant reporting system. Biomedical Engineering and Hospital and Health Centers Risk Management perform a thorough investigation in a timely manner, sequestering equipment as appropriate, documenting findings, identifying deficiencies that could result in future incidents, and recommending corrective action to eliminate any identified deficiencies. All reported incidents are reviewed by the SMDA Committee for evaluation of effectiveness. In the event that the incident reasonably suggests that a medical device has or may have caused or contributed to a serious injury, illness or death, the SMDA Committee reports the incident as required by the Safe Medical Device Act of 1990 to the manufacturer and/or the Food and Drug Administration. The SMDA Committee in turn reports directly to the Environment of Care Committee.Data collection/management: The primary tool and resource for data collection/management is a computerized maintenance management system. This system incorporates the equipment inventory, all service history records for equipment in the inventory, a work order system, and the preventive maintenance schedules/procedures. This system is used as an administrative tool to track equipment, to initiate work orders, to measure performance indicators, to determine equipment failure trends, to identify training needs, and to produce management reports.Orientation and continuing education (users of equipment): Users of equipment require orientation to equipment either upon initial hire, upon reassignment to new job responsibilities, upon introduction of new equipment, or upon individualized recognition of need. Upon initial hire or reassignment to new job responsibilities, each department is responsible for providing orientation to employees to provide them with the skills needed to safely utilize the equipment in their work environment. Some departments have developed specific classroom training programs, while other departments rely on supervisor or mentor review with the employee at the direct worksite. Upon introduction of new equipment, in conjunction with hospital policy 05-02-005 “Medical Device Training and Education,” it is each individual departments responsibility for assessing new equipment and developing appropriate educational plans for all departments who may interface with the equipment. Educational plans shall address initial orientation needs as well as ongoing continuing education, if appropriate. Ongoing continuing education needs are typically specified in departmental annual competency programs. Training conducted upon individualized recognition of need can be provided either by an employees supervisor/mentor who recognizes need through daily activity or by service maintenance department personnel who recognize operator error problems through repair calls. Orientation and continuing education (maintainers of equipment): Maintainers of equipment require orientation to equipment either upon initial hire, upon reassignment to new job responsibilities, or upon introduction of new equipment. Upon initial hire or reassignment to new job responsibilities, the service maintenance department managers provide orientation to employees to provide them with the skills needed to maintain and/or repair equipment in their work environment. Orientation may be provided through a combination of supervisor review with the employee at the direct worksite, staff cross-training, and service school attendance. Upon introduction of new equipment, service maintenance department managers assess what is the most appropriate methodology for obtaining the skills needed to maintain and/or re