University of Kentucky Hospital

Medical Equipment Management Plan

 

 

Scope

The Medical Equipment Management Plan applies to medical equipment utilized in all University of Kentucky Hospital departments, including the Hospital, Kentucky Children’s Hospital, Center for Advanced Surgery, and hospital-based clinics.  The Medical Equipment Management Plan and the policies and procedures that support it blend with the other Environment of Care areas, including Safety Management, Hazardous Materials Management, and Fire Safety Management to achieve a safe, functional, supportive, and effective environment for patients, staff members, and other individuals in the hospital.

 

 

Objective

The University of Kentucky Hospital Medical Equipment Management Plan is designed to safely and effectively manage the risks associated with medical equipment.  The plan outlines the policies and processes the hospital uses to assure the medical equipment is appropriate for the intended use, that staff is trained to use the equipment, and that the equipment is maintained appropriately by qualified individuals.  This medical equipment management program maintains complete and continuous compliance with the JCAHO medical equipment management requirements.

 

 

Performance

 

1.  Medical Equipment Management Plan                                                      (EC.6.10, EP 1)

 

This document serves as the written management plan describing the processes the hospital uses to manage the effective, safe, and reliable operation of medical equipment.  This plan specifically addresses managing risks of medical equipment by ensuring that equipment is appropriate for its intended use, that equipment is maintained according to strategies intended to minimize risks, that maintainers and users of medical equipment are trained and qualified, that performance according to the requirements of this policy is measured and analyzed, and that performance improvement recommendations are implemented and effective.  (See HP04-01 Equipment Maintenance Program)

 

 

2.  Selection and Acquisition of Medical Equipment                                       (EC.6.10, EP 2)

 

The hospital implements HP04-07 Purchasing and Receiving Capital Equipment to select and acquire medical equipment.  The Capital Equipment Coordinator and a representative from Clinical Engineering review equipment specifications for all prospective medical equipment purchases to ensure compliance with applicable policies and standards (e.g. NFPA 99).  Clinical Engineering evaluates the condition and function of the equipment when it is received.  Each department where the equipment is used evaluates the training of users before the equipment is used on patients.  The hospital participates in ECRI Select Plus and University Healthcare Consortium (UHC) programs that provide quotation analysis, comparison analysis, and benchmarking information for further guidance in equipment selection.  (See HP04-07 Purchasing and Receiving Capital Equipment; CE04-01 Acquiring Medical Equipment

 

 

3.  Medical Equipment Inventory Inclusion Criteria                                         (EC.6.10, EP 3)

 

The hospital uses the following risk criteria, at a minimum, for identifying, evaluating, and creating an inventory of equipment to be included in the medical equipment management plan before equipment is used:  Equipment Function, Physical Risks, Equipment History, Maintenance Requirements, and Environment of Use.  Clinical Engineering uses the AIMS database to inventory and assist in equipment evaluation and risk stratification.  (See CE04-02 Medical Equipment Inventory Inclusion Criteria)

 

 

4.  Medical Equipment Maintenance                                                               (EC.6.10, EP 4)

 

In order to achieve effective, safe, and reliable operation of all equipment in the inventory, the hospital uses interval-based inspections and preventive maintenance, corrective maintenance, or metered maintenance strategies.  Model specific strategies and preventive maintenance procedures are developed for this equipment based on the risk stratification, the AHA Manual for Medical Equipment, manufacturer guidelines, and NFPA and ANSI standards.  (See CE04-03 Medical Equipment Maintenance Strategies; CE Inspection Procedures Manual)

 

 

5.  Maintenance Intervals                                                                               (EC.6.10, EP 5)

 

Clinical Engineering defines the time intervals based on, at a minimum, manufacturers’ recommendations, risk levels, and current hospital experience (see 4, above).  Clinical Engineering uses the AIMS database to define and maintain the preventive maintenance and inspection intervals on appropriate equipment in the inventory, automatically generating interval based inspection and Preventive Maintenance work orders monthly. (See CE04-03 Medical Equipment Maintenance Strategies)

 

 

6.  Medical Equipment Hazard Notices and Recalls                                        (EC.6.10, EP 6)

 

Clinical Engineering is notified of potential equipment hazards, alerts, and recalls through various publications, letters, and memos.  The Clinical Engineering Supervisor reviews these notifications to determine whether the UKMC has affected devices.  If affected devices are found in the hospital, the CE Supervisor must approve whatever action is taken to correct the problem in a timely, safe manner.  Equipment notices and recalls are tracked in the AIMS database and reported to the EOC Committee.  (See CE04-04 Medical Equipment Hazard Notices and Recalls)

 

 

7.  Monitoring and Reporting Incidents as Required by the Safe Medical Devices Act of 1990

        (EC.6.10, EP 7)

 

Equipment malfunctions contributing to patient death or injury are reported to Patient Safety.  Patient Safety, with the aid of legal and risk management, will determine if it is appropriate to report the device-related adverse event to the FDA.  (See HP04-13 Safe Medical Device Act; HP10-33 Reportable Occurrences; CE04-05 Safe Medical Device)

 

 

8.  Emergency Procedures                                                                            (EC.6.10, EP 8)

 

Clinicians have access to spare or substitute equipment that they can use in an emergency, either on their floor or a neighboring floor.  Medical equipment considered critical to patient safety (life support, life sustaining, or other critical equipment whose malfunction or failure may result in an adverse patient outcome) may require processes for emergency procedures in the event of failure.  Organizations such as AHA, BLS, and ACLS dictate the procedures to use when medical equipment fails. Clinicians are trained to know when and how to perform these emergency clinical interventions.  All hospital departments can obtain repair services by contacting Clinical Engineering at 3-6383.  Clinical Engineering has an on-call technician available when no one is on-site.  (See HP04-01 Equipment Maintenance Program; CE04-06 Medical Equipment Emergency Procedures)

 

 

Medical Equipment Maintenance, Testing, and Inspection

 

1.  Medical Equipment Inventory                                                                    (EC.6.20, EP 1)

 

Clinical Engineering uses the AIMS database to maintain a current, accurate, and separate inventory of all equipment identified in the medical equipment management program, regardless of ownership.  During scheduled inspections, CE staff verifies the accuracy of the inventory.  In addition, the AIMS database is reconciled annually against the university-based eBars inventory system to ensure accuracy. (See CE04-07 Rental Equipment)

 

 

2.  Documentation of Acceptance Testing                                                       (EC.6.20, EP 2)

 

Before any new equipment is initially put into use, it is tested for safety and performance according to established procedures.  The inventory information and acceptance testing are documented in the AIMS database.  (See CE04-01 Acquiring Medical Equipment)

 

 

3.  Documentation of Maintenance of Life Support Equipment            (EC.6.20, EP 3)

 

Clinical Engineering identifies life support equipment in the AIMS database.  The definition of life support equipment adopted by Clinical Engineering is:  medical devices intended to sustain life and whose failure to perform its primary function, when used according to manufacturer’s instructions and clinical protocol, is expected to result in imminent death in the absence of immediate intervention.  The maintenance of life support equipment receives the highest priority in the medical equipment management program.  The inspection schedule compliance goal is 100%.  (See CE04-02 Medical Equipment Inventory Inclusion Criteria)

 

 

4.  Documentation of Maintenance of Non-Life Support Equipment        (EC.6.20, EP 4)

 

Clinical Engineering maintains non-life support equipment according to a maintenance plan (see Performance #4, above).  This maintenance is documented.  Inspection and service records are maintained in the AIMS database.  These records are used to determine inspection intervals, based on an analysis of the history of failures during scheduled inspections.  The inspection schedule is also adjusted to meet any requirements for preventive maintenance.  The goal is to exceed 90% completion of planned maintenance on a monthly basis and 95% on an annual basis.  (See CE04-02 Medical Equipment Inventory Inclusion Criteria)

 

 

5.  Documentation of Performance Testing of Sterilizers                     (EC.6.20, EP 5)

 

UKMC tests the performance of its sterilizers and reprocessors according to the procedures outlined by the equipment manufacturers and individual departmental procedures.  Testing results on equipment used in the sterilization of devices used for patient procedures (i.e. sterilizers located in the OR, Central Sterile, etc.) are reported to the Infection Control Department on a monthly basis.  Testing results on equipment used in the autoclaving of waste prior to disposal (i.e. Clinical Lab) are maintained in the Clinical Laboratory.  (See OR03-09 Steris System 1 Processor; OR03-10 Sterilization Controls and Monitoring)

 

 

6.  Documentation of Testing Water Used in Renal Dialysis                            (EC.6.20, EP 6)

 

Water used for the Dialysis Unit is tested according to AAMI standards.  This testing is documented in the Dialysis Unit.  Infection Control monitors the testing.  Significant water quality issues are reported to the Safety Committee.  (See CE-01 Dialysis RO SOP; Renal Dialysis Equipment Checks SOP; Monitoring Purity of Water Used for Hemodialysis SOP; Maintenance and Repair of Dialysis Equipment SOP)

 

Program Evaluation/Effectiveness

 

Reports can be run at any time to show the effectiveness of the Medical Equipment Management Plan.  Using these reports, Clinical Engineering will report quarterly to the Medical Equipment Management Committee and to the Safety Committee on the effectiveness of the Plan.  Any changes to the plan will be made with the goal of minimizing the clinical and physical risks identified in the plan.

 

The Medical Equipment Management Subcommittee evaluates the Medical Equipment Management Plan annually based on established criteria.  The scope, objectives, performance and effectiveness of the plan are measured against JCAHO standards and in an effort to assess and minimize the risk to the hospital.