Medical Equipment Management Plan

YOUR HOSPITAL

2006 MEDICAL EQUIPMENT MANAGEMENT PLAN

EC.6.10.1

IPURPOSE

Your Hospital exists to benefit the people of our region by promoting good health, and by healing, caring and comforting. Consistent with this mission, Your Hospital has established and provides ongoing support for the medical equipment management program described in this plan.

The purpose of the Medical Equipment Management Planis to bring together the policies and procedures of the equipment management program as overseen by Clinical Engineering and other departmental activities into a united and coherent plan. The plan has a single focus: to provide the highest quality of patient safety and environment of care possible within the operational scope of the program.

The intent of the Medical Equipment Management Plan is to support a safe patient care and treatment environment at Your Hospital by managing risks associated with the use of clinical equipment technology. The program includes processes for selection and maintenance of equipment designed to assure safe and appropriate support of patient care services. The selection and management processes are based on the risks associated with the equipment. The risk management strategies include training, education, and competency evaluation of individuals who maintain and use medical equipment and appropriate inspection, testing, maintenance, and repair of that equipment.

IISCOPE

The medical equipment management program is designed to assure selection of appropriate medical equipment to support the medical care processes of Your Hospital and to assure effective preparation of staff responsible for the use or maintenance and repair of the equipment. Finally, the program is designed to assure continual availability of safe, effective equipment through a program of planed maintenance, timely repair, ongoing education and training, and evaluation of all events that could have an adverse impact on the safety of patients or staff.

IIIFUNDAMENTALS

A.The sophistication and complexity of clinical equipment continues to expand. Selecting new clinical equipment technology requires research and a team approach.

B. Patient care providers need information to develop an understanding of clinical equipment limitations, safe operating conditions, safe work practices, and emergency clinical interventions during failures.

C.Medical equipment may injure patients or adversely affect care decisions if not properly maintained.

IVOBJECTIVES

A.To provide a safe environment through proper selection, use, testing and maintenance of medical equipment

B.To maintain an accurate medical equipment inventory

C.To educate users and maintainers of medical equipment to help ensure proper use and functioning.

D.To identify deficiencies, failures and user errors to help prevent unnecessary injury to patients

E.To ensure medical equipment and staff perform at an acceptably level to limit the potential for patient injury due to equipment failure or misuse

VORGANIZATION AND RESPONSIBILITY

A.The Board of Directors, through the Quality Council, receives an annual report of the activities of the medical equipment program from the Environment of Care (EOC) Committee. They review the reports and, as appropriate, communicate concerns about identified issues and regulatory compliance to the President/CEO. They provide support to facilitate the ongoing activities of the medical equipment program.

1. The President/CEO receives reports of the status of the medical equipment program through the Quality Council. The President/CEO reviews the reports and, as necessary, communicates concerns about key issues and regulatory compliance to the medical staff, nursing, clinical engineering, and other appropriate staff.

C.The Clinical Engineering Manager assures that the medical equipment program is implemented in all key clinical areas. Program activities including tracking of rental or leased equipment, warranty repairs, contract services, and the activities of specialty contractors providing services to other departments such as radiology, laboratory, respiratory care, and surgery and anesthesia are also managed.

D.The Clinical Engineering staff implements the in-house medical equipment maintenance program and tracks maintenance provided by original equipment manufacturers, and other contractors who provide maintenance and repair services for specific items of equipment.

E.Department directors/managers orient new staff to the department and, as appropriate, to job and task specific uses of clinical equipment. When requested, the Clinical Engineering Department provides assistance.

F.IndividualHospital staff members are responsible for maintaining competencies relative to job and task specific procedures for safe clinical equipment operation.

VIPROCESSES OF THE MEDICAL EQUIPMENT PLAN

The organization manages Medical Equipment risks (EC.6.10)

Medical Equipment Management Plan (EC.6.10.1)

Your Hospital has developed and maintains this written management plan describing the processes it implements to effectively manage emergencies affecting the facility, patients, staff, and to respond to emergencies in the community that cause an influx of patients. This plan is evaluated annually, and changed as necessary, based on changes in conditions, regulations and standards, and identified needs

Selection and Acquisition (EC.6.10.2)

The Director/Materials Management has overall responsibility for coordinating the clinical equipment selection and acquisition process. Department directors/managers and others, as appropriate, collaborate to select and acquire medical equipment. Department directors/managers develop recommendations related to equipment to purchase. The Director/Materials Management coordinates vendor negotiations, and ensures clinical equipment considered for purchase meets appropriate standards of performance and safety.

The Director/Project Management and Engineering works with design professionals and clinical staff to identify needs for space and support of new equipment. The Manager/Clinical Engineering manages the commissioning of new equipment. The commissioning process includes assembly, installation, and testing of new equipment.

The managers of clinical departments where new equipment is installed collaborate with Materials Management and equipment suppliers to assure appropriate education and training are provided to all initial users of the equipment and a program for training additional future users is developed.

Capital equipment requests for clinical equipment are included as part of the annual budget process. The President/CEO has final approval over all new clinical equipment purchases. The Materials Management Department maintains documentation related to the medical equipment selection and acquisition process.

Criteria and Inventory (EC.6.10.3)

Written criteria are used to identify risks associated with medical equipment. The risks include equipment function, physical risks associated with use, and equipment history as it relates to patient safety.

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.

All medical equipment is screened at the time of delivery. In addition, appropriate training and testing of new equipment takes place prior to use on patients.

Equipment requiring a program of planned maintenance is listed as part of a maintenance inventory. The list includes equipment maintained by in-house staff as well as equipment maintained by vendors.

Maintenance Strategies (EC.6.10.4)

The Manager/Clinical Engineering evaluates all equipment used for the diagnosis, treatment, and monitoring of patients to determine the appropriate maintenance strategy, thus assuring safety and maximum useful life. The strategy selected is based on manufacturer recommendations, accreditation or regulatory requirements, local operating experience, and equipment design. The determination of the appropriate strategy is made as part of the initial evaluation of equipment.

Potential strategies include:

• interval testing, based on specified intervals between tests, inspections, or maintenance activity;

• run-time based inspections, based on hours of use, or other time of use processes. This strategy uses on-board clocks or event recorders to trigger specific tests, inspections or service;
• corrective maintenance, based on a request for service or failure of the equipment to pass internal self-tests. Such equipment is subject to an initial test on receipt, and asset management; and,
• other strategies, based on the use of the equipment may include inspection immediate prior to each use, for equipment used infrequently, borrowed or rented from vendors or others.

Inspection, Testing and Maintenance (EC.6.10.5)

The frequency of planned preventative maintenance activities is determined based on manufacturer recommendations, accreditation or regulatory requirements, and local operating experience. The frequency of maintenance is determined at the time of initial evaluation of the equipment.

A work order is used to manage the work for each maintenance event, planned or unplanned. Work orders are issued for maintenance performed by in-house staff and by contractors. The Manager/Clinical Engineering manages the work order generation and completion process. Clinical Engineering technicians perform assigned work orders and return completed work orders to managers. Work done by outside contractors is tracked to assure the work is completed in accordance with the terms of a contract.

In addition, “owner” departments manage the daily performance testing and maintenance of sterilizers and the dialysis water processing system, on a contract basis.

Hazard Notices and Recalls (EC.6.10.6)

The Director/Materials Management and the Clinical Engineering staff manage the medical equipment hazard notice and recall process.

Product safety alerts, product recall notices, hazard notices, etc. are received from a variety of external sources. All such notices are routed to Materials Management. Notices are circulated to department heads to determine if Your Hospital has any of the affected equipment. When a piece or type of equipment subject to a hazard notice or recall is identified appropriate action is taken to address the hazard.

The Clinical Engineering technicians support the process by using the medical equipment inventory to screen known equipment for matches and

by evaluating the relative severity of the risk. When conditions warrant, equipment is removed from service and replaced with a safe, effective substitute. In unusual cases when no substitute is available, the Clinical Engineering department provides support to users to ensure the identified hazard is minimized until it can be corrected.

Safe Medical Devices Act (EC.6.10.7)

The Manager/Risk Prevention is responsible for the Safe Medical Devices Act Reporting process.

The Manager/Risk Prevention collects information about potentially reportable events through the incident reporting and investigation process. The Manager/Clinical Engineering, Safety Officer, and appropriate clinical staff conduct investigations of clinical equipment incidents to determine if the incident is reportable under criteria established by the Food and Drug Administration.

The Manager/Clinical Engineering uses the Sentinel Event Process to investigate and document reportable incidents. The Manager/Clinical Engineering prepares quarterly reports for the EOC Committee on those incidents determined to be reportable. The Manager/Risk Prevention is also responsible for completing all reports and handling other communications with medical equipment manufacturers and the FDA required by the Safe Medical Devices Act.

Appropriate changes in processes and training are made through the performance improvement process. The changes are communicated to all appropriate staff.

Emergency Procedures (EC.6.10.8)

The director/manager of each department using life support or other life-critical medical equipment develops and trains staff about the specific emergency procedures to be used in the event of failure or malfunction of equipment whose failure could cause death or irreversible harm to the patient dependent on such equipment.

These emergency response procedures provide clear, specific instructions for staff responding to an emergency and provide information about notifying appropriate administrative staff of the emergency, actions required to protect patients from harm, contacts for spare equipment or repair services, and contacts to obtain additional staff to manage the emergency.

Each department director/manager maintains copies of applicable emergency procedures in accessible locations in their departments. Departmental staff receives orientation and ongoing education and training about the emergency procedures.

Each department director/manager reviews the department specific medical equipment emergency procedures annually.

Medical Equipment is maintained, tested, and inspected (EC.6.20)

The Manager/Clinical Engineering establishes and maintains a current, accurate, and separate inventory of all equipment included in a program of planned inspections or maintenance. The inventory includes equipment owned by Your Hospital, leased and rented equipment, and personally-owned equipment used for the diagnosis, treatment, and monitoring of patient care needs.

The Manager/Clinical Engineering manages the program of planned inspection and maintenance. All equipment in the program is tested for performance and safety prior to initial use on patients.

The Manager/Clinical Engineering assures that scheduled testing of all life support equipment is performed within the “Service Month”. There is a “grace period” of up to 30 days for equipment that is not available due to patient use during the “Service Month”. Reports of the completion rate of scheduled inspection and maintenance are presented to the EOC Committee each quarter. If the quarterly rate of completion falls below 100%, the Manager/Clinical Engineering will also present an analysis to determine what the cause of the problem is and make recommendations for addressing it.

The Manager/Clinical Engineering assures that scheduled testing of all non-life support equipment is performed within “Service Month”. There is a “grace period” of up to 90 days for equipment that is not available due to patient use during the “Service Month”. Reports of the completion rate of scheduled inspection and maintenance are presented to the EOC Committee each quarter. If the quarterly rate of completion falls below 90%, the Manager/Clinical Engineering will also present an analysis to determine what the cause of the problem is and make recommendations for addressing it.

All equipment on which the scheduled testing is not performed within the “Service Month” will be included on the Could Not Locate (CNL) Report and submitted to the respective owning department at the end of the “Service Month”. This Report will state that these pieces of equipment

must be located and promptly quarantined when found, so Clinical Engineering can perform the Safety and Performance inspection and/or PM. These pieces of equipment are not considered overdue as long as they fall within the appropriate grace period.

Any device not located within the “grace period” will have the PM cancelled due to device not located. A PM Canceled report will be sent to the respective owning department listing the devices affected and stating that the equipment is no longer safe for use. If found, the equipment must be promptly quarantined and brought to the attention of Clinical Engineering for a proper inspection or PM prior to clinical use. Violations will be reported by Clinical Engineering to the EOC Committee.

Devices not found within one year, will be reported by Clinical Engineering to Materials Management, with a copy to the EOC Committee with a recommendation for the device’s removal from inventory. Upon authorization from Materials Management to remove the affected devices from inventory, an “inactive” report will be sent to the owning department with an explanation of Inactive.

The Manager/Clinical Engineering assures that scheduled testing and maintenance of all types of sterilizers used in Your Hospital are complete and appropriately documented. Records of load testing and regular maintenance of sterilizers are maintained by the Supervisor/CPD. Any improper or unacceptable results are documented as patient safety incidents and reported to the Risk Manager for evaluation and action.

The Nurse Manager/Dialysis is responsible for maintenance of the water purification equipment through a contracted service agreement and the program of maintenance, which includes regular cleaning and disinfecting of all dialysis equipment and testing for compliance with biological and chemical standards for the dialysis water supply. All out of range results are documented as Patient Safety incidents and reported to the Manager/Risk Prevention for evaluation and action. Any event resulting in a patient injury or death will be treated as a Sentinel Event.

The Manager/Clinical Engineering assures that scheduled testing and maintenance of the dialysis equipment used in Your Hospital is completed.

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