St. Elizabeth Healthcare

2011 Medical Equipment Management Plan

Covington, Edgewood, Falmouth, Florence, Ft. Thomas, Grant County

Scope

St. Elizabeth Healthcare has a medical equipment management program that involves an integration of measures with all departments to ensure a high level of medical equipment performance, availability, and safety in support of patient care. This medical equipment management program maintains complete and continuous compliance with TJC medical equipment management requirements. These requirements are designed to assess and control the clinical and physical risks of fixed and portable medical equipment used for the diagnosis, treatment, monitoring and care of patients.

Clinical Engineering is responsible for maintaining compliance with this program. All programs are implemented in accordance with the healthcare system’s Mission, Vision and Values, Equipment Management Policy, Federal, State and Local governing authorities and JCAHO recommendations.

Objectives

  • Improve the procedures on how medical equipment that fails is tagged and segregated by the user.
  • Improve the testing, documentation and tracking of rented, leased, and demo equipment coming into the medical center.
  • Formulate a standard operating procedure for the integration of equipment acquired with physician’s offices.

The Hospital Manages Medical Equipment Risks

Management Plan

St. Elizabeth Healthcare has a medical equipment management plan which promotes the safe and effective use of medical equipment. The plan addresses all of the elements of performance of EC.02.04.01 and EC.02.04.03.

Equipment Selection & Acquisition

Clinical Engineering provides guidance and direction in the selection and acquisition of all medical equipment through active involvement in the Technology Assessment Committee, a sub-committee of the Value Analysis Committee. The Director of Clinical Engineering and the Director of Purchasing co-chair the Technology Assessment Committee that addresses purchasing issues. The process also includes an initial evaluation of the condition and function of the equipment.

Criteria & Inventory

The Clinical Engineering Department maintains a current, accurate, and separate inventory of all equipment*(regardless of ownership) covered by the medical equipment management plan. Each piece of equipment is issued a unique alpha-numeric code that is entered into the database and a tag is affixed to the item. The hospital has established and uses risk based criteria for identifying and evaluating equipment to be included in the medical equipment management plan. The equipment is scored for risk assignment using a modified feature that is incorporated in the medical equipment management software. The criteria takes into account equipment function (diagnosis, care, treatment, life support and monitoring), physical risks associated with use, and equipment incident history.

* The Plant Engineering Department employs a similar strategy for managing certain pieces of medical equipment (surgical beds, sterilizers, scope washers…).

PM, Repair & Inspection

All medical equipment brought into the health system is included in the inventory program, which involves labeling, electrical safety and performance testing, and documentation. Clinical Engineering uses Medical Equipment Management Software called Medi-Mizer. The medical equipment is evaluated on a risk criteria program that places the medical equipment into three classifications. These classifications are known as Alpha (highest priority, includes life support), Beta (medium priority), and Theta (low priority). The algorithm used allows us to determine the level of periodic maintenance necessary to ensure safe and dependable medical equipment. The medical equipment risk classifications are approved by the Safety and Risk Management departments. The schedule is generated monthly. 100% of the alpha inspections, which includes life support equipment, are completed within 31 days of the date opened. Greater than 85% of the beta inspections are completed within 31 days of the date opened and 100% completion within 90 days. Equipment that cannot be located for preventive maintenance in the allotted time are documented as such and tracked. Items not found during two consecutive PM cycles are considered inactive and the maintenance schedule is amended. Any inactive equipment that is found will be tested, documented appropriately and returned to service. Periodic maintenance completion rates are reported bi-monthly to the Safety Committee and Quarterly to the Quality Management Division. The Plant Engineering Department employs a similar strategy for managing certain pieces of medical equipment (surgical beds, sterilizers, scope washers…).

Medical equipment rental companies must perform routine preventive maintenance and performance testing on their equipment prior to use at the medical center. A copy of the results shall be included in the appropriate file in the Clinical Engineering Department.

Clinical Engineering provides emergent, urgent and routine corrective maintenance on all medical, clinical, therapeutic, and diagnostic imaging equipment used within the health system. These services are obtained by contacting the Clinical Engineering Department. An on-call support program is used after regular business hours, on weekends, and holidays.

PM Frequencies

Clinical Engineering has defined the intervals for inspecting, testing, and maintaining appropriate equipment on the inventory. We use a risk criteria program that takes into consideration:

Clinical Application Issues/Risk Levels

Maintenance Requirements/Manufacturers’ Recommendations

Incident History/Hospital Experience

Equipment Functions

Special Facility Issues

The first four bullets are well defined by TJC. The fifth bullet is used to adjust the overall score of the medical equipment based on special facility considerations. These special conditions are well documented and reviewed by the Safety and Risk Management Departments. A cumulative score is determined and used as a guideline for the medical equipment periodic maintenance inspection frequency for each piece of medical equipment. The program is designed around individual pieces of equipment and not device types.

Safe Medical Devices Act

Clinical Engineering and Risk Management monitors and responds to all medical equipment hazard notices, recalls, and alerts. This information is reported to the Safety Committee.Clinical Engineering and Risk Management monitors, investigates and reports incidents in which a medical device is involved in the death, serious injury or illness of an individual, as required by the Safe Medical Device Act of 1990. These reports are sent to the medical device manufacturer and FDA using MedWatch.

Emergency Procedures

Clinical Engineering has procedures on how medical equipment users will request and receive emergent, urgent and routine medical equipment service. The user is to contact Clinical Engineering in the event of medical equipment failure. An on-call program is used for after business hours, on weekends, and holidays. The departments have protocols describing when and how to perform clinical intervention in the event of critical medical equipment disruption or failure. Clinical Engineering also has a small variety of loaner medical equipment to be used when appropriate.

The Hospital Inspects, Tests, andMaintains Medical Equipment.

Testing Medical Equipment Prior To Initial Use

All medical equipment brought into the medical center is tested for performance and safety prior to its initial use. Appropriate documentation of these tests is stored in the Clinical Engineering Department.

Testing Life Support Equipment

Medical equipment used for life support is inspected and maintained according to the maintenance strategy of the medical equipment management plan. A history of each piece of equipment is recorded in the Clinical Engineering Database.

Testing Non-Life Support Equipment

Non-life support equipment is inspected and maintained according to the maintenance strategy of the medical equipment management plan. A history of each piece of equipment is recorded in the Clinical Engineering Database.

Testing Sterilizers

The Plant Engineering Department documents the performance testing of all sterilizers used in the medical center.

Testing Dialysis Equipment

The Clinical Engineering Department (in conjunction with the Dialysis Department) documents the chemical and biological testing of the water used in renal dialysis. All testing is done in accordance with state, local, and federal regulations. The manufacturers’ recommendations and the hospitals’ experience are also taken into account.

Nuclear Medicine Equipment

The Clinical Engineering Department has qualified staff that inspects, tests, and calibrates the nuclear medicine equipment. The dates of theses activities are documented.

Evaluating The Plan

The Director of Clinical Engineering evaluates the scope, objectives, performance and effectiveness of the plan on an annual basis.

Terry Teipel

January 24, 2011