Medical equipment management

Medical Equipment Management (known as biomedical/clinical engineering management) is a fundamental part of managing a clinical/biomedical engineering department. It defines the mechanisms for interaction and oversight of the medical equipment used in the diagnosis, treatment, and monitoring of patients. The related policies and procedures govern activities from selection and acquisition to incoming inspection and maintenance of medical equipment. The organization's mission is to ensure that equipment used in patient care is operational, safe, and properly configured to meet the mission of the medical treatment facility. These managers are charged with incredible roles and responsibilities including:

 • Equipment Management Implementation
 • Equipment Control & Asset Management 
 • Equipment Inventories
 • Work Order Management
 • Data Quality Management
 • Personnel Management
 • Quality Assurance
 • Patient Safety
 • Risk Management
 • Hospital Safety Programs
 • Radiation Safety
 • Medical Gas Systems
 • In-Service Education & Training
 • Accident Investigation
 • Safe Medical Devices Act (SMDA) of 1990
 • Health Insurance Portability and Accountability Act (HIPAA)  
 • Careers in Facilities Management

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Equipment Control & Asset Management

Every medical equipment area has its policies and processes on Equipment Control & Asset Management strategy which constitutes tracking equipment within the facility through a computerized management Systems (e.g. civilian's use AIMS and military use Defense Medical Logistics Standard Support (DMLSS) automated information system. When a new item is purchased it enters the Logistics warehouse then later inspected by in-house BMETs. Next, BMETs will affix an equipment control/asset number that begins the history for that item. This is similar to creating a new chart for a new patient that will be seen at the medical facility. Once an equipment control number is attached then the device is safety inspected and ready to be delivered to the using section.

Next, plans may include the use of a combination of equipment service providers such as manufacturers, third party services, etc. Managers make certain careful oversight and responsibility for ensuring maximum equipment performance through constant full service maintenance. Managers must be willing to assume responsibility for technological planning and management in all areas within a medical treatment facility (e.g. developing policies and procedures for the medical equipment management plan, identifying trends and the need for staff education, resolve defective biomedical equipment issues).

Work Order Management

A system used to record all acceptance/initial inspections, preventive maintenance, and calibrations, or repairs by generating scheduled and unscheduled work orders. This system can be non-automated or electronically automated to maintain work orders on file and to meticulously document the most recent safety inspection of a biomedical device. The work order management system can be used by managers for various reports such as personnel time, total number of hour’s technician spent working on equipment, maximum repair dollar for one time repair, or total dollar allowed to spend repairing equipment versus replacement. After that, quality checking work orders can be accomplished two ways: all work orders or taking a statistical sample’s (e.g. 100% critical items and 50% non critical items). Let’s say that you have 110 work orders, 10 are critical, and 100 are non critical then quality check all 10 critical and 50 noncritical work orders. Please note: it’s highly recommended and encouraged to do all work orders but again manage your time wisely and use statistics to your advantage. Work orders must be tracked weekly and all discrepancies must be corrected.

Data Quality Management

The Data Quality project is an initiative to have clinical/biomedical engineering department and medical equipment management office personnel clean up equipment data accuracy of certain basic or fundamental data elements. These data fields are variable but the most common are: nomenclature, manufacturer, nameplate model, serial number, acquisition cost, condition code, and maintenance assessment. Others to include should be: warranty, location, other contractor agencies, scheduled maintenance due dates, and intervals. These fields are crucial to the proper maintenance being performed, the accountability of an item, and safety of the item for patient use.

• Nomenclature: It defines what the device is, how, and the type of maintenance is to be   
  performed. Common nomenclature systems are taken directly from the Emergency Care Research 
  Institute (ECRI) Universal Medical Device Nomenclature System. 
• Manufacturer: This is the name of the company that received approval from the FDA to sell 
  the device, also known as the Original Equipment Manufacturer (OEM)
• Nameplate model: The model number is typically located on the front/behind of the equipment 
  or on the cover of the service manual and is provided by the OEM. E.g. Medtronic  
  PhysioControl’s Lifepak 10 Defibrillator can actually be anyone of the following correct 
  model numbers listed: 10-41, 10-43, 10 -47, 10-51, and 10-57. 
• Serial number: This is usually found on the data plate as well, is a serialized number 
 (could contain alpha characters) provided by the manufacturer. This number is crucial to 
  device alerts and recalls.
• Acquisition cost: The total purchased price for an individual item or system. This cost 
  should include installation, shipping, and other associated costs. These numbers are crucial 
  for budgeting, maintenance expenditures, and depreciation reporting.
• Condition code: This code is mainly used when an item is turned in and should be changed 
  when there are major changes to the device that could effect whether or not an item should 
  be salvaged, destroyed, or used by another Medical Treatment Facility.
• Maintenance assessment: This assessment must be validated every time a BMET performs any 
  kind of maintenance on a device. 

Several other management tools, such as equipment replacement planning and budgeting, depreciation calculations, and at the local level literature, repair parts, and supplies are directly related to one or more of these fundamental basics. Data Quality must be tracked monthly and all discrepancies must be corrected.

Personnel Management

This area is crucial to the daily work activities. Biomedical mangers must be able to correctly assign staff for the right job. Having a team leader/veteran is important for mentoring staff that might not have as much experience. The monthly timesheet provides a method to record the time each person was available for work during the month. The timesheet provides a gross breakout of how the time was spent, and provides a basis for productivity analysis reports. It also provides the monthly man-hour accounting data. This data can be used to process performance information about individual staff/team members. Each staff member should provide the following values of time, rounded to the nearest tenth of an hour, for monthly processing:

• Regular hours
• Overtime hours
• Non-duty absence
• Duty absence
• Administrative support hours
• Technician training hours
• Supervisory hours
• Travel hours

The following examples are calculations you can use for personnel management:

• Total hours = Regular hours + Overtime hours
• Hours available for work = Total hours - (Non-duty absence and Duty absence)
• Hours available for maintenance = Hours available for work - (Administrative support hours, 
  Technical training hours, Supervisory hours, and Travel hours)

Quality Assurance

Quality Assurance is a way of identifying an item of supply or equipment as being defective. A good quality control/engineering program improves quality of work and lessens the risk of staff/patient injuries/death.

Patient Safety

Safety of our patients/staff is paramount to the success of our organizations mission. Every year, the Joint Commission lists new “National Patient Safety Goals” to be implemented by organization. The development and annual updates of these goals is supervised by experts in the field such as, patient safety experts, nurses, physicians, pharmacists, risk managers, and other professionals who have hands-on experience in dealing with patient safety issues in a wide variety of health care settings. Patient safety is the mindset of everyone in health care, and participating in a hospital committee provides a way for biomedical managers and clinical engineering departments to gain visibility and positively affect their workplace.

Risk Management

This program helps the medical treatment facility avoid the likelihood of equipment related risks, minimize liability of mishaps and incidents, and stay compliant with regulatory reporting requirements. The best practice is to using a rating system for every equipment nomenclature such as defibrillators are considered high risk, infusion pump, general purpose are medium risk, electronic thermometers are low risk, and otoscopes are no significant risk. This system could be setup using Microsoft excel or access program for a managers or technicians quick reference.

In addition, user err, equipment abuse, no problem/fault found occurrences must be tracked to assist risk management personnel in determining whether additional clinical staff training must be performed.

Hospital Safety Programs

There are seven management plans and one is called “Safety.” Safety can be anything related to preventing mishaps or injuries on the job or a patient. The most common safety mishaps are staff accidentally stick themselves with a needle (it happens!) or a patient gets shocked on a unit. As a manager, ensure all staff and patients are safe within the facility. Note: it’s everyone’s responsibility!

There are several meetings that medical equipment managers are required to attend as the organizations technical representative. The following are:

 • Patient Safety
 • Environment of Care 
 • Space Utilization Committee
 • Equipment Review Board
 • Infection Control (optional)

Safe Medical Devices Act (SMDA) of 1990

This act altered the Federal Food, Drug, and Cosmetic Act requiring medical treatment facilities to report to the Secretary of Health and Human Services, the manufacturer, or both whenever there is a probability that a medical device has caused or contributed to a death, illness, or injury.

Devices are reported through “Med Watch” using form FDA 3500A/ Mandatory reporting which is used by staff personnel. Managers will complete the form and fax it or submit it via online.

Associations

• META - Medical Equipment & Technology Association
• AAMI - Association for the Advancement of Medical Instrumentation
• CMIA - California Medical Instrumentation Association