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Medical Equipment Management (also known as biomedical equipment management, clinical engineering, or clinical equipment management) is a fundamental part of managing a clinical/biomedical engineering department. It includes the business processes used in interaction and oversight of the medical equipment involved in the diagnosis, treatment, and monitoring of patients. The related policies and procedures govern activities from the selection and acquisition through to the incoming inspection, acceptance, maintenance, and eventual retirement and disposal of medical equipment. Medical equipment management is a recognized profession within the medical logistics domain. The medical equipment management professional's purpose is to ensure that equipment used in patient care is operational, safe, and properly configured to meet the mission of the medical treatment facility. Some but not all of the medical equipment professional's functions are:
- Equipment Control & Asset Management
- Device Assets Inventory
- Financial Management
- 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
- Service Contracts
Equipment Control & Asset Management
Every medical treatment facility should have policies and processes on equipment control & asset management. Equipment control and asset management involves the management of medical devices within a facility and may be supported by automated information systems (enterprise resource planning systems from Lawson Software are often found in U.S. hospitals, and the U.S. military health system uses an advanced automated system known as the Defense Medical Logistics Standard Support (DMLSS)) suite of applications. Equipment control begins with the receipt of a newly-acquired equipment item and continues through the item's entire life-cycle. Newly-acquired devices should be inspected by in-house or contracted biomedical equipment technicians (BMETs), who will establish an equipment control / asset number against which maintenance actions are recorded. 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 established, the device is safety inspected and readied for delivery to clinical and treatment areas in the facility.
Facilities or healthcare delivery networks may rely on a combination of equipment service providers such as manufacturers, third party services, in-house technicians, and remote support. Equipment managers are responsible for continuous oversight and responsibility for ensuring safe and effective equipment performance through full service maintenance. Medical equipment managers are also responsible for technology assessment, 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, resolution of defective biomedical equipment issues).
This industry is new, and there is not a clear line between IT and Biomed.
Work Order Management
Work order management involves systematic, measurable, and traceable methods to all acceptance/initial inspections, preventive maintenance, and calibrations, or repairs by generating scheduled and unscheduled work orders. Work order management may be paper-based or computer-base and includes the maintenance of active (open or uncompleted) and completed work orders which provide a comprehensive maintenance history of all medical equipment devices used in the diagnosis, treatment, and management of patients. Work order management includes all safety, preventive, calibration, test, and repair services performed on all such medical devices. A comprehensive work order management system can also be used as a resource and workload management tool by managers responsible for 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. Post-work order quality checks involve one of two methods: 100% audit of all work orders or statistical sampling of randomly-selected work orders. Randomly-selected work orders should place more stringent statistical controls based on the clinical criticality of the device involved. For example, 100% of items critical to patient treatment but only 50% of ancillary items may be selected for sampling. In an ideal setting, all work orders are checked, but available resources may dictate a less comprehensive approach. Work orders must be tracked regularly and all discrepancies must be corrected.
Data Quality Management
Accurate, comprehensive data is needed in any automated medical equipment management system. Data quality initiatives can help to insure the accuracy of clinical/biomedical engineering data. The data needed to establish basic, accurate, maintainable automated records for medical equipment management includes: nomenclature, manufacturer, nameplate model, serial number, acquisition cost, condition code, and maintenance assessment. Other useful data could include: warranty, location, other contractor agencies, scheduled maintenance due dates, and intervals. These fields are vital to ensure appropriate maintenance is performed, equipment is accounted for, and devices are safe for use in patient care.
- 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.
This area is crucial to the daily work activities. Biomedical managers 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 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.
Safety of our patients/staff is paramount to the success of our organizations mission. The Joint Commission on the Accreditation of Healthcare Organizations publishes annual lists detailing “National Patient Safety Goals” to be implemented by healthcare organizations. Goals are developed by experts in patient safety nurses, physicians, pharmacists, risk managers, and other professionals with patient-safety experience in a variety of settings. Patient safety is among the most important goals of every healthcare provider, and participation in a variety of committees and processes concerned with patient safety provides a way for biomedical managers and clinical engineering departments to gain visibility and positively affect their workplace.
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 type. For example, a risk-rating system might rate defibrillators as considered high risk, general-purpose infusion pumps as medium risk, electronic thermometers as low risk, and otoscopes as no significant risk. This system could be setup using Microsoft Excel or Access program for a managers or technicians quick reference.
In addition, user error, 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.
Risk management for IT networks incorporating medical devices will be covered by the upcoming standard ISO/IEC 80001. Its purpose is: "Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and activities that are necessary for RISK MANAGEMENT of IT-NETWORKS incorporating MEDICAL DEVICES to address the KEY PROPERTIES". It resorts some basic ideas of ISO 20000 in the context of medical applications, e.g. configuration, incident, problem, change and release management, and risk analysis, control and evaluation according to ISO 14971. IEC 80001 "applies to RESPONSIBLE ORGANIZATIONS, MEDICAL DEVICE manufacturers and other providers of information technologies for the purpose of comprehensive RISK MANAGEMENT".
Hospital Safety Programs
The Joint Commission stipulates seven management plans for hospital accreditation. One of the seven is safety. Safety includes a range of hazards including mishaps, injuries on the job, and patient care hazards. The most common safety mishaps are "needle-sticks" (staff accidentally stick themselves with a needle) or patient injury during care. 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
Service contracts afford peace of mind regarding the maintenance of your medical equipment. A smart service contract does not start with what the vendor writes into it, but with what you as the equipment owner first know about your own collective needs. Before even sitting down to review written options, a hospital must have a thorough and detailed equipment inventory with individual device-performance histories and service records in order to navigate toward the best decision—which may include opting to forgo a service contract on particular devices.
Smart service contracts fill the gap if an in-house clinical/biomedical engineering department has insufficient test equipment, manpower or responsiveness, or technical skills; or if an in-house program would require costly training or specialized test equipment; or if it would simply cost more than using contractor services. What makes a contract smart? Evaluating different contract types, knowing what services to include, what tricks to avoid, and how to negotiate additional discounts or training.
The core offerings of a service contract hardly differ from offer to offer, so a keen eye is all the more necessary in differentiating among contracts to find which is the most economical, peace-of-mind-ensuring package for all concerned—from the biomedical/clinical engineering department to department users and directors to physicians, and the c-level suite (CFO, CEO, COO, etc). To properly understand and respond to your need for a service contract, involve all related teams from the beginning, which in turn helps get all the right questions asked during the shopping and negotiating phases.
"It is important that the users of the equipment and tech services groups from biomed and IT standpoints have an opportunity to participate in the process," says Joe Medina, AAS, biomed department supervisor at Exempla Good Samaritan Medical Center, Lafayette, Colo. Well-versed in organizing such open communication, Medina is part of a team that analyzes the need for service contracts at his facility. The team ensures that all necessary considerations and evaluations are addressed, including decisions ensuring construction, workflow, and temperature and humidity factors of a room where a new imaging device is to reside.
For new equipment purchases, biomedical/clinical engineering needs to be involved in the vendor presentations, along with other department directors, to help encourage realistic vendor promises. The biomedical/clinical engineering department should in turn receive advance notice of new equipment purchases and items coming off warranty through regular attendance at materials management or environment of care meetings. Having sufficient notice allows for proper planning and research on contract options from device to device, preventing uneducated, hasty decision-making. 
Know what you need
Regardless of vendor, we suggests that at the very least, any service contract for PM, calibration, repairs, or even one-time repair actions address and answer the following:
- Medical devices to be covered;
- Whether parts and supplies are included;
- Whether technical support is included (telephone, remote diagnostics, etc);
- Whether, if requested, a loaner will be provided, and at what cost, if any;
- Estimated total cost;
- Estimated travel and labor cost;
- Contract coverage period;
- Three different suggested sources or manufacturers;
- Regular business hours;
- Response time by contractor;
- Frequency of service PMs and calibrations;
- How the contractors will report to biomedical/clinical engineering (a sign-in and out log, for example);
- Circulation of service reports;
- Accurate documentation, specifications, tolerances, and results for PMs, calibrations, and repairs;
- HIPAA's compliance plan and violation consequences;
- After-hours vendor response procedures for security purposes;
- Site visit by vendor within 30 days of signing to cover installation plans (layout, room preparation drawings, and instructions); and
- Operator training from the manufacturer for both biomeds and users. 
- ↑ Minassian, Veronik., "Service Solutions: Essentially Smart Contract". 24x7 Magazine. February 2009. Essentially Smart Service Contracts
- ↑ Minassian, Veronik., "Service Solutions: Essentially Smart Contract". 24x7 Magazine. February 2009.