Monthly Archives: July 2014


It is necessary that clinical engineers become familiar with mandated standards, voluntary standards, accreditation body requirements, and licensing agency requirements that apply to their particular health-care institution and to the medical equipment for which they are responsible. Typical examples are shown below (20). An in-depth list of Biomedical Stan­dards is available in The Guide to Biomedical Standards (21).

Voluntary Standards Organizations

American Association of Blood Banks (AABB)

American Dental Association (ADA)

American National Standards Institute (ANSI)

American Society of Histocompatibility and Immunogenet – ics (ASHI)

Association for the Advancement of Medical Instrumenta­tion (AAMI)

College of American Pathologists (CAP)

National Fire Protection Association (NFPA)

Underwriters Laboratories (UL)

Governmental Agency Standards

Federal Communications Commission (FCC)

Food and Drug Administration (FDA)

Standards for the Operation of Hospitals

Local and state requirements, such as the Department of Health

American Hospital Association

Joint Commission on Accreditation of Healthcare Organi­zations (JCAHO)

Joint Commission

The Joint Commission on Accreditation of Healthcare Organi­zations (JCAHO) runs voluntary three-year accreditation pro­grams for health-care facilities aimed at improving the qual­ity of patient care. Information gathered about a hospital can be released to the public. Accredited health-care facilities are eligible to receive federal Medicare reimbursement. Many state governments recognize accreditation as a requirement for licensure and Medicaid reimbursement (22).

The environment of care (EC) in which today’s health care is provided is complex. It includes plant facilities, medical equipment, drugs, information, finance, staff, third-party ser­vices, and diverse technologies (23). JCAHO is concerned that this environment be managed so as to provide a hazard-free environment that reduces the risk of human injury.

JCAHO requires management programs to be set up that deal with safety, security, hazardous waste, emergency pre­paredness, life safety, medical equipment, and utility sys­tems. Clinical engineers tend to be most involved with activi­ties that constitute a medical equipment management program, the purpose of which is to promote the safe and ef­fective use of the institution’s medical equipment. The medi­cal equipment management program encompasses equipment acquisition, technical management, and education for both equipment operators and maintainers. As part of this pro­gram, JCAHO requires clinical engineering to submit periodic reports to the institutions safety committee. Performance standards (quantifying factors relevant to program effective­ness) are developed and selected indicators (activities) such as those dealing with timely PM and repair performance are tracked. Changes observed in the indicators are used to spot and correct deficiencies in the clinical engineering program. The aim of this activity is to improve the quality and cost – effectiveness of the clinical engineering services provided (24).

Safe Medical Devices Act

The Safe Medical Devices Act (SMDA) of 1990 and its 1992 amendment requires health-care institutions to report equip­ment incidents resulting in serious injury or death to a pa­tient or employee. An institution’s risk manager determines whether the incident is reportable, using a documented deci­sion-making process. Medical-device-related deaths must be reported within 10 days to the FDA and to the manufacturer. Medical-device-related serious injuries or illnesses must be reported within 10 days to the manufacturer, or if the manu­facturer is unknown, to the FDA. Periodic summary reports are also required. The SMDA also requires that specific medi­cal devices be tracked, and that medical equipment be prop­erly disposed of when it is taken out of service (25,26). SMDA compliance is also a requirement of the JCAHO.

However, as a result of a reform bill, the FDA Moderniza­tion Act of 1997, in a few years all hospitals may no longer be required to submit reports to the FDA when patient deaths or serious injuries involving medical devices occurs. Instead the FDA will rely on a small sample of representative hospi­tals and nursing homes called ‘‘sentinels’’ to collect the data.

Patient Incident Investigation

When a patient incident occurs, incident reports from nurs­ing, physicians, and others are submitted to the risk manage­ment department. A clinical engineering technical evaluation is also prepared and submitted. Risk management staff uses this material to determine what caused the incident (e. g., was the equipment at fault or was operator error indicated). The intent of the investigation is to prevent a recurrence and to determine if the incident must be reported under the SMDA of 1990.

Clinical engineering should be notified about an incident as quickly as possible to allow a thorough technical evalua­tion to be made. Doing so may allow investigation and on-site testing to be done with the equipment setup still intact (mak­ing note of how the unit was used, dial settings, etc.) and with peripheral equipment still in place. Subsequently the instru­ment, accessories, and disposables are taken out of service and sequestered. Further inspection and testing may be re­quired within the clinical engineering laboratories (Fig. 6), or by a third party. Such determination is made by clinical engi­neering working with the risk manager. The manufacturer should only be contacted with the risk manager’s approval. Sometimes during investigation, minor equipment problems are detected, that could not have caused the incident. Prior to repairing these, the risk manager should be consulted to determine the legal ramifications. Determination must also be made as to whether the equipment needs modification to prevent future recurrences. The clinical engineer’ report will be important should a lawsuit ensue. For this reason impre­cise language must be avoided, so as not to jeopardize the institution’s legal position. For legal reasons, the equipment must be stored in a secure location and not put back into ser­vice until the risk manager concurs.

User Error; Equipment Abuse; No Fault Found

It is important that clinical engineering workers track service requests whose resolution indicates no fault found (NFF), equipment abuse, or user error. This information should be submitted to risk management for analysis even if patient in­jury did not result. User errors are typically more common than true equipment malfunctions. JCAHO requires that user errors that have a potential for harm receive the same type of review that hazardous equipment failures receive. Risk management analysis may indicate the need for additional user in-service education to alleviate future problems.

Informal one-on-one training is provided by clinical engi­neering staff to the user when returning such equipment back to service, by demonstrating the proper equipment operating technique. Through this educational activity clinical engi­neering helps improve patient care and reduces the possibil­ity of lawsuits.

Hazard Alerts and Recalls

The clinical engineering department acts as the hospital’s hazard and recall coordinator. Typically the manufacturer no­tifies clinical engineering and risk management about recalls and alerts. At other times the clinical engineering depart­ment, upon review of commercially available listings, notifies appropriate hospital departments including risk manage­ment. Hazard alerts and recalls are available from the FDA, as well as from private publishers such as the Emergency Care Research Institute (ECRI) and Quest.

The clinical engineering department queries the equip­ment inventory list to locate equipment affected, and when

Figure 6. Incident investigation—fiber optic light. Equipment-related incident investiga­tion is conducted by clinical engineering whenever there is the possibility that a medi­cal device may have caused injury to a patient or clinician. This requires investigation at the scene, as well as additional testing within the clinical engineering laboratories. Picture tak­ing (a digital camera is most useful) docu­ments observations. Clinical engineering staff may also anticipate and resolve equipment problems before they result in an incident. Shown here, an examination lamp bracket was found to not meet the lamp OEM specifi­cation, which could result in the lamp being easily dislodged and falling. The bracket manufacturer in coordination with the lamp OEM worked with clinical engineering to re­solve the issue and supplied newly designed brackets.

required removes it from service and sequesters it until reme­dial action is taken. Should equipment retrofiting be required, the manufacturer may choose to provide an upgrade kit with instructions, opt to send a field-service engineer on-site, or require that the equipment be picked up or sent to the fac­tory. Appropriate paperwork must be provided to the institu­tion for inclusion in the instrument’s history folders, and en­tries made into the computerized equipment records. Updated operators’ manuals and additional user in-service training may also be required.

Research and Development assistance Patent and grant assistance

Institutional Review Board (IRB) approval assistance Equipment planning for clinical areas and new programs Generating reports to administration including clinical capital equipment purchase tracking Computerized clinical instrumentation inventory Centralized patient-care instrumentation history files Centralized instrumentation technical manuals library Equipment evaluation library Instrumentation pre-purchase evaluation

RFQ generation Purchase requisition review Bid evaluation

Vendor and manufacturer interface Coordination of outside services

Acceptance testing (initial checkout, incoming inspection, incoming test) of new equipment safety, operation, and technical specifications Clinical equipment installation coordination and supervi­sion

Defect resolution and documentation User in-service training

Preventive maintenance test procedure generation and up­date

Testing of rental, loaner, demonstration, patient-owned, and physician-owned equipment for hospital use Scheduled PM Equipment repairs Equipment upgrades

Oversight and evaluation of equipment service contracts Emergency clinical engineering support to all patient-care areas

On-call and recall for critical care areas Specialized clinical engineering support dedicated to cardi – othoracic surgery Quality assurance and risk management Regulatory agency survey support Equipment related patient incident investigation Hazard and recall alert notification

Clinical engineering participation on hospital and health center committees Represent hospital on the University Healthcare Consor­tium (UHC) Clinical Engineering Council Represent hospital in the New York City Metropolitan Area Clinical Engineering Director’s group BMET internship programs

NYC Board of Education Substitute Vocational Assistance (SVA) internship programs Volunteer training

Clinical engineering staff and departmental development.

Equipment Modification. At times clinical engineering is called on to modify instrumentation. Modification must not be done indiscriminately. Care must be taken so as not to violate the integrity of the equipment. It is best to limit modifications to external operations. Nonmanufacturer approved internal modifications must be approached with extreme caution and are best not done as they may void warranties and violate FDA guidelines. This includes securing devices to a cart so they will not fall off in transit or be stolen, assembly of de­vices into working systems, and modification of equipment to allow easier PM. For example, a monitor used in an endo­scopic video system may have to be secured to a cart, or, a medication cart may have to be modified to allow its use as a crash cart. Crash carts typically are medication carts that house a defibrillator, suction device, O2 tank, and supplies. Purchased as separate entities, integration is required. Elec-

Figure 5. Equipment modification, crash cart. Equipment modification takes many forms and runs the gamut from modifying a specific device to assembling separately pur­chased components into functioning systems which may not be available commercially, or which must have specific characteristics to satisfy institution requirements. Shown here, a medication cart was modified by clinical en­gineering to accept an electrical outlet strip and retractable reel (with 25-ft line cord), O2 cylinder, a defibrillator, and an aspirator so that it can be used as a cardiac arrest crash cart, which is brought to the patient bedside for resuscitation during patient cardiac or re­spiratory emergencies.

tric reel extension cords, auxiliary power outlets, as well as on/off switches and tie-down straps to prevent defibrillator removal must be added (Fig. 5). Another example is the con­struction and assembly of an operating room (OR) transport cart connected to the patient bed upon transport from the OR to the Cardiothoracic Intensive Care Unit (CTICU), which houses a ventilator, monitor, defibrillator, and dc to ac supply. An example of a modification that assists in PM is the exter­nal provision for a jumper (with manufacturer approval), which when removed allows the backup thermostat of a hy­perthermia blanket to be tested, without the need for disman­tling the unit. Equipment controls may also be physically con­stricted so as to prevent inadvertent operator-induced error. Examples include covering of stylus heat adjustment controls (after optimization), limiting rotation of a ventilator alarm control to prevent complete alarm shut-off, and plugging an unneeded ECG sync-pulse phone jack output to prevent its use with a defibrillator as it induces too much signal delay.

Research and Education. Most health-oriented universities with teaching hospitals have education, research, and health care as their mission. Clinical engineering is capable of pro­viding support for all of these goals. Clinical engineering as­sistance with health care has already been discussed. With regard to education, in addition to providing in-service educa­tion, clinical engineers are called on to teach courses in the health-related professions. Clinical engineering support for research activities includes assistance in the selection of ex­perimental equipment, setting up a laboratory, measurement technique, grant writing, patent applications, and IRB ap­proval. Also included are the design, prototype development, and final construction of special-purpose devices that are not readily available commercially or that can be more cost effec­tively built in-house.

Involvement in research and educational activities are beneficial to a clinical engineering department. These chal­lenging opportunities help to keep the staff technically compe­tent and involved at the forefront of technology. Such activi­ties also bring prestige to the department, enhancing its professionalism and reputation, helping it to gain additional resources.

Clinical Engineer Supervisor Director or Department Manager

Goal and Responsibilities

Goal. A hospital-based clinical engineering department’s goal is to support its institution in its mission (typically pa­tient care, education, and research), and while so doing en­sure the safety and efficacy of the hospital’s medical instru­mentation. This goal is achieved by providing appropriate technical services. These services can range from the basic maintenance, calibration, and repair of medical equipment, to the more sophisticated research activities of design and devel­opment of medical equipment and devices usually associated with biomedical engineering, thus resulting in some overlap between these two disciplines (Fig. 3).

Equipment Responsibilities. Clinical engineers apply engi­neering and management principles to issues that relate to medical equipment’s entire life cycle. They help determine what equipment to purchase and how long it is cost-effective to keep this equipment in service, and when to turn to newer technologies. Such guidance saves hospitals money and re­duces liability.

Clinical engineers manage a diverse group of medical de­vices located throughout their institutions. This includes in­strumentation used in cardiology, intensive care, clinical labo­ratory, respiratory therapy, anesthesiology, neurology, physical therapy, ultrasound, and the operating rooms. Some clinical engineering departments also provide service for x – ray or ionizing radiation devices used in radiology, radiation therapy, or nuclear medicine that are typically managed by radiation physics staff. Others may service purely mechanical devices such as stretchers, hospital beds, and wheelchairs, but these are usually managed by facilities engineering.

Clinical engineers provide emergency instrumentation troubleshooting expertise. This can take place within an op­erating room during cardiothoracic surgery, a patient-care area (Fig. 4), or in a researcher’s laboratory during animal experimentation. Typically clinical engineers do not operate the medical equipment or select levels of treatment (i. e., bal­loon pump inflate or deflate timing), or give fluids to or take

Figure 4. Emergency support, balloon pump. Clinical engineering plays a key role in providing emergency support to troubleshoot and answer questions relating to equipment operation and capability. Here a clinical engineer is running a test to assure that a balloon pump located outside a Cath-Lab is functioning properly. This device provides support to critically ill patients by reducing their heart’s workload until it strengthens. Balloon inflate/deflate timing and mode of triggering assure optimal patient assistance.

fluids from patients (i. e., cell saver). This is left to clinical specialists, perfusionists, and licensed technicians specially trained for these purposes. However, clinical engineers do provide instrumentation troubleshooting expertise during these procedures and provide guidance on the operation and performance of the equipment.

Typically clinical engineers do not maintain the physical plant. They deal with medical equipment external to the walls. This equipment may require connection to utilities in­cluding electricity, gases, and water, as well as to other elec­trical systems that may not fall within clinical engineering’s domain [e. g., patient line isolation monitors (LIM) within headboards or nurse call systems which interface with bed­side monitor alarms]. Knowledge of the physical plant and such systems is, however, helpful especially during equip­ment selection and installation, when analyzing the cause of equipment failure, and when setting policies for equipment use during utility failures. A useful reference guide is the Na­tional Fire Protection Association (NFPA) Health Care Facili­ties Handbook (15).

Changing Responsibilities. As health care changes, some hospital-based clinical engineering departments are starting to investigate the feasibility of providing a broader range of services. They are becoming areas of excellence for items that were previously outside their domain, including x-ray devices, computers, telecommunications, and nurse-call systems. Some also take on risk management and many clinical engi­neering departments have technology assessment responsibil­ities.


As a service department, clinical engineers interface daily with staff from most other departments and entities within a health-care institution, all of which are considered to be clini­cal engineering clients. A partial list includes facilities engi­neering and planning, hospital administration, cardiothoracic surgery, central sterile, expenditures, contracts, risk manage­ment, OPD administration, clinics, clinical laboratories, am­bulatory surgery, pharmacy, surgery, anesthesiology, off-site satellite clinics, clinical areas, nursing units, the personnel department, purchasing, and cardiology. Interaction between researchers and educators also occurs.


Clinical engineering participation in committees is important for a successful clinical engineering program. It provides clini­cal engineering with greater exposure to other hospital de­partments and administrators and vice-versa and provides in­formation about how the department is doing which supplements the formal survey process. Equipment-related problems and questions voiced allow clinical engineering to provide immediate feedback to the clinical user. This keeps open and improves channels of communication between clini­cal engineering and their clients. It allows clinical engi­neering to become essential members of the multidisciplinary team of health care delivery and have an input on decisions relating to that delivery. It also allows trends to be spotted that clinical engineering staff may be unaware of, for exam­ple, equipment that is down but was not yet formally reported to clinical engineering.

Committees include:

Safety committees such as safety and laser safety.

Clinical committees such as neonatal interdisciplinary, special care units, adult critical care, cardiopulmonary resuscitation (CPR), infection control, and the Institu­tional Review Board.

Equipment-related committees such as capital acquisition, product standardization, and sole source (some of which may be chaired by clinical engineering).

Quality assurance and investigatory planning committees such as clinical departments, quality assurance, and those related to JCAHO such as Environment of Care.

Ad hoc special committees such as those for efficient light­ing studies, research activities, year 2000 (Y2K) compli­ance and so on.

Physical Plant Requirements

To ensure efficient services, clinical engineering must be allo­cated adequate facilities to allow all clinical engineering func­tions to be performed. This includes sufficient space to store new equipment delivered, equipment awaiting servicing, and equipment awaiting delivery back to the user, as well as equipment sequestered because of its involvement in a pa­tient incident. Space must also be adequate to house all of the tools, test equipment, computers, office equipment, parts and if possible a machine shop. As clinical engineering is the cen­tral repository of all regulatory-related medical instrumenta­tion history files both active and inactive, adequate accessible storage for them is needed as well as for the equipment opera­tor and service manuals and technical library.

Test space must be such that it allows performance of ac­ceptance testing, PM, and repair. It must contain appropriate electrical power, suction, compressed air, secure gas tank storage, proper lighting, ventilation, sinks, fume hoods, work­benches, and storage cabinets.

Test Equipment, Tools, and Test Fixtures

Required test equipment includes electrical safety analyzers, physiological simulators, oscilloscopes, power supplies, mul­timeters, ventilator testers, electrosurgery analyzers, wave­form generators, photometer or radiometer lightmeters, laser power meters, etc.

Tools required include screwdrivers, pliers, wrenches, drills, soldering stations, etc. A machine shop equipped with a drill, lathe, grinder, and milling machine is useful.

It is beneficial for the clinical engineering staff to construct setups of equipment, which are readily available for equip­ment testing purposes during acceptance testing, PM, and re­pair. These devices can sometimes be purchased, but most times they can be put together in-house. All such devices should be inventoried in a test-fixtures manual for ease of access.

Full-Service In-House Department

Service Overview. A full-service clinical engineering de­partment provides a multitude of services. As example, the biomedical/clinical engineering department (Scientific and Medical Instrumentation Center) of the State University of New York, Health Science Center at Brooklyn, University Hospital of Brooklyn has a broad-based clinical engineering program that includes biomedical engineering components such as support for research and education (19).

Its program includes the following:

Clinical engineering consultation

Design, construction, and modification of clinical instru­mentation and devices including electronic, electrome­chanical, and mechanical Education



Health-care facilities of varying size tailor their clinical engi­neering programs to satisfy the needs of their own specific environments, while striving to meet regulatory requirements such as that of the JCAHO. For example, community hospi­tals with less sophisticated health-care systems tend to re­quire less clinical engineering services than tertiary care teaching hospital centers.

The depth and breadth of services that clinical engineering can provide are directly related to the personnel and financial resources allocated to it. Smaller clinical engineering depart­ments must select services that are feasible for them to pro­vide, that is, concentrating their efforts mainly on the very core elements of equipment management such as PM and re­pair. As many clinical engineering services are geared toward risk reduction, each institution must realize that by choosing to limit these services, they are at the same time increasing their risk exposure and the possibility of lawsuits.

Institutions that cannot afford in-house programs turn to shared services in which several neighboring institutions share their specialists, or to independent service organiza­tions.

Report Structure

An institution’s structure determines to whom clinical engi­neering reports. Some clinical engineering departments re­port to facilities engineering and are grouped with other engi­neering services. Some report to hospital administration. Others, viewed as university departments, report to a univer­sity vice president. Generally, the higher up in the reporting structure, the more resources are made available to clinical engineering. The department status is also more credible. These resources include staff allocation, other-than-personnel service funding (OTPS), and physical plant space.

Department Structure

Full service clinical engineering departments could include clinical engineers, BMETs, machinists, equipment designers and prototype builders, and possibly an optics specialist (for lasers, microscopes, and other optical devices). The technical staff is supplemented by administrative, secretarial, and cler­ical staff. Such departments have the capability to be involved in sophisticated equipment maintenance and repair, equip­ment modification, and research activity.

Staff Duties. The director responsible for all managerial as­pects of the department interfaces with hospital administra­tion and other departmental managers both local and na­tional, and sits on institutional committees. The director negotiates on behalf of the institution with vendors, manufac­turers, and other service providers. He or she sets the course for the department, adopts policies that provide cost-effective quality service, and tracks industry trends and standard practice to benefit the institution. The director also ensures compliance with regulatory and investigatory agency require­ments.

The administrator, a key position, handles personnel is­sues, as well as matters related to financial analysis, budgets, billing, tracking of capital equipment purchases, and supervi­sion of the secretarial and clerical staff (Fig. 2).

The clinical engineering managers are responsible for en­suring smoothness of day-to-day operation, assigning jobs, managing on-call and recall, providing engineering consulta-

Figure 2. Administrative support, purchase order processing. The clinical engineering ad­ministrative function including secretarial support is critical to a successful department. The administrator serves a key function and is heavily involved in tracking the institu­tion’s clinical capital equipment purchases and clinical engineering’s own purchases. The administrator is also involved in budget prep­aration, monthly financial report analysis, and preparation of clinical engineering an­nual reports. Shown here, purchase requisi­tion information is being reviewed to assure timely processing so as not to delay equip­ment service. Such delay loses income for the hospital.

Figure 3. Research design and development, optical tomographic system. Research activi­ties enhance a clinical engineering depart­ment’s image and keep the staff current with the latest technological developments. Special – purpose devices that are not available commer­cially or are cost prohibitive are constructed. A team with diverse expertise in electronics, mechanics, electromechanics, and physiology is required. A precision machinist plays a prominent role. Shown, a positioning device is being modified for incorporation into an optical tomographic laser system, which one day may prove as clinically beneficial as MRI.

tion, and in-service education. They also assist in setting standards, policies, and procedures.

The clinical engineers are involved in acceptance testing, PM, repair, on-call and recall, providing emergency assis­tance, design and prototype construction, and in-service edu­cation.

The BMETs are primarily responsible for performing PM, repair, and calibration of equipment, per procedures set by clinical engineers.

The clerical staff assists with data entry and documenta­tion filing.

Job Titles. The Journal ofClinical Engineering conducts an annual nationwide survey of salaries and responsibilities for hospital biomedical and clinical engineering and technology personnel (18). This survey includes a set of generic titles and generalized job descriptions that provide a convenient indus­try overview. These titles follow:


Equipment Specialist [Laboratory (RES) or Radiology (RES)]