1980s

Medical Equipment Advances. During the 1980s medical equipment became more sophisticated. Designers utilized de­vices, techniques, and technologies that had been developed and then filtered down from NASA and military contract work and also focused more on safety. Included were ultra­sound imaging techniques, charge-coupled devices (CCD) first used in spy satellites now used in endoscopic cameras, solid – state electronics, integrated circuits, denser multilayer board packaging, microprocessors, and dedicated computers. Health care became more equipment-dependent. The number of med­ical devices purchased increased, and sophisticated medical programs and procedures grew in number. The services that the clinical engineer was requested to provide expanded from just maintenance, repair, and safety testing of medical equip­ment to include activities now considered to be part of an equipment management program, namely patient incident in­vestigation, medical device regulation reporting, equipment planning, and new equipment acquisition. This further in­creased the demand for clinical engineers.

Modification of Inspection Requirements

As the economics of health care started to change and funding became more scarce, the JCAHO modified its PM inspection frequency requirement, reducing it from quarterly to semi­annually. This was done to reduce the cost of compliance to health-care institutions. In 1988 JCAHO introduced risk – based management. This allowed institutions to create more realistic PM programs. Gone was the requirement that all electrically powered equipment had to be tested regularly. AAMI and NFPA electrical leakage test parameter specifica­tions also became less stringent.

Ralph Nader

Ralph Nader raised national consciousness about accidents that could occur in hospitals as a result of poorly designed or faulty medical equipment. His article in the March 1971 La­dies Home Journal claimed that ‘‘too many hospitals are haz­ardous electrical horror chambers.’’ To eliminate these dan­gers, Nader suggested that hospitals hire engineers to provide advice on electrical equipment and its installation, as well as on electrical wiring (10). As a result, the clinical engineering profession was spurred forward as hospitals hired additional staff to test their equipment and verify electrical safety. This was also the beginning of independent service organizations (ISO), which provided an alternative to original equipment manufacturer (OEM) service. Nader’s claims have since been refuted (11).

Kellogg Foundation. The W. K. Kellogg Foundation (estab­lished in 1930 to help people improve their quality of life by providing grants to solve identifiable problems) addressed the need for improved equipment maintenance prior to the Nader article when it funded the nation’s first experimental preven­tive maintenance (PM) program for hospital equipment. A three-year grant starting May 1, 1970 was awarded to the biomedical/clinical engineering department of the State Uni­versity of New York’s Downstate Medical Center. The Down – state Medical Center has since changed its name to the Health Science Center at Brooklyn, University Hospital of Brooklyn. The department, the Scientific and Medical Instru­mentation Center (SMIC) established in 1963, one of the first biomedical/clinical engineering programs in the nation, is still active today. The Kellogg Foundation also funded the na­tion’s first shared clinical engineering program in 1972, the Northwest Ohio Clinical Engineering Center. The center pro­vided equipment maintenance, consultation, and educational services to hospitals in that local (12,13).

Response of the Joint Commission on the Accreditation of Healthcare Organizations. The Joint Commission on the Ac­creditation of Healthcare Organizations (JCAHO) also re­sponded to the apparent need for additional safety testing. Their 1974 standard required quarterly leakage testing for electrically powered equipment. Their April 1976 Accredita­tion Manual for Hospitals required hospitals to establish com­prehensive instrumentation programs that included preven­tive maintenance programs with written records of inspection testing and corrective action taken. It also required all new patient-related equipment to be evaluated for proper perfor­mance before being used clinically (9). The JCAHO require­ments further hastened the establishment of in-house clinical engineering departments that strove to satisfy these require­ments as well as to improve on manufacturer-provided main­tenance.

During the 1970s professional organizations such as AAMI and ASHE became more prominent. They sought to promote safer use of medical equipment. AAMI and the National Fire Protection Association (NFPA) issued standards for leakage current and grounding, which further promoted electrical safety testing of medical equipment (14,15).

HISTORY I

Mid 1960s-1970s

Clinical engineering’s great impetus for growth occurred in the 1970s. This came about as follows.

Equipment Problems

During the mid-1960s the medical device industry as a whole did not yet have adequate performance or safety standards. Equipment designers were not fully familiar with the require­ments of the hospital environment. Equipment design defects included inadequate energy from defibrillators, ungrounded equipment chassis, and alarms that could be falsely triggered. Quality control was also poor as evidenced by physiological monitors that were grossly out of calibration and equipment
that was cracked, broken, or missing components. New medi­cal equipment that was purchased and delivered in suppos­edly ready-to-use condition was found to have incidence of de­fects ranging from 25% to 50% (9).

At this time the dangers of microshock and leakage cur­rent were starting to be recognized and discussed. Of special concern was the medical equipment used for coronary care and the procedures used to maintain this equipment.

Ethics

Confidentiality. Working in a health-care environment, clinical engineers and BMETs have access to information that must be kept confidential. If confidentiality is not adhered to credibility is soon lost.

For example, the following applies

Patient data must not be indiscriminately discussed.

Some service manuals are proprietary.

During the bid process in which new equipment is being purchased, bidder quotes and bid evaluations must not be shared with competitors.

Research activities must not be discussed until data are published.

Code of Ethics. The ACCE addresses these and other issues in their code of ethics (2), which states that a clinical engineer will act as follows:

• Strive to prevent a person from being at risk of injury due to dangerous or defective devices or procedures.

• Accurately represent my level of responsibility, author­ity, experience, knowledge and education.

• Reveal any conflict of interest that may effect informa­tion provided or received.

• Protect the confidentiality of information from any source.

• Work toward improving the delivery of health care to all who need it.

• Work toward the containment of costs by better utiliza­tion of technology.

• Promote the profession of clinical engineering.

Professional Organizations

Participation in professional organizations exposes a clinical engineer and BMET to the latest industry trends. These orga­nizations provide up-to-date information, the sharing of ideas, and networking. National, regional, state, and local organiza­tions exist.

National organizations include:

Association for the Advancement of Medical Instrumenta­tion (AAMI)

American Society of Healthcare Engineering (ASHE) American College of Clinical Engineers (ACCE)

Institute of Electrical and Electronics Engineers (IEEE), Engineering in Medicine and Biology Society Instrument Society of America (ISA)

Continuing Education

Expositions. The environment in which clinical engineering functions changes daily as new technologies such as telemedi­cine, robotics, and wireless local area networks (LAN) are in­troduced into the clinical setting. In this dynamic field contin­uing education is the rule. One method of obtaining this education is by attending technical expositions and profes­sional organization meetings. The Association for the Ad­vancement of Medical Instrumentation (AAMI) and the Amer­ican Society of Healthcare Engineering (ASHE) hold meetings and expositions that expose attendees to the latest medical instrumentation being introduced into the marketplace. The pulse of the health-care industry can be sampled in a rela­tively short time by attending roundtable discussions and member and industry presentations. Courses are provided in regulatory requirements, medical devices, instrumentation repair and maintenance, clinical engineering and BMET pro­fessional certification preparation, and clinical engineering management. Technical information is also presented at monthly meetings of the Institute of Electrical and Electron­ics Engineers (IEEE) Engineering in Medicine and Biology Society, as well as local clinical engineering and BMET orga­nization meetings.

Service Training. As new medical equipment is acquired, employee technical knowledge must be updated with regard to its operation, preventive maintenance, and servicing. Training is available from the manufacturer or from indepen­dent schools. Training can sometimes be included in purchase requisitions and request for quotations (RFQs) for new equip­ment. Service training not only benefits the clinical engineer and BMET involved in maintaining this equipment, it also benefits the equipment user each time clinical engineering is called on to assist them with equipment-related questions. Formal service training can be expensive. In addition to tu­ition there are travel and lodging expenses. To supplement, but not replace service training, clinical engineering staff can attend equipment operator training provided by vendors for clinical users of medical equipment, within their own institu­tion. Training can also be obtained using the expertise avail­able within the clinical engineering department (Fig. 1).

Self-Study. Formal training can be supplemented with self­study of technical journals, periodicals, and trade publica­tions, as well as equipment operator and service manuals, VCR training tapes and computer-based training programs. A clinical engineering library provides an invaluable tool for the clinical engineering staff and for other health-care work­ers (physicians, nurses, laboratory technicians) to whom clini­cal engineering services are provided. Libraries could include technical video, equipment operator and service manuals, and technical publications (books and magazines). Such material also allows staff to keep pace with changes in regulatory re­quirements and biomedical standards.

Safety Training. Employee right-to-know and safety train­ing that discusses the hazards encountered in the workplace is also necessary. This includes subject matter related to blood-borne pathogens, hazardous materials, proper protec­tion when entering patient-care areas (gloves, masks, etc.), environmental hazards, fire hazards, patient’s bill of rights, and other items. The latest trend makes use of interactive computer program modules. This allows training at a time convenient to the employee and no longer requires attendance at lengthy seminars.

Certification

Certification is provided for clinical engineers [Certified Clini­cal Engineer (CCE)] and biomedical equipment technicians [Certified Biomedical Equipment Technician (CBET)] by ex­amining boards guided by the International Certification Commission for Clinical Engineering and Biomedical Tech­nology. The Commission is composed of health-care commu­nity members including engineering, medical, industrial, and governmental groups and agencies. Certification provides for­mal recognition that an individual has mastered a body of knowledge that is useful in job performance. This knowledge, which is both theoretical and practical, includes theory of op­eration of medical equipment, physiological principles, and safety issues related to medical equipment (8).

Clinical engineering certification requires passing a writ­ten exam (multiple-choice and essay questions), and an oral interview, aimed at determining the candidate’s depth and breadth of experience. BMET certification requires passing a written multiple choice examination. The Association for the

Figure 1. In-service education, ventilator tester. Inservice education can be provided by manufacturers and vendors, as well as by clinical engineering staff. Here a clinical engi­neering supervisor is providing training to other clinical engineers in the use of an auto­mated ventilator tester. Such devices are used during preventive maintenance and repair. They reduce the number of individual test in­struments required as they integrate several test functions into one device. This reduces service time leading to more rapid equipment turnaround. Such education also helps to sat­isfy JCAHO training requirements for clinical engineering staff.

Advancement of Medical Instrumentation (AAMI) assists can­didates by providing certification training courses and study materials.

Certification renewal requires demonstration of continued training. Points are assigned and accumulated for various ac­tivities that contribute to one’s ability to do his job.