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).

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