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M Ridgway

Publications and source records attributed to M Ridgway.

7 recordsLinked to original sources

Guidelines for clinical engineering programs--Part I: guidelines for electrical isolation; Part II: performance evaluation of clinical engineering programs.

This series presents guidelines for: electrically isolated inputs and outputs; measuring the performance of hospital biomedical engineering programs; evaluating the risk of electric shock in hospitals; and for isolated power in anesthetizing locations. In Part I, specific recommendations are given for the use of insulated approach, battery-powered monitors in surgery, and for isolation requirements for devices connected to cardiac leads. In Part II, checklists are provided for the self-evaluation of an in-house, biomedical engineering staff. Parts III and IV, in future issues of this Journal, will include discussion of the theoretical electrical hazard potential in reference to the use of isolated power systems. The question of whether isolated power should be required in all anesthetizing locations will be discussed in Part IV.

Accident Prevention↗

Guidelines for clinical engineering programs--Part III: the risk of electrical shock in hospitals; Part IV: isolated power in anesthetizing locations? History of an appeal.

This four-part series presents guidelines for: electrically isolated inputs and outputs; measuring the performance of hospital biomedical engineering programs; evaluation the risk of electric shock in hospitals; and for isolated power in anesthetizing locations. Parts I and II, covering the first two topics above, were published in the Oct.-Dec. 1980 issue of this Journal. Part III constitutes an attempt to place the risk of electric shock in hospitals in a quantitative perspective. Arguments are presented that indicate that electrical safety precautions usually take up a larger share of the hospital's biomedical equipment safety budget than is justified by the actual hazard levels. Part IV reviews the need for isolated power in anesthetizing locations. Three independently proposed revisions to the 1973 edition of NFPA Standard 56A would have significantly simplified the safety requirements for hospital anesthetizing locations (a) by reducing the area in flammable locations classified as hazardous to the internationally accepted "zone of risk," and (b) by permitting the use of conventional electrical power rather than isolated power in locations where the risk of electrical accidents can be shown to be no greater than it is in other areas of the hospital. Despite extensive technical testimony supported with substantial supporting documentation, the revisions were vetoed by the Technical Committee after they were voted into the document by a floor vote of the general membership attending the NFPA Annual Meeting in Anaheim in 1978. The chronology of the major events surrounding the subsequent appeal of this veto is traced back to 1974, and an analysis is presented of what are considered to be shortcomings in the NFPA appeals process revealed by this particular case history.

Accident Prevention↗

Classifying medical devices according to their maintenance sensitivity: a practical, risk-based approach to PM program management.

Many medical equipment items need periodic attention to ensure that they continue to operate properly and safely; and most inspecting agencies require healthcare facilities to have a competent equipment maintenance program that is focused on the most critical of those devices. There is however a long-standing lack of consensus on how best to determine which devices should be included in this critical device category, and which can reasonably be excluded. A new methodology is proposed for establishing a logical, fact-based framework for determining which devices should be included. It is based in part on a new FDA-sanctioned definition of what an appropriate regimen of planned maintenance activities for a medical device should include. This new definition addresses the medical device users' concerns about periodic performance verification and safety testing as well as detecting and correcting the wear or progressive deterioration of any non-durable parts, which is the primary focus of the conventional preventive maintenance programs found in less critical industries. The analytical approach proposed utilizes technical information that is either already available or which can be easily developed. It characterizes each different device by means of a 3-letter maintenance sensitivity profile that can be used to analyze the effectiveness of the maintenance procedures as well as quantify the device's sensitivity to planned maintenance. A collaborative effort to assemble and organize this data would provide the industry with a sound, logical platform for narrowing the scope of most PM programs and allow us to redirect a significant amount of scarce technical manpower into more productive activities such as device user training.

Equipment and Supplies↗