The escalating cost of energy is of concern to the hospital industry, and this cost has led to increasing interest by hospital administrators in energy conservation programs as part of their cost-containments efforts. An effective and comprehensive program should be based on an energy management approach which includes the careful analysis of the activities of the entire hospital staff. The clinical engineer has significant opportunities to contribute to this effort through his own department's activities and in other areas where his engineering training can be effectively utilized.

Biomedical Engineering↗

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Evaluation of alarm systems for medical equipment.

The provision of automatic alarm systems on medical equipment is generally designed to supplement the user's ability to monitor a variety of device and patient variables simultaneously. The potential value of such systems in improving the safety and efficacy of medical care is accompanied by the potential for false reliance on or other misuse of the alarm systems. Therefore the alarm provisions become an important aspect of clinical engineering assessment of equipment with respect to selection, user training, hazard analysis, and the provision of effective and appropriate preventive maintenance programs.

Biomedical Engineering↗

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Risks associated with diagnostic devices.

Therapeutic medical devices alter patients' physiological functions. Diagnostic devices are for information gathering, manipulation, and display. Despite this difference in purpose, both types of medical equipment have potential risks associated with their use that must be recognized and subjected to the principles of risk management. For diagnostic equipment, special concerns include direct side effects, clinical misinterpretation of results, malperformance, obvious non-function, and inherent limitations. The role of clinical engineering in diagnostic risk management must be consistent with its general obligations in equipment acquisition, training, maintenance, and hazard identification. Since sharp lines of distinction often cannot be drawn between equipment, operator, and clinical issues, clinical engineering has the opportunity and responsibility to extend its contributions into an integrated systems approach to medical device safety and effectiveness.

Diagnostic Errors↗

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Information sources for medical equipment risk management.

An effective risk management program must include specific consideration of medical equipment, and must address hazard identification, incident prevention, and the coordination of efforts to minimize losses when incidents do occur. The hazard identification and prevention components require an organized effort to utilize external and internal information sources to determine both generic and device-specific hazards, recalls, alerts and related data. Equally important is the effective processing of this information so that it is integrated into the routine activity of the hospital. Attention to these information sources can contribute to the broad clinical engineering goal of helping to assure the safe and effective use of medical equipment throughout the hospital.

Equipment Safety↗

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Legal liability in the development and use of medical expert systems.

The application of medical expert systems is likely in some instances to result in patient injury litigation. Such legal action will be based on the same principles now applicable to medical practice and products liability. These principles define legally wrongful acts, product defects, and theories of recovery: negligence, breach of warranty and strict liability. The resolution of such litigation will depend on whether the clinician should have relied on the advice of the expert system when the advice and patient treatment is alleged to have been wrong, as well as the overall quality of the expert system, its functional design, and claims made for it. Clinical engineers who become involved with expert system development, selection or implementation should understand the risk management implications of this technology.

Expert Systems↗

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Device-related litigation & clinical engineering.

The investigation of patient-related incidents often must include consideration of the role of the associated medical devices. In addition to being good practice from quality review perspectives, federally mandated MDR requirements generally need to include clinical engineering input. Medical devices also play a significant role in patient litigation aimed at medical providers, hospitals and device manufacturers. Clinical engineering has an important role to play in supporting and tracking litigation as it relates to medical equipment. This role requires an understanding of the litigation process and active participation as a claim progresses. It also should include careful evaluation of the assertions and defenses raised by the various parties both during and at the conclusion of litigation.

Biomedical Engineering↗

PubMedDate not supplied

Holding power of threaded external skeletal fixation pins in the near and far cortices of cadaveric canine tibiae.

We compared the pin-bone interfaces at the near and far cortical penetration sites of positive-profile end-threaded external fixation pins in cadaveric canine tibiae. The holding power of the pins in each cortical surface was independently measured in 21 pin-bone sections. Scanning electron microscopy (SEM) was used to compare subjectively the microstructural appearance of the pin-bone interfaces at the near and far cortical penetration sites in eight pin-bone sections. The far cortical penetration site provided greater holding power than did the near cortical site. SEM evaluation suggested more bony microfractures and debris with less pin-bone SEM evaluation suggested more bony microfractures and debris with less pin-bone interlock in the near cortical penetration sites than in the corresponding far cortical penetration sites. This study showed that after low-speed power insertion of positive-profile end-threaded pins in canine cadaveric tibiae, the near cortical penetration site contributes approximately 25% less to the overall holding power of the pin than does the far cortical penetration site.

Animals↗

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User problems and medical device recalls.

Explore the source record for details and available documents.

Equipment Failure↗

PubMedDate not supplied

Design of medical device alarm systems.

Medical device alarms are intended to enhance safety by augmenting the operator's ability to monitor an array of system and patient variables. To this end, alarm design must consider both technical and human requirements. Technical factors include selection of variables, limit-setting techniques, alarm reliability, and alarm output system. Human factors include the types of controls, displays, and instructional materials that assist the users in effective use of the machine. The designer and the user of medical devices must recognize that alarms can at times present problems unless the operator takes care to maintain correct use and to avoid false reliance on the alarm's ability to indicate all unacceptable conditions in the clinical setting.

Biomedical Engineering↗

PubMedDate not supplied

Home-environment controls for the mobility-impaired.

One aspect of self-care and independence for many older individuals concerns their ability to control their home environment when their mobility is impaired. Although rehabilitation devices have often been custom designed, the availability of these devices has been limited because of high manufacturing costs and a lack of production and marketing channels. It should therefore be recognized that many devices already available to consumers offer a wide range of environmental control without the problems associated with custom design.

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