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Vol 10, No 7	OR Manager	19
JCAHO Continued from page 17 hospital doesn't actually buy but receives free in exchange for using a product. Because they may not enter the hospital through normal channels, the devices may not be checked by clinical engineering and may be left out of the inventory and device-monitoring program. New desflurane vaporizers for anesthesia machines are an example. Unlike the traditional vaporizers, they require electrical power to heat the anesthetic. Hospitals may use these vaporizers without purchasing them in exchange for buying the drug, or the vaporizers may be placed on an extended trial basis. Service contracts may leave out specific support such as electrical safety testing. Regardless of ownership, these devices must be included in the equipment management program, Barkalow emphasized. They must be included in the inventory, have an initial inspection, and have maintenance documented. If your hospital contracts with an outside firm for equipment services, be sure you know which equipment the contract covers and what services are included. A common error is to think all equipment is covered when it isn't. This can be a serious problem when the hospital has a set of equipment from different manufacturers used as one system. An anesthesia machine with several monitors or an endoscopy system with multiple components are examples. Service contracts may cover only certain pieces of the system and even leave out specific support such as electrical safety testing. Conduct a detailed review of in-house services and contracted services to spot areas of overlap or deficiency. For instance, if a mobile x-ray machine used in the OR is serviced under the contract, does the contract include electrical safety testing? May do not.	Incidents stem from failure to develop action plan
	Two recent incidents dramatize the importance of an equipment management program. In one case, a hospital was using a new type of anesthesia vaporizer, installed by a sales rep. It seemed like a good deal. The hospital got the use of the $9,000 device in exchange for buying the new fast-acting anesthetic agent, desflurane. But there's a twist. Unlike conventional vaporizers, this one needs electricity and has its own power cord. And because it was not purchased, it bypassed biomedical engineering and the proper education process. The first time the vaporizer was used, the anesthetist noticed the indicator light was off. Searching frantically, the circulator found the unit was plugged in. Following the cord to the other end, he saw it had fallen out of its connection under the vaporizer. The plug was quickly reinserted, and the case continued. The consequences could have been serious. Because the agent is so fast-acting, patients can awaken in a minute or two. That happened in another situation, and the patient sued. This time the agent was isoflurane. Because of a leak in the anesthesia machine, the patient, who was having surgery to correct an earlier	botched operation on her neck, charged that she received too little of the drug and awoke during the case. In the trial, her lawyer argued that the anesthesia team knew the machine was not working properly but did not replace it. The halothane vaporizer apparently came unseated during the case and may have been leaking. The jury, after 4 1/2 hours of deliberation, found the anesthesia team not liable, apparently because they had done a preuse check showing the equipment was working properly before the case, monitored the patient, and managed as best they could with the equipment available. But the hospital was found liable for 15% of the award (along with the surgeons and Coca Cola, whose truck was involved in the wreck causing the patient's original injury.) Testimony showed the anesthesia equipment, an off brand with a history of problems, had not received its scheduled preventive maintenance. Documented training on the equipment was lacking. And the hospital was relying on a manual labeled "preliminary draft." No one had ever initiated a quality improvement process to look at the pattern of problems and develop an action plan.
	"Even if there is a third party vendor for the equipment maintenance, the hospital is required to have its own list to confirm status of safety training and maintenance." he said. Collaboration needed. Having a good equipment management program, of course, depends on collaboration between clinical departments and the department directly responsible for PL.3. When the system is in place and working, Barkalow says, "the OR benefits because it has a powerful means to control risk factors associated with medical equipment. Spotting troublesome areas and taking prompt, targeted action means better patient care."	Bruce H. Barkalow, PhD, is a consulting clinical engineer who works with hospitals to improve medical device equipment control and meet Joint Commission and Food and Drug Administration standards. He also conducts risk management and device incident investigations. He may be reached at 616/652-2228. ECRI in Plymouth Meeting, PA is a non-profit organization that evaluates biomedical technology. Call 215/825-6000. References Keil O R. the Joint Commission's Agenda for Change: What does it mean for equipment managers? Biomedical Instrumentation & Technology. January/February 1994;28:14-17. 1994 Accreditation Manual for Hospitals. Oakbrook Terrace, Ill: Joint Commission on Accreditation of Healthcare Organizations, 1994.