Device Malfunction

Device Malfunction

Pedro Tanaka

Diane Alejandro-Harper

Arjun Desai


Equipment-related incidents in the operating room (OR) can affect patient safety and quality of care. Machine failures can consume several hospital resources and lead to unexpected operating delays, critical events for life-sustaining procedures, and significant costs for parts and personnel. Many institutions lack clear guidelines for faulty equipment identification, lending to a pervasive culture of underreporting. Equipment failure has been implicated in 14% of all anesthesia-related adverse or unexpected events in the operative setting. Monitor failure associated with ventilator machines or computer charting is the most often cited failure, followed by the breathing circuit and airway components. Overall, the anesthesia machine and ventilators attributed to 12% of all reported events.

Government oversight agencies stress the importance of adequate equipment management. Anesthesia departments need to have complementary policies combined with education for technicians in order to maintain compliance with national standards. In addition to safety and quality, efficiency is an important factor in surgical environments. Much like support personnel and block time, surgical and anesthesia equipment must be carefully planned and regimented for daily procedures. Equipment-related incidents are listed among the most common causes of OR delays.

The objective of this chapter is to clarify the proper role of an anesthesia technician in the service, communication, and documentation of faulty machinery. Additionally, this chapter highlights the U.S. Food and Drug Administration’s (FDAs) regulatory policies regarding machine service standards and regulations.


Institutions must have specific protocols in place for the removal of malfunctioning devices from the operating environment. Most investigations into a device’s integrity and function are originated by the user, usually a physician experiencing a problem. Technicians respond to the inquiry by visiting with the doctor at the device site and gathering relevant information as well as machine-specific specifications. If applicable, the technician will use necessary supplies and equipment to troubleshoot the device malfunction.

Assuming nothing is disconnected or errant from the patient side, the technician should contact the biomedical engineering (biomed) department to aid in further diagnostics. The biomed department will conduct a similar background investigation and provide appropriate device testers to confirm malfunction. If declared faulty, the device in question will be isolated, taken out of service, and the vendor will be contacted for consult and further recommendations. If an anesthesia device malfunction is unresolved after anesthesia technician and/or biomed analysis, the device must be taken out of service. In addition, the manufacturer must be contacted for clarification and replacement.

A device that is declared faulty or malfunctioning is removed from the operating suite and placed in a specific location for faulty devices. This process is facilitated via the charge nurse so that proper precautions can be placed in the OR in question to prevent further risks. Notation such as a sticker or tape detailing the time, date, and a brief description of the current malfunction must be visibly applied to any devices in question.
Each health care institution should have replacement machinery on hand in the event that any device used in the operating suite malfunctions or becomes disabled.

If a device results in patient harm or death, equipment will be seized and appropriate personnel will be notified, including the charge nurse, department manager, compliance manager, OR administration, and risk management.


Background of Medical Device Error Reporting

The FDA first required the manufacturers and distributors of medical devices to report any device-related deaths, serious injuries, and specific malfunctions in 1984. However, numerous reports have shown that there is widespread underreporting. In fact, in 1986, a study conducted by the General Accounting Office (GAO) of the FDA showed an inverse correlation between the severity of a device-related malfunction and the likelihood to report that device. In response, in 1990, the Safe Medical Devices Act (SMDA) was initiated to monitor the compliance of nursing facilities and hospitals reporting for equipment-related deaths, severe injuries, and illnesses to both the FDA and device manufacturers.

As described above, applicable health care entities must institute policies to incorporate the SMDA of 1990 into their departmental infrastructure. Most commonly, medical device incident investigation and reporting involves the departments of clinical technology/biomed and risk management. Health care professionals must be aware of their organizations’ policies and procedures regarding the reporting of faulty medical devices.

May 23, 2016 | Posted by in ANESTHESIA | Comments Off on Device Malfunction

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