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How to use medical devices safely

AORN Journal, Dec, 2002 by Doreen Wagner

Much of the surgical care provided today involves the use of multiple medical devices. In fact, many devices no longer just support clinical practice; many now are an integral part of surgery. Unfortunately, with the high level of medical device use and the risk of human error, it is inevitable that device-related injuries and even deaths occur in the perioperative setting. How can perioperative nurses work toward eliminating this type of adverse event?

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In exploring medical device problems and the effect devices have on patient safety, three types of problems have been identified--device problems, clinical problems, and use problems. (1) The "Patient Safety First" column in the October 2002 Journal focused on device problems, including defective manufacturing, malfunctions, and material problems (eg, product instability), and the US Food and Drug Administration's (FDA's) Safety Information and Adverse Event Reporting Program. This column addresses clinical and use problems.

CLINICAL PROBLEMS

Clinical problems may occur when patients have risks or characteristics that would make a medical device difficult or risky to use. Performing a thorough preoperative assessment and communicating all risk factors to surgical team members is important for ensuring patient safety and preventing harm. Some patient risks or characteristics of concern include

* abnormal skin conditions (eg, excessive hair, rashes, open wounds);

* cardiac, respiratory, endocrine, renal, or neurological disease;

* multisystem trauma;

* history of allergic reactions (eg, latex); or

* psychosocial risks (eg, excessive anxiety, language barriers, altered mental status).

Perioperative nurses can avoid common clinical problems with medical devices by understanding their proper use and the conditions in which devices are not considered safe. For example, heat from warming blankets never should be applied to the lower body when the aorta is cross clamped during aortic aneurysm repair because the application of heat to ischemic limbs will cause burns. (2)

USE PROBLEMS

In spite of thorough training and user caution, medical device use problems happen, and patient harm may result. This type of adverse event occurs due to human error, not device failure. A manufacturer's device design itself, however, may be a causative factor in user error. Some examples of manufacturers' design problems that can contribute to user error include

* complicated arrangements of user controls;

* hard-to-read display panels;

* confounding or intrusive alarms;

* poorly designed labeling; and

* operating procedures that are confusing or difficult to remember. (3)

It is important to realize that neither individual nurses nor manufacturers are the primary cause of device use problems. Other human factors are involved. Manufacturers use human factors principles when designing medical devices that require human interaction. This helps minimize the risk of error, increases productivity, and enhances overall safety and user comfort. Knowledge of human strengths and limitations leads to better product designs, more effective training of users, and a better assessment of the usability of a product. Numerous individual factors also can affect human interaction with medical devices.

Human error can occur when psychological and physical human factors, such as stress, interruptions, and information overload, are involved during medical device usage. Human factors are more likely to cause device use problems when devices are technologically advanced (eg, programmable devices). (4) Safe device design and use begins with the manufacturer and continues with the perioperative clinician's careful attention to the possible failure modes of a device in a real-world environment. Perioperative practitioners can make an impact on patient safety by reporting device use problems to both the manufacturer and the FDA because this type of reporting can lead to changes in the design of medical devices.

The misuse of devices is another area of concern related to use problems. Any device can cause harm if nurses are not familiar with its proper use or choose to use it in a manner that is not recommended by the manufacturer. Clinicians may see others repeatedly use a device against the manufacturer's recommendations with no resultant patient harm, which may begin a custom of misuse in an institution. If patient injury occurs because of such misuse, the clinician and institution have no defensible excuse.

An example of misuse is hosing or the misuse of a forced-air warming device. Forced-air warming devices consist of a warming unit, hose, and warming blanket. When clinicians choose to use the warming system without attaching the blanket to the hose, the higher temperature air flow from the hose is concentrated on one area of the patient's body, and bums may occur. In fact, hosing has led to first, second, and even third degree bums. In one case, the thermal injury progressed to muscle necrosis, and an above-the-knee amputation was required. (5)

Health Care Industry

How to use medical devices safely

AORN Journal, Dec, 2002 by Doreen Wagner

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