Glove monitoring devices in medical procedures

October 28, 1997

The Honorable Brian P. Bilbray
US House of Representatives
[Recipient address omitted]
Dear Congressman Bilbray:

This is in response to your letter dated July 7, concerning the application of glove monitoring devices to aid in the detection of gloves that fail during medical procedures. Your letter requests that the Occupational Safety and Health Administration (OSHA) recommend the use of these devices to prevent transmission of diseases in the workplace. Please accept my apology for the delay in this response.

The glove monitoring device alerts the healthcare worker when a tear or leak occurs in the glove they are wearing. In simple terms, both the patient and the healthcare worker are connected to an electrode. If a glove fails and fluid enters the glove, the fluid completes the circuit and the glove user is alerted by an alarm.

OSHA does not endorse, review, or approve medical devices. This glove monitoring method may be covered by the Food and Drug Administration (FDA). The FDA review such devices and clears the product for marketing. If the glove monitoring method is in use at a site where OSHA conducts an inspection, the compliance with the OSHA's Bloodborne Pathogen Standard, 29 CFR 1910.1030, will be evaluated on a case-by-case basis. However, it is important to note that the OSHA standard provides protection to employees when disposable gloves are torn or punctured. The section, 29 CFR 1910.1030(d)(3)(ix)(A), requires that disposable gloves be replaced as soon as practical when contaminated. It is the employer's responsibility to evaluate the existing policies on the use of disposable gloves and to review the feasibility of instituting more advanced methods if necessary. Training employees on the correct ways to use personal protective equipment is also required by the standard.

There are reliable and safe work practices that can serve as effective alternatives to glove monitoring devices. The standard requires that gloves be worn when it is reasonably anticipated that the employee will have contact with blood. Further, it requires that all personal protective equipment (PPE), including gloves, be removed and replaced immediately or as soon as possible if the PPE needs repair or replacement. Healthcare workers engaged in a high risk activity can change gloves more frequently, or they can choose to double glove. Employers can purchase a good, high quality glove that will not readily rip or tear for their employees to use. In addition, one of the most important steps of preventing disease transmission is hand washing. OSHA requires that employees wash their hands each time they remove their gloves. If employees have lacerations or cuts on their hands that may serve as a site of entry, they can take extra precautions. If the skin is intact and there is no sign of skin eruptions such as dermatitis, there is no route to injury.

Thank you for your interest in safety and health. If you have further questions, please feel free to call [the Office of Health Enforcement at (202) 693-2190].

Sincerely,

Greg Watchman
Acting Assistant Secretary

[Requester letter reproduced on OSHA page; omitted here.]