October 28, 1997

The Honorable Brian P. Bilbray
US House of Representatives
Washington, D.C. 20515

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 Wanda Bissell of the Office of Health Compliance Assistance (OHCA) at (202) 219-8036 ext. 49).

Sincerely,

Greg Watchman
Acting Assistant Secretary



July 7, 1997

Assistant Secretary Ruth McCulley
U.S. Department of Labor-OSHA
200 Constitution Avenue, NW
Washington, DC 20210

Dear Assistant Secretary McCulley:

As members of the San Diego congressional delegation, representing an area that has a substantial concentration of surgical hospitals. we are concerned with the high rate of hospital-acquired infections and the resulting death of many patients. The staggering statistics indicate that more than 2 million patients contract infections resulting in some 77,000 deaths. These numbers could be reduced with the application of existing technologies.

One way to enforce blood-borne pathogen standards and universal precautions to better safeguard both health care workers and patients alike, is by recommending the use of continuous glove monitoring. Glove monitoring technologies have been developed and tested, and can be utilized to prevent the contraction of infections.

Latex gloves are a primary infection control barrier in the operating room suite, and more than 300 peer-reviewed and scientific studies support the fact that glove failure occurs at a very high rate during use. The most recent research illustrates that approximately 400 million of the 1.2 billion gloves used each year in the U.S. may fail during use. Of this 400 million, approximately 180 million of these failures go undetected, which could result in the contraction of such fatal diseases as HIV and Hepatitis B and C, if bodily fluids penetrate the barrier.

Surgical latex gloves are an accepted standard of care, and when sold into the market they are well within accepted FDA guidelines (AQL's). However, the fact remains that due to the porous nature of latex and the conditions of surgery (bone chips, sharp edges, scalpel handles, duration of surgery, etc.), gloves tend to fail at a very high percentage rate. Every failure, whether in the OR, ER or ICU, represents a potential transmission of life-threatening viruses or bacteria, since OSHA's standards state that "all human blood and certain body fluids should be treated as if they are infectious."

In addition to what a doctor can contract from a patient during surgery, medical journals have reported that doctors can also transmit infectious diseases to patients, even under current medical safety procedures. These guidelines need to be upgraded in order to keep pace with current technologies in the medical industry. If not, then we face a serious public health threat in the near future.

OSHA is the agency charged with the enforcement and implementation of current medical safety guidelines. We request that your agency take the initiative on this matter by recommending cost effective, real-time glove monitoring.

We look forward to hearing from you regarding this matter, and appreciate your consideration of developing an implementation plan to achieve this goal.

Sincerely,

Brian P. Bilbray
Member of Congress

Bob Filner
Member of Congress