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Prevention of device-mediated bloodborne infections.

The Federal government gave the health care community a unique opportunity to discuss problems and needs with regulators and industry representatives.

ON AUGUST 17 through 19 of this year a remarkable three-day conference was held in Washington, D.C. It represented the first collaboration of this kind by the Centers for Disease Control (CDC), the Food and Drug Administration (FDA), and the Occupational Safety and Health Administration (OSHA)--in itself evidence of the (sudden) high priority of health care worker safety at the Federal level. The purpose of the meeting was to bring together industry representatives, designers of phlebotomy and other devices, users of the equipment, and regulators in an open forum for the exchange of ideas on what is needed in this field.

The conference was attended by over 700 infection control managers, public health officials, laboratorians, union representatives, inventors, manufacturers, and other participants. I was representing the College of American Pathologists.

A number of formal presentations updated attendees on the current state of knowledge regarding the risk of bloodborne infections to workers. In addition, the program included numerous smaller breakout sessions in which dialogue was encouraged between the producers and users of safety devices in settings including the clinical laboratory, emergency room, operating suite, outpatient clinic, and home health care.

OSHA estimates that approximately 600,000 to one million needlestick injuries, the majority unreported, occur in the United States each year. Yet according to the CDC, only 31 proven cases of occupational transmission of HIV infection have been documented to date, almost all by percutaneous needle or sharps injury. This number pales in contrast to the 6,500 new infections with occupation-related hepatitis B virus (HBV) reported in 1991 alone, despite the availability of an effective vaccination program. The danger of nonparenteral transmission is much higher for HBV than for HIV.

Susan Harwood, Ph.D., is OSHA's director of risk assessment and the chief architect of that agency's Final Standard for Bloodborne Diseases, which is now in full effect and covers 5.6 million workers. Harwood emphasized that the Standard had deliberately been kept nonspecific regarding the methods or materials to be employed. It was considered impossible, she explained, to anticipate all types of risk situations and to prescribe the optimal methods for dealing with them. Instead, she said, the Standard is "performance-oriented." This means that the responsibility is placed on the employer to monitor the success of the individual facility's safety program and to modify it as the need arises. Furthermore, Harwood pointed out, in the search for a safe workplace the courts have not permitted safety regulations to be constrained by cost-benefit considerations.

The most dramatic moments of the conference occurred during thoughtful, eloquent presentations by two young women: a nurse from a San Francisco hospital and a physician in charge of an AIDS unit in a Texas hospital. Each had contracted HIV infection during the last year as a result of a needlestick accident on the wards. Both said they had found the most difficult period emotionally to be the three months immediately following the accidents, spent in a constant state of fear and uncertainty, as they awaited the report of seroconversion. Despite varying courses of prophylactic azidothymidine (AZT), both seroconverted at around three months post exposure. Of particular interest to the audience was that the two speakers had learned of at least 12 other health care workers (HCWs) in their geographic areas who had contracted occupational HIV, including two anesthesiologists. None had been among the CDC's figure of 31 cases of occupationally acquired HIV. The conclusion is that official statistics may significantly underestimate true incidence, due to underreported and probably untested seroconversions.

One reason for underreporting of accidental exposures was offered from the audience by a representative of a health care workers' union in California. She suggested that California's strict requirement that 3 to 10 separate reports be filed for each accident--despite the fact that reporting forms are not yet available in Spanish--does little to encourage worker compliance. Fear of losing one's job is another factor contributing to underreporting of these incidents.

What of the FDA's role in this effort? Jane Henney, M.D., the agency's deputy commissioner for operations, reported that to date the agency has granted approval to 80 medical safety devices designed to protect workers. In addition, the FDA recently issued a warning against "piggybacking"--that is, connecting a second intravenous line into the first one with a hypodermic needle.

Further, the FDA, in cooperation with the American Association for Respiratory Care, has established the Medical Device & Laboratory Product Problem Reporting Program to identify device-related sources of worker infection. According to a letter distributed at the meeting, reports or questions may be referred to the United States Pharmacopeial Convention, Inc., which is coordinating this effort and will provide postpaid forms on request, at 12601 Twinbrook Pky., Rockville, MD 20852. The toll-free number outside Maryland is (800) 638-6725; from within Maryland, call collect: (301) 881-0256.

At least half of the protective devices approved by the FDA to date, we were told, were conceived of and, in many cases, designed by health care workers. Still, the machinations involved in bringing an original idea to fruition through the complex process of convincing a manufacturer of its value and eventually gaining FDA acceptance discourage all but the most determined inventors. It is no less a challenge to market a product that adds significant expense to the user's budget. Nonetheless, a recurring theme throughout the conference was that the psychological and financial damage caused by even one needlestick injury to an employee is considerable, even when seroconversion does not take place. All such costs must be factored into the cost-benefit determination related to purchasing a new safety device.

* Technologic innovations. New devices designed to eliminate the danger of needlestick injuries were exhibited or described in the poster sessions, some already available and others still under development. A particularly impressive device was a needle unit with an automatically retracting sheath that provides continuous needle point protection. Produced by Sterimatic Medical Systems of the United Kingdom, it fits on both Luer Lock syringes and vacuum tube devices. Its only apparent drawback is its cost, approximately one dollar per unit.

One manufacturer demonstrated an ingenious device consisting of a high-amperage electronic unit into which a needle is inserted directly after use, still attached to the syringe. Insertion automatically activates the generation of a high temperature current that incinerates the needle instantly. This compact unit can be operated by standard wall current or by battery.

We may be at the dawn of a needle-less era. A C|O.sub.2~ jet-powered injection syringe was shown that permits subcutaneous delivery of medication. Not mentioned at the conference but discussed recently in the science media is an emerging technology of biosensors that can be patched directly to skin. The technique is similar to that of the pulse oximeters that are now universally used to monitor blood oxygenation during surgery. These needle-less devices, which utilize tiny lasers or near infrared light sources, spectroscopically analyze the capillary absorption of certain emitted frequencies. These devices, soon to be marketed, are now capable of measuring blood glucose, urea, and even cholesterol and certain drug levels.

* How great the risk? A particularly insightful analysis of the problem we all face in trying to estimate the true magnitude of the risk of occupational bloodborne infection transmission was presented by Peter Sandman, Ph.D., a well-known authority on risk assessment. Risk in general, he proposed, has two components: hazard, which attracts the attention of experts in the field, and outrage, which attracts the attention of the public. The proper approach to the state of alarm created by the public's perception of any environmental threat to health must take into account not only the hazard but also the sources of outrage. Concerning the potential acquisition of HIV in the workplace, outrage is magnified by the dreadful consequence of AIDS itself, the involuntary nature of the hazard (as opposed to a worker's free choice of exposure to other hazardous substances, such as cigarettes and red meat), and the perception of the danger as being unfairly imposed by an institution and often minimized by authorities who may be viewed by the worker as untrustworthy.

Our efforts to achieve a rational level of concern by both the public and the health care worker over the danger of HIV transmission in the workplace, Sandman stressed, are unlikely to succeed as long as the level of outrage remains high.

Laurence I. Alpert, M.D., a member of MLO's Editorial Advisory Board, is director of laboratories and nuclear medicine, Northern Westchester Hospital Center, Mount Kisco, N.Y., and associate professor of pathology, Mount Sinai School of Medicine, New York City.
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Author:Alpert, Laurence I.
Publication:Medical Laboratory Observer
Date:Nov 1, 1992
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