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HOSPITAL STERILANT/DISINFECTANT MANUFACTURERS SHOULD BE IDENTIFIED BY FDA

This article was originally published in The Gray Sheet

Executive Summary

HOSPITAL STERILANT/DISINFECTANT MANUFACTURERS SHOULD BE IDENTIFIED BY FDA, and their compliance with FDA regulations enforced, the General Accounting Office recommends in a June 14 report presented to Rep. William Clinger (R-Penn.), ranking minority member of the Committee on Government Operations. The report was prepared in response to a Jan. 17, 1992 request from retired Rep. Frank Horton (R-N.Y.), who previously held Clinger's post. The agency's "current regulation of sterilants and disinfectants has not provided adequate assurance that these products are safe and effective in killing harmful microorganisms," according to the report. FDA currently regulates sterilants and disinfectants used to clean medical instruments as devices. However, GAO says, the agency "should make a more concerted effort to identify manufacturers and seek compliance with the requirements." According to the GAO report, "manufacturers have not generally complied with" registration and premarket notification requirements. The Environmental Protection Agency, which regulates hospital disinfectants and sterilants as pesticides, gave FDA a list of registered manufacturers "three years ago," but GAO says it was told by an FDA official that the agency "has not reviewed the list to identify manufacturers" subject to FDA regulation. The report also suggests that FDA "devise a strategy to ensure that in the future sterilants and disinfectants are not marketed without FDA's prior authorization." FDA periodically could, for example, "obtain EPA information on hospital sterilants and disinfectants and use the information to monitor and enforce compliance" with germane laws and regulations. As of April, GAO notes, FDA had cleared three sterilants and 13 disinfectants via the 510(k) substantial equivalence process. FDA has recently tested the efficacy of 26 additional sterilants for EPA. Of these, GAO says, "five products failed or are expected to fail, seven passed or are expected to pass, and 14 are still pending." FDA also tested nine of the 14 pending products "for its own regulatory purposes," five of which "failed or are expected to fail" and four of which should pass. In addition, the agency has inspected 23 germicide manufacturing facilities. "Serious deficiencies," according to the GAO report, were found "at over 50% of them." Whereas EPA has registered 300 firms to sell sterilants and disinfectants, FDA has only five manufacturers on its books. GAO also notes that EPA has registered for sale 59 sterilants and approximately 1,200 hospital disinfectants. "While clearly the 59 sterilants are medical devices," GAO says, "FDA has not reviewed the 1,200 disinfectants registered by EPA to determine what number of them are intended for use with medical devices." In 1990, FDA developed a sterilant and disinfectant monitoring plan that called for inspecting manufacturing facilities, assessing product samples and requesting premarket notifications. The agency, however, limited the plan to 22 of the registered sterilants and 24 disinfectants. GAO says it was informed by an FDA official that "the lack of FDA resources limited the plan's scope." Despite the agency's "limited resources," GAO believes "that FDA should devote more attention to these products because ineffective products can pose a serious health risk." FDA critiques the GAO findings in a June 23 Talk Paper. "GAO failed to make the critical distinction between the uses of sterilants and disinfectants, and to examine the agency's corresponding approaches to the two kinds of germicides," the Talk Paper states. Disinfectants, according to FDA, "are routinely used to kill microorganisms on walls and floors and such noncritical equipment as wheelchairs." Sterilants, on the other hand, "are potent germicides...for killing all microbial life on surgical devices and other instruments that penetrate the blood barrier or contact mucous membranes." FDA says it "intentionally focuses its resources on vigorous enforcement of standards for sterilants" as opposed to disinfectants. In support of its contention, FDA cites the "three- pronged strategy formed by FDA several years ago" that "seeks to promote design and production of more easily cleaned medical devices," to "intensify...review of the effectiveness of equipment for cleaning and disinfecting such instruments," and to intensify "review of the safety and effectiveness of liquid chemical sterilants." The agency also mentions that it has "identified 25 firms that provide an estimated 90% of the liquid chemical sterilants on the U.S. market," of which it has inspected 23. The agency also may have pre-empted some of GAO's criticisms through its June 4 memorandum of understanding with EPA ("The Gray Sheet" June 21, I&W-5). For example, GAO recommends that FDA "in coordination with EPA [should] develop procedures that would satisfy" both agencies' testing requirements "to avoid unnecessary duplication of product testing." Under the MOU, "FDA will be primarily responsible for the premarket review of safety and efficacy requirements for liquid chemical germicides that are sterilants" (defined as "germicides used to reprocess critical" devices, which are "introduced directly into the human body" and "semicritical devices," or "those which contact intact mucous membranes" but do not "enter normally sterile areas of the body"). EPA will be responsible for the regulation of the other category of germicides -- general purpose disinfectants, which are defined as "those chemical germicides used to reprocess noncritical devices and medical equipment surfaces." No comments on the MOU are included in the GAO report; however, Clinger said that the accord "was clearly prompted by the imminent release of [the GAO] report." Although the MOU gives "no indication of when it's going to be implemented," the agreement represents "real progress," Clinger added. Clinger was asked during a press conference on the report whether he was considering legislation related to FDA's sterilant and disinfectant regulation policies. The congressman replied that rather than enact new legislation, "what we really need to do is hold FDA's feet to the fire and, apparently, they are responding." In addition to conducting efficacy tests, FDA has taken regulatory action against at least two germicide manufacturers, Metrex and Sporicidin (see following story). In January 1992, FDA issued a guidance document detailing germicide 510(k) application requirements. The GAO report may bolster FDA's recent call for labeling and promotional materials from approximately 400 liquid chemical germicide manufacturers ("The Gray Sheet" March 22, p. 15). The Chemical Specialties Manufacturers Association is protesting the request; in a March 12 letter to FDA Commissioner David Kessler, CSMA called the action "unfortunate and premature."
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