Tobacco Documents Online

Post Washington, DC JUN 2 31993 FDA Called Lax in Overseeing Medical Sterilizers, Disiiii!ectants S 0 By John Schwartz w.rP. t"sus wdrr The Food and Drug Adtuinistra- tion has not adequately protected the public from disinfectants and "sterilants" that do not work, a fed- eral report has found. But FDA of- ficials disputed the conclusions and said that the problems cited have been addressed. The report by the General Aa counting Office is an investigation of a highly publicized seizure in De- cember 1991 of $1 million worth of sterilants made by Sporicadin Inter- national of Rockville. The Washington Post obtained the executive summary from an advance copy of the report, which is scheduled for release today by Rep. William F. Clinger Jr. (R-Pa.), rank- mg minority member of the Gov- ernment Operations Committee. Sterilants are used to clean med- ical instruments and to protect pa- tients against infections from noa sterile equipment. Sporicidin Cold Sterilizing Solution was, at t6e time, one of the most widely tved: sterilants in hospitals and deatst clinics, with as much as 25 percent of the total market. FDA investigators found that Sporicidin's products did not kill germs effectively, and found "sig- nificant violations of good manufac- turing practices regarding cleanli- ness and recordkeeping," the GAO report said. The GAO found that "FDA took proper action against Sporicidin lnternational." Sporicidin International officials could not be reached for comment, but have strongly disagreed with the FDA's findings and filed a statement with the GAO. Yet stopping Sporicidin was not enough, the report continued. The agency's "overall regulation of oth- er manufacturers of hospital ster ilants and disinfectants has been in- adequate." Of the hundreds of ster- ilants and disenfectants on the mar- ket, the report said, "only a few" have registered their products with the FDA, and few have been au- thorized for marketing by the FDA. The report recommends that the FDA "devise a stntegy to ensure that in the future sterilants and dis- infectants are not marketed without FDA's prior authoritation." FDA officials said they were pleased with the part of the report that supports the controversial sc- tioa taken against Sporicidin. FDA Cammissianer David A. Kessler said, 'We will not tolerate products that would permit the transmission of dis- eaae from one patient to another. That is why we acted against Spo- riddin, and the GAO report acknowl- edges that we acted properly." As for the report's criticism of the agency, FDA officials say that the GAO did not recognize an un- portant distinction between ster- ilants-which are crucial to stop- ping the transmission of such deadly diseases as AIDS, tuberculoeis and hepatitis-and disinfectants, which include common cleaners used to wash down hospital walls and fkoocs. "We tried to foan our resources on what's rmportant," says FDA spokesman Jim O'Hara, "and that means making certain that aterilants work." The FDA has identified 25 companies that make 95 percent af the surilants on the market, and has conducted inspections of 23 of thoee. Those inspectioos have resuhed a other reca<lls, warning letters and seizures, agency officials said. FDA officials said yesterday that the agency has since taken Iteps to ensure the safety of dismfectanis. The agency released a "memorao- dum of understanding" executed o. June 4 between itself and the Eu.l- roamental Protect= Agency that di- vides responsibility for review sd surveillance of chemical germiddes between the two agencies. Under the agreement, the FDA will have primary responsibility for sterilants used on "aitical devica"• such as surgical instruments that• come into contact with blood, and "semi-critical devias" that contact mucous membranes. Cleaners used on devices such as wheel chairs, operating room lamps,~ medical beds and other "noncriticaP : instruments would be regulated by; the EPA. The FDA intends to pro- i mulgate new rules based on the ' agreement, but did not announce a; tunetableforthe process.