FDA PUBLISHES FINAL RULE ON SURGEONS' GLOVES

The FDA published a final rule in the Dec. 19 Federal Register on test procedures and accepted criteria for patient examination and surgeons' gloves.

The rule will improve the barrier quality of medical gloves marketed in the U.S. "by reducing the current acceptable quality levels (AQLs) for leaks and visual defects observed during FDA testing of medical gloves," the agency said. By reducing the AQLs for medical gloves, the FDA also expects to harmonize its AQLs with consensus standards developed by the International Organization for Standardization and American Society for Testing and Materials International.

The final rule will result in public health gains by reducing the frequency of blood-borne pathogen transmissions due to defects in the barrier protection provided by medical gloves, the agency said. Further, the FDA expects "an annualized monetary benefit of $14.8 million (using a 3 percent discount rate) or $15.1 million (using a 7 percent discount rate) will be realized due to fewer pathogen transmissions and unnecessary blood screens."

The final rule will become effective Dec. 19, 2008. It can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/2003n-0056-nfr0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/2003n-0056-nfr0001.pdf).