FDA requires testing of medical gloves - Food and Drug Administration

FDA Consumer, March, 1991

FDA Requires Testing of Medical Gloves

Effective mid-March, manufacturers of rubber and plastic gloves worn by health-care workers must test their products using standardized methods and must meet minimum quality levels defined by FDA.

Until FDA announced test methods and quality requirements last December, medical glove manufacturers could devise their own testing programs. Gloves must now undergo a water leak test developed by FDA in which 1,000 milliliters of water (about a quart) are poured into the glove, which is then checked for leaks.

The maximum allowable failure rate for patient examination gloves is 40 per 1,000; for surgeons' gloves it is 25 per 1,000. (The rate is lower for surgeons' gloves because they may have longer exposures to blood and other body fluids than do examination gloves.)

"Previous FDA surveys had shown that some batches of gloves had failure rates far in excess of the new limits," says Walter E. Gundaker, acting director of the agency's Center for Devices and Radiological Health. "The quality levels we have established are minimal requirements, which means that most glove batches will have lower failure rates," Gundaker says. He anticipates that the new program should result in gloves that are far more reliable than in the past.

Gloves that do not meet these standards cannot be sold for medical uses. As part of its glove inspection program, FDA will examine randomly selected samples for tears and holes and for any foreign matter embedded in the gloves.

Foreign-made gloves must also meet the new requirements. Manufacturers may be placed on an import detention list if their gloves consistently fail to meet the standards. Domestic gloves that do not meet the standards will be seized, if necessary.

The federal Centers for Disease Control in Atlanta recommends that health-care workers wear gloves for protection against diseases such as hepatitis B and AIDS, which can be transmitted through blood and other body fluids.

People who have a certain type of artificial heart valve manufactured by Shiley Inc. are being notified about rare, but often fatal, valve fractures under a plan that has been developed by the device's Irvine, Calif., manufacturer and accepted by FDA.

Under the plan, the nonprofit foundation Medic Alert is asking all heart specialists in the United States and Canada for the names of patients implanted with the Bjork-Shiley 60-degree convexo-concave heart valve ("C-C" valve). Hospital administrators are also being asked to search their records to locate C-C valve patients. (A plan to notify foreign governments about the U.S. program is also being developed.)

Medic Alert will then send an information kit about the C-C valve, along with a letter addressed to each patient, to the patient's doctor.

"When one of these valves fractures, the patient's life can sometimes be saved if the valve is replaced quickly," says FDA Deputy Commissioner James S. Benson. "That's why it is important for C-C valve patients to ask their doctors how to recognize early signs of valve fracture and what to do should it occur.

"We hope that the Shiley program will encourage this dialogue between implant patients and physicians, and we will be closely monitoring it to be sure people are being reached with the information they need."

Replacing an intact valve is generally not recommended, because the surgical risk far outweighs the risk of fracture.

In addition to the information kit, the Shiley plan includes an international implant registry operated by Medic Alert. Once enrolled, patients will receive an ID card and a bracelet or neck chain that indicates the wearer has a C-C valve and provides special information for emergency medical personnel.

About 82,000 people worldwide-23,000 in the United States and Canada-have a C-C valve. FDA has been notified of 313 fractures, 204 of which were fatal.