FDA Proposes Amendments to Regulation of Medical Glove Testing
WASHINGTON--The Food and Drug Administration (FDA) is proposing the amendment of its regulation on medical glove testing by implementing stricter acceptable quality levels (AQLs).
The FDA samples patient examination and surgical gloves and examines them for visual defects and water leaks. Glove lots are considered adulterated if they do not meet the specified quality levels. The amendment, which also would affect the sampling plans and test methods of medical glove testing, would improve the barrier quality of medical gloves in the domestic market, and would harmonize better with consensus standards.
Currently, in accordance with the regulation, the FDA examines the gloves for visual defects and water leaks, which are considered adulterated if they do not meet certain quality levels. The proposed update would reduce what the FDA considers an acceptable level of defects. If the proposed amendment is accepted, the new AQLs would better harmonize with standards developed by the International Organization for Standardization and the American Society for Testing Materials.
The Need for Gloves
On August 21, 1987, the Centers For Disease Control (CDC) published a report emphasizing the need for all healthcare workers to routinely use appropriate universal precautions when they expect to come into contact with blood or other body fluids of any patient. This report recommended that healthcare workers (HCWs) wear medical gloves when:
- Touching blood or other body fluids, mucous membranes, or non-intact skin of patients
- Handling items or surfaces soiled with blood or other bodily fluids; and performing venipuncture and other vascular access procedures.
After the publication of the CDC's recommendations and the rise in HIV infections, HCWs increasingly relied on gloves as a barrier to the transmission of HIV and other blood- and fluidborne infectious agents. The CDC's recommendations recognized that defects in medical gloves had the potential of resulting in transmission of HIV between patients and HCWs. The FDA reviewed and evaluated the quality control procedures that manufacturers used in making medical gloves and concluded that manufacturers could only meet reasonable expectations of barrier protection by establishing adequate specifications for medical gloves, and adequate test procedures to detect defects in gloves. Glove defects include rips, tears, embedded foreign objects in the glove that may cause the glove to rip or tear upon stretching, or holes that allow the passage of fluids and fluid-borne microorganisms. Each of these defects compromises the glove barrier integrity and may expose HCWs and patients to infectious agents. Articles written by healthcare professionals who studied glove quality and the use of gloves as a barrier to infectious agents noted that gloves with defects may not provide this protection.
The FDA's Stance
In 1989, the FDA said existing consensus standards did not establish adequate test methods and acceptance criteria for patient examination or surgeons' gloves; therefore, the agency said it needed to communicate clearly the test procedures and the acceptance levels it would use to determine whether medical gloves were adulterated.
In the Federal Register of December 12, 1990, the FDA issued a final rule identifying minimum AQLs for patient examination and surgeons' gloves, and established the sample plans and test method for determining whether a lot of gloves were acceptable. This rule defined defects as "leaks, tears, mold, embedded foreign objects, etc."
In a 1998 report, the CDC reaffirmed its expectation that HCWs should use medical gloves as an effective barrier to HIV, hepatitis B virus and other bloodborne infections, and that these gloves should provide effective protection against exposure to pathogenic microorganisms in blood and other body fluids.
In the December 10, 1999 Morbidity and Mortality Weekly Report (MMWR), the CDC estimated that the prevalence of HIV at the end of 1998 ranged from 800,000 to 900,000 infected persons. CDC estimated that, of these 800,000 to 900,000 persons, HIV infection or AIDS was diagnosed in approximately 625,000 of the individuals. In June 1999, the CDC reported that 54 documented cases of HIV seroconversion resulted from occupational exposure to HIV. In April 2002, the CDC reported that, as of December 31, 1999, 22,218 out of 437,407 adults reported diagnosed with AIDS were HCWs.
The FDA concluded that medical gloves play an important role in the prevention of infectious disease transmission in healthcare settings, and that lowering the acceptable level of defects is necessary to further reduce the risk of transmission of such diseases and to harmonize the quality of gloves sold in the United States with international consensus standards.
Following the publication of Sec. 800.20, several consensus standards organizations, such as the ISO and the ASTM, adopted the FDA test methodology and acceptance criteria for patient examination and surgeons' gloves. As glove manufacturing capabilities improved, these organizations lowered the minimum acceptance criteria for holes/leaks for these gloves. In 1994, ISO published standards for surgeons' and patient examination gloves with AQLs of 1.5 and 2.5, respectively. ASTM adopted these same acceptance criteria in April 1998 and March 1999, for surgeons' and patient examination gloves, respectively. Because the organizations updated their standards to reflect the improvement in manufacturing technology, the consensus standards currently have lower AQLs for medical gloves than FDA's regulation.
The consensus standards differ from the current FDA regulation in two other respects: They use metric units for specifying dimensions and they refer to sampling plans from the ISO's document ISO 2859, "Sampling Procedures for Inspection by Attributes," instead of the MIL-STD-105E sampling plan that is currently referenced in Sec. 800.20.
The FDA believes it is important to harmonize its requirements with consensus standards to ensure an acceptable standard of safety and effectiveness for all manufacturers. The FDA has recognized the ASTM standards for patient examination and surgeons' gloves for the purpose of premarket notification submissions, and believes that it is appropriate to use the same standards for determining the acceptability of lots of medical gloves.
Since issuing Sec. 800.20, the FDA has received many questions from FDA field laboratories, glove manufacturers, importers and private laboratories regarding the definition of defects in the current regulation. Many questions concerned whether lumps of latex material on or beneath the glove surface are considered defects. These questions arise because the definition of defects in Sec. 800.20 refers to "embedded foreign objects" and latex is not "foreign'" to a latex glove. Other questions were whether "mold" is an appropriate defect to be included in a sampling plan intended primarily to detect physical defects. The FDA has addressed them in the proposed amendments.
The FDA recognizes the difficulty of adequately representing a large lot of gloves with a relatively small sample size. The agency has sometimes allowed manufacturers and importers to segregate and retest portions of the lot(s) or sizes of reconditioned gloves that initially failed FDA or private laboratory analysis to identify those portions of the larger lot(s) or sizes that meet quality requirements. The agency recognizes, however, that passing a retest does not provide the same assurance of quality as when the lot passes the initial analysis. This is due, in part, to the nature of the standard sampling plans, and in part to the fact that retesting is performed to identify acceptable portions of the larger lot(s) after failing the initial test. Recognized consensus standard sampling plans address the issue of previous test failures by allowing tightened sampling during retesting in order to provide additional assurance to the consumer. FDA proposes to apply this principle to testing of reconditioned lots that have failed an initial analysis.
On July 30, 1999, the FDA published a proposed rule in the Federal Register (64 FR 41710) that addressed several issues pertaining to medical examination gloves, including their reclassification from class I to class II in order to provide reasonable assurance of safety and effectiveness. To provide this assurance, appropriate special controls (applicable to class II medical devices) were also proposed. The proposal to reclassify medical examination gloves reflects the increased importance of these devices in the healthcare arena and is consistent with the changes FDA is now proposing for Sec. 800.20. However, this proposal to lower the acceptable level of defects in medical gloves is an independent initiative that will go forward as FDA continues to review the comments it received on the reclassification proposal.
The FDA proposes:
- Lowering the AQL to which the level of defects in lots of gloves is tested, thereby assuring improved quality of gloves
- Lowering the AQLs, converting units of measure to the metric system; eliminating references to obsolete sampling plans, and reference current ISO standards; thereby harmonizing with recognized consensus standards
- Clarifying visual defects and current methodology for conducting water leak testing
- Providing tightened sampling plans for testing reconditioned lots of medical gloves that have already failed one analysis.
Specifically, the FDA is proposing to lower the AQL for surgeons' gloves from 2.5 to 1.5 and to lower the AQL for patient examination gloves from 4.0 to 2.5. Lowering the AQLs for medical gloves will reduce the allowable defect level for patient examination gloves. The FDA is also proposing to amend the regulation to tighten sampling plans for reconditioned lots of medical gloves that have failed to meet the 1.5 or 2.5 AQL level. These reconditioned gloves would have to be sampled under a more stringent inspection standard in order to provide additional assurance that they meet the AQLs. This practice is consistent with the ISO sampling plans, which allow for tightened sampling when failures occur under normal sampling.
Approximately 30.8 billion medical gloves were sold in the United States during 2000. According to FDA records, there are 417 manufacturers of medical gloves. Of these, only six are domestic firms. Malaysian manufacturers supply almost 44 percent of the medical gloves in the United States.
The FDA expects the demand for medical gloves to increase by the same rate as employment in the medical services industry. The Bureau of Labor Statistics (BLS) projects annual employment growth of 2.6 percent for this industry, which implies an annual demand for almost 40 billion medical gloves within 10 years.
The FDA estimates that the proposed regulation would have an average annualized cost of about $5.2 million.
The proposed regulation would result in public health gains by reducing the frequency of bloodborne pathogen transmissions due to defects in the barrier protection provided by medical gloves. An annualized monetary benefit of $12.3 million would be saved due to fewer pathogen transmissions and unnecessary blood screens. Moreover, fewer glove defects would reduce the number of, and, therefore, the cost and anxiety associated with, unnecessary blood screens (i.e., those that yield negative results for HCWs).
The implications of this expected reduction in defective gloves are significant. The current AQL is associated with 740 million glove defects in the present year and within 10 years would result in 955 million annually marketed defective medical gloves. If the proposed AQL were in place, the current annual number of defective gloves would approximate 548 million and within 10 years would reach 709 million. The number of defective gloves, therefore, would be reduced by more than 25 percent due to the new AQL.
The FDA expects that reduction in defective gloves would result in almost seven fewer cases of chronic HBV, seven fewer cases of HIV, and 1.1 million fewer unnecessary blood screens.
Source: FDA and Federal Register
Dealing with Pathogens
By Tina Brooks
What are some important steps you can take to avoid the transmission of pathogens, and what are you doing to encourage handwashing compliance?
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