FDA Proposes Amendments to Regulation of Medical Glove Testing

June 1, 2003

FDA Proposes Amendments to Regulation of Medical Glove Testing

FDA Proposes Amendments to Regulation of Medical Glove Testing

WASHINGTON--The Food and Drug Administration (FDA) is proposing the amendmentof its regulation on medical glove testing by implementing stricter acceptablequality levels (AQLs).

The FDA samples patient examination and surgical gloves and examines them forvisual defects and water leaks. Glove lots are considered adulterated if they donot meet the specified quality levels. The amendment, which also would affectthe sampling plans and test methods of medical glove testing, would improve thebarrier quality of medical gloves in the domestic market, and would harmonizebetter with consensus standards.

Currently, in accordance with the regulation, the FDA examines the gloves forvisual defects and water leaks, which are considered adulterated if they do notmeet certain quality levels. The proposed update would reduce what the FDAconsiders an acceptable level of defects. If the proposed amendment is accepted,the new AQLs would better harmonize with standards developed by theInternational Organization for Standardization and the American Society forTesting Materials.

The Need for Gloves

On August 21, 1987, the Centers For Disease Control (CDC) published a reportemphasizing the need for all healthcare workers to routinely use appropriateuniversal precautions when they expect to come into contact with blood or otherbody 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 HIVinfections, HCWs increasingly relied on gloves as a barrier to the transmissionof HIV and other blood- and fluidborne infectious agents. The CDC'srecommendations recognized that defects in medical gloves had the potential ofresulting in transmission of HIV between patients and HCWs. The FDA reviewed andevaluated the quality control procedures that manufacturers used in makingmedical gloves and concluded that manufacturers could only meet reasonableexpectations of barrier protection by establishing adequate specifications formedical gloves, and adequate test procedures to detect defects in gloves. Glovedefects include rips, tears, embedded foreign objects in the glove that maycause the glove to rip or tear upon stretching, or holes that allow the passageof fluids and fluid-borne microorganisms. Each of these defects compromises theglove barrier integrity and may expose HCWs and patients to infectious agents.Articles written by healthcare professionals who studied glove quality and theuse of gloves as a barrier to infectious agents noted that gloves with defectsmay not provide this protection.

The FDA's Stance

In 1989, the FDA said existing consensus standards did not establish adequatetest methods and acceptance criteria for patient examination or surgeons'gloves; therefore, the agency said it needed to communicate clearly the testprocedures and the acceptance levels it would use to determine whether medicalgloves were adulterated.

In the Federal Register of December 12, 1990, the FDA issued a final ruleidentifying minimum AQLs for patient examination and surgeons' gloves, andestablished the sample plans and test method for determining whether a lot ofgloves 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 usemedical gloves as an effective barrier to HIV, hepatitis B virus and otherbloodborne infections, and that these gloves should provide effective protectionagainst exposure to pathogenic microorganisms in blood and other body fluids.

In the December 10, 1999 Morbidity and Mortality Weekly Report (MMWR), theCDC estimated that the prevalence of HIV at the end of 1998 ranged from 800,000to 900,000 infected persons. CDC estimated that, of these 800,000 to 900,000persons, HIV infection or AIDS was diagnosed in approximately 625,000 of theindividuals. In June 1999, the CDC reported that 54 documented cases of HIVseroconversion resulted from occupational exposure to HIV. In April 2002, theCDC reported that, as of December 31, 1999, 22,218 out of 437,407 adultsreported diagnosed with AIDS were HCWs.

The FDA concluded that medical gloves play an important role in theprevention of infectious disease transmission in healthcare settings, and thatlowering the acceptable level of defects is necessary to further reduce the riskof transmission of such diseases and to harmonize the quality of gloves sold inthe United States with international consensus standards.

Testing Standards

Following the publication of Sec. 800.20, several consensus standardsorganizations, such as the ISO and the ASTM, adopted the FDA test methodologyand acceptance criteria for patient examination and surgeons' gloves. As glovemanufacturing capabilities improved, these organizations lowered the minimumacceptance criteria for holes/leaks for these gloves. In 1994, ISO publishedstandards for surgeons' and patient examination gloves with AQLs of 1.5 and 2.5,respectively. ASTM adopted these same acceptance criteria in April 1998 andMarch 1999, for surgeons' and patient examination gloves, respectively. Becausethe organizations updated their standards to reflect the improvement inmanufacturing technology, the consensus standards currently have lower AQLs formedical gloves than FDA's regulation.

The consensus standards differ from the current FDA regulation in two otherrespects: They use metric units for specifying dimensions and they refer tosampling plans from the ISO's document ISO 2859, "Sampling Procedures forInspection by Attributes," instead of the MIL-STD-105E sampling plan thatis currently referenced in Sec. 800.20.

The FDA believes it is important to harmonize its requirements with consensusstandards to ensure an acceptable standard of safety and effectiveness for allmanufacturers. The FDA has recognized the ASTM standards for patient examinationand surgeons' gloves for the purpose of premarket notification submissions, andbelieves that it is appropriate to use the same standards for determining theacceptability of lots of medical gloves.

Since issuing Sec. 800.20, the FDA has received many questions from FDA fieldlaboratories, glove manufacturers, importers and private laboratories regardingthe definition of defects in the current regulation. Many questions concernedwhether lumps of latex material on or beneath the glove surface are considereddefects. These questions arise because the definition of defects in Sec. 800.20refers 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 planintended primarily to detect physical defects. The FDA has addressed them in theproposed amendments.

The FDA recognizes the difficulty of adequately representing a large lot ofgloves with a relatively small sample size. The agency has sometimes allowedmanufacturers and importers to segregate and retest portions of the lot(s) orsizes of reconditioned gloves that initially failed FDA or private laboratoryanalysis to identify those portions of the larger lot(s) or sizes that meetquality requirements. The agency recognizes, however, that passing a retest doesnot provide the same assurance of quality as when the lot passes the initialanalysis. 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 acceptableportions of the larger lot(s) after failing the initial test. Recognizedconsensus standard sampling plans address the issue of previous test failures byallowing tightened sampling during retesting in order to provide additionalassurance to the consumer. FDA proposes to apply this principle to testing ofreconditioned 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 examinationgloves, including their reclassification from class I to class II in order toprovide reasonable assurance of safety and effectiveness. To provide thisassurance, appropriate special controls (applicable to class II medical devices)were also proposed. The proposal to reclassify medical examination glovesreflects the increased importance of these devices in the healthcare arena andis 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 anindependent initiative that will go forward as FDA continues to review thecomments 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 from2.5 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 forpatient examination gloves. The FDA is also proposing to amend the regulation totighten sampling plans for reconditioned lots of medical gloves that have failedto meet the 1.5 or 2.5 AQL level. These reconditioned gloves would have to besampled under a more stringent inspection standard in order to provideadditional assurance that they meet the AQLs. This practice is consistent withthe ISO sampling plans, which allow for tightened sampling when failures occurunder normal sampling.

Approximately 30.8 billion medical gloves were sold in the United Statesduring 2000. According to FDA records, there are 417 manufacturers of medicalgloves. Of these, only six are domestic firms. Malaysian manufacturers supplyalmost 44 percent of the medical gloves in the United States.

The FDA expects the demand for medical gloves to increase by the same rate asemployment in the medical services industry. The Bureau of Labor Statistics (BLS)projects annual employment growth of 2.6 percent for this industry, whichimplies an annual demand for almost 40 billion medical gloves within 10 years.

The FDA estimates that the proposed regulation would have an averageannualized cost of about $5.2 million.

The proposed regulation would result in public health gains by reducing thefrequency of bloodborne pathogen transmissions due to defects in the barrierprotection provided by medical gloves. An annualized monetary benefit of $12.3million would be saved due to fewer pathogen transmissions and unnecessary bloodscreens. 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 aresignificant. The current AQL is associated with 740 million glove defects in thepresent year and within 10 years would result in 955 million annually marketeddefective medical gloves. If the proposed AQL were in place, the current annualnumber of defective gloves would approximate 548 million and within 10 yearswould reach 709 million. The number of defective gloves, therefore, would bereduced by more than 25 percent due to the new AQL.

The FDA expects that reduction in defective gloves would result in almostseven fewer cases of chronic HBV, seven fewer cases of HIV, and 1.1 millionfewer unnecessary blood screens.

Source: FDA and Federal Register

Reader Feedback
Dealing with Pathogens

By Tina Brooks

What are some important steps you can take to avoid the transmission ofpathogens, and what are you doing to encourage handwashing compliance?

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Employee Health
KidsPeace, Orefield, Pa.

"I am one of five infection control practitioners (ICPs) at auniversity-affiliated tertiary-care center. I believe one of the most importantsteps healthcare professionals can take is to make a commitment to practicinggood hand hygiene. Thankfully, with the introduction of waterless handantiseptics, that has become easy and time efficient. We have gone from usingthese products in targeted ICUs to installing them in every area of thefacility."

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Memorial Hermann Hospital
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"Besides handwashing, education on the transmission of pathogens, aswell as availability of waterless hand products help promote the reduction ofinfections. At this time, we do not monitor, handwashing compliance rates. Whenperforming daily patient care rounds, we encourage handwashing."

Carol Ward, RN, CIC
Infection Control Program Manager Virtua Health, Mount Holly, N.J.

"Salem Hospital strongly encourages hand washing, but we also stronglyencourage the use of Purell hand sanitizer."

David O'Brien
Director, Environmental Services
TNSMC - Salem Hospital, Salem, Mass.

JUNE 2003

8-12
Annual meeting, San Antonio, Texas
www.apic.org

22-25
Community and Hospital Infection Control Association, Canada
National educational conference
Valhalla Inn, Thunder Bay, Ontario, Canada
(204) 897-5990 or www.chica.org

AUGUST 2003
17-20
Association for Healthcare Resource and Materials Management (AHRMM)
Annual meeting, San Diego
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SEPTEMBER 2003

17-19
Managing Today's OR Suite
Annual meeting, San Diego
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21-25
American Society for Healthcare Environmental Services
18th annual conference
Philadelphia Marriott, Philadelphia
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OCTOBER 2003

9-12
Infectious Diseases Society of America (IDSA)
Annual meeting, San Diego
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18-21
American Society for Healthcare Central Sterile Service Professionals (ASHCSP)
Annual meeting, Grand Rapids, Mich.
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NOVEMBER 2003

9-12
International Association of Healthcare Central Services Materials Management (IAHCSMM)
Cancun, Mexico
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