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By Kelly M. Pyrek
It will only consist of a few paragraphs in anupcoming guidance document, but it will go a long way toward supporting patientand healthcare worker safety. What the glove manufacturing industry is talkingabout is pending guidance from the American Society for Testing and MaterialsInternational (ASTM) addressing the coloration of medical gloves todifferentiate natural rubber latex (NRL) gloves from synthetic ones.
The guidance has been at the discussion level for about thepast year, according to Milt Hinsch, technical services director for RegentMedical and a member of the ASTM subcommittee tasked with studying the issue. Hesays the glove coloration topic evolved from one of proposed regulatory statusto guidance status during that time.
There were numerous discussions at the beginning, withcommittee members trying to sort out how the glove coloration topic was going tobe handled, Hinsch says. Wava Truscott of Kimberly-Clark Healthcare initiatedthe first draft and led the discussions trying to push the proposal forward.Discussions went from the possibility of being an FDA-enforceable type ofrequirement, to an ASTM standard, to a guidance document, to being part ofanother guidance document. It evolved as the committee was figuring out wherecolor should fi t in. The FDA said that we cannot enforce color for medicalgloves its simply not enforceable. We agreed that we should look at glovecoloration as a guidance document, and because there was not enough to make it astand-alone guidance, we decided to make it a part of what will ultimately be anASTM general guidance document for gloves. Hinsch adds that the FDA does not address glove colordifferentiation as a requirement in its 1999 proposed glove guidance document,nor does the ASTM talk about color in its numerous glove standards and otherglove-related documents. Hinsch emphasizes that the guidance is not a standard,and is not enforceable by any agency. What it says to manufacturers is, Hereis what you should know and consider when developing medical gloves.
While the guidance is primarily instruction for medical-glovemanufacturers, Hinsch says it is an important stride forward in the area ofpatient and healthcare worker safety, specifically when it comes to avoidinglatex allergies.
As an industry, we have become extremely safety conscious,and thats a good thing, says Carolyn Twomey, RN, BSN, a clinical nurseconsultant with Regent Medical. As healthcare facilities become shorterstaffed, there are some very simple things that can be done to help stop us frommaking terrible mistakes, whether its taking a time-out before surgery orchecking a glove color and its material to prevent allergic reactions to latex.
Twomey adds, A common complaint among clinicians is thatone manufacturer makes a blue or green glove which is assumed to be synthetic,but its not. And that can be confusing.
Hinsch says the guidance is a simple way to ensure properglove differentiation. He explains that NRL glove colors typically aremanufactured in shades of buff, beige, tan, brown and off-white.
Historically, we referred to a white surgical glove as thestandard surgical glove because it was a whitish glove with a fairly goodcontent of titanium dioxide or other whiteners in it. So it was considered a whiteglove, he says. Every other color could be for synthetics. That leavesevery color in the rainbow except for the buff, beige, tan, brown and whiteshades that have been proposed for the ASTM guideline.
There are some problems with this, however, that we have towork out. There are some dilemmas with vinyl gloves, for instance. Vinyl is notlatex and they typically are not colored; they are usually clear. The way to getaround this is to say, OK, if you do not have a color that readily identifies it as latex or synthetic, then the manufacturer should identify the basematerial on the cuff, identifying it as either a latex or a synthetic glove.
Hinsch adds, For instance, Regent Medical has a green latexglove that is designed to be used as a breach-indicator glove. It has a veryspecifi c purpose, and there is no way we can change the color of that glove.The green color could imply that its synthetic when in fact its latex. Sowhat to do? We print on the cuff that this is a latex glove.
Hinsch says these labels are important because many times,clinicians dont look at the packages. Many times in surgery, cliniciansdont read the package the surgeon or the nurse only see the gloves. So there must be something on the glove that tells the userthis is something other than what one might think it is. In the operating room,color is critical. A surgeon will say, I want that blue suture. They talkcolors, and they get used to color coding.
Thesame thing has happened with gloves that have been removed from their boxesand/or are in a dispenser bracket that hides the box label. Clinicians will grabsome purple or blue exam gloves and say Im using synthetic, howeverwhen they look on the box, they turn out to be latex after all. This hashappened to nurses who have experienced latex allergic reaction before fi ndingout. They think that because the gloves are colored, they are synthetic.
Hinsch confirms that dialogue on glove coloration was drivenlargely by clinician concern for safety, as well as the desire forstandardization among glove manufacturers.
Everyone wanted to address the color issue, he says. Industry,clinicians, government NIOSH was concerned about safety and lateallergyissues, manufacturers were saying We really should consider this, andhospitals and consumers were asking, Why cant we do this?
I think its a wonderful safety initiative, Twomeyconfirms. I think clearing up this color issue, as in, What color gloveam I holding and what does it mean? for clinical practitioners is important.I think it will be a shame if glove manufacturers fail to educate consumersabout the color issue. I think there might be some initial confusion, but anysurgical glove manufacturer must take the responsibility of alerting cliniciansby hanging material at the scrub sink, in-servicing at healthcare facilities,and writing letters to physicians. The manufacturers will need to have programsin place to address the questions that will come up among clinicians.
Hinsch says many glove manufacturers already follow theappropriate coloration schematic, and for those that dont, there will be somework to do. However, he warns, Its simply a guidance; they shouldcomply, but they dont have to. Theres no one coming to their factory andshutting them down if they dont. Its voluntary, and it will take a numberof years until everyone is in compliance. I think the subject of color will bebrought up over and over again as companies introduce new gloves. The industrywill want to do the right thing.
Essentially, the guidance facilitates the rapid identification of NRL gloves by those who must avoid their use due to latex allergy, andglove coloration should be restricted as follows:
I think newsabout the guidance will be primarily word of mouth, with ASTM members tellingother members of industry, and clinicians discussing it, Hinsch says. Whenyou look at the surgical glove industry, its pretty small, so communicationis easy. You get to the much larger examination glove industry and its a lotmore difficult to communicate with everyone. But we have a lot of the bigplayers in the ASTM, and the raw material suppliers are like bees on flowers theyll talk to all the companies, and the glove coloration guidance willcome up. It will get out to the community, but it will take some time and someadjustments. I think everyones hearts are in the right places, and thatswhy it got through the ASTM subcommittee so quickly. This guidance isreasonable, doable, and the right thing to do. And even if its notenforceable, well have it out there.
Hinsch says that pending final approval by the ASTM, theguidance could be released in the next six to nine months.