Medical Glove Manufacturers Working Toward COLOR Standardization
By Kelly M. Pyrek
It will only consist of a few paragraphs in an upcoming guidance document, but it will go a long way toward supporting patient and healthcare worker safety. What the glove manufacturing industry is talking about is pending guidance from the American Society for Testing and Materials International (ASTM) addressing the coloration of medical gloves to differentiate natural rubber latex (NRL) gloves from synthetic ones.
The guidance has been at the discussion level for about the past year, according to Milt Hinsch, technical services director for Regent Medical and a member of the ASTM subcommittee tasked with studying the issue. He says the glove coloration topic evolved from one of proposed regulatory status to guidance status during that time.
There were numerous discussions at the beginning, with committee members trying to sort out how the glove coloration topic was going to be handled, Hinsch says. Wava Truscott of Kimberly-Clark Healthcare initiated the first draft and led the discussions trying to push the proposal forward. Discussions went from the possibility of being an FDA-enforceable type of requirement, to an ASTM standard, to a guidance document, to being part of another guidance document. It evolved as the committee was figuring out where color should fi t in. The FDA said that we cannot enforce color for medical gloves its simply not enforceable. We agreed that we should look at glove coloration as a guidance document, and because there was not enough to make it a stand-alone guidance, we decided to make it a part of what will ultimately be an ASTM general guidance document for gloves. Hinsch adds that the FDA does not address glove color differentiation as a requirement in its 1999 proposed glove guidance document, nor does the ASTM talk about color in its numerous glove standards and other glove-related documents. Hinsch emphasizes that the guidance is not a standard, and is not enforceable by any agency. What it says to manufacturers is, Here is what you should know and consider when developing medical gloves.
While the guidance is primarily instruction for medical-glove manufacturers, Hinsch says it is an important stride forward in the area of patient and healthcare worker safety, specifically when it comes to avoiding latex allergies.
As an industry, we have become extremely safety conscious, and thats a good thing, says Carolyn Twomey, RN, BSN, a clinical nurse consultant with Regent Medical. As healthcare facilities become shorter staffed, there are some very simple things that can be done to help stop us from making terrible mistakes, whether its taking a time-out before surgery or checking a glove color and its material to prevent allergic reactions to latex.
Twomey adds, A common complaint among clinicians is that one 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 proper glove differentiation. He explains that NRL glove colors typically are manufactured in shades of buff, beige, tan, brown and off-white.
Historically, we referred to a white surgical glove as the standard surgical glove because it was a whitish glove with a fairly good content of titanium dioxide or other whiteners in it. So it was considered a white glove, he says. Every other color could be for synthetics. That leaves every color in the rainbow except for the buff, beige, tan, brown and white shades that have been proposed for the ASTM guideline.
There are some problems with this, however, that we have to work out. There are some dilemmas with vinyl gloves, for instance. Vinyl is not latex and they typically are not colored; they are usually clear. The way to get around this is to say, OK, if you do not have a color that readily identifi es it as latex or synthetic, then the manufacturer should identify the base material on the cuff, identifying it as either a latex or a synthetic glove.
Hinsch adds, For instance, Regent Medical has a green latex glove that is designed to be used as a breach-indicator glove. It has a very specifi 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. So what 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, clinicians dont read the package the surgeon or the nurse only see the gloves. So there must be something on the glove that tells the user this 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 talk colors, and they get used to color coding.
The same thing has happened with gloves that have been removed from their boxes and/or are in a dispenser bracket that hides the box label. Clinicians will grab some purple or blue exam gloves and say Im using synthetic, however when they look on the box, they turn out to be latex after all. This has happened to nurses who have experienced latex allergic reaction before fi nding out. They think that because the gloves are colored, they are synthetic.
Hinsch confirms that dialogue on glove coloration was driven largely by clinician concern for safety, as well as the desire for standardization among glove manufacturers.
Everyone wanted to address the color issue, he says. Industry, clinicians, government NIOSH was concerned about safety and lateallergy issues, manufacturers were saying We really should consider this, and hospitals and consumers were asking, Why cant we do this?
I think its a wonderful safety initiative, Twomey confirms. I think clearing up this color issue, as in, What color glove am 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 consumers about the color issue. I think there might be some initial confusion, but any surgical glove manufacturer must take the responsibility of alerting clinicians by hanging material at the scrub sink, in-servicing at healthcare facilities, and writing letters to physicians. The manufacturers will need to have programs in place to address the questions that will come up among clinicians.
Hinsch says many glove manufacturers already follow the appropriate coloration schematic, and for those that dont, there will be some work to do. However, he warns, Its simply a guidance; they should comply, but they dont have to. Theres no one coming to their factory and shutting them down if they dont. Its voluntary, and it will take a number of years until everyone is in compliance. I think the subject of color will be brought up over and over again as companies introduce new gloves. The industry will 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, and glove coloration should be restricted as follows:
- NRL glove coloration will be limited to buff, beige, tan, brown and white tones; this also applies to NRL/synthetic blends
- Or, if the color limitation is not or cannot be followed, the presence of latex must be designated on each glove
- Synthetic gloves must be readily distinguished from NRL, limiting their finished appearance to colors other than buff, beige, tan, brown or white tones; gloves may be distinguished by identifying synthetic or the base material composition, such as vinyl, on each glove
I think news about the guidance will be primarily word of mouth, with ASTM members telling other members of industry, and clinicians discussing it, Hinsch says. When you look at the surgical glove industry, its pretty small, so communication is easy. You get to the much larger examination glove industry and its a lot more difficult to communicate with everyone. But we have a lot of the big players in the ASTM, and the raw material suppliers are like bees on flowers theyll talk to all the companies, and the glove coloration guidance will come up. It will get out to the community, but it will take some time and some adjustments. I think everyones hearts are in the right places, and thats why it got through the ASTM subcommittee so quickly. This guidance is reasonable, doable, and the right thing to do. And even if its not enforceable, well have it out there.
Hinsch says that pending final approval by the ASTM, the guidance could be released in the next six to nine months.