FOOD AND DRUG ADMINISTRATION
|Issue No. 21||Fall 1997|
Manufacturers of latex gloves are now using cornstarch to help users slip on gloves more easily. Previously, talc was used as a donning powder, but it can cause post-operative complications such as adhesions and granulomas. For this reason, the Food and Drug Administration (FDA) recommends that talc no longer be used.
Eliminating talc significantly reduces the risk of granuloma formation, but cornstarch has also been implicated in other complications. Some of these problems have been documented in the clinical literature. For example, cornstarch is a highly absorbent powder that reduces the skin’s natural moisture and oils; this can cause dryness and cracking of the user’s hands. This drying and cracking can allow infectious agents, chemicals, and even cornstarch particles themselves to penetrate the skin.
Cornstarch also has a propensity to bind the proteins that are present on natural rubber latex gloves. These proteins are known to cause latex allergy. When the cornstarch and proteins are aerosolized and inhaled, the results can be severe respiratory reactions in latex allergic individuals. The chance of non-allergic users becoming allergic may increase after direct contact of latex proteins with mucous membranes. In an environment where glove use is great, the amount of aerosolized allergens may be high enough to affect not only glove users, but also other individuals in the area who are not using gloves. Allergenic powder may remain on clothing and equipment, even when powdered gloves are not in use.
Patients can also be affected in other ways. Cornstarch can enter a patient’s tissues during surgical and post-surgical procedures. Powder could be on the inside and the outside of the gloves. Each time a healthcare worker dons or removes gloves, the powder becomes airborne and stays in the environment for some time. If cornstarch enters the surgical site, it can cause an acute inflammatory process that later may become chronic and result in tissue adhesions. Because adhesions of the peritoneal tissues after surgery have been observed in clinical practice, the role of glove powder in this process remains a concern.
It is important to note that the level of an airborne allergen depends not only on the amount of powder, but also on the amount of protein on the gloves. Cornstarch, without latex proteins, does not cause allergic reactions. Therefore, the problems caused by airborne latex allergens can be decreased by reducing the amount of powder in the air and the amount of allergen contained in the natural rubber latex gloves. Manufacturers are already developing latex gloves with reduced levels of protein and reduced amounts of powder as well as powder-free gloves. Several of these products are now on the market.
Some manufacturing processes that make the gloves powder-free also lower the total protein allergen on the finished latex product. Based on preliminary observations, the use of powder-free gloves appears to reduce both the level of airborne allergen and the amount of allergen remaining on the finished latex glove. But, the new technologies for production of powder-free gloves may affect other glove properties, such as barrier effectiveness and shelf life.
Since the primary concern with glove powder is its role as an allergen carrier, both the amount of powder and the amount of protein on finished latex devices are important. For these reasons, latex sensitive healthcare workers should consider using the reduced-protein, reduced-powder, or powder-free latex gloves now available.
Vesna J. Tomazic-Jezic, Ph.D., is an immunologist in CDRH’s Office of Science and Technology.
On September 30, 1997, the Food & Drug Administration (FDA) issued a final rule (Federal Register, Vol. 62, page 51021) requiring cautionary statements in the labeling of all medical devices that contain natural rubber likely to come in contact with humans. This rule also affects device packaging that contains natural rubber. Highlights of the rule are:
This final rule is effective on September 30, 1998. If manufacturers reorder labeling stock before the effective date, FDA encourages them to add the required labeling and/or to remove the hypoallergenic claim at that time.
A copy of the final rule can be obtained from either CDRH’s Facts-on-Demand system or the World Wide Web at http://www.fda.gov/cdrh/fr/fr0930bf.html. For Facts-on-Demand, dial 800-899-0381 or 301-827-0111 from a touch tone phone and follow the prompts:
For more information on this rule, call the Division of Small Manufacturers Assistance, 301-443-6597 or 800-638-2041 and ask for Andrew Lowery on extension 116 or Arthur Yellin on extension 146. You may also send your comments or questions by FAX to 301-443-8818.
Q. Does FDA agree with the recommendations in the NIOSH Alert published June 23, 1997?
A. FDA agrees that latex allergy is a significant problem for some healthcare workers and that switching to reduced-protein gloves, reduced-powder gloves, or powder-free gloves to minimize exposure to latex protein may help to minimize the chance of developing an allergy. But, we are concerned that if all medical facilities were to switch immediately, a shortage of reduced-protein gloves and powder-free gloves would occur. If this results in some healthcare workers not using gloves, it could endanger them and their patients. Another concern is that manufacturing processes for reduction of powder and protein may compromise barrier properties and shelf life of gloves. From a public health standpoint, this could be a more serious problem than the potential for latex allergy.
The most prudent course of action would be to immediately provide non-latex gloves to all latex-sensitive healthcare workers and then to phase in the use of reduced-protein gloves, reduced-powder gloves, and powder-free gloves by those healthcare workers who are not sensitive to latex as supplies become available.
Q. How many reports of allergic reactions has FDA received and how many were of deaths?
A. Since 1974, FDA has received over 1700 reports of allergic reactions to latex. Seventeen deaths have been reported. However, since adverse reactions are often under-reported to FDA, it is possible that there are many more adverse reactions and deaths. Other sources of data suggest a frequency of latex allergy among healthcare workers greater than would be indicated in the FDA reports. The records do not differentiate between powdered and powder-free gloves.
Q. Are powder-free gloves as good as powdered gloves?
A. All latex gloves currently marketed (powdered and powder-free) are required to meet the same performance specifications, but the shelf life for powder-free gloves may be shorter than for powdered gloves. Although there are no special requirements or limitations on the use of powder-free gloves, some non-allergic healthcare workers may prefer to continue to use the powdered type.
Q. Why is FDA continuing to allow the marketing of latex gloves?
A. The basic criterion FDA uses in allowing the marketing of latex gloves is their effectiveness in creating a barrier against the transmission of infectious agents. Although FDA is concerned about latex allergies, the agency recognizes that many of the materials used in medical products can cause allergic reactions in some people. FDA believes healthcare workers and medical facilities are responsible for protecting sensitive individuals by choosing non-allergenic products where appropriate. In the case of latex allergies, there are several types of non-latex gloves on the market, as well as several brands of reduced-protein gloves and powder-free gloves.
Q. Will using petroleum-based skin care products affect latex gloves?
A. Any skin care product or lubricant containing petroleum oils (petrolatum, mineral oil, etc.) can degrade latex. In the case of gloves, this could cause tearing and premature failure. Thus, when handling infectious agents, it is especially important to avoid the use of skin care products containing petroleum oils.