FDA Requires Higher Standards for Medical Gloves; Industry Insiders Forecast Impact

The Food and Drug Administration (FDA) in December issued a final ruling on its standards for surgical and patient examination gloves. The result: not dramatic. Most glove manufacturers, after all, have been meeting the new standards for years.

By lowering its acceptable quality levels (AQLs), the FDA is requiring higher barrier standards for the gloves, a move that is expected to create fewer occurrences of bloodborne pathogen transmissions between patients and healthcare workers.

Not as many defective gloves pass inspection, but dangers, of course, will still exist, says Jim Drummond, manager of rubber and plastics physical testing at Akron Rubber Development Laboratory Inc.

A lot of (safety issues are) in the eye of the beholder, Drummond says. Do you feel safe under those conditions or dont you feel safe under those conditions? Let the beholder make his own decision.

About 940 million defective gloves are sold in the U.S. every year, which is 2.4 percent of all marketed gloves, according to the FDAs final ruling which was published in the Federal Register. These gloves sometimes lead to transmission rates of Human Immunodeficiency Virus (HIV), hepatitis B (HBV), and perhaps hepatitis C (HCV) in healthcare settings, but thanks to the new standards, 25 percent fewer defective gloves will make it to the market.1

The new standards will go into effect Dec. 19, 2008. Part of the appeal in changing the standards was to make them more consistent with the benchmarks used by the International Organization for Standardization (ISO) and ASTM International (ASTM), two influential regulators.

Standards set by the ISO and ASTM International have been different than the FDAs since 1999, and in 2003 the FDA proposed that it would try to align with the consensus. Indeed, the decision was long overdue, according to Milt Hinsch, technical services director for Molnlycke Healthcare. Hinsch has 23 years of experience in the glove industry.

The decision to lower the AQLs, is not a surprise at all to the industry,  he says. Its a non-event. If anything, its good news in the sense that we no longer have to try to explain to customers why if they go to the FDA regulations theres a different AQL than what were telling them is required.

During the 90-day comment period, however, several interested, unnamed parties expressed concerns with the FDAs ruling, its wording, and the way in which agency researchers gathered evidence. One concern was that lowering AQLs would cost glove manufacturers and consumers more money, and that the new standards would force manufacturers to downgrade gloves that dont pass inspection.

FDA researchers have deduced that only a small percentage of gloves will have to be downgraded. If a sampling from a lot of gloves fails inspection, the lot is often sampled again, sold in foreign markets, or as non-medical gloves. Lot sizes vary from 25 gloves up to 500,000.1

The FDA, the ISO, and ASTM International tests gloves for visual abnormalities and defects that occur through water and tension testing. Tools for these tests include an automatic water dispenser, elastic and Velcro strapping, rods, hooks, and plastic cylinders. Surgical gloves are held to higher standards than examination gloves because the former are more likely to come in contact with bodily fluids.

The FDA expects, demand for medical gloves to increase by the same rate as employment in the medical services industry. The Bureau of Labor Statistics has projected annual employment growth of 2.6 percent for this industry which implies an annual volume of over 50 billion medical gloves in 10 years.1

In regard to finances, the FDA stated in its final ruling that extra costs will have a minimal impact on the industry, because a vast majority of glove manufacturers already produce gloves that meet the Dec. 19, 2008 standards.

The final ruling adds that, significant changes in the manufacturing processes will not be necessary. In addition, there is no universal economic presumption that costs are passed on to consumers in order to maintain a constant profit margin to manufacturers. Due to the competitive nature of the glove industry, price hikes will likely not trickle down to the consumer, but will instead be absorbed by the manufacturers, according to the FDA.

Hinsch agrees.

It will not be prohibitively expensive, he says. Always, making better gloves does cost the industry more, but we actually are producing (AQLs) below what the FDA will be requiring in 2008.

As far as Hinsch knows, there is no talk in the medical glove industry about appealing the decision. The new standards wont cause much of a ripple in the healthcare industry, either, Hinsch predicts.

There will be no tangible effects that (healthcare facilities) will notice, he notes. Unless, that is, healthcare providers decide to change products. Healthcare providers dont experiment with new types of gloves very often, but when they do, they sometimes, freak out, Hinsch comments.

Its just the nature of the industry, he said. The hospitals are reluctant to change. Everyone wants progress but no one wants change. (Switching products) is a monumental ask, and Ive often said that OR supervisors would rather go through a root canal than a glove conversion.

They just shudder, Hinsch adds, partly in jest. You can see them physically shake when you start talking about changing their gloves.

The most important changes that the new AQLs will bring, hopefully, are cost savings and decreased risk of infection at healthcare facilities.

While the new AQLs will be slightly more expensive for manufactures particularly for companies based in Malaysia, China and other foreign countries that are not already following the 2008 quality levels the annual benefits to society should far outweigh the costs.

When a healthcare practitioner or patient notices that the security of a glove has been compromised, one or both parties often get blood tests that are expensive for the healthcare system. These occurrences add up quickly and lead annually to millions of dollars in tests. If fewer damaged gloves hit the market, there should be an annual savings between 14.8 and $15.1 million.1 After subtracting the higher cost of making better gloves, the average annual benefits will be between 8.2 and $8.5 million, according to the FDA.

Due to glove defects, 2.4 people per year receive bloodborne pathogens that lead to HIV infections, and another 2.4 people end up with chronic HBV.1 FDA researchers could not predict the amount of HIV infections that the new AQLs will prevent, but expressed confidence in their final ruling that the infection rates will go down when glove quality improves.

The FDAs final ruling, based partly on research from the Centers for Disease Control and Prevention (CDC), states that an average of 40 out of 140 annual occupational transmissions of HBV in healthcare settings may be blamed on current medical glove quality levels.

HCV transmission rates in healthcare settings, however, will likely not change. The FDA and CDC find that there is little evidence that glove defects are associated with HCV exposures.1

Patients and healthcare professionals are the highest priority for glove testers and manufacturers, Hinsch says.

Absolutely, he added. Ultimately, thats were the importance is, is to the patient. (Manufacturing expenses) are going to be more than offset by the cost savings that the patients will incur. Thats priceless.

The new AQLs should cut the amount of unnecessary blood screens by 120,000 per year under current conditions, according to the FDA.

Since the healthcare industry will grow, during the tenth year of the evaluation period the improved AQLs are expected to cut down on blood screens by 155,000 per year. Through the whole evaluation period, the rule could lead to more than 1.4 million fewer unnecessary blood screens.1 The average cost of each blood test is about $76.1

The FDA expects that a decline in defective gloves will also decrease the amount of psychological anxiety and physical stress that people feel when they think they have been exposed to bloodborne pathogens.

Symptoms of this anxiety and stress include depression, crying, lack of concentration and mental lucidity.1

One public comment suggested that the new AQLs should not be used until 2010. The FDA disagreed again, and retorted in its final ruling that manufacturers and consumers will be able to adjust aptly by the 2008 deadline.

The 22-month preparation span offers plenty of time, Hinsch says.

The changes have already been implemented, he added. All the manufacturers in the US that I know are meeting the current ISO and ASTM standards I dont know anyone who is considering the FDA as the lead in these standards.

There was one aspect of the ruling that did not incite debate -- the FDAs finding that the new AQLs will have not have a significant impact on the environment.

About 39 billion medical gloves were imported to the U.S. during 2004, but only about 15 percent of them were surgical gloves, according to FDA records. There are more than 400 medical glove manufacturers worldwide, and just as the FDA stated in its final ruling, the industry is indeed competitive, Hinsch says.

We try to be civil to each other and do the right thing, he says, but it is (laughing) very competitive. Theres a lot of infighting and trying to get that market share and make that sale and get the better product and so on. It takes a special mentality to even be in the glove business because its such a difficult product to sell.

Hinsch explains that it can take two years to convince a consumer to buy a new brand. Business may be cut throat at times, but Hinsch still respects his competitors.

I find that the other manufacturers are good people and they try to do the right things, he says. I wouldnt point any fingers at other manufactures and say, boy they are really bad people. I do believe some manufacturers are trying to do more than others but I believe that everybody is trying to do a good job.

He added that he cant speak for foreign-based manufacturers since he isnt well acquainted with them. Most, if not all, domestic companies manufacture in other countries, but are still based in the U.S.

There is sometimes a communication lapse between domestic and foreign-based glove producers and their product suppliers, and that gap can lead to problems, Drummond says. In a global market it helps to have consistent standards. He adds that the FDAs recent lowering of its AQLs for the glove industry helps a little since the levels are now synchronized with the ISOs and ASTM Internationals standards.

Everybodys trying to have one book that were reading out of, so to speak, Drummond says.

The FDAs test requests are mostly random and are often contracted to independent testing facilities. The current cost of conducting the patient examination and surgical glove tests at manufacturing sites is about $310 per lot, the FDA reports. The new quality levels will likely tack another $45 to that price. In the end, its worth it, Hensch and Drummond say. The results probably wont be perfect, but theyll be a few steps closer. 


Reference:

1. Department of Health and Human Services, Food and Drug Administration, 21 CFR Part 800, Docket No. 2003N-0056, Medical Devices; Patient Examination and Surgeons Gloves; Test Procedures and Acceptance Criteria. Federal Register. Dec. 19, 2006.

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