On The Quick
Evaluating manufacturer claims about antibacterial products
With all the concern about hospital-acquired infections (HAIs), some manufacturers have begun offering a diverse array of antimicrobial products aimed at hospitals and healthcare workers, including everything from bacteria-resistant mattress covers to antibacterial scrubs.
That might sound like a great idea, but before you replace your work wardrobe, you may want to investigate what federal regulators have to say about these products.
THE FDA AND MEDICAL DEVICES
Ordinarily, consumer products and clothing like scrubs or a stylish new pair of clogs wouldn’t come under the scrutiny of the Food and Drug Administration. However, that can change in a hurry if the manufacturer claims the product can help prevent the spread of HAIs.
Any product that purports to cure or prevent disease is subject to FDA regulation. Depending on the product and how it works, the FDA may classify it as a drug, a medical device or a combination product (a device combined with a drug). Antimicrobial shoes designed to prevent nurses from tracking disease-causing bacteria from room to room might qualify as a device while a medicated bandage would probably be considered a combination product.
The FDA’s requirements for medical devices and combination products vary greatly depending on how much risk the products present to users and whether or not there are already similar products on the market. In general, however, manufacturers of any product that advertises medical or health-related claims must register with the FDA and submit information about the product before putting it on sale.
FDA registration is only one side of the regulatory coin. If you read the brochures or ads for a new antimicrobial product, you may also see a note indicating that the product is approved by the Environmental Protection Agency.
That’s because products that kill or inhibit the growth of microorganisms — including bacteria and viruses — are classified as pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). FIFRA requires manufacturers to register such products with the EPA and demonstrate that they don’t pose an unreasonable hazard when used as directed.
Clothing and other products treated with properly registered pesticides are generally exempt from FIFRA as long as the manufacturer doesn’t claim (or imply) that the treated product provides any public health benefit. For example, if a manufacturer claims that its new clogs have an antibacterial lining that reduces unpleasant odors, the shoes would likely be exempt from FIFRA because reducing odors isn’t a public health claim.
It’s a different story if the manufacturer claims those clogs can also reduce the spread of HAIs. Preventing disease is a public health claim, so the manufacturer would need to register the shoes with the EPA and submit proof of those claims. Failing to do so can mean
The EPA takes this requirement very seriously. Earlier this year, the agency ordered four Florida companies — EcoActive Surfaces, Inc.; WellShield, LLC; BioRelief, Inc.; and Nano Defense Solutions, Inc. — to stop selling antimicrobial products whose advertising allegedly made unregistered public health claims.
As we all know, there are countless products on the market that imply all sorts of health benefits only to resort to cautious
disclaimers in the fine print. Some of those products might still be beneficial — but on the other hand, they might not be.
Evidence-based practice is an essential part of modern nursing. You don’t make major changes in your practice just because someone thinks it would be a good idea; you want to see clinical evidence. By the same token, if a manufacturer really believes their product can do a better job of stopping the spread of infections than just proper laundry techniques, it seems reasonable to expect the manufacturer to prove it before you lay your money down — especially where that proof is required by law.
How To Research Manufacturer Claims Filed With the FDA and EPA
FDA: FINDING THE 510(K)
For most noninvasive, low- to moderate-risk medical devices and combination products, manufacturers must submit what’s called a Premarket Notification, or 510(k), that lists any claims for the product, the indications for use and whether there are any comparable FDA-registered products already on sale. (The FDA uses these to help classify how risky a new product is likely to be. Products with no obvious precedent may be subject to additional scrutiny, although the manufacturer can ask the FDA for “De Novo” classification in a lower risk class.)
Filing a 510(k) does not mean that a particular product has been reviewed or approved by the FDA; the tougher Premarket Approval (PMA) process is generally reserved for high-risk products like implanted devices. A 510(k) just means that the manufacturer has duly registered its health-related claims. However, 510(k), De Novo, and PMA filings provide a way for consumers to find out just what representations, if any, a manufacturer may have made to the FDA.
How can you find out if the maker of those new antimicrobial scrubs you’re trying on has registered the product with the FDA? First, go to the 510(k) Premarket Notification database at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm and search for the name of the product (in the Device Name field) or the manufacturer (in the Applicant Name field). If the search returns any results, click on each result and then click “Summary” to see a copy of the 510(k) in PDF format.
If you don’t find anything, you can also try your search in the De Novo database at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm and the PMA database at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. (It seems unlikely that something like antimicrobial clothing would be deemed high-risk enough to require PMA, but it doesn’t hurt to check.)
You can also check the Establishment Registration & Device Listing database at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm to see if the manufacturer has registered with the FDA. If not, any medical claims the manufacturer makes about any product it sells could land them in hot water. Selling medical devices or drugs without first registering with the FDA is against the law.
EPA: FINDING THE REGISTRATION
To find out what claims a manufacturer has registered with the EPA for a particular product, you can look up the product name or EPA registration number on the National Pesticide Information Retrieval System at ppis.ceris.purdue.edu.
Clicking on the small EPA logo next to any result will allow you to view the product’s EPA registration in PDF format, including any claims and any stipulations the agency may have added. A common one for antimicrobial products is a warning to manufacturers not to advertise any benefits beyond the ability to protect that specific product or item from odor or deterioration.
This article is from workingnurse.com.