by David Pittman, Washington Correspondent, MedPage Today
Published: December 13, 2012
WASHINGTON — Requiring that antiseptic skin preparation products be sterile — a standard not currently mandated by the FDA — is unnecessary and wouldn’t produce a dramatic drop in infections, manufacturers, clinicians, and policy analysts told the FDA Wednesday.
The requirement would instead cause undue burden for companies, manufacturers said at a public hearing on the issue hosted by the FDA.
Topical antiseptic products are used before surgery, before an injection, or to reduce the risk of skin infection, but some have been recalled recently because of microbial contamination. There have been roughly 40 reports of contaminated antiseptic products submitted to the FDA, noted Joyce Ryan, DNP, director of clinical affairs at Sage Products in Cary, Ill., which makes antiseptic products.
To address the issue, the FDA is examining ways to reduce the risk of contamination and the patient complications and infections that could follow.
But it’s hard to trace the source of a surgical site infection, if not impossible. For example, patients’ skin carries a large number of bacteria that hold a great risk of causing infection.
“We live in a bacterial world,” said John Thomas, PhD, pathology professor at the West Virginia University School of Medicine in Morgantown. “Bug presence in a solution doesn’t mean it’s going to be a problem downstream for the patient.”
There is also no data suggesting non-sterile products have resulted in an infection or that sterile products have proven safer, said Ryan.
“It’s important to note that nonsterile doesn’t imply contaminated,” Ryan said, adding that the product is still clean.
The FDA noted Wednesday that the lack of studies on sterile antiseptic products shouldn’t translate to them not being safer.
Bhaveen Kapadia, MD, from Sinai Hospital in Baltimore, Md., presented data from a study the hospital did internally that found no infections in patients who were treated with chlorhexidine cloths before an operation compared with six infections among patients who didn’t receive the skin prep. Their prospective, randomized trial involved 180 patients.
Forcing more stringent standards on antiseptics would cause more disruption for providers and manufacturers than it would bring in patient benefit, several speakers said. For example, Sage said it would have to completely redesign its facilities to properly manufacture sterile products, a costly requirement for the company.
Instead, providers and clinicians need to focus on education and proper use of antiseptic products, said Hudson Garrett, PhD, senior director of clinical affairs at Professional Disposables, an antiseptic products maker in Orangeburg, N.Y. Too often, products aren’t used as directed or intended, he noted.
“It doesn’t matter who the provider is,” Garrett said. “We need to focus more on the appropriate use of these products.”
Clinicians who want to reduce infections can focus on a number of areas they can control — such as patient nutrition and prolonged hospital stays, he added.
Michelle Stevens, MD, medical director of the 3M Company’s infection prevention division, said the FDA needs to enforce its current manufacturing regulations to better prevent product contamination.
Jennifer Yttri, PhD, senior fellow at the National Research Center for Women & Families in Washington, noted there’s a general lack of awareness from providers that these types of products aren’t sterile.
“We need to have better communication that a product is not sterile,” Yttri said, adding that could come from product labeling.
The biggest problem comes from multi-use solutions used outside of the operating room, the FDA said Wednesday.
In that instance, contamination can be passed from one patient to another. “You’re creating an additional route for contamination,” Garrett said.
This week isn’t the first time in recent history the FDA has tried to address this issue.
In August 2009, an FDA advisory committee discussed whether products used on non-intact skin should be required to be produced in sterile conditions. Committee members looked at cost, effects on the active drug ingredients and the product packaging, and uncertainties about the scope of the problem, but did not make a final determination.