Notification of FDA Study into the Safety and Efficacy of Skin Antiseptics

Healthcare antiseptic products used up to 100 times a day by clinicians must prove themselves to be safe and effective, especially over the long haul, to remain on the market under proposed regulations announced today by the US Food and Drug Administration (FDA).

The antiseptic products in question are found in hospitals, nursing homes, physician offices, clinics, and other outpatient settings. Their manufacturers would have to submit safety and efficacy data on 29 active ingredients, which include alcohol, iodine, phenol, and hexachlorophene.

The FDA is looking for information about, among other things, topical absorption, potential hormonal changes, possible bacterial resistance, and the effects, if any, on pregnant and breast-feeding healthcare workers.

The proposed regulations do not apply to consumer antiseptics such as antibacterial soaps and hand sanitizer rubs.

Today’s announcement could create cognitive dissonance for physicians, nurses, and other healthcare workers, who are urged to heed increasingly stringent infection control protocols. They include faithful use of hand washes and rubs, including those for surgeons, and preoperative skin preparations for patients, all of which come under the FDA proposal.

At a news conference today, an FDA official encouraged clinicians to stick to their infection-control habits and to continue using the antiseptic products with the 29 targeted ingredients. “We don’t believe they’re ineffective and unsafe,” said Theresa Michele, MD, director of the non-prescription drug department in the FDA’s Centre for Drug Evaluation and Research.

However, confirmatory studies are needed in light of changing infection control procedures, more frequent use of antiseptic products, new technology that can detect low levels of antiseptics in the body, and new findings about their effects, Dr Michele said. “Emerging science suggests that for some ingredients, systemic exposure is higher than previously thought.”

She added that her agency “thought long and hard” about the possibility of clinicians perceiving a mixed message on antiseptics.

“I think for healthcare workers, these [products] are critical elements of infection control,” Dr Michele said. “The fact that healthcare workers are now using these much more than they used to emphasizes why we need to gather this additional data.”

The 29 antiseptic active ingredients in question currently fall into the FDA regulatory category of GRASE, or generally recognized as safe and effective. The proposed regulations released today would require manufacturers to submit safety and efficacy data in the next 12 months to re-earn this stamp of approval. Meanwhile, the FDA will accept public comments on the proposed regulations for 180 days, followed by a 60-day rebuttal period. The agency then will evaluate the comments as well as the data from manufacturers and publish a final set of regulations that determine the GRASE status for each ingredient. Those that make the cut will stay on the market.

Two healthcare organizations have already weighed in favourably on the proposed FDA regulations.

“Since all infection prevention and control guidelines are evidence-based, it is important to stay up-to-date on safety and effectiveness data to protect healthcare personnel and their patients,” the Society for Healthcare Epidemiology of America and the Association for Professionals in Infection Control and Epidemiology said in a joint news release. They also said they agreed with the FDA that clinicians should continue to use antiseptic products while more data are gathered.

Comments from professionals involved in infection control

Dr Andrew K PhD

5pts Featured

In light of the recent reports that alcohol gels actually increase bacterial counts on hands over time, I hope they look at the effects of antiseptics over time as well as the instant gratification tests that are currently used.  One study showed an increase of almost 3 x more bacteria on hands after 1 hour than if the hands had just been washed with soap and water! Edit (in 1 minute)

Dr. Myrto A  Family Medicine
5pts Featured
We should definitely worry about Triclosan (antibacterial ingredient in soap and lotions).

http://www.ncbi.nlm.nih.gov/pubmed/23146048

Given the level of available information it could be a liability/worker’s comp issue.

Dr. Tami B General  Surgery
5pts Featured
I have had long-standing concerns regarding the use and rapid proliferation of such ‘aseptic’ chemicals in our healthcare system.

It is less expensive for hospitals to put in hand sanitizer pumps than it is to install sinks I suppose. But the threat to health is beyond obvious. My skin feels like it has a film on it after use. In many cases I develop a minor rash by the end of the day—until I can scrub it all off.

Many of these substances have been banned in European countries as they have been definitively linked to neuroendocrine disorders in children. In no way are these chemicals safe for pregnant physicians.

Perhaps any further study and investigation on safety and efficacy should be done in a multidisciplinary fashion—so we can trust the results.

R M  Registered Nurse (RN)
5pts Featured
(RN)Amen to Dr AF, Dr HG S,&AW. Wake up people!!! Who is the spin doctor paid to come up with this one?? Systematic levels already found. The MANUFACTURERS are submitting safety & efficacy data to FDA. “Those that make the cut will stay on the market”??? I wager they will all” make the cut” Please, healthcare professionals don’t be so naive as to believe this ruse is going to prove ANYTHING.(EXCEPT once again big pharma will win out over us in the trenches.) Anyone who might have negative data won’t have the funding &time (due to ridiculous restrictions ) to oppose this, especially nurses & even doctors. By the time anything is done to get these “unnamed” substances banned, how many of us will end up with CA or neuro issues or worse? Of course no one will have a clue about “How could this have happened? ”

Dr. H Gerhart S DO  Orthopaedic Surgery 5ptsFeatured

What are the chemicals they are studying?

Efficacy has been done on many of these in the past!

Are we going to rely on the manufacturer only? Fox guarding the chicken coop!

A W  Registered Nurse (RN)
5pts Featured
Oh you mean they’re finally going to determine if the crap we use on our hands all day long is a health hazard or not? After so many of us have used them for years? And some healthcare workers are now showing up with multiple chemical sensitivities? That’s OK though…the FDA will approve a pill for that. Carry on.