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.