The FDA is considering whether manufacturers of single-use sterility products should upgrade plants to make their products in sterile conditions.
The agency next week will hold hearings in the Washington, DC, area to get input from manufacturers and healthcare professions. The concern reached a fevered pitch two years ago when bacteria-laden wipes were tied to the death of a Texas toddler who developed bacterial meningitis after surgery, NBC News reminds. That event was tied to the closure of plants operated by H&P Industries/Triad Group and the seizure of $6 million worth of alcohol wipes. The companies filed for Chapter 11 bankruptcy protection in August.
In a study published today in The New England Journal of Medicine, FDA researchers say contamination can occur during manufacturing or at the point of use. The study points out that requirements for manufacturing these products were developed in the 1970s when it was believed that the solutions in them would keep them from getting contaminated but that numerous reports since then show that is not always the case.
"Nothing is 100 percent. Bacteria are really diverse and they're adapted to living in different environments," Dr. Bruce Hirsch, an attending physician in infectious diseases at North Shore University Hospital in Manhasset, NY, tells HealthDay. He says he believes that the FDA "should require sterilized manufacturing whenever possible."
The agency has been alert to the problem among manufacturers. It recently issued an import alert against Jianerkang Medical Dressing, after an inspection found sterility issues with its antiseptic wipes. Wipes made by the Chinese company had to be recalled by Dukal when it was discovered that they might be contaminated with the bacteria Burkholderia cepacia.