The FDA is warning that there is a possibility of health care-related infections caused by the antiseptics, which are supposed to prevent infections, used to disinfect skin before health care procedures.
In the New England Journal of Medicine¹, Drs. Christina Y. Chang and Lesley-Anne Furlong of the FDA’s Center for Drug Evaluation and Research explain that pre-operative antiseptics had never examined for infection risks. They were grandfathered into FDA approval because they had been on the market long enough before the FDA began assessing such products. The authors state, “The reported outcomes range from localized infections at injection sites to systemic infections resulting in death. The reports implicate all commonly used antiseptic categories, including alcohol, iodophors, chlorhexidine gluconate, and quaternary ammonium products.”
Review articles in different journal list dozens of cases over decades in which disinfectants and antiseptics were contaminated either during manufacture and packaging, or as a result of being mixed or stored once they reached a health care institution.
The New England Journal of Medicine article states that nosocomial infections associated with contaminated antiseptic products are difficult to assess. Several factors may limit the identification of infections related to antiseptic products as health care providers do not consider these products as a source of potential post-procedural infection. It’s always been assumed that antiseptic properties preclude microbial infection.
- Chang, C. Y, et al., Microbial Stowaways in Topical Antiseptic Products. N Engl J Med 2012; 367:2170-2173. DOI: 10.1056/NEJMp1212680