Well, this is ironic. The Food and Drug Administration is warning the country of the possibility of health care infections caused by the antiseptics used to disinfect skin before health care procedures — that is, to prevent infections. They consider it a serious enough problem that they have scheduled a hearing about it next week.
In this week’s New England Journal of Medicine, Drs. Christina Y. Chang and Lesley-Anne Furlong of the FDA’s Center for Drug Evaluation and Research explain that pre-operative antiseptics have never been examined for infection risk. They were grandfathered into FDA approval because they were on the market long before the FDA began assessing such products, as a result of expert testimony that they would kill any microbes that contaminated them. That assumption turns out to have been incorrect. The authors say:
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.
Here are just a few of the outbreaks caused recently by contaminated antiseptics:
- In 2010-11, patients at a children’s hospital developed serious infections from alcohol wipes contaminated with Bacillus cereus.
- In 2009, patients at an allergy clinic developed abscesses wherever they got allergy shots, due to Mycobacterium abscessus contamination in a benzalkonium chloride wash used to prep their skin.
- Between 1996 and 1999, 28 infants in intensive care were made seriously ill, and one died, as a result of Klebsiella oxytoca that survived in a formaldehyde-based disinfectant used to wash down ICU equipment.
In fact, two review articles, published in different journals in 2003 and 2007, 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.
And those counts are probably an underestimate. Chang and Furlong say:
Although the scope of nosocomial infections associated with contaminated antiseptic products is difficult to assess, it is most likely broader than has been indicated by postmarketing reports and the medical literature. Several factors may limit the identification of infections related to antiseptic products. Health care providers may not consider these products as a potential source of postprocedural infection because they assume that antiseptic properties preclude microbial survival. Cases of contamination might be under-reported, since epidemiologic investigation and infection workups require a high index of suspicion on the part of the treating clinician. In addition, single-use containers are typically discarded at the conclusion of a surgical procedure, so the residual product may not be available for investigation when an infection becomes apparent.
This issue has obviously been building for a while, but honestly it’s new to me, and somewhat jaw-dropping. With all that is truly difficult to accomplish in health care infections, from detecting multi-drug resistant organisms to instituting surgical checklists, one might think that the safety of things intended to keep patients safe would have been long since assured. But, no. So, credit at least, I guess, for it being taken up now.
The hearing on the issue takes place in Silver Spring, Md. next Wednesday and Thursday. The FDA’s page of details on it is here and the Federal Register notice is here. Note, if you have a story to tell of contamination or infection related to such products, and you can get to Silver Spring, you can sign up to speak at the meeting. The deadline for signing up is today, Dec. 7, and the address to email is: CDER-AntisepticPreOpPublicMeeting@fda.hhs.gov.
Cite: Chang, CY and Furlong LA. Microbial Stowaways in Topical Antiseptic Products. N Engl J Med 2012; 367:2170-2173. DOI: 10.1056/NEJMp1212680
