Evidence suggests that patient bathing in the acute care setting, particularly when combined with proper medical device insertion and removal protocols, may reduce infection risk.1 The rationale is a logical one: Billions of microorganisms, including the “good” commensals and the “bad” pathogens, reside on our skin.2 A compromised immune system, breakdown in the skin barrier, or portal of entry through a medical device can all lead to an infection caused by those microorganisms. Thus, proper bathing to reduce the bioburden on the skin may mitigate that infection risk.

Do your bathing products put patients at risk? Find out more.

Some of the most common products used for patient bathing in the acute care setting are topical antiseptics. When topical antiseptic products were first brought under the regulatory purview of the FDA in the 1970s, it was assumed that antimicrobial products were essentially “sterile” because of the inherent pharmacologic activity of the drug.3 We now know that is far from the case. An unfortunate and ironic reality is that the very products we use to try to reduce that risk may in fact themselves be a vehicle for infection.

Contaminated Topical Antiseptics
Since the early 2000s, a number of infection outbreaks have been linked to contaminated topical antiseptic products. Causative organisms have included Burkholderia cepaciaa, Pseudomonas aeruginosa, Achromobacter xylosoxidans, Bacillus cereus, Ralstonia pickettii, Serratia marcescens, and Mycobacterium abscessus, among others.3

According to the FDA, “Reported outcomes ranged from localized infections at injection sites to more widespread infections resulting in death.”4 As of 2015, “FDA has reviewed reports of:

  • four deaths
  • five cases of wound infection
  • seven cases of peritonitis
  • 10 cases of septic arthritis
  • 14 cases of indwelling catheters requiring replacement
  • 16 cases of injection site infection, and
  • 32 cases of bacteremia.

These infections have been confirmed to be caused by contaminated antiseptic products.”4

FDA Response
In each infection outbreak where the product contamination was found to have occurred during the manufacturing process, the FDA has issued recalls for the relevant product.3 Furthermore, because contamination of topical antiseptics can occur both during the manufacturing process (intrinsic) and during handling by the end user (extrinsic), in 2013 the FDA began requiring that manufacturers of over-the-counter topical antiseptics make two changes:4

  1. Use single-use packaging to minimize the risk of end-user product contamination.
  2. Label product sterile or nonsterile to inform healthcare providers of the potential for contamination from the manufacturing process.

The FDA considered a mandate for sterile manufacturing of topical antiseptics; however, they did not come to a final decision, in part over concerns that the sterilization process might adversely affect “the purity and quality of active ingredients.”4 Sterilization can generate free radicals in some antimicrobials, affecting their pharmacologic activity and pharmacokinetic properties.5 For example, a common antiseptic—chlorhexidine gluconate (CHG)—is unstable to gamma irradiation, one of the most widely-used means of sterilization.6,7

Theraworx Protect: A Gamma-Irradiated Solution
Theraworx Protect* is a non-drug solution that has met the non-inferiority threshold as an appropriate clinical, cross-referenceable solution necessary for high-acuity ICU bathing. To maintain consistency and help ensure patient safety, every Theraworx Protect product is treated with gamma irradiation and tested via the USP 51 preservative challenge test method. Additionally, each Theraworx Protect product is stable for a 3-year shelf life.

To learn more about how you can protect your patients, contact us at Theraworx Protect.

*Theraworx Protect is not a replacement for CHG surgical-site preparation wipes.


  1. Sturgeon LP, Garrett-Wright D, Lartey G, Jones S, Bormann L, House S. A descriptive study of bathing practices in acute care facilities in the United States. Am J Infect Control 2019; 47(1): 23-6.
  2. Sender R, Fuchs S, Milo R. Revised estimates for the number of human and bacteria cells in the body. PLoS Biol 2016; 14(8): e1002533.
  3. Chang CY, Furlong LA. Microbial stowaways in topical antiseptic products. N Engl J Med 2012; 367(23): 2170-73.
  4. U.S. Food and Drug Administration. Questions and answers: FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infection. 2015. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-fda-requests-label-changes-and-single-use-packaging-some-over-counter-topical. Accessed 29 October 2019.
  5. Wilczynski S, Pilawa B, Koprowski R, Ptaszkiewicz m, Swakon J, and Olko P. Free radicals properties of gamma-irradiated penicillin-derived antibiotics: piperacillin, ampicillin, and crystalline penicillin. Radiat Environ Biophys. 2014;53(1):203–210.
  6. In: Block SS, ed. Disinfection, Sterilization, and Preservation. 5th edition. Philadelphia, PA: Lippincott, Williams & Wilkins; 2001: 323.
  7. 3M Company. 3M Steri-Drape CHG Antimicrobial Incise Drape [510(k) Summary]. U.S. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf14/K140250.pdf 23 July 2014. Accessed 28 October 2019.