BD Launches Fully Sterile Surgical Skin Preparation

Skin antiseptic products are used to reduce bacterial burden on skin prior to performing invasive medical procedures, such as injections or surgical incisions. In this role, skin antiseptics, including alcohol, iodine, and chlorhexidine gluconate (CHG), are part of the frontline in infection control. [i],[ii],[iii],[iv],[v]

As our understanding of factors leading to infection has evolved, so have antiseptics and aseptic technique. The goal of any aseptic procedure is to reduce the risk of contamination by pathogens that are prevalent on the skin and in the environment. Appropriately, it is standard practice to use sterile instrumentation and take great care to prevent contamination from the surrounding environment. However, only recently has the antiseptic solution itself been investigated as a possible source of contamination.[i]

In a survey, 92% of healthcare providers indicated they were not aware that antiseptic solutions are not sterile.[vi] Sterile means free of microorganisms (any microscopic organism such as bacteria), and sterile products are treated with a process during manufacturing to eliminate potential microorganisms.

The idea of contaminated antiseptic solutions goes against common perception because the primary function of an antiseptic is to kill bacteria. Yet, antiseptics are not “self-sterilizing,” and bacteria can persist for prolonged periods of time within antiseptic products. Unfortunately, numerous outbreaks have occurred worldwide as a result of antiseptics contaminated with persistent bacteria.[i],[vii] In 2007, a review article summarizing over 50 years of documented patient infections was published. It showed how infections were caused by various contaminated germicides, including patient skin antiseptics and surface disinfectants.[i]

In 2010, an outbreak of patient infections occurred as a result of contaminated alcohol prep pads. In 2013, the U.S. Food and Drug Administration (FDA) reported that all commonly used antiseptic categories have been linked to infection-causing contamination.[viii] Documented results included:

• Bacteremia in 32 cases
• Wound infection in five cases and peritonitis in seven cases
• Replacements required for indwelling catheters in 14 cases
• Sepsis in two cases
• Infection of the injection site in 16 cases
• Death of five patients due to B. cereus
• Product recalls of alcohol prep pads following 40 out of 60 testing positive for B. cereus

Outcomes associated with contaminated antiseptics may be underreported for a range of reasons, including[i]:

• Disposal of the contaminated product before infection is discovered
• Inconsistent contamination within the same product lot

Manufacturers are not required to sterilize antiseptics so the risk of bacterial contamination continues to exist; however, sterile and nonsterile labeling allows healthcare professionals to make informed decisions. The majority of preoperative skin preparation components (applicators, sponges, ampoules) are sterilized using an ethylene oxide chemical process; however, the solution itself is nonsterile. CHG is a thermally sensitive compound.[ix] While heat exposure during terminal sterilization would sterilize the solution, it will also damage its chemical integrity. Thus, any terminal sterilization process must balance the integrity of the CHG molecule (i.e., strength and purity) while achieving thermal exposure conditions necessary for sterilization.

Standard belief, among most manufacturers, is that it is impossible and impractical to sterilize CHG-based antiseptics on a scale large enough to fulfill surgical needs in the U.S.[x] Contrary to this thinking, BD (Becton, Dickinson and Company) (NYSE: BDX) researched and developed a patented sterilization process to achieve the temperature control, precision and scale necessary to effectively sterilize CHG.

As antiseptics have evolved to reduce bacterial threats, this new sterilization technology has allowed BD to bring a fully sterile skin preparation option to healthcare providers. BD invested significant resources and research hours to create a patented sterilization process to achieve a minimum sterility assurance level (SAL) of 10-6.[xi]

“We invested six years of effort, more than 50,000 research and development hours and millions of dollars to develop the only commercially available sterile CHG skin antiseptic, because we knew it was the right thing to do for patient safety,” said Gary M. Cohen, Executive Vice President, Global Health, and President, BD Foundation.

BD ChloraPrep™ Patient Preoperative Skin Preparation with sterile solution is the only commercially available patient preoperative skin antiseptic in the U.S. that combines:

• FDA-approved dual formulation of 2% chlorhexidine gluconate (CHG) + 70% isopropyl alcohol (IPA)
• Packaged in a proprietary one-step, single-use sterile applicator
• CHG-based sterile antiseptic solution

The result is BD ChloraPrep™ Patient Preoperative Skin Preparation with sterile solution which builds on the proven history of ChloraPrep™ and its over 4 billion applicators used to date, more than any other 2% CHG/70% IPA skin prep applicator. ChloraPrep™ is supported by more than 50 peer-reviewed publications demonstrating its efficacy in driving patient safety and better clinical outcomes.

[i] Chang C, Furlong LA. Microbial stowaways in topical antiseptic products. N Eng J Med. 2012;367;23:2170-2173. doi: 10.1056/NEJMp1212680.

[ii] Poole K. Bacterial stress responses as determinants of antimicrobial resistance. J Antimicrob Chemother. 2012;67:2069–2089. doi:10.1093/jac/dks196.

[iii] Hijazi K, Mukhopadhya I, Abbott F, et al. Susceptibility to chlorhexidine amongst multidrug-resistant clinical isolates of Staphylococcus epidermidis from bloodstream infections. Int J Antimicrob Agents. 2016;48(1):86-90. Doi 1016/j.ijantimicag.2016.04.015.

[iv] Tansirichaiya S, Reynolds LJ, Cristarella G, et al. Reduced susceptibility to antiseptics is conferred by heterologous housekeeping genes.Microb Drug Resist. 2017. doi: 10.1089/mdr.2017.0105.

[v] Rose H, Baldwin A, Dowson CG, et al. Biocide susceptibility of the Burkholderia cepacia complex. J Antimicrob Chemother. 2009;63(3):502–510. doi:10.1093/jac/dkn540.

[vi] BD, data on file.

[vii]Weber DJ, Rutala WA, Sickbert-Bennett EE. Outbreaks associated with contaminated antiseptics and disinfectants. Antimicrob Agents Chemother. 2007;51(12):4217–4224. doi: 10.1128/AAC.00138-07.

[viii] FDA Drug Safety Communication: FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infection. Food and Drug Administration website. http://www.fda.gov/drugs/drugsafety/ucm374711.htm. Published November 13, 2013. Updated February 29, 2016. Accessed July 31, 2019.

[ix]Zong Z, Kirsch L. Studies on the instability of chlorhexidine, part I: Kinetics and mechanisms. J Pharm Sci. 2012;101(7):2417–2427. doi: 10.1002/jps.23151.

[x] Pyrek KM. Sterility of antiseptic products: FDA investigates, deliberates on potential recommendations. Infection Control Today website. https://brnskll.com/wpcontent/uploads/2013/12/FDA-investigates-Antisepti.... Accessed April 20, 2019.

[xi] Degala, et al. United States Patent 9,078,934. July 14, 2015.