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A sterile applicator for a non-sterile solution: Making sense of new FDA requirements


by Allan J. Morrison, M.D.


ealth care providers, hospitals, am- bulatory surgical centers (ASCs), and professional and government bodies agree that reducing infection rates is vital to improve patient care. Data sug- gest that 700,000 to 1.7 million people will contract a health care-associated infection (HAI) annually1 as a result2


H and nearly 100,000 will die , even though it is estimated that


at least 50 percent of HAIs are preventable.3, 4 Even though significant effort is made to control infection, it is now understood antiseptic products and applicators, themselves, may be contaminated with microbial organisms5


, which is why in


December 2012, the U. S. Food and Drug Administration (FDA) held a public meeting to gather comments regarding microbial adulteration of antiseptic prod- ucts indicated for preoperative or pre- injection skin preparation. The FDA also published an article in the New England Journal of Medicine6


to raise awareness of


the issue. As a result, in 2013, the FDA re- quested manufacturers of over-the-counter topical antiseptics voluntarily update their products in an ongoing effort to improve patient safety. The modifications included a request that manufacturers use single-use packaging and revise product labels to indicate whether the antiseptic solution contained within the product and applicator are sterile or non-sterile for patient preoperative and pre-injection skin preparation.


ChloraPrep: The first priority is patient care Understanding the need to always put patient safety first, CareFusion quickly ad- hered to the FDA’s request by voluntarily revising product labels for its ChloraPrep™ line of topical antiseptics. Before addressing the impact of this change, it’s important to examine the des- ignation of sterile or non- sterile for skin antiseptic products. First and foremost, it is critical to understand that a product labeled as non-sterile does not suggest that it is contaminated with microorganisms;


What quality control testing is performed on ChloraPrep applicators?


Every manufactured lot of ChloraPrep applicators undergoes extensive testing before being released for use. • Chemical testing to test the concentration and purity of the chlorhexidine, isopropyl alcohol and water used to formulate ChloraPrep.


• Applicator integrity to test the physical integrity of the applicator, the internal ampoule and foam sponge; also tested is applicator sterility to ensure effectiveness of our Ethylene Oxide treatment.


• Package testing to test the integrity of the applicator packaging, ensuring that a sterile barrier is formed and maintained for at least 3 years.


instead, it simply means that its solution has not been sterilized individually. Though all ChloraPrep applicators are sterilized at the end of the manufacturing process, the solution inside of the applicators is not treated with a separate sterilization process and, therefore, is not deemed sterile by the FDA’s definition. Unless a product says “sterile solution” on the label, health care professionals should be aware that they are using a non-sterile solution product. Currently, there are no sterile chlorhexi- dine gluconate-based (CHG) products, because an efficient method does not exist to sterilize these antiseptic solutions on a large scale. Instead, the FDA recommends manufacturers take precautions to reduce the risk of intrinsic contamination, such as following current good manufacturing processes (cGMP). All ChloraPrep products are manufac-


tured in cGMP facilities and ChloraPrep applicators undergo an ethylene oxide (EtO) gas treatment at the end of the manu- facturing process. This kills any potential microbes found on the surface of the ap- plicator, sponge and packaging. The CHG/ IPA (chlorhexidine gluconate/isopropyl alcohol) solution inside the applicator does not get sterilized by EtO treatment, nor does it undergo a separate sterilization step and, therefore, is not sterile.


“As market leaders in skin antiseptics and infection prevention, we strongly believe it is CareFusion’s obligation to provide clinical education regarding ChloraPrep product enhancements in our


effort to be transparent with our customers and improve patient safety,” said Colleen Glynn, Senior Director of Marketing, CareFusion.


Recognizing the importance of prop- erly labeling its products to give health care professionals the most information possible for clinical decision making, CareFusion acted on the FDA’s recom- mendations because of its dedication to continuously improving patient safety and providing quality products to its custom- ers. It is important to note that ChloraPrep patient preoperative skin preparation has not changed and continues to be the trusted one-step, broad-spectrum antisep- tic that reduces bacteria on the skin that can cause infection. It is also the only FDA- approved formulation of 2% CHG and 70% IPA with a single-use applicator that has appeared in more than 20 peer-reviewed publications and shown to outperform other iodine-based products. HPN


References


1. Magill SS, et al. Multistate Point-Prevalence Survey of Health Care–Associated Infections. N Engl J Med 2014; 370:1198-1208. 2. Klevens RM, Edwards JR, Richards CL Jr, et al. Estimating health care associated infections and deaths in U.S. hospitals, 2002. Public Health Rep 2007; 122:160-166.


3. Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU.


N Engl J Med. 2006;355(26):2725-2732.


4. United States Centers for Disease Control and Prevention. Mak- ing health care safer: reducing bloodstream infections. http:// www.cdc.gov/VitalSigns/pdf/2011-03-vitalsigns.pdf. Accessed September 1, 2012.


5. Chang, C., Furlong, L. Microbial stowaways in topical antiseptic products. N Engl J Med, 2012, 367:2170–2173.


6. Chang, C., Furlong, L. Microbial stowaways in topical antiseptic products. N Engl J Med, 2012, 367:2170–2173.


www.hpnonline.com • HEALTHCARE PURCHASING NEWS • August 2015 29


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