Disinfect Med Devices Pt. 3

How to Properly Disinfect Reusable Medical Devices: Part III In Part II of “How to Properly Disinfect Reusable Medical Devices” (Novo blog 12/1/17) we discussed various disinfectants that are commercially available for use in healthcare facilities along with their intended uses. In Part III of this series we will continue our look at various FDA approved disinfectants. The goal of this series is to help you select appropriate disinfectants for your reusable medical devices and how to best use them in the most efficient way. In today’s fast-paced healthcare environment, “Operating rooms (ORs) demand quick turnover times for surgical instruments. Therefore, disinfectants and sterilants should support productivity in the CS/SPD. Fast contact times, ready-to-use solutions and products that don’t require activation prior to use not only simplify the disinfection and sterilization process but enable staff compliance, which is of utmost importance when reprocessing medical equipment.”¹ Chlorine: One of the more popular families of disinfectants is chlorine and chlorine compounds. Hypochlorites, the most widely used of the chlorine disinfectants, are available as liquid (i.e., sodium hypochlorite) or solid (i.e., calcium hypochlorite). The vast majority of chlorine products are diluted solutions of between 5.25% to 6.15% sodium hypochlorite. We recognize the majority of these products by their more commonly known name, household bleach. Most common, hospital approved bleaching agents exhibit a host of favorable properties. These properties include: a broad spectrum of antimicrobial activity; they are not impacted by water hardness; they do not leave toxic residues on the devices; they are inexpensive and fast acting². Additionally, they remove dried or fixed organisms and biofilms³, and they have a low incidence of serious toxicity^4-6. The broad-spectrum effectiveness of bleach is due to its chemical reactivity with microbes. After initial contact, it reacts rapidly with microbial cells to permanently denature and destroy many pathogens. The range of micro-organisms effectively killed by bleach, especially sodium hypochlorite, is quite extensive, making it a very versatile and useful disinfectant. As is the case with many disinfectants, sodium hypochlorite at the concentration used in household bleach can produce ocular irritation or oropharyngeal, esophageal, and gastric burns (7-10). Other disadvantages of hypochlorites include corrosiveness to metals in high concentrations (>500 ppm), inactivation by organic matter, discoloring or “bleaching” of fabrics, release of toxic chlorine gas when mixed with ammonia or acid (e.g., household cleaning agents), and relative stability^11-13. Formaldehyde is approved for use as a disinfectant and sterilant in both its liquid and gaseous states. If you are using formaldehyde based products, you need to know that OSHA has indicated that formaldehyde is a potential carcinogen. Accordingly, OSHA has set employee exposure standards for formaldehyde^14-15. It has also been demonstrated that long-term exposure to low levels of formaldehyde in the air or on the skin can cause respiratory problems and skin irritation. Additionally, ingestion of formaldehyde can be fatal. In light of these many issues with formaldehyde, employees should have limited direct contact with formaldehyde-based products. Glutaraldehyde is a saturated dialdehyde that has gained wide acceptance as a high-level disinfectant and chemical sterilant¹⁶. Aqueous solutions of glutaraldehyde are acidic and generally in this state are not sporicidal. Despite the wide-spread use of glutaraldehyde, like all disinfectants, it does have risks associated with its use. “Short term (acute) contact with glutaraldehyde liquid and vapor can cause severe eye irritation, skin burns, and irritation to the nose, throat and respiratory tract, coughing wheezing, nausea, headaches, drowsiness, nosebleeds and dizziness. Long term (chronic) glutaraldehyde exposure can lead to occupational asthma, skin allergy and chronic eczema.”¹⁷ In order to use the sporicidal properties of glutaraldehyde, you must activate it by the use of alkalinating agents. Once you activate a glutaraldehyde solution, the solution will usually have a shelf-life of two weeks or more. Shelf-life will vary among different brands, formulations and concentrations of glutaraldehyde so you must always consult the manufacturer’s labeling. When it comes to using any type or brand of disinfectant, always check the manufacturer’s IFU to ensure that the IFU has been validated by an independent testing laboratory using AAMI and FDA recommended validation testing protocols. Without independently validated IFUs, you will have no way of knowing that your medical devices won’t be damaged by the disinfectant and that your employees will not suffer an adverse reaction from its use. Read Part 4 here 1. Nadeau K., Connecting the dots, removing the spots. HPN November 20, 2017 2. Rutala WA, Weber DJ. Uses of inorganic hypochlorite (bleach) in health-care facilities. Clin. Microbiol. Rev. 1997; 10:597-610. 3. Merritt K, Hitchins VM, Brown SA. Safety and cleaning of medical materials and devices. J. Biomed. Mater. Res. 2000; 53:131-6. 4. Jakobsson SW, Rajs J, Jonsson JA, Persson H. Poisoning with sodium hypochlorite solution. Report of a fatal case, supplemented with an experimental and clinico-epidemiological study. Am. J. Forensic Med. Pathol. 1991; 12:320-7. 5. Heidemann SM, Goetting MG. Treatment of acute hypoxemic respiratory failure caused by chlorine exposure. Pediatr. Emerg. Care 1991; 7:87-8. 6. Hoy RH, Accidental systemic exposure to sodium hypochlorite (Clorox) during hemodialysis. Am. J. Hosp. Pharm. 1981; 38:1512-4. 7. Landau GD, Saunders WH. The effect of chlorine bleach on the esophagus. Arch. Otolaryngol. 1964; 80:1746. 8. French RJ, Tabb HG, Rutledge LJ. Esophageal stenosis produced by ingestion of bleach: report of two cases. South. Med. J. 1970; 63:1140-4. 9. Ward MJ, Routledge PA. Hypernatraemia and hyperchloraemic acidosis after bleach ingestion. Hum. Toxicol. 1988; 7:37-8. 10. Ingram TA. Response of the human eye to accidental exposure to sodium hypochlorite. J Endodontics 1990; 16:235-8. 11. Mrvos R, Dean BS, Krenzelok EP. Home exposures to chlorine/chloramine gas: review of 216 cases. South. Med. J. 1993; 86:654-7. 12. Reisz GR, Gammon RS. Toxic pneumonitis from mixing household cleaners. Chest 1986; 89:49-52. 13. Gapany-Gapanavicius M, Yellin A, Almog S, Tirosh M. Pneumomediastinum. A complication of chlorine exposure from mixing household cleaning agents. JAMA 1982; 248:349-50. 14. NIOSH. Formaldehyde: evidence of carcinogenicity. NIOSH Current Intelligence Bulletin 34. DHEW (NIOSH) Publication No. 81-111. 1981. 15. Occupational Safety and Health Administration. OSHA amends formaldehyde standard. Occupational Safety and Health News 1991:1. 16. Cheung RJ, Ortiz D, DiMarino AJ, Jr. GI endoscopic reprocessing practices in the United States. Gastrointest. Endosc. 1999; 50:362-8. 17. Nadeau K., Op cite