Citation Information :
Mishra VV, Solanki SB, Mishra N, Dhiman AS. How Accurate Are We When It Comes to the Reprocessing and Reuse of Gynecological Equipment?. J South Asian Feder Obs Gynae 2023; 15 (4):480-485.
Despite high per capita income and strong health insurance coverage, healthcare is expensive for a sizable section of the population. Reprocessing of devices began in the late 1970s in an effort to lower procedure costs. Reprocessing involves a number of steps, including appropriate cleaning, disinfection, and sterilization techniques. Reprocessing has the potential to compromise patient safety due to cross-contamination following insufficient sterilization because it is intended to save costs. During the sterilization/disinfection processes, there is also a chance that the reconditioned equipment would work differently. Therefore, it is necessary to provide appropriate criteria to choose reprocessing procedures for diverse gynecological equipment. Additionally, it is important to talk about and resolve the issues that gynecologists confront. In September 2022, a PubMed search was conducted using several search terms, including “recycling of medical devices”, “Single Usage Devices”, “methods of reprocessing of equipment in medical practice”, “use of formalin chamber”, “gynecological disposable disinfection”, etc. All English articles were checked by title and abstract after duplicates were eliminated. After obtaining the whole contents of a few articles, we checked them against other connected articles to see if there were any. The articles were all examined. A product can be reused if it can be cheaply treated again using methods that have been proven effective while maintaining its functionality. After one use, it does not need to be thrown away. This procedure helps to limit the cost of a gynecological case and lessens the financial load. Food and Drug Administration regulations now in effect are rigorous. In medical practice, the contamination that is used to assess the sterilizing procedure is never truly present. New regulations that take the clinical research scenario into account are therefore preferred.
Crawford TC, Eagle KA. Reuse of catheters and devices labelled for single use: Evidence, recommendations and oversight. Heart Asia 2018;10(2):e011033. DOI: 10.1136/heartasia-2018-011033.
Greene VW. Reuse of disposable devices. In: Mayhall CG, editor. Infection Control and Hospital Epidemiology. Philadelphia: Lippincott Williams and Wilkins; 1999. pp. 1201–1208.
Vandenberk T, Storms V, Lanssens D, et al. A vendor-independent mobile health monitoring platform for digital health studies: Development and usability study. JMIR Mhealth Uhealth 2019;7(10):e12586. DOI: 10.2196/12586.
Holzmüller-Laue S, Göde B, Stoll R, et al. A highly scalable information system as extendable framework solution for medical R&D projects. Stud Health Technol Inform 2009;150:101–105. PMID: 19745275.
Arankalle VA, Gandhi S, Lole KS, et al. An outbreak of hepatitis B with high mortality in India: Association with precore, basal core promoter mutants and improperly sterilized syringes. J Viral Hepat 2011;18(4):e20–e28. DOI: 10.1111/j.1365-2893.2010.01391.x.
Ling ML, Ching P, Widitaputra A, et al. APSIC guidelines for disinfection and sterilization of instruments in health care facilities. Antimicrob Resist Infect Control 2018;7:25. DOI: 10.1186/s13756-018-0308-2.
Leichsenring ML, Psaltikidis EM, de Oliveira Figueiredo MJ, et al. Conception and validation of a protocol for reuse of non-irrigated electrophysiology catheters in a Brazilian teaching hospital. J Interv Card Electrophysiol 2018;51(1):45–50. DOI: 10.1007/s10840-017-0301-3.
Society of Gastroenterology Nurses and Associates, Inc. Reprocessing of endoscopic accessories and valves. Gastroenterol Nurs 2010;33(2):139–140. DOI: 10.1097/SGA.0b013e3181d92b32.
Spaulding EH. The role of chemical disinfection in the prevention of nosocomial infections. In: Brachman PS, Eickoff TC, editors. Proceedings of the International Conference on Nosocomial Infections, 1970. Chicago: American Hospital Association; 1971. pp. 254–274.
Spaulding EH. Chemical disinfection of medical and surgical materials. In: Lawrence C, Block SS, editors. Disinfection, Sterilization, and Preservation. Philadelphia: Lea and Febiger;1968. pp. 517–531.
Pflug IJ. Microbiology and Engineering of Sterilization Processes, chapter 1–3. 7th edition. Minneapolis: Environmental Sterilization Laboratory; 1990.
Rutala WA, Weber DJ. FDA labeling requirements for disinfection of endoscopes: A counterpoint. Infect Control Hosp Epidemiol 1995;16:231–235. DOI: 10.1086/647095.
Lewis DL, Arens M. Resistance of microorganisms to disinfection in dental and medical devices. Nat Med 1995;1(9):956–958. DOI: 10.1038/nm0995-956.
Muscarella LF. Sterilizing dental equipment. Nat Med 1995;1(12):1223–1225. DOI: 10.1038/nm1295-1223b.
Vickery K, Pajkos A, Cossart Y. Removal of biofilm from endoscopes: Evaluation of detergent efficiency. Am J Infect Control 2004;32(3):170–176. DOI: 10.1016/j.ajic.2003.10.009.
Ulatowski TA. FDA: Reuse of single-use devices. In: Rutala WA, editor. Disinfection, Sterilization and Antisepsis: Principles, Practices, Challenges, and New Research. Washington, DC: Association for Professionals in Infection Control and Epidemiology; 2004. pp. 15–23.
Reichert M. Preparation of supplies for terminal sterilization. In: Reichert M, Young JH, editors. Sterilization Technology for the Health Care Facility. Gaithersburg, MD: Aspen Publication; 1997. pp. 36–50.
Miller CH, Riggen SD, Sheldrake MA, et al. Presence of microorganisms in used ultrasonic cleaning solutions. Am J Dent 1993;6(1):27–31. PMID: 8329158.
Lee CH, Cheng SM, Humar A. Acute febrile reactions with hypotension temporally associated with the introduction of a concentrated bioenzyme preparation in the cleaning and sterilization process of endomyocardial bioptones. Infect Control Hosp Epidemiol 2000;21:102.
Hutchisson B, LeBlanc C. The truth and consequences of enzymatic detergents. Gastroenterol Nurs 2005;28(5):372–376. DOI: 10.1097/00001610-200509000-00003.
Lipscomb IP, Sihota AK, Botham M, et al. Rapid method for the sensitive detection of protein contamination on surgical instruments. J Hosp Infect 2006;62(2):141–148. DOI: 10.1016/j.jhin.2005.07.008.
Position statement: Reprocessing of flexible gastrointestinal endoscopes. American Society for Gastrointestinal Endoscopy. Gastrointest Endosc 1996;43(5):541–546. DOI: 10.1016/s0016-5107(96)81581-1.
Alvarado CJ, Reichelderfer M. APIC guideline for infection prevention and control in flexible endoscopy. Association for professionals in infection control. Am J Infect Control 2000;28(2):138–155. PMID: 10760223.
Nelson DB, Jarvis WR, Rutala WA, et al. Multi-society guideline for reprocessing flexible gastrointestinal endoscopes. Society for Healthcare Epidemiology of America. Infect Control Hosp Epidemiol 2003;24(7):532–537. DOI: 10.1086/502237.
Rutala WA, Weber DJ. Guidelines for Disinfection and Sterilization in Healthcare Facilities; 2008:16–17.
Murtough SM, Hiom SJ, Palmer M, et al. A survey of rotational use of biocides in hospital pharmacy aseptic units. J Hosp Infect 2002;50(3):228–231. DOI: 10.1053/jhin.2001.1155.
Nye RN, Mallory TB. A note on the fallacy of using alcohol for the sterilization of surgical instruments. Boston Med Surg J 1923;189:561–563. DOI: 10.1056/NEJM192310181891603.
McCulloch EC, Costigan S. A comparison of the efficiency of phenol, liquor cresolis, formaldehyde, sodium hypochlorite and sodium hydroxide against Eberthella typhi at various temperatures. J Infect Dis 1936;59:281–284. DOI: 10.1093/INFDIS/59.3.281.
Sagripanti JL, Eklund CA, Trost PA, et al. Comparative sensitivity of 13 species of pathogenic bacteria to seven chemical germicides. Am J Infect Control 1997;25(4):335–339. DOI: 10.1016/s0196-6553(97)90026-2.
Occupational Safety and Health Administration. Formaldehyde: OSHA Fact Sheet: Occupational Safety and Health Administration; 2002.
Cheung RJ, Ortiz D, DiMarino AJ, Jr. GI endoscopic reprocessing practices in the United States. Gastrointest Endosc 1999;50(3):362–368. DOI: 10.1053/ge.1999.v50.99615.
Babb JR, Bradley CR, Ayliffe GA. Sporicidal activity of glutaraldehydes and hypochlorites and other factors influencing their selection for the treatment of medical equipment. J Hosp Infect 1980;1(1):63–75. DOI: 10.1016/0195-6701(80)90033-x.
Scott EM, Gorman SP. Glutaraldehyde. In: Block SS, editor. Disinfection, Sterilization, and Preservation. Philadelphia: Lippincott Williams and Wilkins; 2001. pp. 361–381.
Boucher RM. Potentiated acid 1, 5 pentanedial solution – A new chemical sterilizing and disinfecting agent. Am J Hosp Pharm 1974;31(6):546–557. PMID: 4366802.
Miner NA, McDowell JW, Willcockson GW, et al. Antimicrobial and other properties of a new stabilized alkaline glutaraldehyde disinfectant/sterilizer. Am J Hosp Pharm 1977;34(4):376–382. PMID: 16488.
Beauchamp RO, Jr, St Clair MB, Fennell TR, et al. A critical review of the toxicology of glutaraldehyde. Crit Rev Toxicol 1992;22(3–4):143–174. DOI: 10.3109/10408449209145322.
Corrado OJ, Osman J, Davies RJ. Asthma and rhinitis after exposure to glutaraldehyde in endoscopy units. Hum Toxicol 1986;5(5):325–328. DOI: 10.1177/096032718600500505.
Norbäck D. Skin and respiratory symptoms from exposure to alkaline glutaraldehyde in medical services. Scand J Work Environ Health 1988;14(6):366–371. PMID: 2975045.
Hession SM. Endoscope disinfection by ortho-phthalaldehyde in a clinical setting: An evaluation of reprocessing time and costs compared with glutaraldehyde. Gastroenterol Nurs 2003;26(3):110–114. DOI: 10.1097/00001610-200305000-00005.
Sokol WN. Nine episodes of anaphylaxis following cystoscopy caused by Cidex OPA (ortho-phthalaldehyde) high-level disinfectant in 4 patients after cytoscopy. J Allergy Clin Immunol 2004;114(2):392–397. DOI: 10.1016/j.jaci.2004.04.031.
Favero MS. Sterility assurance: Concepts for patient safety. In: Rutala WA, editor. Disinfection, Sterilization and Antisepsis: Principles and Practices in Healthcare Facilities. Washington, DC: Association for Professional in Infection Control and Epidemiology; 2001. pp. 110–119.
Favero MS, Bond WW. Chemical disinfection of medical and surgical materials. In: Block SS, editor. Disinfection, Sterilization, and Preservation. Philadelphia: Lippincott Williams and Wilkins; 2001. pp. 881–917.
Block SS. Disinfection, Sterilization, and Preservation. Philadelphia: Lippincott Williams and Wilkins; 2001.
Rutala WA, Weber DJ. Clinical effectiveness of low-temperature sterilization technologies. Infect Control Hosp Epidemiol 1998;19(10):798–804. DOI: 10.1086/647730.
Adler S, Scherrer M, Daschner FD. Costs of low-temperature plasma sterilization compared with other sterilization methods. J Hosp Infect 1998;40(2):125–134. DOI: 10.1016/s0195-6701(98)90091-3.
Mangram AJ, Horan TC, Pearson ML, et al. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Am J Infect Control 1999;27(2):97–132. PMID: 10196487.
Hüller C, Martiny H, Christiansen B, et al. The efficacy of low temperature plasma (LTP) sterilization, a new sterilization technique. Zentralbl Hyg Umweltmed 1993;194(4):380–391. PMID: 8397686.
Rutala WA, Gergen MF, Weber DJ. Comparative evaluation of the sporicidal activity of new low-temperature sterilization technologies: Ethylene oxide, 2 plasma sterilization systems, and liquid peracetic acid. Am J Infect Control 1998;26(4):393–398. DOI: 10.1016/s0196-6553(98)70034-3.
Alfa MJ, Olson N, Degagne P, et al. New low temperature sterilization technologies: Microbicidal activity and clinical efficacy. In: Rutala WA, editor. Disinfection, Sterilization, and Antisepsis in Healthcare. Champlain, New York: Polyscience Publications; 1998. pp. 67–78.
Ernst RR, Doyle JE. Sterilization with gaseous ethylene oxide: A review of chemical and physical factors. Biotech Bioeng 1968;10:5–40. DOI: https://doi.org/10.4265/bio.22.1.
Jay WM, Swift TR, Hull DS. Possible relationship of ethylene oxide exposure to cataract formation. Am J Ophthalmol 1982;93(6):727–732. DOI: 10.1016/0002-9394(82)90468-8.
Salinas E, Sasich L, Hall DH, et al. Acute ethylene oxide intoxication. Drug Intell Clin Pharm 1981;15(5):384–386. DOI: 10.1177/106002808101500509.
Berrington AW, Pedler SJ. Investigation of gaseous ozone for MRSA decontamination of hospital side-rooms. J Hosp Infect 1998;40(1):61–65. DOI: 10.1016/s0195-6701(98)90026-3.
Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities. Rockville, MD: Food and Drug Administration, Division of General and Restorative Devices; 1993.
Graham GS, Riley R. Sterilization manufacturers: Interactions with regulatory agencies. In: Rutala WA, editor. Disinfection, Sterilization, and Antisepsis in Healthcare. Champlain, New York: Polyscience Publications; 1998. pp. 41–48.
Nystrüm B. Disinfection of surgical instruments. J Hosp Infect 1981;2(4):363–368. DOI: 10.1016/0195-6701(81)90069-4.
Rutala WA, Gergen MF, Jones JF, et al. Levels of microbial contamination on surgical instruments. Am J Infect Control 1998;26(2):143–145. DOI: 10.1016/s0196-6553(98)80034-5.
Alfa MJ, Nemes R. Inadequacy of manual cleaning for reprocessing single-use, triple-lumen sphinctertomes: Simulated-use testing comparing manual with automated cleaning methods. Am J Infect Control 2003;31(4):193–207. DOI: 10.1067/mic.2003.22.
Alfa MJ, Nemes R. Reprocessing of lumened instruments. In: Rutala WA, editor. Disinfection, Sterilization and Antisepsis: Principles, Practices, Challenges, and New Research. Washington DC: Association for Professionals in Infection Control and Epidemiology; 2004. pp. 189–199.
Roncoroni AJ, Casewell MW, Phillips I. The disinfection of clinically contaminated Matburn suction pumps and baby incubators in an ‘Aseptor’ formalin cabinet. J Hosp Infect 1980;1(3):251–259. DOI: 10.1016/0195-6701(80)90063-8.