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Decontaminated Single-Use Devices: An Oxymoron That May Be Placing Patients at Risk for Cross-Contamination

Published online by Cambridge University Press:  02 January 2015

Peter Heeg ,
Klaus Roth ,
Rudolf Reichl ,
C. Philip Cogdill  and
Walter W. Bond
Peter Heeg*
Affiliation:
Department of Hospital Infection Control, University of Tuebingen, Tuebingen, Germany
Klaus Roth
Affiliation:
Center for Testing of Medical Devices and the Steinbeis Transfer Center for Minimally Invasive Surgery, University of Tuebingen, Tuebingen, Germany
Rudolf Reichl
Affiliation:
Natural and Medical Science Institute of the University of Tuebingen, Reutlingen, Germany
C. Philip Cogdill
Affiliation:
Corporate Sterilization and Microbiology, Boston Scientific Corporation, Natick, Massachusetts
Walter W. Bond
Affiliation:
Research Consulting Service Associates, Inc, Lawrenceville, Georgia
*
Department of Hospital Infection Control, University of Tuebingen, Calmer Strasse 7, D-72076 Tuebingen, Germany
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Abstract

Objective:

To determine whether reprocessed single-use devices would meet regulatory standards for sterility and meet the same materials standards as a new device.

Design:

The study included single-use and reusable biopsy forceps and papillotomes and a reusable stone retrieval basket. The suitability of these devices for cleaning and disinfection or sterilization was examined.

Methods:

Testing of cleanability was conducted on devices contaminated with technetium 99-radiolabeled human blood. Instruments were cleaned using hospital recommended practices for manual cleaning. Gamma counts per second were determined before and after cleaning to localize contaminants, which were additionally visualized using light and scanning electron microscopy. X-ray phc-toelectron spectroscopy was used to quantify contamination elements on the materials tested. Residual bioburden testing on instruments contaminated with microorganisms suspended in coagulable sheep blood was carried out to establish the efficacy of disinfection and sterilization.

Results:

All devices remained contaminated after cleaning, but single-use devices and the stone basket tended to be more heavily contaminated than reusable forceps and papillotomes. Cleaning procedures facilitated distribution of contaminants further into the lumens of the disposable forceps. Decreased concentrations of silicon and increased concentrations of carbon and nitrogen suggested that layers of silicon lubricant had been removed and contaminants were organic material. Reusable devices were effectively disinfected, but single-use devices were not Sterilization could not eliminate the challenge microorganisms completely.

Conclusions:

None of the reprocessed single-use instruments were effectively cleaned, disinfected, or sterilized. This condition may provide an opportunity for the viability of non-resistant or nosocomial organisms and viruses. Additionally, reprocessing procedures may result in material destruction of fragile devices. Cost-saving initiatives that have inspired reprocessing of single-use devices, despite the absence of data establishing the efficacy of decontamination and the durability of materials throughout reprocessing, should be pushed into the background.

Type
Original Articles
Information
Infection Control & Hospital Epidemiology , Volume 22 , Issue 9 , September 2001 , pp. 542 - 549
Copyright
Copyright © The Society for Healthcare Epidemiology of America 2001

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References

1.Green, VW. Reuse of disposable medical devices: historical and current aspects. Infect Control 1986;7:508–513.Google Scholar
2.Mayhall, CG. Types of disposable medical devices reused in hospitals. Infect Control 1986;7:491–494.CrossRefGoogle ScholarPubMed
3.Greene, VW. Disinfection and sterilization of disposable devices/equipment. In: Rutala, WA, ed. Chemical Germicides in Healthcare. Washington, DC: Association for Professionals in Infection Control and Epidemiology; 1995:111–128.Google Scholar
4.Woolard, K. Reuse of single-use medical devices: who makes the decision? Med J Aust 1996;164:538.Google Scholar
5.Hanlon, GW. Reuse of disposables. In: Russell, AD, Hugo, WB, Ayliffe, GAJ, eds. Disinfection, Preservation and Sterilization. 3rd ed. Oxford, UK: Blackwell; 1998:777–786.Google Scholar
6.Greene, VW. Reuse of disposable devices. In: Mayhall, CG, ed. Hospital Epidemiology and Infection Control. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 1999:1201–1208.Google Scholar
7.Bronowicki, JP, Venard, V, Botte, C, Monhoven, N, Gastin, I, Chone, L, et al. Patient-to-patient transmission of hepatitis C virus during colonoscopy. N Engl J Med 1997;337:237–240.Google Scholar
8.Buess, G, Cuschieri, A, Perissat, J. Operative Manual for Endoscopic Surgery. Vol 1. Berlin, Germany: Springer; 1994.Google Scholar
9.Association for the Advancement of Medical Instrumentation. Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers. AAMI TIR no. 12. Arlington, VA: AAMI; 1994.Google Scholar
10.Association for the Advancement of Medical Instrumentation. Good Hospital Practice: Steam Sterilization and Sterility Assurance. American National Standards Institute (ANSI)/AAMI ST 45-1993, Arlington, VA: AAMI; 1994.Google Scholar
11.International Standardization Organization. Sterilization of Healthcare Products: Requirements for Validation and Routine Control: Industrial Moist Heat Sterilization. Geneva, Switzerland: American National Standards Institute (ANSD/AAMI/ISO 11134; 1994.Google Scholar
12.International Standardization Organization. Sterilization of Healthcare Products: Requirements for Validation and Routine Control: Industrial Ethylene Oxide Sterilization of Medical Devices. Geneva, Switzerland: American National Standards Institute (ANSD/AAMI/ISO 11135; 1994.Google Scholar
13.Centers for Disease Control and Prevention. Guideline for handwashing and hospital environmental control, 1985. Am J Infect Control 1986;14:110–126.Google Scholar
14.European Committee for Standardization (CEN). Sterilization of Medical Devices: Requirements for Medical Devices to Be Labelled 'Sterile.' Brussels, Belgium: EN 556, 1995.Google Scholar
15.Schrimm, H, Sieber, JP, Heeg, P, Roth, K, Mueller-Schauenburg, W, Keller, KD, et al. A new method for validating and verifying the cleaning of tubular instruments. Zentral Sterilisation-Central Service 1994;2:313–324.Google Scholar
16.Reichl, R, Beckmann, P, Dreher, WF, Inacker 0, Mueller, E, Heeg, P, et al. Innovations in medical technology based on surface and interface analytical methods (part 1). Zentral Sterilisation-Central Service 1998;6:222–231.Google Scholar
17.German Society for Hygiene and Microbiology (DGHM). Guidelines for Testing and Evaluation of Chemical Disinfectants. Stuttgart, Germany: G. Fischer Publishers; 1981.Google Scholar
18.International Standardization Organization (ISO). Sterilization of Medical Devices: General Requirements for Characterization of Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process. ISO/DIS 14937; 1999.Google Scholar
19.European Committee for Standardization (CEN). Sterilization of Medical Devices: Validation and Routine Control of Ethylene Oxide Sterilization. Brussels, Belgium: EN 550; 1994.Google Scholar
20.Chaufour, X, Deva, AK, Vickery, K, Zou, J, Kumaradeva, P, White, GH, et al. Evaluation of disinfection and sterilization of reusable angioscopes with the Dutch hepatitis B model. J Vase Surg 1999;30:277–282.Google Scholar
21.Rolansky, PF, Dawson, ME, Novitsky, TJ. Plastics, endotoxins and the Limulus amebocyte lysate test. J Parenter Sci Technol 1991;45:83–87.Google Scholar
22.Bond, WW. Endoscope reprocessing: problems and solutions. In: Rutala, WA, ed. Disinfection, Sterilization and Antisepsis in Healthcare. Washington, DC: Association for Professionals in Infection Control and Epidemiology (APIC); 1998:151–163.Google Scholar