February References

February 1, 2002

February References

"Reprocessing Update," by Kelly M. Pyrek, page 28.

1. US General Accounting Office, Report to Congressional Requesters.Single-use medical devices: Little available evidence of harm from reuse butoversight warranted. June 2000. GAO/HEHS-00-123, www.gao.gov.

2. Medical Device Manufacturers Association, www.medicaldevices.org/public/alert/2001/agenda.asp.

3. GAO report, p. 19, www.gao.gov.

4. ibid.

5. GAO report, pp. 7-8, www.gao.gov.

6. GAO report, p.8, www.gao.gov.

7. GAO report, p. 10, www.gao.gov.

8. GAO report, p. 11, www.gao.gov.

9. ibid.

10. US Surgical Corp vs. Orris, Inc. 5 F. Supp.2d 1201 at 1207.

11. GAO report, p. 11, www.gao.gov.

12. ibid.

13. GAO report, p. 12, www.gao.gov.

14. www.cdc.gov/ncidod/hip/sterile/sterilgp.htm.

15. GAO report, p. 12, www.gao.gov.

16. AORN Guidance Statement, Reuse of Single-Use Devices. www.aorn.org.

17. Cohen, J., et al. A prospective study of the repeated use of sterilizedpapillotomes and retrievel baskets for ERCP: quality and cost analysis. GastrointestinalEndoscopy 1997:Vol. 45, No. 2, pp. 122-127.

18. FDA Center for Devices and Radiological Health. www.fda.gov/cdrh/osb/guidance/1334.pdf

19. GAO report, p. 15, www.gao.gov.

20. ibid.

21. CDC. Nosocomial infection and pseudoinfection from contaminatedendoscopes and bronchoscopes. MMWR. 1991:Vol. 40, No. 39, pp. 675-678;and CDC. Bronchoscopy-related infections and pseudoinfections. MMWR.1999:Vol. 48, No. 26, pp. 557-560.

"Matching the Disinfectant to the Job," by Michelle Gardner,page 14.

1. www.epa.gov

2. APIC Guideline for Selection and Use of Disinfectants. American Journalof Infection Control. 1996.

3. www.ehs.ucdavis.edu/sftynet/sn-51.html

4. www.epa.gov/pesticides/citizens/motherjq.htm

"Avoiding Healthcare's Hazards: An Occupational Health Update,"by John Furman, page 36.

1. Centers for Disease Control and Prevention, (1998). Guideline forInfection Control in Healthcare Personnel. Amer Journal of Infec Control.26(3)

2. American Nurses Association. Health & Safety Survey. 2001. www.NursingWorld.org.

3. American Nurses Association. Staffing Survey. 2001. www.NursingWorld.org

4. Public Law 106-430. Needlestick Safety and Prevention Act. FederalRegister, 2001.

5. Centers for Disease Control and Prevention (2001). Updated US PublicHealth Service Guidelines for the Management of Occupational Exposures to HBV,HCV, and HIV and Recommendations for Postexposure Prophylaxis. MMWR.50(RR-11).

6. OSHA Recordkeeping Rule 29 CFR 1904.

7. CDC. Draft Guideline for Hand Hygiene in Healthcare Settings. 2001. www.cdc.gov/ncicod/hip/hhguide.htm

8. NIOSH. Control of Smoke From Laser/Electric Surgical Procedures. NIOSHHazard Alert.

"FDA Labeling of Liquid Chemical Sterilants: Are ModificationsNeeded?" by Lawrence F. Muscarella, PhD, page 50.

1. Heller, J. New sterilization system cuts repair costs for rigid scopes. MatMgmnt. 1996 Sept;70.

2. Fuselier, H.A. and Mason, C. Liquid sterilization versus high leveldisinfection in the urologic office. Urology. 1997;50(3):337-40.

3. Muscarella, L.F. Current instrument reprocessing practices. Results of anational survey. Gastroenterol Nurs. 2001;24(5):253-60.

4. Muscarella, L.F. Anticipated reliability of liquid chemical sterilants. AmJ Infect Control. 1998 Apr;26(2):155-6.

5. Food and Drug Administration. Guidance for industry and FDA reviewers.Content and format of premarket notification [510(k)] submissions for liquidchemical sterilants/high level disinfectants. Issue date: January 3, 2000.

6. Muscarella, L.F. Are all sterilization processes alike? AORN J.1998 May;67(5):966-70, 973-6.

7.www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM 

8. Bond, W.W. Biological indicators for a liquid chemical sterilizer: asolution to the instrument reprocessing problem? Infect Control HospEpidemiol. 1993 Jun;14(6):309-12.

9. Struelens, M.J.; Rost, F.; Deplano, A.; Maas, A.; Schwam, V. and Serruys,E., et al. Pseudomonas aeruginosa and Enterobacteriaceae bacteremia afterbiliary endoscopy: an outbreak investigation using DNA macrorestrictionanalysis. Am J Med. 1993;95(5):489-98.

10. Alvarado, C.J.; Stolz, S.M.; and Maki, D.G. Nosocomial infections fromcontaminated endoscopes: a flawed automated endoscope washer. An investigationusing molecular epidemiology. Am J Med. 1991 Sep 16;91(3B):272S-280S.

11. Mitchell, D.H.; Hicks, L.J.; Chiew, R.; Montanaro, J.C.; and Chen, S.C.Pseudoepidemic of Legionella pneumophila serogroup 6 associated withcontaminated bronchoscopes. J Hosp Infect. 1997;37:19-23.

12. Humphreys, H. and Lee, J.V. Water quality for endoscopewasher-disinfectors. J Hosp Infect. 1999;42(1):76-8.

13. Phillips, G.; McEwan, H. and Butler, J. Quality of water inwasher-disinfectors. J Hosp Infect. 1995;31:152-4.

14. Cooke, R.P.D.; Whymant-Morris, A.; Umasankar, R.S. and Goddard, S.V.Bacteria-free water for automatic washer-disinfectors: an impossible dream? JHosp Infect 1998;39(1):63-5.

15. Berlau, J. A new risk for high-tech surgery? Investor's Business Daily.February 14,2000;16:A1, A26.

16. Muscarella, L.F. Disinfecting endoscopes immediately before the firstpatient of the day. AORN J. 2001 Jun;73(6):1159-63.

"Multi-drug Resistant Bacteria: Mechanisms of Resistance,Epidemiology and Prevention," by Keith Kaye, MD, MPH, page 42.

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9. Groom, A.V.; Wolsey, D.H.; Naimi, T.S., et al. Community-acquiredmethicillin-resistant Staphylococcus aureus in a rural American Indiancommunity. JAMA. 2001; 286:1201-5.

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