Reprocessing single-use medical devices

AORN Journal,  March, 2002  by Barbara D. Cohoon

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(31.) US General Accounting Office, "Single-use medical devices: Little available evidence of harm from reuse but oversight warranted," document no GAO/HEHS-00-123 (Washington, DC: US General Accounting Office, June 2000).

(32.) L Kahan, "Executive summary: Open meeting: FDA's proposed strategy on reuse of single-use devices, Tuesday, Dec 14, 1999," Center for Devices and Radiological Health, http://www.fda.gov/cdrh /reuse/1214execsum.html (accessed 14 Aug 2001).

(33.) G M Agolini, A P Russo, M Clementi, "Effect of phenolic and chlorine disinfectants on hepatitis C virus binding and infectivity," American Journal of Infection Control 27 (June 1999) 236-239; J Descoteaux, et al, "Residual organic debris on processed surgical instruments," AORN Journal 62 (July 1995) 23-30; J W Granzow et al, "Evaluation of the protective value of hospital gowns against blood strike-through and methicillin-resistant Staphylococcus aureus penetration," American Journal of Infection Control 26 (April 1998) 85-93; K K Leonas, "Effect of laundering on the barrier properties of reusable surgical gown fabrics," American Journal of Infection Control 26 (October 1998) 495-501; M J Neff et al, "To reuse your circuit: The HME debate," (Abstract) AA NA Journal 67 (October 1999) 433-439.

(34.) US General Accounting Office, "Single-use medical devices: Little available evidence of harm from reuse but oversight warranted."

(35.) "Recycled equipment: A 'ticking medical time bomb,'" American Health Line (Sept 16, 1999), http: //www.americanhealthline.com (accessed 15 June 2000).

(36.) "Legislative alert: Senate appropriations bill sample letter," Association of Medical Device Reprocessors, http://www.amdr.org /legmenu.html (accessed 6 Feb 2002).

(37.) W B Stoermer, "Reprocessing `single-use' devices: Why is there so much debate?" (Review) Todays Surgical Nurse 21 (March/April 1999) 27-33.

(38.) Ibid.

(39.) R Mancuso, M F Bickham, "Estimating the true costs of disposable and reusable instruments," AORN Journal 62 (July 1995) 39-48.

(40.) US General Accounting Office, "Single-use medical devices: Little available evidence of harm from reuse but oversight warranted."

(41.) P J Furman, "Letter submitted April 11, 2000 by the Association of Medical Device Reprocessors re: Docket No. 00D-0053," Association of Medical Device Reprocessors, http://www.amdr.org/AMDRComme nts.htm (accessed 14 Aug 2001).

(42.) Re: Citizen Petition to Ban Reprocessed Single Use Devices (news release, Washington DC: Medical Device Manufacturers Association, May 20 1999).

(43.) "ASHCSP comments to FDA's two guidance documents," American Society of Healthcare Central Services Professionals, http://www .ashcsp.org/public/articles/details.cfm ?id=9 (accessed 6 Feb 2002).

(44.) "Docket No. 97N-0477, Medical devices; refurbishers, rebuilders, reconditioners, servicers, and 'as is' remarketer of medical devices: Review and revision of compliance policy guides and regulatory requirements: Request for comments and information," Food and Drug Administration, http://www .fda.gov (accessed 14 Aug 2001).