Loren Data Corp.

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COMMERCE BUSINESS DAILY ISSUE OF SEPTEMBER 6,1996 PSA#1674

37th CONS/LGCXS, 1655 Selfridge Ave, Lackland AFB TX 78236-5300 Attn:LGCXS/Cathy E Garcia

Q -- REUSABLE INSTRUMENT - RESTORING OF SURGICAL MATERIALS DUE 091996 POC Cathy E Garcia tel: 210/671-1759 CNT F4163696Q2353 Solicitation #F41636-96-Q2353, DUE 091996, POC Contact Purchasing Agent Cathy E Garcia (210)671-1759. The 37 Contracting Squadron is conducting a sources sought synopsis to determine potential sources for a complete off-site processing service for Wilford Hall Medical Center (WHMC) to restore and resterilize surgical materials to their original quality. Potential shall be ETO Sterilized and a laboratory validation of all surgical materials shall be performed. All potential sources must be FDA regulated and adhere to the same Good Manufacturing Practices that are required of the OEM for assurance that product integrity is the same if not better than when it was originally purchased. The sorting of all instruments requiring restoration and resterilization will be performed by the contractor. The required government turnaround time for restoration and resterilization of these materials is 7 days. Weekly pickup and delivery. Transporation charges and responsiblity for the items while in transit from or to WHMC shall be borne by the contractor. The collection units will be provided by the company. Assign lot number and implement tracking system. There must be a tracking system for all instruments that refurbished and reprocessed. Sort the products by color-code and then place in closed container work bins. Orange labeled - All used disposable instruments for refurbishing. Green labeled - All open, but not used instruments for reprocessing. First Decontamination Process - Be done by certified personnel. Use Automated cleaning equipment so that temperatures will reach high enough to guarantee all bacteria is killed. Orange labeled - Thermal and chemical disinfecting. (Ham 850 washer/decontamination System) Green labeled - Germicidal handwash. (Outer surfaces & all components) Inspection - internal and external examination under high intensity lamps and 10x magnification. Sharpening and refurbishing be done by certified personnel with automated equipment. All Instrument Sharpeners must have at least 6 months of apprenticeship and then pass a written certification exam and a practical certification exam. Instruments sharpened by machine will be restored to OEM specs. Inspection - internal and external done for functional testing where applicable. Second Decontamination process, thernal and chemical, lubrication is applicable. Done by certified personnel and by automated equipment. All workers must have Central Supply Certification through an Association of Health Care Central Service. Refurbished and resterilized item will be repackaged and labeled in a Class 10,000 Clean Room. The contractor will label all reprocessed items with the original products name, catalog number, and sterilization lot number. Products from company must be double packaged. Inspection of seal and pouch integrity, testing for residual moisture is also performed at this time. Contractors must have liability insurance. Product is returned to our facility. Potential offerors are asked to provide descriptive/catalogs detailing their capabilities, product lines, certified personnel, equipment, inspection process and tracking system to restore and resterilize surgical materials. All interested parties must submit the requested information by 19 September 1996. (0248)

Loren Data Corp. http://www.ld.com (SYN# 0072 19960905\Q-0008.SOL)


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