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COMMERCE BUSINESS DAILY ISSUE OF SEPTEMBER 6,1996 PSA#167437th 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)
Q - Medical Services Index Page
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