6515-- O.R. Sterilizer Cases Intent to Sole Source
ID: 36C24226Q0183Type: Special Notice
Overview

Buyer

VETERANS AFFAIRS, DEPARTMENT OFVETERANS AFFAIRS, DEPARTMENT OF242-NETWORK CONTRACT OFFICE 02 (36C242)ALBANY, NY, 12208, USA

NAICS

Surgical and Medical Instrument Manufacturing (339112)

PSC

MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES (6515)

Original Source

https://sam.gov/workspace/contract/opp/72c8f3573a804590a3f8e6c4e410d16a/view
Timeline
    Description

    The Department of Veterans Affairs (VA) intends to award a sole source contract to Arthrex, Inc. for the procurement of specialized Arthrex OR Sterilizer Cases, essential for the proper reprocessing and sterilization of proprietary Arthrex surgical instruments used in orthopedic surgeries at the Albany VAMC. These sterilizer cases are specifically designed and validated by the manufacturer to ensure compliance with FDA regulations, Joint Commission standards, and VA policies, thereby safeguarding patient safety and preventing potential surgical delays due to improper sterilization or instrument damage. The estimated cost for this acquisition is $38,700, and interested parties can direct inquiries to Contract Specialist Barry Sawyer at Barry.Sawyer@va.gov or by phone at 585-393-8563.

    Point(s) of Contact
    Barry SawyerContract Specialist
    (585) 393-8563
    Barry.Sawyer@va.gov
    Files
    Title
    Posted
    36C24226Q0183.docx
    The Department of Veterans Affairs (VA) Albany VAMC intends to award a sole source contract to Arthrex, INC. for the purchase of Arthrex OR Sterilizer Cases. This notice, identified by solicitation number 36C24226Q0183, is an intent to award and not a request for quotes. The VA requires these specific sterilizer cases because they are designed and validated for use with proprietary Arthrex surgical instrument sets, which are essential for orthopedic surgeries at the facility. The use of Arthrex-validated cases ensures compliance with manufacturer instructions, protects delicate instruments, and maintains patient safety by preventing issues such as improper sterilization or instrument damage. Using generic sterilizer trays is not FDA-cleared for Arthrex instruments and would lead to non-compliance with regulatory and policy requirements.
    P03- Single Source Justification MPT to SAT-Sterilizer Cases.pdf
    The Department of Veterans Affairs (VA), specifically VISN 2 Albany Stratton VHA Medical Center, requires a single-source acquisition of Arthrex sterilizer cases. These cases, essential for Arthrex surgical instruments used in orthopedic surgeries, are proprietary and validated by the manufacturer for proper reprocessing and sterilization, ensuring compliance with FDA, Joint Commission, and VA policies, as well as patient safety. The estimated cost is $38,700.00. Market research confirmed Arthrex as the sole manufacturer and distributor of these FDA-cleared, custom-fit cases, with no compatible alternatives found on GSA, FPDS, or SBA. Generic options are not suitable, posing risks of non-compliance, instrument damage, and surgical delays. The Contracting Officer has approved this single-source justification in accordance with FAR 13.106-1(b).
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    6515-- O.R. Sterilizer Cases Intent to Sole Source
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