Sterilizer, Surgical Instrument
Type: Special Notice
Overview

Buyer

DEPT OF DEFENSEDEPT OF THE ARMYW40M USA HCAJBSA FT SAM HOUSTON, TX, 78234-5074, USA

NAICS

Surgical Appliance and Supplies Manufacturing (339113)

Original Source

https://sam.gov/opp/ee8d0b6dc6094e7a81cbc1237986ca0f/view
Timeline
    Description

    The Department of Defense, specifically the Department of the Army, is seeking qualified vendors to provide a surgical sterilizer as outlined in a Special Notice. The procurement requires a device that meets specific operational capabilities, including FDA clearance, the ability to sterilize a wide range of surgical instruments, and chamber dimensions of at least 12.0” in diameter by 23.5” in length, with a sterilization temperature range of 250°F to 275°F. This sterilizer is crucial for maintaining operational efficiency in military healthcare settings, ensuring that surgical instruments are properly sterilized to meet health standards. Interested parties should contact Werner Martin at werner.b.martin.civ@health.mil or Arturo Castro at arturo.castro8.civ@health.mil for further details regarding the submission process and requirements.

    Point(s) of Contact
    Werner Martin
    werner.b.martin.civ@health.mil
    Arturo Castro
    arturo.castro8.civ@health.mil
    Files
    Title
    Posted
    RFI Attachment 1 CODS Surgical Sterilizer.pdf
    The document outlines Critical Operational Device Specifications (CODS) for a surgical sterilizer intended for government procurement, emphasizing necessary regulatory compliance and operational capabilities. Key requirements include FDA clearance for the device's classification, ability to sterilize a comprehensive range of surgical instruments, chamber dimensions of at least 12.0” diameter x 23.5” long, and a sterilization temperature range between 250°F to 275°F. Desired features include a larger chamber size, robust power supply adaptability, and enhancements like additional training and warranty support. Logistical specifications require detailed repair parts support, a one-year minimum warranty with options for extended coverage, and inclusion of User Manuals. Equipment must be contained in durable transport cases meeting military standards for environmental resilience. The document serves as a framework for evaluating vendors' offerings in line with government RFP processes, ensuring that critical performance and logistical criteria are upheld to guarantee operational efficiency in healthcare settings. Compliance with Trade Agreements Act (TAA) regulations is also stressed, highlighting the necessity for adherence to quality and legal standards in procurement.
    RFI Attachment 2 Company and Product Information Surgical Sterilizer.pdf
    This document serves as an attachment for a Request for Information (RFI) related to medical devices under RFI No. W81K04-25-Q-1970. It outlines the information required from companies interested in providing medical devices, focusing on company background (name, address, registration details, socio-economic classifications), and the supportability and maintainability of the devices offered. Companies must provide details on supply support, maintenance strategies, technical data, training plans, and power requirements for the medical devices in austere environments. Key sections include the identification of repair parts, maintenance agreements, and any proprietary support equipment needed. Additionally, companies are required to outline any training resources available and address potential challenges in shipping and labeling. This document is critical for assessing companies' capacities to ensure that the requested medical devices are reliable, maintainable, and supported effectively, which underscores the broader goals of military readiness and healthcare delivery in challenging conditions.
    Lifecycle
    Title
    Type
    Sterilizer, Surgical Instrument
    Currently viewing
    Special Notice
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