Surgical Sterilizer
ID: HT942726QE001Type: Combined Synopsis/Solicitation
Overview

Buyer

DEPT OF DEFENSEDEFENSE HEALTH AGENCY (DHA)ARMY MED RES ACQ ACTIVITYFORT DETRICK, MD, 21702, USA

NAICS

Surgical Appliance and Supplies Manufacturing (339113)

PSC

HOSPITAL FURNITURE, EQUIPMENT, UTENSILS, AND SUPPLIES (6530)

Set Aside

No Set aside used (NONE)
Timeline
    Description

    The Department of Defense, through the Defense Health Agency Contracting Activity, is seeking quotes for the procurement of surgical sterilizers intended for use in deployed medical, dental, veterinary, and laboratory settings. The requirement includes the acquisition of four surgical sterilizers for operational and environmental testing, with options for three additional units, and a potential future procurement of approximately 711 units over five years starting in Fiscal Year 2028. These sterilizers must meet specific technical requirements, including FDA clearance, the ability to sterilize all surgical instruments, and compliance with the Trade Agreements Act, among other logistical and performance parameters. Interested vendors should contact Jamie Diggs at jamie.l.diggs.civ@health.mil or Shannon Lertora at shannon.p.lertora.civ@health.mil for further details and to ensure compliance with the necessary documentation, including the Medical Device and Equipment Risk Assessment (MDERA).

    Point(s) of Contact
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    Posted
    The U.S. Army's Program Executive Office Soldier (PEO Soldier), Soldier Medical Devices (SMD) requires a new surgical sterilizer for deployed medical, dental, veterinary, and laboratory settings. The government intends to award a single contract for four surgical sterilizers for operational and environmental testing, with options for three additional units. Following successful testing, the government plans to procure an estimated 711 surgical sterilizers over five years, starting in Fiscal Year 2028. Vendors are encouraged to collaborate with the Defense Logistics Agency (DLA) to list the device on the Electronic Catalog (ECAT) for streamlined procurement. Key requirements include FDA clearance, ability to sterilize all surgical instruments, specific chamber and tray dimensions, operating and sterilization temperature ranges, balanced power supply with auto-detection, and a distilled water generator. Logistical requirements include Trade Agreements Act (TAA) compliance, provision of repair parts information, annual maintenance, manuals, onsite training, Risk Management Framework (RMF) documentation, copyright release, and robust transport cases meeting MIL-STD-810H standards. Desired additional performance parameters include a five-year procurement and support commitment and existing or willingness to obtain a DLA ECAT contract.
    The Medical Device and Equipment Risk Assessment (MDERA) Version 1 is a critical questionnaire for vendors providing medical systems to the Department of Defense (DoD) and Project Manager Soldier Medical Devices (PM-SMD). Its purpose is to ensure security compliance with US Federal Government, DoD, and PM-SMD policies, and NIST standards. Vendors must fully complete the MDERA as part of the Request for Offer (RFO)/Risk Management Framework (RMF) Change Control Board (CCB) review process. The questionnaire gathers detailed information on medical device identification, technical specifications (hardware, software, operating systems, applications, architecture, endpoint protection, vulnerability management, remote access, wireless capabilities, mass storage), and data processing capabilities (ePHI/PII handling, encryption). Failure to disclose complete and accurate information can result in ineligibility for purchase or contract cancellation. The MDERA serves as a pre-procurement selection tool to support RMF Authorization efforts, identifying technical characteristics and potential actions required for cybersecurity assessment.
    This document outlines instructions for using a hardware and software import template, likely for a government information system asset management database like eMASS. It details required fields for both hardware (Machine Name, Manufacturer, Model Number if either is specified) and software (Software Vendor, Software Name, Version), along with character limits and acceptable input values for various fields. The document emphasizes the importance of accurate data entry, proper spelling, and adherence to specific formatting to avoid import errors. It also references defining critical information system assets and the process for applying a digital signature once the template is complete. The overarching purpose is to ensure consistent and accurate data entry for tracking government IT assets.
    The document outlines mandatory requirements for topology diagrams within government enclaves, likely for federal RFPs or grants. It specifies that all diagrams must include a topology date, CCSD, and IP addresses for all devices. Critical devices such as firewalls, IDS, servers, and workstations require additional details including manufacturer, model, software/firmware versions, server functions, and operating systems with service pack information. The document emphasizes that the enclave and network infrastructure must comply with DoD-level policies, procedures, and guidance, referencing NIAP-CCEVS for compliant devices. This ensures secure and standardized network configurations in government projects.
    This document outlines the rating standards and definitions for evaluating quotes in a government procurement process, specifically for federal government RFPs, federal grants, and state/local RFPs. It details three evaluation factors: Technical Capabilities/Specifications, Risk Management Framework, and Past Performance. For Technical Capabilities, ratings range from Outstanding to Unacceptable, based on the approach, understanding, strengths, and risk of unsuccessful performance. The Risk Management Framework is rated as either Acceptable or Unacceptable, depending on whether the quote meets solicitation requirements. Past Performance is also rated as Acceptable or Unacceptable, based on the government's expectation of successful performance. A key note clarifies that quoters without a relevant past performance record will receive a neutral (unknown) rating, which is considered acceptable.
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    Surgical Sterilizer
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    Combined Synopsis/Solicitation
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