Surgical Sterilizer

The Defense Health Agency Contracting Activity (DHACA), acting on behalf of the Army Program Executive Office Soldier, Soldier Medical Devices Project Management Office, is soliciting quotations for four surgical sterilizer test articles with onsite in-person training and an option for three additional units, with quotations due June 1, 2026 (extended from May 18 via Amendment 0001) and questions due April 30.

This is full and open competition under FAR Part 12 for commercial products, with no set-aside. Place of performance and delivery is Fort Detrick, Maryland, with delivery required within 150 calendar days of award. The procurement will be executed as a single Firm-Fixed-Price purchase order for the initial requirement. Following successful operational and environmental testing per MIL-STD 810-H in Fiscal Year 2028, the Government intends separate sole source procurement of an estimated 1 to 711 additional surgical sterilizers over five years.

The surgical sterilizer must be FDA-cleared or registered as a Class I or II medical device, with minimum chamber dimensions of 12.0 inches diameter by 23.5 inches long (desired: 13.5" by 24"). Critical operational specifications include sterilization capability at temperatures of 250°F to 275°F (121°C to 135°C), operation across 35°F to 130°F ambient conditions, dual voltage support (110–120 VAC 60Hz and 220–240 VAC 50Hz with auto-detection), stainless steel tray, distilled water generator, and maximum 35 pounds weight and 4 cubic feet volume. Critical logistical specifications mandate Trade Agreements Act compliance, comprehensive repair parts support, annual or less frequent maintenance, User/Operator and Maintenance/Service Manuals, one-time onsite training for 5–10 operators and maintainers, Risk Management Framework/Authority to Operate documentation, hardened transport cases meeting MIL-STD 810H criteria, one-year warranty, and Item Unique Identification per DFARS 252.211-7003.

Quoters must submit company details, technical specifications, a completed Medical Device and Equipment Risk Assessment questionnaire, one to three past performance references from projects completed within three years, pricing for all line items, acknowledgement of amendments, and DFAR Provision 252.204-7017 representation. SAM registration is required at award.

Evaluation uses a best-value tradeoff basis with four factors in descending order of importance: Technical Capabilities/Specifications (five-level adjectival scale: Outstanding, Good, Acceptable, Marginal, Unacceptable), Risk Management Framework (binary: Acceptable or Unacceptable), Past Performance (binary: Acceptable if reasonable expectation of success or neutral rating; Unacceptable if record indicates inability to perform), and Price (evaluated for reasonableness and completeness). The NAICS code is 339113, Surgical Appliance and Supplies Manufacturing; PSC is 6530, Hospital Furniture, Equipment, Utensils, and Supplies.