P03_ Single Source Justification STRIS 608_Redacted.pdf
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- Attached to
- STERIS InnoWave Irrigator Federal contract opportunity
- Solicitation number
- 36C24126Q0765
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This is a Single Source Justification for Commercial Item Acquisition under FAR Part 12 Simplified Procedures, issued by the Department of Veterans Affairs.
The Manchester VA Medical Center, located in Manchester, New Hampshire, seeks to acquire two (2) STERIS InnoWave PCF Sonic Irrigator units to replace existing inoperable STERIS ultrasonic cleaning equipment purchased in 2019 under contract 36C24119P0642. The STERIS InnoWave PCF is a high-capacity, automated ultrasonic cleaning system designed for complex and lumened surgical instruments, capable of processing up to 20 lumened devices or 44 pounds of instruments per cycle. The equipment includes touch-screen controls, USB cycle export capability, standard instrument baskets, optional thermal disinfection, and direct integration into sterile processing workflows. The contractor must provide delivery, installation, operational verification, user training, old equipment removal and disposal, and all manufacturer warranties and documentation. The acquisition is classified as over the micro-purchase threshold but not exceeding the simplified acquisition threshold.
The justification for single source award is based on Manchester VAMC's established workflows, instrument sets, and reprocessing practices being built exclusively around STERIS technology, with only STERIS providing full compatibility with the facility's existing infrastructure and regulatory obligations. Alternative brands cannot ensure seamless integration, do not match validated performance requirements for lumened and robotic instruments, and would introduce unnecessary training burdens and workflow disruption that could negatively impact surgical operations and patient care. Market research identified multiple capable Small Business distributors authorized to provide STERIS InnoWave PCF Sonic Irrigators and confirmed prior Small Business participation in similar STERIS procurements. The acquisition is approved under FAR 12.102, FAR 12.201-1, and FAR 12.203, with contracting officer certification dated August 24, 2026.
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| 36C24126Q0765.docx | DOCX document |
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Revision: 02 Effective Date: 12/30/2025 Page 1 of 2 Acquisition ID# 36C241-26-AP-3947
Part 12 Acquisition of Commercial Products and Commercial Services Single Source Justification for Commercial Item Acquisition Under Simplified
Procedures
DEPARTMENT OF VETERANS AFFAIRS
Justification for Single Source Awards IAW Part 12 For
Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold
Acquisition Plan Action ID: 36C241-26-AP-3947 Contracting Activity: Network Contracting Office 1, Regional Procurement Office East on behalf of the Department of Veterans Affairs, Veterans Integrated Service Networks (VISN) 1, Manchester VA Medical Center, 718 Smyth Road, Manchester, NH 03104-7007. Funding 608-26-4-7760-0020.
Brief Description of Supplies/ Services required and the intended use/Estimated Amount: Manchester VAMC�s Sterile Processing Services (SPS) Department is looking to acquire (2) STERIS InnoWave PCF Sonic Irrigator manufactured solely by large business Steris Corporation. The STERIS InnoWave PCF Sonic Irrigator is a high-capacity, automated ultrasonic cleaning system designed specifically for complex and lumened surgical instruments. It uses powerful ultrasonic energy paired with sonic irrigation to remove bioburden from up to 20 lumened devices or 44 pounds of instruments per cycle. he unit includes touch-screen controls, USB cycle export capability, standard instrument baskets, and optional thermal disinfection, and is built to integrate directly into SPS workflows for safe, consistent, and efficient instrument reprocessing. The Contractor will provide delivery, installation, operational verification, user training, removal/disposal of old equipment, and provision of all manufacturer warranties and documentation The total estimated amount for all equipment is
Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Manchester VAMC is looking to acquire new STERIS InnoWave PCF Sonic Irrigators to replace its existing STERIS ultrasonic cleaner purchased under contract number 36C24119P0642 in 2019, which has become inoperable and can no longer support daily sterile processing operations. Manchester VAMC�s current workflows, instrument sets, and reprocessing practices are already built around STERIS technology, only the STERIS brand provides full compatibility with the facility�s established processes, existing infrastructure, and regulatory obligations for cleaning reusable medical devices. Alternative brands cannot ensure seamless integration, do not match the validated performance requirements for lumened and robotic instruments, and would introduce unnecessary training burdens, workflow disruption, and potential risks to patient care�risks highlighted by SPS leadership, who noted that failure to procure this specific STERIS unit would negatively affect surgical operations, outpatient clinics, and overall SPS capacity.
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