6515--Reprocessed Non-Critical Single Use Devices

Enterprise Reprocessing of Non-Critical Single Use Devices (SUDs) RFI Number: 36C24E26Q0115 Release Date: August 28, 2026 Response Due Date: September 11, 2026 Point of Contact: Brett Cook Disclaimer and Purpose This is a Request for Information (RFI) issued by the Department of Veterans Affairs (VA) solely for market research and planning purposes in accordance with Federal Acquisition Regulation (FAR) Part 10, Market Research. This RFI does not constitute a solicitation (Request for Proposal, Request for Quotation, or Invitation for Bids), does not commit the Government to any contract or acquisition strategy, and does not obligate VA to award a contract now or in the future. No entitlement to payment of direct or indirect costs or charges by the Government will arise as a result of contractor responses to this RFI or the Government s use of such information. Any future procurement will be conducted in accordance with the FAR and the VA Acquisition Regulation (VAAR), including applicable VAAR provisions implementing the Veterans First Contracting Program and other socioeconomic requirements. Responses to this RFI may inform VA s acquisition planning, including potential small business or Veterans First set aside decisions, contract type, and performance-based acquisition approaches, but will not be used as evaluation criteria for any future solicitation. Proprietary and business sensitive information should be clearly marked; VA will handle such information in accordance with applicable laws and regulations. Executive Summary The Department of Veterans Affairs, America s largest integrated healthcare system, is exploring enterprise-wide adoption of FDA cleared third party reprocessing and reutilization of non-critical single use medical devices (SUDs). VA s objectives are to achieve significant cost savings, measurable medical waste reduction, and the highest possible patient safety through robust, scalable, and innovative reprocessing partnerships. To support rigorous acquisition planning and a defensible Independent Government Cost Estimate (IGCE), respondents must provide comprehensive cost and technical information for pilot phase, phased deployment, and full enterprise implementation. VA will prioritize evidence-based safety, interoperability with VA systems, digital integration, supplier diversity (including Veterans First participation), Section 508 accessibility, and a commitment to continuous improvement. This RFI is issued under FAR Part 10 and applicable VAAR provisions governing VA acquisition planning and market research. 1. Strategic Context and Objectives The VA is committed to: Reducing cost and optimizing resource utilization through safe, compliant reprocessing of non critical SUDs. Lowering environmental impact and regulated medical waste. Supporting digital transformation and supply chain modernization. Maximizing value, safety, and effectiveness in patient care for non critical applications. Advancing sustainability, supplier diversity, Veterans First participation, and Section 508 accessibility. Respondents should describe how their solutions align with these objectives and support performance-based acquisition and outcome focused contracting strategies consistent with FAR guidance. 2. Background VA is considering enterprise-wide solutions to reprocess non - critical SUDs (a representative list is provided in Appendix A) and seeks insights, outcomes, and recommendations from vendors serving government, military, or large integrated delivery networks. Robust cost estimates and evidence-based performance data are essential to support VA s business case evaluation, IGCE development, and acquisition planning under FAR/VAAR. 3. RFI Scope VA seeks market input on capabilities, approaches, and pricing models that could inform a future acquisition of enterprise non critical SUD reprocessing services. Areas of interest include: End-to-end collection, secure logistics , chain of custody, and tracking of non critical SUDs from VA facilities (see Appendix A for device types). FDA-cleared reprocessing, cleaning/disinfection, functional validation, relabeling, and safe release for reuse of non critical SUDs. Systems interoperability with VA informatics, supply chain, and EHR platforms, including adherence to Federal and VA standards for data protection and accessibility (e.g., Section 508). Training, onboarding, and change management for VA staff handling non critical SUDs. Environmental and financial impact measurement and transparent reporting specific to non critical SUDs. Detailed cost/pricing models and phased deployment estimates including pilot phase, a multi-year phased implementation resulting in full system implementation. These cost/pricing models should include annualized and cumulative scenarios to inform IGCE development and contract type selection. Data security, adverse event management, recall procedures, and regulatory compliance. Full scale enterprise ramp up, scalability, continuity, supplier diversity, and risk mitigation plans. Commitment to innovation, continuous improvement, and client engagement. 4. Key Definitions and Abbreviations Non-critical SUD: Device intended for one-patient/one-procedure use, contacting only intact skin (not mucous membranes/sterile body sites). FDA-cleared reprocessor: Third-party vendor with FDA 510(k)/PMA for reprocessing non-critical SUDs. QMS: Quality Management System (e.g., ISO 13485). CAPA: Corrective and Preventive Action. Section 508: Federal requirement for accessibility. IGCE: Independent Government Cost Estimate. Other acronyms/terms as used herein. 5. Information Requested Please organize your response according to the sections below and reference relevant non-critical SUDs (see Appendix A). Responses should not exceed 20 pages, plus optional appendices. Clearly identify proprietary information and any data that should be treated as business sensitive. Throughout your submission, provide sufficient detail, data, and explanation to allow VA to prepare an IGCE and to assess potentially appropriate contract types and risk allocations under FAR. A. Executive Summary Briefly describe your organization, capabilities, and your vision for VA s non-critical SUD reprocessing program. B. Regulatory Compliance & Quality Keep your existing bullets, and add: Identify any experience with federal healthcare or VA contracts and describe how you ensured compliance with FAR/VAAR requirements, quality standards, and applicable agency policies (no contract numbers needed). Provide FDA clearance documentation for all non-critical SUDs you are authorized to reprocess. Provide a list of non-critical SUDs you are not authorized to reprocess, explaining the rationale for not reprocessing these items. Include your QMS certifications (e.g., ISO 13485), audit/inspection history (last 5 years), and CAPA process. Describe how your Quality Management System and CAPA processes support performance-based contracting, measurable outcomes, and potential quality assurance surveillance by the Government in accordance with FAR principles. Provide sample device labels and chain-of-custody/logistics reports for representative non-critical SUDs. State readiness to comply with VA policies and update your status in response to regulatory changes. Describe anticipated challenges and solutions for addressing non-standard business processes (such as variations in device handling, workflow, collection, and onsite management) and the existence of multiple software systems/platforms across VA points of care. Specify how you will assess, adapt to, and mitigate the risks associated with these process and IT system variations during implementation and system integration. Explain how your proposed risk mitigation strategies for these variations will inform or alter your approach to phased deployment, including pilot planning and scaling to full enterprise adoption. C. Technical Approach, Workflow, and Interoperability Outline your non-critical SUD collection, sorting, logistics, and chain-of-custody system for VA s national footprint. Describe all tracking (barcoding, RFID, UDI), relabeling, and cycle management practices specifically for non-critical SUDs. Explain interoperability and data exchange with VA enterprise platforms (supply chain, EHR), including Section 508 accessibility and dashboard/reporting features. Attach a sample device tracking and utilization report for non-critical products. Identify any Government furnished property, data, or integration support you anticipate would be needed and how you would protect such assets in accordance with federal requirements. D. Reprocessing, Functional Validation, and Safety Detail all validated cleaning/disinfection, functional testing, and packaging processes for non-critical SUDs. Include evidence of device equivalency, validation studies, and sample performance metrics specific to non-critical SUDs. Explain recall, adverse event response, and reporting practices. Provide safety outcome data and case studies from similar non-critical SUD reprocessing in large integrated systems. E. Implementation, Training, and Change Management Detail your onboarding and ongoing education/training program for clinical, sterile processing, and supply chain staff specific to non-critical SUD handling and processes. Provide sample training materials or access to digital learning modules (508-compliant). Explain your approach for pilot/phased rollouts and scaling across VA regions for non-critical SUDs. Attach references and contact info for government or large-provider implementations involving non-critical SUDs. Describe how your implementation approach supports continuity of operations and minimizes disruption to clinical services in a federal healthcare environment. F. Environmental & Economic Outcomes (Evidence and Cost Estimate) Provide a detailed cost estimate for your proposed non-critical SUD reprocessing solutions. Break out: Per-device reprocessing costs (by SUD type and by volume tier, both collection and return-to-service); Up-front/recurring program costs (training, IT, logistics, account management); Any expected implementation/set-up costs (for pilot and system scale); Cost escalation formulas, savings guarantees, discount/volume thresholds, warranty/recall cost handling; Monetized environmental/waste savings estimates (if possible). Provide pilot-scale cost estimates and phased, 1-year-through-3-year total cost projections based on: Proposed pilot size (VA sites and device types), Anticipated adoption rates, Logistics/transport assumptions, Full deployment scenarios appropriate for VA enterprise-wide adoption. Include sample cost worksheets or templates and summarize cost drivers and price adjusters VA should consider for IGCE. Quantify, using anonymized/de-identified client case studies, total and average annual costs, and cost-avoidance/savings realized by other large health system/federal clients. Explain major cost drivers, assumptions, and contingencies to help VA assess cost realism and reasonableness and to inform selection of contract type (e.g., fixed price , IDIQ, or other structures consistent with FAR). G. Scalability, Timeline, and Supply Chain Risk Mitigation Describe your ability to scale processing operations nationwide for VA s anticipated non-critical SUD demand, including current capacity and expansion plans. Provide a timeline and milestones for scaling to full VA demand (with volume/phasing at each stage). Offer recommendations for phased implementation (by site, region, or device), including onboarding schedule. Identify key supply chain and operational risks (e.g., labor, logistics, materials, regulatory, collection variability) and provide mitigation strategies, disaster recovery, and business continuity plans. Include annualized and cumulative cost projections for each phase of proposed scale-up, highlighting cost inflection points associated with geographic expansion or device portfolio growth. Include examples of successful, rapid scale-up for other large integrated/federal clients related to non-critical SUDs. Describe how performance against these plans is tracked and reported. Identify any risks or dependencies that could affect contract performance and describe mitigation strategies that would be important for VA to consider in developing performance requirements and quality assurance measures. H. Data Security, Privacy, and Cybersecurity Detail your cybersecurity, privacy, HIPAA/HITECH, FISMA/FedRAMP compliance and security protocols for VA data exchange and device tracking related to non-critical SUDs. Provide evidence of third-party penetration testing and certifications where applicable. Confirm all reports, portals, and digital tools are or can be made Section 508 compliant. Describe any experience complying with VA-specific cybersecurity or privacy requirements (if applicable), including Authority to Operate (ATO) processes or similar activities. I. Contracting, Supplier Diversity, and Socioeconomic Participation Summarize your business model, contract types (fixed price, IDIQ, etc.), and service-level agreements for non-critical SUD reprocessing. Include a clear pricing model and breakdown for all contract types, with detailed pilot, interim, and full deployment price schedules. Describe any cost implications or incentives for inclusion of small/veteran-owned businesses as subcontractors. Summarize your preferred business/contract models for non-critical SUD reprocessing (e.g., firm fixed price, IDIQ, performance-based arrangements), including how you structure service level agreements, incentives, and remedies. Describe how your pricing model could be adapted to support VA s potential use of small business or Veterans First set asides, including approaches to teaming or subcontracting that maintain transparency and auditability. State your status (if any) as a Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), or other small/socioeconomic category, and describe your approach to meeting VA/VAAR socioeconomic subcontracting goals and Veterans First priorities. Describe any cost implications or incentives associated with inclusion of VOSB/SDVOSB and other small or disadvantaged businesses as subcontractors or teaming partners. J. Continuous Improvement, Innovation, and Roadmap Provide your roadmap for ongoing improvement, new non-critical device category addition, and technological innovation. Share frameworks for collaborative improvement, feedback cycles, and clinical engagement. K. Pilot / Proof of Concept Participation Your current section already supports phased acquisition and risk reduction activities that are consistent with FAR market research and acquisition planning practices. You may add one clarifier: Indicate willingness and best practices for a VA pilot or POC on non-critical SUDs, including proposed metrics, risk management, conversion to full implementation, and pilot-specific cost projections. Indicate whether your proposed pilot or POC construct could readily transition into a competitive procurement under FAR/VAAR and identify any constraints or considerations VA should plan for. L. Attachments Please find attached Appendix A MSPV Categories and Ready Matches. These are VA Medical Surgical Prime Vendor (MSPV) items and the associated categories active on the national product list that have been identified as having potential reprocessed equivalents. Please identify which items in Appendix A have a reprocessed equivalent. Also, please identify additional non-critical single use devices in your reprocessed item catalog for the VA s review and consideration.