Exalt Controller Processor

Sought VETERANS AFFAIRS, DEPARTMENT OF VETERANS AFFAIRS, DEPARTMENT OF -NETWORK CONTRACT (36C245) ND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES

Place of Performance Department of Veterans Affairs Baltimore VA Medical Center Page 1 of Page 1 of Page 1 of Page 1 of

This is not a solicitation but rather a Request for Information (RFI/Sources Sought) for market research purposes only. Department of Veterans Affairs, Veterans Health Administration, Network Contracting , is issuing this Sources Sought in order to identify capable firms and obtain information for planning purposes only. Responses must be submitted by 3:00 PM EST, July 17th 2026. Submit responses to this Sources Sought via email to [email protected] All SDVOSB and VOSB firms that respond shall include proof of SBA certification via https://veterans.certify.sba.gov/All small business firms that respond shall include proof of small business status via their Representations and Certifications in accordance with (FAR 4.1102 Policy). While SDVOSB/VOSB firms are preferred, all capable firms are welcome to respond to this Sources Sought. All respondents to this Sources Sought shall include as part of their response answers to the below

questions and provide any additional pertinent information that supports the answers. If there are any ambiguities in this Sources Sought, please identify them in your response. The results of this market research will assist in the development of (1) the requirement, and (2) the acquisition strategy (e.g., socioeconomic set-aside, full and open competition, etc.). VA assumes no responsibility for any costs incurred associated with the preparation of responses. Suggested NAICS: 339112 Surgical and Medical Instrument Manufacturing Suggested PSC: 6515 Medical and Surgical Instruments, Equipment, and Supplies Open to suggestions from the market as to a more proper NAICS and/or PSC, as well as any potential GSA/FSS Schedule SIN categories. Product ID# Product Quantity M00542430 EXALT Model D Controller 12 Month Lease Service/Maintenance 1 Year Statement of Work Exalt disposable duodenoscope processor for the disposable single use duodenoscope generation 4 Purpose Replacement of standard Olympus duodenoscope with disposable single use duodenoscope that requires the duodenoscope processor: EXALT Controller

Background Duodenoscope used in ERCP carry a significant infection risk due to there complex design, particularly the elevator mechanism, which is difficult to clean and disinfect. On December 10, 2018 the U.S. Food & Drug Administration (FDA) released interim results from post-market surveillance studies on contamination rates with duodenoscopes after reprocessing. FDA has issued a Safety Communication and provided a detailed list of supplemental duodenoscope reprocessing measures that can be implemented to reduce the risk of infection transmission, such as: microbiological culturing, sterilization, use of a liquid chemical sterilant processing system and repeat high-level disinfection. Interim results from these studies indicate higher-than-expected contamination rates after reprocessing, with up to 3% of properly collected samples testing positive for enough low concern organisms to indicate a reprocessing failure, and up to 3% of properly collected samples testing positive for high concern organisms. High concern organisms are defined as organisms that are more often associated with disease, such as E. coli, and Pseudomonas aeruginosa. The FDA recommends facilities and staff strictly adhere to the manufacturer s reprocessing and maintenance instructions, and follow these best practices: Recent evidence indicates infections rates are substantially higher than previously recognized, with persistent contamination. There has been a sharp increase in global reporting of duodenoscope-related infectious outbreaks, with the majority unrelated to identifiable breaches in disinfection protocols. This has led experts to question the design of the standard duodenoscope. In the Netherlands, a recent nationwide study found that 22% of duodenoscopes were persistently contaminated after high-level disinfection Exalt single use duodenoscope eliminates the risk of patient of patient infection due to ineffective reprocessing while also eliminates the reprocessing cost. The single use duodenoscope also delivers consistence performance the endoscopist expect from duodenoscope.

Objectives The