This document serves as a Request for Information (RFI) for medical device suppliers under RFI No. W81K04-25-Q-1993, aimed at gathering detailed company and product information pertinent to the operational and maintenance support of medical devices in austere environments, as utilized by the U.S. Army. Organizations are prompted to provide comprehensive company details including tax IDs, registration statuses, and socio-economic classifications, alongside a requisite outline of product support elements. Key inquiries encompass familiarity with the Defense Logistics Agency's electronic catalog, repair parts and kits, maintenance strategies, and the provision of operator and maintainer telephonic support. Additional focus includes packaging and transportation requirements, technical documentation, and training resources. The document also requests data on the device's power requirements and compliance with cybersecurity protocols, ensuring that products can operate effectively within the Department of Defense framework. This RFI aims to assess the capability of different suppliers to meet the U.S. Army's needs for reliable and maintainable medical devices, thereby streamlining the government’s procurement and logistical processes.

The United States Army Health Contracting Activity has issued a Request for Information (RFI) for a Portable Dermatome, designated RFI Number W81K04-25-Q-1993. This RFI aims to gather market insights to help determine if commercial solutions can meet specific requirements for this surgical instrument, which is essential for harvesting skin grafts. The RFI, issued on January 31, 2025, seeks responses by February 14, 2025, without any obligation for the Government to award contracts based on the information provided. Interested parties must demonstrate their capabilities in relation to the Critical Operational Device Specifications attached to the RFI. The North American Industry Classification System (NAICS) code for this project is 339113, aligning with surgical applications and supplies manufacturing. Respondents are advised to submit detailed and complete responses, while noting that all proprietary information must be marked as such. The RFI signifies the Government's intent to refine its requirements and explore viable commercial options, emphasizing that it is not a solicitation for proposals.

The Critical Operational Device Specification (CODS) outlines essential requirements for a Dermatome device intended for skin grafting procedures. It establishes both minimum and desired specifications for operational characteristics, including FDA regulatory clearance, operational pressure (minimum 100 psi), maximum oscillating speed (6,500 cycles/min), cutting width (1-4 inches), and thickness capabilities (0.000”-0.030”). Additionally, the device must support dual voltage power supply and have specific size and weight restrictions. The document also delineates critical logistic specifications, such as warranty provisions of at least one year, comprehensive repair parts support, and compliance with Trade Agreements Act (TAA). Desired features include a three-year warranty and vendor training. Moreover, an additional performance parameter highlights a preference for a medical-grade stainless steel instrument case equipped for sterilization. The CODS serves as a framework for manufacturers bidding for government contracts under RFP processes, ensuring that products meet rigorous standards necessary for medical use while promoting compliance and operational reliability.