Vascular Shunt

THIS IS NOT A REQUEST FOR PROPOSALS OR A REQUEST FOR QUOTATIONS; IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT. 1. SUBJECT: The Air Force Medical Evaluation Support Activity (AFMESA) is conducting market research to identify vascular shunts, specifically indicated for treatment of distal vascular injuries, which can be applied in field or aeromedical evacuation (AE) conditions. Solutions should include commercially available devices, as well as prototypes that are expected to become commercially available. Responses are due to this request for information (RFI) by 1:00pm cst on 14 November 2014. 2. DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Respondents are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI marked as "proprietary" will be handled accordingly. Information provided as a response to the RFI will not be returned. AFMESA will not entertain any questions concerning the composition, requirements, or the nature of services to be performed under any future request for proposal (RFP). 3. BACKGROUND: Military combat operations have resulted in a high incidence of extremity injuries which can be associated with a high incidence of amputation. In order to improve the salvage rate of injured limbs, forward surgical teams need an improved capability to utilize vascular shunts in field conditions. The ability for a trained physician of any specialty to apply a vascular shunt in the field would be a marked improvement from current capability. Therefore, the Air Force Medical Support Agency, Requirements Division (AFMSA/SG5O) is requesting information regarding extremity vascular shunt that can be easily and quickly applied to wounded vasculature in a trauma situation. 4. REQUIREMENTS: AFMESA is seeking information on products that are commercially available, or that anticipate submission for regulatory approval to become commercially available. The device sought must meet the following requirements: Requirement Threshold Objective Comments Key Performance Parameters Device must pass Air Worthiness Certification (AWC) safe-to-fly criteria for all USAF AMC and rotary aircraft commonly used for medical missions. Yes T=O Or have appropriate waiver indicating AWC is not required. Device must be "approved for market" (PMA), "cleared to market" (510k), or "legally marketed" (as defined in the Code of Federal Regulations - 21 CFR807.92(a)(3) for class I and II devices). Yes T=O The device must maintain patency. Yes T=O The device must resist collapse, be resistant to kinking. The device must be easily inserted and secured with hemostatic junctions Yes T=O The device must be easily placed and stay in place and not leak at the junctions. The device must support distal perfusion 24 hrs 72 hrs The device must be non-thrombogenic. Must maintain distal perfusion until definitive revascularization. Requirement Threshold Objective Comments Key System Attributes Must include Industry standard for package insert Yes T=O Compliant with FDA requirements Device does not require power Vendor will provide initial training Train the trainer T=O Device must be pre-sterilized packaged ready for use Yes T=O i.e. gas, heat Device must be disposable as routine medical waste Yes T=O The device must be atraumatic to vascular and adjacent tissue during its entire use Yes T=O The device size variations must accommodate for range of luminal diameters in proximal and distal shunted truncal, nuccal, extremity vessels Yes T=O The device must accommodate for length variations in vessel disruptions Yes T=O The device must use only basic surgical equipment for insertion Yes T=O The device must use only basic surgical equipment for extraction Yes T=O The device must have the capability for diagnostic and therapeutic agents to be infused through the device Yes T=O Please indicate any compatibility restrictions The device must allow continuous confirmation of shunt blood flow Yes T=O The device must be radio opaque Yes T=O The device must be Doppler ultra-sound compatible Yes T=O The device must have the capability to support repeated blood sampling Yes T=O i.e. multiple ports; (To be able to insert medication and draw blood.) The device must assume its native configuration if deformed Yes T=O If cross-clamped, device must return to its natural form; travel along the contour of the wound The device must allow no more than 25cc of blood loss during insertion Yes T=O The device must allow no more than 25cc blood loss during extraction Yes T=O The device must not induce emboli Yes T=O The device must meet EMEDS minimal environmental requirements Yes T=O Please indicate storage temperature range The device must meet EMEDS minimal shelf-life storage requirements Yes T=O Please indicate shelf life of product The device does not injure blood cells or perturbe soluble blood components that pass through it Yes T=O Manufacturers are encouraged to submit a response to this RFI, even if a system does not meet all the requirements at this time. For requirements that are not met, trade-off considerations will also be considered. AFMESA also seeks information about academic, prototype, developmental, foreign and domestic commercially available products that meet or can be readily modified to meet the requirements discussed above. Submissions should include the provided vendor survey with additional supporting information. 5. RESPONSE INFORMATION: Response to this RFI must be submitted to Ms. Ashley Fredlock. Market Research Analyst, via e-mail to AFMSA.SG5T.Market@us.af.mil. Email responses should be no larger than 10 megabytes (MB) in size. If larger attachments are required, please notify Ashley Fredlock at the above listed email address. Each RFI response will receive a confirmation email; if a confirmation is not received please call 301-619-8600. Please include a point of contact, phone number, e-mail address, website information, and indicate whether the company is a foreign or domestic entity in the contents of the e-mail. Responses must be received by this office on or before 1:00pm cst on 14 November 2014. This RFI is not a commercial solicitation. The Government will not pay for any information submitted, or for any costs associated with providing the information. 6. LATE SUBMISSIONS: Failure to respond to this RFI does not preclude participation in any future competition, nor will information provided in response to this RFI be used to exclude anyone from responding to any future requests for proposals. Communications with AFMESA in regard to this RFI will only be permitted in writing during the RFI response period. Responses to the RFI received by AFMESA after the submittal deadline and time indicated may be considered. The respondent assumes the risk of the method of dispatch chosen. Postmarking by the submittal date and time shall not substitute for actual response receipt. 7. OWNERSHIP OF RESPONSE TO RFI: All informational material submitted in response to this request becomes property of AFMESA. Physical samples will be returned to the vendor at the owner's expense. 8. RELEASE OF CLAIMS, LIABILITY, AND PREPARATION EXPENSES: Under no circumstances shall AFMESA be responsible for any response preparation expenses, submission costs, or any other expenses, costs, or damages of whatever nature incurred as a result of the respondent's participation in this RFI process. Respondent understands and agrees that they submit a response at their own risk and expense, and release AFMESA from any claim for damages or other liability arising out of the RFI process. 9. ERRORS IN RESPONSE: AFMESA shall not be liable for any errors in respondent's response. Respondent is responsible for careful review of its entire response to ensure that all information is correct and complete. Respondents are liable for all error or omissions contained in their responses. 10. ADDENDUM: AFMESA reserves the right to issue an addendum to this RFI at any time for any reason. 11. CONTACT INFORMATION: Ms. Ashley A. Fredlock Air Force Medical Evaluation Support Activity (AFMESA) 1270 Montevue Lane (Area B) Fort Detrick, MD 21702 Phone: 301-619-8600 AFMSA.SG5T.Market@us.af.mil Vendor Survey (Please return with supporting documentation) Requirement Meets? Y/N Comments (Mandatory) Key Performance Parameter Device must pass Air Worthiness Certification (AWC) safe-to-fly criteria for all USAF AMC and rotary aircraft commonly used for medical missions. Please indicate whether AWC has been completed, and if not please indicate willingness level to participate in AWC testing. Device must be "approved for market" (PMA), "cleared to market" (510k), or "legally marketed" (as defined in the Code of Federal Regulations - 21 CFR807.92(a)(3) for class I and II devices). Please provide FDA 510(k) or anticipated submission date. The device must maintain patency. Please provide details The device must be easily inserted and secured with hemostatic junctions Please provide details The device must support distal perfusion Please provide details Key System Attribute Must include Industry standard for package insert Please provide details Device does not require power Please provide details on power requirements (if any) Vendor will provide initial training Please provide details Device must be pre-sterilized packaged ready for use Please provide details Device must be disposable as routine medical waste Please provide details The device must be atraumatic to vascular and adjacent tissue during its entire use Please provide details The device size variations must accommodate for range of luminal diameters in proximal and distal shunted truncal, nuccal, extremity vessels Please provide details The device must accommodate for length variations in vessel disruptions Please provide details The device must use only basic surgical equipment for insertion Please provide details The device must use only basic surgical equipment for extraction Please provide details The device must have the capability for diagnostic and therapeutic agents to be infused through the device Please provide details The device must allow continuous confirmation of shunt blood flow Please provide details The device must be radio opaque Please provide details The device must be Doppler ultra-sound compatible Please provide details The device must have the capability to support repeated blood sampling Please provide details The device must assume its native configuration if deformed Please provide details The device must allow no more than 25cc of blood loss during insertion Please provide details The device must allow no more than 25cc blood loss during extraction Please provide details The device must not induce emboli Please provide details The device must meet EMEDS minimal environmental requirements Please indicate storage temperature range The device must meet EMEDS minimal shelf-life storage requirements Please indicate shelf life of product The device does not injure blood cells or perturbe soluble blood components that pass through it Please provide details