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 on compartment syndrome monitors suitable for use in assessing patients in the en route care environment. Responses are due to this request for information (RFI) by 2:00 PM Central Standard Time (CST) on 29 August 2012.
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: Air Mobility Command (AMC) has identified a need for a monitor with the ability to detect compartment syndrome. The compartment syndrome monitor should be able to measure clinical tissue pressure and/or equivalent surrogate of compartment syndrome in the hand, forearm, upper arm, abdomen, buttock, and entire lower extremity. Research has shown that proper and early detection of compartment syndrome can be limb/lifesaving, and a delay in diagnosis can be lethal. Therefore, AMC is looking for detection methods to improve diagnosis and treatment of compartment syndrome.
AFMESA is collecting information on commercial off-the-shelf (COTS), government off-the-shelf (GOTS), and foreign off-the-shelf and research and development (R&D) projects in relation to compartment syndrome monitoring.
4. REQUIREMENTS: The compartment syndrome monitor sought must operate in a variety of austere environments, including in the en route care environment. The compartment syndrome monitor should meet the following high level requirements:
1. Device should be "approved for market" (PMA), "cleared to market" (510k), or "legally marketed" (as defined in the Code of Federal Regulations - 21 CFR 807.92(a)(3) for Class I and II devices).
a. For R&D and prototype projects, must anticipate submission to FDA.
2. Device must measure clinical tissue pressure and/or equivalent surrogate of compartment syndrome.
3. Device must be man-portable.
4. Device should be able to meet all Department of Defense (DOD) Airworthiness Certification, Environmental Testing to Joint Airworthiness Certification (JAC), and Military Standard (MIL-STD-810G).

Manufacturers are encouraged to submit responses to this RFI, even if a system does not meet all the requirements. For requirements that are not met, trade-offs will be considered.
5. RESPONSE INFORMATION: Response to this RFI must be submitted to Ms. Ashley Fredlock, Market Research Analyst, via e-mail to [email protected]. Email responses should be no larger than 10 megabytes (MB) in size. If larger attachments are required, please notify AFMESA 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 by 2:00 P.M., Central Standard Time (CST) on 29 August 2012. 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.
The response should describe the company's capability to offer, field, and sustain the compartment syndrome monitor as characterized by the requirements addressed in this RFI. If unable to provide a compartment syndrome monitor capable of meeting all requirements, the respondent should offer tradeoff considerations.
Please ensure responses specifically address each requirement listed in section 4. Requirements. At a minimum, please complete and return the table provided below. Additional detailed information is encouraged.
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 Fredlock
Air Force Medical Evaluation Support Activity (AFMESA)
1270 Montevue Lane (Area B)
Fort Detrick, MD 21702
Phone: 301-619-8600
[email protected]

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