Compartment Syndrome Monitoring Device

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 for a Compartment Syndrome (CS) monitoring device suitable to assess patients in the aeromedical evacuation (AE) environment (i.e., AE as it relates to the movement of patients under medical supervision to and between military medical treatment facilities by air transportation). Responses are due to this request for information (RFI) by 4 PM (1600) EDT four weeks from the date of posting. 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: The Office of the Air Force Surgeon General (AFMSA/SG5R) has identified a need for a CS monitoring device that will enhance the Air Force Medical Service's (AFMS) ability to provide a higher and standardized level of care for patients during AE missions undertaken by Critical Care Air Transport Teams (CCATT). The CCATT is a three-person, highly specialized medical team that operates a portable intensive care unit in an aircraft during flight. The CCATT is a limited, rapidly deployable resource and a primary component of the Air Force's AE system. Reducing the medical footprint in theater drives the movement of critically ill patients sooner, resulting in the need for CCATT to monitor and possibly treat more patients while en-route to a higher level of care. The CS monitoring device being sought will increase medical certainties and capabilities in the forward care operating locations that can result in saving the limbs and preventing permanent muscle damage to the warfighters. 4. REQUIREMENTS: The CS monitoring device sought must (1) operate in the AE environment, (2) provide the ability to monitor and improve the detection of CS, and (3) track serial measurements of compartment pressures to improve detection and avoid surgical intervention. Responses should address the requirements identified in this RFI, particularly those outlined in 4A and 4B below. 4A. MANDATORY REQUIREMENTS: The CS monitor must satisfy the following top-level requirements: 1. Meet air worthiness certification or safe-to-fly requirements for all USAF AMC and rotary aircraft commonly used for medical missions 2. Must provide proof of compliance with FDA regulations, Title 21 of the code of Federal Regulations and 510k marketing process 3. Measure clinical tissue pressure and/or equivalent surrogate of CS 4. The device must be man-portable 5. Work during all phases of the AE mission in places where external power is not readily available or not practical using common electrical sources 6. Meet Net ready standards 4B. FURTHER SPECIFICATIONS/CHARACTERISTICS: Address whether the CS monitor satisfies the following requirements: 1. Provides adjustable audio and visual alarms (compatible with flight platforms/health-care settings and threat environment despite extremes of light, noise, or vibration )that will alert the health care provider 2. Offers an analog or digital read out 3. Meets the industry standard for all patient data documentation in storage and/or export 4. Stamps the time/date on pressure readings 5. Transfers data between ground facilities and the AE environment 6. Offers wireless patient monitoring technology 7. Stores data in real time (24 hrs - 72 hrs), link to electronic health records, and maintain and export patient data 8. Captures standard data for transfer to e-health records 9. Offers the capability to inform the operator of device's status in all states of operation 10. Provides the capability for the users to dim the visual indicators or other lights 11. Meets applicable FCC standards 12. Does not introduce any new environmental or safety hazards other than those already common to operation of device in similar setting 13. Meets standard infection control guidance as prescribed by CDC and AF Guidelines 14. Meets environmental, safety, and occupation health (ESOH) standards 15. Offers system controls that are easy to operate. 16. System layout, involved operations and inputs are easy to grasp and manage 17. Detects the pressure reading or surrogate within the compartment either by spot check or continuously 18. Weighs between 2-10 lbs. 19. Sized between 6"x6"x2" and 1 cubic foot 20. Device can be placed and removed at bedside 21. Presents minimum risk to the patient (minimally invasive) 22. Offers a disposable catheter tip, needles, and catheter (invasive) if needed 23. Provides a ruggedized carrying case that shall be able to fit all parts of the device including cables 24. Device can be utilized and secured in any configuration and with any certified fixed/rotary wing transport stretcher/litter 25. Supports continuous use 26. If powered and continuous read-out, auditory and visual shall have low battery alarm and shall be mutable 27. Device shall renew or change power sources without interrupting operations 28. Battery shall be hot swappable 29. Battery shall maintain an operational charge 30. If device is battery operated, it shall be trickles recharge 31. Device shall have a charge indicator 32. Vendor must provide initial hands-on training 33. Device must have an operator's manual with pre-use/testing procedures and a list of any spare or replacement parts 34. Initial training will take place on user MTF/site no later than 3 days of device arrival 35. Vendor will provide user guidance materials for general device use 36. Vendor will provide training materials for users on new functionality and enhancement 37. Vendor must provide follow-on training to end user on new functionality or enhancements 38. Parts should be obtainable by any DoD entity without additional constraints 39. Complete system will operate at manufacturer's specification within the operational temperature ranges, 40? to 130? Fahrenheit 40. Complete system shall be capable of withstanding storage temperature ranges from -35? to 160? Fahrenheit without damages 41. Complete system shall be capable of withstanding a high humidity operational environment of 86? Fahrenheit at 95% RH when not in operation 42. Complete system shall operate at manufacturer's specifications in a dusty environment (particle size ? 105 - m) with a settlement rate of ? to 6'1g/m/day for 3 days 43. Minimum pressure measurement range shall be between -10 to 100 mm Hg 44. Ability to re-calibrate in operational environment 45. Repair of the device must not require use of proprietary tools or test equipment 46. System can be tested and basic repairs made a the unit level by technicians currently in the inventory 47. Battery charger uses 100-240 VAC, 50/60 HZ and has a 12 VCD adaptor. The battery will charge to 70% within 4 hours and to full capacity within 12 hours 48. AC and rechargeable battery power: Internal rechargeable battery life must be a minimum 6 hours with indicator of remaining battery life. Power cord is included. AFMESA 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. Anyone offering commercial off-the-shelf (COTS), foreign off-the-shelf (FOTS) or Government off-the-shelf (GOTS) or research and development (R&D) options that fulfills the capabilities outlined above should respond to this RFI. 5. CONTACT INFORMATION: Response to this RFI must be addressed to Mr. Rodney D. Aytch, Contract Administrator, via e-mail to: rodney.aytch.ctr@afncr.af.mil, Mrs. Virginia Wolcott, Medical Market Research Manager, via e-mail Virginia.Wolcott.ctr@detrick.af.mil, and Mrs. Susan T. Starks, Contracting Officer, via e-mail susan.starks@afncr.af.mil. Responses must be received by this office on or before 4 PM (1600) EDT four weeks from the date of posting. 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. 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. The response should describe the company's capability to offer, field, and sustain a compartment syndrome monitoring device as characterized by the requirements addressed in this RFI. If unable to provide a compartment syndrome monitoring device capable of meeting all requirements, the respondent should offer tradeoff considerations. 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 with 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(s) submitted in response to this request become property of AFMESA. No physical samples should be sent at this time. 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 it submits its response at its own risk and expense, and releases 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.