SOURCES SOUGHT
65 -- Negative Pressure Wound Therapy (NPWT)
- Notice Date
- 11/15/2012
- Notice Type
- Sources Sought
- NAICS
- 334519
— Other Measuring and Controlling Device Manufacturing
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-13-RFI0001
- Archive Date
- 2/15/2013
- Point of Contact
- Laura N. Charles, Phone: 3016198392
- E-Mail Address
-
laura.n.charles@amedd.army.mil
(laura.n.charles@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- This Request for Information (RFI) is in accordance with the Federal Acquisition Regulation (FAR) clause 52.215-3, Request for Information or Solicitation for Planning Purposes and is published only to encourage interested parties to gather information about commercially available products that meet or can be readily modified to meet the requirements discussed below. THIS IS NOT A REQUEST FOR PROPOSALS OR A REQUEST FOR QUOTATIONS; IT IS STRICTLY A 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 United States Army Medical Materiel Agency (USAMMA) is conducting market research on technology solutions for Negative Pressure Wound Therapy (NPWT) suitable for field use in a battlefield setting. Responses are due to this Request for Information (RFI) by 31 Jan 2013, 4:00 PM EDT. 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 that is marked Proprietary will be handled accordingly. Information and representative samples as responses to the RFI will not be returned. At this time, USAMMA 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: Wounds sustained on the battlefield can be especially problematic, given the nature and severity of the injuries and the environment in which they are sustained. In the deployed environment, one modality that is being considered to improve wound healing is Negative Pressure Wound Therapy (NPWT). With NPWT, subatmospheric pressure is applied to a wound via a suction unit, dressing, evacuation tube, and outer dressing. The system is connected to a collection container that collects excess fluid from the wound bed, thereby enhancing circulation and disposal of cellular waste from the lymphatic system. Clinical benefits associated with the treatment reportedly include increasing local blood flow, decreasing bacterial colonization, facilitating the ability to measure and assess wound fluid, and increasing the rate of granulation tissue creation, contraction, and epithelialization. In addition, the wound is uniformly drawn closed by applying controlled, localized negative pressure. The USAMMA has identified a need for a NPWT for use by troops in deployed environments. Accordingly, the NPWT device will be used in non-standard medical environments with variable weather and lighting conditions. 4. REQUIREMENTS: There are two types of wound vacs that are required: one (1) for the intensive care unit (ICU) and one (1) for transport (the latter would be designated as a patient movement item (PMI) equipment). It is conceivable that one model could meet the requirements of both locations. The NPWT solution will provide a cost-effective, portable method for treating wounds. The tool must be lightweight, durable, and operable on the battlefield. The NPWT solution must be able to be used in-flight and in austere environmental conditions. Responses should address the requirements identified in item 4A of this RFI. Responses should include a representative sample of the device for limited examination. Sample items submitted will not be returned. 4A. MANDATORY REQUIREMENTS: The candidate NPWT device shall satisfy the following top-level requirements: 1. Devices shall be Food and Drug Administration (FDA) cleared. 2. Inpatient and portable units offered shall have compatibility of consumables and support items. 3. Portable device shall be able to pass air-worthiness certification (fixed wing and rotary wing) before final down-select and contracting. Specifically, the device shall have a Joint Airworthiness Certification (JAC) consisting of a safe-to-fly letter from the U.S. Air Force (for Fixed and Rotary Wing), Fleet Airworthiness Release (AWR) and an Aeromedical Certification Letter (AWC) from the U.S. Army. 4. Devices shall allow for regulation of suction from 75 to 200 mmHg negative pressure with "lockouts" to prevent inadvertent change of therapy. 5. Intermittent and continuous suction option with "lockout" shall be offered. 6. Therapy display shall include level and timing of therapy and alarm indicators. 7. The device display shall have low-light and Night Vision Goggle (NVG) compatible modalities. 8. Visual and audio alarms are required for blockage, leakage, loss of suction, and periods of no therapy applied to wound (5-10 minutes) and shall have adjustable settings for therapeutic levels and light and volume settings. Specifically, the device shall have alarm conformance in accordance with (IAW) IEC 60601-1-8, Medical Electrical Equipment - General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. The high and low alarm limits shall be independently adjustable and read on the display. 9. Screens shall be easily viewable in various lighting. 10. Drainage device should be a closed system. 11. Units shall have enclosed/secure disposable canister design for safety/integrity of therapy. 12. Replaceable collection canister with sufficient capacity for the portable and inpatient units is required. 13. A variety of dressing types shall be offered that will be suitable for wound care throughout the spectrum of patient care, providing for considerations of sizes, applications, and durability. 14. Devices shall have the following electrical characteristics: a. Safety switches in the event of a power surge via a fuse (Threshold) or surge protector (Objective). b. Units run on 100 to 240 VAC and rechargeable battery power. Internal rechargeable battery run time shall be a minimum 10 hrs. (portable units) and 4 hrs (inpatient units) with indicator of remaining battery life at -32ºC (-25ºF) to 49ºC (120ºF). Power cord to be included. c. Battery charger uses 100 to 240 VAC, 50/60 Hz or a 12 VDC, and shall have one (1) battery (Threshold) and the ability to charge to 70% within 4 hours and to full capacity within 12 hrs 15. The Portable and Inpatient NPWT units shall meet the following reliability, maintainability, and supportability requirements: a. Offerors shall submit reliability and maintainability data, to include mean time between failures (MTBF) and mean time to repair (MTTR) with any offered system. b. Offerors shall submit user references for the offered systems. c. Maintenance support items should be commercially available and not proprietary. d. Unless sold as a single use device (disposable), the systems shall be field maintainable by military biomedical engineering technicians. This includes unimpeded access to technical literature, parts, schematics, and other information necessary to repair and maintain the devices. e. The Device shall be maintainable by military Biomedical Equipment Technicians (BMET) using standard tools (as provided in standard BMET kit; no special tools required) without voiding warranty and shall be capable of being cleaned by commonly accepted methods. Repair parts and/or telephone consultation before and after warranty period will be provided to Department of Defense (DoD) BMETs without need to attend manufacture specific training. f. Device system software that may require modification during system life shall be upgradable in the field by military Biomedical Engineering Technicians using a computer interface, the Internet, or a CD supplied by the manufacturer without changing hardware components of the device. Manufacturer notification of product software modification and updates sold to customers is required. Outdated software should not render the device unusable. 16. Packaging: a. System Package. Each complete Portable and Inpatient NPWT unit, including all components, shall be packed in reusable hardened cases. b. The Device shall have Shipping and Storage temperature ranges within allowable limits for cold and hot storage and operational environments per Joint Enroute Care Equipment Test Standard (JECETS), which specifies temperature limits and specifies using the test methods in 810G for Tactical-Standby to Operational environmental Tests. c. Weight. Portable devices shall be lightweight and have a sturdy carrying case. Portable unit weight (including batteries) shall not exceed five (5) pounds, with objective weight of three (3) pounds. d. User's quick reference guide shall be provided and attached to unit. e. Shall be designed such that consumables and other materials that deteriorate (e.g., batteries) shall be stored in a non-installed position to prevent damage but still be available for testing of the system. f. Cube. The government desires the smallest possible cube size. 17. Environmental Performance: a. The complete system shall be capable of withstanding storage temperature ranges from -35 degrees to 160 degrees Fahrenheit without damage. Evaluation shall be in accordance with MIL-STD-810G. b. The complete system shall operate at manufacturers' specifications within the operational temperature ranges from 40 to 110 degrees Fahrenheit (Threshold), 40 to 130 degrees Fahrenheit (Objective). Evaluation shall be in accordance with MIL-STD-810G. c. The complete system shall be capable of withstanding a high humidity operational environment of 86 degrees Fahrenheit at 95% RH and 140 degrees Fahrenheit at 95% RH when not in operation. Evaluation shall be in accordance with MIL-STD-810G. d. The complete system shall operate at manufacturers' specifications in a dusty environment in accordance with MIL-STD-810G. 18. A one (1) year warranty on parts and in-house labor and technical support including 24 hours per day, 7 days per week operator/maintainer telephone support during the warranty period shall be included. A one (1) year maintenance agreement to include software/hardware upgrades, with an optional renewable agreement. 19. One (1) CD or DVD-based training video covering system setup, use, and troubleshooting for operator and maintenance personnel shall be included for each unit. 20. Documentation: a. All component and printed card schematics shall be included. b. Two (2) copies of printable electronic manuals shall be in English (Threshold) or multilingual (Objective) including Spanish, French, German, and Arabic. The following shall be included with copyright release for military use only: i. Operators manual. Include check out procedure. 1. OEM or vendor shall provide materials necessary for operator and maintenance training, both for initial and future deployment, as well as the cost of available training courses and materials. 2. Training materials and courses used in commercial deployment of the monitor devices are preferred. Training material can be via classroom, CD, online (web-based), or in a manual form. ii. Service manual. Include recommended maintenance checks. 1. Electronic and hard copies of operator's and service manuals shall be available. 2. Shall also include, but not limited to: all schematics (e.g., electronic, pneumatic, and as applicable), troubleshooting guide, and theory of operation. 3. Service manual shall include parts layout with part numbers for each replaceable component. 4. Service manuals shall be identical to vendor service technician manuals and should not require vendor service training to obtain. iii. Parts Lists with costs. 1. This system shall have Unique Item Identification markings in compliance with Department of Defense Federal Acquisition Regulations (DFARS) clause 252.211-7003, Item Identification and Valuation. 2. All cables and accessories (to include disposables) needed to initially operate the Device shall be included within the case. 3. Device shall be provided with but not limited to the following accessories: two (2) each 5-lead ECG patient cables, 10 feet minimum length. Three each pre-gelled electrodes. One (1) each power adapter 100-240 volt, AC, 50/60 Hz, and IEC power cord for specified country. One (1) each temperature, NIBP, 12-lead and invasive pressure cables. One (1) each CO2 sensor and airway adapter set. One (1) each 8-foot (2.4 meter) extension cable. Two (2) each disposable pulse oximetry sensors to fit an adult. USAMMA seeks to gather information about commercially available products that meet or can be readily modified to meet the requirements discussed above. 5. CONTACT INFORMATION: Electronic responses to this RFI shall be addressed to Laura N. Charles, Contracting Officer, email: laura.n.charles@amedd.army.mil. Samples must be addressed to: U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Rd, Ft Detrick MD 21758, no later than (NLT) 31 January 2013, 4:00 P.M. This RFI is not a commercial solicitation and the Government will not pay for any information or items in reference to this RFI. 6. RESPONSE SUBMISSION: Responses in reference to this RFI shall be submitted via e-mail or mail. Responses that are mail shall be submitted in a sealed envelope or package with the Respondents name and address clearly marked on the outside of each sealed envelope or package. Please include point of contact, phone number, email address, and web site information inside the sealed envelope or package. Respondents shall certify whether the company they represent is a U.S. business. The response should describe the company's capability to offer, field, and sustain a NPWT device as characterized by the requirements addressed in this RFI. If unable to provide a NPWT device capable of meeting all requirements, the respondent should offer tradeoff considerations for unmet requirements. Respondents should mark all proprietary data as appropriate. The USAMRAA and USAMMA will protect proprietary information from unauthorized use and disclosure. Unless clearly marked otherwise, submission of a response to this RFI signifies agreement to allow USAMMA personnel to use the information to aid in developing an acquisition approach. 7. 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 RFPs. Communications with USAMRAA in regards to this RFI shall be submitted in writing during duration of this RFI. Responses received after the closing deadline of this RFI 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. 8. OWNERSHIP OF RESPONSE TO RFI: All material submitted in response to this RFI shall become the property of Government. 9. RELEASE OF CLAIMS, LIABILITY, AND PREPARATION EXPENSES: Under no circumstances shall the Government be responsible for any contractor expenses in preparation of this RFI, such as: submission costs, any other expenses, costs, damages, or whatever nature incurred. Respondent understands and agrees that respond submission is at their own risk and expense, and the Government is released from any claim for damages or other liability arising out of the RFI process. 10. ERRORS IN RESPONSE: USAMMA shall not be liable for any errors in Respondents 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. 11. ADDENDUM: USAMMA reserves the right to issue an addendum to the RFI at any time for any reason. 12. SAMPLES: USAMMA requests the Respondents submit a test copy of any or all products or services described and identified in the RFI response(s). All interested, capable, and responsible sources that wish to respond to this RFI are encouraged to submit documentation on their specific capabilities. In addition to relevant and relative capability statements, past performance, and other information, the Government requests responses to provide, as a minimum, the following: 1) Title Page: The capability package shall be assembled with a title page containing the following information: Company name, address, point of contact, telephone number, DUNS number, cage code, and business size. Please include any socio-economic information. 2) Experience: Offeror shall provide prior/current experiences for the same or similar size and scope including contract number point of contact (POC), and company or agency. Indicate whether a prime or subcontractor, contract value, and Government or commercial point of contact with current telephone number and email address.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-13-RFI0001/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Ft Detrick, Maryland, 21702-5014, United States
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN02931438-W 20121117/121115234721-11cf08707a7cd6564395d615fe5eff26 (fbodaily.com)
- Source
-
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