--CASPOD FIELD TRIALS FOR MEDICAL TECHNOLOGIES

NA The Defense Threat Reduction Agency (DTRA) is sponsoring the Joint Chemical Field Trials-II (JCFT-II) as part of the Contamination Avoidance at Seaports of Debarkation (CASPOD) Advanced Concept Technology Demonstration (ACTD). The JCFT-II will be used as the technical test bed to evaluate key performance parameters of selected tec hnologies/devices for possible inclusion in the ACTD. Four commodity areas will be evaluated: Detection, Decontamination, Personal/Collective Protection, and Medical. Each commodity area will be advertised in a separate announcement. This announcement is for mature medical technologies and devices. The word - mature, is used to mean Technology Readiness Level (TRL) Seven or higher per DoD 5000.2-R, Appendix 6. TRL-7 means that a system prototype demonstration has occurred in an operational environment and that the prototype is near or at planned operational system level maturity. Your device/technology must offer significant improved performance and/or other potential benefits (such as reduced logistics burden) over currently fielded military items to be considered for inclusion in CASPOD. Field trials are planned to be held at Dugway Proving Ground (DPG), UT, during the November 2002 to April 2003 period (although actual on-site testing time will likely be less than a few weeks). For some medical items, technical testing may occur elsewhere . These field trials will provide technology developers an opportunity to both demonstrate their devices'/technologies' potential for inclusion in the CASPOD ACTD or future CB defense programs, and obtain unique performance data that can be used in their developmental work. In addition, technologies/devices participating in the trials may become visible to a number of U.S. and foreign agencies. If invited, you must be willing to provide your device/technology and any required on-site support to the trial site at no cost to the government. In return, you will be provided detailed technical and operational test data on your device/technology follo wing the conclusion of all testing. The key user needs for medical technologies focus on four medical functional areas: - Field expedient medical diagnostics - CB patient isolation systems - Personnel decontamination (both individual and collective) - Skin protection - Language translators - Collective protection - Human remains containment - Decontaminable field litters - Digital patient records and medical surveillance - Field telemedicine, including telecommunications Field expedient medical diagnostics devices are small, preferably hand-held or compact devices capable of detecting chemical or biological agents in human bodily fluids and tissues. Technologies should: - Detect multiple agents (chemical or biological) on one platform - Be approved (or approvable) by the FDA for all claims made by the licensee. Approvable means the vendor has written information from the FDA that they have reviewed the product dossier and specifically declared it - approvable - Not require extensive sample clean up prior to analysis - Rapidly analyze samples - Be producible using a validated manufacturing process CB patient isolation systems effectively permit isolation of non-ambulatory patients from their external environment. Once isolated, contaminated patients will not cross- contaminate treatment or holding personnel and non-contaminated patients can travel t hrough contaminated areas without risk. All isolation technologies should: - Reliably protect against cross contamination of chemical and biological agents, (including Toxic Industrial Chemicals/Materials (TIC/TIM) as a secondary requirement to CB) - Permit advanced trauma and life support to patient, including full body monitoring and drug administration - Be decontaminable and re-usable, except for specific consumable components - Be of size and weight that enables carriage on standard NATO litters and evacuation platforms and entrance to collective protection systems Personnel decontamination includes systems individuals can use to decontaminate bare skin in a self- or buddy-aid scenario and systems designed to decontaminate a number of individuals quickly and effectively, such as mass casualty scenarios. The systems may use wet or dry decontaminants. For consideration, potential medical decontamination systems must: - Have proven decontamination efficacy against chemical warfare agents in vivo (required) and in vitro (desired). Provide testing results on the efficacy against VX, HD and a G-type agent performed by a reputable Chemical Agent Surety Laboratory, either d omestic or foreign. Efficacy studies should meet Good Laboratory Practices standards or equivalent. - Be approved (or approvable) by the U.S. FDA for all claims made by the licensee. Approvable means the vendor has written information from the U.S. FDA that they have reviewed the product dossier and specifically declared it - approvable for human use. - Demonstrate a preliminary capability to kill bacterial spores such as Bacillus anthracis or simulant such as B. subtilis, B. globigii, or B. thuringensis, etc. - Supply information on material compatibility. If data on the system do not exist, at the minimum, a paper study of the components should be provided. - Supply MSDS's on all products. - Supply samples that are representative of the commercial production lot (for the JCFT II testing if requested by the government). - Provide evidence of production capability/capacity. - Describe or illustrate packaging and/or mixing options - Disclose detailed shipping and storage requirements or restrictions as well as the results of pot and shelf life testing. - Provide the results of operational testing using their product in the decontamination of large pieces of equipment, fixed facilities such as buildings, or terrain. - Provide procedures for applying the decontaminant The system should consider safely removing the decontaminant from the area of operation such that the decontaminant does not build up to create a hazardous situation. NOTE: Any change in the formulation of a selected product requires resubmission of updated surety, material compatibility, potency life, shelf life, and other data. In addition, mass casualty decontamination systems must: - Use FDA approved decontaminants and meet all specifications above - Permit rapid set up time using a small number of people - Permit whole body decontamination of both ambulatory and non-ambulatory patients - Have sufficient room (under cover) to enable triage, decontamination, and clearing without significant risks of cross contamination - Provide a safe operating environment to patients and operators, such as warmed solutions and environmental controls - Provide lighting, spacing, and raised platforms sufficient to examine, treat, and monitor patients during decontamination - Provide a distinct - hot line between contaminated and clean areas, including ways to ensure integrity of the line - Accommodate use of standard NATO litters Offerors of mass casualty decontamination systems must also describe: - Time and personnel required to set-up, test, and operate mass casualty decontamination facility adjacent to hospital or other - cold zone - Number of casualties per hour (ambulatory and non-ambulatory) thoroughly decontaminated and cleared to enter the medical treatment facility or other - cold zone - Time required to decontaminate and clear ambulatory patient. - Time required to decontaminate and clear non-ambulatory patient. Language translators are small hand held devices that permit medical personnel to communicate (i.e., speak and hear) in foreign languages. These devices will enable first responders and medical care providers to acquire and provide medical information nec essary to triage, diagnose and treat non-English speaking casualties. Language translations technologies should; - Have at least 1000 phrases each in multiple languages, including those used in the Middle East - Detect the task specific medical operations, but also have a full contingent of generic phrases (e.g., greetings, date and time questions, and answers and questions) - Be audio based, but supplemented with written language capabilities - Have capability to interface with external loud speaker systems - Produce a clearly human voice with inflection, rhythm and accent versus machine voice - Operate on standard batteries (rechargeable preferred) - Not weigh more than 20 ounces with batteries installed and small enough to fit comfortably in one hand - Be capable with USDII / COE standards Skin protection technologies are FDA approved medical products that can be applied by individuals before CB attack and provide protection against dermal absorption of hazardous liquid, solid, or gaseous agents. Skin protectants: - Have proven efficacy on the skin for over 8 hours following a single application - Provide effective barrier protection (i.e., significantly reduce percutaneous absorption through intact skin) for at least 4 hours of constant contact with agent - Protect against sulfur mustard, thickened soman, sarin, VX and T2 toxin - Can be applied to vulnerable areas of the body, e.g., face and neck, groin area, and areas where over garments seam with gloves, boots, and at waistline. - Effective when used with standard military protective clothing and equipment - Stable in formulation and when stored in hot, cold, wet, and dry environments without special holding equipment Medical Collective Protection systems will offer users collective protection equipment, such as easily erected shelters, having sufficient space for at least 40 patients and requisite medical staff. Collective protection technologies must provide: - Environmental protection against chemical and biological warfare agents (required) and Toxic Industrial Chemicals/Materials (TIC/TIM) as a secondary requirement. - Environmental controls that ensure the system is useful in hot and cold climates - Configured as a complete, integrated system - Easy set up with a minimum of personnel - Capability to be stored in non-climatic controlled environments with temperatures rising to 160-degrees F CB protective human remains containers, or pouches, provide effective containment of hazardous agents on or in deceased personnel. These pouches eliminate risks to medical and mortuary affairs personnel and facilities until thorough decontamination of the remains can be completed. In addition, CB protective human remains pouches: - Are easily deployed and easy to contain remains - Readily decontaminated with standard military decontamination solutions - Permit venting of gases that build up inside the pouch, but do not allow unsafe off-gassing of vaporous agents or leakage of liquid or solid agents - Nearly instantaneous equilibration of air pressure with outside environment - Easy to carry and move short distances without the aid of a litter - Durability under military operational conditions - Do not require forced air blowers or other powered mechanisms to be effective - Readily identify the identity of the contained remains Decontaminable field litters enable carriage of non-ambulatory patients through the relatively tight passages of CB facilities (e.g. decontamination facilities and medical collective protection systems) and are readily and effectively decontaminated using standard military decontaminants. In addition, these litters: - Are light weight yet highly durable under military operational conditions - Tolerate repeated decontamination - Reliably holds a person (and personal gear) in the 95th percentile of normal body weight - Easy to deploy by one person - Easy and compact to store when not in use - Have patient tie downs with adjustable positioning to avoid injured areas of the body Digital patient records with medi cal surveillance technologies enable rapid and reliable electronic capture of personal information, signs and symptoms, diagnosis, and treatments given; aggregate such data; and analyze them for epidemiological significance. All technologies should: - Have proven application in the U.S. health industry or in military health operations - Meet U.S. Defense Information Infrastructure/ Common Operating Environment (DII/COE) standards - Use client: server approaches to distribute patient data acquisition functions widely (e.g. at treatment sites) on clients, and aggregate regional data centrally at the server. - Use state-of-the-art algorithms for quickly analyzing population data with high resolution, such as change point detection technologies - Produce commonly used medical surveillance reports, including NATO standard reports - Safeguard patient privacy - Capability to be linked via a network to a medical command center Telemedicine technologies are hardware, software, and telecommunications systems that enable remote health care providers to consult with regionalized medical specialists. The most common application for remote field use may be - store and forward treatme nt of digital patient records and graphics, e.g., photographs, wave forms, or text. Telemedicine technologies may be integrated with digital patient records with medical surveillance systems. Telemedicine technologies should: - Have proven field application in the U.S. military - Be DII/COE compliant - Be a fully integrated system of hardware, software, communications, and data capture devices (data capture devices must be U.S. FDA approved) - Enable multiple telecommunications modes, including RF, LAN, - Safeguard patient privacy In addition, all medical technologies and products must have: - Capability to be stored in non-climatic controlled environments with temperatures rising to 160-degrees F - If it operates on external power sources, must run on dual (110/220) voltage at 50/60 Hz - Minimal training skills and logistics support requirements For submissions to be considered, developers/sponsors must electronically supply (.doc or .pdf format) the following information in the order and format in which it is presented below IAW the user needs specified above to Dr. James Stewart, contact@example.gov g, no later than close of business June 14 2002: - Technical specifications and description of the science & technology principles upon which the device/technology is based. Submissions should include: - a picture of the item - size, weight, power requirements & power consumption - Your concept of employment for the product, covering the following aspects of its use: - Where the product would be used in actual operation - When the product would be used - Who specifically would use the product (e.g. first responders, physicians, emergency operations centers, etc) - Which CB agents the product specifically has utility - How quickly the system can be deployed on site - When is utility realized (e.g. immediately, after 12 hours, etc). - Cost of the device/technology in small quantities (less than 10), including cost of any replenishment items (consumables), and delivery lead time - Your estimate of the operator skills and training time required/availability of training material - Summary (with references) of Test Data from independent government sources. Alternatively, summary of other test data (with references). The cost of preparing submissions in response to this announcement is not considered an allowable direct charge to any resulting purchase or any other contract. There will be no formal request for proposals or other solicitations regarding this announcemen t. The Government reserves the right to select one, some, or none of the submissions for further investigation. Submissions shall not exceed five (5) 8.5 X 11 inch, single-sided pages per product. Product MSDS, independent technical reports, and laborator y report s may be attached in an appendix and will not count against the length requirement. Vendors who submit packages for review do so with the understanding that U.S. Government personnel as well as their support contractors will review their literature. The p urpose of this document is to identify potential sources. There is no solicitation document at this time. Any requests for a solicitation package will be disregarded. Special Notice: If you have responded to or participated in the Restoration of Operations (RestOps) ACTD and there are no significant improvements to your device/technology, or if you responded to the Broad Agency Announcement 02-Q-4655 - Under Secretary o f Defense for Acquisition, Technology and Logistics [USD (AT&L)] and Combating Terrorism Technology Support Office Technical Support Working Group (TSWG), which closed at 1600 (4:00 pm) EST 23 Dec 01, you need not respond to this announcement. You are al ready under consideration for the CASPOD ACTD.