Elastomeric Respirator Exhaled Breath Filter Adaptors – Prototypes

NOTICE OF INTENT TO ISSUE AN ORDER/CONTRACT. This is not a request for competitive proposals/quotes. The Centers for Disease Control and Prevention (CDC), National Center for Occupational Safety and Health (NIOSH), hereby announces its intent to issue a sole source order/contract to High Valley Design, Inc., 15328 Eastvale Rd, Poway, CA 92064-2336 The NAICS code for this acquisition is 541330 Engineering Services, with a size standard of $16.5 million. _______DRAFT SOW________ Elastomeric Respirator Exhaled Breath Filter Adaptors – Prototypes Background Healthcare providers are using reusable Elastomeric Half-Mask Respirators (ENMRs) to mitigate the effect of depleting stocks of disposable Filtering Facepiece Respirators (FFRs); also referred to as “N95 filter masks” at times of high demand such as during a pandemic such as COVID-19. One drawback of EHMRs is potential contamination of the sterile field and general areas from the wearer’s exhaled breath. The concern is that an asymptomatic Health Care Personnel (HCP) infected with COVID-19 and wearing an EHMR may spread the virus due to this unfiltered breath exiting through the exhalation valve. Some hospitals address this concern by placing a surgical mask or FFR over the exhalation valve area of the EHMR and have the Health Care Personnel (HCP) wear a faceshield during medical procedures and moving around other areas. These interim solutions to the EHMR for practical use in filtering the exhaled breath was required during contingency and crisis surge uses needed by HCP for their protection and most effective delivery of healthcare services. Project Objectives The objective of this project is to design and produce prototypes adaptors to retrofit commonly used commercially available EHMRs by HPCs to filter the exhaled breath discharged through the exhalation valve. These adaptors will be designed, produced by additive and/or other manufacturing processes to be evaluated by respiratory protection and healthcare experts at NIOSH – NPPTL and external hospital sites contracted by NIOSH to conduct use studies. Prototype adaptors to fit four commercially available EHMRs will be produced, each one going through three design iterations. These adaptors will be tested by NIOSH and feedback on the performance will be given to improve the design between each iteration with a view to minimizing the deviation from the respirator approval criteria that each EMHR currently meets. The final adaptor design iteration will be used in the hospital studies. A drawing package and report will be generated for record of the work completed. Through this approach, custom adaptor designs for select EHMRs used by HPCs and application in their working environment will be available for filtering the exhaled breath, assessing the deviation from the approvals and for further research. Design and Configuration The adaptors will be designed to fit onto the respective respirator encasing the exhalation valve assembly, sealing it from the ambient air and incorporate features to accommodate 95% or 100% single sheet or multi-layer filter media. The adaptors will direct the exhaled breath downward and/or rearward passing it through filter media before exiting the adaptor. Four adaptors will be designed, each going through three iterative design steps. Each of the four adaptors will be custom designed to fit commercially available EHMRs as listed below. Adaptor-1 for 3M 6200 (#7000001933) respirator with 7093 P100 cartridges (#7000002155) Adaptor-2 for 3M 7500 (#7000002162) respirator with P100 cartridges (#7000002155) Adaptor-3 for Honeywell North RU8500 (#RU85004) respirator with P100 filter cartridges (#7580P100) and cover (#N750029) Adaptor-4 for MSA Advantage 200 LS (Mfr. #815444) respirator with low profile P100 cartridges (Mfr. #815369) Each adaptor will undergo three design iterations in consultation with NIOSH-NPPTL. Each iteration will be submitted to NIOSH for performance tests according to a protocol developed for this purpose before commencing on the next iteration. The performance of the succeeding iteration will improve upon the performance and reduce the weight of the preceding one. Design iteration 1 – Initial design. 6 prototype adaptors for testing to be produced using polymer based plastic type material employing an additive manufacturing process. Design iteration 2 – Intermediate design. 6 prototype adaptors for testing to be produced using polymer based plastic type material employing an additive manufacturing process. Design iteration 3 – Final design. 30 prototype adaptors for testing to be produced using polymer based plastic type material employing an additive manufacturing process or limited run production molds. Tasks and Deliverables The project will commence with feature evaluation and performance criteria of the target commercial respirators in order to determine the best design direction for the adaptors. Then, detailed drawings with materials and performance / design requirements must be created and the prototypes constructed in three iterative steps. The prototype adaptors must be capable of being bench tested to evaluate their performance on NIOSH breathing machines. The final prototype must be durable enough for testing using human subjects in a hospital setting. High quality additive manufacturing and or tooling as required must be used for this purpose. Some individual parts may be machined instead of making tooling. The deliverables from this project will be the initial, intermediate and final prototype adaptors, a design package of the final prototype adaptor and final report as follows: Six (6) each initial adaptor prototypes for four (4) respirators. Six (6) each intermediate adaptor prototypes for the same four (4) respirators. Thirty (30) each final adaptor prototypes for the same four (4) respirators. Note: Preliminary prototypes need to be constructed for design review purposes. This would be an iterative process where multiple prototypes will need to be made and checked to improve the design incrementally. One (1) package (on readable CD) Solid model/ drawings of the final prototype adaptors One (1) Final Report detailing the development of the adaptor design _____________________________ A determination by the Government not to compete this proposed action will be based on responses to this notice and is solely in the discretion of the Contracting Officer. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. All vendors must be registered in the System for Award Management (SAM) at www.sam.gov , prior to an award of a federal contract. This action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) and 10 U.S.C. 2304(c)(1). Interested persons may identify their interest and capability to respond to the requirement or submit quotations. This is not a request for competitive quotations ; however, the Government will review any/all product, capabilities, and pricing information submitted prior to the closure of this notice. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Responsible sources that believe they possess the expertise and capabilities identified above are hereby afforded the opportunity to submit to the Contracting Officer within 5 days from the posting date of this notice, their written capabilities statement and pricing information in the format they choose, not to exceed 10 pages. Please forward product and pricing information to Diane Meeder, Contracting Officer, CDC, OAS, through email at [email protected]. Any responses should be emailed to Diane Meeder at [email protected] by July 10, 2020 at 12:00 P.M. ET .