In support of biopreparedness acquisition strategies, the Centers for Disease Control and Prevention (CDC) is seeking information from the manufacturing community on Respiratory Protective Device (RPD) and surgical mask products and manufacturing capabilities.
Respiratory Protective Devices are critical for health care providers treating or providing care for patients experiencing respiratory illness that could result from pandemic influenza or emerging infectious disease.
In addition, they are critical for first responders at other chemical, biological or radiological incidents. These incidents can quickly overwhelm the health care and first responder resources of the locale and the region. In a public health emergency, hospitals will need to surge the medical capabilities required to provide Respiratory Protective Devices to patient support personnel and first responders.
The 2009 H1N1 influenza pandemic exemplified the unpredictability and rapidity with which a novel influenza strain can impact the world’s population. With a historic effort from both Government and industry partners, vaccines were developed and available to the public six months after the initial outbreak.
“Despite high infection rates, the 2009 H1N1 virus was only mildly pathogenic, with relatively low rates of accompanying morbidity and mortality in the general population. However, it is possible that future pandemics will feature morbidity and mortality rates comparable with more severe pandemics such as 1957,” states the announcement. “The ever-present and ever-evolving threat of pandemic influenza presents a compelling need for the federal government to optimize preparedness using medical countermeasures currently available in the marketplace and to develop innovation in the prevention and treatment of influenza disease.”
Respondents are asked to provide information for the top 5 selling products that are or potentially could be used in the healthcare industry for Powered Air Purifying Respirators, Elastomeric half-facepiece respirators (EHFRs), N95 Filtering Facepiece Respirators (FFRs), and Surgical Masks.
Specifically sought is information on manufacturing capabilities, capacities and market information that address the following questions
- Time required to deliver high volume orders to a new buyer at normal demand
- How the product packaged for volume purchase, including container dimensions
- Length of time each model can be stored on shelf in original packaging and remain effective for use
- Whether expiry date is displayed on product packaging or product itself
- Average monthly domestic and international manufacturing production over the past year
- Percentage of production surplus
- Maximum monthly surge capacity that can be achieved and sustained over a 12 week period
- Ramp up time needed to initiate and achieve maximum production.
- Estimated number of each RPD model sold for disaster preparedness
- List of required components, subassemblies, and accessories as well as quantities needed, for complete assembly for each model (filters, hoods, battery packs and other related items)
- Location of manufacturer for these components, subassemblies, and accessories
The CDC anticipates the information obtained via this Request for Information (RFI) will inform future acquisition activities.
Further details are available under Solicitation Number: 2014-RFI-16513. The response deadline is June 5, 2014.