Replacment Attachment D - Faceshields.docx

B70FA2020R00000011 Attachment D – Face Shields Background

The mission of the Division of Strategic National Stockpile (DSNS), of the United States (U.S.) Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), is to ensure the availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of biological, chemical, radiological, natural disasters or other emerging infectious disease agents. When state, local, tribal, and territorial public health and medical systems request federal assistance to support their response efforts, DSNS ensures that the right medicines and supplies get to those who need them most during a public health emergency or pandemic event.

The Strategic National Stockpile (SNS) is a national repository of pharmaceuticals, vaccines, medical supplies, and medical equipment stored in strategic locations around the nation. These assets are designed to supplement state and local public health departments in the event of a large-scale public health emergency that causes local supplies to run out.

Protection of healthcare workers and first responders from transmission of pathogens is essential to maintaining resilience of the U.S. healthcare system. Eye protection is one part of an infection control strategy and is an example of personal protective equipment (PPE) that are devices used to help protect health care workers from splashes, sprays, and splatters of body fluids and infectious material in the air. Eye protection is designed to either cover the eyes only or to cover both the eyes and entire face. The appropriate use of PPE is an important component of the overall strategy of certain infection control guidelines.

Purpose

The U.S. Government is interested in establishing multiple awards for immediate purchases of Eye protection used in healthcare settings as described below. This will enable the United States to ensure sufficient availability of such items during national emergencies and/or pandemic events. The Government is concerned about the risks of disruption of any manufacturing facilities or supply chains located outside of the United States. Thus, offerors are advised to pay special attention to the instructions regarding manufacturing capability and/or supply chains located outside of the United States as well as the evaluation criteria related to manufacturing capability and foreign supply chains. The Government is concerned about the risks related to excessive pricing of critical PPE and intends only to acquire PPE at prices that it can determine are fair and reasonable. Thus, offerors are advised to pay special attention to the instructions regarding pricing.

Face Shield - A face shield is a device used to protect the user's eyes and face from bodily fluids, liquid splashes, or potentially infectious materials. Generally, a face shield is situated at the crown of the head and is constructed with plastic to cover the user’s eyes and face. Face shields are medical devices when they meet the definition of a device set forth in section 201(h) of the FD&C Act. Under section 201(h) of the FD&C Act, these products are devices when they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease.

Eye protection is an example of personal protective equipment that, depending on the type of device, can protect the eyes, face or associated mucous membranes from splashes, sprays, and airborne body fluids. Goggles provide direct eye protection for healthcare workers, whereas face shields offer a protective barrier to the entire facial area, eyes, nose and mouth. The choice of Eye protection is dependent on the level of risk of contamination.

Eye and face protection is manufactured in accordance with the American National Standards Institute (ANSI) International Safety Equipment Association (ISEA) Z.87.1-2010 standard. The following is a list of acceptable protective Eye protection based on their intended use and risk of contamination that may be proposed as part of the requirement:

1. Goggles – used to protect the eyes from splashes, sprays and infectious material

2. Face shields – used to protect the facial area, including mucous membranes (eyes, nose, mouth) from splashes, sprays and infectious material

Scope of Work

The Contractor, as an independent organization and not as an agent of the Government, shall furnish all labor, materials, supplies, facilities, equipment, transportation and travel necessary to deliver one or more of the following acceptable eye protection equipment. Preference will be given in order by:

· Disposable Face shields

· Must meet ANSI/ISEA Z.87.1-2010 standard

· Must cover the front and sides of the face; be full face length with outer edges of the face shield reaching at least to the point of the ear, include chin and forehead protectors, and cover the forehead

· Include a single Velcro strap and or elastic strap

· Treated for anti-glare, anti-static, and anti-fogging properties

· Equivalent or similar to Medline NONFS300

· Disposable Goggles (medical use)

· Must meet ANSI/ISEA Z.87.1-2010 standard

· Be indirectly vented

· Include solid side shields

· Include anti-fog lenses

· Reusable Face Shields and Goggles (medical use)

· Must meet ANSI/ISEA Z.87.1-2010 standard

· Face shields should follow same criteria listed above for disposable face shield

· Goggles should follow same criteria listed above for disposable goggles

Under the current FDA enforcement discretion (guidance), Registration and Listing requirements, Quality System Regulation requirements, reports of corrections and removals, and Unique Device Identification requirements are not required under COVID-19 emergency response declarations. FDA currently believes such devices would not create such an undue risk where the product is labeled as follows:

· The product includes labeling that accurately describes the product as a face shield and includes a list of the body contacting materials (which does not include any drugs, or biologics);

· The face shield does not contain any materials that will cause flammability, or the product meets Class I or Class II flammability requirement per 16 CFR 1610 (unless labeled with a recommendation against use in the presence of high intensity heat source or flammable gas);

· · The product is not intended for any use that would create an undue risk in light of the public health emergency, for example, the labeling does not include uses for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses, or for radiation protection.

A combination of the eye protection described above may be acceptable to meet the Government’s requirement.

Declaration of conformity to applicable standards listed above must be provided.

Offerors shall disclose and identify the following the following information

1. FDA Registration and date registered (if applicable)

2. FDA Listings and date listed for respective gown FDA product codes (if applicable)

3. FDA Premarket Document Number (e.g. 510k clearance) for respective product codes proposed (if applicable)

Product manufacturer and part number, description, and literature must be included in the proposal for consideration and mapped to appropriate FDA Product Codes.