Replacement Attachment B - Gowns_coveralls_Supply_Listing.docx

70FA2020R00000011 Attachment B – Gowns Overalls 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. Gowns are one part of an infection control strategy and are examples of personal protective equipment (PPE) that is a device intended for medical purposes that is worn over the arms and body to prevent contamination between patient and health care personnel. The appropriate use of PPE is an important component of the overall strategy of certain infection control guidelines. Coveralls are also included in this solicitation.

Purpose

The U.S. Government is interested in establishing multiple awards for immediate purchases of Gowns 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.

Gowns are examples of personal protective equipment that are intended to promote infection control practices and help protect patients and healthcare workers against microorganisms and body fluids during routine care, examinations, and medical procedures. The choice of gown is dependent on the level of risk of contamination. The American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) PB70 establishes a system of classification for surgical and isolation gowns used in healthcare facilities, based on their liquid barrier performance. The ANSI/AAMI PB70 standard includes four standard tests to evaluate the barrier effectiveness of surgical gowns, isolation gowns, and surgical drapes. Based on the results of these standardized tests, four levels of barrier performance are defined, with Level 1 being the lowest level of protection, and Level 4 being the highest level of protection. ANSI/AAMI PB70 levels are as follows:

a) Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit

b) Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab

c) Level 3: Moderate risk, to be used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases

d) Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed, or infectious diseases are suspected (non-airborne)

The following is a list of acceptable protective gowns based on their intended use and risk of contamination that may be proposed as part of the requirement:

a) Isolation gowns – Typically non-sterile, used to protect health care personnel and patients from the transfer of microorganisms and body fluids in patient isolation situations, used for routine patient care in healthcare settings.

a. Low risk of contamination – isolation gowns that claim minimal or low levels of barrier protection; ANSI/AAMI PB70 Level 1 or Level 2. These gowns should not be worn during surgical or invasive procedures, or for medium to high risk contamination patients care activities.

b. Medium to high risk of contamination – isolation gowns that claim moderate to high barrier protection; ANSI/AAMI PB70 Level 3. These gowns are called surgical isolation gowns. They can be provided either sterile or non-sterile. Sterile surgical isolation gowns can be used in surgical settings, while the non-sterile surgical isolation gowns cannot.

b) Surgical gowns – sterile devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate matter.

a. Surgical gowns are regulated by the Food and Drug Administration (FDA) under 21 CFR 878-4040 as a Class II medical device.

b. Medium to high risk of contamination – surgical gowns that claim moderate to high barrier protection; ANSI/AAMI PB70 Level 3 and Level 4.

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 Gowns.

· All gowns

· May be woven or non-woven fabric.

· Must be latex free

· Must meet ASTM F2407 standard

· Must meet CPSC standard 16 CFR Part 1610, Class 1 or Class II for flammability

· Must be clearly labeled with manufacturer, size, barrier protection level and dimensions/locations of critical and non-critical zones.

Preference will be given in order by:

· Isolation Gowns Level 2 and Surgical Isolation Gowns Level 3

· Barrier Protection

· Passes ANSI/AAMI PB70 Level 1 requirements or made of fabrics and seams that pass at a minimum AATCC 42 ≤ 4.5 g

· Passes ANSI/AAMI PB70 Level 2 requirements or made of fabric and seams that pass at a minimum AATCC 42 ≤ 1 g and AATCC 127 ≥ 20 cm H20 or EN 20811 ≥ 20 cm H20

· Passes ANSI/AAMI PB70 Level 3 requirements or made of fabric and seams that pass at a minimum AATCC 42 ≤ 1 g and AATCC 127 ≥ 50 cm H20 or EN 20811 ≥ 50 cm H20

· Passes ANSI/AAMI PB70 Level 4 requirements or made of fabric and seams that pass at a minimum ASTM F1671 or ISO 16604 ≥ 14 kPa

· Biocompatibility

· Materials used in the construction is non-sensitizing and non-irritating in accordance with ISO/ANSI/AAMI 10993-10

· Natural Rubber Latex

· Gowns that contain natural includes the latex caution statement CFR 801.437, “THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTION.”

· Design

· Full coverage, no open back

· Equivalent or similar to Medline NONLV200 and Medline NONLV315

· Size

· Sizes: small, medium, regular/large, extra large, extra extra large

· Other than Surgical Gown Labeling

· Labeled as a gown other than a surgical gown (e.g., isolation gown) and it is not described in its labeling as a surgical gown. The product includes labeling that accurately describes the product as a “gown,” or “toga,” or other apparel (as opposed to a “surgical gown,” or “surgical toga”) and includes a list of the body contacting materials (which does not include any drugs or biologics);

· Includes statements relating to barrier protection, and such statements are for only minimal or low barrier protection (e.g., ANSI/AAMI PB70 barrier protection Level 1 or 2).

· The product includes labeling that makes recommendations that would reduce sufficiently the risk of use, for example, recommendations against: use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected, use in a clinical setting where Level 3 or 4 protection is warranted, and use in the presence of high intensity heat source or flammable gas; and

· 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.

· Surgical Gowns

· Barrier Protection

· Passes ANSI/AAMI PB70 Level 2 requirements or made of fabric and seams that pass at a minimum AATCC 42 ≤ 1 g and AATCC 127 ≥ 20 cm H20 or EN 20811 ≥ 20 cm H20 at the critical zones defined by ANSI/AAMI PB70

· Passes ANSI/AAMI PB70 Level 3 requirements or made of fabric and seams that pass at a minimum AATCC 42 ≤ 1 g and AATCC 127 ≥ 50 cm H20 or EN 20811 ≥ 50 cm H20 at the critical zones defined by ANSI/AAMI PB70

· Passes ANSI/AAMI PB70 Level 4 requirements or made of fabric and seams that pass at a minimum ASTM F1671 or ISO 16604 ≥ 14 kPa at the critical zones defined by ANSI/AAMI PB70

· Passes EN 13795 standard performance gown requirements

· Passes EN 13795 high performance gown requirements If labeled as Level 4 gown, FDA 510(k) clearance is necessary

· Biocompatibility

· Materials used in the construction of surgical gowns passes ANSI/AAMI BE78 or ISO 10993-10

· Sterility Assurance Level

· Sterile gown. Selected sterilization process for surgical gowns has a sterility assurance level of at least 10-6. Appropriate sterilization processes include those specified in ISO 11134 for moist heat, ISO 11135 for EtO, ISO 11137 for Gamma or ISO 13683 also for moist heat.

· Has been demonstrated to be sterile if intended for use in surgical settings

· Flame Spread

· Materials used in the construction of surgical gowns meets the requirements for Class 1 or Class II in accordance with 16 CFR Part 1610 before and after the conditioning specified in Section 9.

· Natural Rubber Latex

· Gowns that contain natural rubber latex should be clearly labeled and include the latex caution statement CFR 801.437, “THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTION.”

· Must be sterile

· Must be low lint

· Must meet Laser and ignition resistance standard (ISO 11810)

· Surgical Gowns (liquid penetration), (penetration by bloodborne pathogens) standard specifications Must meet Laser and ignition resistance standard (11810)3, and Level 4 small, medium,

· Design

· Full coverage, no open back

· Equivalent or similar to Medline DYNJP2002, Cardinal 9545, and Cardinal 9040

· Size

· Sizes: small, medium, regular/large, extra large, extra extra large

· Coveralls

· Single use

· Barrier Protection

· Made of fabrics and seams that pass at a minimum AATCC 42 ≤ 4.5 g

· Made of fabric and seams that pass at a minimum AATCC 42 ≤ 1 g and AATCC 127 ≥ 20 cm H20 or EN 20811 ≥ 20 cm H20

· Made of fabric and seams that pass at a minimum AATCC 42 ≤ 1 g and AATCC 127 ≥ 50 cm H20 or EN 20811 ≥ 50 cm H20

· Made of fabric and seams that pass at a minimum ASTM F1671 or ISO 16604 ≥ 14 kPa

· Pass NFPA 1999 coverall minimum performance requirements

· Pass EN14126 coverall minimum performance requirements (all types, all classes)

· Natural Rubber Latex

· Coveralls that contain natural latex include the latex caution statement CFR 801.437, “THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTION.”

· Size

· Sizes: medium, large, extra large

· Labeling

· Statements in the labeling that a gown is a surgical gown (which includes “surgical isolation gown”) provide strong evidence that the gown is a “surgical gown,

· Is labeled as such;

· Is described as such in its labeling;

· It has statements relating to moderate or high-level barrier protection

Offerors shall provide proof of meeting applicable standards as noted above, in their proposals.

Offerors shall demonstrate conformance to the applicable performance requirements as noted above by either 1) Manufacturers declaration of conformity or 2) ISO 17025 accredited laboratory declaration of conformity (please indicate which requirements are met and by which method).

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