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PPEsupply

The document outlines specifications for personal protective equipment that healthcare workers require to safely treat COVID-19 patients. It provides details on necessary items like goggles, masks, gowns and gloves, and the standards they must meet to be effective. With global shortages of PPE, anyone able to produce these items should carefully consider manufacturing them to the specifications listed.

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rdbranaweera
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75 views3 pages

PPEsupply

The document outlines specifications for personal protective equipment that healthcare workers require to safely treat COVID-19 patients. It provides details on necessary items like goggles, masks, gowns and gloves, and the standards they must meet to be effective. With global shortages of PPE, anyone able to produce these items should carefully consider manufacturing them to the specifications listed.

Uploaded by

rdbranaweera
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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The novel coronavirus, COVID-19, has been classified as a pandemic as it continues to spread

globally. The continued rise in viral activity has caused significant global supply chain shortages in the
production of necessary medical supplies, in addition to increased demand. This has reduced the ability
of healthcare workers to provide adequate care for infected patients and with the dire consequences of
not being able to protect themselves from the very illness they are working to treat.

COVID-19 is spread from person-to-person and is transmissible via respiratory droplets, such as
those produced when coughing or sneezing. These droplets can spread the virus when they contact the
eyes, nose, or mouth of nearby persons and possibly when inhaled. Due to the highly infectious
capabilities of the virus, healthcare workers require personal protective equipment (PPE).

PPE is critical to the protection of healthcare workers, acting as a barrier and therefore
controlling exposure to COVID-19. Some of the most fundamental items comprising PPE include gloves,
goggles, surgical masks, respirators, protective gowns, and disinfectant. Many of these crucial PPE items
are now in short supply due to interruptions in the supply chain, and also from the massive demand as
the number of patients infected continues to grow exponentially.

Shortages of necessary PPE will continue to pose a significant problem for healthcare workers
and patients around the globe. Anyone with production capabilities should carefully consider the
manufacture of the following PPE items in accordance with the provided specifications:

1.Goggles
 Good sealing with the facial skin
 Flexible PVC frame that can be easily adapted to all facial contours with even pressure
 Encloses the eye area and neighboring areas
 Compatible with prescription glasses
 Compatible with various models of FFP respirators
 Clear plastic lens with scratch-resistant anti-fog treatment
 Adjustable strap for secure attachment
 Indirect ventilation to prevent fogging
 Can be reusable * (made of sturdy material that can be cleaned and disinfected) or disposable
Norms / standards:
- Regulation (EU) 2016/425
- EN 166
- ANSI / ISEA Z87.1
or equivalent standards
 
2. Full face masks
 Made of clear plastic
 The area of the forehead is filled with material that touches the skin to prevent the ingress of liquids
and / or droplets.
 Adjustable band that is firmly attached around the head and clings closely to the forehead
 Fog protection (preferably)
 Complete coverage of the sides and length of the face
 Can be reusable (made of sturdy material that can be cleaned and disinfected) or disposable
Norms / standards: - Regulation (EU) 2016/425 - EN 166 - ANSI / ISEA Z87.1 or equivalent standards
 
3. FFP2 (Full Face Protection)
 Breathable design that does not collapse against the mouth (e.g. duckbill, cup-shaped)
 Equipped with exhalation valve
 Provided with a metal plate on the tip of the nose
 Can be reusable * (made of sturdy material that can be cleaned and disinfected) or disposable
Norms / standards:
- Respirator "N95" according to FDA class II, under 21 CFR 878.4040, and CDC NIOSH, or "FFP2"
according to EN 149
Regulation 2016/425 category III
or equivalent standards
 
4. FFP3 (Full Face Protection)
- equipped with exhalation valve
Norms / standards:
- "FFP3" according to EN 149: 2001 + A1 or equivalent standards
 
5. Surgical masks
 High fluid resistance
 Good breathability
 Inside and outside surfaces are clearly marked
 Design that does not collapse against the mouth (e.g. duckbill, cup-shaped)
Norms / standards:
- EN 14683 Type IIR performance - ASTM F2100 Level 2 or Level 3 or equivalent - Liquid resistance at a
pressure of at least 120 mmHg based on ASTM F1862-07, ISO 22609 or equivalent - Breathability: MIL-
M-36945C, EN 14683 Appendix C, or equivalent - Filtration efficiency: ASTM F2101, EN 14683 Annex B or
equivalent standards
 
6. Protective gown
 Single use, disposable
 calf length
Norms / standards:
- Regulation 2016/425
- Directive 93/42 / EEC
- FDA Class I or II medical device
- EN 13795 each level
- AAMI PB70 all levels acceptable
or equivalent standards
 
7. Full body protective suit
 Single use, disposable
 Resistant to liquids
 With hood, long sleeve, thumb / finger straps or elastic cuffs to anchor the sleeves in place
Norms / standards:
- Option 1:
- Resistance to liquid penetration: EN 13795 high performance, or
- AAMI PB70 Level 3 performance or higher,
- or equivalent standards - Option 2:
Blood flow resistant to pathogens: AAMI PB70 level 4, or
- EN 14126-B and partial body protection EN 13034 or
EN 14605,
or equivalent standards
 
8. Disposable gloves
Nitrile, powder-free, non-sterile. Long cuffs (at least 230 mm total length) Sizes: S, M, L, XL Norms /
standards: - Directive 93/42 / EEC Category III - Regulation (EU) 2016/425 Category III - EN 455 - EN 374 -
ANSI / ISEA 105 - ASTM D6319 or equivalent standards
 
9. Sampling materials
Swab with a synthetic tip (such as polyester or Dacron®) with aluminum or plastic shaft. (Note: swabs
with calcium alginate or cotton tips with a wooden shaft are not acceptable).
 
10. Disinfectants
For chemical disinfection, agents with proven effectiveness are to be used with the range of activity
"limited virucidal" (effective against enveloped viruses), "limited virucidal PLUS" or "virucidal". Suitable
agents include the list of disinfectants and procedures tested and recognized by the RKI ( RKI list ) and
the disinfectant list of the Association for Applied Hygiene ( VAH list ). The RKI list must be consulted for
officially ordered disinfection measures.

Sources:

1. Zunkuft Hospital https://www.zukunft-krankenhaus-einkauf.de/2020/03/11/bedarfsliste-an-


schutzausr%C3%BCstung-und-desinfektionsmitteln-des-bmg/?fbclid=IwAR3XT6-FFM0B7-
l4Ulrh91IqxRodsQyOpxbdfnVRyG7QW6rFUPLCOP6WHMY

2. Interim Infection Prevention and Control Recommendations for Patients with Suspected or
Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings
https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html?
CDC_AA_refVal=https%3A%2F%2Fptop.only.wip.la%3A443%2Fhttps%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp
%2Finfection-control.html

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