What is the problem or challenge?


Problem: Local machinist manufacture of Biohazard suits can stop-gap a shortfall, or delay in supply, of fully CE marked PPE. Biohazard suits are integral for protection  frontline staff treating positively tested patients in a pandemic.  

Manufacturers of Biohazard Suits usually have multiple designs each depending the on the 'grade' required. There is usually a lag time between need and delivery. Current manufacturer designs result in the user being hot and sweaty, which may cause the user to be less careful in correct doffing (removal) of the suit which can result in infection transmission. Particularly in hotter and humid climates.  

-Use of materials in design that are more breathable, but still offers protection, so that the user is less uncomfortable and sweaty. 
-Design for a more safe removal method of the suit so that infection from doffing (removing) is lessened.  

Who does it affect and how?
Healthcare workers (HCW); non-infected persons in the community if HCW are infected due to improper PPE or rushed doffing; Biohazard Suit use by family at hospital deathbeds, funerals, etc. 

Existing Designs/ Ideas/ Solutions:

- Velcro and zipper open source design options by Open Source COVID-19 Medical Supplies (OSCMS). 
- Design for production of reusable cotton suits or disposable non-woven and plastic versions by 'Creatives tegen Corona' under a BY-NV-SA 4.0 licence (COVID medical supply emergency). 

Even if there is an adequate solution currently available (or the need has subsided), there may still be aspects to consider within this project.

For example:
-A low-cost alternative is needed for low resource contexts.
-Breathability of material to reduce sweating, and thus the wearer could be more careful in doffing the Biohazard Suit. 
-More designs using sustainable or eco-friendly materials. 

Velcro and zipper open source designs by OSCMS.
Reusable Cotton Suit design pattern by 'Creatives tegen Corona'. Design hosted on Wikifactory. 
Personal protective equipment for preventing highly infectious diseases due to exposure to contaminated body fluids in healthcare staff.
The first medically-reviewed open source PPE design is here.
Hazmat suit designed to be easily removed and falling away from the body, limiting potential infection exposure to outside fabric/ plastic. Initially designed in 2015 for Ebola outbreaks

1. Application by a Manufacturer for a Regulatory Derogation for a non-CE marked Medical Device for COVID-19, here

2. Medical devices: Consultant letter for compassionate use during COVID-19 here

3. If you are building for use, get in contact with #urgent_appeals_volunteers needed group to direct your builds where needed most. See slack link above.

4. Make sure you get the disclaimer form signed, see #legal_regulatory_information group

5. and have a label on it with "Custom" , #legal_regulatory_information can advise)

Waiver template is now available Via Daniel Mooney
https://docs.google.com/document/d/1gGhxPPeFrSrvrtFQtpbsh7V0xwt2m49jKIKGVFpRNXw/edit?usp=sharing