Makespace

Visor

Makespace Visor

This page captures information about the Visor PPE activity happening in Makespace during March and April 2020.

If you want to request visors, email Covid19.visor.requests@makespace.org

Update

Makespace has successfully produced 5000+ visors and delivered them to Addenbrooke’s and 40+ other local organisations to fill the short-term gap between immediate demand and commercial supply becoming available.

These visors were all provided free-of-charge; Makespace sponsored all the materials and equipment, and over 80 volunteers contributed to development and shifts making them.

This map gives you an idea of where the visors went:

We also published the documents and processes that were developed in collaboration with Addenbrooke’s for making these masks to NHS standards. These are now being used by other organisations to make many more visors.

The Makespace community continues to work on Covid-19 response projects where we can have an impact.

Introduction

The Covid-19 pandemic has meant the appropriate Personal Protective Equipment (PPE) that healthcare workers must rely on has suffered supply shortages, creating an immediate need for supplementing standard procurement channels.

Based on discussions with NHS Addenbrooke’s Clinical Engineering and Innovation team, Makespace and its community of volunteers have understood the requirements, developed the capabilities and executed on the production and delivery of PPE Visors for supply to NHS and other healthcare workers on the frontline. This page documents the activity, intended for our own reference and to share our learnings with others.

Context

Creating new PPE requires the basics of designs, materials, tools and people as the means of production, plus ensuring the processes and results adhere to regulations, are fit for purpose, and meet a required need by hospitals and other environments.

Here we have documented the design, materials and process used to make visors including tracking production, managing quality and associated key documentation such as requirements and risks. This has been undertaken in collaboration with Addenbrooke’s Clinical Engineering and Innovation team such that it has been approved for use in Addenbrooke’s. In principle, they could be used to seek CE marking for this product.

The documents are published as an indication of the process and thought behind creating and supplying such a product. Both replication and deviation from these processes will need to be assessed by someone suitably competent and agreed with those receiving the items.

Documents

All the key documents are available on GitHub:

https://github.com/Makespace/visor/

The following directories are included:

  • Requirements – The device specification, regulations and risk assessments
  • Design Files – The delve mask design files
  • Materials – The materials, BOM, and data sheets
  • Production – Manufacturing Standard Operating Procedure (SOP), Training and Worker/Batch Tracking
  • Documentation – The accompanying documentation and labelling for shipping

The Manufacturing SOP and Manufacturing SOP checklist documents found in the production directory are the key documents describing the whole process, and the place to start if you want to learn about the activity.

The Workstation single point lessons ppt is also useful to get a feel for the activities that need to be performed.

The requirements directory is good reading for context on how the essential safety requirements mandated in regulations are fulfilled by the design and documentation. This is what is required when the UK government relaxed the rules on PPE for hospitals from ‘at least CE marked’ to ‘meet essential safety requirements’.

The job card software created to help run the process has also been released; see:

https://github.com/axiomsofchoice/jobcardsystem

Support, Questions and Requests

If you would like to volunteer to help as part of the visor production team, or other Makespace Covid-19 projects, fill in this form on our Covid-19 response page.

Please direct any visor questions or requests to: covid19.visor.requests@makespace.org

Licence & Credits

CC BY-NC-SA 3.0 – Published under the Creative Commons, Attribution required, No unlicensed Commercial use, Share Alike

With thanks to the Makespace community for developing the production process and making the visors, and Delve, Midwest Prototyping and University of Wisconsin-Madison Makerspace for creating the basic design.