Makespace Mask Clips

This page captures information about the Mask Clip PPE activity happening in Makespace during April 2020.

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

Introduction

Healthcare workers are now having to wear surgical masks for long periods, and the tension from their elastic can cause ear pain. For many users the masks also do not naturally fit well (meaning they can leak air, reducing their effectiveness), so users must tie knots in the elastic to increase the tension, further exasperating the pain.

Addenbrooke’s asked Makespace to help develop a disposable clip to improve fit and comfort.

Design & Production

A range of designs were explored, prototyped and refined based on user feedback. The favoured design was then produced in large quantities at Makespace (~50k units), in parallel with being transferred to high volume production.

Documentation

All the key documents are available on GitHub:

https://github.com/Makespace/mask-clips/

The following directories are included:

Requirements – The device specification, regulations and risk assessments
Design Files – The mask clip design files
Materials – The materials 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 is the key document describing the whole process, and the place to start if you want to learn about the process.

This documentation pack was created through a collaboration between the Makespace community and Addenbrookes Clinical Engineering and Innovation team to describe the process used to make the clips, track production, manage quality, risk assessments and other key documentation for the technical file.

The design and technical file have been approved by users and the Clinical Engineering and Innovation team for use in Addenbrookes. Technically the clip is a medical device, in a category where CE marking is self certified, so in principle this technical file is sufficient for the clips to be considered CE marked without requiring a notified body.

The documents are a record of what we did, and an indication of the process and thought behind creating and supplying such a product. Other organisations will need to consider differences in materials, equipment, abilities and requirements. Any deviation from these processes will need to be assessed by someone suitably competent and agreed with those receiving the items.