Personal Protective Equipment (PPE) for COVID-19

Personal Protective Equipment (PPE) for COVID-19

By Lisa Derby Oden

The news is full of reports of the shortages of personal protective equipment (PPE) for dealing with the COVID-19 pandemic. According to the World Health Organization, industry and government have called on to increase manufacturing of these products by 40% to meet the rising global demand.

Massachusetts has an immediate need for N95 respirators in particular, and MassMEP can help direct companies who have the capability of helping. Contact Tom Andrellos, MassMEP Director of Growth Services, [email protected].

Crowdsourcing has also been active in working to meet the demand for PPE. As part of the innovative responses to assist in solving the demand issue, a maker community at OSCMS has prepared an open source compendium of manufacturing blueprints and specs for many of the critical items on state and hospital critical needs lists. Please go to this google doc repository to view: https://docs.google.com/document/d/1-71FJTmI1Q1kjSDLP0EegMERjg_0kk_7UfaRE4r66Mg/preview#heading=h.6rcgzhjv3lfe

Safety and liability is a serious issue and must be mentioned, and is so in the OSCMS document: There are engineering and manufacturing risks around medical devices. Though the FDA has issued Emergency Use Authorizations (EUA) (Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices, FDA), to avoid doing more harm than good, it is recommended to attempt to the best of your ability and circumstances to follow regulations, which may seem cumbersome, but exist for good reason.

Regulatory standards that apply to the supplies and devices in question:

eCFR: QUALITY SYSTEM REGULATION (especially Identification and Traceability, Production and Process Controls, and Labeling)

eCFR: GENERAL HOSPITAL AND PERSONAL USE DEVICES

References:

Technical Considerations for Additive Manufactured Medical Devices (FDA)

General Controls for Medical Devices (FDA)

This document has a great deal of information and is a good source of manufacturing information for making the following:

Supplies

Hand Sanitizer

PPE

N95 Respirators

Surgical Face Masks