Safety & Liability

Reference: Open Source COVID19 Medical Supplies: Our Intent, Needs, and Your Role, Version 1.1 see entire document here (local copy of version 1.1 here)

See Also: 3D Printing: Getting started, safety, and Designs

A Note About Safety and Liability

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)



Technical Considerations for Additive Manufactured Medical Devices (FDA)

General Controls for Medical Devices (FDA)

Recommended Content and Format of Non-Clinical Bench Performance Testing Information (FDA)

Good Samaritan Laws in the United States

In the United States, Good Samaritan laws offer legal protection from civil lawsuits to people who voluntarily provide reasonable aid to those who are injured, ill, in danger, or otherwise incapacitated. A claim of negligent care can also be raised if the injuries or illness were made worse by the volunteer’s negligence. Laws generally do not exempt a Good Samaritan who acts in a willful, wanton or reckless manner in providing care, advice, or assistance.

We are providing you with the specifications you will need to manufacture items which are much-needed during this pandemic; however, you are responsible for your creations, so please practice due diligence (the care that a reasonable person exercises to avoid harm to other persons or their property). We want your contributions to help, not harm!

If you are familiar with similar laws in other countries, please reach out to us with relevant references.

References: Good Samaritans (US Legal)