Legal

Disclaimer:

The design and products facilitated here are being created in response to an emergency. As such these designs have not been vetted by any kind of government authority. The designs have not been approved for any kind of medical use. Anyone who accepts these designs does so without any kind of warranty, express or implied, and accepts any and all liability or responsibility for any consequences of using these products.

When adopting spare parts due to urgent need it is very important to consider safety, legal and operational risk factors. For any given part a risk profile is created with key responsible persons (KRPs) to ensure rapid intake, engineering, review, digital distribution, local manufacturing, quality control, and last mile delivery. These will vary from part to part and our representative will talk you through them to help you make the right decisions for your organization. A risk profile typically includes:

Safety

A component can be roughly categorized as:

All parts are important, but the more critical a part is, the more care (and time) must be taken in the design and review of a part. So whereas a comfort critical part might be delivered in less than 24 hours, a safety-critical part might take days or weeks or simply not be feasible.

Legal

Spare parts may be covered by service contracts and IP that will have to be considered in order to mitigate liability to caregivers and fabricators. Although we understand that emergency conditions can cause exemptions to rules, legal waivers must be signed where applicable to protect our organization, staff and volunteers' ability to continue operations at a critical time.

Operational risks

Operation risks are risks linked to the ability to deliver spare parts that are fit for purpose in a timely manner. Ensuring available resources for engineering, review, production and delivery, as well as ability to trace parts throughout the process requires good process and production control, as well as redundancies as time is usually a critical factor.