Crisis (C) Rating System for Personal Protective Gear

Inventables has an incredible community of makers and small businesses that have the capability to manufacture personal protective gear.  Our customers are all over the world and likely don't have access to contacts at the FDA, CDC, or FEMA to get any of their designs approved.  Working with a few doctors and an epidemiologist we created this rating system.  Our customers and the maker community at large are engaged in the production of C3 and C4 equipment.

Crisis (C) Rating System - Based off the CDC Guidelines
The purpose of this rating system is to provide clarity as well as a quick guide to healthcare workers and patients on how to evaluate and prioritize the use of protective equipment in time of crisis.

Conventional Equipment C1 & C2
C-1 FDA approved personal protective equipment. C1 measures consist of providing patient care without any change in daily contemporary practices. This set of measures, consisting of engineering, administrative, and personal protective equipment (PPE) controls should already be implemented in general infection prevention and control plans in healthcare settings.

C-2
Equipment that is manufactured to the specifications of FDA approved equipment. These measures may change in daily standard practices but may not have any significant impact on the care delivered to the patient or the safety of healthcare personnel (HCP). These practices may be used temporarily during periods of expected face mask shortages.  Examples include manufacturers who typically do not manufacture masks but have the capacity and capability to manufacture them to exact specifications contemporary personal protective equipment is manufactured to.

Contingency Equipment C-3 & C-4
C-3
Equipment that is manufactured under process control but these are not yet FDA approved products. In settings where FDA-approved face masks are not available, HCP might use PPE manufactured by companies or individuals that have process control in place for care of patients with COVID-19 as a third to last resort. Their capability to protect HCP is unknown because while process control was followed this equipment has not yet been approved by the FDA. Caution should be exercised when considering this option.

C-4
Equipment that is manufactured without process control and not FDA approved.  In settings where FDA approved face masks are not available, HCP might use PPE manufactured by companies or individuals that do not have process control in place for care of patients with COVID-19 as a second to last resort. Their capability to protect HCP is unknown because industrial process control was not followed. Caution should be exercised when considering this option.

Crisis equipment C-5
C-5
Homemade equipment fashioned from found objects like bandanas or cotton cloth. In settings where face masks are not available, HCP might use homemade masks (e.g., bandana, scarf) for care of patients with COVID-19 as a last resort. However, homemade masks are not considered PPE, since their capability to protect HCP is unknown. Caution should be exercised when considering this option. Homemade masks should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face.

This document was written by Zach Kaplan the CEO of Inventables as a guide to help people understand what kind of equipment they have and should use in their situation.  This document is based on the CDC guidelines and not an official CDC document.

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