Table 4 Risk assessment of emergency use authorizations for mechanical ventilators during the COVID-19 crisis
No. | Emergency use authorization measure | Consequence | Severity (1–4) | Probability (1–4) | Risk level (low, medium, high) |
|---|---|---|---|---|---|
1 | Import without CE mark and/or Declaration of conformity [38] | Unknown manufacturer Unknown applied standards and directives Missing test results Responsible person | 4 | 3 | High |
2 | Product without national manufacturer representative [16] | Missing installation of the product Missing education about the product Missing urgent service Missing preventive service inability to use the product non-functional usage of the product | 4 | 3 | High |
3 | Fast approval of prototype | Legal and health consequences | 4 | 4 | High |
4 | Change of prescribed usage [39] | Lowering the capacity of healthcare system usage out of intended scope | 2 | 4 | Medium |
5 | Modification of existing functions by manufacturer [40] | Lower quality of the product restricted functionality | 1 | 4 | Low |