AS engineers and a public health physician, we are proposing several practical ways to balance safety and speed when producing new medical equipment during times of crises, such as face masks, protective gowns and gloves.
The world has adopted health and safety regulations for the benefit of citizens and consumers. In crises, however, overly complex and numerous regulations can be detrimental when supplies are low and there is a dire need for them.
In such times, governments must balance between the safety of “ticking all the boxes for certifications” and the flexibility to “obtain all supplies we possibly can”.
In times of crisis, we need new production lines to retool and spring into action in the shortest time possible. This means that regulatory bodies and standards must change to balance safety and speed. As an overarching idea, we may need a Temporary Standards for Malaysia that is monitored by Sirim.
We propose several specific suggestions. One, regulatory bodies must identify “must-haves” and “nice-to-haves”. Authorities could justify relaxation of certain criteria to increase supply in the market and/or create different tiers of compliance for different categories. Some criteria may not be critical for achieving the performance required. For example, some three-ply masks (even those for the public) may not need to meet the same blanket requirements as those intended for medical use.
Two, regulatory bodies can play a more active role. Current procedures rely on a "waterfall model" where certain boxes have to be ticked before progressing to the next step. In this model, regulatory bodies play a passive role. During crises, regulatory bodies could adopt the "agile model" where they play an active role and are involved in the whole process, from conception to delivery. This makes the process transparent to all stakeholders.
Three, regulatory bodies could deliver a pre-approved solution. Instead of approving endless proposals from the private sector, regulatory bodies could offer an open-sourced blueprint that is pre-approved. As long as the manufacturer adheres to the exact blueprint from start to finish, they are considered pre-approved until proven otherwise.
For example, in the case of face masks, there could be a blueprint “solution in a box” where operational aspects (e.g. modular factory floor plan) and design aspects (e.g. product size, range of material thickness) are fixed. Manufacturers can use the textbook solution for much quicker production.
This is an example of the unconventional thinking and inter-disciplinary collaboration needed to fight Covid-19. The balance between safety and speed is crucial during crises. We hope that Malaysia is able to look beyond previously set practices and convention and rethink some of our approaches to overcome this outbreak.
KEN CHIEW LEONG (Engineer, consultant and entrepreneur)
DATUK MADANI SAHARI (CEO, Malaysia Automotive, Robotics & IoT Institute)
DR KHOR SWEE KHENG (Physician and public health specialist)
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