The corona crisis is sweeping around us. Growing demand threatens shortages of personal protective equipment and medical devices such as surgical masks, diagnostic tests and respirators. The EU is (temporarily) relaxing strict rules governing the production of these products. This relaxation also carries risks that we need to be aware of.
Corona crisis
The tension between safety and innovation of medical products in times of crisis
Introduction
The corona crisis is sweeping around us. Increasing demand threatens shortages of personal protective equipment such as masks, aprons, gloves and goggles, as well as medical equipment such as surgical masks, diagnostic tests and respirators. To meet growing demand faster, the EU is (temporarily) relaxing strict rules governing the production of these products: Under conditions, products not fully certified under applicable standards are temporarily allowed. This article describes the tension between safety and innovation.
What we see
In a short space of time, initiatives are springing up everywhere, both inside and outside the industry. According to initial data from TU-Delft, face masks, normally suitable for single use, seem to be sterilised up to 5 times without too much impact on quality and filter capacity. Radboudumc investigates whether it is possible to 3D-print parts of corona tests. Students are working on a new respirator. Companies from outside the sector, with serious scaling-up potential, are starting to produce mouthpieces.
These creative solutions can make a difference in time of need but how can we ensure that products are safe enough and do what they promise? The medical sector is among the most regulated industries in the world. The EU2016/425 directive defines what personal protective equipment must comply with. Medical technology manufacturers must adhere to ISO 13845, a comprehensive quality management system specifically for the design and manufacture of medical products. All this is to ensure that medical products are manufactured safely. Strict regulations ensure that medical products reach the market safely. The so-called CE marking granted by 'notified bodies' guarantees that the product has been manufactured according to the agreements in the European Union. After the time of marketing, the law also requires manufacturers to systematically monitor the performance of the product in practice.
Relaxing these rules opens the door to creativity and innovation, and in a crisis situation, something sufficient may be good enough. But even in a crisis, a seemingly "simple mouthpiece" must do what it promises. Face masks come in all shapes and sizes but to prevent contamination of healthcare workers, respiratory protection masks must be used that are at least FFP2 compliant. The requirements for these masks are higher than other 'normal caps' used in healthcare. Crucial to protection is the right base material, but also preventing false air from leaking in past the mask. If this is not the case, healthcare workers unknowingly become infected and in turn infect others. A high infection rate among caregivers is a disaster scenario. Ensuring quality and safety is not that simple, and the complexity increases rapidly with more complex technology like ventilation equipment.
What can you do?
The directive from the EU Commission offers some guidance to serious innovators. You may no longer have to comply with the letter of the law, but work according to the spirit of the law as much as possible and gradually make sure you keep records, such as: what specifications am I aiming for, what assumptions am I making, what risks are there and how do I mitigate them. The new European regulation on medical devices that will come into force next May throughout the European Union, the so-called 'Medical Device Regulation', provides good guidance on minimum requirements and technical documentation in Annexes I and II.
Providers of devices for patient care around corona, such as mouth caps, can contact the NFU (middelencorona@nfu.nl) or the Ministry of Health, Welfare and Sport (coronabeschermigsmiddelen@minvws.nl).
Find and engage the right expertise
KIVI is the professional association of engineers with more than 18,000 members. Every conceivable engineering discipline is represented within KIVI. Under the title "KIVI engineers help with corona crisis", KIVI has launched an initiative to bring demand to supply. Organisations with requests for help are put in touch with experts from all sections of KIVI. More than 400 experts have now signed up and the counter continues. Experts in the field of materials, production techniques, but also medical technology and certifications can help you contribute to corona crisis solutions as safely and responsibly as possible even in times of crisis.
Links
COMMISSION RECOMMENDATION (EU) 2020/403 https://eur-lex.europa.eu/legal-content/GA/TXT/?uri=CELEX:32020H0403
Regulation (EU) 2016/425 on personal protective equipment
https://eur-lex.europa.eu/legal-content/nl/TXT/?uri=CELEX%3A32016R0425
MEDICAL DEVICE REGULATION (EU) 2017/045
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20170505
Position IGJ
https://www.igj.nl/onderwerpen/coronavirus/nieuws/2020/03/11/coronavirus-wat-bij-een-tekort-aan-medische-hulpmiddelen
KIVI
