CzechMed draws attention to an important publication of the Office for Standardization, Metrology and State Testing (UNMZ): "Guide to the regulation of personal protective equipment and medical devices"
Few health-related products are receiving such attention these days as personal protective equipment. The respirators, originally intended to protect health in industry and in dusty operations in general, have become a key aid in the fight against the Covid-19 pandemic, at the level of each individual. Worldwide. In connection with their spread, questions repeatedly arise as to what their characteristics are, who and how assesses their effectiveness, and many other nuances. The Office for Technical Standardization, Metrology and State Testing (ÚNMZ) responds to them with the professional publication "Guide to the Basics of Regulation of Personal Protective Equipment and Medical Devices". "In 2020, we experienced a very strong demand for the creation of a comprehensive educational text that would explain in a concise and comprehensible form to suppliers, buyers in various organizations, but also the general public the full basics of product regulation, which are necessary to combat pandemics," says Viktor Pokorný. , Chairman of ÚNMZ.
The publication helps the professional and lay public, manufacturers, suppliers and contracting authorities to navigate the complex conformity assessment process, which ensures that the devices are safe and effective. "For the Czech healthcare industry, the coronavirus pandemic represents a great threat on the one hand, and a great opportunity on the other. The publication of ÚNMZ, which is part of the Ministry of Industry and Trade, can help him significantly. I am pleased with it, it is an important guide for all domestic producers, it will help them with the proper marketing of medical and personal protective equipment, "adds Deputy Prime Minister and Minister of Industry and Trade Karel Havlíček. The requirement that only safe and effective medical and personal protective equipment be present on the market in the Czech Republic is crucial, especially for first-line medical workers. They are completely dependent on the quality of such products. "In connection with notified bodies for medical devices in the Czech Republic, the medical and technical community has gained basic insight into the complexities of the conformity assessment process and the legal placing on the market of medical devices. This forced experience has opened our eyes to how complicated, for example, certification, clinical trials or the implementation of a quality management system are. It is for this reason that I was very pleased to have the opportunity to meet this guide from the workshop of ÚNMZ and Porta Medica, "says Professor Jiří Beneš, a member of the board of the Czech Medical Society JEP.
A team of experts from the educational and consulting company Porta Medica played a significant role in the professional preparation of the publication. "We were honored to be part of this educational and community service project. I really appreciate that even in the current hectic time, ÚNMZ, as well as the Ministry of Industry and Trade, does not forget that public administration should be primarily a service to citizens, "concludes Jakub Král, founder of Porta Medica. "Personal protective equipment brings several interesting paradoxes today," says Miroslav Palát, president of the CzeczMed association. "Perhaps never before have so many millions of people globally relied on such a narrow group of products to protect their health as they do today. The present publication follows their dissemination with much-needed awareness of how they are manufactured, approved and used to meet the key - to protect the health of individuals and society in the face of today's unprecedented challenge, the Covid-19 pandemic. " The guide is published in printed form in a print run of ten thousand copies, which will be distributed free of charge to a wide range of recipients, from hospitals to social service providers, state authorities, regions and municipalities with extended powers. The online publication is also available on the websites of ÚNMZ, MIT, Porta Medica and CzechMed for free use by the general public.