Developments surrounding the coronavirus are following each other in rapid succession. We hereby inform you about some matters that are relevant to the medical devices/technology market and therefore possible for your company.
CE mark / MDD / MDR
The Inspectorate has indicated that in the event of shortages of medical devices, the obligation to care takes precedence over product regulations in certain situations. Due to the outbreak of the coronavirus, there is a possibility that regular medical devices are no longer available due to shortages. It may then be necessary to deviate from the guidelines in order to still comply with the obligation to provide care.
In that case, it is of course the responsibility of the healthcare provider to make a careful and responsible assessment either himself or within the professional group between the various risks entailed by the use of an alternative aid and the responsibility to provide care.
Central purchasing of Medical Devices
From Tuesday, March 17, the ROAZ (Regional Consultation for Acute Care) structure will come into effect for the purchase and distribution of certain protective equipment. This concerns the following products: Ffp1,2,3 masks, aprons, gloves, protective glasses, surgical masks, disinfectants, diagnostic tests. This means that for general practitioners, GGD, ambulances and hospitals, the inventory, purchasing and distribution of the above-mentioned products will run through the ROAZ structure.
The purchasing of the above products will be carried out by a central team of hospital buyers. If shortages arise in other medical devices, these devices can also come under the direction of the ROAZ.
Information about ROAZ and contact details can be found at:
https://www.digitale-enquete-fhi.nl/pdf/roaz_structuur.pdf
https://www.digitale-enquete-fhi.nl/pdf/coordinatoren_pbm_roaz.xlsx
Inventory survey
Last Thursday, FHI set up an inventory survey. More than 220 medical companies have now completed this survey. To date, this has provided very useful information for all organizations involved. Given the importance of continuity for Dutch healthcare, we urgently ask you to complete this short survey. Thank you very much in advance for that.
The survey can be accessed via:
https://www.digitale-enquete-fhi.nl/mt/index.php?r=survey/index&sid=359324&lang=nl
If you cannot access it via this link, you can copy the full link and paste it into your browser's address bar.
Childcare medical device companies
Some parents or caregivers will be able to make use of childcare options at their own school or daycare center in the coming period, so that they can do their best to keep society running. This applies, among other things, to healthcare, including the production and transport of medicines and medical devices.
Report shortages and specific groups
If your company is confronted with supply problems of critical medical products, in addition to the previously mentioned products (protection materials), we request that you report this to FHI (knaven@fhi.nl). If your company is active in the field of respiratory products (equipment or disposables), we request that you also make this known to FHI.
Nederlands