Coronavirus: what to do in case of a shortage of medical devices
As a result of the coronavirus outbreak, medical devices normally used may no longer be available due to shortages. In that case, it may be necessary to temporary deviate from the guidelines in order to still be able to comply with the obligation to provide care.
Addition 11 August 2020
Of course, in that case, the care provider is responsible, personally or within the framework of the professional group concerned, to strike a carefully considered and responsible balance between the various risks posed by the use of alternative devices on the one hand and the responsibility to provide care on the other.
Medical devices with a CE marking has the appropriate quality guarantees for the intended application. This has not been assessed for products without a CE marking or for a different application than the intended one.
Registering the considerations
The IGJ (Health and Youth Care Inspectorate) considers it important for care providers in the complex situation at hand to have the flexibility to organise the care system as optimally as possible. However, in order to be able to account for their actions retroactively, they have to register their considerations and decisions in a traceable manner.
Role of the IGJ
The IGJ monitors compliance with laws and regulations in the area of healthcare, including the Healthcare Quality, Complaints and Disputes Act (Wkkgz). The Wkkgz is based on the principle that care providers and caregivers are responsible for providing good care. In addition, the IGJ assesses the working procedures and methods of care providers with the help of field standards and guidelines. The professional groups concerned have drafted these themselves.