Medical technologyThe supervision of medical technology
General overview of the supervision in the Netherlands
Medical technology is about products, technologies and applications used in the diagnosis, treatment and support of diseases and disorders. Innovative technologies are rapidly being developed to improve care. Increasingly, medical technology determines the quality of care.
What are medical devices?
Medical devices are defined as products used for diagnosis or treatment in the health care sector, with the exception of medicines. Examples include implants like pacemakers or prostheses, surgical instruments and MRI scanners, but also a blood glucose meter for home use or software such as a medical app on a smartphone.
In vitro diagnostic medical devices
In vitro diagnostic medical devices (IVDs) constitute a separate group of medical devices. They are tests that help to identify diseases, disorders or abnormalities. IVDs are used at different times in the care process. They help doctors to make a diagnosis. Special laboratories, such as those in hospitals, are important users of IVDs. But general practitioners also use IVDs in their practice, for example to examine urine for an infection. There are also IVDs that a person can use at home. Examples include a pregnancy test and a blood glucose meter.
Supervision to address the greatest risks
Medical technology and its application open up opportunities. Innovations result in new treatment methods that serve the interests of the patient. Medical technology also involves risks. The risks must be known and they must be controllable.
The basic principle is that there must be a good balance between the health benefits of the technology and the risks posed by its application. Risks always exist and there is never a 100% guarantee of safety.
The Health Care Inspectorate arranges its supervision to address the greatest risks for patient safety and their early identification. For this purpose the Inspectorate acts on signals received from members of the public, manufacturers, health care providers and other parties.
The Inspectorate monitors and promotes optimum safety of medical technology and its application so as to enhance the quality and safety of care for members of the public. To accomplish this goal, the Inspectorate maintains supervision over the safety of medical devices, but also over their safe us by heath care providers. The Inspectorate’s perspective is based on the entire life-cycle of the medical technology, in which the following subsequent phases can be identified, as also presented in the figure:
- Market introduction
- Selection & purchase
- Clinical use
- Post market surveillance (PMS)
(click the images to open an enlargement in a new window)
The supervision of medical devices is subject to international legislation, so the Inspectorate cooperates with other countries. The Inspectorate is an active member of EU committees and working groups involved in the assessment and development of medical devices regulation on the market.
The Inspectorate checks whether manufacturers and suppliers of medical devices are complying with the rules and laws and takes action when breaches occur. The Inspectorate evaluates received reports of problems with medical devices and again takes action when breaches occur. The Inspectorate also maintains supervision over notified bodies established in the Netherlands.
Furthermore the Inspectorate monitors the safe use of medical technology.
Safe use of medical technology
A safe medical product is required to provide safe care. But a safe medical product does not necessarily translate into safe care. Injudicious use and inadequate risk assessment may result in serious harm to health instead of the intended goal of health enhancement. The supervision maintained by the Inspectorate over medical technology therefore embraces the entire life cycle: from market introduction of a medical device up to and including its safe use by care providers.
National legislation covers the provision of medical care (and thus the application of medical technology). This legislation is widely framed (defining what must be achieved rather than how) and is often further elaborated through professional standards.
An example of supervision of the safe application of medical technology is the surveillance on the Medical Technology Covenant (Dutch) and on eHealth (Dutch).