Finally, this article provides an overview of the need for action arising from the current revision for healthcare facilities such as hospitals, practice facilities and pharmacies.
The medical device law revised in the spring of this year tightens the regulatory requirements for all players in the distribution chain. In our series of articles, we have already reported on the new requirements with which manufacturers, importers and distributors are confronted as a result. Finally, this article provides an overview of the need for action arising from the current revision for healthcare facilities such as hospitals, practice facilities and pharmacies.
Definition of "health care facilities"
The legislator understands a "healthcare facility" in the sense of the new medical device law to mean, in particular, hospitals, medical practices and purchasing groups. In the present context, this therefore refers to all institutions that purchase medical devices.
Registration of implantable medical devices
Healthcare facilities have the obligation to record and store the UDI (Unique Device Identification) number of the Class III implantable devices they have purchased or supplied. The documentation of the data can be done in paper form or preferably in electronic form.
Entry in the implantation certificate
In this respect, healthcare institutions are also obliged to enter the identity of the person who has been implanted with a device in his or her implantation card and to hand this card over to the person being treated. This ensures that patients are in direct possession of the information concerning their implant and can obtain sufficient information about it at any time.
Disclosure and retention requirements
Furthermore, healthcare facilities must comply with the disclosure and retention obligation for at least ten (in general) and 15 (implants) years. Disclosure and retention concern information on the sources of supply and purchasers. The documentation and proof of the entire value chain is intended to ensure the traceability of medical devices and thus ultimately product monitoring. This should enable Swissmedic, as the competent authority, to obtain the necessary information quickly even after a product has ceased to be manufactured or placed on the market, and to order the measures required to protect patients.
"Manufacturer's obligations" for the reprocessing of medical devices"
With regard to the reprocessing of medical devices, healthcare facilities are subject to certain "producer obligations" such as the cleaning, disinfection and sterilisation of used devices as part of their activities. Correct reprocessing according to the current state of science and technology with validated procedures is of exceptional importance for product safety in connection with the prevention of a potential risk of infection. The reprocessing procedure must be carried out in accordance with the principles of a quality management system and must be traceable and reproducible at all times.
Information and notification requirements
The manufacture and use of medical devices manufactured in healthcare facilities are now subject to comprehensive notification and information or publication obligations. The reporting obligation is intended to enable Swissmedic to obtain an overview of the products that have been put into service. Only in this way is it possible to initiate any risk-based investigations or (monitoring) measures.
Preparation with a view to supply bottlenecks
A further obligation for healthcare facilities may be to prepare for possible supply bottlenecks due to additional requirements for certification and technical information. In this regard, there is a recommendation to consult with manufacturers, importers and distributors.
Duty of cyber security
Finally, healthcare facilities are subject to a general duty of care in connection with cyber attacks. Cyber security measures must be evaluated, determined and documented. Healthcare facilities are obliged to take all technically and organisationally necessary measures to protect network-capable products (e.g. surgical robots or analysis devices) against electronic attacks and to document them in accordance with the principles of a risk management system (as part of quality management).
Entry into force of the new provisions
For reasons of coherence, the new provisions of medical device legislation in Switzerland were brought into force gradually. The exemptions for the placing on the market and putting into service of medical devices that have not undergone a conformity assessment procedure already entered into force on 1 August 2020. The most important provisions, which concern, among other things, the requirements for placing on the market, market surveillance or the new requirements for clinical trials, were brought into force on 26 May 2021.
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