The Danish parliament has adopted amendments to the rules on reprocessing and reuse of single-use medical devices. The rules will apply as from 26 May 2021.
The Danish act on research ethics treatment of clinical trials of medical devices, etc., also introduces changes in the rules governing the reprocessing and reuse of single-use devices in Denmark. The object of the amendment is to adapt Danish legislation to new EU regulations.
EU Regulations on medical devices
The applicable EU directives on medical devices will be replaced by Regulation (EU) 2017/745 on medical devices (MDR) on 26 May 2021 and by Regulation (EU) 2017/746 on medical devices for in vitro diagnostics (IVDR) on 26 May 2022. The regulations on medical devices allow Member States to permit the reprocessing and reuse of single-use medical devices, provided such reprocessing and reuse take place in accordance with a number of requirements set out in the regulations, and any supplementary national rules.
In this context, reprocessing will be performed on used single-use medical devices to allow safe reuse. Typically, reprocessing and reuse are performed by professional external reprocessors that clean, disinfect, sterilise and prepare the devices for reuse in hospitals. FDA has issued guidelines complete with examples of single-use devices having been reprocessed and reused, such as catheters, masks, scissors, needles, syringes and tubes.
Current Danish legislation and practice
Applicable Danish legislation on medical devices includes no rules on reprocessing and reuse of single-use devices. Statens Serum Institut (SSI) has published infection-control guidelines with professional recommendations for health institutions and health professionals. According to the original bill the healthcare system has no general practice to reuse single-use devices. However, in connection with the drafting of the new rules, the Ministry of Health has stated that it should be permitted to allow reuse in the healthcare system. The Ministry further states that it could be appropriate, particularly for economic reasons.
In a consultation response, the Danish Medical Association questions the Ministry's assessment, pointing out that the possibility of reusing single-use devices constitutes a risk to patient safety and that the liability of healthcare professionals using reused devices is unclear. Any single-use devices that are assessed as being reusable should not be defined as single-use devices in the first place. This issue should be clarified before any marketing activities commence, says the Danish Medical Association in its consultation response.
Moreover, in connection with its response to a question to the bill – concerning experience gathered from other countries – the Danish Medicines Agency has approached the German healthcare authorities. As early as in 2001, Germany introduced a scheme for the reprocessing and reuse of "critical" single-use devices. Under German legislation, the reprocessing of single-use devices is considered to be reprocessing of so-called critical devices, which must comply with national guidelines. Further, German institutions that reprocess critical devices must be certified by a special body that evaluates the institution's quality management system and compliance with national guidelines. In Germany, the reprocessing of single-use devices for reuse is usually performed by external reprocessors, and a few large hospitals have their own departments to perform their own reprocessing.
New rules for reprocessing and reuse of devices in Denmark
Under the new rules, reprocessors of single-use devices that prepare the devices for reuse (reprocessing enterprises) are deemed to be manufacturers and as such are liable for the devices complying with the safety and performance requirements.
The amendment provides the Danish Medicines Agency with the statutory basis to set out special national rules on the reprocessing and reuse of single-use devices in accordance with MDR.
The Medicines Agency may decide which types of single-use devices may be reprocessed and reused as well as lay down any supplementary requirements for e.g. manufacturing methods and quality control. The rules may provide that only the minimum requirements of MDR must be met as regards single-use devices to be reprocessed and reused in an individual healthcare institution, including the healthcare institution's use of an external processor. Similarly, the Medicines Agency may also set out stricter requirements than those set out in MDR.
Implementation of the provision will take place on the basis of, among other things, a professional statement by SSI and guidelines for infection hygiene.
A healthcare professional, who simply uses reprocessed single-use devices, is subject to the same liability as when using other medical devices.
For more details on the legal amendments, click here.