Reuse of single-use devices - Safety and Ethics not so clear
Eucomed, the European Medical Technology Industry association, welcomes the European Commission's (EC) report on the reprocessing of medical devices. While remaining typically neutral in terms of action at this stage of the debate, the EC report confirmed that even with all the evidence and scientific opinion available "...it is not possible to quantify the risk associated with the use of reprocessed single use medical device."
Nor was there a comforting picture on the ethics, where the balance between informed consent of patients and the cost saving to the healthcare services could not be determined. The EC intends to try and tackle these and other thorny issues around 'reuse' in the upcoming Recast of the legislation, a process where the EC and Eucomed are already in close dialog. Eucomed will continue to ensure that patient safety remains paramount in the reuse debate.
The EC today publishes their report on the issue of reprocessing of medical devices in the European Union. The report is an assessment of the issue regarding public health, ethical, legal, economic and environmental aspects. As indicated in a meeting with the EC in July this year, the report does not contain any policy measures and the EC confirms that such measures will be addressed within the context of the Recast of the Medical Devices Directives.
In the report, the EC recognises that the "reuse of single use medical devices may not be without risk from a public health point of view" and highlights the fact that "to date, no comprehensive study clearly demonstrates that reprocessing single use medical devices is globally a cost effectiveness and environmental friendly practice when done under high quality standards". The EC also points out that in order to identify the potential risks associated with this practice the entire reprocessing cycle needs to be "evaluated and validated".
The EC has confirmed that they are currently working on the reuse question within the scope of the recast of the medical devices Directives. This process will explore the pros and cons of various policy options available by analysing their potential impact from a social, environmental and economic standpoint. Eucomed, who have already been talking closely with the Commission on the recast, is confident that the EC will propose additional legal measures that will secure the highest level of safety regarding the use of single-use devices in the EU.
Background info
The EC's report comes after the latest revision of the Medical Devices Directive introduced an Article requiring the EC to produce a report on this issue by 5 September 2010. To support their work, the EC mandated the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) in October 2009 for a scientific opinion on the safety of reprocessed single-use medical devices. In light of this mandate, a call for information to submit documented evidence on the topic was issued by the Committee. Eucomed responded to the call by submitting their White Paper on the reuse of single use devices published in December 2009.
Interesting links
• European Commission report on reprocessing of medical device
• Eucomed White Paper on the reuse of single-use devices
• SCENIHR scientific opinion
31.08.2010
