Navigation path



Consumers (27-08-2010)

Commission looks at the issue of the reprocessing of single-use medical devices

Today the European Commission adopted a report on the reprocessing of medical devices in the European Union.

The report looks in particular at the practice of reprocessing of medical devices which are intended for single use, such as needles, syringes or catheters. The practice has been examined in the light of public health, ethical, liability, economic and environmental considerations.

The report concludes that the practice may not be without risks. The Commission stresses that particular care must be taken to ensure that the reprocessing of single-use medical devices does not endanger patients' safety or health.

In the light of the findings, the Commission will assess which measures are to be put forward as part of the forthcoming review of the Medical Devices Directives to ensure a high level of protection for patients.

Before adopting the present report, the Commission had requested an independent scientific opinion on the issue from a committee of experts (Scientific Committee on Emerging and Newly Identified Health Risks or SCENIHR). SCENIHR recommendations have fed into the present report.

Background

The current EU law (the Medical Devices Directive) distinguishes between reusable medical devices and medical devices intended for single use:

  • Some medical devices, such as many of the surgical instruments, are intended by their manufacturers to be reused. In this case, the legislation sets specific requirements that the manufacturer must fulfil in order to allow safe reuse.
  • Other medical devices, such as syringes, needles and catheters, are intended to be used once only for a single patient. Such devices are defined as single-use medical devices.

Currently the practice of the reprocessing of single-use medical devices is not regulated at European level. Most EU countries have no specific national laws regulating this practice. On the other hand, some countries allow the reprocessing of single-use medical devices while others prohibit the practice.

The report to the European Parliament and to the Council on the reprocessing of medical devices in the European Union adopted today is a requirement set by the EU legislation on medical devices.

The full report is available at: http://ec.europa.eu/consumers/sectors/medical-devices/files/pdfdocs/reprocessing_report_en.pdf