Stakeholders discuss how to enhance safer use of medical devices

Participants in an EP public hearing discussed ways to prevent injuries by sharp devices and the re-use of medical devices manufactured for a single use only.

Healthcare workers across the EU are being affected byinjuries caused by needles and other sharp medical devices. Such injuries lead to distress, sickness and absenteeism, or, in the worst of the cases, the transmission of a potentially fatal disease. These injuries are mainly caused by non-compliance with existing EU Worker Safety and Health Directives, particularly as regards better information and education, safety of the workplace and the use of proper protection technology designed for high-risk medical procedures.

Another risk factor is there-use of medical devices that are designed to be used only once. This is a widespread practice in the EU, affecting both patients and healthcare workers. Due to the difficulty of cleaning single-use devices, the re-use of such devices may pose a general risk of infection. Reprocessing a single-use device may also result in the impairment of its performance as it is contrary to the manufacturer’s design. European patients lack information about the potential risks of re-using a single-use medical device.

 

Positions

ThePresident of the General Council of Nursing, Maximo Gonzalez Juradointroduced the participants to a Spanish initiative which aims at reducing sharps injuries in hospitals. This initiative supports better education, safer work practices, initiatives promoting the use of protective technologies, media campaigns and the building of strategic partnerships.

A nurse,Martin Alster from the UK Royal College of Nursing, works with intravenous drug users. He described what it felt like between the time he suffered a needlestick injury and the moment when he finally received his test results.

Simon Williams, from the Patients' Association (UK)pointed to the fact that most authorities do not consider infection control a priority area for action and 30 per cent of medical practitioners are against greater public awareness of decontamination issues, as well as the re-use of medical devices.

Prof. Dr. med. Werner from the Centre for Hygiene and Medical Product Safety Ltd. (Schwerin)underlined that the there are less experts dealing with hygiene nowadays than before. Based on his information, 40-60 per cent of endoscopes, considered "ready for use" were contaminated from previous patients. If a small part of a medical device gets into the blood vessels, it results in death in 50 per cent of the cases. Mr. Werner stressed that the reprocessing of sigle-use medical devices falls outside the scope of any directive, as it is a paradox.

Eucomed, the Medical Technology Industry Associationhas been active in both the prevention of

sharps injuriesandre-use of single-use devic es. Eucomed campaigns with nurses, patients and doctors in both areas.

Based on her draft report, in the context of the imminent review of the Medical Devices Directive,Rapporteur Minerva Mallioriwould:

  • encourage the Member States to take the necessary measures to ensure that single use devices are not reused;
  • support the reclassification of some devices;
  • make clinical data available to manufacturers;
  • improve post-market surveillance;
  • and improve the designation and monitoring of Notified Bodies.

Experts from theCommission, drew attention to the guidelines available online on the website of the European Agency for Safety and Health at Work regarding sharps injuries prevention. As regards the re-use of medical devices, the Commission underlined that market surveillance is a responsibility of the individual Member States.

 

Background

Researchers, nurses, doctors, patients, industry and interested parties from the EU institutions gathered in the European Parliament on 19 March to discuss two important topics relating to medical devices. The public hearing, chaired byMEP Minerva Malliori, dealt with injuries caused by needles and other sharp medical devices (or "sharps injuries"), as well as the health risks related to the re-use of single-use medical devices.

Two directives on medical devices, the Medical Devices Directive and the Directive on Active and Implantable Medical Devices, are scheduled to go under review in the coming months. In this context, the European Parliament is currently considering an own-initiative report drafted by Ms. Malliori on the health implications of directive 93/42/EEC concerning medical devices.

 

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