Comments by the EFHSS

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

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"Sharps injuries and reuse of single use devices"
Comments by EFHSS (Wim Renders et.al.)

Bruges, 2003-03-27

To: Mrs Minerva Malliori
To: Mr John Bowis

Madam, Sir

Firstly, we would like to thank you for the opportunity to participate in the European Parliament seminar on March 19th, 2003: "Preventing Sharps Injuries and the case against reuse of single use medical devices: the dangers to patients and healthcare workers". With a lot of interest we have followed the seminar as representatives of "EFHSS - European Forum for Hospital Sterile Supply". In this European forum we try to unite as many as possible, national and regional associations who occupy themselves with the central sterilization of instruments. Our website www.efhss.com gives you an idea of our activities. Still, we would like to make some critical notes with a few of (from our point of view) arbitrary stands. We would like to point out that the opinions we express are personal and not the ones of the forum.

• About the prevention of sharps injuries:
  Everybody agrees that we should keep the amount of sting accidents as low as possible. Universal precautions, education and continuous training contribute significantly. Safety devices can also be very useful, but unfortunately they are so expensive that they are, from a budgetary point of view, difficult to apply in a general way. The financial consequences could be pernicious for other patients through necessary economisation. Here, for example, I'm thinking about the possible pressure from the management to reuse single use items to keep it balanced. A cost benefit study should (according to us) show the necessity for a general action. The prove of the efficiency of the device is of course a second condition. In case of an obligation for the reuse of safety devices is brought up, we should have to foresee financial compensation. It seems more attainable to us to introduce safety devices for risk services and risk procedures. Through this, the amount of sting accidents can possibly be diminished and the financial consequences are minimal.
• Reuse of single use medical devices:
  Reuse in non-controlled circumstances is indeed a very serious invisible problem that threatens the health of many patients. The medical device directive only regulates the first usage of a product. This leaves some possibilities open for interpretation. Not only in Belgium but also in other European countries the government says that the reuse of single use devices is not prohibited but under the complete responsibility of the concerning hospital. On the seminar we learned that it is up to the government to take measures and write them in the national law. The commission abides the directive. And also in case of reuse we must be careful with the arbitrary prohibitions to avoid a movement of the problems to other disciplines and/or to prevent that patients can not be treated anymore. We think for Belgium specifically about the electro physiology investigations of the heart.
  On top of that the problem of reuse is not as big as it seems at first. In case the central sterilisation unit works according to the 'state of the art', only a few expensive products are eligible for reuse. That's why we would opt for a constructive dialogue with the European institutions and Eucomed to look for solution for this group of products in all openness.
  It is important to point out that there's not only a problem with resterilised disposables. The presence of tissue residues on medical equipment was already pointed out at the previous meeting.
  Also, the cleaning and sterilisation of reusable instruments is way below standard in many European sterilisation units. It is our opinion that that is where the true priority is. The following is, according to us, an urgent necessity:
  • Getting the CSSD-staff a compulsive education and acknowledge the profession. Having competent co-workers is a real must to deliver quality and to give the patient a safe aid.
  • To guarantee that the central sterilisation department has the right equipment.
  • To talk openly with EU, EUCOMED and the reprocessors (e.g., EFHSS) about reuse. The guidelines from the German Robert Koch institute about the reprocessing of medical devices can be the basis here. The possibility of reprocessing single use devices through 'a third party' can also be discussed here.

We hope that we have served you with these marginal notes. We are the people who prepare the instrumentarium for reuse, we are responsible for when it goes right and even more so for when it goes wrong. In this way we would like to be involved in the debate. We would again like to stress that everything stands or falls with the education. A European obligation for the education of the coworker central sterilisation will not only make a difference for the sterilisation unit but mainly for the patient. We would like to keep ourselves available for discussion of these problems, in case you wish.

Yours sincerely,
Wim Renders / Ghislaine De Decker / Walter Accoe