It has been the practise within New Zealand to reprocess EP Catheters and resterilise then utilising Ethylene Oxide. More recently some hospitals have used Low Temperature Gas Plasma.

Recent changes within the USA re FDA requirements and material produced by MDA in the UK have increased our wish to no longer reprocess EP catheters. Before this can be finally approved we have been requested to seek information on what is happening in the European Community

It would be appreciated if someone could please provide an update

Tony Blackler
Manager Sterile Services

Tony

I can only endorse the MDA recommendations that re-processing be discontinued. There are different protocols in Europe based on either tradition or pragmatism and I am not sure whether a unified approach will ever exist. Within the Medical Device Directives anyone reprocessing such devices will take any responsibility during their re-use. In the UK, with its particular vCJD problems this is to greta a burden.

Best wishes and good luck - Peter Hooper, UK

Pattern of electrophysiologic and ablation catheter reuse in Belgium.
Yves Vandekerckhove, Hilde Beernaert, Wim Renders. (AZ St.-Jan Brugge, Belgium).

Introduction:

Electrophysiologic testing and catheter ablation are invaluable in diagnosis and treatment of cardiac arrhythmias and prevention of sudden cardiac death. While the cost of diagnostic and ablation catheters is high, reimbursement of the procedure is not sufficient to finance the catheters. Diagnostic and ablation catheter reuse has therefore been common practice in many European countries, USA and Canada. Much has been debated about recent European medical devices directive applicable to all medical devices placed on the EU market. An institution that reuses these catheters may not be considered a new manufacturer, but every hospital is still obliged to insure the highest level of safety to the patient. Information about current practice in Belgium is lacking.

Methods and results:

We performed a simple telephone, fax, or E-mail interview of 31 laboratories involved in electrophysiology in Belgium; 29 responded. Of these 23/29 (79 %) reuse solid (non luminal) diagnostic catheters and 21/27 (78 %) also reuse ablation catheters. The main reason for reuse is financial. Safety is never reported a problem, if certain precautions were respected. The main reason for not reusing diagnostic and ablation catheters is obligation by hospital administration.

Conclusion:

1. Resterilization and reuse of diagnostic and ablation catheters remains common practice in Belgium. Main reason is financial.
2. The reason for not reusing was never adverse effects encountered after resterilization, but obligation by hospital administration.
3. Although many interviewed cardiologists would prefer single use, they are convinced that catheters can be safely reused if a strict protocol is followed. Large randomized trials are lacking.
4. Most cardiologists are waiting for national guidelines about reuse and/or separate reimbursement for single use catheters.

Note to the answer of Yves Vandekerckhove:

Afterwards the Belgian authorities made their point of view clear by the mouth of the Pharmaceutical Inspection (see also the discussion page 11/07/2000, Re-use of medical devices). They subscribe to article 2 of the Medical Device Directive: "Member states shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they do not compromise the safety and health of patients, users and, where applicable, other persons when properly installed, maintained and used in accordance with their intended purpose."
This includes a prohibition of the re-use of medical devices meant for one time use. In between 5 centers ended the re-use of electrophysiology and ablation catheters.

Kind regards,
Wim Renders