This session covered the issue “Time for clarification of the problem of device recalls”. It was remembered that the European Working Group on Cardiac Pacing, which was created 30 years ago, had as its first mission to find out and discuss how to manage pacemaker failures. In 2006 at the World Congress of Cardiology the same issue received attention because the population benefiting from pacemakers and defibrillators has increased to about 3 million in the whole world. We can approach the problem from two angles: on the one hand, this is a huge problem because hundreds of thousands of patients might be concerned, or on the other hand it could be blown out of all proportion because it might only concern one in 10,000 patients.
The industry’s position was presented by Dr S. Nisam (Guidant) who insisted on the increasing reliability of the product. He said that a 100% safety record will never be achieved by any manufacturing procedure, which is in contrast to the general opinion. Based on this, the concept of component failure has to be accepted. In his opinion a 1-3% failure rate at three years is reasonable and the manufacturers make a continuous effort to improve on that. This extremely low failure rate has to be compared to the effectiveness of the therapy. Action in the field should only be taken when a product does not reach the predicted performance level, which means that we have to accept the presence of “individual” random failures. Feedback on such defects from the medical community or legal authorities is essential. As industry is continuously improving the product, small technical changes are not necessarily publicised to the medical community. Manufacturers have an internal board, which includes physicians, that decides at what level information on technical improvement should be circulated. Based on his recent experience and legal as well as emotional reaction, failures should possibly be announced in the manual.
Despite the huge reaction in the lay press, the regulatory authorities have no reason to intervene said Dr S Ludgate (British Health Authorities). This was because failure to reach predicted performance levels was not a factor in the recent recall episodes. These authorities will only take action when a patient’s safety is threatened and intervene only when such events become a legal issue. Moreover, the health authorities in Europe as well as overseas, have no means of following a product once it is marketed. They completely rely on post market vigilance, which means reporting by physicians. Dr Ludgate proposed that the reporting of malfunctions should be incorporated into “the instructions to use” implantable devices. In the UK an initiative was taken to promote user reporting, but nevertheless it seems that most problems are not reported. When a major malfunction was discovered, her institution foresees four levels of intervention: (i) informing the medical community, (ii) publicising information on the internet, (iii) fielding corrective action, (iv) recall.
Only the latter would have an impact on patient care and this last point was at the centre of the debate at the European Heart Rhythm Association (EJRA) conference this spring. It reached the same conclusions as its sister organisation in the U.S., as co-chair of this session Dr A. Curtis (Tampa, US) pointed out. The reporting committee concluded that despite the catastrophic consequences of a device failure in an individual patient, a field action is only warranted when the patient’s risk is higher than the risk of replacement, which according to recent publications is in the order of 8%.
Unfortunately, announcing without preparation a recall can have unpredictable consequences and lead to confusion and to work overload of pacemaker facilities, as well as to shift legal responsibilities said Dr. J Merino (Madrid, Spaine). In his experience reaction to recalls could vary from 0 to 100% replacement rate. Again, the concern now is that the risk of device replacement can only be accepted if this improves patient safety. In the centre of the debate were the actual information practices where the medical community should speak through authorised boards of scientific bodies such as EHRA in Europe or HRS (Heart Rhythm Society) in the U.S. This is important to prevent any rumours on product reliability, which could have unpredictable impact even on stock markets.