Fifty years after its introduction in clinical cardiology, artificial pacing for patients with bradyarrhythmias has made a huge leap forward.
1 The development from bulky, simple fixed-rate pacemakers to small, complex, multi-programmable devices paralleled the vast technological achievements of the second half of the 20th century. In the late 1990s hope emerged even for patients with severe heart failure, with the introduction of biventricular pacing which resulted in an additional class I indication according to the recent guideline of the European Society of Cardiology.
2 Consequently, the number of implantations has steadily increased, resulting in more than 10,000 implantations (both first implants and replacements) in the Netherlands in 2007.
3Despite the well-documented cost-effectiveness of pacemaker therapy, accumulating healthcare costs have raised issues on the financial burden associated with pacemaker implantation. Many industrial products are available at substantially different prices within the 27 member states of the European Union. These price disparities are the base for commercial companies focussing on medical devices, facilitating import in ‘cheap’ countries and distributing these devices in ‘expensive’ countries. Recently, these companies have also explored the Netherlands for this parallel import of pacemakers and pacemaker leads. Although competition for many products between manufacturers should certainly be encouraged, things may be different as far as pacemakers are concerned. A number of important considerations in this respect are discussed below.
1
When pacemakers from parallel import are assembled, labelled and provided with a manual in the local language by the hospital, according to Dutch law the hospital is regarded as the manufacturer. In contrast to pharmacological products, there are no formal regulations for the labelling and the manual for medical devices. This implies that the hospital is responsible for this product and that consequently the hospital is also responsible for any claims in case of malfunctioning, e.g. recall procedures. Hospitals should be aware of the enormous costs involved in case of malfunctioning or defective devices.
2
Both the hospital using parallel imported pacemakers and the company facilitating parallel imports are obliged to develop a post-marketing surveillance system. In addition, both parties have legal obligations for medical supplies to maintain and guarantee the quality of the product involved. Hospitals should check if medical supplies are not sold after the expiry date and whether supplies are adequately stored. Obviously, storing conditions may be hard to monitor when parallel imported pacemakers are imported from remote regions, such as East European countries.
…
