The recent acquisitions of two leading American reprocessing businesses by leading medical devices manufacturers have relaunched the debate around the reprocessing of medical devices. In 2009, Stryker acquired Ascent and, more recently, Johnson & Johnson acquired SterilMed. This represents a major shift in the strategy of large medical devices companies. In the past, they were very critical of the concept of reprocessing medical devices and, through various organisations (e.g., Eucomed in Europe), attempted to persuade regulators that it was unsafe. It is clear that this argument cannot be used by these organisations or their peers any longer – not without coming up with some persuasive evidence: if reprocessing was intrinsically unsound, they would not have acquired these businesses and continued to operate them.
More significantly, a substantial body of evidence has accumulated in Germany over the last 15 years, which can be evaluated with a view to assessing the safety, sustainability and economic benefits of the reprocessing of medical devices in Europe.
Patient Safety
Vanguard AG, the European market leader in the reprocessing of single-use medical devices, has collaborated on several studies which have examined patient safety. Two such studies were carried out by the Kerckhoff Klinik in Bad Nauheim, Germany, with whom Vanguard has worked since 1996. The first study, published in 2000, examined 110 patients and the second study, published in 2004,1 examined 220 patients. Both reviewed electrophysiological ablation catheters and compared patient safety data for first-use and reprocessed devices, the latter being subjected to up to six reprocessing cycles. The studies found no increased risk in those patients using reprocessed catheters. The study examined the following parameters: duration of examination, duration of screening, number of energy emissions, strength of energy emissions and radiation dosage. In addition, follow-up examinations were carried out on discharge and six months after discharge to determine whether there were any significantly higher rates of complications or arrhythmia recurrence in patients who had been treated with reprocessed ablation catheters. No differences were found.
A more recent study from the hospital of the Ludwig-Maximilian University (LMU) in Munich,2 published in 2011, reviews the experience of the LMU with the reprocessing of more than 33,000 devices over a period of 15 years. The volume of devices reprocessed by the LMU has grown steadily, from 1,400 in 1997 to 3,300 in 2010. This comprehensive review also concluded that there is no increased patient risk from using reprocessed medical devices.
All these studies, however, clearly state that a precondition for obtaining this result is that devices are reprocessed by a suitably qualified and experienced reprocessor who has acquired the appropriate reprocessing skills. Standard central sterile supply department (CSSD) facilities are not capable of achieving appropriate levels of quality, nor is off-the-peg disinfection and sterilisation equipment. For the reprocessing of single-use devices, special equipment and processes are required. Additionally, the reprocessor needs to ensure that the devices can be identified and tracked, so that no more than the approved number of reprocessing cycles are carried out, and is also required to test the devices’ functionality after reprocessing.
Vanguard has invested heavily in the development of cutting-edge proprietary reprocessing technologies capable of fully refurbishing complex medical devices. These technologies include cleaning and disinfection machines, were developed with leading scientists from Berlin University, and are at least two generations ahead of any competitor’s technologies on the market. Vanguard has chosen to brand its premier reprocessing technology RECONIC Technology®. Vanguard is also the first European reprocessor to have obtained a Conformité Européenne (CE) mark for a fully refurbished medical device. The fully refurbished products are certified in accordance with EU guideline 93/42/EEC (which covers the placing on the market and putting into service of medical devices) and bear the CE mark.
Sustainability
Reducing hazardous waste and adopting an environmentally sound resources policy are gaining increasing importance. This places a premium on systems allowing the re-use of devices that are costly and difficult to dispose of. Sustainability also needs to be seen in the context of limited budgetary resources – not improving sustainability could effectively mean that the number of procedures that can be funded has to be rationed. Controlled re-use can increase the number of procedures offered to patients – in many cases, fivefold or more.
Economic Benefits
The 15 years’ experience in Germany clearly shows the substantial economic benefits that can be made through professional reprocessing. With an average of five reprocessing cycles per device, savings of around 50 % per cycle can be obtained. Several landmark European studies on the economic benefits of reprocessing have been carried out with the cooperation of Vanguard. These include the 2002 study by Ischinger et al.,3 which estimates savings made in Germany from reprocessing balloon catheters to be up to €20 million per year.
A more recent study, published in December 2011, by health economist Wilfried von Eiff4 estimates the savings from reprocessing ablation catheters across Europe to be about €70 million per year. This figure is for the radiofrequency ablation catheter, which costs €1,200 net of value added tax and can go through five reprocessing cycles. Clearly, as these studies show, the savings are substantial.
Regulatory Framework
Since 2002, in Germany, reprocessing has been subject to monitoring and surveillance by public authorities and the EU-accredited Notified Body. Rules on the reprocessing of medical devices were put into place in 2001 through the joint recommendation, issued by the Commission for Hospital Hygiene and the Prevention of Infection at the Robert Koch Institute in Berlin and the German Federal Institute for Drugs and Medical Devices, on hygiene requirements when reprocessing medical devices. The rules on the reprocessing medical devices do not differentiate between single-use and multi-use medical devices, requiring the same high standards for both.
While Germany has defined a tried and trusted regulatory path, this is still the exception in Europe, and the European Commission is currently examining how to best regulate this field.
Some European countries prohibit reprocessing. It is our view that this prohibition is directed at the reprocessing of single-use devices by hospitals in standard CSSD facilities, which indeed should not be permitted given the inadequacy of such facilities for the purpose. However, the experience in Germany shows that, under the appropriate regulatory framework, safe, sustainable and economic reprocessing is possible.
As we understand, the European Commission, after having considered and rejected an EU-wide ban on reprocessing, is currently debating the appropriate regulatory framework. We understand that the points outlined below are being discussed.
- One point being debated is whether the same requirements should be imposed on the reprocessor as on the manufacturer, which would effectively mean that the reprocessor would have to obtain a CE mark for the fully refurbished device. Such an approach would considerably increase the cost of developing reprocessing technologies and, in many cases, render them uneconomic. The German regulatory procedure of certifying through a Notified Body has shown its effectiveness over 15 years and makes reprocessing viable on a wider scale.
- It is also being debated whether individual countries should be allowed to ban the reprocessing of medical devices. This would be contrary to the free movement of goods and services in Europe. If the requirements of an EU-wide regulatory framework are met, a national ban should not, in our view, be permitted.
- A third point being debated is whether it is advisable to adopt lists defining in advance which devices are allowed to be reprocessed and which are not. We think that it is often difficult – verging on impossible – to determine ex ante which technologies will be developed in the future. Such an approach would stunt creativity in technology development and thus limit the scope of reprocessing. It should be left to Notified Bodies to validate technologies and determine whether or not they are sound. This should be carried out according to rigorously defined criteria. In that respect, substantial experience has been accumulated under the German regulatory framework.
Conclusion
We believe that it is important that a consistent EU-wide regulatory framework is adopted in order to allow all European countries to enjoy the benefits of reprocessing. Clearly, the right balance needs to be found. It is important that patient safety is ensured, but on the other hand overregulation should be avoided. Requiring full CE marking while restricting the market scope by allowing national bans and determining in advance what devices can or cannot be reprocessed will make it uneconomic to develop reprocessing technology. This would be a shame, because 15 years of regulated reprocessing in Germany have demonstrated that it is possible to achieve substantial economic benefits while maintaining patient safety through an appropriate regulatory framework.