Experts expect “soft” compromise – Market dominated by cost pressure – Conditionally reusable medical devices gaining ground
Berlin, Bonn – 8 May 2015 – Reprocessing and reuse of complex single-use medical devices is a standard practice across Europe, but it has been regulated differently between countries. For the first time, the European Commission and the European Parliament now have presented suggestions on a uniform regulation in Europe. Although the drafts are slightly contradictory, a EU-wide ban on reprocessing of single-use products seems to be off the agenda. “Today, the question is not whether complex medical devices should be reprocessed at all, but how this should be done”, said Robert Schrödel, CEO of Pioneer Medical Devices AG at a convention of the German Medical Technology Association (BVMed) held in Bonn on 23 April. “Therefore I welcome the initiative of the EU to give due consideration to the practice of reprocessing and to establish an authoritative framework in the interest of patient safety.” Host Joachim M. Schmitt, managing director of the BVMed, was also pleased: “After years of stagnancy, the discussion on reprocessing and reuse of medical devices has finally gained momentum.”
However, the exact specifications of a European legal framework are still unclear. The EU parliament had caused irritation by suggesting to classify all single-use products as reusable unless listed on a negative list. “This suggestion would have thwarted the traditional principle, by which manufacturers are responsible for proving the safety of their medical devices”, criticized Dr. Hans Heindl, expert for medical devices at the BVMed event in Bonn. Criticism also came from Pioneer CEO Schrödel whose company runs two reprocessing facilities in Bochum and Aschersleben. In his opinion, not all complex medical devices are suitable for reprocessing and it would be downright negligent to bring any such products into circulation again.
New EU regulation on medical devices not expected before 2016
Experts therefore see little chances for the parliament’s suggestion, but they do expect the EU to agree on a “soft” compromise that will basically follow the suggestions of the Commission and is favored also by the EU Council. This draft stipulates that reprocessing will be put on a level with the manufacturing process, but at the same time governments would reserve the right to ban reprocessing of single-use products on a national level. “This compromise is better than none”, said Peter Schröer, Director QSRA at Johnson & Johnson, “because unlike the parliament’s suggestion, it would improve patient safety in any case.” However, nobody seriously expects a new EU regulation before the middle of 2016.
It is undisputed amongst experts that a uniform regulatory framework is needed urgently. One reason is that some products are in fact reprocessed in-house by clinics although they really would require special facilities. Also, medical devices are becoming increasingly complex – some products feature integrated software, which must function properly after reprocessing individual components. Already today, reprocessors have to grant a “manufacturer’s warranty” for this.
“The market requires expensive medical devices to be reusable to improve cost-effectiveness”, Schrödel described the situation in Europe. However, this should not be at the expense of quality, as it is increasingly witnessed today. Already in the design stage, the focus should rather be on cleanability and sustainability.
Hybrid devices as the binding link between economy, ecology and quality
To solve the dilemma of cost pressure and quality, Pioneer Medical Devices AG takes a completely new approach with so-called hybrid devices. These products are too complex for in-house reprocessing in a clinic, while at the same time they are designed only for a limited number of reprocessing cycles. A conditionally reusable shaver system for orthopedics is already on the market, and numerous other hybrid devices are due to follow in the next years in cooperation with the affiliate Rudolf Medical. “If I can use a shaver system four times instead of once, that saves me at least 35 per cent after deduction of all reprocessing costs”, Schrödel explained the economic advantage for clinics. Considering that a big clinic group consumes hundreds of thousands of shaver systems per year, reprocessing only a fraction of them would be profitable.
Currently, the redesign and revalidation of a modular, reusable trocar system for minimally invasive surgery and laparoscopy instruments, which can also be reprocessed, are the first priority in Pioneer’s development pipeline.
However, many manufacturers are still reluctant to make their medical devices reusable. They are concerned about possible sales losses and the high effort. Reusability means that the manufacturer has to define a process for cleaning the product, then validate the process and have it certified by a designated body. That is why many prefer to attach the “single-use” label. However, according to statements made on the BVMed event, that is no longer appropriate today for economic and ecological reasons. “Mass-reprocessing of single-use products shows that we have to make medical devices safer in the first place”, said Schrödel.
New technologies aid in germ reduction
In addition to the development of conditionally reusable devices, Pioneer’s CEO also referred to a new coating technology called nanogiene. It combines a nano-coating with a method for germ reduction. In a study supported by the German Federal Ministry for Education and Research (BMBF), Pioneer was able to demonstrate that nanogiene reduces the formation of microorganisms on surfaces of medical devices more than ten-fold. “Our products are delivered from the beginning with the nano-coating, which is re-applied after every reprocessing”, Schrödel explained. “This means another plus in hygienic safety for users.”
BVMed director Joachim Schmitt spoke of such manufacturer initiatives as “ground-breaking”. “Medical devices must be safe at any time and everywhere”, he said. He praised companies for their creative attempts at solving the dilemma between economy and ecology on the one hand, and quality and patient safety on the other hand – regardless of the EU’s upcoming decision.