New lease of life for cardiac catheterisation
Antje Grone holds in his hands a nondescript thin tube, which means the difference between life and death. "This is a high-tech piece of medical technology, used thousands of times over in all developed countries to treat cardiac arrhythmias, provided the costs can be covered," explained the young woman, who for the past two years has managed AscaMed, the re-processing centre of Pioneer Medical Devices AG in Aschersleben. The problem with this is that the majority of these €1,500, and in some cases €3,000, catheters are considered disposable materials according to many manufacturer's instructions. This means that after use, these expensive devices usually end up in the bin, as if they were cheap disposable syringes.
In the small offices of AscaMed however, they have long since been working on a reasonable way of recycling these devices, in order to put a stop to the practice of throwing them away. According to the German Medical Devices Act and the recommendations and guidelines from the Robert Koch Institute, Pioneer has developed methods for several product groups, in order to clean catheters and other medical devices after use, to test their function, to sterilise them independent of re-processing, and to allow them to be released for re-use.
In the light of various scandals, there have been concerns in Europe for some time now regarding viruses and contaminants from needles or blood products, that the re-use of tubing or infusion lines could present a risk. Appropriate regulations and guidelines, such as those issued in Germany by the Robert Koch Institute and the Federal Institute for Drugs and Medical Devices, are still lacking in most countries. The use of re-processed heart catheters is also practical, according to many independent experts, provided the strict hygiene rules are observed: "When it comes to the re-processing of medical products, patients' safety always comes first", assured Prof. Matthias Antz from the Cardiac Centre at the University of Oldenburg. According to specialists, it would be ideal if manufacturers could integrate re-processing in to their own development and certification process. This integration took place for the first time in the case of the Master2cout catheter, developed by Pioneer/AscaMed in collaboration with international partner companies, which can be used up to ten times.
Pioneer Medical Devices AG, the parent company of AscaMed, was the first company in the world to specialise in the development, manufacturing and re-processing of innovative, complex medical products which are approved for limited re-use right from the start. Pioneer has succeeded in integrating re-usability into the manufacturing process to such a level that the medical products are approved for multiple use in all 27 EU countries from the first day of CE certification. The newly established centre in Saxony-Anhalt will be equipped to deal with the appropriate technology and processes.
What is more, it is also possible to develop a process for products which have, for whatever reason, been labelled by the manufacturer as disposable materials. Several visual and functional tests would be carried out, some under a microscope, in order to detect even the slightest damage to the material. Finally, the products are put into four large basins in a class 7 clean room - which is similar to the operating environment in hospitals - and then rinsed again and finally sterilised with ethylene oxide, a concentrated gas. "The fact is that we intensively examine and treat the catheters in a way that is virtually impossible in mass production," says Antje Grone.
Robert Schrödel, founder and CEO of the Berlin-based parent company, Pioneer, reckons that in the face of cost pressures, the trend towards the high-quality reprocessing of complex medical devices, which is already popular in Germany, will also carry through to more hesitant countries. Moreover, the CE certification of the first limited re-use medical products, described above, provides a legal opportunity to distribute the products EU-wide. „We have therefore decided to expand Aschersleben into the largest European centre for the manufacturing and re-processing of innovative medical products“, stated the CEO of Pioneer.
A new manufacturing facility with clean rooms and storage space, costing around €5 million, will be built by late autumn, in order to cover the corresponding demand from the whole of Europe in the medium term. Transport links were also essential in the investment decision. Using services such as the DHL-Express-Hub at Leipzig/Halle airport even remote locations can be delivered to practically overnight. Our vision for Aschersleben is to establish an economically viable, secure recycling process for products which, until now, have been declared disposable: Then we will definitely be running a three-shift operation," says Antje Grone. This also includes the expansion of currently small-batch manufacturing, in which medical tubing is bought-in so far, combined with other components, and sold on to medical technology distributors.
Author: Manfred Schulze