MedAustron Particle Accelerator successfully certified
MedAustron has now taken the final hurdle to becoming an authorized center for cancer treatment with the successful completion of the certification process. The particle accelerator is now an approved medical device and may be used for irradiating patients with immediate effect.
The MedAustron particle accelerator is not only a unique machine, but now also a CE-certified device. It was carefully audited in accordance with the European Medical Device Directive 93/42/EEC to ensure its compliance with all relevant health- and safety regulations. Additionally, it had to adhere to further European regulations. Audits according to the MDD 93/42/EEC are conducted by a notified body; in the case of MedAustron, this body was mdc medical device certification GmbH with headquarters in Stuttgart and a branch office in Vienna.
“Receiving this certification marks a special day for MedAustron. Starting as a vague idea and becoming more controversial during the planning phase many years ago, the center has now become a reality. Today, the decision of the County of Lower Austria, and its Governor Dr. Erwin Pröll in particular, to realize this project and to invest in the future has been proven farsighted and right. I have been able to personally accompany MedAustron from the very beginning, and today I am very proud that the outpatient clinic is ready to start patient treatment, thereby bringing hope to patients with specific tumors in their fight against cancer”, says Mag. Klaus Schneeberger, Chairman of the Supervisory Board of MedAustron.
About 200 suppliers from over 20 different countries provided the components that form the MedAustron particle accelerator, which was developed by MedAustron physicists and engineers in close cooperation with experts from CERN, the European Organization for Nuclear Research. If such a device is used for patient treatments, safety requirements are extremely high and the certification process is very extensive.
Therefore, certification with the notified body was conducted in multiple parts: the first audit was held by mdc in June 2016, further audits followed continuously until November, either directly on-site or via submitted documents. In addition to the Technical Documentation of the whole facility, also the Quality Management System, which regulates all processes of daily work with the accelerator, was reviewed. Roughly 8,000 documents were compiled altogether. After the final, positive assessment by mdc, MedAustron – as the producer of the accelerator – filed the declaration of conformity with the Austrian Ministry of Health, thereby obtaining the legal operating permit.
The successful completion of the certification process was the last step on the way to patient treatment at MedAustron. In September, the center had already received the operating approval as an outpatient clinic according to the Hospitals Act (Krankenanstaltengesetz). Together with the positive CE-certification, the center now fulfills all relevant legal requirements to start patient treatment with protons. First patients have already been to MedAustron for consultations and preparatory examinations during the past weeks, and will now start their irradiation cycles.
“The successful certification is a special milestone for MedAustron. Developing an accelerator that has now been certified as a medical device is a remarkable achievement. We would like to thank everyone involved in this process, and are very excited to take up work as a treatment center together with our team,” say the Managing Directors of MedAustron, DI Alfred Zens, MBA, and Prof. Dr. med. Eugen B. Hug.
Within the technical framework available in the beginning, initial patient treatment will start with those indications for which particle therapy has already been established: tumors of the brain, the skull base or the spinal cord, as well as pelvic tumors. Until 2020, the spectrum of indications will be expanded hand in hand with the step-by-step commissioning of the remaining irradiation rooms and types of particles. At the same time, the number of patients treated per year will steadily increase: while in 2017 about 150 patients will be treated, this number will rise up to 1,000 patients by 2020.
Picture © Franz Baldauf: Dr. Peter Grübling (Head of Quality Management of MedAustron), Dr. Klaus Hogh-Janovsky (Dep. Managing Director and Senior Auditor of medical device certification GmbH), Mag. Klaus Schneeberger (Chairman of the Supervisory Board of MedAustron), Harald Rentschler (Managing Director of medical device certification GmbH), Dr. Peter Urschütz (Head of Therapy Accelerator of MedAustron)