Quality and Safety
Since 1998 our highly motivated and skilled team has built up experience from over 3,500 successful treatments and stands for quality and performance in radiosurgery. To guarantee our quality and performance, our quality management has been run according to ISO 9001 right from the beginning. That makes the Gamma Knife Centre in Krefeld the first and so far the only radiosurgical establishment anywhere in the world where not only the quality of service is subject to quality management, but also the whole medical treatment process right up to examination of results.
Quality Assurance
In the world of medicine, and especially in the application of radiation, a high level of quality assurance is required.
The top priority for all quality assurance activities is to ensure that the treatment is safe at all times. Both you, the patient, and your doctor must be able to rely on all devices used during the Gamma Knife treatment being in perfect condition. This ensures that the irradiation is applied with the greatest possible precision.
We inspect all the Gamma Knife’s safety systems every working day, check the figures relevant to radiation and conduct several short irradiation tests, before the device may be used on patients.
Every two weeks the system undergoes a comprehensive check including all the medical imaging devices (for MRI, computed tomography, etc.). This test uses a crosswire-type target which is mechanically inserted into a phantom. The procedure is just like treating a real patient. Medical imaging is used to locate the crosswires and send their position to the planning system. Then an irradiation plan is calculated and executed. A radiosensitive film shows how accurately the mechanically pre-set crosswires have been targeted. The radiation delivered may not deviate from the position of the target by more than 0.5 mm in any spatial dimension. Furthermore, the dose measured is compared with the planned dose and here the deviation may not exceed 7% (the precision of film dosimetry).
Every month we inspect all the mechanical components of the Gamma Knife that are used for irradiation. In addition the dose delivered at the focal point is also determined and compared with the planning system.
External Quality Assurance
The Gamma Knife Centre in Krefeld is audited regularly by the independent organisations responsible for quality management.
- Ärztekammer (regional medical association)
Every two years the quality of treatment and devices is inspected by the Ärztekammer Nordrhein (North-Rhine medical association). - Gesundheitsamt (regional health authority
Regular checks concerning hygiene regulations - Equipment manufacturers
Every six months the manufacturer services the system and checks all the components. This is recorded in a report of about 80 pages. The check also includes a test of how closely the mechanical centre agrees with the centre of irradiation at the focal point. The deviation in all three spatial dimensions must be less than 0.5 mm and is typically close to 0.2 mm. This value has been constant for five years and is determined again whenever a radiation source is replaced. - Landesamt für Umwelt (regional environmental authority)
Once a year, an environmental expert carries out a complete check of the system. The test report is forwarded directly to the approval authority, which decides whether the machine may continue to be used. - LGA-TÜV InterCert (certification company)
Annual inspection of the quality management system with recertification every three years
QM System Complies with ISO 9001
Passenger aircraft are subject to numerous checks and controls ensuring that they can take off and land safely. Passengers can relax on board and enjoy their flight. In the automotive industry, too, it is normal practice to check the products thoroughly to ensure the safety of drivers and passengers. Both of these areas – aviation and the automotive industry – are known for applying quality standards. The manufacturing processes are checked, which leads to greater safety and efficiency. In order to ensure the required quality, the standards are checked and certified regularly by independent organisations.
Certification in accordance with ISO 9001 is still rather unusual for medical establishments. The Gamma Knife Centre in Krefeld was already certified as meeting the ISO 9001 standard as early as 2001.
The areas certified are:
The practice, the radiosurgical treatment using the Gamma Knife and the physics.
Fundamentals for the management system are:
- The medical treatment.
- Quality assurance of the method and of the device.
- Patient-oriented practice management.
- Process orientation.
- Continual improvement.
- Economic efficiency.
- Consideration of all partners: patients, referring doctors, employees, health insurers, the operating company GKZ GmbH, society and the environment.
- Benchmarking between centres
