The LASIK-TÜV Süd Quality Seal
Providing an Objective View on the Quality of Laser Eye Surgery
Everyone has seen the blue octagon logo with the famous three letters: TÜV.
It is the epitome of German thoroughness and stands for safety and quality.
What once began as a technical inspection association testing German automobiles is now an international service organization. There is hardly any industry that can not be checked or certified. In the healthcare sector, two different and at first sight almost indistinguishable TÜV seals are the cause for excitement: The well-known TÜV Süd certification based on ISO 9001:2008 and the fairly new LASIK TÜV Süd for laser eye surgery which was introduced in 2006.
The ISO 9001:2008 certificate (left) is a pure process-oriented quality management label that has been introduced 20 years ago and is awarded across all industries, for example also to online travel agencies. It only reflects the optimization of processes and tells nothing about the expertise of the surgeons, quality of medical treatment or technical equipment used during surgical procedures.
The LASIK TÜV Süd is considerably more
The ISO 9001:2008 certificate is one of many prerequisites for to aquire the LASIK TÜV Süd seal (right). In addition, the LASIK TÜV Süd criteria catalogue includes very specific requirements for patient outcomes, experience of the surgeon, number of performed surgical procedures, complication rates, hygiene standards, technical equipment and patient satisfaction.
The LASIK TÜV Süd allows eye laser centers to have the quality of their work confirmed by an impartial third party. It also helps patients to choose the right laser surgeon or eye laser center.
What exactly does the LASIK TÜV Süd examine?
To give a few specific examples, under examination are:
1. Qualification of eye surgeons and staff
Testing is inter alia whether staff and physicians have the necessary qualifications. Physicians must have completed at least 1,000 LASIK procedures in the last five years, with 250 of them during the last year. In addition, the entire staff, including doctors, must provide proof of expertise in his or her medical field and participate in continuing training.
2. Technical equipment of the eye laser clinic
Also, the technical equipment is put to test. For eye laser surgery such as the LASIK, only up-to-date or so-called "state of the art" equipment can be used for diagnostics and treatment. The high technical standards have established by a scientific advisory board. In addition, all devices are subject to annual maintenance requirements.
3. Operating room
The thourough inspection starts with the infrastructure (e.g., an uninterruptible power supply needs to be on site) and goes to hygiene requirements. To ensure the high hygiene standards of the Robert Koch Institute (RKI) for sterile surgical conditions, each LASIK TÜV SÜD certified provider must have a hygiene supervisor with appropriate training and experience on staff.
4. Quality control
A number of stringent requirements need to be fulfilled by the management, most importantly quality control for a continuous review and documentation of patient outcomes. The rate of major intraoperative and postoperative complications must be below 1%, the re-operation rate under 10% and the success rate of the visual correction for 90% of all patients within ± 0.5 diopters.
5. Patient satisfaction
Last but not least, patients' satisfaction with the institution itself is measured and documented using standardized questionnaires.
Looking for the most qualified LASIK provider?
For patients looking for the right clinic and surgeon, an objective proof of quality such as the "LASIK TÜV Süd" is of special importance.
The introduction of the "LASIK TÜV" certificate is one of the most far-reaching security guarantees for patients. The LASIK TÜV Süd seal indicates that the strict quality requirements were objectively reviewed and verified by a team of external auditor constisting of technical experts from TÜV SÜD, an eye doctor serving as medical expert and a hygiene specialist. In addition, the certification criteria and requirements are reviewed by the scientific advisory board consisting of representatives of the TÜV SÜD, the Association of German Opthalmosurgeons (BDOC) and the Commission of Refractive Surgery (KRC) on a regular basis to ensure scientific validity.
The LASIK TÜV Süd seal benefits people seeking vision correction with individual LASIK, Femto-LASIK, LASIK or LASEK. LASIK is the most common surgical procedure, accounting for over 90% of all laser eye surgeries.
Although there are over 300 eye laser centers offering LASIK in Germany, so far only 24 of them have been certified with the prestigious LASIK TÜV Süd seal.
Again and again, foreign clinics advertise with the TÜV-certificate:
Patients must pay attention to exact wording
For many patients, the cost of the procedure is a key criteria for choosing a LASIK provider, leading them to foreign eye laser clinics which offer the procedure considerably cheaper. Since it is almost impossible for the lay person to judge a surgeon's expertise, quality of treatment or outcomes, many patients rely on the well-known TÜV seal when choosing their provider. But beware - with more and more foreign eye laser clinics advertising their services using the TÜV seal, it is important to look very closely at the certificate.
Most of the foreign institutions have only aquired the quality management certificate ISO 9001:2008 and not the stringent LASIK TÜV Süd.