New national standard SFS 7515 acts as a quality guarantee for refractive surgery services
Eye surgeons from around the world are converging in the Helsinki Expo and Convention Centre on 6–8 March 2026. ESCRS Winter Meeting is the first major eye surgery congress to be held in Finland. With the publication of the new national standard SFS 7515, Finland has become a pioneer in refractive surgery. Other countries are yet to implement such national standards for eye surgery services.
Published in 2024, SFS 7515 sets the standard for effective and safe vision-improving refractive surgery, including laser and lens surgery. Instead of offering clinical instructions, the standard focuses on the patient-provider-interface, defining the conditions for service delivery that are most likely to ensure optimally safe and effective treatment and results dependent on each patient’s individual circumstances.
The scope covers systematic requirements for the service delivery model, ethical principles plus service transparency and assigned responsibilities prior to, during and after surgery. The standard helps providers manage their operation in a way that safeguards patient interests and ensures effective treatment, which in turn will positively impact their business.
Foundations in Finnish expertise
The initiative for SFS 7515 was made by Jarno Ylitalo, a Finnish refractive surgeon and founder of The First Clinic. The standard is based on a checklist developed by Patient Advocate & Clinic Manager Anriikka Viik. The checklist helps those interested in refractive surgery find the safest option for vision-improving surgery, considering their individual circumstances, without the need for in-depth knowledge of the field.
The work group drafting the standard comprised refractive surgery experts as well as professionals from various other stakeholder groups. Members of the work group included representatives from the University of Helsinki, Tampere University, University of Turku and University of Jyväskylä, Metropolia University of Applied Sciences, the Finnish Institute of Bioethics, the Wellbeing Services County of Ostrobothnia and the HUS Division of Eye Diseases.
The legal department of the Consumers’ Union of Finland and the Centre for Consumer Society Research at the University of Helsinki participated in the work group as observers, representing patient interests and rights. The work group’s efforts resulted in a standard built around a definition of an effective service delivery process for refractive surgery.
The work group’s efforts resulted in a standard built around a definition of an effective service delivery process for refractive surgery.
By complying with SFS 7515, providers can improve the quality of their refractive surgery services and mitigate the negative impacts associated with surgery. They can also offer their prospective patients tools for weighing risks against the expected results prior to committing to treatment, something that previously would have required specialist expertise in the field.
“In the end, drafting the standard was simple. All we had to do was think about how we ourselves would like to be treated in the context of any vision-improving surgery and write it out in the form of a standard”, refractive surgeon Jarno Ylitalo says.
“The standard protects patients from the negative effects of a purely profit-seeking operating model in many ways. Examinations must be thorough, the details of the treatment must be communicated to the patient in a comprehensive and clear manner, and the treatment must not be rushed. A further practice welcomed by consumers, the total cost of the treatment must be clearly stated prior to commitment to help ensure there will be no surprises”, says Patient Advocate Anriikka Viik.
SFS 7515 helps ensure providers and patients are on the same page
Refractive surgery differs from traditional medicine in that instead of treating an illness, it aims to improve the patient’s quality of life by reshaping a healthy eye. Bioethically speaking, this places a certain responsibility on the surgeon. With a healthy patient, the expectations for the treatment are generally very high, while risks, however small, are also involved.
With a healthy patient, the expectations for the treatment are generally very high, while risks, however small, are also involved.
From a bioethical perspective, it may be that patients are only given promises without a real ability to assess the effectiveness or risks related to surgery. The focus on quality and ethical considerations in the new standard helps ensure that the surgeon, the provider and the patient have a shared understanding of realistic expectations and responsibilities.
Guarantee period included
SFS 7515 helps protect patient rights by enforcing a guarantee period that starts from the date of surgery. The agreed treatment must be completed within the guarantee period, and no additional fees may be charged for visits during the period. When no additional fees are collected for post-surgery care such as the treatment of complications or additional monitoring, all patients are treated equally. The service delivery model also includes a guarantee for the expected improvement in the refractive state of the eye as a result of surgery.
“Understandably, the monetary guarantee for the end result as stipulated in the standard was opposed by many professionals in the field during the drafting of the standard. The guarantee is, however, of utmost ethical importance”, Ylitalo says.
Providers complying with the standard commit to performing additional adjustments within the guarantee period if the patient experiences any negative impacts from a residual refractive error and agrees to the risks of a repeat surgery when weighed against the expected results. Although overall treatment times may vary, surgical treatment of refractive errors generally takes two years at most. This covers the whole treatment process including any potential complications.
Standardization of medical services is rare
The standardization of medical services is often not possible, as the difficulty in objectively determining the presence of an illness and the effectiveness of treatment is in fundamental conflict with the requirement of unambiguity in standardization.
In the case of SFS 7515 this was not an issue, as refractive surgery aims to adjust the refractive qualities of the eye instead of treating an illness. The refractive state of a healthy eye can be measured exactly, and there is no uncertainty resulting from an illness complicating the assessment of the expected results of the treatment.
The true value of SFS 7515 lies in the guidance it provides for ensuring the quality of treatment. Instead of replacing clinical expertise, the standard enforces it by defining quality criteria and calling for comprehensive and detailed examinations prior to surgery. The equipment used to determine the refractive state of the eye is also standardized.
Buy the standard in SFS Store
SFS 7515 is available for purchase to all clinics and surgeons performing refractive surgery in Finland. The next step in improving the quality of refractive surgery services is to further develop the national standard into a common European standard. SFS 7515 is available for purchase in SFS Store.