MEDICA.de spoke with Dr. Christoph Röder from the University of Bern about approval procedures and regulations that are being pursued in Swiss operating rooms.
Dr. Röder, how does Switzerland assess the benefit of medical devices?
Christoph Röder: Benefit assessments and approval are closely connected. When it comes to medical services, the legislator generally assumes that the criteria in terms of effectiveness, usefulness and cost-effectiveness are being met. Thanks to this reliance principle, new treatments are introduced comparatively quickly in Switzerland. On the other hand, the country may formally declare a service as being "controversial". In this case, the care provider or the manufacturer must compile the existing evidence in a dossier of proposal according to the guideline by the Swiss Federal Office of Public Health (BAG).
A health technology assessment (HTA) is then asked to consider the characteristics of the medical devices as well as their specific approval and compensation procedures during market launch. At this point, many countries have established so-called HTA institutes that assess medical procedures and make recommendations or – depending on the country – reach decisions on whether these procedures are being compensated or not.
According to which regulations are the products being tested?
Röder: There is a strong harmonization process with the European Union at this point. The Swiss Agency for Therapeutic Products Swissmedic enforces the drug policy, and in some areas, this is done by cantonal authorities. Switzerland has concluded treaties on the mutual recognition of conformity assessments for medical devices with EC members, EFTA member states and Turkey. The foundation for these treaties is the European CE marking as well as the implementation of European medical device regulations.
To obtain relevant data, it may be necessary to conduct clinical trials with patients. To be able to do this, the test product has to be sufficiently developed for application on humans, the test organization has to be established, the positive vote of the responsible ethics commission has to be on hand and Swissmedic has to be notified. However, there is no need to notify Swissmedic, when CE or MD-marked – the Swiss equivalent of the CE marking – medical devices are solely used under the specific functions and settings that are already permitted for their commercialization in Switzerland.
The "Coverage with Evidence Development" or CED process is a special procedure for testing the usefulness and safety of a therapy or product. This is a specific approach to make promising technologies and therapies available to patients, even though evidence about their effectiveness is still unclear.
What limits do medical device manufacturers encounter with these procedures?
Röder: The CED processes in particular are (still) not sufficiently standardized, so that every new product launch constitutes its own evaluation project. This is about building a medical register, for which contents as well as data acquisition designs and technologies need to be organized and means provided. The outcome of these projects in terms of the quality of generated evidence and consequences for approval is completely open. There are also fewer competent partners for CED projects, since medical informatics, methodology and medical competence should ideally exist in a team. Consequently, companies make risky investments, which can definitely be called into question considering the size of the potential Swiss market. On the other hand, an Europeanization and internationalization can provide new opportunities to also include the findings in approval procedures into other markets.
What approaches are being pursued in Switzerland in terms of the care safety in the operating room?
Röder: For years, the Swiss Foundation for Patient Safety has sponsored the "Surgical Safety in Switzerland" program, in which the "Safe Surgery Saves Lives" recommendations by the World Health Organization WHO and the Foundation’s recommendations on the prevention of surgery mix-ups are conceptually merged.
The follow-up project "Progress! Safe Surgery" runs until 2015. Volume No. 5 "Operation Safe Surgery", prepared by the Swiss Foundation for Patient Safety, includes comprehensive basics to implement the checklist, which can also be implemented in all Swiss hospitals independently from the "Progress! Safe Surgery" follow-up project. The volume explains the effective implementation of the checklist in practice and was delivered to all Swiss facilities offering invasive procedures. Studies show that working consistently and completely through the three-part checklist significantly assists in avoiding mistakes or catching them in time and thereby increasing patient safety.
How do these approaches differ from those in other countries?
Röder: That is a difficult question, since this area has truly attracted the attention of authorities, the public and science only recently over the past few years. According to literature, until a few years ago there wasn't even robust and valid data to capture the extent of safety problems for the life and health of patients in the operating room on an international level. What’s more, extensive methodological issues had to be resolved.
By now, the Organization for Economic Co-Operation and Development, OECD, has designed a list of 21 safety indicators that are meant to facilitate international comparisons. As far as active measures and not just measuring are concerned, internationally the trend likely goes towards checklists such as SURPASS (Surgical Patient Safety System - Netherlands) or the already mentioned WHO program.
What is more, in many countries there are initiatives for an improved reporting of unwanted events and more transparent quality measurement and reporting systems in the inpatient sector. With programs such as ANQ - The National Society for Quality Development in Hospitals and Clinics - Switzerland is also at the cutting edge in this regard.