Product Quality Aspect in Reimbursement of Medical Devices: Comparison of Turkey Verse Europe.

Abstract

FDA has long recognized that dramatic increase in adverse event reports due to medical devices and recalls may reflect quality flaws. While some of this increase can be explicated by FDA’s greater outreach emphasizing reporting requirements, failures in product design and manufacturing process cause more than half of all product recalls. Therefore, FDA’s concern regarding low quality products remains. In the EU, medical device pre-market quality is assured by CE mark authorization. This regulation is the prerequisite for market registration also for Turkey. However, due to heterogeneity and complexity of devices, manufacturers, imported devices and multiple use environments, there is strong need for post-market quality assurance. This study investigates whether post-market quality assurance (measured by less adverse events/better health outcomes) can be applied through local reimbursement policies. First, it is investigated whether there are reimbursement rules in Europe acting as post-market quality assurance. Then, a comparison is made with Turkey’s existing reimbursement scheme. Our comparative analysis reveals only Belgium and France implement quality or brand based reimbursement rules. In Turkey, there is no quality based reimbursement scheme; however current reimbursement application guideline requirements may act as a gate keeper for lower quality products. Our Results show in addition to pre-market regulations, post-market quality can be assured by local reimbursement authorities. There are several opportunities to improve quality assurance and reduce risk across medical device industry; i. e. enhancing visibility of comparative quality to harness market forces and increasing the collaboration between stakeholders. From health policy perspective, implementation of new value based reimbursement models require providers to prove that they’re meeting quality standards and benefitting patients while cutting costs. Therefore, while value based payment contracts are still in their infancy in Europe and Turkey, they will have a direct impact on the assurance of continued medical device quality.