Safety Issues Compared for Devices First Approved in Europe Versus the United States
July 25, 2016—Medical devices first approved in the European Union are associated with an increased risk of postmarketing safety alerts and recalls compared with devices first approved in the United States, concluded Thomas J. Hwang et al in a study recently published online in the British Medical Journal (BMJ). The investigators further advised that poor trial publication rates mean that patients and clinicians need greater regulatory transparency to make informed decisions about treatment.
The investigators sought to evaluate safety alerts and recalls, publication of key trial outcomes, and subsequent United States approval of high-profile medical devices introduced in the European Union.
As summarized in BMJ, the study looked at cardiovascular, orthopedic, and neurologic devices receiving CE Mark approval in the European Union between 2005 and 2010. The investigators searched public and commercial databases up to January 2016 for press releases and announcements of approvals; public US Food and Drug Administration and European regulatory authority databases for approvals, safety alerts, and recalls; and Medline, Embase, and Web of Science for peer-reviewed publications.
The investigators categorized the novelty of the devices in the study sample as a “major innovation” or “other change” and extracted descriptive data about the devices and information on any safety alerts and withdrawals. Linear regression models examined factors associated with differential European and United States approvals.
Cox proportional hazards regression models were used to evaluate factors associated with safety alerts and recalls and the publication of trial outcomes for devices categorized as major innovations. Models were controlled for time, therapeutic category, regulatory pathway, size of sponsoring company, and indicator variables for devices approved first in the European Union and devices approved only in the European Union.
The investigators found that 67% (206/309) of devices identified were approved in both the United States and the European Union, of which 63% (129/206) were approved first in the Europe. The unadjusted rate of safety alerts and recalls for devices approved first in the European Union was 27% (62/232) compared with 14% (11/77) for devices first approved in the United States. The adjusted hazard ratio for safety alerts and recalls was 2.9 (95% confidence interval, 1.4–6.2) for devices first approved in the European Union. The results of pivotal trials were published for 49% (37/75) of devices categorized as major innovations, with an overall publication rate of 37% at 5 years after approval, reported the investigators in BMJ.