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Registry data may help promote implant safety, performance in Europe
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EFORT, the European Federation of National Associations of Orthopaedics and Traumatology, has issued a statement that addresses recently published articles that questioned the safety and evaluation of surgical implants used in Europe. According to the statement, the reorganization of the regulatory framework by the European Union and the use of registries to collect data on all implants are essential for monitoring implant performance.
“[Registries] are important to safeguard implant safety since they give feedback to the individual hospitals and surgeons on their performance,” Rob G. H. H. Nelissen, MD, PhD, professor in orthopaedics at Leiden University Medical Center and chairman of the Network Orthopaedic Registries of Europe or NORE, told Healio.com/Orthopedics.
Across Europe, the development of a far wider variety of these registries and the exchange of knowledge from these registries is being promoted by EFORT in collaboration with NORE. EFORT is also working closely with the Orthopaedic Data Evaluation Panel, which has benchmarked joint replacement implants and evaluated their efficacy for the past 15 years, according to the statement.
Also noted in the statement is “the use of implants is also dependent on the training of surgeons.”
Although patient-reported outcome measures can be subjective based on a patient’s daily activities, Nelissen said the efficacy of an implant can be measured by the satisfaction of patients postoperatively.
“Is he a skier or a person who likes to golf or is he a person who likes to hike in the mountains, being 60-years-old or 64 [-years-old] or 70-years-old?” he said. “He or she will have a different perception of the outcome than the person who likes to play chess or likes to garden in a small garden.”
The Advanced Medical Technology Association or AdvaMed, a U.S.-based trade organization focused on advanced medical technology that has international members, also released a statement in response to the articles. The AdvaMed statement noted that, while a patient’s experience should not be discounted, the positive experiences of millions of patients are overlooked when only a few patient’s experiences are magnified.
“We take seriously all reports of patient impact, and though the medical community can never completely eliminate risk, we always strive to improve our technologies and care delivery,” according to the AdvaMed statement. “As we do that work, we recognize why we developed these technologies in the first place: to address the critical, debilitating and often life-threatening needs of patients who are desperate for solutions—who need a miracle.” – by Casey Tingle
References:
www.efort.org/efort-are-orthopaedic-and-trauma-implants-safe/
www.advamed.org/newsroom/press-releases/advamed-statement-icij-medical-device-stories
Disclosure: Nelissen reports no relevant financial disclosures.