CommentaryFrom OT Europe

EFORT takes on the demanding implant and patient safety initiative

When we, as orthopaedic surgeons, plan a surgical procedure, we certainly demand that safe implants be used. When a patient accepts to undergo surgery performed by us, he or she expects the implants we use are safe. When the manufacturer produces and delivers implants to us to be used in our patients, they take the implants through a meticulous investigation followed by an evaluation of the products by regulators and notified bodies, before the implant is released for free use on the European market by physicians. In this way, all “stakeholders” expect and desire to do their best to bring about safe implants that are used in surgery for patients, which fulfills patients’ expectations of receiving safe treatment.

Per Kjaersgaard-Andersen, MD
Per Kjaersgaard-Andersen

However, history has shown that, although all participants in this process do their job to treat the patient safely, some implants may still unexpectedly fail. We need to know why this occurs and the trends associated with such failures, such as whether the implant or patient’s characteristics led to the problem or if there is some unforeseen reason that caused the implant to fail.

Regular meetings proposed

Among the EFORT leadership, incoming EFORT president Prof. Klaus-Peter Günther, MD, of Dresden, Germany, wondered whether all those who are “stakeholders” in the safety of orthopaedic implants could meet regularly to discuss relevant issues related to safe implants used to safely treat our patients. The EFORT board immediately took notice of this and asked Prof. Günther to draft an initiative to bring all “stakeholders” together regularly to start discussing these key topics.

As a result, EFORT held the first such meeting, “EFORT Implant & Patient Safety Initiative. Inauguration Workshop,” on January 21 in Brussels. Fifty participants from the EU Commission, notified bodies, regulators, patient organizations, European orthopaedic specialty societies, manufacturers and EFORT board participated in this first initiative. Lectures on historical pitfalls, actual situations with new medical device regulations in Europe and safety challenges as seen from the surgeon’s, health politician’s, patient’s and manufacturer’s perspective were followed by creative workshops to recommend future introduction of innovative implants, off-label use of implants, mix-and-match product use and its clinical consequences for recertification of legacy implants. Finally, a workshop produced some initial thoughts about recommendations for future analysis of failed implants.

Second meeting in June

The next meeting on this initiative will be held on June 10 during the EFORT Congress in Vienna, Austria.

The initiative had a perfect start. All relevant stakeholders were represented, and they praised the initiative in the name of safe implants used to treat our patients safely. The hope is that since this initiative has now launched, it will serve as a needed forum for relevant stakeholders to discuss combined efforts and challenges. Will this initiative prevent implant failures in the future? Probably not, because no foreign material implanted in the human body can be expected to have 100% survival. However, the initiative can bring stakeholders together to openly discuss the challenges they face and ways to minimize the risk for implant failure.

Disclosure: Kjaersgaard-Andersen reports no relevant financial disclosures.

When we, as orthopaedic surgeons, plan a surgical procedure, we certainly demand that safe implants be used. When a patient accepts to undergo surgery performed by us, he or she expects the implants we use are safe. When the manufacturer produces and delivers implants to us to be used in our patients, they take the implants through a meticulous investigation followed by an evaluation of the products by regulators and notified bodies, before the implant is released for free use on the European market by physicians. In this way, all “stakeholders” expect and desire to do their best to bring about safe implants that are used in surgery for patients, which fulfills patients’ expectations of receiving safe treatment.

Per Kjaersgaard-Andersen, MD
Per Kjaersgaard-Andersen

However, history has shown that, although all participants in this process do their job to treat the patient safely, some implants may still unexpectedly fail. We need to know why this occurs and the trends associated with such failures, such as whether the implant or patient’s characteristics led to the problem or if there is some unforeseen reason that caused the implant to fail.

Regular meetings proposed

Among the EFORT leadership, incoming EFORT president Prof. Klaus-Peter Günther, MD, of Dresden, Germany, wondered whether all those who are “stakeholders” in the safety of orthopaedic implants could meet regularly to discuss relevant issues related to safe implants used to safely treat our patients. The EFORT board immediately took notice of this and asked Prof. Günther to draft an initiative to bring all “stakeholders” together regularly to start discussing these key topics.

As a result, EFORT held the first such meeting, “EFORT Implant & Patient Safety Initiative. Inauguration Workshop,” on January 21 in Brussels. Fifty participants from the EU Commission, notified bodies, regulators, patient organizations, European orthopaedic specialty societies, manufacturers and EFORT board participated in this first initiative. Lectures on historical pitfalls, actual situations with new medical device regulations in Europe and safety challenges as seen from the surgeon’s, health politician’s, patient’s and manufacturer’s perspective were followed by creative workshops to recommend future introduction of innovative implants, off-label use of implants, mix-and-match product use and its clinical consequences for recertification of legacy implants. Finally, a workshop produced some initial thoughts about recommendations for future analysis of failed implants.

Second meeting in June

The next meeting on this initiative will be held on June 10 during the EFORT Congress in Vienna, Austria.

The initiative had a perfect start. All relevant stakeholders were represented, and they praised the initiative in the name of safe implants used to treat our patients safely. The hope is that since this initiative has now launched, it will serve as a needed forum for relevant stakeholders to discuss combined efforts and challenges. Will this initiative prevent implant failures in the future? Probably not, because no foreign material implanted in the human body can be expected to have 100% survival. However, the initiative can bring stakeholders together to openly discuss the challenges they face and ways to minimize the risk for implant failure.

Disclosure: Kjaersgaard-Andersen reports no relevant financial disclosures.