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The orthopaedic industry continues to evolve in its approaches to innovation and safety. So, do we need continuing medical education (CME) for physicians, medical staff and healthcare professionals in the 21st century? In this article, we look at the current state of CME in Europe and what the future could bring as the tracking and analysis of outcomes becomes more prevalent in today’s performance-payment system.
First, when did medical education start?
Continuing medical education isn’t a new concept. The earliest organized CME in Europe occurred around 1300 in the city of Venice, where a minimum standard of professional competence was ensured by requiring specialty certification for initial medical licensure. Annual refresher courses were also a requirement for practitioners wishing to keep their licenses. The first public autopsy took place in 1537 in the city of Leuven, near Brussels. In 1811, Massachusetts General Hospital was founded as an academic teaching hospital.
Where are we today?
Clinical outcomes vary widely across hospitals and surgeons. Opinions on CME in Europe depend upon location. In Netherlands, there’s a mandatory CME system. Spain has no mandatory requirements and no sanctions if you don’t participate. In Albania, most are unfamiliar with the CME concept.
No central body upholds the standards of CME accreditation across Europe, much like the Accreditation Council for Continuing Medical Education does in the U.S. Progress is being made to develop a more coherent approach to CME in Europe; however, there is currently no unified approach.
Quality management and audits have taught all stakeholders that when CME is a required process, it improves quality assurance in medicine and healthcare. Likewise, CME is a pathway to enhancing knowledge, competency and career advancement.
What are the challenges to CME?
Patient safety is paramount in medicine. Preventable adverse events significantly contribute to morbidity and mortality during a patient’s hospital stay. Manufacturers are held to regulations and expectations in terms of product quality and safety. Companies are investing the utmost effort to receive the CE Mark and FDA approval or clearance for their innovations. These existing regulations stipulate processes starting with product launch via postmarket surveillance studies and customer device complaint through to recall action. Hospitals have started implementing and integrating quality management systems and auditing processes.
These stakeholders are satisfied with a 98 percent excellent outcome rate. But to put it in different terms, would you take a seat in a plane for which the airline reports a two percent annual failure rate?
Product recalls and infection rates are increasing in numbers, today. The underlying errors cannot be explained solely by medical technical inadequacies, but are more often attributed to difficulties in the transition of theoretical knowledge into tasks under the conditions of clinical reality.
It seems that we need to change our handling of information, and take the opportunity to establish a new safety culture and adjust medical education. Key to this is the understanding that the learning curve is more a circle than a bending line.
Advances in medical technology with ever-faster and shorter innovation cycles, as well as professional challenges associated with modern healthcare and clinical research, signal that all stakeholders should be required to constantly update their medical and technical knowledge and skills. The causes for errors do not lie purely in medical/technical deficit, but in difficulties in the practical implementation of knowledge under conditions of reality. Crew resource management and human factors, which determine the safety and performance of humans in complex situations, can help to eliminate these causes.
What would happen if all of the medical device sales reps no longer assist actively in the OR? Sales reps are in surgery a couple of times each week. That’s cost-intensive for the industry, and the margins decrease annually. Sales reps move in a situation that is juridical, not safe. How do we improve the situation for all parties?
An adjusted safety culture and training on medical and surgical education that considers transferability of knowledge are a challenge for healthcare facilities and medical device suppliers. These activities can come in many forms, from accredited to non-accredited education in the form of events and courses (both in person and online). Physicians tend to be grateful for high-quality, unbiased education.
Who is funding CME and surgical training today?
Today, CME is indirectly funded by the patient via insurance premiums. More directly, it’s funded and provided by the medical device industry, which backs approximately 80 percent of all CME activities. It’s important to remember the previously-mentioned situation in the OR with respect to industry employees joining medical staff. Last but not least, it depends upon who is funding it. If the current funders would reduce or cease their efforts, we could expect to see an adverse effect on patient care.
What could the future of CME and surgical training look like?
Training could expand on the basic concepts of fault information and opportunities to develop and promote a safety culture of systemic learning. Cooperation and networking of the stakeholders in the healthcare systems also are important conditions for improving.
Medical education itself is changing. Simply the acquisition of knowledge and the achievement of competence seem to be history. The industry leans toward a more innovative and interactive approach that makes demands on both teacher and those taught. (Pilots are trained on simulators before they sit in a real plane.) There are new and existing technologies and approaches by which medical staff could be educated in simulated situations. Virtual anatomy reality models, holographic technology and 3-D eyeglasses will revolutionize CME, surgical training and also the curriculum at medical universities and teaching hospitals.
CME and surgical training will become an independent market in the healthcare sector. Essential to success will be the balance of complex conflicts of interest from all stakeholders. Medical device companies may request that their customers prove that they have the skills to work with their products, and provide a license to the medical staff. Those who don’t attend won’t complete the training, and may not receive a license to use the innovative medical device.
Patient safety and quality improvement will become key performance indicators for medical device companies and healthcare facilities. Reimbursement systems will change from DRG (Diagnosis-Related Groups) to a quality-performance payment system. Medical device companies will give a warranty for the device when the medical staff has successfully finished the CME and training process. License and warranty could be extended annually when the user attends another CME training program.
Healthcare facilities will document procedure outcomes by department and medical staff to identify and analyze weaknesses, and then act upon them in a timely fashion. CME and training programs will be adjusted to every product and user. Surgical site infections, MRSA, revision surgeries and reoperations will be reduced significantly through consistent implementation of a new CME and training strategy, which will help healthcare systems become more efficient and cost-effective and will continue to offer benefits beyond patient outcomes.
All stakeholders—industry, healthcare systems and government—have to invest in order to win. Only by this common effort and investment will CME be modified and implemented. Joint collaboration and performance is essential to success.
Stefan Pickartz has 27 years of general management, business development, international sales and marketing experience in the healthcare, medical device and education industries, with a focus on applying innovative technologies to solve business problems. Mr. Pickartz, owner of Comtaix, is based in Germany.
