This article is more than 5 years old. Information may no longer be current.
A personal perspective on ethics in orthopaedics
Click Here to Manage Email Alerts
Three years ago, the Board of the European Federation of National Associations of Orthopaedics and Traumatology set up an ethics committee. Its first aim was to prepare a document outlining how ethical considerations should apply in the very different countries of our federation. Its second aim was to support the board when potential ethical problems arose. Sadly, the first chairman of the Ethics Committee, Jean Puget, MD, died. I replaced Dr. Puget and was supported initially by Nikolaus Böhler, MD, Miklos Szendroi, MD, and Luigi Zagra, MD, and later by Henri Coudane, MD.
Our paper, Ethical Orthopaedics for EFORT, was published in 2014. I do not propose just to restate its principles here, but rather wish to consider some of the issues we have learned from it.
A few ethical concerns have been brought to the committee’s attention. In one instance, for example, a submitted paper had been previously published and this was not acknowledged. In another case, results were included as original when they were, in fact, the work of another surgeon. In one submission, the main researcher was not included in the paper and it was attributed only to the senior colleagues.
The Board of the European Federation of National Associations of Orthopaedics and Traumatology (EFORT), not its Ethics Committee, decides what action, if any, needs to be taken. This may range from a simple reprimand to a decision not to accept any further contribution from those authors for several years. Every surgeon should report instances of fact falsification, plagiarism and malpractice to the committee. Only if we all do this can we live up to the ideal of offering the best care to our patients.
Ethical interactions with industry
There have long been concerns about the relationships between the medical device industry and orthopaedic surgeons. It is essential that surgeons be involved in the whole process of device design, development and trials. It is, however, the wise surgeon who does not climb onto the bandwagon of each new unproven prosthesis or implant.
The European Commission (EC) 2 years ago sought to regulate this development and evaluation. By background, medical devices do not need pre-market authorization by a regulatory authority, but do need a conformity assessment by an independent third party, the notified body. There are about 80 notified bodies throughout Europe and each acts under the control of its national authority. Once certified, devices bear the CE marking, which allows them to be circulated freely in European Union (EU) countries and EFTA Member States and Turkey. While the EC recognized that the new regulatory framework in Europe at its best should allow development and proper evaluation of new devices more quickly than in the United States, for example, it has laid down more stringent requirements to protect patients, physicians and industry from the premature launch of a new product.
Device industry response
The European medical device industry also recognized that the regulatory system needed an overhaul due to increased expectations and technological advances. It agreed unanimously that incidents like the Poly Implant Prothèse breast implant disaster should never happen again. Eucomed noted, “The overarching objective should be to achieve a clear, predictable and effective legislative framework that is consistently implemented across the EU and increases patient safety, maintains timely access to the latest medical technologies and keeps Europe’s medtech research and innovation engine running.”
So far, it has been so good. But how can companies involved in our field pursue potential clients ethically? What is reasonable? Is free travel and registration at national meetings fine? How should companies sponsor events? If the event is clearly a company-sponsored promotion, whether as a separate meeting or a satellite session at a recognized educational congress, reasonable free travel and economic accommodations may be ethically acceptable. Luxury trips and entertainment are not. We also should be mindful that those most in need of financial support are our trainees. We need the financial support of industry at local, national and international orthopaedic meetings and congresses, but this should be given with clearly defined parameters, and the selection of presenters, speakers and papers must not be influenced by such sponsorship.
Ethics in surgeon education
Turning to “training” of young surgeons, we should first consider the term. We train animals; we should educate ourselves and our new colleagues. It should not be learning by rote but by a proper intelligent understanding of our patients’ needs and the options available. We are all aware there is a learning curve both in patient care and operative technique and we must take precautions to minimize the risks associated with this. We need to be careful to ensure our younger surgeons do not have to combine shorter or inappropriate working hours with a shorter period of supervised practice before they work independently. Becoming a good surgeon is a lifelong process. Thoughtful reflection on our own outcomes and those of others should give us all a most important quality — good surgical judgment.
Where health care resources are limited, there may be a greater temptation for surgeons to behave unethically. For example, should private hospitals pay surgeons a retainer to treat all their patients in their own institution? Should surgeons own the institution in which they practice, thereby increasing the risk they may encourage full bed occupancy for financial gain? As European borders open (forgetting momentarily the migration crisis), how great a responsibility do we each share to ensure those who practice in a new country can be readily understood by both patients and colleagues? I am not answering these questions here, but these are matters we need to consider.
Limit errors, resist unreasonable claims
I also want to discuss litigation risk. In England and Wales, this is now a major concern. The National Health Service Litigation Authority, which is responsible for indemnifying the Service against legal action, has set aside 30 billion (almost one quarter of the 140 billion annual health budget) to cover future problems. More than 1.7 billion was paid in medical negligence claims last year alone and one third of this was spent on legal fees. While it is entirely appropriate for those who suffer at our hands to receive fair settlement, we should of course limit the risks of error wherever possible and resist unreasonable and excessive claims.
In conclusion, I repeat the summary of our EFORT paper: “As orthopaedic surgeons we should continue to treat our patients with honesty, compassion, skill and care. If we rely solely on technique and neglect our ethics of service we become a trade and not a profession. We have a long tradition of earning the respect of our patients and colleagues and must ensure that we continue to deserve the trust they place in us.”
- References:
- Benson M, et al. Bone Joint J. 2014; doi:10.1302/0301-620X.96B8.34206.
- Benson M, et al. Ethical Orthopaedics for EFORT; 2014.
- Eucomed Medical Technology (2008). Eucomed code of ethical business practice. www.eucomed.org/key-themes/ethics
- For more information:
- Michael KD Benson, MBBS, FRCS, can be reached at Ridgway, Harberton Mead, Oxford OX3 DB, United Kingdom; email: michael.benson@doctors.org.uk.
Disclosure: Benson reports no relevant financial disclosures.