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- Newsletter September 2019 | Nr. 180
- Editorial: Regulation of robot-assisted surgery
Editorial: Regulation of robot-assisted surgery
It’s a battle ground when it comes to robot-assisted surgery (RAS) and it’s getting messy with new platforms, applications and patient demands. How do we make the most – and ensure the appropriate use – of this disruptive technology when stakeholders (industry, clinicians, patients, governments, policy makers, payers, insurers) often have an inconsistent position? The pace of technology development is astounding, but it uptake can be delayed because of concerns or lack of evidence regarding safety and effectiveness. Primum non nocere is sacrosanct, so why doesn’t this drive safety, quality, effectiveness and funding decisions?
Regulation is a relatively easy, but a blunt approach to manage technology uptake: disruptive technologies like RAS present significant challenges. We are on the cusp of a ‘conflict on robots’ as new surgery platforms are appearing, with new applications, vying for market share, but current regulation is not fit-for-purpose the forthcoming conflict. Instead of doing what we’ve done since 2003, regulation should: drive safer systems, expedite market access for new systems, improve surgeon training so they have the necessary skills and experience, inform ongoing surgeon credentialing to improve experience and outcomes and ensure we collect real world data that allows comparison of prospective clinical and patient relevant outcomes. This new regulation should also consider clinical (e.g. life cycle) safety and cybersecurity, surgeon training and minimum datasets, both clinical and patient focused. RAS can be a poster child for such enhanced regulation that ensures system and patient safety and quality clinical and patient outcomes (1, 2).
Regulation also presents as frameworks: some have been established to address such concerns, including FDA’s National Evaluation System for Health Technology (NEST) and Europe’s Regulation on medical devices (4), as well as ‘responsible research and innovation frameworks’ (4). These could be applied to RAS to further deliver better clinical and patient outcomes.
As a government policy maker and funder, such regulation is needed to inform decisions about investing in surgeon training and credentialing, procuring technology for our hospitals, reimbursing procedures, collecting data and subsequent health technology assessments to validate or inform how these policy and investment decisions might be revised. Health resources are scarce, but the right regulation is needed to ensure appropriate investment to deliver good outcomes and ensure a safe, high quality and sustainable health system.
Dr. Paul Fennessy, Division-Manager (Genomics & Health Technology, Cancer, Specialty Programs, Medical Research and International Health Branch, Health & Wellbeing) in Department of Health & Human Services, Australia (Victoria)
(1) NSW Ministry of Health & Victoria Department of Health and Human Services (2018). Review of Robot-Assisted Surgery.
(2) Addressing regulatory considerations for medical robotic devices (2017). https://legacy-uploads.ul.com/wp-content/uploads/sites/40/2017/08/BNG-UL17-Medical-Robots-White-Paper-080117-1.pdf.
(3) National Evaluation System for health Technology (NEST). https://www.fda.gov/about-fda/cdrh-reports/national-evaluation-system-health-technology-nest
(4) Leenes R et al. (2017) Regulatory challenges of robotics: some guidelines for addressing legal and ethical issues. Law, Innovation and Technology, 9:1, 1-44, DOI: 10.1080/17579961.2017.1304921 To link to this article: https://doi.org/10.1080/17579961.2017.1304921