FDA public workshop: Orthopaedic sensing, measuring, and advanced reporting technology (SMART) devices

Abstract

Traditional orthopaedic devices do not communicate with physicians or patients post-operatively. After implantation, follow-up of traditional orthopaedic devices is generally limited to episodic monitoring. However, the orthopaedic community may be shifting towards incorporation of smart technology. Smart technology in orthopaedics is a term that encompasses a wide range of potential applications. Smart orthopaedic implants offer the possibility of gathering data and exchanging it with an external reader. They incorporate technology that enables automated sensing, measuring, processing, and reporting of patient or device parameters at or near the implant. While including advanced technology in orthopaedic devices has the potential to benefit patients, physicians, and the scientific community, it may also increase the patient risks associated with the implants. Understanding the benefitrisk profile of new smart orthopaedic devices is critical to ensuring their safety and effectiveness. The 2018 FDA public workshop on orthopaedic sensing, measuring, and advanced reporting technology (SMART) devices was held on April 30, 2018, at the FDA White Oak Campus in Silver Spring, MD with the goal of fostering a collaborative dialogue amongst the orthopaedic community. Workshop attendees discussed four key areas related to smart orthopaedic devices: engineering and technology considerations, clinical and patient perspectives, cybersecurity, and regulatory considerations. The workshop presentations and associated discussions highlighted the need for the orthopaedic community to collectively craft a responsible path for incorporating smart technology in musculoskeletal disease care.

The Effectiveness of IoT Based Wearable Devices and Potential Cybersecurity Risks: A Systematic Literature Review from the Last Decade

“…The applicability of wearable devices and mobile applications is increasing in healthcare perspectives, making patient monitoring and comprehension of daily behaviours more straightforward than before [26]. According to [27], the usage of intelligent technologies speeds up clinical studies. Smart gadgets may speed up clinical research by collecting data in real-time, resulting in enhanced data collection compliance and quality improvement.…”

Is in vivo sensing in a total hip replacement a possibility? A review on past systems and future challenges

“…An implanted medical device (IMD) with sensing capabilities and telemetric link could provide a means of continuous monitoring as oppose to traditional episodic monitoring [8]. This would enable clinicians to track the post-operative recovery process, better guide personalised postoperative care [9], [10] and empowers patients with the ability to review and manage the health of their implant.…”

“…An instrumented hip implant could give quantitative data demonstrating an adverse event providing an early indication for the need for clinical review. This could reduce the diagnostic pathway providing a quicker diagnosis thus reducing the impact of time sensitive conditions [8]. This review will look at the current state of the art of instrumented hip implants focusing on their capability to perform in-vivo sensing and translation into routine clinical practice.…”

Understanding Patient Perspectives Regarding Remote Monitoring Devices Following Total Joint Replacement

“…Advances in smart technology have expanded into the field of orthopedic surgery to deliver enhanced patient care and improve outcomes, while decreasing health-care expenditures [ [1] , [2] , [3] ]. Smart technology has been incorporated into several applications ranging from external wearable trackers, intraoperative guides facilitating surgical precision, to fully implantable devices that each can provide diagnostic and therapeutic modalities to the physician and patient [ [4] , [5] , [6] , [7] ].…”