scholarly journals Using Medical Device Standards for Design and Risk Management of Immersive Virtual Reality for At-Home Therapy and Remote Patient Monitoring

10.2196/26942 ◽  
2021 ◽  
Vol 6 (2) ◽  
pp. e26942
Author(s):  
Joseph Peter Salisbury

Numerous virtual reality (VR) systems have received regulatory clearance as therapeutic medical devices for in-clinic and at-home use. These systems enable remote patient monitoring of clinician-prescribed rehabilitation exercises, although most of these systems are nonimmersive. With the expanding availability of affordable and easy-to-use head-mounted display (HMD)-based VR, there is growing interest in immersive VR therapies. However, HMD-based VR presents unique risks. Following standards for medical device development, the objective of this paper is to demonstrate a risk management process for a generic immersive VR system for remote patient monitoring of at-home therapy. Regulations, standards, and guidance documents applicable to therapeutic VR design are reviewed to provide necessary background. Generic requirements for an immersive VR system for home use and remote patient monitoring are identified using predicate analysis and specified for both patients and clinicians using user stories. To analyze risk, failure modes and effects analysis, adapted for medical device risk management, is performed on the generic user stories and a set of risk control measures is proposed. Many therapeutic applications of VR would be regulated as a medical device if they were to be commercially marketed. Understanding relevant standards for design and risk management early in the development process can help expedite the availability of innovative VR therapies that are safe and effective.

2021 ◽  
Author(s):  
Joseph Peter Salisbury

UNSTRUCTURED Numerous virtual reality (VR) systems have received regulatory clearance as therapeutic medical devices for in-clinic and at-home use. These systems enable remote patient monitoring of clinician-prescribed rehabilitation exercises, although most of these systems are nonimmersive. With the expanding availability of affordable and easy-to-use head-mounted display (HMD)-based VR, there is growing interest in immersive VR therapies. However, HMD-based VR presents unique risks. Following standards for medical device development, the objective of this paper is to demonstrate a risk management process for a generic immersive VR system for remote patient monitoring of at-home therapy. Regulations, standards, and guidance documents applicable to therapeutic VR design are reviewed to provide necessary background. Generic requirements for an immersive VR system for home use and remote patient monitoring are identified using predicate analysis and specified for both patients and clinicians using user stories. To analyze risk, failure modes and effects analysis, adapted for medical device risk management, is performed on the generic user stories and a set of risk control measures is proposed. Many therapeutic applications of VR would be regulated as a medical device if they were to be commercially marketed. Understanding relevant standards for design and risk management early in the development process can help expedite the availability of innovative VR therapies that are safe and effective.


Author(s):  
Catherine Buck ◽  
Rita Kobb ◽  
Ron Sandreth ◽  
Lisa Alexander ◽  
Sherron Olliff ◽  
...  

Abstract  Objective: The Veterans Health Administration has one of the largest remote patient monitoring programs in the United States and is supported by an enterprise-wide infrastructure for providers, clinicians, staff, Veterans, and caregivers. The COVID-19 pandemic, however, presented new challenges: a sudden need to provide large-scale remote monitoring for a new disease that did not yet have a disease management protocol. VHA needed to be ready within weeks to provide this daily monitoring for hundreds — even thousands — of Veterans.  Methods: The U.S. Department of Veterans Affairs Office of Connected Care already had a comprehensive infrastructure in place for its Remote Patient Monitoring – Home Telehealth (RPM – HT) program. Connected Care activated and built on this infrastructure to support providers, clinicians, and staff in their efforts to rapidly bring RPM – HT to Veterans across the nation when they had COVID-19 symptoms or exposure. To do this, Connected Care activated an emergency management plan, rapidly developed a new COVID-19-specific disease management protocol, added weekend monitoring, and procured critically needed monitoring supplies, such as thermometers and pulse oximeters. Connected Care’s strong foundation allowed for innovation and flexibility, such as the training of non-RPM – HT staff in RPM – HT processes, RPM – HT enrollment within acute care settings, and new strategic partnerships. Outcomes: More than 23,500 Veterans were enrolled for COVID-19-related monitoring from March 2020 to May 2021. At points in December 2020 and January 2021, the number of Veterans being monitored in a single day topped 2,000. Even with this rapid buildup, patient satisfaction levels remained at about 90% in numerous categories. In addition, the percentage of Veterans admitted to VA facilities while on COVID-19-related home monitoring has been extremely low, at 4%, a potential indicator that the monitoring system has been helpful in enabling Veterans who did have the virus to convalesce at home. Further study is needed to determine the impact RPM – HT enrollment for COVID-19 care had on the need for inpatient care. Conclusion: The Office of Connected Care’s established, enterprise-wide RPM – HT business, clinical, and technical infrastructure enabled VHA to enter the COVID-19 public health emergency well-positioned for the rapid deployment and growth of at-home and mobile monitoring. As the COVID-19 emergency made at-home management of Veterans increasingly important, the national RPM – HT program successfully adapted its practices to meet Veteran, caregiver, and staff needs.


2020 ◽  
Vol 14 (6) ◽  
pp. 595-601
Author(s):  
David Donohue

The pandemic caused by the coronavirus disease of 2019 (COVID-19) challenged primary care providers (PCPs) to continue to deliver care for their patients, while also remaining financially stable. Most practices have experienced declining revenue due to fewer in-person patient visits. To help offset this and to continue to provide safe patient care, practices have shifted toward using remote options. Chronic Care Management (CCM) and Remote Patient Monitoring (RPM) are benefits available to Medicare fee-for-service patients, which allow a medical practice to deliver expanded care and generate much-needed revenue. These services can be delivered by clinical staff called care managers. A top health priority for most seniors is to effectively self-isolate to reduce risk of COVID-19, while maintaining mental and physical health. We developed a Safe at Home program, designed to be run by care managers through CCM and RPM, with the use of a remote monitoring technology. Safe at Home tracks signs and symptoms of COVID-19, mental and physical health, and lifestyle behaviors that can affect immune function. We project that this service can complement regular telehealth PCP visits and deliver population health monitoring services, while generating substantial revenue for the practice.


2020 ◽  
Vol 29 (10) ◽  
pp. 2409-2412
Author(s):  
Harry Hothi ◽  
Stewart Tucker ◽  
Masood Shafafy ◽  
Colin Nnadi ◽  
Kenneth M. C. Cheung ◽  
...  

Abstract Introduction At the time of writing, we are all coping with the global COVID-19 pandemic. Amongst other things, this has had a significant impact on postponing virtually all routine clinic visits and elective surgeries. Concurrently, the Magnetic Expansion Control (MAGEC) rod has been issued with a number of field safety notices and UK regulator medical device alerts. Methods This document serves to provide an overview of the current situation regarding the use of MAGEC rods, primarily in the UK, and the impact that the pandemic has had on the management of patients with these rods. Results and Conclusion The care of each patient must of course be determined on an individual basis; however, the experience of the authors is that a short delay in scheduled distractions and clinic visits will not adversely impact patient treatment. The authors caution against a gap in distractions of longer than 6 months and emphasise the importance of continued remote patient monitoring to identify those who may need to be seen more urgently.


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