{"id":387900,"date":"2020-11-24T11:28:56","date_gmt":"2020-11-24T16:28:56","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=387900"},"modified":"2020-11-24T11:28:56","modified_gmt":"2020-11-24T16:28:56","slug":"remote-controlled-hospital-devices-get-covid-19-guidance","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/remote-controlled-hospital-devices-get-covid-19-guidance\/","title":{"rendered":"Remote-Controlled Hospital Devices Get COVID-19 Guidance"},"content":{"rendered":"
\n

Arlington, VA, Nov. 24, 2020 (GLOBE NEWSWIRE) — <\/p>\n

\n

For Immediate Release<\/strong><\/p>\n

Remotely controlled hospital wards may sound like something out of science fiction, but they\u2019re already becoming reality, and an innovation that could save time and even lives during the COVID-19 pandemic.<\/p>\n

That\u2019s why the Association for the Advancement of Medical Instrumentation (AAMI) has published a new consensus report (CR) detailing guidelines for the implementation of remote control for many critical medical devices.\u00a0 Notably, the U.S. Food and Drug Administration (FDA) has already issued emergency use authorizations for many remote devices.<\/p>\n

AAMI CR511,\u00a0<\/em>Emergency use Guidance for Remote Control of Medical Devices<\/em><\/a>, is the latest in a suite of consensus reports that represent the combined expertise of clinicians, the medical device industry, and regulators on AAMI\u2019s COVID-19 Response Team.<\/p>\n

\u201cWe\u2019re following where the greatest need is,\u201d said Dr. Julian Goldman, an anesthesiologist at Massachusetts General Hospital (MGH), medical director of biomedical engineering for the Mass General Brigham health network, and co-chair of the Response Team. \u201cWe started when a demand for inexpensive ventilators<\/a> created what was basically a \u2018wild west\u2019 of innovation. Since then, the situation has evolved. We\u2019ve provided emergency design and user guidelines for resuscitators, BiPAP, ventilatory helmets<\/a>, and now remote-control capabilities.\u201d<\/p>\n

\u201cThis is the time to innovate,\u201d added Sandy Weininger, co-chair of the Response Team. \u201cThe FDA has paved the way for innovation with very low overhead because the clinical need is recognized.\u201d<\/p>\n

Weininger is a senior electrical\/biomedical engineer at the FDA\u2019s Center for Devices and Radiological Health, which is responsible for the FDA\u2019s regulation of medical devices. In March, the FDA issued a new enforcement policy<\/a> for non-invasive remote monitoring devices used to support patient monitoring during the COVID-19 emergency, followed by emergency use authorizations<\/a> for certain remote or wearable patient monitoring devices. The rationale is straightforward: if a device or application can reduce how often healthcare providers need to be in the same room as their COVID-19 patients, it will be harder for the SARS-CoV-2 virus to spread. However, what remained unclear to device developers was where to begin.<\/p>\n

\u201cEarly in the pandemic, there was uncertainty,\u201d said Weininger. \u201cYou had this perfect storm of scarcity of parts, testers who aren\u2019t in labs, and constructors trying to innovate in spaces they\u2019re not entirely familiar with. So, we\u2019ve leveraged existing device standards while narrowing the scope, slicing up the apple and only taking the immediately useful parts.\u201d<\/p>\n

CR511 focuses on highlighting common system elements for engineers and outlining safety and risk control measures that both manufacturers and caretakers should consider. The document also carefully defines what \u201cremote-control\u201d is when referring to medical devices.<\/p>\n

For example, some mechanical ventilators are built with a detachable screen interface on a short cord.<\/p>\n

\u201cSome hospitals have figured out how to have that screen just<\/em> outside a patient\u2019s room, so they don\u2019t have to don and doff PPE before adjusting device settings,\u201d Goldman explained. \u201cIs that remote control? Actually, no. It\u2019s still the same device. It hasn\u2019t been modified to add remote control capability.\u201d<\/p>\n

The document describes a remote-control innovation as an \u201cauxiliary human machine interface\u201d that allows caretakers to operate a medical device \u201cfrom a location not co-located with the patient, device, or its primary interface.\u201d This even includes the concept of apps for controlling many devices installed on a common platform, such as a secure tablet.<\/p>\n

It\u2019s a future for patient-care environments that Goldman has been envisioning for years. As part of a national initiative requested by the White House in 2014, Goldman and his colleagues at the Medical Device Plug and Play Interoperability & Cybersecurity Program at MGH first demonstrated<\/a> how the remote control of medical devices would be ideal for patient care during an Ebola outbreak.<\/p>\n

\u201cWe developed a reservoir of knowledge and working prototypes during the 2014 Ebola initiative. For instance, we know that it can take 10 to 15 minutes to put on PPE before going into a patient room. By then, a patient could be in dire straits if they\u2019re waiting for critically important treatment such as turning up the oxygen level on a ventilator or adjusting an infusion pump,\u201d said Goldman. \u201cFast forward to COVID-19, and now there\u2019s real interest.\u201d<\/p>\n

\u201cNow the opportunity is here to apply this knowledge expeditiously,\u201d added Colleen Elliott, director of standards at AAMI. \u201cThis consensus report resulted from a collaboration between AAMI\u2019s Interoperability Working Group and our COVID-19 Response Team. We deeply appreciate the subject matter experts and industry leaders who offered their knowledge for the sake of safe and effective medical device innovation.\u201d<\/p>\n

AAMI CR511, Emergency Use Guidance for Remote Control of Medical Devices<\/em> is available for download alongside more than a dozen freely available resources on the AAMI COVID-19 Emergency Guidance web page<\/a>.<\/p>\n

About AAMI<\/b>
AAMI (www.aami.org) is a nonprofit organization founded in 1967. It is a diverse community of more than 9,000 healthcare technology professionals united by one important mission\u2014supporting the healthcare community in the development, management, and use of safe and effective health technology. AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for health technology and sterilization professionals.<\/p>\n

Contact<\/b>
Brian, Media relations manager
bstallard@aami.org<\/a><\/p>\n


<\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Arlington, VA, Nov. 24, 2020 (GLOBE NEWSWIRE) — For Immediate Release Remotely controlled hospital wards may sound like something out of science fiction, but they\u2019re already becoming reality, and an innovation that could save time and even lives during the COVID-19 pandemic. That\u2019s why the Association for the Advancement of Medical Instrumentation (AAMI) has published a new consensus report (CR) detailing guidelines for the implementation of remote control for many critical medical devices.\u00a0 Notably, the U.S. Food and Drug Administration (FDA) has already issued emergency use authorizations for many remote devices. AAMI CR511,\u00a0Emergency use Guidance for Remote Control of Medical Devices, is the latest in a suite of consensus reports that represent the combined expertise of clinicians, the medical device … <\/p>\n

Continue reading “Remote-Controlled Hospital Devices Get COVID-19 Guidance”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-387900","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nRemote-Controlled Hospital Devices Get COVID-19 Guidance - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/remote-controlled-hospital-devices-get-covid-19-guidance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Remote-Controlled Hospital Devices Get COVID-19 Guidance - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Arlington, VA, Nov. 24, 2020 (GLOBE NEWSWIRE) — For Immediate Release Remotely controlled hospital wards may sound like something out of science fiction, but they\u2019re already becoming reality, and an innovation that could save time and even lives during the COVID-19 pandemic. That\u2019s why the Association for the Advancement of Medical Instrumentation (AAMI) has published a new consensus report (CR) detailing guidelines for the implementation of remote control for many critical medical devices.\u00a0 Notably, the U.S. Food and Drug Administration (FDA) has already issued emergency use authorizations for many remote devices. 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