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Weekly COVID-19 Update: Emergency Use Guidance for Remote Control of Medical Devices, Guidance for Alternative Care Sites

11/30/2020
ANSI News

The ANSI Federation and standardization community are stepping up with guidance, resources, and initiatives to support public health, safety, and infrastructure during the COVID-19 outbreak. Suggestions for news items may be submitted to pr@ansi.org. All submissions are published at ANSI's discretion.

AAMI Publishes Guidance for Remote Control of Medical Devices

AAMI, the Association for the Advancement of Medical Instrumentation, has published a new consensus report detailing guidelines for the implementation of remote control for many critical medical devicesincluding ventilators, infusion pumps, and vital signs monitors­­—used to treat patients with COVID-19. The document describes a remote-control innovation as an “auxiliary human machine interface” or HMI, which allows caretakers to operate a medical device “from a location not co-located with the patient, device, or its primary interface.”

"The use of remote control and monitoring can eliminate treatment delays, reduce infection risk to the HCW (healthcare workers), help preserve limited supplies of PPE, and improve patient care," according to the guidance.

AAMI CR511,Emergency use Guidance for Remote Control of Medical Devices, represents the combined expertise of clinicians, the medical device industry, and regulators on AAMI’s COVID-19 Response Team. The guidance highlights common system elements for engineers and outlines safety and risk control measures relevant to manufacturers and caretakers.

As AAMI notes, in 2020, the U.S. Food and Drug Administration issued emergency use authorizations for many remote devices, though what remained unclear to device developers was where to begin. Read more information in the AAMI the press announcement.

ASHRAE Releases Guidance for Alternative Care Sites

The ASHRAE Epidemic Task Force in November announced the availability of the Alternate Care Site HVAC Guidebook, developed by the ASHRAE Alternate Care Sites Task Force. The guidance was developed in response to a need for alternative care sites (ACS) to be deployed in locations where permanent hospital beds are insufficient for the number of COVID-19 positive patients needing care.

The guidebook is a result from a request to the ASHRAE Epidemic Task Force from the U.S. Army Corps of Engineers to provide engineering recommendations, solutions, and guidance to address the HVAC systems for ACS.

Specific recommendations include guidance for design requirements, air flow, filtration, space conditions and a methodology for identifying which mechanical system approaches may be pursued knowing that most ACS must prioritize certain features due to limited time, budget, and site characteristics. The guide is primarily applicable to host sites with large open spaces such as convention centers. It is also applicable to the conversion of smaller facilities with open areas such as school gymnasiums, ASHRAE reports.

“Our work over several months has resulted in a guidebook that will be useful in current and future efforts to address the demand for additional hospital beds in combatting COVID-19,” said David Eldridge, ASHRAE Epidemic Task Force healthcare team member and co-chair of the ASHRAE Alternate Care Sites Task Force. "This has been a collaborative initiative from the start and we want to thank the U.S. Army Corps of Engineers, as well as military and private engineering experts who came together to develop this timely resource.”

Alexander Zhivov, Ph.D., the other ASHRAE Alternate Care Sites Task Force co-chair, noted that the guidebook provides recommendations for applying standards that are used for permanent facilities to temporary sites “under less than ideal conditions or with time, budget and technical feasibility constraints.”

Access more information via ASHRAE's press announcement.

See more ANSI member efforts in the ANSI COVID-19 Resource Webpage Highlighting Standardization Community Response

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