share: Updated:2021-01-25 00:00:00

In a remarkable medical study conducted by researchers from Johns Hopkins Medicine, a quadriplegic man was able to slice and eat a piece of cake by controlling prosthetic arms with his mind. This is believed to be a medical first, representing a significant milestone where the use of electrodes implanted into the brain allowed Robert “Buz” Chmielewski to control and coordinate both arms, therefore using both sides of the brain. Prior instances of “brain-computer interface” have focused on the use of only one arm. Mr. Chmielewski has been paralyzed for over three decades, and has only minimal movement in his arms and hands.

The coordinated use of two limbs is a challenge in brain-computer interface technology. The devices use artificial intelligence to coordinate a portion of the robotic control in order to make it possible. While the patient uses their brain to make decisions such as which food to eat and where to cut the food, artificial intelligence is used to handle more rote parts of the task.

From implantable medical devices to artificial intelligence in healthcare, many elements of the technology used in this incredible study are supported by standards. ANSI/AAMI ES60601-1:2005 (R2012), Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, is a standard published by the Association for the Advancement of Medical Instrumentation (AAMI), a member and accredited standards developer of the American National Standards Institute (ANSI). This document supports the safe and effective use of medical electrical equipment like that used for Mr. Chmielewski’s 2019 surgery, when doctors implanted six electrodes into his brain. This American National Standard (ANS) is identical to international standard IEC 60601-1, except it includes modified requirements to comply with the U.S. National Electrical Code and relevant standards of the National Fire Protection Association (NFPA).

Standards are in place to support artificial intelligence technology use in a wide variety of settings, and healthcare is no exception. ANSI/CTA-2089.1-2020, Definitions/Characteristics of Artificial Intelligence in Health Care, defines terms related to artificial intelligence and associated technologies as they are used in a healthcare setting, including terms related to assistive intelligence, synthetic data, remote patient monitoring, and artificial intelligence enabled diagnostic systems. This ANS was developed by the Consumer Technology Association (CTA), an ANSI member and accredited standards developer, through its dedicated working group on artificial intelligence in healthcare.

For many years, standards have promoted the development and use of prosthetics, assistive technologies, and other accommodations that support the independence and abilities of people with disabilities. Among others, here are a few of the many contributions that ANSI members and international standards developers have made to these technologies:

ASTM F1027-86(2017), Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices, developed by ASTM International, an ANSI member and audited designator.

ANSI/RESNA ASE-1:2019, RESNA American National Standard for Adaptive Sports Equipment – Volume 1: Winter Sports Equipment, developed by the Rehabilitation Engineering and Assistive Technology Society of North America (RESNA), an ANSI member and accredited standards developing organization (SDO).

SAE J 1903-1997, Automotive Adaptive Driver Controls, Manual, developed by SAE International, an ANSI member and audited designator.

ISO 13405-3:2015, Prosthetics and Orthotics – Classification and Description of Prosthetic Components – Part 3: Description of Upper Limb Prosthetic Components, developed by the International Organization for Standardization (ISO) Technical Committee (TC) 168, Prosthetics and orthotics. ASTM is the U.S. Technical Advisory Group (TAG) administrator to TC 168. ANSI is the U.S. member body to ISO.

As advancements in medical technology, devices, and procedures continue to support the abilities of all people, standards are in place to provide guidance and promote innovation. To learn more about new brain-computer interface technologies, and to see a video of Mr. Chmielewski slicing and eating cake using only his thoughts, see the Johns Hopkins news item.

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