By AAMI
Remote-Controlled Hospital Devices Get COVID-19 Guidance
Remotely controlled hospital wards may sound like something out of science fiction, but they’re already becoming reality, and an innovation that could save time and even lives during the COVID-19 pandemic.
That is 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. Notably, the U.S. Food and Drug Administration (FDA) has already issued emergency use authorizations for many remote devices.
AAMI CR511, Emergency 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 industry and regulators on AAMI’s COVID-19 Response Team.
“We’re following where the greatest need is,” 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. “We started when a demand for inexpensive ventilators created what was basically a ‘wild west’ of innovation. Since then, the situation has evolved. We’ve provided emergency design and user guidelines for resuscitators, BiPAP, ventilatory helmets and now remote-control capabilities.”
“This is the time to innovate,” added Sandy Weininger, co-chair of the Response Team. “The FDA has paved the way for innovation with very low overhead because the clinical need is recognized.”
Weininger is a senior electrical/biomedical engineer at the FDA’s Center for Devices and Radiological Health, which is responsible for the FDA’s regulation of medical devices. In March, the FDA issued a new enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the COVID-19 emergency, followed by emergency use authorizations for certain remote or wearable patient monitoring devices.
CR511 was created to help innovators get involved. It highlights common system elements for engineers and outlines safety and risk control measures that both manufacturers and caretakers should consider. The document also carefully defines what “remote-control” is when referring to medical devices.
For more information, read the whole story at AAMI.org. AAMI CR511, Emergency Use Guidance for Remote Control of Medical Devices is available for download alongside more than a dozen freely available resources on the AAMI COVID-19 Emergency Guidance web page.
AAMI Explores Artificial Intelligence in New Standards Initiative
Taking an important first step toward artificial intelligence (AI) standards and guidance for much of the health care industry, AAMI is standing up a new AI committee consisting of representatives from BSI, the FDA and developers of machine learning technology.
The AAMI AI committee and a mirroring BSI AI committee are pooling experts to draft risk management guidance for AI and machine learning in medical devices. Like the AAMI/ADA effort, this new document will repurpose key lessons from an internationally known standard, ANSI/AAMI/ISO 14971, Medical devices – Application of risk management to medical devices, while leveraging the joint drafting committees’ international AI expertise.
“When we talk about AI in health care, we’re talking about machine learning, data-driven systems that reach conclusions that we can’t necessarily predict,” explained Joe Lewelling, senior advisor on content and strategy at AAMI. “These are disruptive technologies in that they will change the way health care is designed, delivered, maintained and even regulated.”
In May 2020, AAMI joined forces with BSI to publish the position paper, Machine Learning AI in Medical Devices: Adapting Regulatory Frameworks and Standards to Ensure Safety and Performance, which examines how machine learning is different from traditional medical devices and software. It outlines a need for new standards and regulator initiatives to promote the safety, effectiveness and availability of AI and machine learning in health care. The new AAMI AI committee will be responsible for developing the guidance documents and other work identified in the white paper.
Steam Sterilization Standard ST79 Receives Community-Driven Update
After three years, a widely used standard in health care and industry has undergone an important update. The Association for Advancement of Medical Instrumentation (AAMI) has released four amendments to ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, offering users new clarity and fresh guidance to stay in compliance with accrediting bodies.
“All standards are living, evolving documents,” said Sarah Freidberg, a microbiology manager at Stryker Endoscopy and co-chair of the AAMI working group that authored the amendments. “As technology advances, scientific knowledge improves and, industry practices change, there’s often a need to revisit our standards.”
ANSI/AAMI ST79 is a particularly important standard because it provides comprehensive guidance to health care personnel who use steam for sterilization, regardless of the size of the sterilizer or the type of facility. This includes hospitals, ambulatory surgery facilities, physician offices, cardiac catheterization laboratories, endoscopy suites, radiology departments and dental offices. It remains a go-to document for The Joint Commission.
Recommendations and clarifications have been added for maintaining the integrity of the sterile processing area. This includes even “common sense” additions, such as stipulating that there should be no food or drink in the area. Other amendments were made to best practices, such as how often sterilizers in health care facilities should be cleaned. The group also built upon recommendations for the instrument inspection process, recognizing that relatively new technologies, such as borescopes and Adenosine Triphosphate (ATP) monitoring, enable more thorough inspections and record keeping.
“These amendments weren’t made in the interest of one company or one hospital. We set our day jobs aside and that’s what made it work so well,” added Friedberg. “Even manufacturers and hospitals, despite obvious differences, want the same thing. An instrument should work perfectly each-and-every time … That kind of reliability ensures user and patient safety.”
The amended document is available through AAMI at aami.org/ST79. ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities will be automatically updated for users with an AAMI eSubscription. For those who previously purchased the printed version or own a PDF of the current edition, a PDF of the amendments will be emailed to them at no cost. The amendments will also be available for purchase in the AAMI Store.