Ask The Joint Commission
Do you have a burning question about a Joint Commission regulation, standard or practice?
Here’s your chance to ask all your questions and have them answered by The Joint Commission (TJC) team. Just submit your question and name at www.aami.org/AskTJC, and be on the lookout for the answer to your question in AAMI’s weekly Ask the Joint Commission post in AAMI Connect (connect.aami.org) and in AAMI’s journal, BI&T (www.aami.org/BIT).
Health Technology Alliance: New Energy, New Activities
The Health Technology Alliance (HTA), a joint collaboration between AAMI, the American College of Clinical Engineering (ACCE) and the Health Information Management Systems Society (HIMSS), is bringing new energy and plans for 2020.
“The past year was spent redefining the alliance’s mission, polishing its strategic plan and building a strong bond among our three organizations,” said Danielle McGeary, AAMI’s vice president of HTM and member of the HTA committee. “ACCE, AAMI and HIMSS members have immense expertise; bringing these associations together to achieve a common goal creates a powerful solution.”
The precursor to the HTA began in 2008 as the CE-IT Collaborative Community. Recently, the alliance consolidated AAMI’s former Wireless Strategy Task Force (WSTF), a group of experts working to clarify the roles and responsibilities of wireless technology management and often guidance to the health technology field.
HTA’s newly integrated WSTF is preparing to publish a set of wireless community frequently asked questions (FAQs) to tackle many of the most pressing wireless issues seen in the health care environment. It includes updated answers to long-standing issues, expanded sections on security, Bluetooth technology, risk mitigation and troubleshooting IEEE 802.11 connectivity issues.
The alliance currently is developing a toolkit for HTM-IT professionals, intended to include basic guidelines for establishing a more effective HTM program as well as practical examples of how organizations of different scales can implement these guidelines – from 100-bed hospitals to 2,000-bed academic medical centers.
The HTA has hosted several free webinars, currently available for download. These include an update on medical device cybersecurity resources and practices, using the new version of MDS2, and building cybersecurity into the medical device life cycle.
The HTA is seeking volunteers to share their ideas, expertise and time. Membership is open to anyone who has an interest in healthcare technology.
For more information about membership and the alliance’s activities and to download resources, go to www.healthtechnologyalliance.org.
AAMI Publishes First Consensus Report
AAMI has published its first consensus report, a new kind of document developed to provide concise, prompt and practical guidance on narrowly focused topics of high importance to the health technology community.
“The pace at which technology is evolving makes it difficult for traditional standards and technical information reports to keep up. AAMI members have voiced the need to have quicker guidance on issues where limited data exist, where there is variation in practice, or where there is confusion among stakeholders,” said Jen Padberg, AAMI senior vice president of standards program and policy. “To that end, the AAMI staff have, with consultation from members, developed a process by which much more rapid guidance can be provided in a new deliverable – an AAMI consensus report on emerging issues, or consensus report.”
AAMI CR500:2019: Basic Introduction to the IEC 60601 Series, is intended to clarify and to point out the importance of the IEC 60601 series of standards as well as to provide guidance to understanding and to implementing the series. It is available in the AAMI Store at www.aami.org/store.
2020 International Standards Conference to Focus on Health Technology Lifecycle
Registration is now open for the April 2020 International Conference on Medical Device Standards and Regulations (ISC 2020). This year, meeting topics will focus on the health technology life cycle and delivering better patient outcomes. ISC 2020 is hosted by AAMI, the Food and Drug Administration (FDA) and the British Standards Institution.
The conference’s keynote speakers will be Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, and Graeme Tunbridge, director of devices at Medicines and Healthcare products Regulatory Agency in London, UK. Other ISC 2020 schedule highlights include a deep dive into the European Union’s impending implementation of the Medical Device Regulation and a workshop on compliance with the FDA Accreditation Scheme for Conformity Assessment program.
ISC 2020 will take place in Arlington, VA, at the AAMI Center for Excellence and the neighboring Westin Arlington Gateway Hotel from April 20 to 23.
For more information and to register, visit www.aami.org/ISC.
AAMI Risk Management Standard, TIR Recognized by FDA
The FDA has designated two AAMI risk management resources as recognized consensus standards: ANSI/AAMI/ISO 14971:2019, Medical devices – Application of risk management to medical devices and AAMI TIR97, Principles for medical device security – Postmarket risk management for device manufacturers.
By attaining FDA recognition, voluntary consensus standards can be used in premarket submissions to demonstrate conformity with relevant FDA regulations and requirements.
A fundamental risk management standard, the newly updated ANSI/AAMI/ISO 14971:2019 establishes a process for medical device manufacturers to identify, evaluate and mitigate risk. The 2019 update aligns the standard with international medical device regulatory changes and clarifies technical requirements. An accompanying draft technical report, AAMI/ISO DTIR24971:2020, Medical devices—Guidance on the application of ISO 14971, is currently available for preorder.
TIR97 is a new AAMI resource that provides detailed guidance for addressing the unique challenges of maintaining the security of a medical device during its entire life cycle. Designed to be used in conjunction with TIR57:2016, Principles for medical device security – Risk management, TIR97 provides guidance on performing postmarket security risk management for medical devices in the context of the safety risk management process required by ANSI/AAMI/ISO 14971.
AAMI standards are available for purchase in the AAMI Store at www.aami.org/store.
*By entering your email address, you agree to receive emails regarding TechNation Magazine, Webinars, and Exclusive Promos.
© 2020, TechNation Magazine. Site designed by MD Publishing, Inc.