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Updated: 1 hour 39 min ago

FDA Issues Guidance and Recommendations for Ventilators Needed for COVID-19 Crisis

Tue, 2020-03-24 23:00
In response to the limited supply of ventilators during the Coronavirus (COVID-19) pandemic, the Food and Drug Administration (FDA) issued an immediately in effect guidance for ventilators and a letter for healthcare providers based on the issued guidance that outlines supply mitigation strategies to increase availability of respiratory devices for patients with respiratory failure or insufficiency.

Coronavirus HTM/IT Town Hall

Mon, 2020-03-23 23:00
During this March 24 online town hall, healthcare technology management and IT professionals shared their insights, experiences, and answers to your questions about the COVID-19 virus and its implications.

The Joint Commission’s Herman McKenzie Answers Your Coronavirus Questions

Wed, 2020-03-18 23:00
A recurring theme emerging from an update by The Joint Commission (TJC) on Sunday during the AAMI Exchange in Cleveland, OH, was the importance of healthcare technology management (HTM) departments having documented, defensible evidence supporting their equipment management strategies.

FDA Expands 510(k) Third Party Review Program in Bid to Increase Device Access

Sun, 2020-03-15 23:00
The Food and Drug Administration (FDA) has issued final guidance on its 510(k) Third Party Review Program, as well as updated the list of devices that are eligible for review under the program.

‘SweynTooth’ Vulnerabilities May Affect Devices Using Bluetooth Low Energy, Advises FDA

Tue, 2020-03-10 23:00
A group of cybersecurity vulnerabilities known as SweynTooth have the potential to affect certain medical devices, according to a safety communication from the Food and Drug Administration (FDA). The family of 12 vulnerabilities are associated with Bluetooth Low Energy (BLE)—a wireless communication technology that “allows two devices to ‘pair’ and exchange information to perform their intended functions while preserving battery life,” wrote the agency.

AAMI Update on Coronavirus

Thu, 2020-03-05 23:00
AAMI is closely monitoring the situation involving the COVID-19 coronavirus outbreak and is following all precautions as directed by the Center for Disease Control and Prevention (CDC) and World Health Organization (WHO). The health and safety of our community is our highest priority. AAMI will be providing periodic updates regarding events and activities.

FDA’s eSTAR Pilot Seeks to Improve Efficiency, Consistency of 510(k) Submission Process

Mon, 2020-03-02 23:00
A final guidance document issued by the Food and Drug Administration (FDA) on Feb. 13 details recommendations for 510(k) submissions for peripheral vascular atherectomy devices, which are designed to remove plaque from arteries outside of the heart. The guidance pertains specifically to atherectomy devices used in the peripheral vasculature (regulated under 21 CFR 870.4875 with product code MCW).

FDA Issues Final Guidance on 510(k) Submissions for Peripheral Vascular Atherectomy Devices

Mon, 2020-02-17 23:00
A final guidance document issued by the Food and Drug Administration (FDA) on Feb. 13 details recommendations for 510(k) submissions for peripheral vascular atherectomy devices, which are designed to remove plaque from arteries outside of the heart. The guidance pertains specifically to atherectomy devices used in the peripheral vasculature (regulated under 21 CFR 870.4875 with product code MCW).

Health Technology Alliance to Offer Interoperability Session at HIMSS20

Tue, 2020-02-11 23:00
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 developing a session for the 2020 HIMSS Global Health Conference & Exhibition (HIMSS20) that explores the increasing connectiveness of medical devices—as well as the importance of minimizing potential security risks.

FDA Reclassifies Certain Medical Image Analyzers

Mon, 2020-01-27 23:00
In a final rule titled Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices, the Food and Drug Administration (FDA) identified several Class I and Class II medical devices for which 510(k) premarket notifications are no longer required. The final order, which was published in the Federal Register on Dec. 30, amends the Code of Federal Regulations (CFR) to reflect final determinations for these exemptions.

AAMI Risk Management Standard, TIR Recognized by FDA

Tue, 2020-01-14 23:00
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.

FDA Exempts Some Devices from Premarket Notification

Sun, 2020-01-12 23:00
In a final rule titled Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices, the Food and Drug Administration (FDA) identified several Class I and Class II medical devices for which 510(k) premarket notifications are no longer required. The final order, which was published in the Federal Register on Dec. 30, amends the Code of Federal Regulations (CFR) to reflect final determinations for these exemptions.

First Fully Disposable Duodenoscope Receives FDA Clearance

Tue, 2020-01-07 23:00
The Food and Drug Administration (FDA) has granted 510(k) premarket clearance to the first fully disposable duodenoscope. The EXALT Model D duodenoscope, developed by Boston Scientific, is intended to eliminate the risk of transmitting infection-causing bacteria from one patient to another.

FDA Final Rule Requires Medical Device Submissions in Electronic Format

Mon, 2019-12-16 23:00
Effective Jan. 15, 2020, medical device premarket submissions will be required to be sent in electronic format, according to a final rule issued by the Food and Drug Administration (FDA) on Dec. 16.

Stephen Hahn Confirmed as FDA Commissioner

Mon, 2019-12-16 23:00
The U.S. Senate confirmed Stephen Hahn, chief medical executive of the University of Texas MD Anderson Cancer Center in Houston, TX, as the new Food and Drug Administration (FDA) commissioner. This will be Hahn’s first government post for Hahn, a radiation oncologist and educator.