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Health Technology Alliance Continues to Forge Connections
Earlier this year, AAMI joined with the American College of Clinical Engineering (ACCE) and the Health Information Management Systems Society (HIMSS) to create the Health Technology Alliance. Since its inception, the HTA has worked to ensure greater collaboration between the healthcare technology management (HTM), clinical engineering, and IT fields.
Cybersecurity Lessons Follow First Ransomware-Linked Death
For the cybersecurity community, the ransomware-linked death of a patient in September was more than just a wake-up call.
FDA Allows At-Home Endoscopy Device Use During COVID-19
Capsule endoscopy, a procedure that uses a tiny wireless camera to take pictures of a person’s digestive tract, has been available for several years in a clinical setting. But during the COVID-19 pandemic, the FDA has announced that it will apply enforcement discretion to allow at-home administration of a small bowel capsule endoscope produced by Silicon Valley-based Capsovision.
COVID-19 Algorithm Gets FDA Emergency Use Authorization
An algorithm developed by Dascena, Inc., a California-based machine learning diagnostic company, has been found to successfully predict which COVID-19 patients are at risk for either unstable blood pressure or respiratory failure. As a result, the Food and Drug Administration has issued the company an Emergency Use Authorization (EUA) for its “COVID-19 Hemodynamic Instability and Respiratory Decompensation Prediction System.”
CDRH Establishes Digital Health Center of Excellence
The FDA’s Center for Devices and Radiological Health (CDRH) has announced a game changer for the future of digital health technology, by establishing the agency’s Digital Health Center of Excellence (DHCoE). The new center is intended to provide “centralized expertise” and serve as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff, according to the agency, allowing it to pursue a “comprehensive approach to digital health technology.”
HTM Professionals Provide Crucial FDA Feedback Using MedSun
Thanks to their role using, managing, and repairing medical devices, healthcare technology management (HTM) professionals are crucial providers of voluntary feedback to the FDA about the health technology they’re using every day. In a Sept. 22 HTM Live! webinar, FDA representatives described how they can use the agency’s Medical Product Safety Network (MedSun) to do just that.

Press Releases

New Guide Standardizes Healthcare Technology Management Training
AAMI's Healthcare Technology Leadership Committee has developed a new guide for HTM departments looking to establish biomedical equipment technician training programs, internships or volunteering.
CMMS Suppliers Unite to Standardize Medical Device Failure Codes
Six competing computerized maintenance management system (CMMS) suppliers recently set aside their differences to standardize how medical device failure codes are configured. The ultimate goal is to create more consistent and actionable data for HTM.
New Report Guides Drug-Device Combination Risk Management
Experts from industry and the U.S. FDA recently joined forces to publish the new technical information report, AAMI TIR105:2020. It provides recommendations for identifying and proactively avoiding risks to patients and users throughout the life cycle of combination products.

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