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Updated: 2 hours 27 min ago

Draft Service Standard for Medical Imaging Equipment Sparks Mixed Reactions

Mon, 2017-11-13 23:00
The Medical Imaging Technology Alliance (MITA) has released a draft of a standard for the servicing of medical imaging equipment to a mixed early reaction from stakeholders. The proposed national standard would apply to any entity that services imaging equipment.

Cybersecurity Threats Named Top Health Technology Hazard for 2018

Tue, 2017-11-07 23:00
Ransomware and other cyberthreats are the number one health technology safety concern to watch out for in 2018, according to an annual report published by experts at the ECRI Institute.

Experts Promote Information Sharing to Protect against Growing Cyberthreats in Healthcare

Mon, 2017-11-06 23:00
No organization can go it alone when confronting evolving cyberthreats, according to experts who presented at the Medical Device Innovation, Safety and Security Consortium’s fall conference, held last week in Arlington, VA. For conference participants, information sharing is key to protecting medical devices—and patients—from potential attacks by a variety of actors.

Tech Entrepreneurs, Lawmakers Champion Business Value of Federal Research Funding

Mon, 2017-10-30 23:00
Entrepreneurs from eight technology (six healthcare technology) companies and members of the Senate Competitiveness Caucus shared stories of gritty success and called for more federal funding for basic research during a Capitol Hill briefing with other lawmakers. According to speakers at the Oct. 25 event, such funding is not just essential for fueling innovation but also for strengthening the U.S. economy.

FDA Qualifies First Medical Device Development Tool

Thu, 2017-10-26 23:00
The Food and Drug Administration (FDA) has qualified the first tool under its new medical device development tool (MDDT) program. After approximately 20 years of use, manufacturers of devices designed to address heart failure will no longer have to justify using the Kansas City Cardiomyopathy Questionnaire (KCCQ) in their submissions.

Experts Urge Healthcare Facilities, Device Makers to Redouble Efforts to Address Cybersecurity Challenge

Tue, 2017-10-24 23:00
The healthcare technology industry has yet to develop a full understanding of the cybersecurity landscape and has a narrow view of its potential vulnerabilities, according to several experts who spoke at the Cyber Security Summit 2017 in Minneapolis, MN.

FDA Guidance Seeks to Get Technology to Patients Faster

Mon, 2017-10-23 23:00
In an effort to speed up the development and review of innovative medical devices, the Food and Drug Administration has issued draft guidance outlining a new Breakthrough Devices Program.

Sterilization Professionals Address Field’s Top Challenges during Standards Week

Tue, 2017-10-17 23:00
Efforts are underway to tackle patient safety issues related to endoscope reprocessing, the cleaning of reusable medical devices, and much more during AAMI Sterilization Standards Week in Baltimore, MD. This four-day standards meeting, which is taking place Oct. 16–19, is a heads-down, detail-oriented affair that has brought together 15 far-flung working groups whose more than 300 members are stationed all over the world.

Medical Device Industry Takes Hit with Hurricane Damage in Puerto Rico

Mon, 2017-10-09 23:00
Medical device manufacturers are calling on federal officials to help mitigate disruptions to the supply chain following Hurricane Maria, which devastated Puerto Rico after making landfall on Sept. 20.

Industry Leaders Look to ‘Future-Proof’ Medical Devices

Mon, 2017-10-02 23:00
Leaders from medical device manufacturers and healthcare delivery organizations, as well as security professionals working in the healthcare industry, are looking for ways to effectively address emerging cybersecurity threats—before they are fully understood or even apparent.

Apple, Fitbit, Johnson & Johnson to Participate in FDA’s Digital Health Pilot Program

Tue, 2017-09-26 23:00
Nine technology and device companies, including several well-known names, have been selected to participate in a Food and Drug Administration (FDA) pilot program intended to fast-track health software.

Strong Evidence for Sterilization of Endoscopes Presented at Stakeholder Meeting

Tue, 2017-09-12 23:00
Evidence indicating that sterilization is a superior method to high-level disinfection (HLD) for the reprocessing of endoscopes was reported during a meeting held on Sept. 11 at AAMI headquarters in Arlington, VA. In addition to not reducing microbial contamination as effectively as sterilization, reprocessing endoscopes using HLD is overly complex and involves far greater risks to patient safety.

AAMI Wireless Group, MDISS Commence Discussions on Improving Cybersecurity

Sun, 2017-09-10 23:00
AAMI’s Wireless Strategy Task Force (WSTF) met with Dale Nordenberg, executive director of the Medical Device Innovation, Safety, and Security Consortium (MDISS), via conference call to learn about MDISS's efforts and explore potential collaborations between the groups, both of which have interest in improving medical device cybersecurity.

Mills to Leave Joint Commission

Tue, 2017-09-05 23:00
After nearly 13 years as the director of engineering at The Joint Commission (TJC), George Mills, a familiar and widely respected figure in the healthcare technology management (HTM) community, will be leaving the accreditation organization on Oct. 6 to join JLL, a leading professional services firm.

Historic Flooding Tests Hospitals in Texas

Tue, 2017-08-29 23:00
The epic flooding in southeastern Texas, spawned by Hurricane Harvey, is testing the ability of healthcare facilities to effectively function during a natural disaster and underscores the importance of preparing for such nightmare scenarios.

Senate Bill Calls for Cybersecurity ‘Report Card’ on Medical Devices

Thu, 2017-08-17 23:00
Following a string of high-profile cyberattacks, one U.S. senator thinks it’s time for the government to take a more aggressive role in bolstering the cybersecurity of medical devices, saying that industry itself has failed to adequately address the problem.

AAMI Seeks to Amend Bylaws

Mon, 2017-08-14 23:00
The AAMI Board of Directors will hold a special business meeting on Nov. 3 to vote on two proposed amendments to the association’s bylaws.

FDA Finalizes Guidance on Medical Device Development Tools

Sun, 2017-08-13 23:00
Three years after launching a pilot, the Food and Drug Administration (FDA) has released final guidance outlining a voluntary program that qualifies the tools the industry uses in medical device development and evaluation.

Congress Requires FDA to Address Issue of Device Service

Mon, 2017-08-07 23:00
After passing the Senate 94-1 on Aug. 3, the FDA Reauthorization Act of 2017 is just a signature away from becoming law. The measure is poised to impact the healthcare technology community in two significant ways: through the renewal of the “user fees” imposed on medical device manufacturers and with a call for a report that will dive into the hot issue of medical device service, especially by third parties.

FDA Releases Plan for Digital Health Regulation

Sun, 2017-08-06 23:00
Recognizing that the traditional approach to regulation cannot keep up with the fast-paced iteration of digital health products, the Food and Drug Administration (FDA) has released a plan to promote “digital health innovation.” As part of this regulatory plan, the Center for Devices and Radiological Health (CDRH) will issue new guidance, pilot a firm-based approach to reviews, and strengthen its digital health unit.