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Updated: 5 hours 55 min ago

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.

FDA Patient Engagement Advisory Committee to Tackle Challenge of Clinical Trials

Thu, 2017-07-27 23:00
The Food and Drug Administration’s first advisory committee dedicated solely to patient-related issues will hold its inaugural meeting this fall. The focus will be clinical trials for medical devices.

MDISS Launches Worldwide Device Security ‘Proving Grounds’

Tue, 2017-07-25 23:00
In the face of massive and debilitating cyberattacks, the nonprofit Medical Device Innovation, Safety and Security Consortium (MDISS) has launched a worldwide network of security “proving grounds” specifically designed to test the security of medical devices, identify vulnerabilities, and develop solutions. The MDISS World Health Information Security Testing Lab (WHISTL) includes healthcare delivery organizations (HDOs), medical device manufacturers, academic institutions, and technology companies.

Patch Management Tips Every HDO Should Know

Mon, 2017-07-24 23:00
Healthcare delivery organizations (HDOs) continue to struggle in the face of cyberattacks that seek to paralyze networks and devices, steal or encrypt sensitive information, and extort money. The WannaCry ransomware cyberattack in May, considered one of the largest in history, underscored the importance of ensuring network-connected devices are running the latest software and deploying mitigation strategies for those that can’t be updated.

FDA Promotes ‘Greater Use’ of Standards for Medical Devices

Mon, 2017-07-24 23:00
The Food and Drug Administration (FDA) says it is moving ahead with plans to reduce regulatory burden and promote medical device innovation as required by the 21st Century Cures Act, including changes to the way it recognizes voluntary consensus standards for medical devices.

Battery Fires on Medical Carts Heats Up as Safety Priority

Tue, 2017-07-18 23:00
The healthcare industry needs a better understanding of the troubling issue of fires and explosions in high-capacity batteries used in hospital carts and should turn to standards and education to address the problem, according to a diverse group of experts.

Standards Developers Applaud ‘Public-Private Partnership’ during Capitol Hill Event

Tue, 2017-07-11 23:00
Leaders of several standards development organizations, including AAMI, hosted an event on Capitol Hill Tuesday to highlight the importance of standards in supporting product quality and safety for various industries, especially healthcare technology.

FDA Commissioner Announces Risk-Based Plan for Digital Health Technology

Sun, 2017-06-18 23:00
Promising a “modern and efficient” regulatory process, the head of the Food and Drug Administration (FDA) announced a pilot program aimed at supporting the development of digital health technologies.

AAMI 2017 Conference & E

Mon, 2017-06-12 09:23

AAMI 2017 Conference & E

Mon, 2017-06-12 09:23

AAMI 2017 in Pictures

Sun, 2017-06-11 23:00
Highlights from the AAMI 2017 Conference & Expo in Austin, TX, June 9-12.

Chief Technology Officer: Let ‘Clinical Need’ Be Your Guide in Purchasing Decisions

Sun, 2017-06-11 23:00
Using systems engineering principles to take a hard look at the clinical needs, processes, and workflow factors involved with the deployment of clinical technology can result in substantial cost savings for healthcare facilities, said Eliezer Kotapuri, chief clinical technology officer for Mass Technologies, during a presentation Monday at the AAMI 2017 Conference & Expo.