AAMI News September 2017

News in Brief

AAMI Seeks to Amend Bylaws

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.

The first amendment would allow the Board to determine when AAMI’s fiscal year begins and ends. The second amendment would allow bylaw changes to be considered at any meeting of the association, not just the Annual Meeting, as long as a quorum was present and notice of the proposed changes had been sent in writing to voting members.

All AAMI members should cast their vote on these proposed amendments either by filling out and returning the proxy card that’s included in this issue or by completing the online form, which is available at www.aami.org/proxy. The deadline is Oct. 6, 2017.

Checklists Provide Easy-to-Use Resource to Prevent HAIs

2017 HAI ChecklistsAAMI has published a free resource to help healthcare delivery organizations reduce the risk of transmitting healthcare-associated infections (HAIs). Checklists for Preventing Healthcare-Associated Infections: Key Considerations for the Purchase and Use of Reusable Medical Devices includes recommended steps when purchasing a new medical device, training considerations, and stakeholder-specific checklists for sterile processing, infection prevention, environmental services, and healthcare technology management personnel.

This tool draws from the lessons learned during AAMI’s 2016 HAI forum, in which AAMI and its partners met with more than 100 stakeholders concerned about the safety of reusable medical devices—healthcare administrators, clinicians, researchers, instrument processing personnel, and device manufacturers—to explore how and why device and equipment-associated infection transmissions occur and to identify solutions to the problem.

The checklists are designed to be filled out electronically or printed out and completed by hand. Download them at www.aami.org/HAI_Checklists.

AAMI Foundation Publishes Four Alarm Management Papers

The AAMI Foundation has completed publication of four clinical alarm management papers that mark a major milestone for its coalition focusing on that topic. Members of the coalition authored the articles, which were published in AAMI’s peer-reviewed journal BI&T from 2016–2017. Three of the papers are “how to” practical guides, while the fourth presents the results of a survey of hospital monitor watcher programs.

“These four papers are absolutely ‘must-reads’ for anyone working to improve clinical alarm management. They more fully flesh out how to implement the recommendations of the coalition’s Clinical Alarm Management Compendium, and they provide a fuller picture of what good alarm management looks like,” said Marilyn Neder Flack, executive director of the AAMI Foundation and senior vice president of Patient Safety Initiatives at AAMI.

Later this year, the coalition will release the final deliverable of its initial two-year phase, an SpO2 toolkit. For more information about these safety initiatives, visit www.aami.org/foundation/alarms_coalition.

FDA Clears MRI Device Designed to Scan Newborns’ Brains

Embrace Neonatal MRI System
The Embrace Neonatal Magnetic
Resonance Imaging (MRI) System allows premature babies  to receive MRI scans while remaining in the neonatal intensive care unit.

The Food and Drug Administration (FDA) has given 501(k) premarket clearance to the Embrace Neonatal Magnetic Resonance Imaging (MRI) System. This MRI device, developed by Aspect Imaging in Tel Aviv, Israel, is the first MRI designed specifically to provide neonatal brain and head imaging in the neonatal intensive care unit (NICU).

“It is now possible to routinely scan premature babies in the NICU, almost immediately after birth, helping to increase the quality of life and improve care for newborns by assisting in the early detection of health issues, enabling at-risk babies to grow into healthy children,” said Uri Rapoport, CEO and founder of Aspect Imaging, in a press release.

The Embrace system accommodates infants who weigh 1 to 4.5 kg and whose head circumference is up to 38 cm. The device includes an incubator to control the child’s temperature. The fully enclosed system does not require shielding and can be used in the NICU near other medical devices. However, the system is not recommended for infants who have a metallic or electronically active implant.

FDA Advisory Committee to Tackle Challenges Related to Clinical Trials

The FDA’s first advisory committee dedicated solely to patient-related issues is set to address common clinical trial challenges including “inconsistent or minimal participation,” according to a blog post by Kathryn O’Callaghan, assistant director for strategic programs in the FDA’s Center for Devices and Radiological Health (CDRH), and CDRH Director Jeffrey Shuren.

The first meeting of the new Patient Engagement Advisory Committee (PEAC), which is intended to be “a forum for the voice of patients,” will take place Oct. 11 and 12 at the Hilton Washington, D.C. North/Gaithersburg. Attendees will discuss issues related to clinical trial design, conduct, and reporting.

Although patient representatives currently participate in many FDA advisory committee meetings, the agency has never had a committee specifically dedicated to addressing patients’ needs, views, and concerns related to medical devices. More information about meeting content and times has been published in the Federal Register.

Fresenius Medical to Acquire NxStage to Boost Dialysis Unit

Fresenius Medical Care, the world’s largest provider of dialysis products and services, is set to buy NxStage Medical, Inc. for about $2 billion in an effort to bolster Fresenius’ presence in the at-home dialysis market. Germany’s Fresenius owns a network of 3,690 dialysis clinics around the world. If the deal goes through, Fresenius will gain control of NxStage’s System One, a portable hemodialysis system designed for home use, and a pipeline of new technologies.

“Home dialysis is a critical component of renal care, and this acquisition would help us accelerate growth and innovation in this important modality,” said Bill Valle, CEO of Fresenius Medical Care North America.

As both a supplier to and rival of Fresenius, NxStage also sees benefits in the sale. “The combination of Fresenius Medical Care’s industry leadership with NxStage’s innovative  products and employees has the potential to significantly advance the standard of care for patients around the world,” said Jeff Burbank, NxStage’s founder and CEO. “Fresenius Medical Care would like us to continue doing what we do best, and a lot more of it. I strongly believe our opportunities would be greater working together for the benefit of patients, customers, and shareholders.”