AAMI Seeks Nominations for Awards Programs
Do you know a health technology innovator, safety advocate or revolutionary individual? How about a standards leader or humanitarian? You can make sure that health technology’s finest are recognized for their achievements by nominating them for an AAMI or AAMI Foundation award.
The winners will receive a monetary prize, a plaque commemorating their achievements, and recognition at the AAMI Exchange, June 12-15 in New Orleans, Louisiana.
Nominations are due January 6, 2020.
For more information, visit www.aami.org/awards.
AAMI Foundation Embarks on New Direction
With a new focus on advancing the professional development of health technology professionals and the safety of technology through scholarships, awards and grants, the AAMI Foundation is in the midst of launching several exciting initiatives.
“Over the last decade, the foundation’s greatest success has been helping professionals enter the health care field, rewarding excellence through awards, and funding important research,” said Steve Yelton, chair of the AAMI Foundation Board and professor emeritus at Cincinnati State Technical and Community College in Ohio. “That need is growing, and the AAMI Foundation is ideally suited to help.”
Taking the helm of the foundation as its executive director is Steve Campbell, AAMI’s chief operating officer (COO). Campbell and Deputy Director Jim Piepenbrink have big plans for another valuable program – The Mary K. Logan Research Grant, which is named after AAMI’s former president and chief executive officer, who championed the foundation’s patient safety initiatives.
“In 2016, the AAMI Foundation designated $3 million to this grant program, and we’ve had good success funding important projects in healthcare technology,” said Campbell, who will continue to serve as AAMI’s COO. “Now, we want to take the program to new heights.”
The AAMI Foundation recently awarded the $40,000 Mary K. Logan Research Grant to the Cincinnati Children’s Hospital Medical Center in Ohio to fund a project intended to disseminate and distribute recently developed indications for continuous pediatric monitoring to ensure the appropriate monitoring of patients.
New TIR Helps Industry Meet Global Quality Management Expectations
A new technical information report (TIR) published by AAMI aims to help U.S. medical device manufacturers better understand Food and Drug Administration (FDA) regulatory requirements during the agency’s transition from the quality management standard 21 CFR 820 to the international standard, AAMI/ANSI/ISO 13485:2016.
The FDA originally announced its intention to replace 21 CFR 820 with the international standard in May 2018.
Using AAMI TIR102:2019, U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems, manufacturers can identify the key similarities and differences between 21 CFR 820 and 13485. This mapping will prove useful to manufacturers that currently comply with both standards as well as to manufacturers as they transition to 13485.
While the transition may be painful in the short-term, having one global set of quality management system standards is expected to offer long-term benefits thanks to eliminating redundancy.
“The FDA’s plan represents a huge step toward true global harmonization of medical device quality management systems, and AAMI TIR102 will help remove the mystery and facilitate a smooth transition,” said Wil Vargas, director of standards at AAMI.
TIR102 contains a “translational matrix” consisting of two sets of tables that compare the differences, similarities and quality system considerations between 21 CFR 820 and 13485 requirements. The TIR is intended to be used by medical device manufacturers that are already familiar with quality management system requirements and terminology.
TIR102 is available for purchase at the AAMI Store. In addition, AAMI has updated its quality systems training courses to reflect the transition to the harmonized international standard.
Call for Human Factors Papers
The summer 2020 issue of Horizons will focus on the importance of human factors in healthcare technology management, device design, standardization, manufacturing and regulation.
Submission categories include research articles based on scientific method, analysis articles based on scholarly investigation, case studies describing valuable real-world experiences or practice innovations, tools-based papers detailing emerging methods, measures, instruments and commentaries expressing informed opinions about events, trends and/or developments
Submissions are due January 15, 2020.
For more information, including important dates and details on submitting a paper, visit www.aami.org/Horizons.
AAMI Board Member Takes the Helm of UConn Clinical Engineering Program
Carol Davis-Smith, a member of the AAMI Board of Directors and principal of Carol Davis-Smith & Associates, is now the director of the clinical engineering program at the University of Connecticut (UConn). She follows in the footsteps of Frank Painter, an AAMI member and contributor who led the program for two decades.
In her new role, which began in August, Davis-Smith manages interns and relationships with hospitals that provide internships and teach clinical rotation courses.
“I am super honored, and I feel very fortunate to have the opportunity to do this,” Davis-Smith said. “I want to be very respectful of the incredible history and reputation of this program. I want to build upon it.”
The leadership transition comes as the UConn program itself is transitioning from a largely face-to-face learning experience to a more digital program with a distance learning format.
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