Medical devices are designed for when they perform as intended. They should have the same thoughtfulness in design for when they fail.

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.

The Food and Drug Administration has issued final guidance describing the rigorous methods it uses when considering uncertainty during benefit-risk determinations related to premarket decisions for medical devices.

AAMI and the International Organization for Standardization have published two sterilization standards that focus on the packaging of sterilized medical devices.

News from the field.

Sterile processing departments regularly come across complex devices and sterilization situations. A quality management system, like the ones described in ANSI/AAMI ST90:2017, can help manage these very important issues.

Can collaboration between industry and clinical users of technology in the realm of standardization help spur innovation and advance patient care? AAMI Managing Editor Joe Sheffer asked five sterile processing experts this question in a roundtable discussion for the September/October 2019 issue of AAMI’s journal BIT.

Carol Davis-Smith, a member of the AAMI Board of Directors and principal of Carol Davis-Smith and Associates, is now the director of the clinical engineering program at the University of Connecticut.

After a nearly two-year hiatus, AAMI recently revived its mentorship program, which pairs early-career AAMI members and seasoned healthcare technology management professionals for a year long mentoring relationship.

For the first time, AAMI will offer an online review course to help biomedical equipment technicians prepare for the exam to become certified biomedical equipment technicians.

AAMI’s publications continued their track record for editorial excellence, winning no fewer than six national awards this year for the peer-reviewed journal Biomedical Instrumentation and Technology and its Horizons supplement, the monthly newsletter AAMI News, and a social media campaign that promotes the healthcare technology management field.

A new technical information report published by AAMI aims to help U.S. medical device manufacturers better understand Food and Drug Administration regulatory requirements during the agency’s transition from the quality management standard 21 CFR 820 to the international standard, AAMI/ANSI/ISO 13485:2016.

Eddie Conklin is the central sterile processing manager at Peninsula Regional Medical Center in Salisbury, MD.

Bhumika Patel and MJ McLaughlin at the Georgia Biomedical Instrumentation Society meeting.

This regular feature showcases questions and answers from professionals participating in AAMI’s online discussion groups, collectively known as AAMI Connect.

Lucas Marsh is chief of healthcare technology management for the Ralph H. Johnson VA Medical Center in Charleston, SC, and a member of the Technology Management Council.

HORLANDO CINTRON, CRCST, CHL, is a manager in the central processing department at Memorial Sloan Kettering Cancer Center in Middletown, NJ.

Jia Yao is the principal biomedical engineer in the diabetes business division at Medtronic.

Learn about the promotions and career changes of our members.

AAMI has published a new standard that marks the start of a grander vision for the field of medical device interoperability—an integrated clinical environment.

Advertisers in the October 2019 Issue