AAMI News February 2018

News in Brief

Joint Commission Names Mills’s Successor

Filling one of the most high-profile positions in the world of healthcare technology management, The Joint Commission (TJC) has named its successor to George Mills.

Kenneth Monroe was appointed senior associate director of the commission’s Standards Interpretation Group’s Department of Engineering in late December. Monroe replaces Mills, who held the position for nearly 13 years before leaving to work for a professional services firm.

Starting at TJC in April 2016, Monroe previously served as an associate project director in TJC’s Department of Standards and Survey Methods, where he was responsible for maintenance, updates, and improvements to life safety and environment of care standards, as well as assisting with emergency management standards, which included workplace safety issues.

Monroe has more than 25 years of healthcare experience, having also worked as a healthcare facilities professional. During this time, he directed numerous projects, from planning and design to construction and operations. Monroe has implemented a facility master plan for a 305-bed hospital, and he has been a facility director at a 1.3-million-square-foot healthcare facility.

Medical Device Tax Is Back on Ice—For Now

The passage of a three-week funding bill to end a federal government shutdown on Jan. 22 included a provision to suspend the medical device tax, which industry has long criticized as a barrier to innovation that increases healthcare costs, for two years.

The 2.3% excise tax on medical device sales first imposed by the Affordable Care Act was reinstated at the start of this year to the dismay of many in the medical device industry, who balked at impending deposits to the Internal Revenue Service (IRS). The suspension is retroactive to the end of 2017.

In a statement, the medical device trade association AdvaMed applauded the passage of the resolution but described the suspension as an “interim step.”

“Congress’s action—just days before medical technology innovators were set to start cutting checks to the IRS—means funds will not be diverted from current investments in jobs, capital improvements, and research into new treatments and cures,” said Scott Whitaker, president and CEO of AdvaMed, in a press release. ”We look forward to continuing to work with the Hill on a bipartisan basis to drive towards permanent relief.”

Robert Jensen
Robert Jensen

AAMI President Named to ANSI Board of Directors

AAMI President and CEO Robert Jensen has been named a director-at-large by the American National Standards Institute (ANSI) Board of Directors. Jensen, who was nominated to fill a vacated position, began his one-year term on Jan. 1.

“I am deeply honored to have been selected as an ANSI director-at-large and look forward to working with the rest of the Board toward advancing ANSI’s significant and valuable mission,”

Jensen said. “Standards are a fundamental component of promoting quality and safety in a multitude of industries, and AAMI is proud of its standards-setting role in the world of health technology.”

ANSI is a nonprofit organization that promotes, facilitates, and safeguards the integrity of the voluntary standardization and conformity assessment system. AAMI was accredited by ANSI as a National Standards Organization in 1977 and published its first ANSI-recognized American National Standard in 1978.

South Korea to Streamline Approval of Cutting-Edge Devices

Government officials and medical technology companies in South Korea have reached an agreement to help speed up the release of “novel medical devices with an immediate value to society” when the success of the device “hinges on entering the market ahead of competitors,” according to a report by the Korea Herald.

Under the agreement, a new “value-based evaluation track” will be established to evaluate which technologies should gain fast track approval.

The system will weigh the benefits to society as well as clinical evidence against potential safety concerns, according to the report. Technologies that pass this value-based evaluation will be given a clinical usage period of three to five years before being evaluated again.

Medical devices represent an approximately $5 billion industry in South Korea, according to the International Trade Administration, with the United States supplying nearly half of imports.

Vessel Grafts
Photo courtesy of University of Minnesota.
The blood vessel grafts acted and appeared similar to real blood vessels six months after implantation in baboons.

Engineers Grow Ready-to-Implant Tubes to Replace Blood Vessels

Engineers at the University of Minnesota (UM) successfully tested lab-grown blood vessel grafts in baboons in a preclinical trial. These grafts were created using human skin cells placed into a gel-like protein that’s used in blood clotting. The skin cells build out a scaffold of collagen and other proteins. Once the cells are washed away, the graft consists of nonliving but biologically based materials that other cells can eventually call home.

“We harnessed the body’s normal wound-healing system in this process by starting with skin cells in a fibrin gel, which is nature’s starting point for healing,” said UM Biomedical Engineering Professor Robert Tranquillo, who led the study. “In the future, thousands of the lab-grown vessels could be made from a small skin biopsy from one donor and then stored on the shelf for when they are needed by patients.”

Once implanted in the body, the grafts take on the biological tissue of the recipient. The final product, described in a November 2017 Science Translational Medicine cover story, looks like an endogenous blood vessel, self-heals when pricked, and does not generate an immune response. The next step is seeking Food and Drug Administration approval for a clinical trial in children with pediatric heart defects, according to the researchers.