New standards for disinfecting devices could reduce sterilization capacity by upward of 50%, advocates estimate. 

"Diversity is vital to healthcare, and this court ruling deals a serious blow to our goal of increasing medical career opportunities for historically marginalized and minoritized people."

The primary concern is that sterilization facilities and healthcare providers would not have enough time to adapt to the proposal. Devices impacted would include pacemakers, angioplasty balloons and catheters, just to name a few. 

The new therapy, made from the pancreatic cells of deceased donors, is designed to help adult type 1 diabetes with severe hypoglycemia go a year or longer without needing to take insulin. 

The sales representative is alleged to have falsely documented his sales numbers on invoices submitted to the hospital’s billing department in addition to interfering with their sterilization processes, according to the DOJ.

The FDA has said this is a Class I recall, which means using the devices “may cause serious injuries or death.” A total of 18 injuries have been reported so far. 

The Germany-based corporation said this is the “only contrast agent approved for this indication” in America. 

“We must not lose momentum," ACR, the Academy for Radiology & Biomedical Imaging Research and more than 100 other organizations wrote to leaders of the U.S. Senate.