CDRH Asked to Consider Hill-Rom Bed Flaw

CDRH has been asked to evaluate information that a design flaw in the Hill-Rom Total Care hospital bed reportedly used in many ICUs across the country can put patients at risk of exposure to biohazardous materials. The concern was raised by cardiac surgeon Hooman Noorchashm, whose wife is a patient at the Hospital of the University of Pennsylvania (HUP), and noticed the potential hazardous substance in the joint alcoves of her hospital bed.

Noorchashm brought his concern to Hill-Rom and to a contact at FDA, associate commissioner Peter Lurie, who forwarded the information to CDRH.

Company officials indicated to Noorchashm that they take the concern very seriously and will collaborate with CDRH and HUP on next steps. Noorchashm suggested that the company and agency together notify all user facilities of the potential problem and then move on to steps to correct the joint design flaw and to create mechanisms for the adequate sterilization of the beds between uses.