Amendment seeks to increase medical device monitoring

Patient Safety Monitor Insider

July 15, 2015

Last week, the U.S. House of Representatives passed the 21st Century Cures Act, which contains an amendment requiring healthcare professionals add the make or model number of a medical device used on a patient to the patient’s electronic medical records (EMR).

The amendment was prompted by issues around power morcellators, which have been linked to the spread of cancer in a small number of women who underwent uterine fibroid removal. These finding led the FDA to issue a black box warning on the devices, and the leading manufacturer, Johnson & Johnson stopped manufacturing them. However, devices still remain on the market.

Read the full article at Outpatient Surgery here.