[Skip to Content]
[Skip to Content Landing]
September 28, 1994

Medical DevicesSignificant Risk vs Nonsignificant Risk

JAMA. 1994;272(12):955-956. doi:10.1001/jama.1994.03520120065032

A RECENT experience at our institution demonstrates a pitfall that awaits essentially any hospital in this country if its institutional review board (IRB) is not careful to distinguish between a significant risk device study and a nonsignificant risk device study.

CASE STUDY  In 1992, our infection control department was approached by a well-known manufacturer of medical devices that wished to sponsor a randomized trial involving three urinary catheters. Two of the catheters were already marketed. The third catheter, the study catheter, was the same as one of the marketed catheters, but it had an additional anti-infective coating. Based on prior investigations of the study catheter outside the United States, our IRB approved the research protocol provided by the manufacturer. In the research protocol, the manufacturer stated it considered the study catheter to be "a nonsignificant risk device," and the manufacturer asked that our IRB write itsSee also p 968.