FDAnews Device Daily Bulletin

ADVERSE DEVICE EFFECTS MORE SERIOUS THAN DRUG ADVERSE EVENTS

June 9, 2006
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Differences in the regulations for device trials as opposed to those for drugs can lead clinical sites into trouble if they do not understand those differences, said officials at a company currently conducting two Phase III investigational device exemption (IDE) trials. The solution is education.

"We generally educate our sites and monitors upfront. We educate everybody," said Joyce Maga, vice president of clinical and regulatory affairs at Mountain View, Calif.-based SpinalMotion, which is currently conducting trials of artificial lumbar and cervical discs for patients with degenerative disc disease.

Sites and monitors whose experience is mainly with clinical drug trials may be confused about why there seems to be so little adverse event reporting in device trials, Maga said. The reason is that serious adverse events (SAEs) and the rules on reporting them apply only to drugs. The analog in a device trial is an unanticipated adverse device effect (UADE), which "is actually much more serious," Maga said.

Drugs are systemic and could potentially cause adverse events anywhere in a patient's body; whereas "an artificial knee won't cause a heart attack," Maga said. Thus, a device failure resulting in a UADE is a cause for grave concern.

"If something is wrong, you should have known about it before you tested it on people. It's more serious than an SAE," said Maga, a former FDA official. A UADE has to be reported to the FDA within 10 days, compared to a 30-day reporting period for a drug SAE.

Institutional review boards (IRBs) will have their own reporting rules for unexpected events in a device trial, with some wanting to be notified about anything that happens right away and others content to receive notification in an annual report, Maga said. ()a href="http://www.fdanews.com/ddl/33_23/" target=_blank>