FDA's April public health notification on absorbable hemostatic agents is the first of its kind to stem from a MedSun report.

According to device center staffers, a report from a MedSun facility, received last year, prompted FDA to review medical device adverse event reports for absorbable hemostatic agents.

FDA discovered that since 1996 there have been more than 110 adverse event reports associated with the devices, which are intended to promote coagulation and stop internal bleeding during surgical procedures.

Of particular concern were the 11 reported cases in which improper use of the agents is believed to have caused paralysis or other neural damage. The most recent paralysis case reported to the agency occurred last October.

Aimed at healthcare practitioners, the ¹ April 2 health notification underscores the importance of following device labeling contraindications, warnings and precautions. FDA also emphasizes that practitioners avoid using excessive quantities of absorbable hemostatic agents.

Specifically, healthcare providers should apply the smallest amount that will be effective and "remove as much of the agent as possible after hemostasis is achieved "when using the products "on or near bony or neural spaces."

"This will reduce the likelihood of neural and other soft tissue damage from swelling of the absorbable hemostatic agent, and/or migration and swelling of fragments of the agents," FDA explains.

Firms with absorbable hemostatic agents listed in the CDRH adverse event database include Baxter, Cohesion Technologies, J&J/Ethicon, Integra Lifesciences and CR Bard.

Mandated by the FDA Modernization Act of 1997, the MedSun adverse event reporting system for user facilities launched in 2002. Under the MedSun pilot, 240 sites are expected to be on-line by the end of FY 2004, with a maximum of 250 by fiscal 2005.

Hemostatic Agent Public Health Notification Sparked By MedSun

More from Archive

More from Medtech Insight