Dive Brief:
- Integra LifeSciences has recalled wound and burn treatments over issues linked to 14 serious injuries, the Food and Drug Administration said Thursday.
- The FDA published an early alert after Integra wrote to customers about packaging failures that affected the sterile barrier and could lead to patient infection.
- Integra wrote to customers last week, around five months after recalling other wound and burn devices because of inadequate sealing of sterile barrier packaging.
Dive Insight:
The products covered by the early alert treat wounds and burns by helping to maintain a moist wound environment and protect the skin from breakdown, irritation and damage. Most of the devices are part of Integra’s MediHoney product line. The recall also covers CVS Wound Gel products.
As of Dec. 19, Integra had reported 11 serious injuries related to MediHoney products and three serious injuries related to CVS Wound Gel products, according to the FDA. There are no deaths associated with the issue.
The MediHoney injuries stem from packaging failures that could cause a breach in the sterile barrier. Patients could become infected after using products with a breached sterile barrier. The FDA added that the inability to use products with breached sterile barriers may delay care.
Integra also identified production and process control issues for certain CVS Wound Gel products. Again, use of the affected devices may lead to infection and recognition of the fault pre-application could delay care. A recall notice sent to Integra customers in Europe earlier this month describes three skin reaction complaints linked to MediHoney products with “inadequately good manufacturing processes.”
The issues led Integra to advise customers to remove affected devices from service and quarantine them. Customers should dispose of any expired products. Healthcare professionals who have used an affected product and followed standard operative care do not need to perform additional patient follow-up.
Integra asked distributors to remove affected products from their supply chains. Distributors should also check customer traceability records and contact organizations that bought recalled devices, Integra said.
The company acquired the MediHoney franchise as a result of two deals struck in January 2017. First, Integra agreed to buy Derma Sciences. The following day, Derma inked a deal to buy the MediHoney brand from its long-term partner Comvita for $13.3 million in cash. MediHoney sales in 2016 were around $20 million.
