A total of 113 patients in some states may have tuberculosis after undergoing spinal surgery or fracture repair, including contaminated bone repair products. Washington post Reported on June 18th. The CDC, FDA, and state health departments are investigating the outbreak.
The cause of death has not yet been identified, but eight patients died after treatment containing contaminated products.
A product called FiberCel is manufactured by Aziyo Biologics and distributed by Medtronic. It is a malleable bone putty made of human cells and is involved in many orthopedic surgeries. Aziyo recalled 154 product containers shipped to 37 facilities in 20 states between March 3 and April 2. Position..
A total of 136 FiberCel containers have been transplanted to 113 patients, and health officials are now Recommended Everyone who receives a contaminated product is treated for tuberculosis, regardless of whether they are symptomatic or not.
Indiana and Delaware report most cases. Position Report. In Indiana, health authorities are monitoring 30 people who have received affected bone repair products, and in Delaware 23 patients have received the products.
Aziyo announced a voluntary recall of a single lot of product on June 2, after seven of the 23 patients who received FiberCel from a lot at an unidentified hospital complained of postoperative infection. ..Of them, 7 patients were tested positive for tuberculosis, the FDA Said With that recall notification.
Since then, the state has been able to quarantine 18 of the contaminated products to prevent them from being used in additional steps.
In a statement to Position“We continue to work with the FDA and the CDC at the right time to investigate the issue,” Aziyo said. [it] The company also said that the affected products were from a single donor.
Beverly Bliss, Vice President of Certification and Standards for the American Association of Tissue Banks, said: Position Tuberculosis is very rare in bone grafts (the last such case occurred in 1953) and the bacteria that cause the infection are not currently being tested. Human tissue transplant products are more commonly tested for HIV, hepatitis C, and other illnesses, she said.
A spokeswoman for Medtronic, the product distributor, told the press that quality control was in place, but the product was not tested and distribution was suspended until the investigation was completed. ..
At least one patient in Delaware who underwent spinal fusion on April 13 at Christiana Care Hospital using the affected product filed a proceeding against Aziyo and Medtronic.
To read the full text Washington post Click here for the story.
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