This article is more than 5 years old. Information may no longer be current.
Patients contract SSIs after receiving FDA-regulated amniotic tissue product
Click Here to Manage Email Alerts
A cluster of surgical site infections at an acute care hospital in Ohio possibly was caused by intraoperative applications of an FDA-regulated amniotic tissue product used to assist wound healing, according to a presentation made during the CDC’s Epidemic Intelligence Service Conference in Atlanta.
In October 2015, the CDC was notified of four patients who developed surgical site infections (SSIs) after spine surgery in August and September. An investigation revealed that all patients, two of whom were infected with Mycoplasma hominis, received an amniotic tissue product from a common donor.
Shannon A. Novosad
Shannon A. Novosad, MD, MPH, an epidemic intelligence service officer with the CDC, and colleagues discovered that five other patients at the Ohio facility received tissue products from the same donor, and a total of 27 vials of product were distributed to facilities in seven states. The researchers reported that laboratory testing on two sealed and unused vials of product were positive for M. hominis and Ureaplasma parvum.
Novosad and colleagues determined the infections were most likely transmitted through amniotic tissue. A multistate investigation is ongoing to identify additional cases.
Although suppliers screen donors for a variety of bloodborne and sexually transmitted infections and test products for microorganisms before distribution, Novosad told Infectious Disease News that tissue-transmitted infections can still occur.
“To reduce the risk of future infections, testing could be expanded to include microorganisms known to colonize the genitourinary tract,” she said. “But it may not be possible to test for all microorganisms which may be present in the product.
“Amniotic tissue products are not guaranteed to be free from contamination by microorganisms, and providers should weigh the risks and benefits of using them.” – by Stephanie Viguers
Reference:
Novosad SA, et al. Mycoplasma Hominis Surgical Site Infections Following Receipt of Amniotic Tissue Product — Ohio, 2015. Presented at: Annual Epidemic Intelligence Service Conference; May 2-5, 2016; Atlanta.
Disclosure: Novosad reports no relevant financial disclosures.