Bulletin 19-3

Home » Regulatory » Bulletins » Bulletin 19-3

Events with Potential Impact on
Tissue Recovery and Processing

Bulletin 19-3

March 13, 2019

AATB has received information about two separate events that may have an impact on tissue recovery and processing establishments.

The first event is an Urgent Medical Device Recall announced on March 7th by Medical Action Industries, Inc. regarding specific lots of their Laparotomy Sponge(s). This recall is in response to concerns of potential Sterility Assurance Levels (SAL) other than 10-6. In addition to the normal risk of infection that any procedure carries, SAL deviation may contribute to a potential increase in infection transmission risk. To date, there have been no reports of any adverse events or serious injuries. Affected product first shipped October 4, 2018. The Urgent Medical Device Recall is being done with the knowledge of the U.S. Food and Drug Administration (additional information available here). For clinical and product inquiries, please contact Medical Action Industries at (800) 645-7042.

The second event is the closure of the Illinois Sterigenics sterilization plant that was prompted by concerns about possible environmental pollution with ethylene oxide. Multiple hospitals have inquired with tissue processors about the possible disruption of HCT/P supply as a result of the Sterigenics plant closure (additional information available here).

Establishments that have received critical supplies from Medical Action Services or used the services of Sterigenics for sterilization of critical supplies should perform a risk assessment, and determine appropriate action based on the assessment results.