Red Cross puts distribution center on ice

Deirdre Newman

An American Red Cross facility has suspended distribution of donated

skin tissue and heart valves in response to sanitation violations

cited by the Food and Drug Administration.

The distribution center, on Hyland Avenue, suspended distribution

of skin tissue used for transplants and heart valves on March 19,

based on a warning letter from the FDA on March 11.

The organization is assessing how to respond to the problems,

spokeswoman Michelle Hudgins said.

“We want to evaluate the facility to see the steps that need to be

taken to get into compliance because compliance is key to safety and

safety is our priority,” Hudgins said.

Some of the problems with the heart valves include an inadequate

disinfection process and inadequate packaging and shipping

containers. Issues with the donated human tissue include the lack of

valid procedures for the prevention of infectious disease

contamination and cross-contamination.

The Red Cross will prioritize its response to the complaints,

Hudgins said.

“Those issues of major concern, we will put those to the

forefront, so families can continue to trust in the Red Cross and

[so] they can have the opportunity to continue the legacy of their

loved ones, which is important to us,” she said.

None of the tissue or heart valves has caused any problems,

Hudgins said.

“Everything we have distributed is safe so people shouldn’t feel

like they can’t trust the tissue that’s out there,” Hudgins said.

“We’re doing everything in our power to address the issues.”

The Costa Mesa facility is one of the main distributors of the

affected items, Hudgins said. The organization is collaborating with

partners to continue distribution elsewhere, Hudgins added.

FDA public affairs specialist Laurel Eu said she couldn’t comment

on the ongoing investigation.