In the United States, some hospitals have canceled and rescheduled surgeries because millions of surgical gowns were recalled. The recalled surgical gowns were made in China and were found that they may not be sterile.
On January 30, Cardinal Health admitted that a Chinese contractor, which has been supplying surgical gowns, was using factories that were not registered with the U.S. Food and Drug Administration (FDA).
We had to reschedule nearly 200 surgeries, said Alan Levine, CEO of Ballad Health in Tennessee, adding “We still don’t know if whether we’ve hit the worst of it or not.”
The company said these factories did not “maintain proper environmental conditions.” The factories manufactured gowns in poor facilities, exposing them to contaminants through open windows. They also failed to provide hand sanitation to operators. In addition, operators were found eating in the production area.
Cardinal Health caught the same Chinese supplier in 2018 for using a factory that was not registered with the FDA. At the time, the company did testing and found that there was no impact on the products so it did not inform the FDA.
The surgical gowns often come in packages, along with other surgical instruments. And it is important for all surgical packs to be sterile.
However, since the companies cannot guarantee that the surgical gowns are sterile, there is a possibility that other surgical equipments in the packs is not sterile.
The FDA declined to comment when asked whether it has conducted any investigations of the unregistered factories revealed by Cardinal Health.
Cardinal Health has admitted that it is no longer working with the Chinese contractor who supplied millions of surgical gowns and is cooperating with the FDA.
