Earlier this month, Cardinal Health, a large manufacturer of surgical gowns, notified its customers to immediately stop using its Level 3 surgical gowns and PreSource procedural packs that contain these gowns.
An unexpected shortage of surgical gowns across the nation has put patients in a bind after hospitals have been forced to postpone surgeries. Earlier this month, Cardinal Health, a large manufacturer of surgical gowns, notified its customers to immediately stop using its Level 3 surgical gowns and PreSource procedural packs that contain these gowns. The manufacturer stated that it couldn't provide assurance that the products are sterile as some of the gowns were produced in "unapproved locations that did not maintain proper environmental conditions as required by law, were not registered with the U.S. Food and Drug Administration (FDA) and were not qualified by Cardinal Health."
In a statement issued on its website, Cardinal Health stated that the firm "initiated an investigation, quarantined the gowns, placed a hold on the distribution of the gowns and started communicating with customers to ensure that the affected gowns were removed from use." According to CNN, over 9 million gowns are included in the recall of which 7.7 million were distributed to 2,807 facilities across the country.
The U.S. Food and Drug Administration said in a statement that it "is working closely with Cardinal Health to understand and address the quality issues with these products, including the potential risks to users and patients, which specific product lots are impacted, and the potential impact on the supply chain. At this time, we are concerned about possible contamination of the products and agree with the manufacturer’s recommendation about not using the affected lots of Level 3 surgical gowns or PreSource procedural packs."
"We also understand this issue may already be impacting patient care at health care facilities, such as the cancellation of non-elective surgeries. There are very real consequences that medical device supply chain disruptions can have on patients, and we’re committed to taking steps we can to mitigate any adverse patient impact. At this time, we are not aware of any patient harm because of this issue," the administration added. However, despite the FDA's assurance, a Boston-area family told CNN affiliate WBZ that they had to postpone the family patriarch's surgery due to the surgical gown shortage that has hit hospitals across the nation.
Speaking to the publication, the patient's son-in-law Adam revealed that the family was quite shocked when they received the devastating diagnosis on January 7. "[The diagnosis] was brutal. Pancreatic cancer is painful. It’s something that no one expects," he said. During the patient's first oncology appointment at Newton-Wellesley Hospital, the doctor informed them that they had to immediately schedule a procedure for Adam's father-in-law to have a chemotherapy port installed. However, the receptionist had some disturbing news for them. The surgery would have to wait for up to two weeks.
Wowwww. I didn't know that.— Ria S. (@missriasu) January 23, 2020
Now... A surgical gown shortage? https://t.co/Sd9r5Hrplx
"Anger first and foremost. It was something so simple," Adam explained how the concerned family felt at that moment. Fortunately, Adam and his wife were able to convince the hospital to schedule the procedure as soon as possible and the chemotherapy port was installed in the patient on January 15. Although the family is relieved the procedure took place, they aren't happy about the lack of information about the product hold and the potential delay they feared.
"That’s not something you would ever anticipate or think about. The lack of information is what’s killing me. It’s not a very transparent process... to the end-user, the customer—the patient. It was shocking to know there are other people who could be impacted by this and they don’t know. They’re getting told their surgery is getting delayed for two weeks and they don’t know why," said Adam. In a letter to its employees, Partners Healthcare—the nonprofit that runs Newton-Wellesley and several other hospitals in Boston, said, "We are taking this situation—which is impacting thousands of hospitals across the country—very seriously... We have secured additional gowns to support our hospitals and minimize any impact to our patients... To date, we are not aware of any patient harm associated with this event."