FDA has informed customers about the possible quality concerns associated with specific surgical gowns. Last week, Cardinal Health, a company that manufactures medical devices, released a statement notifying the public regarding the quality concerns related to its Level 3 surgical gowns and the packs used to keep these gowns.
Cardinal Health provides no guarantee regarding the sterility of these surgical gowns and PreSource surgical packs used for them. The company and the Food and Drug Authority have suggested that customers should stop the use of these affected products instantly.
Cardinal Health has collaborated with the FDA for analyzing the origin and effects of these quality concerns. In any health care facility, surgical gowns are found to be beneficial in providing barrier protection and preventing moderate to high risk of contamination.
On the basis of the functioning of their liquid barrier, surgical gowns have been divided into four categories, providing barrier protection of different intensities. Among these, Level 3 surgical gowns are being used in knee replacement or open-heart surgeries, offering moderate risk protection.
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Wearing surgical gowns prevents the transmission of particulate matter, body fluids, and microbes, providing protection to not only patients but also health care professionals. FDA and Cardinal Health are working together to deal with quality health concerns related to these products.
They will make an effort to understand the possible impact of these surgical gowns and packs on the users and patients. The team will also identify the particular lots that are affected and their affect on the supply chain.
Right now, FDA is majorly concerned about the potential contamination of Cardinal Health’s medical products and has suggested customers avoid their use. FDA’s spokesperson said that the company would also inform the public about the specific products affected and issue a recall.
The disruption in the supply chain of these products can also affect patient care. In health care facilities like hospitals, this matter may even lead to the cancellation of non-elective surgical treatments. FDA is dedicated to alleviating any harmful effects in the patients as a result of this concern. But currently, there isn’t any evidence regarding the harm caused by this concern.
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Many FDA-approved alternatives for these level 3 surgical gowns are also available in the market that provides protection at the same level. The Food and Drug Administration will proceed with its collaboration with Cardinal Health and warn customers about the impact of these concerns on the supply chain of these medical products and the possible shortages.
FDA motivates healthcare facilities to provide them with data regarding possible or actual supply concerns. The authority’s device shortages mailbox (deviceshortages@fda.hhs.gov) permits patient, user, organization, or manufacturer to notify FDA of any delay in the product distribution or anticipated shortage.
FDA added that it will keep on monitoring the situation and will keep the public informed of the evolving situation.
About Cardinal Health
Cardinal Health, Inc. is a company that provides healthcare products and services at a global level. It supplies its clinically-proven medical devices and solutions to physician offices, pharmacies, hospitals, clinical laboratories, health systems, and ambulatory surgery centers.