On
Surgical gowns are commonly used in health care facilities during surgical procedures and/or to provide moderate to high risk barrier protection. Gowns are classified into four levels of barrier protection based on their liquid barrier performance. Level 3 gowns provide moderate risk protection and are used in a wide-range of surgical procedures, such as open heart surgery and knee replacements. They are intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material.
The FDA is working closely with
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 FDA is engaged in activities to mitigate supply chain disruption that would negatively impact clinical care operations, including identifying alternative Level 3 gowns. There are numerous FDA-cleared surgical gown alternatives on the market that provide Level 3 barrier protection. We will continue to work with
We encourage healthcare facilities to contact the FDA with information about potential or actual supply issues. We have a device shortages mailbox (deviceshortages@fda.hhs.gov) so that any user, patient, manufacturer, or organization within the supply chain that is aware of a delay in distribution of new product, and/or anticipates a potential or actual shortage, can notify us.
The FDA will continue to monitor this evolving situation and will continue to communicate with the public on this matter.
The FDA, an agency within the
Contact:
Tel: 301-348-1956
(C) 2020 Electronic News Publishing, source