FDA Eases Regulatory Requirements on Surgical Gowns, Gloves
As the number of COVID-19 cases increase in the US and hospitals struggle with keeping their doctors and nurses protected, the Food and Drug Administration (FDA) on Monday released guidance explaining how it will relax certain regulatory requirements to increase the production and availability of certain personal protective equipment (PPE) such as gowns and gloves.As early as late February, FDA began warning of PPE shortages, and hospitals in areas hit hard by the coronavirus are now seeing the reuse of some single-use masks and other issues.
To help increase the availability of gowns not intended for use as “surgical gowns” and other minimal- to low-barrier protection surgical apparel not subject to premarket notification requirements, FDA said it does not intend to object to the distribution and use of such gowns as long as they do not create an undue risk in light of the public health emergency.
Examples of non-surgical gowns include those that are intended to protect the wearer from the transfer of microorganisms and bodily fluids in low- or minimal-risk patient isolation situations and that are not intended for use during surgical procedures or invasive procedures.
For surgical gowns, which are considered class II devices and are subject to premarket notification requirements, FDA said it will increase their availability and not object to the distribution and use of ANSI/AAMI PB70 Level 3 moderate- to high-barrier protection surgical gowns that do not comply with certain regulatory requirements, where such surgical gowns do not create an undue risk in light of the public health emergency.
FDA said it currently believes such devices would not create such an undue risk as long as they meet liquid barrier protection at Level 3 or higher, consistent with ANSI/AAMI PB70 for the critical zone areas, meet the Class I or Class II flammability standard and have been demonstrated to be sterile if intended for use in surgical settings.
Such surgical gowns also should include labeling that accurately describes whether it’s sterile or non-sterile, FDA says, including any sterilization method used, barrier protection as Level 3, flammability classification (Class I or Class II) and a list of the body-contacting materials.
Similarly, FDA said it does not intend to object to the distribution and use of surgeon’s gloves that do not comply with certain regulatory requirements as long as they do not create an undue risk during this public health emergency.
The labeling for such gloves also should include a general statement about devices that have not been cleared by FDA and recommendations against their use when FDA-cleared surgeon’s gloves are available.
FDA also does not intend to object to the distribution and use of patient examination gloves that do not comply with certain regulatory requirements as long as they do not create an undue risk.
Last week, FDA also issued guidance on other PPE, including masks and respirators.
Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency