The Food and Drug Administration (FDA) recommends that healthcare facilities and providers NOT purchase or use medical gloves that are imported from companies that are included on Import Alert 80-04 Surveillance and Detention Without Physical Examination of Surgeon’s and Patient Examination Gloves.
When a company is listed on the import alert, the FDA has found enough evidence for detention without physical examination (DWPE) of the company’s products, as they appear to be in violation of the FDA’s laws and regulations. The use of these products creates a potential risk to healthcare professionals, patients, and the users of the products.
A number of steps is taken by the FDA to find and stop the selling of unsafe and unapproved products by investigating, examining, and reviewing medical products. To help ensure that our national supply chain of medical products is safe and are approved, the products are investigated, examined, and reviewed at ports of entry and within domestic commerce.
To allow for increased availability of medical gloves during the COVID 19 public health emergency, the FDA provided increased regulatory flexibility under certain circumstances, but also intends to prevent devices from presenting an undue risk. The FDA is providing regular updates regarding medical gloves.
If you have purchased any medical gloves that are visibly soiled, are a different color, appear to have been used, or otherwise seem to be fraudulent, you can make a report to the FDA by email to FDA-COVID-19-Fraudelent-Products@fda.hhs.gov.
The Import Alert 80-04 Surveillance and Detention Without Physical Examination of Surgeon’s and Patient Examination Gloves can be accessed here.
The FDA’s 510(k) Premarket Notification database which allows the user to search for FDA-cleared medical gloves by product codes can be accessed here.
Further details regarding the enforcement policy for gloves during the COVID-19 public health emergency can be accessed here.
Compliance Perspective
Issue
It is critical that healthcare workers on the frontline battling COVID-19 are provided with personal protective equipment (PPE) that gives them effective protection. The purchasing department must ensure that all PPE is purchased from a reputable company. Staff that utilize PPE should be aware of what they can do if they suspect any PPE is counterfeit or does not provide effective protection.
Discussion Points
- Review policies and procedures that guide the purchasing of PPE to ensure they stipulate that PPE will only be purchased from reputable companies. Update policies as needed.
- Train purchasing department personnel so that they are able to identify and purchase only from reputable suppliers of PPE. Train healthcare workers on the steps that they should take if they suspect that PPE may be counterfeit or ineffective in anyway.
- Periodically audit the inventory of PPE to ensure that it fits properly and provides effective protection. Determine that all PPE and other essential supplies are only purchased from reputable companies.
