Due to recent voluntary recalls of non-sterile alcohol prep pads (APP), the Association for Professionals in Infection Control and Epidemiology (APIC) is providing important talking points regarding considerations for the use of sterile versus non-sterile APP and actions to take to keep patients safe from infection.
APIC is closely following the investigation by the Food and Drug Administration (FDA). It will advise its membership on any resulting FDA and/or Centers for Disease Control and Prevention (CDC) guidance regarding the use of sterile versus non-sterile APP in healthcare.
APIC recommends that its members work closely with product recall coordinators within their institutions to assure a mechanism is in place for obtaining up-to-date information surrounding product recalls, and work with their facilities to ensure immediate notification of any recalled products.
Infection preventionists play an important role in patient safety. Work with your facility to make sure that recalled products are removed and properly disposed from all points of use within your facility or ancillary areas (including outpatient sites, clinics, storage areas, etc.). Communicate with all care providers about the importance of systematically implementing and enforcing product recalls.
Follow your internal facility protocols for outbreak investigations related to products.
Do not assume that all alcohol prep pads are sterile. If you do not see the word sterile anywhere on the packaging, assume that it is not sterile. You may also check with your distributor or manufacturer to confirm the sterility. Of note, the name of the manufacturer is not always on the packaging as it may often only include the name of the distributor.
Quarantine and sequester the APP as soon as possible, store in a safe location in the facility, remove the APP from all kits within the facility, note all the lot numbers, and report the issue to your local health department and to the FDA. The FDA MedWatch program provides the required forms and process for reporting. Another department within your institution may be assigned this responsibility.
There have been numerous recalls of alcohol prep products in 2011. Check
www.fda.gov/safety to learn more and stay informed.