Oct 26, 2011

In January 2011, NHF issued a Medical Advisory (#412) about a recall of nonsterile alcohol wipes produced by one company, Triad Group, Inc. In April, the FDA forced this company to close. Now, additional infections have occurred in patients using nonsterile alcohol wipes manufactured by another company, Professional Disposables International (PDI). This company has also been required by the FDA to recall its products. Both of these companies package their products under their own label and under other companies’ labels.

At this time, it appears prudent to recommend that all individuals who have alcohol wipes or other prep pads/swabs in their home examine the individual packages to see if they contain the word “sterile.” This includes wipes that are packaged with factor or other IV preparation kits.  If the word “sterile” does not appear on the package, there is no way to determine if they are in fact sterile or not. Therefore, individuals should discontinue use of any wipes that do not state on the label that they are “sterile” and request replacement with sterile wipes from their clotting factor distributor.

Nurses should also check their supply of alcohol wipes to ensure that they are only using sterile wipes. This is particularly important for patients with indwelling venous access devices (catheters or ports) and for patients with compromised immune systems, but should be standard of care for all patients.

PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia.

CHAPTERS: Please distribute this information to your membership.

Please sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. The system is confidential and time sensitive. It is administered by an independent third-party organization and is free of charge. To enroll in the PNS, please call (888) UPDATE-U or go online at http://www.patientnotificationsystem.org/

This material is provided for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF under no circumstances recommends treatment for specific individuals and in all cases recommends that you consult your physician or local hemophilia treatment center before pursuing any course of treatment.