Bloodborne Infection Transmissions Increasing 'Progressively': FDA, CDC
The U.S. Food and Drug Administration and the Centers for Disease Control said they have noted a progressive increase in the reports of bloodborne infection transmission over the past 10 to 15 years (primarily hepatitis B virus), resulting from the shared use of fingerstick and point-of-care (POC) blood testing devices. This week, MedWatch, the FDA safety information and adverse event reporting program, issued a safety alert on the subject, recommending that the devices never be used for more than one person.
The MedWatch announcement noted that fingerstick and POC blood testing devices such as blood glucose meters and PT/INR anticoagulation meters used on more than one patient may not be safe for several reasons. Improper use or device malfunction can lead to the use of the contaminated lancet blade on more than one patient. It is difficult for health care staff to ensure that all blood has been removed from POC blood testing devices and the reusable portions of the fingerstick device. If POC blood testing devices are used on multiple patients and are not cleaned and disinfected correctly and thoroughly between each patient, contaminated blood left on them could result in bloodborne pathogen transmission among patients.
MedWatch added that if dedicating POC blood testing devices to a single patient is not possible, the devices should be properly cleaned and disinfected after every use as described in the device labeling.
The announcement encouraged health care professionals and patients alike to report adverse events or side effects related to the use of any blood testing devices to MedWatch by completing and submitting an online report. The form can be found here and submitted at www.fda.gov/MedWatch/report.htm.