Yesterday FDA issued a medical device alert regarding the use of fingersticks and other POC blood-testing devices. The message was clear: Do not reuse these devices. Doing so promotes the transmission of blood-borne infection.
CDC and FDA have seen a progressive increase in reports of blood-borne infections in the past decade. Hepatitis B was the most-transmitted of these infections. The agencies point to the shared use of fingersticks and other similar devices as being a leading cause of this problem. The infections are occurring in a variety of healthcare settings, the agencies say; however, a "significant increase" in Hepatitis B outbreaks are related to the shared use of multiuse fingerstick devices and POC blood-testing devices in long-term-care and assisted-living settings.
The alert is for such devices as blood-glucose meters, PT/INR anticoagulation meters, and cholesterol-testing devices. FDA and CDC recognize that some fingerstick devices are packaged with POC blood-testing devices, while other fingerstick devices and lancet blades are sold separately.
Manufacturers, take note: The agencies cite "unclear labeling and ineffective cleaning/disinfection instructions for fingerstick and POC blood-testing devices" as possible contributors to the problem of increased infection transmission. Specifically, the agencies point to labeling of some multiple-use fingersticks made for use on one patient only that might not clearly specify that one-patient-only requirement. "This may result in the use of these devices in multiple patients," the alert reads.
Soon, FDA will issue "a separate communication describing the actions the Agency will take to assure that these devices are labeled for use on only one patient to reduce the risk of bloodborne infection transmission," according to yesterday's alert.