MB: FDA is alerting healthcare professionals about safety precautions to be used with Huber needles, and about a recall of one company's products. Huber needles are used to access ports that are implanted in chronically-ill patients to withdraw blood and to infuse medication and other solutions.
AR: Huber needles should be designed to penetrate a port without cutting or dislodging any silicone slivers or cores from the port. Coring could damage a port and cause leakage. And, if a silicone core enters a patient's vasculature, it could lead to serious adverse events. FDA inspections of one Huber needle manufacturer, Nipro Medical Corporation, found that this company's needles produced cores in 60-72% of tests.
MB: Because of this, Huber needle products manufactured by Nipro Medical Corporation for Exel International Corporation have been recalled. These products include:
• Exel and EXELint Huber needles;
• Exel and EXELint Huber Infusion Sets;
• Exel Securetouch+ Huber Safety Sets; and,
• EXELint Huber Safety Sets.
AR: You can find the affected lot numbers and catalogue numbers on our website. Hospitals, clinics and patients who have any of the recalled products should stop using them immediately and return them to the company.
MB: As part of a broader investigation, FDA has tested Huber needles from a number of manufacturers. To date, only needles manufactured by Nipro have shown a high frequency of coring.
AR: FDA is continuing to investigate this issue. In the meantime, the agency recommends taking the following precautions when using any Huber needle to access an implanted port:
• When initially confirming a needle's patency, avoid flushing the syringe. If a needle has cored a port, flushing may introduce the core into the patient's body, and this could lead to serious adverse events;
• When possible, consider aspirating a small amount of blood from the port after puncturing the port septum, and then discard the syringe with its contents. Doing this may recapture any silicone sliver. If the needle clogs when attempting to aspirate, remove the needle, discard it and select a new one;
• Watch for signs and symptoms that may indicate damage to the port's septum, such as medication leakage, which can lead to inadequate delivery of therapy, localized erythema, and tissue, nerve or muscle damage. For more complete information, go to our website.

标题
Safety Precautions for Huber Needles (FDA)

视频介绍
FDA Patient Safety News - March, 2010 - Show #96
FDA is alerting healthcare professionals about safety precautions to be used with Huber needles, and about a recall of one company's products.