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PLYMOUTH MEETING, Pa. -- ECRI issued a critical alert to hospitals regarding a potential threat to patient safety caused by some thoracic catheters in Pharmaseal Thoracentesis Trays distributed by Allegiance Healthcare Corporation. The catheters, which are used to aspirate fluid from the lungs, may be brittle and can fragment in the patient's pleural space. Because the catheter is exposed only after it is inserted into the patient, the healthcare provider cannot examine the flexibility or strength of the catheter before insertion. Possible complications resulting from fragmented catheters are foreign-body reactions, infection, and the need for surgery to remove the fragments.
ECRI's Accident and Forensic Investigation Group discovered the problem when a member hospital requested an investigation following the surgical removal of a catheter fragment after aspiration of a patient's parietal cavity. ECRI's team of investigators determined that three more catheters from trays with the same lot number L1N094, were found to be broken or brittle. Another instance has been reported to the U.S. Food and Drug Administration with the same Pharmaseal thoracentesis catheters but with lot number L1K058. "The problem may be more extensive than those particular lots," cautions Mark E. Bruley, vice president for accident and forensic investigation at ECRI. "We'll know more once Allegiance Healthcare has conducted a wider investigation of the catheters."
As part of its commitment to healthcare technology and patient safety, ECRI is immediately distributing a Hazard Bulletin to all hospitals in North America, warning of the potential risk, along with recommendations for action. The information is also posted to ECRI's public Web site as well as its member Web sites and will be published in the upcoming issue of ECRI's Health Devices journal.
ECRI (www.ecri.org) is a nonprofit international health services research agency and a Collaborating Center for healthcare technology assessment of the World Health Organization. ECRI provides information and technical assistance to the healthcare community to support safe and cost-effective patient care. Member programs include the Health Devices System, the premier patient safety and quality resource system for today's healthcare technology, featuring brand-name comparative evaluations; a keyword-searchable hazards and recalls database; and a variety of specialized consultation services.