ECRI Institute, an independent, nonprofit organization that researches the best approaches to improving patient care, has issued a priority medical device alert on its Web site,
Medical Device Safety Resources recommending immediate volume testing of Curlin Medical's 2000 CMS™, 4000 CMS™, 6000 CMS™, and PainSmart™ series pumps for potential overinfusion of medications. The pumps are used in hospitals and home healthcare settings.
Engineers at ECRI Institute's medical device laboratory tested Curlin pumps and found that doors on the pumps do not fully compress tubing during operation, which may result in intermittent gravity flow, releasing medication too quickly. ECRI Institute emphasizes that there may be no visible indication that a pump permits gravity flow and that volume testing is the only way to determine whether a particular pump has a door problem.
"In addition to immediately identifying and testing all Curlin pumps, we recommend instituting a policy of regular volume testing every three months," says Eric S. Sacks, Director, Healthcare Product Alerts, ECRI Institute.
Alerts are issued weekly in Health Devices Alerts, a component of membership in ECRI Institute's Health Devices System, Health Devices Gold, and SELECTplus programs. Each alert includes a priority level, problem summary, perspectives, and recommendations for responding to the problem.
Full access to the May 22, 2008, priority alert, Curlin-CMS and PainSmart Infusion Pumps: Can Permit Gravity Flow, Failure Can Be Detected Only Through Volumetric Testing, is available for free. For more information about ECRI Institute's medical device membership resources, please visit www.ecri.org, or contact them by phone at (610) 825-6000, x5891, by e-mail at clientservices(at)ecri.org, or by mail at 5200 Butler Pike, Plymouth Meeting, PA 19462.