Devices

CDRH Working to Reduce Medical Device Misconnections

CDRH says it is working with standards organizations, federal partners, professional societies, advocacy groups, patients and other stakeholders to reduce the chance of medical device misconnections, which may occur when one type of medical device is mistakenly attached to another device that performs a different function. “Because these connectors are easy to use and may be compatible with different medical devices, users can mistakenly connect unrelated systems to one another,” the Center says. “This may cause medication or other substances to be delivered through the wrong tubing into the incorrect area of the body. These errors are sometimes called tubing misconnections, wrong route errors, catheter misconnections, or Luer misconnections and can result in patient injury or death.”

Manufacturers and health care facilities have tried many methods to prevent these misconnections, including color-coding, labels, tags, and training. “However, these methods alone have not effectively solved the misconnection problem because they are not consistently applied, nor do these methods physically prevent the misconnections,” a CDRH notice says. “Soon, the way devices connect to each other may be changing, greatly reducing the risk for misconnections. New design standards are being developed for tubing connectors for high-risk medical applications (e.g., enteral, respiratory, neuraxial), so that unrelated devices cannot connect with each other.” For additional information, see Reducing Risks through Standards Development for Medical Device Connectors.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome