You wind up in the hospital and the next thing you know, you’re hooked up to a monitor or one kind or another. Hey, how can you be sure that all that wiring is safe? As we say here at Document Center, stay calm — there’s a standard for that! The AAMI EC53 was developed specifically to ensure the safety of wiring for cardiac monitors only, but now the scope covers lots of other ECG devices like diagnostic electrocardiographs, ECG telemetry and ambulatory ECG recorders. It allows for a common interface for the patient cables to various machines in the healthcare environment. Titled “ECG cables and leadwires,” it protects you from problems with interconnectivity and other errors that could have a negative effect on your health!
The standard is directed to manufacturers, covering both disposable and reusable patient leadwires and trunk cables. Test methods are provided for instrumentation, test circuits and test signals. Requirements include labeling, construction, and performance. The document also includes Annex A, “Rationale for the development and provisions of this standard.” This Annex walks you through the various clauses of the standard, giving you the background on the situations that generated the inclusion of each in the document.
The AAMI EC58 was first released in 1995, a result of reports of patient injury (and death) resulting from these types of wires being used incorrectly. The goal was to speed up the move from older designs to standardized designs that facilitated proper use. This new 2013 Edition, the first complete update since 1995, clarifies requirements for disposable and reusable products to align it with new international definitions for “single use” and “single patient use.” So you’ll find the language now refers to multi-patient use where you used to see the term “reusability.” Other changes appear throughout the document, including extensive modifications to Annex A.
You can purchase the AAMI standards you need from Document Center Inc., in either paper format or for pdf download. You’ll use our webstore at www.document-center.com, or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). You’ll use us for your other documentation requirements as well. We carry a wide line of standards and regulatory information, especially useful if you’re in the medical devices industry. We’ve been selling standards since 1982, so make us your Standards Experts!
