Medical Design and Outsourcing

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PRODUCT DEVELOPMENT

Where ISO 80369 applies to the human system ISO 80369 Parts 2 to 7 define small-bore connector standards for six application categories. Its goal is to prevent misconnections between unintended devices.

Beginning in the 1990s, concerns grew regarding the proliferation of medical devices fitted with luer connectors and the reports of patient injuries and deaths arising from misconnections. Thus began a many-years process to develop new industry standards for the small-bore connectors used in medical device applications. © 2015 Colder Products Company. All rights reserved.

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he much-anticipated ISO 80369 series of standards for small-bore connectors seeks to address patient injuries and deaths due to device misconnections that can occur when incompatible applications use the same, common small-bore connectors. Luers, by far the most frequently used connectors in medical settings, have contributed to the incidence of dangerous medical connections because they can connect with unintended systems. The Introduction to Part 1 of ISO 80369 (hereafter referred to as ISO 80369-1) describes the problem: “In a coronary care unit there are as many as 40 luer connectors on the medical devices used with a single patient. Therefore, it is not surprising that misconnections are made.” Why are the new ISO 80369 standards significant for medical device

OEMs? The need to improve patient safety is the most obvious answer. Another concern is that medical misconnections expose manufacturers and caregivers to potential liability. There are also growing regulatory and potential legal issues to deal with. California law (HB1867) specifically prohibits the use of IV, epidural, and enteral connections that fit into a connection port other than the intended type beginning in 2016. The European Device Directive, the U.S. FDA, and other medical regulatory agencies around the world are addressing medical misconnections. The release of the ISO 80369 series of standards provides connector clarification and guidance in relation to minimizing medical misconnections. In spirit, ISO 80369 covers medical device small-bore connectors used to www.medicaldesignandoutsourcing.com

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make connections between equipment and patients. ISO 80369-1, published in 2011, lays out general requirements for small-bore connectors that facilitate the transfer of liquids and gases in healthcare applications. Parts 2 to 7, in varying stages of development, address six application categories that represent the greatest risks to patients should a medical device misconnection occur. These application categories are: a) breathing system and driving gas, b) enteral and gastric, c) urethral and urinary, d) limb-cuff inflation, e) neuraxial, and f) intravascular or hypodermic applications. An accompanying illustration shows were these parts apply on a patient. Reducing the domain of luers Initial work to address medical misconnections focused on defining 6 • 2015

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