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Good medicine
25 Jul 2008
Topics: Medical devices, Healthcare
While standards have typically focused on commonality and creating a universally agreed set of rules and principles, from time to time a standard is needed that ensures things stay very distinct indeed.
Take the case of small bore connectors - such as the "Luer" connection system - used in different fields of medical application. In simple terms, these are commonly used in a variety of healthcare equipment, including drug administration, feeding and monitoring. It is possible to interconnect a wide range of equipment using such connectors and misconnection may have a potentially harmful effect. The past decade has seen several cases of injury or death as a result of medicines administered via such universal small bore connectors.
As a consequence, BSI has recently published BS EN 15546-1, a new standard that aims to prevent injury or death as a result of cross-connection between small bore connectors used in different fields of medical application. BS EN 15546-1 Small bore connectors for liquids and gases in healthcare applications provides a test method for manufacturers to ensure that small-bore connectors for different applications are not compatible with either Luer connector or each other. Doing so will help prevent the wrong medicine reaching the wrong person.
"This is an important milestone in the development of international standards to minimize misconnection errors that cause patient safety incidents in the NHS," says David Cousins, head of safe medication practice and medical specialties, National Patient Safety Agency (NPSA).
"It complements two Patient Safety Alerts issued by the NPSA to provide guidance to minimize the risk of misconnections of oral and epidural devices intended for intravenous use. This standard paves the way for further requirements for connectors which will introduce a physical barrier to prevent error."
BS EN 15546-1 was developed at a European level and has been adopted in the UK by BSI British Standards. Organizations involved in the development of the standard for the UK include the National Patient Safety Agency, the Department for Health and the Association and Royal College of Anaesthetists as well as expert health practitioners and manufacturers of medical devices.
"BS EN 15546-1 is an important standard for industry, healthcare professionals and the public," adds Mike Low, director of BSI British Standards. "We have brought together experts on all sides to produce a standard which has patient safety at its core."
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