BSI British Standards publishes first step in world wide design solution to prevent medical errors

Press release - 3 July 2008

BSI British Standards today publishes a new document which 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.

The Luer connection system is commonly used in a variety of healthcare equipment, including drug administration, feeding and monitoring. It is possible to interconnect a wide range of equipment 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 universal small bore connectors.

Further parts of the standard, to be developed in the next year, will specify the requirements for connectors for each of the applications: respiratory, neuraxial, enteral feeding, endoscopy and NIBP (non-invasive blood pressure connectors).

BS EN 15546-1 has been developed at a European level and is now 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.

David Cousins, head of Safe Medication Practice and Medical Specialties, National Patient Safety Agency, said, “This publication is an important milestone in the development of international standards to minimize misconnection errors that cause patient safety incidents in the NHS. 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.”

Mike Low, Director of BSI British Standards, said, “BS EN 15546-1 is an important standard for industry, healthcare professionals and the public. It is a first step in tackling the challenge of reducing unnecessary injury resulting from misconnection of medical equipment. BSI British Standards has brought together experts on all sides to produce a standard which has patient safety at its core.”


About BSI Group
BSI British Standards is part of BSI Group, a global independent business services organization that inspires confidence and delivers assurance to customers with standards-based solutions. Originating as the world’s first national standards body, the Group has over 2,250 staff operating in over 100 countries through more than 50 global offices. The Group’s key offerings are:

  • The development and sale of private, national and international standards and supporting information
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  • Product testing and certification of services and products
  • Performance management software solutions
  • Training services in support of standards implementation and business best practice.

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