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NHS Takes Action on Tubing Misconnection Issue

The National Patient Safety Agency (NPSA) in the United Kingdom has done something that should serve as an example for regulatory authorities and manufacturers in the US: they have set deadlines for National Health Service (NHS) entities in England and Wales to adopt enteral feeding catheters that do not contain ports with female Luer connectors. Ports with female Luer connectors require the use of parenteral syringes to administer oral liquid medications.

Many enteral catheters manufactured in the US feature ports that accept  parenteral syringes. Even if a liquid medication is prepared in an oral  syringe, the medication must be transferred to a parenteral syringe for administration via an enteral catheter, risking the accidental administration of the drug via a parenteral line. ISMP has published reports of several such events.

The NPSA directive also requires enteral catheters to have end connectors  that are unable to connect to intravenous or other parenteral lines. Ports and connectors on the enteral feeding catheter must feature a male Luer, catheter tip, or other non-female Luer design. For example, administration sets will have a female Luer connector to fit a male Luer on the nasogastric tube(reverse Luer connection).

The NPSA has held meetings with medical device industry representatives  to inform them of their recommendations, and it is anticipated that the design recommendations will be incorporated into catheters an administration sets within 12 months. The design is similar to that mentioned in our June 15, 2006, newsletter issue in which we described an error where an infant accidentally received breast milk intravenously (IV) instead of through a nasogastric tube. The March 28, 2007, NPSA Patient Safety Alert also announced that, when a spoon or graduated measure cannot be used, measurement and administration of oral liquid drug doses must utilize labeled oral syringes that cannot be connected to IV catheters or ports. The measures being undertaken also prohibit three-way taps or syringe tip adapters, as these connecting devices bypass safeguards. Oral syringes must be in use in clinical areas by September 30, 2007, with remaining recommendations in place by March 31, 2008. Special training of healthcare practitioners must occur and policies must be in place by the 2008 deadline.

The NPSA is a special health authority created within NHS to coordinate the safety efforts of all those involved in healthcare, and more importantly, to learn from adverse events occurring in the NHS. There is no equivalent organization in the US although The Joint Commission (TJC) has served a similar role as an accreditation organization. However, a potential TJC 2008   National Patient Safety Goal to prevent tubing misconnections was not approved after field review earlier this year. Representatives from the FDA, American Hospital Association, ISMP, and several other organizations have formed an ad hoc committee that is expected to publish a white paper in 2007 on the issue of catheter misconnections.