PD CR 13825:2000

1 SUMMARY
2 RECOMMENDATIONS
3 BACKGROUND
4 PROBLEMS ARISING FROM THE USE OF LUER CONNECTORS
5 RISK ASSESSMENT
6 DISCUSSION
      6.1 Human factors
      6.2 Safety under single fault conditions
      6.3 Inherent safe design
      6.4 The Medical Device Directive 93/42/EEC14
7 prEN 13014: CONNECTIONS FOR GAS SAMPLING TUBES TO
      ANAESTHETIC AND RESPIRATORY EQUIPMENT
8 CONCLUSIONS
BIBLIOGRAPHY
ANNEX 1
      1.1 - THE LUER CONNECTOR
      1.2 - STANDARDS FOR LUER CONNECTORS
      1.3 - APPLICATION AND USE OF LUER CONNECTORS
ANNEX 2 - COMMONLY USED DEVICES INCORPORATING LUER CONNECTORS
ANNEX 3 - POTENTIAL PROBLEMS WITH LUER CONNECTORS

Medical devices containing Luer connectors and having a wide range of functions have an increased risk of accidental cross connection between devices. An assessment was performed on the hazards arising from accidental misconnection, and a review of adverse incidents that are known to have involved Luer connectors. Three possible strategies were implemented to reduce the risk of misconnection; the use of colour coding and the use of different male/female sequences for different applications were not found to be sufficiently effective. The only strategy found to have any real benefits was the restriction of applications for which the use of Luer connectors is permitted.