What is ISO 80369
A patient may be connected, via catheters or tubes, to several delivery systems to receive parenteralmedication, oxygen, enteral nutrition, anesthesia, etc.The ISO 80369 series of Standards aim to avoid misconnection between two unrelated delivery systems e.g. enteral syringe connected to an IV catheter, which can cause patient injuries or deaths. To do so, ISO80369 created unique international Standard designs of connectors for each application Respiratory, Enteral,Urology, which are non-interconnectable.
ISO 80369 3 Annex A THE CONCERN Concerns have been raised about the possible risks of delivering accurate doses of medicines in certainclinical practices across high risk subpopulations e.g. neonatal patients when using a reversed connectionsystem female to male. This orientation may introduce inadvertent displacement of fluid
1Laboratory testing also shows a mid tolerance E
1 ENFitTM connector pair in a female to male orientationdisplaces a mean average of 0.148ml
1ISO 20695 Annexes A & K LOW DOSE TIP SYRINGE here called alternative enteralsyringe tip The ISO committee has decided to propose [it] for information only as test results lead to contradictoryconclusions on dose accuracy with this alternative enteral syringe tip
2 The design of this alternative enteral syringe tip may not ensure that the dose accuracy for enteral syringesis met; specific user information and education should accompany this alternative enteral syringe
AKSHAR PHARMA
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