insulin infusion set 의 안전성 경고

Safety alert

2014-07-15

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140715.html

Safety alert on cellnovo insulin infusion set the department of health (dh) today (july 15) warned the public not to use the infusion set 5mm stainless steel (part no.: 5mm-inf5) and infusion set 8mm stainless steel (part no.: 8mm-inf5), manufactured by cellnovo, because of the possibility that the stainless steel needle may detach itself. the dh, through its routine surveillance of medical devices, noticed the safety alert from the medicines and healthcare products regulatory agency (mhra) of the united kingdom. according to the alert, there is a remote possibility that the stainless steel needle may detach itself while the patient is attempting to remove the infusion set during the changeover to a new insulin cartridge. the detachment of the needle does not pose a risk to safety, however it may not be possible for the patient to remove the needle without seeking professional medical assistance. the alert indicated that the manufacturer will supply the patient with new replacement infusion sets. patients are advised to pass the entire stock of unused infusion sets to the manufacturer for safe and correct disposal. the dh is checking with the manufacturer whether the affected products have been distributed to hong kong. no adverse incident related to the affected products has been reported in hong kong so far. if you are in possession of the products, please contact your supplier for necessary actions. the dh has informed the hospital authority, private hospitals and relevant medical professional associations about the matter and advised them to remain vigilant. the spokesman said, "the dh will closely monitor developments. members of the public should consult their healthcare professionals for advice if in doubt." ends.