pH Indicator Strips (non-bleeding) pH 0-6.0 & 2.0-9.0 에 대한 현장 안전성 서한

Field Safety Notice

SN2014(24)

2014-05-09

Ireland

HPRA

http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/ph-indicator-strips-(non-bleeding)-ph-0-6.0-2.0-9.0-priority-2-warning-caution-in-use&id=d2cef925-9782-6eee-9b55-ff00008c97d0

A communication issued by merck serono to irish customers in may 2013 indicated that an additional ‘safety feature’ had been introduced for these products, to facilitate their use in non-buffered solutions.  merck serono has informed the irish medicines board (imb) that the safety feature introduced in 2013 does not function as intended over the lifetime of the product.  the manufacturer has issued the attached field safety notice (fsn) to users of these devices to reiterate that these devices should only be used with gastric aspirate. merck serono is also implementing a revision to the instructions for use (ifu) for their ph indicator strips in order to strengthen the warning regarding use with low buffered solutions.  the imb wishes to remind users to use these devices with caution.

The IMB advises users:  (1) Merck Serono pH Indicator strips (0-6.0 product code 090120604 and 2.0-9.0 product code 090120603) should be used with caution.  a. These strips are only for use with gastric aspirate  b. These strips are not suitable for use with low buffered solutions  c. These strips are not suitable for use with any kind of water (distilled, sterilised, potable, bottled or tap water)  (2) Forward this IMB Safety Notice to all those within your organisation that need to be aware of this information. Please also pass this Safety Notice on to any end users or organisations where these devices may have been distributed.