Regulatory Open Forum

HI,

I would be interested to know if if you test the quality of the water specifically for endotoxins used for reprocessing (washer-disinfector equipement) of surgical instruments ?

If not what rationale are you using ?

Thank you.

Quang,

Are you querying about reprocessing of medical devices at the manufacturer? Or querying about the water quality of the hospital or facility where the products are reprocessed?

HI,

I would be interested to know if if you test the quality of the water specifically for endotoxins used for reprocessing (washer-disinfector equipement) of surgical instruments ?

If not what rationale are you using ?

Thank you.

Hi Richard,

My questions is for both meaning at manufacturer and at the hospitals . Thank you.

Quang,

Are you querying about reprocessing of medical devices at the manufacturer? Or querying about the water quality of the hospital or facility where the products are reprocessed?

HI,

I would be interested to know if if you test the quality of the water specifically for endotoxins used for reprocessing (washer-disinfector equipement) of surgical instruments ?

If not what rationale are you using ?

Thank you.

Quang,

You might want to refer to AAMI ST81, ST108, or AAMI TIR12 which talks about reprocessing of medical devices and ST108 water for processing medical devices.  I would say in regards to the hospital or healthcare facility, this would really depend on them with some recommendations provided by the Manufacturer.  With the US and EU pharmacopeia there are references for limits of endotoxin.

Hi Richard,

My questions is for both meaning at manufacturer and at the hospitals . Thank you.

Quang,

Are you querying about reprocessing of medical devices at the manufacturer? Or querying about the water quality of the hospital or facility where the products are reprocessed?

HI,

I would be interested to know if if you test the quality of the water specifically for endotoxins used for reprocessing (washer-disinfector equipement) of surgical instruments ?

If not what rationale are you using ?

Thank you.

HI,

I would be interested to know if if you test the quality of the water specifically for endotoxins used for reprocessing (washer-disinfector equipement) of surgical instruments ?

If not what rationale are you using ?

Thank you.