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De­vel­op­ment of a sim­ple and quick pro­cess for rou­tine eval­u­a­tion of clean­ing and dis­in­fect­ing per­for­mance when re­pro­cess­ing ther­mo­la­bile med­i­cal de­vices

IGF 16932 N

A steadi­ly in­creas­ing num­ber of med­i­cal de­vices is man­u­fac­tured using poly­mers, that can be treat­ed at tem­per­a­tures of 60 °C at max­i­mum. Sub­se­quent­ly these de­vices are de­fined as ther­mo­la­bile. More­over in­stru­ments like e.g. flex­i­ble en­do­scopes and other min­i­mal­ly in­va­sive in­stru­ments fea­ture com­plex ge­ome­tries with e.g. long in­ter­nal canal sys­tems and there­fore need spe­cial ef­forts for re­pro­cess­ing. Due to the ther­mo­la­bile char­ac­ter­is­tics these de­vices can­not be re­pro­cessed using the com­mon and safe ther­mal re­pro­cess­ing pro­ce­dures but have to be dis­in­fect­ed and ster­il­ized using chemo-ther­mal or chem­i­cal pro­ce­dures. The dis­in­fec­tion per­for­mance is clas­si­cal­ly checked using bioindi­ca­tors em­ploy­ing En­te­ro­coc­cus fae­ci­um. The anal­y­sis of the biomon­i­tors lasts sev­er­al days and is high­ly ex­pen­sive. A sim­ple to use method for rou­tine con­trol was not avail­able up to date.

With­in the pro­ject a sim­ple and fast mon­i­tor­ing method was de­vel­oped that al­lows the rapid con­trol and doc­u­men­ta­tion of chemo-ther­mal clean­ing and dis­in­fec­tion pro­ce­dures. The de­vel­oped mon­i­tor sys­tem is based on non-cel­lu­lar prepa­ra­tions of “ex­tremophile” en­zymes that have a de­fined re­sis­tance to­wards the chemo-ther­mal re­pro­cess­ing pro­ce­dures to be con­trolled.

The IGF-pro­ject 16932 N of the re­search as­so­ci­a­tion Europäische Forschungs­ge­mein­schaft Reini­gungs- und Hy­gien­etech­nolo­gie e.V., Cam­pus Ficht­en­hain 11, D-47807 Krefeld, was sup­port­ed via the AiF with­in the fund­ing pro­gramme „In­dus­trielle Gemein­schafts­forschung und –en­twick­lung (IGF)“ by the Fed­er­al Min­istry of Eco­nom­ic Af­fairs and En­er­gy (BMWi) due to a de­ci­sion of the Ger­man Par­lia­ment.

 

 

The re­search re­port is avail­able on re­quest from FRT.

The IGF-pro­ject IGF 16932 N of the re­search as­so­ci­a­tion Europäische Forschungs­ge­mein­schaft Reini­gungs- und Hy­gien­etech­nolo­gie e.V., Cam­pus Ficht­en­hain 11, 47807 Krefeld, was sup­port­ed via the AiF with­in the fund­ing pro­gram „In­dus­trielle Gemein­schafts­forschung und -en­twick­lung (IGF)“ by the Fed­er­al Min­istry of Eco­nom­ic Af­fairs and Cli­mate Ac­tion (BMWi) due to a de­ci­sion of the Ger­man Par­lia­ment.