Cur­rent and, to a much high­er ex­tend, fu­ture med­i­cal de­vices like flex­i­ble en­do­scopes and im­plants are very sen­si­tive and ther­mo­la­bile. Thus they can’t be dis­in­fect­ed and ster­il­ized by the es­tab­lished and safe ther­mal pro­ce­dures. The state of the art pro­ce­dures, which relay on chemo-ther­mal or chem­i­cal dis­in­fec­tion and ster­il­iza­tion, have many dis­ad­van­tages such as e.g. lower pro­cess safe­ty, resid­u­al chem­i­cals, ma­te­ri­al dam­age.

With­in the pro­ject an in­no­va­tive pro­ce­dure for the clean­ing and dis­in­fec­tion of ge­o­met­ri­cal­ly com­plex and ther­mo-la­bile med­i­cal de­vice was de­vel­oped. Pro­cess chal­leng­ing de­vices for flex­i­ble en­do­scopes served as sur­ro­gate model sys­tem. The pro­ce­dure ap­plied in­cu­ba­tion in liq­uid and su­per­crit­i­cal CO2 at tem­per­a­tures <40 °C. With­in a pro­cess times of 15 min­utes a high an­timi­cro­bial ac­tiv­i­ty against bac­te­ria, fungi, virus­es and bac­te­ri­al en­dospores was ob­tained, com­pa­ra­ble to es­tab­lished low-tem­per­a­ture ster­il­iza­tion pro­ce­dures that are as­sumed to ex­hib­it the risk of toxic residues. The clean­ing ef­fi­ca­cy of the new pro­ce­dure could be im­proved by the ap­pli­ca­tion of spe­cial en­zymes. Under ap­pli­ca­tion of spe­cif­ic pro­teas­es a pro­ce­dure was de­vel­oped using the pro­cess chal­leng­ing de­vice of Ap­pendix 8 and 9 of the ac­tu­al guide­line of DGKH, DGSV, DGVS, DEGEA and AKI. Resid­u­al pro­tein con­tent was below the ac­cep­tance level. With re­gard to the test of the over­all pro­cess per­for­mance mi­cro­bial in­ac­ti­va­tion rates of RF>9 (E. fae­ci­um) were mea­sured. The pro­cess time was about 1 hour, pro­cessed ob­jects are ob­tained dry. The new pro­ce­dure over­comes con­ven­tion­al chemo- and chemo-ther­mal pro­ce­dures with re­gard to the spec­trum of af­fect­ed mi­crobes, in­ac­ti­va­tion rates and harm­less­ness of ap­plied sub­stances.

Due to the de­vel­oped new en­zyme-im­proved liq­uid/su­per­crit­i­cal-CO2-pro­ce­dure an in­no­va­tive re­pro­cess­ing pro­ce­dure for ge­o­met­ri­cal­ly com­plex and ther­mo-la­bile med­i­cal de­vices is avail­able for pro­fes­sion­al ser­vice provider com­pa­nies and man­u­fac­tur­ers of med­i­cal de­vices. The num­ber of po­ten­tial fa­cil­i­ties that can apply the pro­ce­dure con­sists of ap­prox. 30,000 hos­pi­tals and num­ber­less med­i­cal prac­tices as well as some thou­sand man­u­fac­tur­ers of ther­mo-la­bile med­i­cal de­vices with­in the EC.

The IGF-pro­ject 32 EN 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 Tech­nol­o­gy (BMWi) due to a de­ci­sion of the Ger­man Par­lia­ment.

The re­search re­port is avail­able on re­quest from FRT.