Op­ti­mi­sa­tion of Clean­ing Pro­cess­es for Med­i­cal In­stru­ments Used in Min­i­mal­ly In­va­sive Surgery (MIS)

AiF 15 ZN

The just-in-time pro­vi­sion of com­plex in­stru­ments like en­do­scopes, es­pe­cial­ly for min­i­mal­ly in­va­sive surgery (MIS) tech­niques, is main­ly ask­ing for ap­pro­pri­ate clean­ing pro­cess­es as a pre­con­di­tion for ef­fec­tive ster­il­i­sa­tion or high-lev­el dis­in­fect­ing: Resid­u­al soil found on sur­faces after in­ad­e­quate clean­ing and in­suf­fi­cient­ly re­moved con­tam­i­nants lead to im­paired op­er­a­tion and loss of func­tion of these in­stru­ments. The fail­ure of ster­il­i­sa­tion pro­ce­dures be­cause of in­ad­e­quate clean­ing lead to the de­mand for val­i­da­tion of re­li­able clean­ing, dis­in­fect­ing and ster­il­i­sa­tion pro­cess­es. Just as the com­plex­i­ty of the in­stru­ments grows, e.g. from the field of MIS, the re­quire­ments ad­dressed to re­pro­cess­ing do also.

The enor­mous range of vari­a­tion of pos­si­ble con­tam­i­nants and the dif­fi­cul­ty as­so­ci­at­ed with quan­tifi­ca­tion of clean­ing qual­i­ty led to the de­mand of es­tab­lish­ing new pa­ram­e­ters of clean­li­ness. Vi­su­al in­spec­tion, not the best method, can only be con­duct­ed on the out­side of in­stru­ments, but is not pos­si­ble to check high­ly com­plex or lumen in­stru­ments. De­tec­tion of dif­fi­cult to re­move con­tam­i­na­tion like pro­teins are one pos­si­ble so­lu­tion to in­crease the hy­giene safe­ty and of in­stru­ments be­fore reuse and the well-be­ing of pa­tients and staff. It has to be guar­an­teed that trans­mis­sion of pathogens from pa­tient to pa­tient or pa­tient to per­son­al can be pre­vent­ed. Quan­ti­ta­tive and qual­i­ta­tive meth­ods have to be val­i­dat­ed to en­sure not only the dis­in­fect­ing ef­fi­ca­cy, ac­cord­ing to the guide­lines of the Robert Koch In­sti­tute in Ger­many. A new ap­proach for qual­i­ty as­sur­ance is nec­es­sary. Lit­er­a­ture and re­ports about in­suf­fi­cient clean­ing re­sults show that cen­tral dis­in­fec­tion units in hos­pi­tals often are over­charged with these prob­lems. A pos­si­ble al­ter­na­tive is the re­pro­cess­ing of med­i­cal in­stru­ments by ex­ter­nal rental com­pa­nies as in the field of op­er­at­ing the­atre tex­tiles. Many hos­pi­tals are al­ready sup­plied by such com­pa­nies with high qual­i­ty, safe­ly ster­ilised ar­ti­cles just in time and at an im­proved qual­i­ty com­pared to tra­di­tion­al so­lu­tions. An im­por­tant pre-con­di­tion, how­ev­er, was the de­vel­op­ment of high-tech ar­ti­cles to­geth­er with ef­fi­cient clean­ing, dis­in­fect­ing and ster­il­i­sa­tion pro­cess­es.

With­in the pro­ject, pos­si­bil­i­ties to de­vel­op clean­ing, dis­in­fect­ing and ster­il­is­ing tech­niques for fil­i­gree med­i­cal in­stru­ments are in­ves­ti­gat­ed which can be the basis for novel ser­vices and new jobs. This will in­clude a con­cept of dis­as­sem­bling, stor­ing and trans­porta­tion of soiled and cleaned in­stru­ments as well as pro­cess­es to clean ef­fi­cient­ly at low costs and high­est safe­ty dur­ing use. Prop­er dis­in­fec­tion and ster­il­i­sa­tion fol­low­ing the clean­ing step shall be op­ti­mised, too. The of­fi­cial­ly per­mit­ted pro­cess­es will be in­ves­ti­gat­ed in com­par­i­son to the novel pro­cess con­cepts.

The an­a­lyt­i­cal meth­ods de­scribed in the draft prEN ISO 15883-1 “Clean­ing and Dis­in­fec­tion Ap­pa­ra­tus – Gen­er­al Re­quire­ments, Def­i­ni­tions, Test Pro­ce­dures” were checked and com­pared with other pro­ce­dures. The ap­pli­ca­bil­i­ty of CO2-clean­ing, plas­ma-tech­nol­o­gy, ozone, en­zymes and fur­ther meth­ods for the re­pro­cess­ing of med­i­cal in­stru­ments is in­ves­ti­gat­ed with­in the pro­ject.


We would like to thank the Ar­beits­ge­mein­schaft In­dus­trieller Forschungsvere­ini­gun­gen “Otto von Gu­er­icke” e.V. (AiF) (As­so­ci­a­tion of In­dus­tri­al Re­search Or­gan­i­sa­tions) for the fi­nan­cial sup­port of the reasearch pro­ject (AiF 15 ZN) fund­ed by the bud­get of the Fed­er­al Min­istry of Eco­nom­ic Af­fairs.


The re­search re­port is avail­able on re­quest from FRT.

The IGF-pro­ject AiF 15 ZN 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 due to a de­ci­sion of the Ger­man Par­lia­ment.