BfArM, the Ger­man Fed­er­al Insti­tute for Drugs and Med­ical Devices, has become aware of risk reports in which patients have been harmed as part of anes­the­sia induction. 

Risk of Pos­si­ble Errors in Con­nect­ing Breath­ing Hoses

In some cas­es, errors in con­nect­ing the breath­ing hoses, which were not rec­og­nized as such or delayed and thus pre­vent­ed a ven­ti­la­tion of the patient could be iden­ti­fied as the cause. BfArM pub­lished a joint rec­om­men­da­tion with the Ger­man Soci­ety for Anaes­the­si­ol­o­gy and Inten­sive Care Med­i­cine (DGAI) at the end of Jan­u­ary 2019 (Joint Rec­om­men­da­tion of the Fed­er­al Insti­tute for Drugs and Med­ical Devices (BfArM) and the Ger­man Soci­ety for Anaes­the­si­ol­o­gy and Inten­sive Care Med­i­cine (DGAI) on anes­the­sia inci­dents due to incor­rect con­nec­tion of breath­ing tubes). 

Rec­om­men­da­tions for Risk Minimization

Con­fig­u­ra­tions of the ven­ti­la­tion hoses, which pre­vent mis­con­nec­tion were dis­cussed as con­struc­tive solu­tions. If dis­pos­able ven­ti­la­tion hoses are used, BfArM rec­om­mends using only those hoses that are glued to the Y-piece and water traps so that faulty con­nec­tion of the indi­vid­ual legs can be ruled out. If reusable tub­ing is used, it should be designed and installed in such a way that it is impos­si­ble to con­fuse the expi­ra­to­ry and the inspi­ra­to­ry tub­ing. On the long run, inter­na­tion­al­ly stan­dard­ized solu­tions should be devel­oped in this regard.

In the case of patient dam­age report­ed to BfArM, an alter­na­tive ven­ti­la­tion source (e.g. man­u­al ven­ti­la­tion bag) was used too late. This fall­back lev­el is a cen­tral step in the DGAI rec­om­mend­ed pro­ce­dures and algo­rithms for ven­ti­la­tion sit­u­a­tions with leak­age or stenot­ic symp­toms. These algo­rithms should be an ele­men­tary com­po­nent of anes­the­si­o­log­i­cal train­ing and should also be prac­ticed reg­u­lar­ly in clin­i­cal prac­tice as part of sim­u­la­tion train­ing. BfArM also sees the aware­ness of the users as very impor­tant for the top­ic and is in exchange with the DGAI.

Source: BfArM