BfArM, the Ger­man Fed­er­al Insti­tute for Drugs and Med­ical Devices, was informed that acces­sories for patients treat­ed in tra­cheosto­my pro­ce­dures are cur­rent­ly insuf­fi­cient­ly described in nor­ma­tive terms. The Ger­man Stan­dard­iza­tion Com­mit­tee for Med­ical Devices for the Res­pi­ra­to­ry Sys­tem is cur­rent­ly work­ing on estab­lish­ing a stan­dard on an inter­na­tion­al lev­el with regard to tra­cheosto­my accessories. 

Back­ground infor­ma­tion on safe­ty issues

In par­tic­u­lar, the indica­tive safe­ty to so-called speak­ing valves cur­rent­ly finds lit­tle use by lack of nor­ma­tive reg­u­la­tion. Ref­er­ence is made to a spe­cif­ic case in which a patient has died due to the wrong use of a speak­ing valve. A speak­ing valve allows patients treat­ed in tra­cheosto­my pro­ce­dures to speak. Exhaled air can escape through the occlu­sion of the valve through the glot­tis of the patient. In the case described, the block cuff of the tra­cheosto­my tube was blocked because the prac­ti­tion­er was unaware that a patient with insert­ed speak­ing valve and blocked tube could not exhale. The result was a mas­sive emphy­se­ma, so that the patient ulti­mate­ly died. 

Three com­pa­ra­ble cas­es (1997, 2011, 2014) with speak­ing valves were report­ed to BfArM. In all three cas­es the out­come was fatal for the affect­ed patients. In the old­est case, expi­ra­tion was pre­vent­ed by mas­sive secre­tion. In the 2011 case, the speak­ing valve was con­fused with an arti­fi­cial nose (HME fil­ter). In the most recent case, the tube was false­ly blocked. BfArM would like to draw the manufacturer’s atten­tion to the product’s prin­ci­ple of inte­grat­ed safe­ty and expects that prod­ucts are ade­quate­ly and appro­pri­ate­ly labeled so that their safe and prop­er use is safeguarded. 

Rec­om­men­da­tion by BfArM for manufacturers

For this pur­pose, accord­ing to the Euro­pean Direc­tive 93/42 / EEC, Annex I, 13.1 and the Euro­pean Reg­u­la­tion 2017/745, Chap­ter III, Art. 23, which becomes valid on 26 May 2020, a warn­ing should be reflect­ed on the prod­uct itself, indi­cat­ing that: the exha­la­tion through the speak­ing valve is not pos­si­ble and the tra­cheosto­my tube should there­fore not be blocked. This infor­ma­tion is con­sid­ered by BfArM as an essen­tial requirement.

Source: BfArM