The Fed­er­al Insti­tute for Dugs and Med­ical Devices (BfArM) in Ger­many has issued a notice where it informs man­u­fac­tur­ers and users about the inad­e­quate ster­il­iza­tion of med­ical devices by Ster­il Milano S.r.l.

The fol­low­ing text is tak­en and trans­lat­ed from the BfArM web­site and can be accessed in Ger­man here.

Ster­il Milano S.r.l. based in Mon­za, Italy, offers a ster­il­iza­tion ser­vice for med­ical prod­ucts using eth­yl­ene oxide (EO) and e-beam. Ster­il Milano S.r.l. pub­lished a press release on its web­site on March 8th, 2021 (, accord­ing to which it closed its indus­tri­al sites in Mon­za and Reg­gi­o­lo after a review of the oper­a­tional process­es in order to car­ry out an inves­ti­ga­tion and also to take mea­sures to strength­en qual­i­ty con­trol at its third loca­tion to seize in Biassonno. 

In the mean­time, the cer­tifi­cate from Ster­il Milano S.r.l has been with­drawn by the respon­si­ble accred­i­ta­tion body. Accord­ing to the cur­rent state of knowl­edge, it can be assumed that the prod­ucts that Ster­il Milano S.r.l. alleged­ly sub­ject­ed to the ster­il­iza­tion process, were not ster­il­ized in accor­dance with the val­i­dat­ed ster­il­iza­tion pro­to­cols to a sig­nif­i­cant extent. 

There are also indi­ca­tions that the under­ly­ing val­i­da­tion steps have been manip­u­lat­ed. On the basis of the cur­rent state of knowl­edge, from the point of view of the BfArM, it is not ensured that the devices processed in the affect­ed peri­od prod­ucts are ster­ile. Checks of the steril­i­ty of cor­re­spond­ing prod­ucts by at least one affect­ed med­ical device dis­trib­u­tor showed that there was no sterility. 

BfArM thus asks all med­ical device man­u­fac­tur­ers and dis­trib­u­tors to check whether the prod­ucts they have placed on the mar­ket have been ster­il­ized by Ster­il Milano and are there­fore affected. 

Source: BfArM

For fur­ther infor­ma­tion on this sub­ject we rec­om­mend to browse our web­site by key­word “BfArM”.