The Carabinieri of the NAS of Milan carried out an inspection at an important company in the province of Monza active in the sterilization of medical devices, cosmetics and other materials, by subjecting them to treatments with the use of beta rays and ethylene oxide, as a result of which serious irregularities in the sterilization processes emerged.
The former owner of the company, who died at the beginning of this year, with the complicity of all the Managers of the Quality Department who succeeded each other from 2016 to today, appears to have, for years, created the certificates relating to the sterilization processes, in order to obtain more work than their actual production capacities, making available to their customers materials that in reality were not sterilized.
The constant tampering with the sterilization reports and the relative falsifications of the certificates returned to the customers, were meticulously reflected both in the investigations of the NAS and in some manuscripts of the former owner of the company, which indicated the batch numbers of the products not subjected to sterilization .
The evidence led to the referral of 4 people in a state of freedom (former managers, quality service managers) to the Public Prosecutor's Office of Monza, for complicity in material forgery committed by private individuals as well as for the serious risks to public health deriving from the use of unsafe medical devices for both healthcare professionals and patients.
In fact, the products not properly subjected to sterilization by the Milanese company fall into the category of Medical Devices (needles, cannulas, gauzes, instruments, implants intended for diagnosis and prevention, control, therapy, conception operations), and diagnostic medical devices. in vitro used for laboratory testing (such as reagents, calibrators, control materials, instruments, equipment), widely used in health facilities and hospitals, both private and public, throughout the national territory.
The military of the NAS of Milan, in agreement with the Ministry of Health, immediately started the checks at all the corporate bodies and client companies of the company to avoid any risk of infections due to the lack of sterilization, but above all in order to implement all procedures aimed at correctly identifying, recalling and sterilizing each individual medical device previously not properly treated.