Non-sterile medical devices affect Swiss patients

Improper sterilization practices at medical device manufacturers and hospitals blamed for rise in infections among patients. 

According to an investigation by the SonntagsZeitung and Le Matin Dimanche papers, contaminated medical devices could be responsible for infections of patients with dangerous bacteria like Mycobacteria chimaera. Around 12 patients in Switzerland have been infected out of around 100 cases worldwide. Infections have been linked to the use of contaminated heating-cooler units found in cardiopulmonary bypass machines. 

Between 2005 and 2018, the Swiss Agency for Therapeutic Products (Swissmedic) carried out 690 recalls of non-sterile medical devices, an average of five warnings per month. These concerned 70 different implants and 65 models of cardiac catheters. 

It is not just manufacturers that have been implicated. Hospital practices surrounding sterilization of medical equipment have also been questioned. The investigation revealed that four Swiss hospitals were reprimanded by Swissmedic in 2018: Aarau Cantonal Hospital, the Zurich Children’s Hospital, the Hirslanden Clinic in Zurich and the Yverdon Hospital. All reports, based on inspections carried out in 2016, flagged up deficiencies in the disinfection of equipment. 

Violations include improper sterilization and storage of endoscope equipment after use and lack of validation of the efficacity of cleaning equipment and agents. The hospitals were not fined but were only ordered to pay administrative costs between CHF1,200 to CHF9,200 depending on how long they took to implement remedial measures. 

Between October 1, 2015 and September 30, 2017, more than 57,000 cases of infection were reported in Switzerland following operations in 168 hospitals, according to the latest reports from the National Association for Quality Development in Hospitals and Clinics (ANQ) and Swissnoso, the national centre for infection control.