Following posts on social media and press releases that show the result of a private laboratory for the detection of toxic substances in the colonies used to perform rapid detection tests, the Ministry of Health emphasizes the following:
- Globally, for decades, ethylene oxide has been used as a method of sterilizing medical equipment designed to protect users from contamination with dangerous pathogens. Therefore, the procedure is essential for the sterilization of medical equipment and necessary for the protection of public health (more: https://bit.ly/2XOIG9g, https://bit.ly/3vJxp6H).
- The substance becomes dangerous when the exposure to it is long (long exposure time and exposure in large quantity). As the substance is highly volatile, it is extremely difficult to retain it in virtually any medical device, including antigen-fast swabs, stored and opened at room temperature. In addition, there are strict rules regarding medical equipment and strict controls take place to ensure that after sterilization, this substance is removed and any residues are well below national and international safety limits.
- Specifically, medical equipment that has been sterilized with ethylene oxide complies with the following standards:
- ISO 11135, Sterilization of health care products – Ethylene oxide – Requirements for development, validation, and routine control of a sterilization process for medical devices. This standard sets out the requirements for the development, validation and regular control of the sterilization process of medical devices.
- ISO 10993-7: Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals. This standard sets specific limits for ethylene oxide (EO) and ethylene chloride (ECH) that must not be exceeded in order to ensure the safety of the product and the patient. The data for the observance of these limits are determined during the validation of the sterilization process with EO.
- It is noted that in the case of sterile medical devices placed on the European market and sterilized with ethylene oxide, the evaluation of the sterilization process requires an inspection by a notified body approved by the European Union (the list of organizations is posted on the website European Commission at the link: https://bit.ly/3GkOb0P).
- It should be noted that the laboratory that appears to have performed the analysis in a crib is not an accredited laboratory for conducting tests on medical devices, but on food according to its accreditation standard (CYS EN ISO / IEC 17025: 2017).
The Minister of Health is in contact with the Attorney General and the Chief of Police to investigate whether any offenses occur, in order to proceed with a complaint.