A sterile medical device is a device that must be free from live bacteria or other microorganisms and their spores. Sterile medical device requirements are defined by national or regional standards and regulations, which detail the sterility requirements. Sterilization of a medical device may include exposure to ethylene oxide, gamma irradiation, steam, dry heat, or chemical sterilization under defined conditions, and any necessary post-treatment required for the removal of by-products.
Sterilization of medical devices is a specialized process and requires specific knowledge and expertise. We are passionate about patient safety and reducing patient risk through microbiology assessments, carried out by our qualified microbiologists. A typical microbiology assessment from BSI would include:
- Verifying effective controls are in place to assure the sterility and product bioburden of your medical device
- Assessing your environmental monitoring and controlled environment room or cleanroom areas
- Verifying effective implementation of sterility assurance levels through sterilization and sterile barrier validations
- Assessing the suitability and effectiveness of disinfectants and sterilizers
- Assessing the suitability and effectiveness of instructions for end user sterilization and reprocessing
Our microbiologists and technical specialists collaborate and are able to support in all areas including dental, ophthalmic, orthopaedic, vascular, active implantable, active, medicinal substances, devices utilizing animal tissue and general sterile devices.
We conduct Quality Management System (QMS) assessments to ensure compliance with ISO 13485 as well as other global regulations and sterilization standards (i.e. MDSAP, MDR, IVDR, EN ISO 11135 and EN ISO 11137-1). We also perform Technical Documentation reviews under the IVDR and MDR.