Be it that the drug eluting stents, magnetic resonance Imaging machines, CT scan machines, X ray and ultrasound apparatus, Color Doppler, ECG or the pacemakers, the lives of individuals depend upon the effectiveness of these devices. Any malfunction in the operation or performance of medical devices may have a critical impact on the state of patients threatening even their very survival. No wonder, the domain name of Bioburden testing has Become so crucial in the overall scheme of things. As embedded applications is increasingly becoming the standard in new medical devices, they ought to be thoroughly checked – directly from the design stage to the whole end to end development cycle.
Medical devices testing experts should conduct Performance testing on medical devices in addition to other tests to make sure they pass muster on regulatory requirements in addition to during clinical trials that are crucial. The role of medical devices in spheres of investigation and treatment of diseases has grown through the years. Additionally, the devices have experienced changes concerning materials used, embedded applications deployment, automation, and how that they capture crucial parameters regarding the identification and treatment of health conditions. As medical instruments become crucial, the importance Of Bioburden testing has received improved traction amongst stakeholders. It is all about increasing use of technologies for designing, building, testing and installation of medical devices.
Aside from meeting design specifications, bioburden testing need to be compliant with the standards set by national and international regulatory bodies. Bioburden testing experts have their jobs cut out when they assess medical instruments for robustness, accuracy, usability, security and responsiveness that a la performance testing. For example, in imaging devices such as CT scan and X Ray machines, the amount of radiation released should be rigorously set according to the specifications laid down by IEC or else, patients may suffer irreparable harm due to radiation exposure. Also, devices for analysing blood, glucose, heart rate, etc. should provide precise results or else, based on therapy or dose of medicines prescribed by doctors can go horribly wrong, seriously impairing the health of patients.
- To Fulfil regulatory requirements and security standards
- To test the efficacy and safety of apparatus
- To integrate testing at the design phase to absorb emerging technologies
- Pre design stage: Here, conformation to regulatory Standards, testing methodology, risk assessment and setup of measurable deliverables are finalised.
- Design stage: Here, test scripts are readied, SOPs for testing are finalised, inputs for designing are accounted for, followed by minding validation protocols and customer sign off.
- Deployment phase: Here, real test is performed, flaws are logged and brought to the notice of growth group, followed by final verification and validation.
To ensure objectivity, meeting standards and Transparency, Bioburden testing ought to be carried out by Medical devices testing experts, preferably from a trusted testing organisation.