Key Aspects to Consider While Testing Bioburden

Modern healthcare depends a lot on technology, be It in the shape of critical care equipment or as crucial diagnostic tools. Its gas without saying that if a gear malfunction occurs, because of insufficient Bioburden testing, it is going to lead to ‘incorrect’ identification for critical care patients and might even prove to be fatal. Also, because most medical practitioners of now increasingly rely on assessing the health parameters of patients to be able to arrive at a proper diagnosis, the diagnostic tools should be in perfect working order.

Let us understand with an example. If the ECG report Due to a software glitch gives a wrong reading, the medical practitioner may make a wrong identification based on that. Thus, the prescribed medications can place the patient at risk. The above example has set forth the critical Significance of medical devices to perform according to criteria, for any deviation may cause disastrous consequences. This calls for medical device performance testing wherein each function of a device isn’t just validated and verified but assessed based on the significant parameters which are laid down by regulatory bodies like the FDA or BIS. As most modern medical instruments have built in Applications their testing becomes crucial for the following reasons.

  • A software glitch can provide wrong health readings thus causing a wrong diagnosis
  • Crucial wellness parameters might not have picked up by critical care devices like Heart Lung Machine or EEG thus delaying prompt intervention of critical care specialists.
  • A wrong diagnosis can prove deadly for patients
  • Company manufacturing such devices can get sued
  • Regulatory bodies may impose huge penalties thus hitting the bottom line of these companies

Medical device performance testing should be guided By a few important variables as given below.

  • Proper verification: After a bioburden testing is constructed the software parameters Should be confirmed against specific inputs. For instance: in the absence of medical device performance testing of an X ray machine or apparatus related to radiation treatment, the consequent dose can prove deadly if gas beyond the permissible threshold.
  • Component of the Hospital network: Modern healthcare centers run on an Extensive information technology network where medical devices form a critical part. Carrying out medical device software testing will ensure these devices continue to work seamlessly within the network and supply information access as and when required.
  • Ensuring security: Any program is prone to intrusion, which if not prevented by taking adequate security measures, can lead to their own manipulation. Such a situation may have grave consequences for the patients in addition to hospitals. Accordingly, by carrying out medical device applications testing exposed points in the program could be plugged and firewalls can be set in place.
  • Prevention of human input error: People are prone to make errors, which if left Unchecked, may cause difficult situations. As an example, providing a wrong command unintentionally while operating a system or device can have unintentional but grave consequences. This may be avoided by undertaking medical device testing.

A comprehensive medical device functionality testing Can go a long way in addressing the concerns of patients in addition to the healthcare community. A comprehensive Bioburden testing framework can stop Patient mortality, expensive litigations and ROI to the organization.