Jan 15, 2021 General

What Are the Important Aspects to Consider While Testing Medical Devices?

Modern medical care Depends a whole lot on technology, be it in the kind of critical care equipment or as crucial diagnostic tools. It goes without saying that if a gear malfunction occurs, due to inadequate medical device 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’s 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.medical device testing

The above example Has put forth the crucial value of medical devices to perform according to specifications, 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 can be laid down by regulatory bodies like the FDA or BIS.As most modern Medical devices have built in applications their testing becomes crucial for the following reasons.

  • A software glitch can provide wrong health readings thus resulting in 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
  • Business manufacturing these devices may get sued
  • Regulatory bodies may impose huge penalties thus hitting the bottom line of these companies

After a device is Constructed the software parameters must be verified against certain 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 goes beyond the permissible threshold.Modern healthcare centers run on an extensive information technology network where medical devices form an essential part. Carrying out medical device testing will ensure these devices continue to work seamlessly within the network and supply information access as and when required.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 software testing vulnerable points in the program can be plugged and firewalls can be set in place.