Modern medical care depends a lot on technology, be it in
the form of critical care equipment or as crucial diagnostic tools. It goes
without saying that if an equipment malfunction occurs, (due to inadequate medical
device testing), it will lead to 'wrong' diagnosis for critical care patients
and could even turn out to be fatal. Also, as most medical practitioners of
today increasingly rely on checking the health parameters of patients in order
to arrive at a correct diagnosis, the diagnostic tools should be in perfect
working order.
Let's understand with an example. If the ECG report on
account of a software glitch gives a wrong reading, the medical practitioner
can make a wrong diagnosis based on that. Thus, the prescribed medicines can
put the patient in danger.
The above example has put forth the critical importance of
medical devices to perform as per specifications, for any deviation can lead to
disastrous consequences. This calls for medical device performance testing
wherein every function of a device is not merely validated and verified but
checked according to the crucial parameters that are laid down by regulatory
bodies such as the FDA or BIS.
What can happen if medical
device software testing is ignored?
As most modern medical devices have built in software
their testing becomes crucial for the following reasons:
·
A software glitch can deliver wrong health
readings thus leading to a wrong diagnosis
·
Crucial health parameters may not get picked up
by critical care devices such as Heart Lung Machine or EEG thus delaying prompt
intervention of critical care experts.
·
A wrong diagnosis can prove fatal for patients
·
Company manufacturing such devices can get sued
·
Regulatory bodies can impose huge penalties thus
hitting the bottomline of such companies
Medical device performance testing should be guided by a
few key factors as given below:
Proper verification: Once a device is built the
software parameters should be verified against specific inputs. For example: in
the absence of medical device performance testing of an X ray machine or
devices related to radiation therapy, the resultant dosage can prove fatal if
goes beyond the permissible threshold.
Part of the Hospital network: Modern healthcare
facilities run on a comprehensive information technology network in which
medical devices form a crucial part. Carrying out medical device software
testing would ensure these devices continue to function seamlessly as part of
the network and provide information access as and when needed.
Ensuring security: Any software is prone to
intrusion, which if not prevented by taking adequate security measures, can
lead to their manipulation. Such a situation can have grave consequences for
the patients as well as hospitals. Therefore, by carrying out medical device
software testing vulnerable points in the software can be plugged and firewalls
can be put in place.
Prevention of human input error: Humans are prone
to make mistakes, which if left unchecked, can lead to difficult situations.
For instance, giving a wrong command inadvertently while operating a system or
device can have unintended but grave consequences. This can be prevented by
undertaking medical device software testing.
Conclusion
A comprehensive medical device performance testing can go
a long way in addressing the concerns of patients as well as the healthcare
community. A comprehensive medical device testing framework can prevent patient
mortality, costly litigations and ROI for the company.
Michael works for Cigniti Technologies, which is the world's first Independent Software Testing Services Company to be appraised at CMMI-SVC Level 5, and an ISO 9001:2008 & ISO 27001:2013 certified organization.

