What are the key factors to consider while testing Medical Devices?

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 Company to be appraised at CMMI-SVC Level 5, and an ISO 9001:2008 & ISO 27001:2013 certified organization.