How to overcome the challenge of beyond-lifetime medical devices in use in India

by Sunil Singh , Founder & CEO, UnivLabs Technologies (www.univlabs.in)

Patients constitute the raison d'être for the existence of healthcare and medical devices. So, should there be a compromise on patient safety? There should not be; however, regrettably, this is often not the case.

Patient risk is frequently very high. Examining the data from the United States, a country renowned for having one of the strictest and most extensive regulatory frameworks, one can grasp the magnitude of the risk. In just 10 years, the USA has recorded over 1.5 million injuries and more than 80,000 fatalities attributed to medical devices. These figures may be greater in India, considering its population and the quality of medical devices in use.

In India, many medical devices are utilized beyond their designated lifespan, posing serious risks to users and patients. Regulations specify the usage end date for most medical devices, and manufacturers consistently state the expected lifetime of each device. It becomes the responsibility of the medical device operator to assess the device's functionality and proper condition as it approaches the end of its lifespan.

India must consider the following measures to ensure that only the best and within-lifetime medical devices are used throughout the country:

1. Government Procurement Policies: Governments purchase devices with a 5-year warranty and an additional 5 years as an Annual Maintenance Contract (AMC). This creates a two-pronged problem: firstly, the government is procuring materials at exorbitant prices, and secondly, no medical device can maintain the same quality level for 10 years. Therefore, there should be a maximum limit on Government e-Marketplace (GeM) purchases to not only ensure cost-effective procurement but also to have the latest and highest-quality products available by freezing the life of the device to a maximum 5 years, comparing the practice with US of 3 years max.
2. Imported Medical Devices Certification: Imported medical devices must have a balance lifetime certificate from the regulator of the country of origin for every imported device.
3. Transparent Display of Lifetime Information: The lifetime end date and the requisite regulatory certificate for the same must be prominently displayed for immediate access by both the user and the patient.
4. Mandatory Certificate of Suitability for Use: A Certificate of Suitability for Use should be made mandatory every two years to ensure timely and adequate servicing of medical devices.
5. Leveraging the Internet of Medical Things (IoMT): Utilize the Internet of Medical Things to ensure that the lifetime of a medical device is counted from the date of first use, and an automatic alarm is activated for its maintenance and end-of-lifetime.

By implementing these measures, India can establish a robust framework to ensure the use of medical devices within their intended lifespan, prioritizing patient safety and elevating overall healthcare standards across the nation.