Pre-owned Medical Devices; to diagnose, prevent, cure, mitigate and treat other conditions

 

Pre-owned Medical Devices are traditionally owned by the healthcare clinics and then are subject to the sale or buying after the refurbishment. The usage of the Pre-owned Medical Devices is done only after the certification from Europe and its CE mark. The hospital segment has been utilizing refurbished clinical devices owing to its cost effectiveness and the price constraints at several levels in the Indian Healthcare industry. Several original producers and standalone refurbishes have started a separate second hand market which has been thriving in India. However, there have been issues that have raised or shown by the domestic producers and needs complete ban on such appliances. However, the refurbished clinical appliances have zero or no bans in the segment. Similarly the import of such technology chews key chunks of the technology imports every year. There are two types of Pre-owned Medical Devices one is refurbished medical devices and the other one is non-refurbished medical appliances.

The refurbished ones are known to be correctly restored devices to the accurate safety and efficiency of the original equipment manufacturer and the companies that are refurbishing are certified. However, to check that it has been restored to the original safety and security along with the efficiency by the OEM is very hard due to the lack of transparency. Many of these equipment are a part of the generation that is obsolete. The non-refurbished medical equipment are those Pre-owned Medical Devices which are bought and sold over the net, that have the vast list of the operators. There is no correct and accurate record that is present anywhere on the cases that are linked to the pre-owned tools due to no OEM problems to do post market surveillance in the Food and Drug Administration or the CR mark as they do for new tools and devices.