Healthcare has always been serious matter to be taken care of, especially in India. Whether it was 17th century or 21st, Indians often compromise with their health issues until and unless it reaches to serious point. Seeking to stimulate better health care devices in the country, The Association of Indian Medical Device Manufacturers (AiMeD), the voice of Indian medical device industry, has proposed complete ban on import of pre-owned and refurbished medical equipments.
Opposing the import of pre-owned and refurbished medical equipment, AiMeD believes that it can lead to cause of serious health issues for Indians as is being lobbied by a segment of importers from the platform of CII. Further, this activity disrupts and can seriously destabilize ‘Make in India’ program in medical equipment sector.
Also, an ‘Inter-Ministerial Committee of Government of India for Restricting Import of Refurbished Medical Equipment including Radiology Products & Flexible Medical Video Endoscopes’ has recently solicited various stakeholders’ view on the matter.
Showing serious setback for ‘Make in India’ program in medical device sector, AiMeD has built a strong case against any leniency for permitting import of these kinds of equipments.
Detailing the health issues related to sub-standard and doubtful second hand medical equipment including radiology equipment and flexible medical video endoscopes, AiMed authorities said that such equipments of doubtful efficacy and quality is leading to incomplete and wrong diagnosis, causing either inadequate or wrong treatment plus undesired medication whereby the deserving patient loose one last hope/chance for proper recovery owing to time constraints or even financial constraints and in some cases even get exposed to unsafe radiation .
Imports of products such as used Flexible Medical Video Endoscopy Systems along with camera imaging systems affect Domestic Flexible Medical Video Endoscope Manufacturers and similarly the Radiology Equipment Manufacturers are equally distressed.
As per latest norms of AERB, the hospital authorities have to obtain procurement forms & submit quality assurance reports of radiological equipment’s for radiation safety. This needs to be checked in case of refurbished radiological equipment’s or should be banned otherwise unchecked radiation can be harmful for patients, attendants and operators. Moreover, the import of old devices can lead to eradication of local manufacturing under “Make in India” as cheap, unsafe, “pre-owned” equipment will be available at throw away prices.
There are two major types of “Pre-owned” medical equipment imported into India :
1. Refurbished: The refurbished ones are supposedly properly restored Devices to the original safety and effectiveness by OEM as well as Certified Refurbishing Companies. But to verify that it has been restored to the original safety and effectiveness by OEM and adequately calibrated is difficult and there is no transparency. Availability of spare parts after 5-7 years of life is doubtful in any electronic item.
2. Non-refurbished/pre owned/ demo/various names are provided/etc.: The Non-Refurbished ones are just “Pre-owned- bought and sold over the net”, there is a huge list of Operators. There will not be a record existing anywhere on the incidences related to “Pre-owned” equipment, because no OEM or reseller in India has any obligations to do post market surveillance under FDA or CE, as they do for a new equipment.