“There are many commercial reasons that companies may want to move EEE or sub-systems cross border for repair or refurbishment, these include:
Return to the manufacturer or to a test house for investigation after an ‘adverse event’ in which a patient or user was harmed (regulatory compliance or for quality assurance monitoring of devices as required by the Medical Device Directives) […]
Return to manufacturer for refurbishment and repair to return the equipment or its major components to the marketplace. For numerous long-lived medical devices and monitoring and control equipment, the product can be refurbished or updated (e.g. software or hardware)”
From p. 2 of response by American Chamber of Commerce to the European Union (AMCHAM EU) to Basel Secretariat. 2011. ‘Draft Technical Guidelines on Transboundary Movement of E-Waste, in Particular Regarding the Distinction between Waste and Non-Waste (Version: 21 February 2011 )’. http://archive.basel.int/techmatters/code/comments.php?guidId=78.
“ [Equipment should not normally be considered waste if] the defective used equipment for professional use such as medical devices or their parts, is sent to the producer or third parties acting on his behalf for root-cause analysis under a valid contract, in case such an analysis can only be conducted by the producer or third parties acting on his behalf.”
From p. 10 of response by European union to Basel Secretariat. 2011. ‘Draft Technical Guidelines on Transboundary Movement of E-Waste, in Particular Regarding the Distinction between Waste and Non-Waste (Version: 21 February 2011 )’. http://archive.basel.int/techmatters/code/comments.php?guidId=78.
“While understanding the need to provide additional tools to control and custom authorities to stop the illegal shipment of e-waste to developing countries under false claims of repair and refurbishment activities, the Healthcare Industry is worried for the consequences of the proposed criteria on legitimate shipments of used Medical Devices.
The Technical Guidelines document proposes a set of criteria based on functionality testing and proper packaging to help authorities to distinguish between used EEE and e- waste and suggests declaring any used equipment that could not meet the aforementioned criteria as waste.
Such criteria will impact legitimate shipment of functioning medical devices for refurbishment and reuse, as the cost of testing could exceed the residual value of the equipment.
They will also impact on the shipment of non-functional medical devices for repair, root cause analysis or meeting regulatory requirements as such non-functional equipment would be considered waste by custom authorities.”
From p. 1 of Joint Healthcare Industry response to Basel Secretariat. 2011. ‘Draft Technical Guidelines on Transboundary Movement of E-Waste, in Particular Regarding the Distinction between Waste and Non-Waste (Version: 21 February 2011 )’. http://archive.basel.int/techmatters/code/comments.php?guidId=78.
“[…] the proposed guidelines will seriously threaten the movement of used medical devices destined for refurbishment and remanufacturing. […]
Used medical devices are refurbished using the highest possible international standards and sold under full warranty equal to new. Philips refurbishing program provides reliable and cost effective refurbished medical devices, allowing more patient access to up-to-date technology. This program relies on transboundary movement of used professional equipment to Philips’ refurbishing locations. Defining used professional electronic equipment destined for refurbishing or repairs as “e-waste” under the proposed guidance threatens to disrupt and may stop legitimate transboundary movement of this equipment, prematurely diverting valuable equipment to waste recycling channels. Medical device refurbishment and repair is an effective means of reducing e-waste while ensuring greater global access to medical device technology. If adopted, we believe this approach would impose new and unjustified barriers to legitimate international trade in used equipment without providing any significant benefit.”
From p. 1 of response by Philips to Basel Secretariat. 2011. ‘Draft Technical Guidelines on Transboundary Movement of E-Waste, in Particular Regarding the Distinction between Waste and Non-Waste (Version: 21 February 2011 )’. http://archive.basel.int/techmatters/code/comments.php?guidId=78.
“Refurbished systems enable more patients to have access to up-to-date technology while helping governments mitigate the rising costs of healthcare. Since the global economic crisis of 2008, the demand for refurbished systems has surged globally. Repairing used parts is also critical to maintaining equipment, keeping customer repair costs down, and ensuring medical equipment servicing worldwide. Without the return flow of used parts, the cost to healthcare providers would increase by €500M annually. Furthermore, legislation requires us to return non-functional (defective) medical devices to the manufacturer or a regional testing center for root cause (failure) analysis.”
From p. 2 of response by Philips to Basel Secretariat. 2012. ‘Draft Technical Guidelines on Transboundary Movement of E-Waste, in Particular Regarding the Distinction between Waste and Non-Waste (Version 8 May 2012)’. http://www.basel.int/Implementation/Ewaste/TechnicalGuidelines/DevelopmentofTGs/tabid/2377/Default.aspx.