Everybody who has anything to do with electrical medical devices has been watching with interest the progress of the WEEE (Waste Electrical and Electronic Equipment Directive) and RoHS (Restriction of Hazardous Substances Directive) Directives through the European political process. RoHS, which should soon be published in the Official Journal of the European Union, has been especially important as the latest iteration of the Directive will see medical devices falling within its scope from about April/May 2014. Manufacturers should already be looking at the implications and planning how they are going to meet the new requirements as complying with RoHS is not necessarily simple and will almost certainly require a production training review, as well as in some circumstances a redesign of some circuit boards in order to accommodate lead-free soldering techniques. Risk management documents will also have to be updated to reflect the new processes and make sure all risks are identified and addressed.
What about the future of RoHS? Well I think we can expect that the number of banned substances, currently six, will increase. We can certainly expect the design and manufacture of electrical medical devices to become much more challenging in the future. As I see it the inexorable drive will be to do more with less, much less. Our ingenuity will be tested to the limit.
Nevertheless, no matter how much more we do with less, at some point everything becomes waste and is thrown away. Look around you. The furniture, the files, cups, boxes, staplers, scissors rulers, computers, printers, scanners and even the building you are probably sitting in, all at some point in the future will become waste and have to be disposed of. Electronic equipment is especially problematic. It contains numerous hazardous substances all intricately interwoven with other materials. The WEEE Directive is there to capture this troublesome consequence of our Hi-Tech lifestyles. The Directive has been around for a while and medical devices are already covered, however the latest revision is going through the political process and looks set for a second reading at the European Parliament.
Despite its good intentions, the latest revision could, as it stands, make life unnecessarily difficult for the medical technology industry and, therefore, some work is still required for it to achieve its purpose in the most efficient way. Although the Directive is mainly of concern for waste handlers and recyclers, there are aspects of WEEE as proposed that could be problematic for the medical technology industry.
One such is the proposed controls on the movement of electrical and electronic equipment across national borders. For some time now, unscrupulous elements have been shipping waste electrical and electronic devices to developing countries for recovery and recycling, claiming that they are for ‘reuse’ in order to circumvent waste shipment legislation. The EU has identified this as a subject for stricter control and is therefore proposing that any Electrical and Electronic Equipment being shipped either has to have evidence it is working or risks being declared “WEEE” by the authorities.
The medical technology industry ships non-working devices and parts of devices across borders all the time for perfectly legitimate reasons but because it is ‘non-working’ it would risk being declared WEEE while in transit. Representations are being made to the relevant bodies to try and find a suitable solution to this issue. Although, arriving at something that could not be exploited by unscrupulous elements is not proving easy.
The other issue is the definition of ‘infected’ devices. In the original Directive medical devices fell within scope ‘with the exception of all implanted and infected products’. The term ‘implanted and infected’ has to date been interpreted to mean ‘implanted and/or implanted’. This was to protect recycling workers as there have been instances where people have become infected with diseases by just handling contaminated devices. How much more at risk is a worker who dismantles contaminated devices with the consequent risk of abrasions and cuts?
More recently, there has been a suggestion for ‘implanted and infected’ to mean precisely that. A device would have to be at the same time implanted and infected. This would obviously result in a far greater amount of contaminated WEEE ending up in recycling plants with consequent increased risks to recycling workers. Of course, one answer is to decontaminate the device at end of life and before disposal but this is not as easy as it sounds.
Unfortunately, although manufacturers do provide decontamination procedures for devices that are used more than once, these procedures expect the device to be working and serviceable. Think of a dishwasher: it is possible to clean a dishwasher by placing a special sachet of detergent in the washer and running a wash cycle. How much more complicated would it be if the washer was not working? Those who have had the pleasure of dismantling a device like a dishwasher or washing machine will also know that even a device that looks clean hides all sorts of unmentionable substances in hidden cracks and crevices. One of the primary reasons for declaring a piece of equipment waste is that it has become unserviceable and it is not economic to repair it.
Medical devices have been included within the scope of WEEE since its inception and the industry should have no issues with that. Nevertheless the operation of WEEE should take into account the particular peculiarities associated with the recovery of devices that have come into intimate contact with humans who are, by definition, not in the best of health.
The operation of WEEE should take into account the particular peculiarities associated with the recovery of devices that have come into intimate contact with humans who are, by definition, not in the best of health.
I have often met those who view every new regulation as an interference, something else to get in the way of ‘doing our job’ and I think many see WEEE and RoHS as fitting very well into that scenario. I don’t see it that way. The aims and objectives of both Directives fit well with objectives of the medical device industry. We in the medical technology industry are primarily concerned with making products that benefit the health of people, how ironic therefore if in making those devices we contribute to the pollution and hazardous environment that make people ill in the first place.
WEEE and RoHS are both aimed at stopping hazardous substances from entering the environment where they can pollute causing disease in humans and other species. We should welcome that. As I see it the medical technology industry should be leading the way. Mustn’t we, who produce devices to improve people’s health, also ensure that we are not contributing to people’s ill health in the process?
– Andy Vaughan, Eucomed Consultant Environment
