The Restriction of Hazardous Substances Directive (RoHS) was primarily designed to address growing concern over what happens to toxic electronic components that go to landfill. It has been widely accepted that these components – containing substances such as lead, cadmium, mercury, hexavalent chromium (Cr6+), polybrominated biphenyls (PBB) and polybrominated diphenyl ether (PBDE) – can pose environmental risks to the land and water that surround them.
Although there is no debate over the need for RoHS, there has been concern over how the directive's broad spectrum will affect specialised industries, including medical devices, as well as the timetable in which these devices will become fully compliant.
According to Andrew Vaughan, chair of the Eucomed WEEE/RoHS working group, the expansion of RoHS directives to include medical devices has always been the long-term goal. But the application had been postponed since RoHS" inception while studies to determine the effects of using alternate, environmentally friendly components could be established. Increasing political pressure to protect the environment makes exceptions to the directive a dividing line between politicians and industry
"Medical devices were excluded from the first version of the directive due to reliability issues," explains Vaughan. "If your television breaks down, it's an inconvenience. But if your ventilator breaks down, it gets more emotional.
"One example of the consequences of bringing medical devices under the RoHS directive will be a ban on the use of lead soldering. Lead soldering is a well understood and predictable technology; everybody has been using it for decades."
Although there are a number of lead-free solders available, their behaviour in different applications varies and they require higher temperatures for use. Therefore, the implications for both processes and reliability remain in question.
"Since the directive has now come up for review, the question asked was 'do we now include medical devices?' There has been a discussion between industry and the commission and the upshot of that discussion is that medical devices can probably be included safely in 2014, provided there are a number of exemptions."
Many industry insiders believe the real reason the moratorium on medical devices is being heavily scrutinised is down to politics. "The commission, understandably, doesn't like exceptions," explains Vaughan. "They try to avoid them everywhere they can. But if you look at the totality of electrical devices on the market, medical devices are substantially less than 1%. Some may ask "what's the point?"
"There are special considerations with medical devices as well. They have to be more reliable than consumer goods. They have to operate in extreme circumstances. Some have to be sterile and some are contaminated during use. Essentially, the reason for them being included could be construed as more political rather than practical."
Despite this, medical devices are scheduled to fall completely under RoHS directives. "All the banned substances will apply to medical devices," says Vaughan. "In addition to this, eight further materials are under discussion for being included in RoHS – eight plus the halogenated substances."
Changes and opportunities
According to Vaughan, there will be two aspects to the application of RoHS that the medical devices industry must navigate. First and foremost is the initial shock, which he anticipates will be both large and costly.
"Manufacturers of medical devices will have to look very closely at their processes to make sure that their products are not compromised in any way," he explains.
"They must also bear in mind that there's going to be a change to components. To some extent this is happening already. Because the rest of the electronic industry is going over to lead-free, RoHS-compliant products, it means the sources of traditional components for the medical device industry are drying up. Nobody is going to produce RoHS non-compliant products for a small market like the medical device industry. So I'm quite sure there are already difficulties in obtaining some components in a traditional format. To some extent, I think that medical device manufacturers are being forced down this route anyway.
"What you can expect is a need for products to be redesigned and there will be changes to components, with implications not only for manufacturing but also for servicing," says Vaughan. "Manufacturers will have some products which are RoHS compliant and some which are not. So, a service strategy will have to be implemented that defines how medical device manufacturers will maintain quality in that environment."
The initial outlay for capital equipment will also be a significant challenge for manufacturers. "They have decisions to make as to whether they run two lines parallel – for example a leaded line and an unleaded line – or do you make a switchover date and say from this date we will only make RoHS-compliant products," says Vaughan. "However you do that, it will have implications for capital equipment in terms of what you've got on the factory floor."
Retraining staff will also be an initial cost factor. For example, soldering techniques will need to be revised. If you hand solder a component with traditional tin lead solder and the joint is nice and shiny, it is considered suitable. "Lead-free solder doesn't behave in that way," explains Vaughan. "You don't get a nice shiny joint. The appearance of the joint looks like a bad joint, using traditional methods. So you need to retrain your staff in terms of how to
solder using the new materials.
Then of course there are the ongoing costs. "Once you've set all this up, the slight cost increase in product isn't that high," says Vaughan. "Though lead-free solder is more expensive than traditional solder, when you add it into the manufacturing cost of the product it isn't very much. 90% of your cost is going to be upfront and you will have the ongoing cost from then on because the materials will be slightly more expensive.
"I think the opportunities will be in marketing more than anything else," he adds. "It may be more so in marketing outside the EU.
"For example, everyone is going to have to change over to RoHS-compliant products in the EU. There won't be any marketing advantage here. But outside of the EU there is growing awareness of environmental issues and many countries are following the EU in this drive towards RoHS-compliant products. So any manufacturer who has switched over will be better placed to take advantage of those new markets."
In order to keep ahead of the curve, Vaughan recommends consulting a local trade association. "Trade associations have been very active in this area and are a pool of knowledge in this respect. Medical devices comprise such a small industry that you are out of the mainstream, so there is not a wealth of mainstream data."
"I think the RoHS directive and medical devices issue do not fit very well," says Vaughan. "The reason for the RoHS directive is very clear and it is very necessary. However, though a material may be hazardous, that does not mean it should be eliminated.
"For example, if you put lead in ultrasound crystals, for diagnostic ultrasound, it improves the performance of the crystal," he explains. "This means that you are able to work with less energy being sent to the patient, thereby reducing patient exposure risks. You have to create a balance between what is a hazard to the environment and what is a benefit to the patient."
This is probably a scenario which is unique to the medical industry, with the possible exception being the aircraft industry, where safety has to be paramount.
"One of the things the medical device industry would like to argue for is risk-based analysis of materials," stresses Vaughan. "The Medical Device Directive (MDD) and AIMD are risk-based systems. The industry uses the standard 14971 and manufacturers must weigh up the clinical benefit against possible harm with a particular medical device.
"However you look at it, the use of medical devices in medicine is the controlled application of harm. Nobody in their right minds would submit to surgery for the fun of it. Nobody would have an X-ray just for the fun of it. Nobody would have cytotoxic drugs pumped into them just for the fun of it because all of these things are harmful.
"But what manufacturers say is that you apply some harm, but the benefit is greater, making the device's use worthwhile. That applies to the environment as well, because you can say "I want to use lead in my product or cadmium if the benefit to the patient outweighs the harm to the environment".
“But with a directive like RoHS, there's no option to do this. These materials are banned, end of story."
Though an exemption process exists for new devices that show benefit to patient populations, the procedure for approval is both exhaustive and time consuming. This further delays any benefit to patients in need of specialised therapies.
For medical device manufacturers who want to take action and push for the implementation of exemptions based on risk analysis, Vaughan recommends contacting your local trade association. "Medical devices are merely a small part of the overall picture," he says.
"I think there is some resistance with people asking 'why are these medical device people getting away with using these substances?' However, I do feel that we should say medical devices are a different matter altogether."