Medical

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With hospital infections on therise and antibiotics losing theireffectiveness, it’s in everyone’sinterests that the hardware ofmedical devices is closely

monitored and controlled so that they toodon’t cause problems. But the regulatoryframework that is intended to ensure thatdevices work as they are meant to and areas safe for patients as possible is beingshaken up – and there are concerns thatthe industry may not quite realise theimportance of the changes.Jeff Vest, senior manager at the testing

and certification group TÜV SÜD ProductService, says that the fundamental changesthat are coming to EU rules on medicaldevices should not be scary if companiesplan for them. “But I’d say that around50% of them know that something ischanging, about 5% have probably got thedocuments, and just 5% of that 5% haveactually read it,” he says. “That’s the reallyscary thing.”Vest is talking about changes that will see

the European Union’s current medicaldevice directives replaced with newregulations – probably set in stone by themiddle of next year and then due forimplementation over the two or three yearsafter that.But those aren’t the only changes afoot.

A new edition of the separate standard formedical electrical equipment, which is asubset of the overall framework for medicaldevices, has changed the whole basis ofhow risk is managed in productdevelopment – see the box on this page.Again, says Jeff Vest, there is evidence of alack of understanding among themanufacturers and developers about whatthe changes mean for them.So why the confusion? For the medical

devices regulatory system as a whole, theapparent aim of the changes that are beingpushed through by the EuropeanCommission is simplification, notcomplication. Currently, says Vest, “we havethe Medical Devices Directive 93/42, andwe have another directive for in vitro

diagnostic medical devices and another foractive implantable devices.”The planned change – and it is what Vest

terms “a sea change” – is that the threedirectives will become two regulations. Thetitle change is significant. “A directive isissued by the European Commission to themember states and the governments thenput into law their version of the directive,”Vest explains. “In the UK, it’s usually donepretty much word for word with thedirective, but in some countries they addthings depending on the regulatoryframework that they had in place before.”That variation between countries is now

being abolished. “With regulations it meansthat every country must use the samewords. You can’t add extra bits or takethings away because you don’t like them. Itwill be the same words throughout Europeso there will be a common approach to theregulation of medical devices.”A further difference is in timing. Where

directives meander their way into nationallaw, regulations have a fixed timetable of

two years for national enactment. TÜV’sview is that the current batch of Euro MPs,due to go for re-election next year, willwant to see this through before they depart.So Vest expects the regulations by themiddle of next year, with a timetable thatwill see them implemented by 2016 or2017. It means, he says, that with a fewsuperficial modifications, the currentproposals will probably be the shape of it.So why, if this isn’t going to come into

effect until 2016 or 2017, do medical devicemanufacturers need to be planning now?Surely there’s time? Ah, says Vest, thatwould be to underestimate the scale of thechanges that are envisaged with presentproposals.Some of these changes are going to be,

frankly, rather mundane and bureaucratic:none the less important for that, andrequiring work that has to be planned for.For example, the current directives expandtheir explanations of the requirements in aseries of annexes, and manufacturers haveto specify in their procedures and

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Electrical changes put the emphasis on risk managementWithin the medical devices regulations,specific standards and subsectionscater for different kinds of equipment,and changes to one of these arecreating some confusion in the market,say the experts at TÜV SÜD.

Jeff Vest, senior manager, says thenew requirements of the third editionof the Medical Electrical Equipmentstandard, EN 60601-1:2006, represent a“sea-change” for manufacturers.

“It’s one of a new style of standardsthat are bringing the concept of riskmanagement to the forefront,” he says.

“It means that you have to startfrom scratch and actually design a goodproduct. It starts from the premise thatthe manufacturer is an expert in theproduct type and knows what can gowrong with it, so they can use thedesign concept and design the risk out.”

This is a change from the previous

editions of the standard, and it’sintroducing concepts that some firmsare finding difficult to handle. “In thesecond edition it was very much a casethat if you’d got your product and thenfound that it didn’t work, you’d try todo something about it. Whereas nowwith the third edition we’re trying tofind out that the design is good so thatpeople don’t have to redesign forthings that might have been easier to

fix at the outset.”The problem that TÜV identifies is

that there is very little training done onrisk management. “It’s particularly aproblem with ‘me-too’ products orfourth generation products,” Vest says.“People say there’s no risk becausethere have been safety recalls or noincidents. But the foreseeable risk isstill there: the probability is whatchanges.”

Changingthe rulesDirectives and standards covering medical devices are inthe throes of big changes, and experts worry thatmanufacturers are not keeping up to speedBy John Pullin

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They’re going to have to changeand it’ll cost them millions

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28 ◆ Environmental Engineering ◆ April 2013

documentation which annex applies.That’ll still be the case – but all the annexnumbers will change.

Devices that go through a Notified Body(such as TÜV) are also in for somebureaucratic change. Currently there aresome 70-80 NBs identified as a codenumber in the product documentation. Theindications, says Vest, are that the numberof NBs will be substantially reduced; thereis no news on whether the survivors willkeep their current codes.

These may seem small changes “but it’s abig piece of work for a multinational with250,000 technical files and 250,000 partnumbers,” Vest says. “We often say that thereason people don’t change Notified Bodyis the cost of relabelling everything. Butthey’re going to have to, and it’ll cost themmillions of euros.”

That, though, is the straightforward part.What concerns TÜV SÜD is that there arepotential wrinkles in the system that meanthat continued compliance even for well-established medical device manufacturersmay be far from straightforward.

What happens, for example, is the NBthat you’ve known and loved for years fallsoff the European Commission’s new list?“You obviously have to get another NB toassess your products,” says Vest. “But ofcourse the reason it’s no longer an NB isthat they’ve failed to demonstratecompetence to the competent authority, sowe can’t just transfer a new client toourselves and use the previous assessment:we have to assess it in its entirety. There’s apotential ‘off-the-market’ until we’re happy.”

There are other changes too. The newregulations as currently set up are alsoincluding for the first time some devicesthat have not come under the previousdirectives. Devices used for largely cosmeticpurposes, such as liposuction equipmentand the kinds of contact lenses that changethe colour of your eyes, are now going to be

covered. Some of this is a direct response tothe breast implants scandal. But the effectis that a lot of new people will need to findtheir way through the system.

They won’t be alone. Currently,manufacturers of medical devices take thebrunt of the responsibility for device safetyand compliance. But the new regulations,Vest says, will involve importers, exportersand “what we call authorisedrepresentatives”, which is likely to meandistributors. These companies will alsohave to demonstrate their familiarity withthe technology and have access to thetechnical documentation and this, Vest

believes, might create a few problems fordistributors who handle products fromseveral competing manufacturers.

Perhaps more arduously, they and allother companies which come under thenew regulations will have to have technicalpeople within their organisation. This is notyet wholly clear. It’s known, says Vest, thatmanufacturers will have to be able to field aqualified person with a degree and fiveyears’ experience in regulatory matters: “It’snot clear whether you can use consultantsfor this role, and the wording implies thatthey should be on your payroll and part ofyour organisation,” he says. Other

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A matter oflife and death:Equipmentsuch as heartvalves facenew andstringentregulations

… electrics and risk management continued...The example he cites is an extreme

one: “The risk might be that you getelectrocuted by the medical device andthe risk from that is the death of theuser. The probability may change fromone in a million to one in 10 millionbecause of control measures put inplace, but the risk is still there. Sowhen we sit down with people in themedical devices world and say thatthey haven’t included the risk of

electrocution and they say that theyhaven’t had any complaints, we have tosay that that shows their controlmeasures are working but notnecessarily that they’ve addressed allthe risk.”

Once the concept of “all foreseeablerisks” is understood, TÜV also findssome manufacturers struggle with howto manage, control and document therisk, which is at the core of the new

way of regulating the safety of devices:“We come across situations wherepeople are using an FMEA tool andthinking they can change the severityof risk because of their controlmeasures,” Vest says. “But if the risk isdeath then no matter what you do theseverity is going to stay the same.”

The “bigger picture” that TÜV istrying to get across is the idea of risk-benefit analysis which should then be

set out in the risk management filethat the standard requires. “Heartvalves are a classic example. No matterwhat you do to improve the reliability,if they do fail then you’re going to killsomeone,” Vest says. “But if youexplain the residual risk and the benefitto the patient then patently the benefitoutweighs the risk.”

In parallel with the new edition ofthe EN60601 standard, and a useful

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To be forced out of the market isgoing to be a fairly public affair

companies seem likely to need a technicalperson with a degree and with five years’experience too, though not necessarilyexperience in regulatory matters.This, again, is something that Vest

believes companies should be alert to. Inaddition to the changes for firms notpreviously directly involved in the medicaldevice directives, there could beimplications for small companies and forthe commercialisation of ideas fromuniversities research incubators in terms ofhaving to have expertise on hand.That tends to cost, and so too does

another proposal in the new regulations.Currently, Notified Bodies are at liberty tomake unannounced visits to devicemanufacturers to carry out spot checks, butthis does not happen with any frequency:“We have enough to do looking after theregular audits, and none of our clients hasreally caused us any trouble,” Vest says.Under the new regulations, however, this isnot just a suggestion but a requirement, andsamples should be taken away for analysis.“Someone is going to have to pay for

this,” Vest says, “but there’s a practicaldifficulty in some cases too. If it’s a mass-produced product and a small item, takingaway a sample worth a few hundredpounds may not be a problem, but what dowe do about a company making x-raymachines?”So there are elements within the

proposed regulations where there are likelyto be modifications and the exact details ofthe transition are not clear, but TÜVbelieves the essential shape is in place. Thechanges to current practice will, Vest says,be beneficial in that there will be a singleset of rules that will apply everywherewithin the European Union, and “rogue”companies will be easier to spot.“It’ll be public knowledge when a

company has lost their certificate. Even ifno one will know why, they’ll still know

that they lost it. We will be able to identifymore easily those companies that areshopping around looking for an easier life.”But the advice to all the companies that

will be affected is that the homework has tostart now. Though the rules will be enacteda couple of years after they are passedthrough the European Parliament, otherdeadlines within the transition period willbe much shorter: there is, says Vest, realdanger that some items could findthemselves off the market because themanufacturer failed to act soon enough. Itmay be, he says, in some cases that the newarrangements and in particular the likely

cost will persuade firms to withdraw somedevices.But to be forced out of the market is

going to be a fairly public affair, and harshon reputations. “We’re urgingmanufacturers to look at the regulations asthey are at the moment because it’s goingto be pretty much as it currently is,” he says.

“If they wait until next year or even laterand miss their deadline and if it’ssomething that buried away inside theregulations, then they could findthemselves off the market even before thepresent directive ends.” And to do so inignorance is not sensible. ■

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… electrics and risk management continuedadjunct, is the broader riskmanagement standard, ISO 14971, whichdetails the procedures and documentsthat companies need to submit formedical devices as a whole. This isparticularly helpful, TÜV says, in that itintroduces a process flow foridentifying, analysing and controllingrisk factors.

“You also then need to see if yourcontrol measures introduce any new

risks, so for example if your controlmeasure is 100% inspection of goodsin, which is often a good idea, you haveto see if you are introducing any newrisks at the goods-in stage.”

The third edition of EN60601demands a risk management file foreach device and the idea is that thisshould introduce some realisticflexibility into the system, rather than asimple pass/fail procedure. The aim is

to be able to show that all foreseeablerisks have been identified and eitherreduced or mitigated, and that theresidual risk is such that the product isas safe as possible.

It also encourages manufacturers totake a broad approach: to look, forexample, not just at electrical safety,but also at the clinical use of devices,and to design for the whole lifecycle ofthe product.

As with the wider medical deviceregulations, the test houses such asTÜV who accredit devices are goodsources of advice and information. Butagain, the changes do requiremanufacturers to take some action:managing compliance with the rules isan integral part of the business ofbeing a medical manufacturer thesedays, and that applies to companiesboth big and small.

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Keeping pace:The rules arechanging alsofor electricalequipmentused in medicaldevices

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