STATE OF THE NATION 2020 - PRODUCT RECALL ALL INDUSTRIES EDITION - DATA , TRENDS & PREDICTIONS FOR EMEA INDUSTRIES - Stericycle Expert Solutions
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
STATE OF THE NATION 2020 PRODUCT RECALL ALL INDUSTRIES EDITION DATA , TR EN DS & P R ED I C TI O N S FO R E M E A I N D U S T R I E S
2020 EMEA STATE OF THE NATION INSIGHTS REPORT Over the course of the year, the expert recall team at Stericycle Expert Solutions has compiled quarterly Spotlight reports* to give manufacturers and retailers an impartial perspective on the past, present and future recall data trends in Europe. The culmination of this research, which includes analysis of recall data and wider market trends, has resulted in the following State of the Nation recall insights report, capturing and explaining cross-industry recall entries for 2019 and making educated predictions on what lies ahead in 2020. This content is designed specifically as a reference guide for manufactuers and retailers to help navigate an ever-changing market, now more so than ever as supply chains become increasingly globalised and complex. There has never been a more important time for industries to be primed and ready for any recall or market withdrawal situations. Pages 4 to 13: Automotive Pages 14 to 19: Pharmaceutical Pages 20 to 27: Medical Device Pages 28 to 35: Electronics Pages 36 to 43: Clothing Pages 44 to 51: Toys Pages 52 to 53: About Stericycle Expert Solutions * Quarterly Spotlight Insight Reports: StericycleExpertSolutions.co.uk/recall-hub/resources/spotlights-indexes
DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 3
AUTOMOTIVE: 2019 OVERVIEW
Needless to say, 2019 has been an interesting year for Since 2016, the quantity of recall notifications due to
recalls in the automotive category. There were a total environmental risks has risen steadily. While the incline
of 510 alerts raised, and all but two were done so as a has been slight (4: 2016, 4: 2017, 2: 2018, 16: 2019),
compulsory measure. it has been significant enough for our team to take
notice because the bigger picture at play intrigues
As usual, the countries with the largest manufacturing us more than the actual numbers themselves.
output had the largest volumes of recalls, but that These nuances in risk types allow us to forecast what
is to be expected for obvious reasons. And these is on the horizon for our clients who rely on us for
figures were pretty much replicated when we looked expert consultancy.
at the notifying countries, because the marques (in
many cases) submitted the notifications themselves.
NUMBER OF RECALLS BY NOTIFYING COUNTRY
This is to be welcomed - responsible manufacturers
will act swiftly to remove an issue after it has been
identified, both to protect existing customers but also 400
its reputation; potential customers may shy away from 350
a brand that has been told to resolve a potentially
300
dangerous issue rather than quickly volunteering to
250
do so.
200
Similarly, the volume of recalls in 2019 almost 150
mimicked the figures noted in the last few years, 100
which made it look like nothing out of the ordinary
50
had happened in the world of automotive recall across
0
EMEA. But that wasn’t true.
Germany
UK
Portugal
France
Italy
NUMBER OF RECALLS BY YEAR
600
500
Responsible manufacturers will
400
act swiftly to remove an issue
300 after it has been identified, to
protect existing customers as
200 well as reputation”
100
0
2016 2017 2018 2019
2020 AUTOMOTIVE SNAPSHOT
Our research into recalls and consumer behaviour in the automotive market
in 2019 unearthed two key trends that will affect this category in 2020.
First of these is the Greta effect, which will take the form of pressure from
consumers to do more to reduce environmental impact of the combustion
engine. The second key player in the auto recall narrative will be smart tech
and its synergy with hacking scandals.
DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 5
AUTOMOTIVE DEEP DIVE
Consumers have been reshaping the automotive However, what we will see across Europe in the coming
industry for as long as it has been around. However, years is collaborations between energy providers and
never before have we seen a shift in consumer OEMs to create better and more numerous charging
behaviour like the new attitudes towards environmental facilities. Companies including Shell, Hyundai and even
responsibility. People are increasingly aware of their McDonalds are now investing in developing convenient
own consumption and are moulding their buying habits charging services to make the lives of their customers
to help the environment in any way they can. This is easier.
something that is not going to go away.
Taking McDonalds in isolation, the fast food restaurant
In 2019, Sero Electric manufactured a National understood the challenges its EV-owning customers
Electric Car in Buenos Aires - a two-seater vehicle with faced when visiting its restaurants, so the company
a top speed of 45kph designed to drive on streets but installed electric car charging stations at its premises in
not highways. The idea was to create an ecological Sweden to encourage them to use their electric cars.
choice to allow drivers to move away from petrol and
diesel cars. As carbon dioxide regulations continue to tighten
across the world in a bid to reduce emissions, it is
While this on its own is a drop in the ocean, on looking expected to become more expensive for OEMs to
at how environmental tech is infiltrating the bigger continue on their path to carbon neutrality. In a paper
brands, it is apparent that we can expect to see recalls by McKinsey & Company (The road to 2020 and
relating to environmental risks in marques increase YoY. beyond: What’s driving the global automotive industry),
which looks at the key drivers for the industry in 2020,
Demand for pure electric cars is anything but it says, “because the easy things have already been
mainstream. Figures from the Society for Motor done, the price of cutting future emissions is rising”.
Manufacturers and Traders (SMMT) for 2019 show The problem is no one really knows which technology
consumers are more than twice as likely to invest in a will prevail as the best in class; therefore, investments
hybrid vehicle than pure EV tech, representing 4.2% of will be made as the pace for more electrification
the market as opposed to 1.6% for EVs. A significant quickens. With this new technology, comes a greater
bottleneck may be availability of charging facilities - chance of recall.
heightening range anxiety.
Since 2010, OEMs have spent $19bn on EVs and
charging technology and $14.3bn on batteries.
OEMs will launch 300 new battery powered EVs by
2025. Knowing this we are expecting recalls relating
2019 shows consumers are
to batteries and lightweight and aerodynamic drag
more than twice as likely to
reducing technologies to increase in 2020.
invest in a hybrid vehicle than
pure EV tech, representing
The uptake of EVs will be relatively low in comparison
4.2% of the market as
to internal combustion engines because there just is not
opposed to 1.6% for EVs.”
enough infrastructure in place to power large quantities
of electric vehicles.
Norway now has more than
250,000 EVs on the roads,
representing 58.4% of sales.”
According to figures released by the European
Automobile Manufacturers Association, electrically
chargeable vehicles, such as battery electric and
plug-in hybrid accounted for 2.4% of sales, with all
alternatively powered vehicles combined making
up 9.2% of the EU market. Petrol vehicles make up
nearly 60% of all new passenger car registrations.
Some countries are leading the way however, with
Norway head and shoulders above other nations -
The International Energy Agency revealed in its
Global EV Outlook that the country now has more
than 250,000 EVs on the roads, representing 58.4%.
It’s no coincidence there are more than 12,000
charging points in the country. They are undoubtedly
the example to follow.
NUMBER OF RECALLS BY COUNTRY OF ORIGIN
China
Rep. of Korea
Poland
Spain
UK
Italy
US
Japan
France
Germany
0 50 100 150
DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 7
SAFETY GATE INSIGHT Electric vehicles and connectivity have remained the core themes of our Recall Spotlight reports for the last year. Manufacturers are in uncharted territory during a period of industrial revolution. The way we live, work, and relate to each other has completely changed in the last decade, enabled by more than just technological advancements. A new breed of motorists are challenging the status quo of the automotive industry and pushing manufacturers to think more about the lives our vehicles help us create, rather than how quickly they think we want to get there. Consumers and regulators alike are increasingly concerned about climate change and they are putting pressure on OEMs to help reduce emissions.
Similarly, automotive manufacturers have been met
with other efficiency issues. As they push to reduce
the weight of their vehicles, the cost of these new
lightweight materials including aluminium and high
intensity steel have increased in line with demand.
That’s to be balanced with new EU fines, with carmakers
to cut average fleet emissions to less than 95g of CO2/
km by 2021. The penalty? €95 for every gramme that
exceeds the target, multiplied by the number of cars
sold that year.
Self-driving cars have been hailed as the answer
to reducing road accidents, however software
shortcomings are regularly exploited by hackers even
before self-driving cars become a reality. For example,
Upstream Auto reported in November that users had
hacked Dacia’s infotainment system - although this was
constrained to changing backdrops - a hacker told Vice
that he was able to hack into popular GPS database
iTrack because all users were given the same default
password. As a result, he was able to demonstrate that
he could kill engines at the flick of a switch. Tesla’s Elon
Musk, meanwhile, congratulated a team of researchers
in China in April last year after they exposed
vulnerabilities in the Model S to hack some of the pure
EV car innovator’s autonomous systems - tricking it into
veering into the opposite lane.
While autonomous cars are still in infancy, the issue of
hacking is something that we as recall experts expect to
become much more common in recalls. We are already
seeing issues with smart TVs, toys and games consoles,
and self-driving cars will soon become a familiar feature
on the data tables. Manufacturers are taking it seriously,
and Tesla - as above - demonstrate terrific foresight
here by working with hackers to eliminate threats.
With smart tech increasingly demanded by consumers
though, and being included in new vehicles at an ever
increasing rate, this will be one of the biggest threats
for manufacturers in 2020.
DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 9SMART LIFE AS WE KNOW IT WILL
ALTER THE DRIVING EXPERIENCE
Cars will be smarter, lighter and more efficient and
motorists will expect a lot from them. Look around any
restaurant, public building, train, car or even hospital
waiting room and you will notice that almost everyone is
fixated on a mobile device.
We believe driving will
become a passive experience
- less about the journey
and more about how the
time spent travelling can be
used as a social efficiency.
Motorists want to take calls,
make appointments, and keep
up with their social circles
while getting from A to B.”
However, the technology is still years away from being
mainstream - as evidenced by McKinsey and Company’s
Future of Mobility report, which suggests one in
20 cars will reach ‘level three’ connectivity in 2020,
which gives each passenger personalised controls, their
own infotainment content - coupled with targeted,
contextualised advertising.
Just like the latest smart phone, people will choose
their cars based on how they will make their lives easier,
more connected and above all - greener. The Greta
Thunbergs of this world are our next generation of
drivers, who will care deeply about the knock-on effect
their behaviour has and personal transport will be under
close scrutiny. Again, Norway leads the way having
already committed to all new cars being zero emission
by 2025; we expect regulation of a similar vein in other
European countries to be passed this year.Known as the Greta Thunberg effect, individuals and
businesses are choosing to offset their emissions by
investing in carbon-reducing projects in developing
countries. At 16 years of age, Ms Thunberg was named
Time’s Person of the Year and has made herself a
posterchild for alternatives to the traditional car; she is
a highly publicised advocate of electric vehicles.
In December 2019, Greta attended the climate summit
in Madrid, arriving in a Seat Mii EV. She refused to fly
to the event, instead travelling by boat. A recent survey
found that one in five travellers is flying less due to the
Greta effect.
As a result, we can expect to see more guilt associated
with getting an SUV/4x4 than a compact town car and
this will start to manifest in sales.
There is a communications
challenge for OEMs to talk
about the ways in which
their bigger (more valuable)
models are eco-friendly - and
to make it happen in practice
- otherwise they’ll start to
see key revenue streams start
to slow down.”
DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 11AUTOMOTIVE CONCLUSION
The internal combustion engine will be around for a long
time still. That said, regulators and consumers are keeping a
watchful eye on how big brands are challenging themselves
to deliver a more environmentally friendly motor vehicle
that is as smart and convenient as their mobile phone.
It is a huge challenge for the industry. However, automotive
manufacturers have never been ones to wait in the wings
for things to get better on their own. Innovation is key to
sustainability. Risks will be taken as they race against each
other to remain competitive with new technology, and with
risk comes recall.
2020 is a pivotal year in deciding whether OEMs will be
pushed into positions by regulators, consumer pressure,
and governments, or whether they will lead the way and
take on a proactive role in helping to transition to an EV
based transport system.
Recalls provide an opportunity for companies to reconnect
with their consumer base and build better loyalty and
advocacy. As damaging as a recall may be, it also presents
a significant (yet, mostly hidden) opportunity if correctly
planned for and executed well.
Planning, testing and testing
again is fundamental to
engineering a vehicle. No
automotive manufacturer
would send a car onto the
production line without
having run rigorous checks.
The same approach applies
to preparing for a recall.”DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 13
PHARMACEUTICAL: 2019 OVERVIEW
In 2019 there were 417 pharmaceutical recall highlighting the importance of investing and acting
notifications submitted by European countries, which on health promotion and disease prevention and
was an increase on the 380 alerts notified in 2018. encouraging the setup of an EU Strategic Framework
The largest volume of recalled products originated for Prevention.
in France (71) closely followed by Portugal (70).
Contamination was the most common issue cited Looking at the President of the European
(94), a sizable uplift from 2018 (49). These findings Commission’s letter, there were only two mentions of
are of note for two reasons. The first, that recalls in “prevention” in the six-page mission instruction. Both
this category are on the up, and the second is their mentions were in the same bullet point under Europe’s
relationship with the upsurge of chronic sickness Beating Cancer Plan.
across Europe.
On 1 December 2019 the President of the European
Commission, Dr Ursula von der Leyen, penned a I want you to put forward
letter to the Commissioner designate for Health and Europe’s Beating Cancer Plan
Food Safety, Stella Kyriakides. The purpose of the to support Member States to
letter was to outline Ms. Kyriakides’s mission. It said improve cancer prevention
that Europeans expect the same peace of mind that and care. This should propose
comes with access to healthcare, safe food to eat and actions to strengthen our
protection against epidemics and diseases. approach at every key stage
of the disease: prevention,
Dr. Leyen pointed out that Europe is becoming an diagnosis, treatment, life
older society and needs more complex and expensive as a cancer survivor and
treatments, bringing sharp focus on the desire to palliative care.”
support the health sector and the professionals
working within it to promote healthy lifestyles and to
co-operate better within the EU. Chronic conditions such as cardiovascular disease,
cancer, respiratory diseases and diabetes are on the
Chronic sickness across Europe is on the rise, which rise across the continent and are the leading causes of
puts pressure on the pharmaceuticals industry to death. Yet the President of the European Commission
research and develop better performing drugs. highlighted only one of the four diseases in her letter
At a time when prevention plays second fiddle to to Ms. Kyriakides, suggesting that treatment in the
treatment, Ms. Kyriakides’ role will be to look at ways other three chronic diseases remains more of a priority
to ensure Europe has a supply of medicines to meet than prevention itself.
its needs. The industry needs her support so that it
maintains its role as innovator and world leader. This leads us to the conclusion that in 2020 and
beyond, investment in treatment will dwarf investment
One month prior to the issuing of this letter, in prevention across the board, resulting in a steady
the President of the European Commission, rise of recalls in pharmaceuticals designed to treat
the European Chronic Disease Alliance (ECDA) cardiovascular and respiratory diseases as well
published a guide for the attention of Ms. Kyriakides, as diabetes.2020 PHARMACEUTICAL SNAPSHOT
Our research into recalls and political shifts in 2019 unearthed two key trends that will affect this category in the
year ahead. The first of these is a fixation on treatment, which will see investment in manufacturing and production
of medicines for chronic illness go up, while R&D for preventative treatments will plateau.
The second key player in the pharmaceutical recall narrative will of course be processing post Brexit which will result
in hyper vigilance around expiration and labelling issues – causing a surge in recalls by every European country
which trades with the UK.
DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 15PHARMACEUTICAL DEEP DIVE
Europeans can expect to live up to 30 years longer The Multiple Sclerosis Society (MSS) issued a guide to
than they did a century ago, in large part thanks to sufferers of the disease in December 2019, to ensure
advancements in pharmaceuticals. Instances of mortality they had a sound understanding of what lies ahead
have reduced in serious illnesses such as cancer and for them in terms of accessing medicines post-31
HIV/AIDS, and problems including high blood pressure January. It stated that “until we know what the final
and cardiovascular diseases are controlled allowing trading arrangements with the EU are, it’s difficult
citizens to live longer, healthier lives. to tell whether there will be extra costs or delays for
medicines and medical devices.”
The European Federation of Pharmaceutical
Industries and Associations (EFPIA) represents the They go on to state that they have been assured that
pharmaceuticals industry operating in Europe. In there are arrangements in place to avoid any shortages.
its report – The Pharmaceutical Industry in Figures: However, with expiration dates front of mind, many
Key Data 2019 – it highlighted the research based European pharmaceuticals manufacturers will be on
pharmaceuticals industry as a key asset of the European high alert and preparing for recalls throughout 2020.
economy and one of the continent’s top performing
high-technology sectors.
Production increased from €194,400m (2010) to
€260,000m (2018). Exports have gone up from
€273,357m (2010) to €410,000m (2018). However,
R&D expenditure has increased from €27,920m to only
€36,500m (2018).
Throughout 2019, the team at Stericycle Expert
Solutions has covered the lack of investment in R&D.
In Q2 2019 the team highlighted a report by Investopia
which stated that, on average, pharmaceutical
companies dedicate approximately 17% of their
budget to R&D which is thought to be as a result of
political pressure. In particular, access to funding, the
sector’s ability to collaborate across the EU in clinical
research and the free movement of goods have left
cause for concern.
The Royal Pharmaceutical Society warned of drug
shortages in a no-deal Brexit, which was in contrast to
the UK Government’s “multi-layered” risk mitigation
strategy. Over three quarters of medicines come to the
UK via the Channel, where disruption is expected to
take six weeks or more after a no-deal Brexit.LOOKING AHEAD TO 2020
At present, the future relationship between the Jorg Geller, spokesperson for the Association of
European Medicines Agency (EMA) and the UK has Pharmaceutical Importers in Germany (VAD) and
yet to be agreed. Both the UK government and the President of the European Federation of Pharmaceutical
MHRA have said that the country’s systems for licensing Importers (EAEPC) echoed the concerns saying:
drugs should be as similar to the EU system as possible, “The scarcity on the European pharmaceutical market
however no one knows what that new system looks like could worsen with the UK’s exit from the EU. We
just yet. fear that after Brexit we will no longer be able to buy
medicines from the UK – but the UK can continue to
Germany’s Chancellor, Angela Merkel, announced buy medicines in the EU. Therefore the market will be
in late December 2019 that Brexit will aggravate imbalanced.”
drug shortages in Germany, with experts warning
pharmaceutical firms will be crippled should a deal not In 2018, 12.9% of all prescription drugs in Germany
be agreed before the end of the transition period. originated from imports, which is thought to be due to
several bottlenecks in its current system. Mr Geller used
the platform to call on the EU to place added pressure
on pharmaceuticals companies to manufacture the
required amount of medicines so that supply falls back
in to line with demand.
At a time when the entire industry is unclear of what
the political unrest means for its future, it is of course
challenging for the team at Stericycle Expert Solutions
to predict exactly what lies ahead. However, what is
crystal clear is that uncertainty results in hyper risk
mitigation strategies, which will impact pharmaceutical
recall figures.
We believe that recalls in this
category will rise throughout
2020 by quite a sizeable
amount. But without an
understanding of what these
new drug licencing systems
look like, we can’t put an
exact figure on it.”
DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 17PHARMACEUTICAL CONCLUSION
The UK accounts for almost a quarter of clinical trial
applications in the EU and is a leader in early-stage
clinical trials, which means it is worth billions. Post
Brexit, the UK market will no longer be looked after
by the European Medicines Agency, therefore a
new industry regulator must assume accountability.
Whether that is to be the MHRA is unclear. What is
clear though is that UK companies are anticipating
a rocky approvals process, more so if the UK exits
with no agreed formal trade treaty.
Of all the industries that
the team at Stericycle
Expert Solutions monitors,
pharmaceuticals is the one
with the most ambiguous
future.”
That said, and as stated previously, this ambiguity
solidifies our belief that recalls in this category
will increase throughout 2020. However, what we
can also be concrete on is that the business heads
at the helm will be making contingency plans for
inevitable recalls that wait on the horizon.DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 19
MEDICAL DEVICE: 2019 OVERVIEW
Innovation is the name of the game when it comes While we await to see if 2019 saw an increase in
to this industry, with manufacturers determined to patents, the year certainly saw an array of medical
find new ways to generate revenue and create new technologies prove their worth - as highlighted
technologies which will benefit healthcare providers by Proclinical in their round-up of the top medical
and patients alike. technologies of the year.
It’s worth noting that, according to the European These included smart inhalers, which send data to
Patent Office’s 2018 annual report, medical technology users’ phones to help track and control asthma.
was the top technology field - with 13,795 patents Wireless brain sensors, meanwhile, allow doctors to
filed. That shows the scale of innovation in the sector, measure temperature and pressure within the brain -
far ahead of the likes of pharma (7,441 patents) and and because the sensors dissolve over time, it negates
biotech (6,742). the need for further invasive surgery.
Wearable health tech continues to be the most
It’s worth noting that, mainstream example of medical devices, with a
according to the European proliferation of people - healthy or otherwise - making
Patent Office’s 2018 annual use of them through popular brands including FitBit
report, medical technology and Apple. Indeed, this subset of medical devices is
was the top technology field - fast becoming its own enormous industry.
with 13,795 patents filed.”
NUMBER OF RECALLS BY NOTIFYING COUNTRY
1,000
900
800
700
600
500
400
300
200
100
0
Germany Italy Denmark United Ireland France
Kingdom2020 MEDICAL DEVICE SNAPSHOT
The medical device industry is set to undergo significant change at the start of the new decade.
From May, European regulations which govern the safety of medical devices will be transformed.
That will force manufacturers to sit up and pay attention.
The new legislation comes at a particularly interesting time, with the trend lines suggesting medical
devices are increasingly being affected by software issues. And with new legal requirements, the
likely consequence is more and more software updates as manufacturers seek to comply with
the updated regulations. Naturally, not all of these software updates will go as planned and will
necessitate further recalls of medical devices – something which manufacturers must begin to plan
for now, or else risk significant damage to their brand reputation.
DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 21MEDICAL DEVICE DEEP DIVE It is difficult to overstate the role medical devices play in today’s society. From diagnosis to treatment - and everything in between - these devices sit at the cutting-edge of medicine today. And according to the European Union, their importance to the economy cannot be overstated either, accounting for around 110bn Euros in sales and 675,000 jobs across the continent. For these companies, the introduction of new legislation will be a massive change. The European Commission has outlined the main elements of these new regulations, which will officially apply to medical devices from May 2020 and in vitro medical devices from May 2022. Improvements include “stricter ex-ante control for high-risk devices... with the involvement of a pool of experts at EU level”. The fundamental aim is to better protect public health and patient safety while boosting confidence in the medical devices industry.” To achieve this, a new risk classification system will be introduced for in vitro diagnostic medical devices, while there will be improved transparency thanks to the creation of an EU database on medical devices. In addition, manufacturers will see a strengthening in post- market surveillance, while EU countries will have improved coordination mechanisms. According to the EU, the new rules “significantly tighten the controls to ensure that medical devices are safe and effective and at the same time foster innovation and improve the competitiveness of the medical device sector. The new rules also better reflect the most recent scientific and technological progress and set the gold standard for medical device regulation globally. The revised rules also provide the conditions needed to consolidate the role of the EU in the long-term as a global leader in the sector.” Manufacturers will welcome the EU’s ambition to ensure innovation is not compromised by the new regulations. They may also welcome more stringent safety checks, recognising the outsized impact faulty products in their sector can have on the end user.
According to MedTech Europe, there are around 27,000 medical technology companies across Europe with most based in Germany, followed by the UK, Italy, Switzerland, Spain and France.” DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 23
MEDICAL DEVICE INSIGHT Across Europe, there are various authorities involved in the regulation of medical devices - as well as other products in the healthcare sector. The European Medicines Agency, a pan- European body, is responsible for maintaining a rapid alert list which includes these authorities across member states as well as the European Commission and international bodies. For example, in the UK the responsibility lies with the Medicines and Healthcare Products Regulatory Agency (MHRA). And looking at agencies like the MHRA and its counterparts, we can paint an accurate picture of the medical device recall landscape across Europe. In 2019, there was a total of 2,841 recalls – a significant number. The first three months of the year started relatively low, with just 309 recalls placed. However, there was a noteworthy jump in April, May and June with 647 recalls recorded. That figure did drop in the third quarter of the year, albeit by only 8 per cent to 593. And in the final three months of the decade, there was a significant increase with a total of 1,292 recalls in the quarter. Digging deeper, the stats show that the United States was the largest country of origin when it comes to recalled medical devices. Several of the world’s leading manufacturers are based in the US - including Johnson & Johnson, General Electric and Medtronic. Indeed, seven of the top ten manufacturers in the industry are American. Therefore, the US being the most significant country of origin is to be thoroughly expected. In total, the US was the country of origin for 703 recalls – but was closely followed by Germany with 647. There was a hefty European presence rounding out the list, with the United Kingdom, Italy, Republic of Ireland, Denmark and France all producing more than 100 medical devices which were recalled in 2019. The majority (61%) of recalls were attributed to quality issues, a wide-ranging term that covers all manner of problems. But the second largest reason was software, which was cited in 350 recalls (13%).
This will be of interest to manufacturers across EMEA, with
software anticipated to play a bigger role in medical devices
in the coming years. Manufacturers will be keen to ensure they
can avoid these software problems as much as possible, while
regulators across EMEA will be maintaining a close watch.
In our Q3 Spotlight Report, we highlighted findings from
Transparency Market Research which said that “software is
driving incredible advancements in medical technology and
opening up exciting opportunities for decentralised healthcare.
But, at the same time, software is also the leading cause of
device recalls and failures prompting calls for a shift in focus”.
We also cited an alert issued by the United Kingdom on a
Dialog+ haemodialysis machine which was at risk of malfunction
due to its temperature sensor. This risked the dialysis fluid being
the incorrect temperature with a potentially negative effect on
patient treatment.
But it’s not simply safety issues that pose a problem. There
are real fears around security of medical devices. This has led
to the Advanced Medical Technology Association to develop
five principles designed to ensure devices are secure: an
effective cybersecurity risk management programme, system-
level security, coordinated disclosure, information sharing and
regulatory requirements.
These principles are something all manufacturers should bear in
mind, but the reality is that quality issues – rather than security
issues – are the most pressing concern.
NUMBER OF RECALLS BY COUNTRY OF ORIGIN
France
Denmark
Rep. of Ireland
Italy
UK
Germany
USA
0 200 400 600 800
DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 25MEDICAL DEVICE CONCLUSION
The introduction of new regulations is set to be a
gamechanger for medical device manufacturers throughout
Europe – as well as those who operate overseas and wish to
sell their products on the continent.
With quality issues remaining the fundamental reason for
medical device recalls in the main, it is hoped that these new
regulations will go a long way to protecting patients from
devices which may not do the job they are intended to do.
But change is difficult. Many manufacturers will fall foul of
the new regulations and be caught on the back foot. That
may result in recall action being necessary, but the reality is
that this does not have to have a devastating impact on your
business.
The most important step a company can take when it comes
to recalls is planning for them, so that if they do end up
being required there is a clear plan in place to handle them
effectively – ensuring minimal damage to your brand while
also limiting any potential effects for those using the devices.
And with software failure a growing issue facing medical
device manufacturers, greater attention must be paid to
managing those vulnerabilities once a product is in market -
with software patches commonplace. Of course, as with any
software, manufacturers will have to beware of potential cyber
threats which could jeopardise the safety of their products.
The new decade, then, is certainly one which manufacturers
will enter with potential wariness. But there is also huge
opportunity - according to expert analysis, the worldwide
medical technology sector could grow by 5.6 per cent to
With software failure
$595bn by 2024. It’s truly an exciting time for the industry.
a growing issue
facing medical device
This report should serve as a guide to businesses when
manufacturers, greater
planning and evaluating recall strategies. We can’t forget that
attention must be paid
recalls are commonplace and if planned for and executed
to managing those
properly, brands can come out the other end with minimal
vulnerabilities once a
reputational damage. In such instances, they present a
product is in market.”
significant – yet mostly hidden – opportunity to reconnect
with customers and build better loyalty – even advocacy.DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 27
ELECTRONICS: 2019 OVERVIEW
With electronic devices more and more commonplace outset is key to being confident that the product
in our everyday life, you might think electrical you sell is fit for the market. Spain and Poland were
appliances and equipment would be one of the more the only other nations to register more than one of
populated recall categories, however, 2019 has been their products being recalled, with only seven other
roughly on track with previous years – despite the countries appearing on the list, with one recall each.
increase in complex handheld or wearable devices. In
fact, the first three quarters of 2019 matched exactly Looking at reasons for recall, electric shock was by
the number of recalls in 2018 – which up until then had far the most common risk factor, accounting for 170
been on a steady upward trend since 2015. recalls in total. With 32 risks of burns and 41 for fire,
quality of wiring clearly remains an issue. Meanwhile,
In total, there were 220 recalls in the category for there were two notifications for cuts and two for
2019, of which 172 were listed as electrical appliances injuries, while environmental concerns were risks for
and equipment, three were listed as ‘gadgets’ and five of the products recalled. Of course, multiple risk
45 lighting appliances. China is once again listed as factors can be listed against one product recalled.
the nation from which most recalled electronic items
originated with a modest increase in the number of Meanwhile, the UK (31), Sweden (34) and Hungary (36)
recalls in 2019, up three from 2018. lodged the most notifications of a product that doesn’t
meet marketplace standards – while 120 of the 220
China had 137 products recalled over the year. By recalls in the year were compulsory, 87 were voluntary
comparison Turkey, with just five recalls, had the and 13 were both compulsory and voluntary. That so
second most products recalled. With just three, many of the recalls were compulsory is concerning, as
Vietnam was third highest. Seven recalls were for it indicates that the risk to the public was deemed very
products without a known originating country – which serious indeed. Long term, it’s hoped this number
should raise alarm bells particularly for buyers. Being will reduce.
able to clearly identify the supply chain from the
NUMBER OF RECALLS BY NOTIFYING COUNTRY
35
30 Electrical Safety First said 98
25 per cent of ‘fake’ chargers
20 ‘put consumers at risk of
lethal electric shock and fire’,
15
something we predicted would
10 be a trend for the remainder of
5 2019 and into 2020 in our Q3
0
Recall Spotlight.”
UK
Sweden
Hungary
Finland
Germany2020 ELECTRONICS SNAPSHOT
Wireless and wearable tech is the growth trend for consumer electronics
in 2020, with mobile phones being hubs for development in associated
technology in recent years. However, cheaper innovations that don’t adhere
to the same manufacturing or safety standards started to flood the market
in 2019, which means OEMs and retailers will have to be on their guard for a
proliferation of phonies in other accessories.
DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 29ELECTRONICS DEEP DIVE The days of mobile phones themselves being the focus of attention for electronic recalls seem behind us. However, their ghost lingers on – with battery chargers for portable devices the biggest single item recalled during 2019, accounting for 66 of the 220 recalls for the year. Seven items were also listed as counterfeit, demonstrating that Europe is still under attack from fraudsters. Stories of chargers combusting or exploding in the home have, sadly, become commonplace in European press; with the continued influx of fake chargers identified as a culprit. So bad had the problem become, that in March the London Fire Brigade joined Devon and Somerset Fire Service in issuing warnings against using fake chargers, with poor quality parts and wiring the main cause of blazes. Similar issues have been reported across Europe, with Germany’s loss prevention institute, the Institut für Schadenverhütung und Schadenforschung der öffentlichen Versicherer, repeatedly issuing warnings throughout the last year over the dangers associated with chargers and poor quality batteries. Electrical Safety First said 98 per cent of ‘fake’ chargers ‘put consumers at risk of lethal electric shock and fire’, something we predicted would be a trend for the remainder of 2019 and into 2020 in our Q3 Recall Spotlight.
Yet, problems keep being reported. In September of
2019, a young woman was burned after her necklace
touched the end of a charger beneath her pillow. Her
phone was not connected at the time, but the contact
still caused an electrical current to flow through the
charger, resulting in the teenager suffering severe
burns to her neck.
And phony phone chargers were subject to more
negative press when in August 2019, a hacker unveiled
a device that mimicked a charger – to the extent it
would charge your phone while plugged into the wall.
However, it was also fitted with a microchip that could
allow a hacker to access a backdoor into your phone –
placing not just your physical safety at risk by using a
poor quality device, but your personal data also.
Revealing his replica Lightning cable, security
researcher Mike Grover told Motherboard: “It looks
like a legitimate cable and works just like one. Not
even your computer will notice a difference. Until I, as
an attacker, wirelessly take control of the cable.”
Such stories will serve as a warning for retailers and
consumers to always seek out official products.
Poor quality travel adaptors were cited 15 times for
recalls in the period, and mains extension leads five
times – with lack of adherence to manufacturing
standards, exposure to live connections and missing
earth connections among the reasons that validate the
need for proper quality control during manufacturing.
DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 31SAFETY GATE INSIGHT With mobile phones, tablets and e-readers as popular as ever, and official charging cables an expensive alternative to cheaper unbranded goods on e-commerce websites, it is highly unlikely that the surge of fake chargers flooding the market will show any sign of abating. While increased scrutiny of the market will mean more of these dangerous devices will be intercepted, it’s anticipated that this will continue to be an issue in 2020 until improved legislation is introduced.
However, it is the consumer behaviour revealed by the While burns and electric shock risks are likely to be
number of fake chargers on the market that we believe relatively minor due to the limited battery charge
reveals the big trends to look out for in 2020 required by such devices, there are other risks inherent
– affordable ‘imitation innovations’. Our 2019 Q3 Recall with any device – particularly one which is designed to
Spotlight discussed research by Which? that more than be inserted into your ear canal.
70% of lookalike Apple products failed safety tests
– highlighting the importance of legitimate products.
This issue was previously highlighted in our Q2 Recall
Spotlight, which showed that most chargers on Amazon We expect to see a flood of
do not fully comply with USB-C specification. fake or poor quality devices
coming into Europe in 2020,
Put simply, without demand, there’s rarely supply – and with counterfeit wireless
the fake charger market is worth hundreds of millions of headphones, smart watches
Euros every year. Underlining the scale of opportunity and fitness trackers.”
for fraudsters, a single seizure of fake chargers by West
Sussex Council removed £1.3million of counterfeits
from the UK market. Consumers want cutting edge
technology, they just don’t always want to pay for it. Any dramatic failure that would result in the
It is for that reason that fake mobile phone chargers headphones coming apart could result in a painful
are popular. injury or procedure to remove parts that fall into the
canal itself. And should a wire become exposed, even
A study by French news outlet Euractiv said that relatively minor burns caused by the devices could have
counterfeiting cost the EU €85billion every year long-lasting impacts on the user. Many issues like this
– around five percent of imports into the EU – with may be revealed by reading through product reviews,
websites and e-commerce most frequently used by but consumers should be aware of fake reviews too.
fraudsters to sell their goods. And with wearable tech Consumer advice site Fakespot last year warned that a
becoming increasingly affordable, we expect to see third of online reviews on major online retailers are fake.
a flood of fake or poor quality devices coming into
Europe in 2020, with counterfeit wireless headphones, It is, however, in chemical contamination that we see
smart watches and fitness trackers the trends to watch the greatest risk in affordable duplicate devices. Six
for over the next 12 months. Such is the anticipated separate models of headphones were recalled in
scale of the issue, that noted audiophile website 2019, all of which tested positive for chemicals either
WhatHiFi has taken the unusual step of producing a prohibited for use in such products, or in excess
buyers’ guide on how to avoid fake headphones. quantities. Predominantly, this revolved around the use
of short-chain chlorinated paraffins. Used in industrial
The catalyst for this is the miniaturisation of wireless solvents, these chemicals bio-accumulate and can
technology, with even budget wireless in-ear poison the user. They can also cause environmental
headphones becoming readily available on e-commerce contamination.
sites. A cursory search on one popular website found
in-ear wireless headphones on sale for as little as 99p. Other headphones contained lead solder in
While it is likely consumers will try them because of the concentrations greater than is allowed – and could
tiny cost, such products come with dangers. result in lead poisoning over time.
DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 33ELECTRONICS CONCLUSION
You don’t have to look too far back into the history books to
see that safety standards in electronic devices have improved
significantly – especially in the last decade.
While innovation, miniaturisation and new materials are responsible
for some of that progress, there’s little doubt that legislation and
improved safety standards have driven this forward. However, the
pace of change in this market is unprecedented, and regulators are
struggling to keep up with innovation.
The continued roll out of 5G is a perfect example of how quickly the
market changes – and with 95% of households in the UK owning a
mobile phone, according to Statista, this fundamental change to the
infrastructure will prompt a wave of new handsets.
That is why it is so important that we continue to scrutinise what
comes into the market, to ensure that the safety of people is not
compromised by a desire to keep up with the latest tech without
the financial hardship.
We live in a society now that looks upon having the latest wireless,
wearable or portable tech as much as a status symbol as a useful
function; so the desire to ‘keep up with the Joneses’ is as much the
reason for the flourishing trade in fake tech as anything else.
With such a lucrative market to exploit, the influx of imitation tech
will continue to rise, placing an onus on manufacturers, distributers
and retailers to respond – and ensure the true products aren’t
overpriced or dis-incentivised when compared to the copycats.
The continued roll out of 5G is a
perfect example of how quickly the
market changes – and with 95%
of households in the UK owning
a mobile phone, this fundamental
change to the infrastructure will
prompt a wave of new handsets.”DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 35
CLOTHING: 2019 OVERVIEW
2019 saw a decrease in the number of alerts placed
in the clothing, fashion and textiles category, falling
from 221 in 2018 to 171 in 2019. A wider trend of
China was followed by
recalls slowing in this market seems to be emerging
Turkey, Italy and Greece with
as, when we look at 2017 (250 notices) and 2016 (245
27, 17 and 15 alerts placed
notices), this year has been markedly lower. In 2019
respectively. Recalls from
the most significant amount of alerts placed were for
other countries of origin were
injuries, (63), strangulation (37), chemical risks (32) and
minimal, with the three above
choking (26).
being the ones to watch.”
The reduction in the number of recalls could be for
many reasons, however we observed a drastic fall in
alerts placed due to a risk of choking (down from
61 in 2018 and 60 in 2017). This suggests the industry Cyprus was the country placing most alerts, with
has taken note and reacted in response to the rising 70 across the year – more than triple that of Germany,
risk, perhaps increasing health and safety and testing who placed the second highest amount of alerts
measures. In addition to this, the fact many of the (22). All of Cyprus’s risks were either injuries or
recalls related to children’s clothing such as hooded strangulation, and all products recalled were children’s
sweatshirts with drawstrings may cause companies to apparel, which may be why alerts are so high.
be extra vigilant.
The vast majority of products recalled (87%) were
There was also a decline in recalls due to chemical children’s and babies’ clothing items including dresses,
risk, almost halving from 68 in 2016 to 32 in 2019. This sweatshirts, tracksuits and shoes, with many relating
reduction may be because in 2018 the EU restricted to the dangers of drawstrings and chords within the
more than 30 hazardous substances from clothing, so clothing items. Other items with recalls, although
the positive effects of this ban may already be coming minimal in numbers, were leather items (10) and
into play. wallets (2), however recalls were negligible which
suggests this was just a blip.
Interestingly, recalls for environmental reasons
have been on the up over the past decade, from A total of 21 recalls were linked to the use of
none in 2009 to three in 2019 – although they still dangerous chemicals including chromium in leather
remain lower than any other risk. Products receiving goods, which has the potential to cause allergic
this notice were three different wallets containing reactions, however it seems this trend is in decline,
chlorinated paraffins, dangerous to aquatic life as well with figures half that of 2017, where there were
as humans and wildlife. While recalls of this nature 43 recalls linked to chromium.
remain marginal, it could be indicative of what’s to
come as we head towards a sustainable future. Three recalls of jewellery items – two in Germany
and one in Sweden – were related to the presence of
As has been the case for a number of years, China cadmium – a neurotoxin. Small amounts of cadmium
remained the country of origin with the highest may be added to alloys used to make jewellery to
amount of alerts placed (60), which is unsurprising impart specific technical and functional attributes to
given its status as a manufacturing powerhouse. the metals, and can cause kidney and bone damage.2020 CLOTHING SNAPSHOT
Extensive industry analysis, taking into consideration global trends and existing statistics, has allowed us to
predict any key trends we may see in the year ahead. We’ve identified the rise of environmental risks, the
rising dangers of chemicals and injury risks from a more globalised and unregulated supply chain.
Within each of these trends is a number of factors to consider, which we’ll delve into in more detail later in
the report.
For further insight and context, view the Stericycle Expert Solutions quarterly Spotlight reports here:
https://www.stericycleexpertsolutions.co.uk/recall-hub/resources/spotlights-indexes
DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 37CLOTHING DEEP DIVE
The past year has seen some key themes emerge, many While our minds may automatically think of food and
of which we will be paying close attention to in the drink when the word ‘allergy’ is mentioned, a trend
coming months. we’ve seen emerging in the clothing and textiles
industry over the past few years is recalls of leather
As previously mentioned, the items most affected products due to a high volume of chromium.
by recalls are those pertaining to children, which is
expected as any risks are treated with the seriousness Real leather products undergo a tanning process using
they deserve if a young life is endangered. From chromium, which can sometimes exceed safe levels.
clothing to bedding, it seems recalls in this category, This is something that was observed as we entered
although slowing, are still very prevalent and sustained the year, and recalls have gone on to increase
throughout the course of the year. steadily throughout.
For retailers and manufacturers, one area to pay
attention to is online parenting forums. Parents can be
quick to raise alarms on these sites when it comes to Although figures for 2019 are
the safety of their children, and they must be regularly lower than previous years, a
monitored to ensure any potentially dangerous situation total of 21 recalls linked to
can be identified and acted upon. While no instances unsafe levels of chromium are
from the clothing category have yet been escalated still enough for retailers to
on such forums, other categories have been affected, be taking notice. A total of 17
including the pharmaceutical industry when users of of these alerts were placed
Mumsnet called for a boycott of Calpol, the result by Germany, with the others
of which hit headlines, highlighting the power these coming from Finland, Estonia
websites have. and Spain.”
Elsewhere, as risks including burns and fire have
reduced, we’ve seen hazards to the environment slowly
creep up. While all the reasons for now remain the use
NUMBER OF RECALLS BY NOTIFYING COUNTRY
of chlorinated paraffins, cheap materials and synthetic
fibres, we might expect more recalls of this nature
going forward. 80
70
For another year, one of the key reasons for recall
60
continues to be chemical risks. As the world becomes
50
more aware of supply chains and customers demand to
40
know the process by which their clothing is made, we
might expect more attention to focus on the chemicals 30
used in production as unlike food packaging, our 20
clothing doesn’t contain an ‘ingredients’ list. 10
0
Cyprus Germany Bulgaria Hungary RomaniaDATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 39
LOOKING AHEAD FOR 2020
A wider look at clothing trends that we might expect in to increase in the coming months and years. A recent
2020 considers the potential impact of fast fashion on report by Grand View Research revealed that the global
recalls, something we highlighted in the Q2 Spotlight leather industry is expected to reach $629.65bn USD by
report. Governments are facing pressure to act in response 2025 and, as demand continues to increase, we might
to growing numbers of manufacturers using chemicals expect to see further recalls as more items are produced
and materials dangerous to not only humans, but the and sold globally.
environment too, including non-biodegradable synthetics.
With recalls for children’s clothing reaching all-time
In the race to mass-produce, we’ve seen a rise of products highs this year, one might wonder why dangerous items
with cheap materials recalled and clothing that has been are continuing to be sold at a time when health and
bleached is leaking into water systems. It’s only a matter of safety regulations are at their most stringent? Simple
time before a more serious environmental disaster occurs. yet important design errors could mean the difference
between life and serious injury or, at worst, death. Loose,
Sweden was the first country to react, when in December long chords are easily caught, especially when children
it placed a higher tax on clothing containing harmful are running around and playing and not necessarily being
chemicals. This is the first step in phasing out – and it’s aware of their surroundings.
something manufacturers need to be aware of when
considering textiles going forward. This trend is only going One reason for a rise in recalls could be the emergence
to spread across Europe. of online marketplaces peppered with unregulated third-
party sellers, largely originating from China, who do not
Next, and linking back to the rise in the number of recalls adhere with European health and safety regulations. This
due to allergies as mentioned previously, we’d expect this is not isolated to the clothing category, it’s an issue thatwe’ve observed more broadly in categories like toys and
electrical, including phone chargers and battery packs.
With 2018 sales from global marketplace merchants using
Amazon Marketplace topping $160bn, it is a potentially
lucrative and relatively easy way for sellers to make money. As we mentioned previously,
China is already the country
We all remember a couple of years ago when the world’s of origin of most recalls, and
attention was brought to the dangers of flammable with 58% of Amazon’s sales
children’s clothing – particularly Halloween costumes. from third-party sellers, we
Although we didn’t observe any recalls of this nature in might expect regulators,
2019, a national newspaper recently revealed the problem manufacturers and retailers
is still very much in existence when it tested several to be looking with an even
costumes from leading retailers – all of which went up in closer microscope in the
flames in a matter of seconds. coming months.”
Under EU rules, fancy dress costumes are technically
classed as toys meaning they don’t need to go through
strict flammability tests – however, as regulators are
lobbied to change these rules, we might see these items
come under the same scrutiny as clothing in the very near
future.
DATA, TRENDS & PREDICTIONS FOR EMEA INDUSTRY: PAGE 41You can also read
