Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations
Abstract
Introduction: Medical devices are healthcare technologies with a significantly growing market worldwide. This study aims to analyze medical device alerts issued by the Portuguese Medicines Agency, INFARMED, I.P. during 2017, as well as to identify the respective regulatory actions and to suggest additional recommendations. Material and Methods: All alerts on medical device alerts publicly available in the website of INFARMED, I.P. were identified and analyzed, including actions taken. Additionally, reports on medical devices from the Portuguese national competent authorities were compared with reports from other European Union member states such as Germany. Results: A total of 32 safety alerts were identified: 18 (56%) related with devices without identified records of commercialization in Portugal, six (19%) related with devices voluntarily withdrawn from the market, such as counterfeit products, and eight (25%) categorized as ‘other’. In both Portugal and Germany, 0.28 and 4.53 reports of national competent authorities per million inhabitants were identified, respectively. Diverse regulatory actions were taken, such as six compulsory indications to not acquire or use devices. Discussion: Considering that the European Union is an open market where citizens should have equal access to medical devices, the Portuguese system of medical device safety alerts seems to be functioning normally. The identified safety alerts seemed relevant, with Portugal registering a proportionally slightly lower number of alerts when compared with higher sales volume markets, which may be explained by an underreporting of this type of problems. Further studies are needed to confirm these preliminary results, although the development of databases comprising data on patients using medical devices is recommended in order to generate automatic email and text message alerts. Conclusion: A limited number of safety alerts on medical devices was identified in Portugal, with few reported cases of counterfeit or falsified devices. The Portuguese Medicines Agency contributes to the citizens’ access to quality medical devices, by issuing safety alerts, recommendations and mandatory market withdrawals for unsuitable or unsafe medical devices.
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ARTIGO ORIGINAL
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RESUMO
In odução: Os disposi i os médicos são ecnologias de saúde com um signi ica i o c escimen o a ní el mundial. Foi obje i o des e
abalho analisa os ale as sob e disposi i os médicos emi idos pela Agência Po uguesa do Medicamen o: INFARMED, I.P. du an e
2017, iden i ica as espe i as ações egula ó ias e suge i ecomendações.
Ma e ial e Mé odos: Todos os ale as e ações sob e disposi i os médicos publicamen e disponí eis no websi e do INFARMED, I.P.
o am iden i icados e analisados. Adicionalmen e, os ela ó ios da au o idade compe en e nacional sob e disposi i os médicos o am
compa ados com ela ó ios de ou os países da União Eu opeia como a Alemanha.
Resul ados: Iden i icou-se um o al de 32 ale as de segu ança de disposi i os médicos: 18 (56%) sem egis os de come cialização
em Po ugal, seis (19%) olun a iamen e e i ados do me cado, como p odu os con a ei os, e oi o (25%) ca ego izados como ‘ou os’.
Em Po ugal e na Alemanha o am iden i icados 0,28 e 4,53 ela ó ios de au o idades compe en es po milhão de habi an es, espe i-
amen e. Di e sas ações egulamen a es o am omadas, como seis indicações ob iga ó ias pa a não adqui i ou u iliza disposi i os
médicos.
Discussão: Conside ando que a União Eu opeia é um me cado abe o no qual os cidadãos de êm igual acesso à u ilização de dis-
posi i os médicos, o sis ema Po uguês de ale as de segu ança sob e es es disposi i os pa ece e uma a i idade no mal. Os ale as
de segu ança iden i icados apa en am se ele an es, com Po ugal a egis a um núme o ligei amen e in e io de ale as quando
p opo cionalmen e compa ado com ou os me cados de maio olume de endas, o que e en ualmen e pode se explicado po uma
subno i icação des e ipo de p oblemas. São necessá ios es udos adicionais pa a con i ma es es esul ados p elimina es, sendo o
desen ol imen o de bases de dados sob e o uso de disposi i os médicos pelos doen es ecomendado de o ma a ge a emails e
ale as ele ónicos au omá icos.
Conclusão: Foi iden i icado um núme o limi ado de ale as de segu ança em disposi i os médicos em Po ugal, com escassas no i-
icações de con a ação ou alsi icação. A Agência Po uguesa de Medicamen os con ibui pa a o acesso dos cidadãos a disposi i os
médicos de qualidade, a a és da emissão de ale as de segu ança, ecomendações e e i ada ob iga ó ia de disposi i os médicos
Analysis o Medical De ice Ale s Issued by he
Po uguese Medicines Agency: Scoping he Pu pose o
New Regula o y Recommenda ions
Análise dos Ale as Sob e os Disposi i os Médicos
Emi idos pela Agência Po uguesa do Medicamen o:
Delineando o P opósi o de No as Recomendações
Regula ó ias
1. Resea ch Cen e o Biosciences and Heal h Technologies. Uni e sidade Lusó ona. Lisboa. Po ugal.
2. Depa amen o de Sócio-Fa mácia. Faculdade de Fa mácia. Uni e sidade de Lisboa. Lisboa. Po ugal.
Au o co esponden e: Ca la Pi es. [email p o ec ed]
Recebido: 11 de janei o de 2020 - Acei e: 12 de maio de 2020 - Online issue published: 01 de ma ço de 2021
Copy igh © O dem dos Médicos 2021
Ca la PIRES1, Dinah DUARTE1, A onso CAVACO2
Ac a Med Po 2021 Ma ;34(3):201-208 ▪ h ps://doi.o g/10.20344/amp.13419
ABSTRACT
In oduc ion: Medical de ices a e heal hca e echnologies wi h a signi ican ly g owing ma ke wo ldwide. This s udy aims o analyze
medical de ice ale s issued by he Po uguese Medicines Agency, INFARMED, I.P. du ing 2017, as well as o iden i y he espec i e
egula o y ac ions and o sugges addi ional ecommenda ions.
Ma e ial and Me hods: All ale s on medical de ice ale s publicly a ailable in he websi e o INFARMED, I.P. we e iden i ied and
analyzed, including ac ions aken. Addi ionally, epo s on medical de ices om he Po uguese na ional compe en au ho i ies we e
compa ed wi h epo s om o he Eu opean Union membe s a es such as Ge many.
Resul s: A o al o 32 sa e y ale s we e iden i ied: 18 (56%) ela ed wi h de ices wi hou iden i ied eco ds o comme cializa ion in Po -
ugal, six (19%) ela ed wi h de ices olun a ily wi hd awn om he ma ke , such as coun e ei p oduc s, and eigh (25%) ca ego ized
as ‘o he ’. In bo h Po ugal and Ge many, 0.28 and 4.53 epo s o na ional compe en au ho i ies pe million inhabi an s we e iden i ied,
espec i ely. Di e se egula o y ac ions we e aken, such as six compulso y indica ions o no acqui e o use de ices.
Discussion: Conside ing ha he Eu opean Union is an open ma ke whe e ci izens should ha e equal access o medical de ices, he
Po uguese sys em o medical de ice sa e y ale s seems o be unc ioning no mally. The iden i ied sa e y ale s seemed ele an , wi h
Po ugal egis e ing a p opo ionally sligh ly lowe numbe o ale s when compa ed wi h highe sales olume ma ke s, which may be
explained by an unde epo ing o his ype o p oblems. Fu he s udies a e needed o con i m hese p elimina y esul s, al hough he
de elopmen o da abases comp ising da a on pa ien s using medical de ices is ecommended in o de o gene a e au oma ic email
and ex message ale s.
Conclusion: A limi ed numbe o sa e y ale s on medical de ices was iden i ied in Po ugal, wi h ew epo ed cases o coun e ei o
alsi ied de ices. The Po uguese Medicines Agency con ibu es o he ci izens’ access o quali y medical de ices, by issuing sa e y
ale s, ecommenda ions and manda o y ma ke wi hd awals o unsui able o unsa e medical de ices.
Keywo ds: Equipmen and Supplies; Pa ien Sa e y/legisla ion & ju isp udence
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Re is a C ie n í ic a d a O de m do s M édi co s ww w.ac am ed ic a po u gu es a.c om
Pi es C, e al. Medical de ice ale s in Po ugal, Ac a Med Po 2021 Ma ;34(3):201-208
INTRODUCTION
The Po uguese Law-Dec ee 145/2009 is based on he
co esponding Eu opean Union (EU) di ec i e 93/42/EEC.1
This Law-Dec ee de ines a medical de ice (MD) as “any
ins umen , appa a us, appliance, equipmen , ma e ial o
ano he a icle, whe he used alone o in combina ion, in-
cluding he so wa e necessa y o i s p ope applica ion
in ended by he manu ac u e , o be used o human be-
ings o he pu pose o diagnosing, p e en ing, con olling,
ea ing o a enua ing a disease; diagnosing, con olling,
ea ing, a enua ing o compensa ing o a lesion o a de i-
ciency; s udying, subs i u ing o al e ing he ana omy o one
physiologic p ocess; and bi h con ol.”
MDs a e classi ied as (i) MDs o class I o low- isk de-
ices (e.g., diape s, incon inence pads, elas ic s ockings,
walking aids, e c.); (ii) MDs wi h a medium isk belong o
classes IIa (e.g., hyd ophilic gauze, u ina y ca he e s, sy-
inges, e c.) o IIb (e.g., insulin pens, diaph agms, con ac
lenses), wi h a likely highe isk in IIb when compa ed wi h
IIa; and (iii) MDs o class III o MDs o high isk (e.g., con-
doms wi h spe micides, in au e ine de ice ha does no
elease p oges ogens, e c.). This classi ica ion is based on
isk c i e ia, such as he ime, deg ee o loca ion o con ac
be ween a MD and he human body, since some MDs a e
mo e in asi e han o he s o a e mean o ch onic use.2
Conside ing he egula ion 2017/746 o he Eu opean Pa -
liamen and o he Council o he 5 h Ap il 2017 on in i o
diagnos ic medical de ices (p elimina y poin 10): “all es s
ha p o ide in o ma ion on he p edisposi ion o a medical
condi ion o a disease, such as gene ic es s, and es s ha
p o ide in o ma ion o p edic ea men esponse o eac-
ions, such as companion diagnos ics, a e in i o diagnos-
ic MDs”.3
Addi ionally, MDs mus ha e a con o mi é eu opéenne
(CE) ma k, which is a con o mi y sign p o ing he de ice
is complian wi h he ele an di ec i es. De ices wi h his
ma k may be ma ke ed in any EU coun y.1-4 The con o mi y
assessmen p ocedu es o MDs may be ca ied ou unde
he esponsibili y o he manu ac u e s o Class I de ices
(gene al ule). Class IIa de ices equi e he in e en ion o a
no i ied body (NB), i.e. bodies esponsible o he con o mi y
assessmen o MDs a e p oduc ion. NBs a e designa ed
by he EU membe s a es and each membe s a e shall
no i y he Commission, as well as he emaining membe
s a es abou he designa ed bodies. NBs may ask he man-
u ac u e o in o ma ion o da a o es ablishing/main ain-
ing he a es a ion o con o mi y o MDs. Classes IIb and III
necessa ily equi e he inspec ion by a NB conce ning he
design and manu ac u e o MDs. Class III p oduc s explici ly
equi e p io au ho iza ion ega ding con o mi y be o e be-
ing placed on he ma ke .1
In he EU, he ma ke o MDs comp ises a ound 27 000
companies: 95% small and medium-sized en e p ises, wi h
g ea inno a ion e o s: on a e age, a new pa en is issued
e e y 40 minu es and he p oduc li ecycle is app oxima ely
o 18 mon hs. These companies employ o e 675 000 wo k-
e s, pa icipa ing in a g owing ma ke (o e €110 billion).
The key end o MD indus ies on cos e iciency is based
on he compulso y c ea ion o alue o paye s and pa ien s,
which is in ended o ensu e ha use s o MDs bene i in
e ms o he p oduc ’s e icacy, sa e y, e iciency, and cos .
Fo ins ance, Aus alian impo e s a e speci ically o ien ed
o acqui e cos -e ec i e MDs, which can imp o e pa ien
heal h ou comes and educe heal hca e cos s due o he
inc easing numbe o an aging popula ion.5
The egula ions on MDs co e di e se aspec s o p od-
uc de elopmen and igilance sys ems, om design o
manu ac u e, clinical es ing, au ho iza ion and pos -ma ke
su eillance.6 Al hough pos -ma ke ing su eillance is es-
sen ial in he de ec ion o non-con o mi ies, quali y issues,
ad e se e en s, o he p esence o alsi ied de ices in he
ma ke ,7,8 a speci ic pos -ma ke su eillance sys em o
medical de ices was only de ined h ough a ecen /new
Eu opean Commission egula ion (EC 2017/745) on medi-
cal de ices in he EU (Chap e VII).9 The 520/2012 EC
Regula ion es ablished a speci ic pha maco igilance sys-
em o medicinal p oduc s,10 al hough a p e ious Council
Di ec i e (93/42/EEC) s a ed ha he p o ec ion o heal h
and he associa ed con ols should be mo e e ec i e by
means o medical de ice igilance sys ems, in eg a ed a
Communi y le el.1,9 In his sense, he Eu opean Da abase
on Medical De ices (EUDAMED) is he in o ma ion sys em
o exchanging legal in o ma ion ela ed o he applica ion o
EU Di ec i es on MDs.7,11,12
Acco ding o he publicly a ailable in o ma ion o he
EU, he o e all numbe o egis e ed ad e se MD e en s
has been s able o he las i e yea s, despi e he cons an
ma ke g ow h.12
In Po ugal, i he ollowing no i ica ions o inciden s and
sa e y co ec i e ac ions ela ed o MDs a e epo ed in he
o icial medicines s a is ics om INFARMED, I.P. (n = MDs
egis e ed/no i ied un il he end o he yea ): 1542 (n = 199
823) in 2014, 1479 (n = 207 443) in 2015, 1790 (n = 226
948) in 2016, 1645 (n = 244 138) in 2017 and 1741 (n = 277
834) in 2018.13
Conside ing he NCAR (Na ional Compe en Au ho i ies
Repo s) om 17 EU coun ies, a o al o 981 ele an e en s
wi h MDs we e no i ied in 2017.7,12 NCARs a e “in ended o
dissemina ion be ween Na ional Compe en Au ho i ies and
he Commission”; hei quali a i e in o ma ion is no public.
NCAR should be c ea ed in acco dance wi h a egula ed
o m/ empla e: “This o m should be comple ed by NCAR
pa icipan s only when exchanging sa e y in o ma ion abou
ele an measu es and/o ecommenda ions ela ing wi h
he p e en ion o ad e se inciden s conce ning medical de-
ices. This o m is designed o exchanging in o ma ion be-
ween NCAR pa icipan s; i should no be passed di ec ly
inadequados ou insegu os do me cado.
Pala as-cha e: Equipamen os e Sup imen os; Segu ança do Doen e/legislação & ju isp udência
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on o pa ien s, use s, hi d pe sons o he public.”. Among
he examples o inciden s and ield sa e y co ec i e ac ions
which he manu ac u e should epo a e “pa ien dies a e
he use o a de ib illa o and he e is an indica ion o a p ob-
lem wi h he de ib illa o ”, “loss o sensing a e a pacemake
has eached end o li e; elec i e eplacemen indica o did
no show up in due ime, al hough i should ha e acco ding
o de ice speci ica ion” o “an in usion pump s ops, due o
a mal unc ion o he pump, bu ails o gi e an app op ia e
ala m; he e is no pa ien inju y”, i.e. se e e (o po en ially
se e e) inciden s wi h MDs.14 In 2017, Ge many (popula-
ion = 82 521 653 inhabi an s), Uni ed Kingdom (popula-
ion = 65 884 142 inhabi an s), and F ance (popula ion =
66 809 816 inhabi an s) had he highes p e alence o such
se ious inciden s (981 (100%) NCARS exchanged be ween
17 Coun ies): 363 NCARs (37.0%), 190 NCARs (19.3%),
and 115 NCARs (11.7%), espec i ely, while only 3 NCARs
(0.3%) such inciden s we e speci ically epo ed in Po ugal
(popula ion = 10 309 573 inhabi an s). As o coun ies wi h
a simila popula ion size o Po ugal, 2017 da a (981 (100%)
NCARs exchanged be ween 17 coun ies), he numbe o
NCARs and inhabi an s: Czech Republic 4 NCARs (0.4%)
(popula ion = 10 578 820 inhabi an s), Aus ia ou NCARs
(0.4%) (popula ion = 8 772 865 inhabi an s), Belgium 40
NCARs (4.1%) (popula ion = 11 351 727 inhabi an s) and
Sweden 44 (4.1%) NCARs (4.5%) (popula ion = 9 995 153
inhabi an s).7,12,15
Besides egis e ing inciden s wi h MDs, na ional medi-
cines agencies (one in each EU coun y) a e esponsible
o o he unc ions, namely designa ion o MDs, inspec ion
o manu ac u e s o MDs, including he collec ion o MDs
samples, p oceedings o in ingemen (e.g. applica ion o
ines) o implemen ing and moni o ing he implemen a ion
o na ional and in e na ional egula ions on MDs, including
he publica ion o MD sa e y ale s.1 These a e di ec ed o
heal hca e p o essionals and pa ien s.16
Gi en ha MDs may be associa ed wi h se e e o po-
en ial se e e inciden s/e en s and pa ien s may unde -
use sa e y in o ma ion on MDs,7, 12-14 he aims o his s udy
we e: (i) o iden i y and ca ego ize all ale s on MDs issued
by he Po uguese Medicines Agency, INFARMED, I.P. du -
ing 2017 and published in i s o icial websi e, (ii) o compa e
he occu ence o Po uguese sa e y ale s wi h he a es in
o he EU coun ies and, (iii) o discuss measu es o mi iga e
he isks associa ed wi h sa e y conce ns on MDs, i.e., o
discuss possible new egula o y sa e y ecommenda ions,
which may be globally accep ed, knowing medicines agen-
cies and heal h au ho i ies ha e a collabo a i e amewo k
owa ds public heal h sa e y.
MATERIAL AND METHODS
Desc ip i e s udy: sa e y ale s on MDs we e collec ed
h ough he web add ess o he Po uguese medicines
agency (INFARMED, I.P.): h p://www.INFARMED.p /web/
INFARMED/ale as/disposi i os-medicos du ing Janua y
2018. These ale s also co e inciden s wi h MDs ma ke ed
in he emaining EU coun ies. Thus, i is possible o ob ain
an indi ec indica o o all signi ican inciden s wi h MDs in
he EU.
Inclusion and exclusion c i e ia
All Po uguese na ional sa e y ale s on MDs published
by INFARMED, I.P. on he o icial websi e in 2017 (inclusion
c i e ia) we e analyzed because i was he mos ecen ly
a ailable in o ma ion when he p esen s udy was ca ied
ou . Exclusion c i e ia: publica ions desc ibing o he ypes
o sa e y issues.
Po uguese sa e y ale s on MDs
S udy da a we e ex ac ed and p ocessed as ollows:
(i) i s ly, sa e y ale s we e iden i ied i.e. all sa e y ale s
on MDs published in he o icial si e o INFARMED, I.P. be-
ween Janua y 1s 2017 and Decembe 31s 2017, (ii) sec-
ondly, hey we e egis e ed i.e. all online a ailable in o ma-
ion was collec ed in a wo d documen and he o iginal in o -
ma ion was a chi ed in digi al o ma ; and (iii) hi dly, hese
sa e y ale s we e analyzed as ollows: ype o equi ed ac-
ion aken by he na ional compe en au ho i y (NCA) (de-
ices ha a e olun a ily wi hd awn om he ma ke e sus
‘o he si ua ions’) o iden i ica ion o MDs ma ke ed in Po -
ugal e sus MDs no ma ke ed in Po ugal. In he g oup o
de ices olun a ily wi hd awn om he ma ke , coun e ei
o alsi ied de ices we e also quan i ied. The ‘o he si ua-
ions’ we e based on quali a i e classi ica ions a ibu ed by
he esea che s a e eading he ull con en o each iden i-
ied sa e y ale (please see ‘Po uguese sa e y ale s on
MDs’ in he sec ion o esul s). The p esen analysis was
double-checked by wo esea che s.
S udy a iables we e con enien ly selec ed based on
he publicly a ailable in o ma ion in he sa e y ale (pub-
lished ale ). O he a iables we e no a ailable in hese
published sa e y ale s (e.g. he se e i y o a possible inci-
den , class o de ice, possible yea o comme cializa ion in
Po ugal, he exis ence o Field Sa e y Ac ions).
Ac ions aken by he egula o y au ho i y
The ac ions aken by INFARMED, I.P. a e p esen ed in
Table 1.
Es ima ed p opo ions o NCARs pe million o inhabi -
an s
A sub-analysis abou NCARs was ca ied ou because
i seems hese epo s a e ela ed wi h se e e o po en ially
se e e sa e y e en s.7,12-14 Besides Po ugal, he selec ed
coun ies o his compa ison we e Ge many, Uni ed King-
dom and F ance because hey a e conside ed leading Eu-
opean economies wi h a much la ge popula ion and MDs
ma ke han Po ugal, hus po en ially app op ia e o de ec
eme ging sa e y issues. Mo eo e , he Czech Republic,
Aus ia, Belgium and Sweden we e e alua ed, since hey
p esen a simila popula ion size o Po ugal.15,17
Acco ding o he o icial epo s, he numbe o NCARs
sen by each coun y we e Po ugal (n = 3), Czechia (n
= 4), Aus ia (n = 7), Belgium (n = 40), Sweden (n = 44),
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Re is a C ie n í ic a d a O de m do s M édi co s ww w.ac am ed ic a po u gu es a.c om
Ge many (n = 363), Uni ed Kingdom (n = 190), and F ance
(n = 115).12
The numbe o NCARs pe million inhabi an s in each o
he e alua ed coun ies was calcula ed conside ing: (i) he
da a o Eu opean 2011 census and he demog aphic da a o
Eu os a (2017 da a) and (ii) he da a o 2017 NCAR; please
see he public epo s he e: h ps://ec.eu opa.eu/heal h/
md_sec o /ma ke -su eillance-and- igilance_en.12,15,17
RESULTS
Po uguese sa e y ale s on MDs
A o al o 32 (100%) sa e y ale s on MDs we e iden i ied
in he o icial websi e o INFARMED, I.P.. O e all, 18 ou o
32 (56%) de ices wi hou eco ds o comme cializa ion a
a na ional le el; eigh ou o 32 (25%) o he si ua ions and
six ou o 32 (19%) de ices olun a ily wi hd awn om he
ma ke (Table 1).
Ac ions aken by he egula o y au ho i y
The main ac ions aken by INFARMED, I.P. a e p esen -
ed in Table 1.
Rega ding, he de ices wi hou eco ds o comme ciali-
za ion a a na ional le el (18 in 32), INFARMED, I.P. has
ecommended no o pu chase o use he MD. These ale s
we e dissemina ed by NCAs om he Uni ed Kingdom, Ge -
many, Denma k, and Poland. Pa icula ly, one ale om he
18 ale s wi hou eco ds o comme cializa ion a na ional
le el was abou in i o diagnos ic medical de ices: a CE
ma king was no a ixed in eagen s o in i o diagnos ics
( hese eagen s we e wi hd awn om he ma ke by he
Ge man au ho i ies). Due he ee mo emen o goods in
he Eu opean Union, INFARMED, I.P. has speci ically ec-
ommended ha hese eagen s should no be pu chased o
used since, he e is no e idence o hei sa e y, quali y o
pe o mance.
The ‘o he si ua ions’ (eigh ale s) conce ned limi a ions
on he unc ioning o he MDs (e.g., so wa e o ins uc ion
upda es o o e come unc ion issues, such as he limi ed
capaci y o a ba e y; suspension o comme cializa ion and
e u n o all de ices o he manu ac u e ; o new ins uc ions
due o a quali y issue). The cases o coun e ei o alsi ied
de ices a e included in he g oup o ale s om de ices ol-
un a ily wi hd awn om he ma ke (six ale s).
Es ima ed p opo ions o NCARs pe million o inhabi -
an s
O e all, a leas h ee ou o 32 MDs sa e y ale s we e
ela ed o se ious inciden s, which is in line wi h he h ee
NCARs no i ied in Po ugal du ing 2017.12 A a e o 0.28
NCARS (i.e. epo s o ele an inciden s, such as se e e
o po en ially se e e inciden s) pe million inhabi an s in
Po ugal was calcula ed using 2011 census da a and/o o
0.29 NCARs pe million inhabi an s using 2017 Eu os a
da a.12,15,17 The EU coun ies wi h he highes p opo ion
o NCARs we e: Ge many wi h 4.53 NCARs pe million in-
habi an s, UK wi h 3.0 NCARs pe million inhabi an s, and
F ance wi h 1.77 NCARs pe million inhabi an s. Rega ding
he coun ies wi h a simila numbe o inhabi an s (popula-
ion size) o Po ugal: Czech Republic wi h 0.38 NCARs pe
million inhabi an s; Aus ia wi h 0.46 NCARs pe million in-
habi an s; Belgium wi h 3.52 NCARs pe million inhabi an s
and Sweden wi h 4.40 NCARs pe million inhabi an s.7,12,15
The Ge man, F ench, UK and Po uguese ma ke s ac-
coun ed o 26; 14.5; 9.8 and 1.2 billion eu os in sales o
MDs, espec i ely (2015 da a).18,19 Rega ding expo s and
impo s espec i ely o MDs (2017 da a), he s udied coun-
ies accoun ed o : Ge man (25 811 and 16 676 million o
eu os), F ance (6984 and 9785 million o eu os), Uni ed
Kingdom (5513 and 7334 million o eu os), Czechia (1053
and 974 million o eu os), Aus ia (1909 and 1930 million
o eu os), Belgium (12 071 and 9689 million o eu os) and
Sweden (1441 and 1595 million o eu os).20
DISCUSSION
O e all, he numbe o public ale s on MDs in he o -
icial websi e o INFARMED, I.P. (32 sa e y ale s in 2017)
is clea ly below he o al numbe o no i ica ions o inciden s
and sa e y co ec i e ac ions conce ning MDs in Po u-
gal (n = 1645 ou o 244 138 egis e ed MDs in 2017).13 In
his sense, i is likely ha INFARMED, I.P. has speci ically
published hese ale s based on sa e y and po en ial isk
c i e ia. Fo ins ance, he medicines agencies o he USA
and Aus alia [Food and D ug Adminis a ion (FDA) and he
The apeu ics Goods Adminis a ion (TGA), espec i ely]
ha e also only published 11 and a ound 20 sa e y commu-
nica ions abou MDs, espec i ely (2017 publica ions),21,22
which seems o be aligned wi h he numbe o sa e y ale s
on MDs published by INFARMED, I.P.. I seems MDs in-
dus y is sa ely ope a ing, conside ing he limi ed numbe o
Pi es C, e al. Medical de ice ale s in Po ugal, Ac a Med Po 2021 Ma ;34(3):201-208
Table 1 – Ac ions aken by he Po uguese na ional medicines agency a e a sa e y ale on MDs (n = 32; 100% sa e y ale s)*
Type o ac ion Desc ip ion
Recommenda ions n1 = 26 (81.2%) - con ac ing he e ail selle o ecei e a new sa e y ale 6.3% (2 in 32)
- con ac ing he dis ibu o s o ecei e a so wa e upda e 9.3% (3 in 32)
- ecommenda ions o no pu chase o use a ce ain MD, conce ning MDs wi hou eco ds o
comme cializa ion in Po ugal 56.3% (18 in 32)
- using he MD acco ding o he ins uc ions 9.3% (3 in 32)
Manda o y Decisions n2 = 6 (1.8%) - immedia ely suspend comme cializa ion and e u n all de ices o he manu ac u e and no
acqui e o use he MD 18.8% (6 in 32)
To al (n1 + n2) 32 (100%)
* The same MD can issue di e en sa e y ale s simul aneously
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205
sa e y ale s published on he websi es o medicines agen-
cies, such as INFARMED, I.P., FDA and TGA.21,22 Howe e ,
mo e s udies on he p esen opic a e ecommended. On
he o he hand, 981 NCARS we e exchanged be ween 17
EU Coun ies du ing 2017,12 al hough hese NCARs may be
abou he same ype o MDs.
Po uguese sa e y ale s on MDs and ac ions aken by
he egula o y au ho i y
Conce ning he 32 sa e y ale s iden i ied in he o icial
websi e o INFARMED, I.P., mo e han hal o hese ale s
we e ela ed wi h de ices wi hou iden i ied eco ds o com-
me cializa ion a a na ional le el. This can be conside ed
e y encou aging ega ding he dissemina ion o sa e y in-
o ma ion, since people and p oduc s can ci cula e wi hin
he EU and ci izens li ing in Po ugal may be using an MD
no ma ke ed in his e i o y. Al e na i ely, i may be an indi-
ca o o lowe usage o MDs wi hin he Po uguese popula-
ion due o a mo e limi ed budge (i.e. economic es ic ions),
en o cemen o na ow c i e ia o selec /buy MDs a hospi al
le el o di e en popula ion heal h needs. In e es ingly, only
one ale abou an in i o MDs no ma ke ed in Po ugal
was de ec ed. This may e lec he lowe p opo ion o in
i o MDs in ela ion o he global numbe o ma ke ed MDs.
Fo ins ance, he o al heal hca e expendi u e in Eu ope is
as ollows: 76.9% inpa ien & ou pa ien ca e, o he ; 15.9%
pha maceu icals & o he medical non-du ables and 7.2%
medical echnology (6.5% medical de ices, including imag-
ing and 0.7% in i o diagnos ics) (2017 da a).20
The ypes o ac ions aken by he na ional medicines
agency ( ecommenda ions o manda o y decisions) we e
dependen on he se e i y o he ale . This was he case o
he six manda o y decisions ela ed wi h quali y issues, e.g.,
coun e ei de ices ecei ing ma ke suspension and ecall
o de aul MDs, which we e in ol ed in he h ee inciden s.
Rele an in o ma ion is lacking on he ale s o s udied MDs,
such as he se e i y o a possible inciden , class o a de ice,
possible yea o comme cializa ion, he exis ence o ield
sa e y ac ions, e c. These could be ela ed wi h con iden ial-
i y issues and/o he in o ma ion o ma . Na ional medicines
agencies a e legally equi ed o p esen his in o ma ion in
a s uc u ed way (NCAR), and some egula o y in o ma-
ion should emain con iden ial (see Annex VII o MEDDEV
2.12/1 e .8).14
Aside om he ale s on he EU websi es, na ional medi-
cines agencies and he compulso y MDs inciden epo ing
sys em (Eudamed),12 compu e -based sys ems in eg a ed
in o MDs o in apps o pa ien s may con ibu e o inc ease
he sa e use o MDs. Fo ins ance, elec onic means (e.g.,
au oma ed emails), o so wa e pla o ms, which a e based
on indi idual da a and sui able algo i hms and a e p o-
g ammed o simula e he use o MDs. O he applica ions
a e cu en ly unde de elopmen o assis he selec ion o
he sa es de ice o a ce ain pa ien .23,24
Ac ions o inc ease he awa eness o heal hca e p o es-
sionals and pa ien s a e also needed. Mo eo e , di e ences
in he p opo ions o no i ied sa e y ale s be ween coun ies
could be jus i iable by a po en ial unde epo ing o cases,
al hough he e is no da a o con i m his assump ion. Use s
o MDs should be mo i a ed o p o ide ac i e eedback on
how o imp o e MDs and how o an icipa e possible inci-
den s. E en hough end-use s a e heo e ically unable o
acqui e MDs (a leas om he high- isk ca ego ies), since
hese MDs a e acqui ed/pu chased by hospi als, pa ien s
should emain in o med on he con en o MDs ale s, es-
pecially i consume s ca y one MDs inside he body (o
di ec ly con ac ing wi h he body). Only MDs coded by IN-
FARMED, I.P. and included in he espec i e da abase may
be pu chased by he Na ional Heal h Se ice (SNS) in Po -
ugal.25 In his sense, a unique ID code o each MD in he
EU ma ke would be an impo an s ep o ensu e aceabili y
and o es ablish causali y in bo h posi i e and nega i e pa-
ien ou comes.26
Es ima ed p opo ions o NCARs pe million o inhabi -
an s
The es ima ed p opo ion o NCARs pe million inhabi -
an s in Po ugal is below he alues egis e ed by he o he
e alua ed EU coun e pa s, including he analyzed coun-
ies wi h simila popula ion sizes o Po ugal (i.e. Czech
Republic, Aus ia, Belgium and Sweden).12 This si ua ion
may be explained by he ac ha Po ugal and he Czech
Republic a e among he coun ies wi h he lowes numbe
o sales o MDs, hus being mo e likely o p esen a small
numbe o NCARs pe million inhabi an s.15,18-20 Addi ion-
ally, his seems o be a low p opo ion o epo s looking a
he Ge man ma ke , which is app oxima ely 23 imes mo e
aluable han he Po uguese one; howe e , Ge many eg-
is e ed a a e o MD sa e y ale s only 16 imes highe han
Po ugal.18-20 Finally, a leas some MDs sa e y p oblems
may no ha e been no i ied by use s/pa ien s o heal hca e
p o essionals (i.e., unde epo ing o sa e y p oblems o
MDs) and he numbe o inspec ions o iden i y alsi ied o
unsa e MDs may be limi ed in ou coun y. In his sense, ig-
ilance and inspec ions sys em on he sa e y o MDs should
be s eng hened by he na ional medicines agency, since
moni o ing sa e y o MD is pa amoun .
New EU egula ion on MDs
Recen EU legisla ion on medical de ices has come
in o o ce ecen ly: he Regula ion 2017/745 o he Eu o-
pean Pa liamen and o he Council o 5 h Ap il 2017 (no ye
ansposed).9 The da a and/o analysis in he p esen s udy
ha e no eme ged om he applica ion o his new egula-
ion, conside ing his egula ion will only be ansposed o
applied by each o he Eu opean coun ies in he nex ew
yea s ( ansi ion pe iod). Impo an ly, i seems ha he old
concep s and de ini ions a e conside ed in his new egula-
ion; howe e , Regula ion 2017/745 is b oade , and among
o he s, i includes mo e designa ions ega ding medical
de ices and/o medical pu poses. Fo ins ance, implan s
and eagen s ha e been speci ically conside ed MDs, as
well as, addi ional medical pu poses ha e been speci i-
cally conside ed such as moni o ing an inju y o disabili y;
Pi es C, e al. Medical de ice ale s in Po ugal, Ac a Med Po 2021 Ma ;34(3):201-208
ARTIGO ORIGINAL
206
Re is a C ie n í ic a d a O de m do s M édi co s ww w.ac am ed ic a po u gu es a.c om
Pi es C, e al. Medical de ice ale s in Po ugal, Ac a Med Po 2021 Ma ;34(3):201-208
in es iga ion, eplacemen o modi ica ion o he ana omy
o a pa hological p ocess o s a e; o “p o iding in o ma ion
by means o in i o examina ion o specimens de i ed om
he human body, including o gan, blood and issue dona-
ions, and which does no achie e i s main in ended ac ion
by pha macological, immunological o me abolic means, in
o on he human body, bu which may be assis ed in i s
unc ion by such means”.8 Thus, as expec ed, he isk clas-
si ica ion was also upda ed, al hough MDs a e s ill classi-
ied in he same numbe o classes: I e.g., non-in asi e de-
ices no included in he o he classes such as non-in asi e
de ices in ended o be used as a mechanical ba ie , o
comp ession o o abso p ion o exuda es; IIa e.g., non-
in asi e de ices in ended o channelling o s o ing blood,
body luids, cells o issues, liquids o gases o he pu pose
o e en ual in usion, adminis a ion o in oduc ion in o he
body o in asi e de ices in ended o sho - e m use – and
no included in ano he class; IIb e.g., non-in asi e de ices
in ended o modi ying he biological o chemical compo-
si ion o human issues o cells, blood, o he body liquids
o o he liquids in ended o implan a ion o adminis a ion
in o he body o in asi e de ices in ended o long- e m
use – and no included in o he class; and III e.g., su gically
in asi e de ices in ended speci ically o con ol, diagnose,
moni o o co ec a de ec o he hea o he cen al ci -
cula o y sys em h ough di ec con ac wi h hose pa s o
he body, o o al o pa ial join eplacemen s. I seems
like class I MDs emain, espec i ely, classi ied as low- isk
de ices, IIa and IIb medium- isk de ices and class III high-
isk de ices in acco dance wi h a icle 51 and Annex VIII o
Regula ion 2017/745. Ano he ele an poin in his docu-
men is he p e ision o a speci ic pos -ma ke su eillance
sys em on MDs (Chap e VII), which s a es ha , “ o each
de ice, manu ac u e s shall plan, es ablish, documen , im-
plemen , main ain and upda e a pos -ma ke su eillance
sys em in a manne ha is p opo iona e o he isk class
and app op ia e o he ype o de ice” (a icle 83).9
Among he possible consequences o he applica ion
o Regula ion 2017/745 a e a highe numbe o egis e ed
MDs and sa e y ale s on MDs in he EU, since he scope o
applica ion o he new Regula ion is b oade . On he o he
hand, i is likely ha he use o MDs in he EU will end o be-
come sa e because mo e ypes o MDs and i s espec i e
applica ions a e co e ed by his new egula ion and manu-
ac u e s a e equi ed o de ine a pos -ma ke su eillance
sys em in acco dance wi h Chap e VII. 9
Addi ional egula o y ecommenda ions on MDs
The de elopmen o da abases comp ising pa ien da a
om MDs use is ecommended because i may ensu e he
gene a ion o au oma ic ale s, e.g., email and/o phone
wa nings. O he ypes o web-based applica ions may be
de eloped o ensu e sa e use o MDs in pa ien s. Among
o he s, new applica ions may be dissemina ed in he web-
si es o egula o y agencies, which a e commonly used o
dissemina e igilance in o ma ion. Social ne wo ks may be
used o dissemina e in o ma ion on sa e y o e icacy ale s
o MDs, al hough mo e s udies on he use o social ne -
wo ks as a way o dissemina ing sa e y in o ma ion on MDs
a e equi ed. Na ional medicines agencies may ecommend
ha na ional medicines agencies suppo /s eng hen he
publica ion o mo e dedica ed in o ma ion abou he sa e y
ale s o MDs in ended o pa ien s and consume s, since
he analyzed sa e y ale s and EU s a is ics only p o ide
limi ed in o ma ion. Fo ins ance, i was no possible o ind
speci ic in o ma ion abou he se e i y o inciden s, possible
causes, class o de ice, e c. This in o ma ion is pa icula ly
ele an o heal hca e p o essionals, and he gene al pub-
lic in o de o inc ease pa ien sa e y.27
As a as he egula o y ecommenda ions on MDs he e
p oposed a e conce ned, he scope o in e en ion o he
na ional medicines agencies may need o be ex ended and
ampli ied, o ins ance wi h he en o cemen o egula ion
2017/745.9 Mo eo e , p i a e o semi-public o ganiza ions
may be c ea ed in o de o supe ise he in e en ion o
medicines agencies, NB and/o manu ac u e s, namely wi h
compulso y en ollmen o pa ien s and p o ide s.
S udy limi a ions
The MDs om he sa e y ale s we e no checked agains
he Po uguese Code o he Medical De ice (CMD) and i s
espec i e Po uguese Nomencla u e o Medical De ices
(NPDM),28 because ei he CMDs o NPDMs we e no made
a ailable in he sa e y ale s published by INFARMED, I.P..
Howe e , b ands and/o p oduce names o MDs we e
p esen ed in he published sa e y ale s, and almos all o
hese b ands and/o p oduce s we e no mo e a ailable in
he CMD Po uguese da abase (h ps://www.in a med.p /
web/in a med/pesquisa-disposi i os)28 (e.g. PRIMEDIC
De iMoni o XD®, A asningsse EPI-SPINAL Pack®, Fenix
Face Resu acing Sys em® o Thomas Moni o Sys ems).
Simila ly, he exis ence o a possible combina ion o de-
ices and he Classes o he MDs o he sa e y ale s we e
no speci ically in es iga ed, which was due o he limi ed
in o ma ion on he published ale s. The websi es o o he
compe en medicines agencies (Eu opean o non-Eu ope-
an) we e no checked ega ding he sa e y ale s on MDs,
al hough compa a i e analyses on ele an inciden s based
on NCARS epo s we e no ca ied ou .12 Finally, speci ic
compa isons (e.g., be ween di e en MD classes o di e -
en se e i ies o e en s) o sa e y ollow-ups we e no spe-
ci ically ca ied ou .
CONCLUSION
The Po uguese Medicines Agency con ibu es o he
ci izens’ access o quali y medical de ices, by issuing sa e-
y ale s, ecommenda ions and manda o y ma ke wi h-
d awals o unsui able o unsa e MDs. Despi e he limi ed
numbe o sa e y ale s in Po ugal, cases o coun e ei o
alsi ied MDs ha e been iden i ied. These si ua ions we e
ollowed by co ec i e ac ions o ensu e public heal h. The
low numbe o sa e y ale s in Po ugal, compa ed o o he
EU coun ies may be explained by he ollowing po en ial
easons: (i) some MDs sa e y p oblems may ha e no been
ARTIGO ORIGINAL
R e i s a C i e n í i c a d a O d e m d o s M é d i c o s w w w.a c a m e d i c a p o u g u e s a . c o m
207
no i ied by use s/pa ien s o heal hca e p o essionals (i.e.,
unde epo ing o sa e y p oblems wi h MDs), (ii) limi ed
numbe o MDs ma ke ed in Po ugal p obably due o eco-
nomic es ic ions, (iii) he numbe o inspec ions o iden i y
alsi ied o unsa e MDs may be limi ed o (i ) MDs in he na-
ional ma ke may be less p one o sa e y p oblems, since
no all MDs ma ke ed in he EU a e a ailable in Po ugal.
Among o he s, ein o cing igilance and inspec ion sys-
ems ega ding he sa e y o MDs is ecommended and
new egula o y sa e y ecommenda ions may comp ise he
compulso y deli e y o elec onic ale s, such as emails o
ensu e he ecep ion o sa e y in o ma ion by all pa ien s.
Mo eo e , he de elopmen o apps o o he applica ions o
assis pa ien use, including op imiza ion o MDs in eal- ime
o he exis ence o a unique ID code in he EU o ensu e he
aceabili y o MDs. Fu he s udies a e equi ed o con i m
hese p elimina y esul s.
DISCLOSURE
A chap e on a simila opic was published in: Pi es C,
Dua e D. A egula o y and sa e y pe spec i e on medical
de ices. In: Mehdi Khos ow-Pou DB, edi o . Encyclopedia
o In o ma ion Science and Technology - Chap e 125. 5 h
ed. IGI Global; 2021:1815-26. doi: doi:10.4018/978-1-7998-
3479-3.ch125.
PROTECTION OF HUMANS AND ANIMALS
The au ho s decla e ha he p ocedu es we e ollowed
acco ding o he egula ions es ablished by he Clinical Re-
sea ch and E hics Commi ee and o he 2013 Helsinki Dec-
la a ion o he Wo ld Medical Associa ion.
DATA CONFIDENTIALITY
The au ho s decla e ha ing ollowed he p o ocols in
use a hei wo king cen e ega ding pa ien s’ da a publica-
ion.
CONFLICTS OF INTEREST
The au ho s epo no con lic s o in e es .
FUNDING SOURCES
Fundação pa a a Ciência e a Tecnologia (FCT) p ojec
UID/DTP/04567/2016.
Pi es C, e al. Medical de ice ale s in Po ugal, Ac a Med Po 2021 Ma ;34(3):201-208
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