Global Atlas of Medical Devices2nd Global Forum of Medical Devices, November 22-24, 2013
2nd Global Forum of Medical Devices, November 22-24, 20132 |
*Global Atlas of Medical Devices 2013
*Global Atlas of Medical Devices 2013
� Objectives:– Present the status of development of health technology programme
dedicated to medical devices in member states.– Share knowledge and resources among the participating countrie
facilitating decision making on a national, regional and global level.
� Methodology:– Nominate an official health technology focal point in the country
ministry who is in charge of coordinating the reply to the country
questionnaire.
– Source: Baseline Country Survey on medical devices that started on
Jan. 2010, and updated on Nov. 2013.*WHA resolution 60.29 urges member states to: 1.1 Collect, verify, update and exchange information on health technologies
In particular medical devices a an aid to their prioritization of needs and allocation of resources (may 2007).
2nd Global Forum of Medical Devices, November 22-24, 20133 |
Baseline Country Survey on Medical Devices 2013 update.
Baseline Country Survey on Medical Devices 2013 update.
*Participation: 90% of WHO member states (n=173 over 194).
Including
more than
90% of low
and lower-
middle income
countries
2nd Global Forum of Medical Devices, November 22-24, 20134 |
National Policy on Health Technology National Policy on Health Technology
82 member states have a Health Technology National Policy (48% or 171 respondentcountries). On the other hand 89 member states do not have any (52%).More than the half of low and lower middle income economies do not have any (from75 low and lower middle income economies).In African, American and Western Pacific region more than 57% of the correspondingparticipant countries do not have any.
Do not
have
89
52%
Have one:
part of
program
60
35%
Have one:
not part
of
program
20
12%
Have one:
2
1%
N=171
20
22
25
22
12
14
18
16
2
4 4
10
01
01
Low income Lower middle
income
Upper middle
income
High income
Do not have one
Do have one and it is part of the National Health program
Do have one but is not part of the National Health program
Have one but did not provided any other information N=171
6
19
21
26
4
13
3
22
10
13
57
56
3 31
21
0 0 0 01
0
5
10
15
20
25
30
EMR EUR AMR AFR SEAR WPR
Do not have one
Do have one and it is part of the National Health program
Do have one but is not part of the National Health program
Have one but did not provided any other information
2nd Global Forum of Medical Devices, November 22-24, 20135 |
Available Outcomes and FutureAvailable Outcomes and Future
Country Profiles of 173 countries distributed for 560 participants during the Global Forum.Poster Global Atlas number L03 within the WHO space 2nd floor (available for spot me).Global Atlas of Medical Devices 2013 Update (PDF draft publication available on medicadevices website, and spot-me) including:
– NOW! 173 country profiles and Basic Statistics and more than 35 maps.
– MARCH 2014: FINAL Publication including Chapters and more statistics!
Your participation is important, please collaborate to update the data, and maintaining odatabase free of inconsistencies. For any commentary write to : [email protected] befo14 February 2014.If you can help us to collect the 21 missing countries we would be very happy to receiany contact in the corresponding ministry of the following states:
African: Algeria, Equatorial Guinea, Lesotho, Rwanda, and South SudanAmerican: VenezuelaEastern Mediterranean: Bahrain, Djibouti, Iran, Kuwait, Syria, and United Arab EmiratesEuropean: Andorra, FYR Macedonia, Sweden, Uzbekistan, and Turkmenistan.Western Pacific: Cook Islands, Niue, Palau, and Tuvalu.
2nd Global Forum of Medical Devices, November 22-24, 20136 |
Regulation of Medical DevicesRegulation of Medical Devices
117 member states have an authority responsible for implementing and enforcingmedical device specific product regulations (68% or 171 respondent countries).
On the other hand 54 member states do not have one (32%).53% of low income countries do not have any regulatory authority
.e 18 countries do not have from 34 low income participant economies).In Africa 45% countries do not have any regulatory authority, and Western Pacific 50%do not have any (19 countries and 11 countries respectively).
Have
68%
Do not
have
32%
N=171
18
1317
6
16
2731
43
0
5
10
15
20
25
30
35
40
45
50
Low income Lower
middle
income
Upper
middle
income
High income
Nu
mb
er
of
cou
ntr
ies
Do not have Have
N=171
4 3
1419
3
1110
45 20
23
8
11
0
10
20
30
40
50
60
EMR EUR AMR AFR SEAR WPRN
um
be
r o
f co
un
trie
s
Have at
least one
Have
none
N=171
2nd Global Forum of Medical Devices, November 22-24, 20137 |
Lists of approved medical devices for public procurement or reimbursementLists of approved medical devices for public procurement or reimbursement
94 Member States do not have any national list of approved medical devices foprocurement or reimbursement in the country (56% of 169 respondent countries).71% of lower middle income countries (29/41 respondents) do not have any national list.American, African and Western Pacific regions have more than 50% of their countriethat do not have any national list of approved medical devices for procurement oreimbursement in the country (AMR = 71%, AFR = 62%, WPR = 59%).
Do not
have
56%
Have one
32%
Have one,
but it is
only a
recomme
ndation
12%
N=169
6 21
2426
4
13
1
23
9
9 58
8
3 1
7
0 1
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
EMR EUR AMR AFR SEAR WPR
Have one but it is only a recommendation
Have one
Do not have N=169
Do not
have
71%
Have one
12%
Have one
but it is
only a
recommen
dation
17%
Lower-middleIncome
2nd Global Forum of Medical Devices, November 22-24, 20138 |
National lists of medical devices for different types of healthcare facilities
National lists of medical devices for different types of healthcare facilities93 member states have recommended lists of medical devices for healthcare facilities(59% or 155 respondent countries).1 of each 3 low to middle income countries do not have any (38 out of 113 countries).Only the African and Eastern Mediterranean regions have more than 70% of thecountries with national lists (39 out of 52 countries).
Do not have
one
41%Do have one
59%
N=155
Do not
have
one
15%
Do have
one
85%
N=39
Do not
have
one
28%
Do have
one
72%
N=13
African Region
World
Eastern Mediterranean Region
2nd Global Forum of Medical Devices, November 22-24, 20139 |
National lists of medical devices for specific procedures
National lists of medical devices for specific procedures
93 member states have recommended lists of medical devices for specific procedures(67% or 150 respondent countries).Almost have of the lower middle income countries do not have any (15 out of 36countries).About 40% of the South-East Asia and Eastern Mediterranean regions do not have any(9 out of 21 countries).
Do not
have
one
67%
Do have
one
33%
N=150
2221
30
27
7
1514 14
0
5
10
15
20
25
30
35
Low income Lower middle
income
Upper middle
income
High income
Yes
No
Yes
54%
No
46%
N=13
Yes
62%
No
38%
N=8
World
Eastern Mediterranean Region
South-East AsiRegion
2nd Global Forum of Medical Devices, November 22-24, 201310 |
National lists of medical devices for high burden diseases and emergency situations
National lists of medical devices for high burden diseases and emergency situations
108 member states do not have recommended lists of medical devices for high burdendiseases or injuries or health emergency situations (67% or 161 respondent countries).More than 50% of the countries who have lists have for communicable, and noncommunicable disease as well as public health emergency situations.
Not Have67%
Have33%
N=161
56.6%50.9%
32.1%
69.8%
18.9%
0%
10%
20%
30%
40%
50%
60%
70%
80%
a)Communicable
diseases
b) Non-communicable
high burdendiseases
c) Injuries thatconstitute the
burden ofdisease
d) Public healthemergencysituations
All kinds a) to d)
Pe
rce
nta
ge
of
co
un
trie
s
Kind of disease or situation
Countries with lists recommending health technology for different diseases or situations
N=53
2nd Global Forum of Medical Devices, November 22-24, 201311 |
Unit within the Ministry at national level that technicall
manages medical devices through HTA
Unit within the Ministry at national level that technicall
manages medical devices through HTA
125 member states have units within the Ministry who technically manages medicaldevices (73% or 171 respondent countries).96 countries (56%) have specifically at least one HTA unit.70% to 77% of the low to upper middle income groups have at least one HTA unit
Do not
have
one: 46
count.:
27%Do
have
one:
125
count.:
73%
N=171
No unit
44%
At least
one unit
56%
N=171
8 9 8
21
26
32
40
27
0
5
10
15
20
25
30
35
40
45
Low income Lower middle
income
Upper middle
income
High income
Do not have on
Do have one
Management Unit
HTA Unit
2nd Global Forum of Medical Devices, November 22-24, 201312 |
Unit within the Ministry at national level that technicall
manages medical devices through technical
specifications for procurement unit
Unit within the Ministry at national level that technicall
manages medical devices through technical
specifications for procurement unit125 member states have units within the Ministry who technically manages medicaldevices (73% or 171 respondent countries).99 countries (58%) have specifically at least one technical specifications forprocurement unit.More than 80% of the Eastern Mediterranean and African regions have at least onetechnical specifications for procurement unit
Do not
have
one: 46
count.:
27%
Do have
one:
125
count.:
73%
N=171
No unit
42%
At least
one unit
58%
N=171
2
1412
7
3
810
1921
34
4
11
0
5
10
15
20
25
30
35
40
EMR EUR AMR AFR SEAR WPR
Do not have one Do have one
Tech. Spec. for procurement Unit
Management Unit
2nd Global Forum of Medical Devices, November 22-24, 201313 |
Unit within the Ministry at national level that technicall
manages medical devices through planning
of medical equipment allocation unit
Unit within the Ministry at national level that technicall
manages medical devices through planning
of medical equipment allocation unit125 member states have units within the Ministry who technically manages medicaldevices (73% or 171 respondent countries).97 countries (57%) have specifically at least one planning of medical equipmentallocation unit.More than 40% of the American, Western-Pacific, and South East Asia regions do nothave at least one medical equipment allocation unit
Do not
have
one: 46
count.:
27%
Do have
one:
125
count.:
73%
N=171
Planning/Allocation Unit
Management Unit
No unit
43%
At least
one unit
57%
N=171
2
1412
7
3
810
26
17
33
4
7
0
5
10
15
20
25
30
35
EMR EUR AMR AFR SEAR WPR
Do not have one Do have one
2nd Global Forum of Medical Devices, November 22-24, 201314 |
Unit within the Ministry at national level that technicall
manages medical devices
through application/user training
Unit within the Ministry at national level that technicall
manages medical devices
through application/user training125 member states have units within the Ministry who technically manages medicaldevices (73% or 171 respondent countries).74 countries (43%) have specifically at least one application/user training unit.Only 1 of each 3 low to upper middle income countries have at least oneapplication/user training unit
Do not
have
one: 46
count.:
27%
Do have
one:
125
count.:
73%
N=171
Application/Training Unit
Management Unit
No unit
57%
At least
one unit
43%
N=171
8 9 8
2120
19
24
11
0
5
10
15
20
25
30
Low income Lower middle
income
Upper middle
income
High income
Do not have one Do have one
2nd Global Forum of Medical Devices, November 22-24, 201315 |
Official Nomenclature for Medical DevicesOfficial Nomenclature for Medical Devices
Only half of the member states i.e 88 countries (51%) have at least one officialnomenclature system for medical devices (83 countries do not have)More than 50% of the low to middle income countries do not use any type ofnomenclature (70 countries from 133 low and middle income countries).Except for the American and European regions, more than 50% of the countries ofWPR, SEAR, AFR, EMR do not have an official nomenclature system.
20
25 25
131416
23
35
Low income Lower
middle
income
Upper
middle
income
High
income
Have none
Have at least one
GMDN Only
UMDNS only
More than one
system
Nationally
developed (may
use others)N=171
5
13
16
30
7
12
10
35
18
12
4
9
0
5
10
15
20
25
30
35
40
EMR EUR AMR AFR SEAR WPR
Have none
Have at least
GMDN Only
UMDNS only
More than on
system
Nationally
developed (m
use others)
N=171
Do not
have one
51%
Do have
one
49%
N=171
2nd Global Forum of Medical Devices, November 22-24, 201316 |
Official Nomenclature for Medical DevicesType and Use
Official Nomenclature for Medical DevicesType and Use
From the 88 countries who has a Nomenclature system (51%): 27% have developedone nationally, 11% have UMDNS only, 10% GMDN only, and 3% more than onesystem.70% of the countries who had developed a national nomenclature system are Highincome countries (12 from 17 countries).Only 32 countries (18%) specified use of nomenclature such as regulatory, procurementor inventory purposes from 171 countries.
Nationally
developed
27%
GMDN
10%
UMDNS
11%
More than
one system
3%
None
49%
N=171
Regulator
y
6%
Procurem
ent
8%
Regulator
y and
procurem
ent
4%
Not
Specified
32%
None
49%
Inventory
1%
N=171
2nd Global Forum of Medical Devices, November 22-24, 201317 |
National guidelines, policies or recommendations on the procurement of medical devices
National guidelines, policies or recommendations on the procurement of medical devices
89 Member States do not have any guidelines (53% of 168 respondent countries)54% of lower middle income countries (21/39 respondents) do not have any guidelindesfor the procurement of medical devices.American, African and Western Pacific have more than the half of their countries with nonational guidelines for procurement.On the other hand Eastern Mediterranean and South-East Asia regions have more thanthe half of their countries with national guidelines for procurement.
Yes
47%No
53%
N=168
1621 23
29
1818 24
19
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Low income Lower
middle
income
Upper
middle
income
High income
Yes
No6
25
2221
3
12
9
22
12
20
79
EMR EUR AMR AFR SEAR WPR
No Yes
2nd Global Forum of Medical Devices, November 22-24, 201318 |
Procurement of medical devices at national levelProcurement of medical devices at national level
61 countries do not have procurement of medical devices carried out at the nationallevel (36% of 169 participant countries).28% of low, lower middle and upper middle income countries (34/122 respondents) donot have procurement of medical devices carried out at the national level.More than 45% of the Western Pacific and European do not have procurement ofmedical devices carried out at the national level.
Yes
64%
No
36%
N=169
810
16
2726
3032
20
0
5
10
15
20
25
30
35
Low income Lower
middle
income
Upper
middle
income
High income
No
Yes
4
2112
122
10
11
2622
308
11
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
EMR EUR AMR AFR SEAR WPR
Yes
No
2nd Global Forum of Medical Devices, November 22-24, 201319 |
Policy/guideline/recommendation on donations for medical devices
Policy/guideline/recommendation on donations for medical devices
87 countries do not have any (51% of 170 respondent countries).83 countries have where 48 countries developed nationally, 29 use WHO guidelines,and 6 use other guidelines.More than the half of upper-middle income countries (25/48 resp.) do not have any.Only South East Asia and African regions have more than the half of their countries withany policy, guideline or recommendation on donations for medical devices.
Do not
have
87
51%
Developed
Nationally
48
28%
Use WHO
guidelines
29
17%
Have
(excluding
previous)
6
4%
N=170
8 2818
19
3
11
3
12 12
12
2
7
3
64
9
4
3
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
EMR EUR AMR AFR SEAR WPR
Do not have Developed Nationally
we use WHO guidelines Yes but not specified
Do not have
25Developed
Nationally
15
we use
WHO
guidelines
8
Yes but not
specified
0
Upper-middle income WB group World
2nd Global Forum of Medical Devices, November 22-24, 201320 |
Recommended technical specifications of medicadevices to support procurement/donations
(publically available)
Recommended technical specifications of medicadevices to support procurement/donations
(publically available)88 member states do not have (53% of 165 respondent countries).56% of lower and upper middle income economies do not have any
.e 48 from 87 low and upper-middle income respondent economies).Only Eastern Mediterranean and South East-Asia regions have more than 50% of theircountries who have.
World
Do not
have
53%
Have one
and it is
publically
available
23%
Have one
but it is not
publically
available
24%
N=165
Do
not
have
1
Have
one
availa
ble
3Have
one
not
availa
ble
10
Do not
have
3
Have
one
availa
ble
4
Have
one
availa
Emr
Sear
15
21
2725
7
108
1211
8
13
8
0
5
10
15
20
25
30
Low
income
Lower
middle
income
Upper
middle
income
High
income
Do not have
Have one and it is
publically available
Have one but it is
not publically
available
2nd Global Forum of Medical Devices, November 22-24, 201321 |
Medical Equipment/Management units with professionally trained employees
(biomedical/clinical engineers or technicians)
Medical Equipment/Management units with professionally trained employees
(biomedical/clinical engineers or technicians)82 of the countries have professionally trained employees79 of the countries have at least one national management unit, 47 at least one regionalmanagement unit and 69 at least one hospital unit.26% of the upper middle income countries do not have at least one management unit(other income groups have less than 20%).
Have
82%
Do not
have
18%
N =159
63
85
64
79
47
69
19
44
53
0
10
20
30
40
50
60
70
80
90
National Regional Hospital
No unit At least one unit Two or more
28 3432
37
4 611
7
0%
20%
40%
60%
80%
100%
Low income Lower middle
income
Upper middle
income
High income
Have Do not have
2nd Global Forum of Medical Devices, November 22-24, 201322 |
National Medical equipment management softwareused in public institutions
National Medical equipment management softwareused in public institutions
87 countries do not use management software (60% of 140 respondent countries).More than 65% of the low and lower income countries do not use management software(52 from 68 respondent countries)More than 50% of the American, African, South-East Asia, and Western Pacific regionsdo not use a management software.
Use a
software
38%Do not
use a
software
62%
N =140
97
20 17
1933
20 15
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Low income Lower middle
income
Upper middle
income
High income
Have Do not have
8
18
98
3
75
16
19
31
4
0
5
10
15
20
25
30
35
EMR EUR AMR AFR SEAR WP
Have Do not have
2nd Global Forum of Medical Devices, November 22-24, 201323 |
Healthcare facilityHealthcare facility
More than 80% of the countries have at least one per 100,000 pop health posts (111respondent countries).More than 55% of the countries have at least one per 100,000 pop health centers(110respondent countries).Around 43% of low middle and upper-middle countries have at least one unit per100,000 district/rural hospitals (120 respondent countries)More than 88% of Low and low income countries have not at least one unit per 100,000provincial hospitals (123 respondent countries)Independently of income level they are almost no countries (only five) with at least oneunit per 100,000 specialized/teaching/research hospitals (124 respondent countries)
Income
Group/Type of
facility Health posts Health Centre Distric/Rural Hospitals Provincial hospitals
Regional/ Specialized/
Teaching and Research
Hospital hospitals
At least one per
100,000 pop
Less than one per
100 000 pop
At least one
per 100 000
pop
Less than
one per
100 000
pop
At least one per
100 000 pop
Less than
one per
100 000
pop
At least
one per
100 000
pop
Less than
one per
100 000
pop
At least one
per 100 000
pop
Less than one
per 100 000
pop
Low 20 4 21 8 5 25 1 27 1 27
Lower middle 29 2 21 10 14 18 3 24 1 28
Upper middle 33 1 15 12 14 19 10 28 2 35
High 18 4 12 11 6 19 7 23 1 29
2nd Global Forum of Medical Devices, November 22-24, 201324 |
Medical EquipmentMedical Equipment
High technology specialized equipment is not available in a higher degree in countrieswhen their level of income is lower i.e low income group have less countries with thistechnology than lower middle income group, and so on.In general high technology specialized equipment is less available in African, South-East Asia, and Eastern Mediterranean regions. More than 50% of the American, African,South-East Asia, and Western Pacific regions do not use a management software.
Countries with at least one unit per 1,000 000 habitants
* MRI CT PET GC NM MAM LA TU RT ALL
Level of Income
Low 0 4 0 20 19 0 0 0
Lower middle 9 18 1 21 21 1 1 4
Upper middle 27 35 1 25 37 11 5 18
High 34 36 10 25 31 26 4 27
Sum 70 93 12 91 108 38 10 49
Region
EMR 8 11 1 10 11 1 1 2
EUR 33 35 7 25 32 26 4 31
AMR 16 23 1 17 23 7 4 11
AFR 4 9 1 26 29 0 1 1
SEAR 2 4 0 3 2 0 0 0
WPR 7 11 2 10 11 4 0 4
Sum 70 93 12 91 108 38 10 49
MRI: Magnetic Resonance Imagin
CT: Computerized Tomography
Scanner
PET: Positron Emission
Tomography Scanner
GC or NM: Gamma camera or
Nuclear Medicine
MAM: Mammograph
LA: Linear accelerator
TU: Telecobalt unit
RT: Radiotheraphy units=LA+TU
2nd Global Forum of Medical Devices, November 22-24, 201325 |
MRI: Magnetic Resonance ImagingMRI: Magnetic Resonance Imaging
Almost half of the respondent countries do not have MRIAny low income country has at least 1 MRI per million population (25 respondents)
Do not
have
one
47%
Have at
least
one
53%
N =131
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Low Lower
middle
Upper
middle
High
Have at least one
Do not have one
2nd Global Forum of Medical Devices, November 22-24, 201326 |
CT: Computerized Tomography ScannerCT: Computerized Tomography Scanner
93 countries have at least 1 CT per million population (134 respondents)76% of the African countries do not have at least 1 CT per million population (37respondents)
Do not
have
one
41
31%Have at
least
one
93
69%
N =134
Do not have
one
76%
Have at least
one
24%
n=37
AfrWorld
2nd Global Forum of Medical Devices, November 22-24, 201327 |
PET: Positron Emission TomographyPET: Positron Emission Tomography
90% of countries do not have at least 1 PET per million population (116 respondents)Low to upper middle countries have less than 5% of countries with 1 PET per millionpopulation (57 respondent)
Do not
have
one
104
90%
Have at
least
one
12
10%
N =116
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Low Lower
middle
Upper
middle
High
Have at least one
Do not have one
2nd Global Forum of Medical Devices, November 22-24, 201328 |
CT: Computerized Tomography ScannerCT: Computerized Tomography Scanner
84% of countries have at least 1 GC or NM per million population (108 respondents)More than 25% of the South East-Asia and Western Pacific countries do not have atleast 1 GC or NM per million population (28 respondents)
Do not
have
one
16%
Have at
least
one
84%
N =108
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
EMR EUR AMR AFR SEAR WPR
Have at least one
Do not have one
2nd Global Forum of Medical Devices, November 22-24, 201329 |
MAM: MammographMAM: Mammograph
13 countries do not have at least 1 MAM per million population (121 respondents)Higher the income group more the quantity of countries that have at least 1 MAM permillion population .
Do not
have
one
13
11%
Have at
least
one
108
89%
N =121
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Low Lower
middle
Upper
middle
High
Have at least one
Do not have one
2nd Global Forum of Medical Devices, November 22-24, 201330 |
LA: Linear AcceleratorLA: Linear Accelerator
81 countries do not have at least 1 LA per million population (119 respondents)Higher the income group more the quantity of countries that have at least 1 LA permillion population .
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Low Lower
middle
Upper
middle
High
Have at least one
Do not have oneDo not
have
one
68%
Have at
least
one
32%
N =119
2nd Global Forum of Medical Devices, November 22-24, 201331 |
TU: Telecobalt UnitTU: Telecobalt Unit
107 countries do not have at least 1 TU per million population (117 respondents)Only European and American countries have more than 10% of the countries with atleast 1 TU per million population.
Do not
have
one
91%
Have at
least
one
9%
N =1170%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
EMR EUR AMR AFR SEAR WPR
Have at least one
Do not have one
2nd Global Forum of Medical Devices, November 22-24, 201332 |
RU: Radiotherapy UnitRU: Radiotherapy Unit
61% of the countries do not have at least 1 RU per million population (125 respondents)African and South-East Asia countries do not have more than 3% of the countries withat least 1 RU per million population.
Do not
have
one
61%
Have at
least
one
39%
N =1250
5
10
15
20
25
30
35
EMR EUR AMR AFR SEAR WPR
Do not have one
Have at least one
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