global atlas of medical devices€¦ · *global atlas of medical devices 2013 objectives: –...

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).


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


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


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.


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


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%


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


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


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


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


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


Unit within the Ministry at national level that technicall

manages medical devices through HTA


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


income

Upper middle

income

High income

Do not have on

Do have one

Management Unit

HTA Unit



manages medical devices through technical

specifications for procurement unit


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


Do not have one Do have one

Tech. Spec. for procurement Unit

Management Unit



manages medical devices through planning

of medical equipment allocation unit


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





manages medical devices

through application/user training


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


income

Upper middle

income

High income



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


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


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


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


No Yes


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%


Yes

No


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%


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


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


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%


income

Upper middle

income

High income

Have Do not have


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%


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


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


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


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


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


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


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%


Have at least one

Do not have one


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


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


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%


Have at least one

Do not have one


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


Do not have one

Have at least one

global atlas of medical devices€¦ · *global atlas of medical devices 2013 objectives: –...

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