|
National Medical Device Survey (NMDS) |
|
Name
(Abbreviation) |
National Medical Device Survey
(NMDS) |
|
Established since:
|
2005 |
|
Contact person: |
Faridah Aryani Md. Yusof, NMDS Manager |
|
Address: |
3rd Floor, MMA House
124, Jalan Pahang
50286 Kuala Lumpur
Malaysia |
|
Phone: |
(603) 40439300/ (603) 40439400 |
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Fax: |
(603) 40439 500 |
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Email: |
nmds@crc.gov.my |
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URL: |
http://www.crc.gov.my/nmds |
|
Sponsor, Funding
and Governance: |
|
Sponsor: |
The Engineering Services Division of the
Ministry of Health (MOH) and The Clinical Research Centre, Kuala
Lumpur Hospital MOH |
|
Funding: |
The NMDS is funded out of sponsors’
operating budget and in part by MRG grants from the MOH.
The CRC of the MOH also provided technical support in the form of
clinical epidemiology expertise, and biostatistical and ICT
services. |
|
Governance Board: |
A Governance Board established to govern
the NMDS.
All major groups involved in medical device issues in Malaysia
such as the MOH, professional bodies, private healthcare providers
and the medical device industry are represented on this board to
ensure that the NMDS stay focus on its objectives, and to assure
its continuing relevance and justification.
Y. Bhg. Datuk Ir. Dr. M.S. Pillay and Dato’ Dr. Zaki Morad b Mohd
Zaher are the current Chairman and Co-Chairman of the Board. |
|
Objectives: |
The objective of the NMDS is to quantify
the present state and time trends of medical device procurement
and utilization at various level of our health care system,
whether national, regional, local or institutional. It will
provide a public information service to ensure that high quality,
reliable and timely information on medical devices are available
for promoting equitable access to and safe and effective use of
such devices in Malaysia.
These data have several applications including:
-
Describe
the demographic patterns of device availability and utilization to
better understand device use in its natural clinical environment.
-
Estimate
expenditure on medical devices, which constitutes a significant
proportion of our public and private healthcare expenditure.
-
Monitor
and evaluate the cost-effectiveness of device-based treatments with
respect to device productivity and equity in provision which may
have significant impact on resource management within our healthcare
system.
-
Monitor
users’ device-experience and evaluate the clinical effectiveness of
medical devices, and their associated health outcomes as well as
factors influencing those outcomes.
-
Support
reporting of adverse events or product problems by suppliers or user
facilities.
-
Relate the
number of adverse device effects reported to our device vigilance
system to the number of people exposed to the device in order to
assess the magnitude of the problem, or to estimate the degree of
under-reporting of adverse events.
-
Stimulate
and facilitate applied clinical and epidemiologic research on the
economics, utilization, safety and effective use of medical devices.
|
|
Scope
and Content: |
NMDS seeks access to data on medical
devices from all sectors (both public and private) and conduct
surveys at the various levels of the medical device supply and
distribution chain in the country, which includes:
-
Establishment and Device Product Survey from
the device industry.
-
Device import data from the Royal Malaysian
Custom.
-
Disposables/asset procurement data from
purchasing databases of both public and private hospitals.
-
Asset inventory from the Engineering Services
Division MOH.
-
Device use and outcomes from User Facility
Surveys and device registry.
And in future, device consumption from
household surveys as well as from device registration & vigilance
databases of regulatory authorities. |
|
Data
collection and transfer: |
All NMDS surveys are conducted
electronically either by:
-
Direct
import of data from existing databases as mentioned above, or
-
Primary
data collection from its various source data providers.
The surveys follow the standard medical
device system as recommended by the GHTF. |
|
Record linkage: |
Not applicable |
|
Reports & Publications: |
Pending |
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Resources: |
|
|
Survey operations: |
The daily operations of the NMDS are
undertaken by dedicated staff, which comprises a full-time
registry manager and two full-time assistants. They work from a
purpose- designed office. |
|
Epidemiology: |
The Clinical Research Centre of the MOH
provided pharmaco- epidemiology expertise for the NMDS |
|
Biostatistics: |
This is outsourced to Biostat Consulting
Sdn Bhd. |
|
ICT support: |
These are outsourced to various IT
companies including NTT (data centre service), MIMOS and KSM
(hardware), Datamed Clinical Computing Sdn Bhd (databases and
applications), SecureTangent (information security), and variety
of specialty software providers (IBM/Ascential, SAS, STATA,
WHODrug/ WHO ATC-DDD etc). |
|
Date updated: |
1/12/2005 |
