There are available 2.048 hospitals and 9.731Primary Health Care facilities at district are at Indonesia. All the health care facilities have the medical electrical equipment and most of them must be testing and calibration by accraditated laboratories to make sure that all the ME comply to standard for patient safety.

1. MANAGEMENT OF
MEDICAL ELECTRICAL EQUIPMENTS
TESTING AND CALIBRATION
LABORATORY IN INDONESIA
SAFETY LABORATORY FOR
HEALTH FACILITIES (BPFK)
HEALTH DEPARTEMENT
Presented by BM. Ginting.ST, M.Si
Clinical Engineer

2. INTRODUCTION
 Medical Equipments have been used widely in
Indonesia; they could be intended for diagnosis
or therapeutic. The situation now, almost Health
Care Facilities Center like Hospital and Primary
Health Care at district are has used medical
equipments from simple equipments up to
sophisticated one. The used of medical
equipments is very important in order to provide
the best health service for patient safety.

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 On the other hand, medical equipments which is not
used properly or using substandard medical
equipments could cause a negative effect to the
patient or operator and user also environment. In
order to protect a negative effect from substandard
a medical equipments use, is very important to
calibrating and testing medical equipments.

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 In relation to protect a negative effect, one of the
duty of Safety Laboratory for Health Facilities
(BPFK) is calibrating and testing of medical
equipments before under and after they use and in
Health Care Facilities. Until now there are 4 (four)
BPFK within the territory of Indonesia such as BPFK
Jakarta, BPFK Surabaya, BPFK Medan, BPFK
Makasar. Each BPFK have territory of calibration
and testing area.

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 There are some obstacles in carrying out to
calibrate and test the medical equipments including:
 A lack of personals or human resource who
capable to their duty properly as calibrator and
tester as a legal aspect
 A lack of medical equipments calibrator and tester
especially for Medical electrical equipments.
 A lack of the medical equipment’s standard
 Etc.

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 Base on the obstacles above, there is very important to
study comparison on medical equipments calibration and
testing for improving and developing medical
equipments calibration and testing system especially for
protecting people from substandard medical equipments.
 According to the Law of Republic of Indonesia Number
36 of 2009 Regarding Health Article 42: “Technology
and health technology products must be comply with the
standards determined in the legislative regulations”.

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 Based on with the ministry of Health’s Regulation
No.54/2015 “All of medical equipments (diagnostic
or therapeutic equipment) which are used within the
territory of Indonesia especially in Health Care
Facilities shall be calibrated at least once a year”.

8. II. OBJECTIVE
 General objective:
 Improving medical equipments calibration and testing for
protecting people from substandard and unsafe medical
equipments.
 Specific objective:
 To improve human resource of Safety Laboratory for Health
Facilities (BPFK).
 To develop medical equipments calibration and testing system
 To develop medical equipments standard evaluation.

9. III. VISION AND MISION
 Vision:
 To be a reliable based on scientific and
professionalism for calibration and
testing medical equipments particularly
medical electrical equipments

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 Mission:
 To protect public health from medical
equipments that unfulfilled Quality, efficacy
and invironment safety requirements.
 To ensure safety and efficacy of medical
equipment in Health Care Facilities.

11. IV. STRATEGIES
 Developing calibration system base on regulation
system
 Improving and developing human resources of Safety
Laboratories for Health Facilities (BPFK) by training,
education and comparison study.
 Developing medical equipments standard base on
International Medical Equipments Standard.
 Developing classification Medical Equipments base
on Global Harmonization Task Force.
 Developing essential principals of safety and
performance of medical equipments.

12. V. ACTIVITIES
 Establishing Technical Guidelines and Date
Bases for Medical Equipments System.
 Harmonization technical requirement for
calibration and testing medical equipments.
 Improve mechanism for national medical
equipments technological screening.
 Establishing officially recognized standard of
quality for the use of medical equipments.

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 Attending workshop, symposium, training, and technical
meeting of medical equipments.
 Mutual cooperation with other countries.
 Study comparison on evaluation, standardization and
calibration and testing medical equipments.
 Marking standard medical equipments according
harmonization on standard and guidelines of medical
equipments.
 Improved performance in medical equipment

14. THANK’S
STANDARD IS NOTHING
WITHOUT UNDERSTANDING