DEVICE WITHDRAWN FROM CIRCULATION

DOCUMENT NO :

KR.02.02/Dirut.IV.I/773/20
13
GENERAL HOSPITAL
Dr. WAHIDIN SUDIROHUSODO
MAKASSAR
STANDARD OPERATIONAL
PROCEDURE
(SOP)

REVISION NO :

PAGE
1/1

SIGNED BY
PRESIDENT DIRECTOR,
PUBLISHED DATE
7 MARET 2013
ABDUL KADIR
NIP 196205231989031001

DEFINITION

Circulation withdrawn device are devices that informed by the

third party and potentially harm to the users

PURPOSE

To determine procedure in responding harmful devices or

withdrawn devices from circulation

POLICY

1. Devices that harmful must not used until from authorized

party published that the device is safe to use along with
feasible certificate

PROCEDURE

1. Hospital occupational health and safety unit coordinates the

existance of harmful device by informing to the departments,
units and installation. Determine whether that device is
harmful to use. Dessiminating, informing and suggesting to
the departments, units, installations that realted to the
harmful device
2. The source of harmful device:
a. Coordinator of Hospital Occupational Health and Safety
b. Manufacturers
c. Technical Installation
3. Classification of hazard alert:
a. URGENT (U): life threatening. Hazard due to the expose
or use of failed products, that can give haelth threatening
or possibly death
b. SERIOUS (S): need to be fixed. Hazard due to the
expose or use of failed products, that can give temporary
health threatening or possibly need a forward health care
c. ADVISORY (A): Hazard due to the expose or the use of
failed products, which is noit give any health threatening
or possibly does not need any forward health care
4. When informed that no harmful device both hospital
occupational health and safety and manufacturers, the
technical unit will go check to the inventory list in which thos
devices is used
5. If the device is established on the report firmly, President
Director should send the reports copy to the hospital
occupational health and safetys Coordinator. If the report
about these withdrawn harmful device coming from the
manufacturers,should be send directly to the hospital health

and safety unit and being documented on the computer.

6. The need action to do:
a. If the notification about these withdrawn device is declare
does not need any correction only to be documented (eg,
the change of instruction use)
b. If the notification about these withdrawn device is declare
need to be fixed and should send back to the
manufacturers, vendors, technical unit should propose a
repair request to the related device ( mention the harmful
notification). Collect the device and give to the vendor to
be fixed. When the device has been repaired, the
technician should documenting the device data to the
SMS systems

WORK UNIT

THE PRESIDENT DIRECTOR AND THE OPERATIONAL OF

FACILITIES
MAINTENANCE
INSTALLATION,
THE
OCCUPATIONAL HEALTH AND SAFETY TEAM