Purpose :
This procedure is to ensure all medical devices are replaced as/when
required and used devices are disposed of in line with waste regulations.
Disposal must comply with relevant Health and Safety legislation, Indian
Directives and AERB legislation.
Procedure apply to:
· Diagnostic and therapeutic equipment
· Ward/Department bio medical
equipment.
Condition :
• When a medical device requires replacing: it has passed its life
expectancy or spare parts are unavailable
• When a medical device is condemned
• When a medical device needs to be disposed of
Equipment may be declared surplus, obsolete or unserviceable if it is:
Surplus to
Requirement
o Where a surplus piece of equipment remains serviceable, management
should be informed. It may be decided to store the equipment, auction it or use
it elsewhere.
Unserviceable or
unreliable
o If equipment cannot be repaired (either no parts available or not
economical to repair) or it cannot be maintained properly it should be scrapped
and replaced.
Obsolete
o When equipment is not usable because parts are out of date or the
clinical technique is no longer recommended it should be scrapped.
Damaged through
negligence or abuse
o Where abuse of equipment is suspected, this should be reported to
management and the equipment taken out of use
Beyond its prescribed
life period
o Such equipment should be reported to management and the condemnation
committee. They should take into account any period of storage in addition to
use, examine the condition of the equipment to see whether the item could be
put to further use and if not they will declaring the item obsolete/surplus or
unserviceable as appropriate.
Notification
When a medical device has passed its life expectancy or unavailability
of spare parts but is still usable, Biomedical Department will issue the user
with a Notification Form. This is to inform the user that they are required to
initiate a replacement process if the device is to be replaced. This device can
still be used until the stated date.
Condemnation
When a medical device is permanently removed
from use, BME Condemnation Committee
will issue the user with a Condemnation Certificate and physically
remove the device. The Condemnation Certificate will be signed by a Committee
chairperson.
Condemnation Committee
The condemnation committee should have five members including one
nominee from Finance department. Once they have passed equipment for disposal,
a report will be prepared in Form In order to ensure unwanted items of
equipment do not cause unnecessary waste of space, it is important that
equipment disposal is done as quickly as possible but not later than six months
after the decision for disposal.
when the device has been physically removed
from service.
·
A Condemnation Certificate will be issued for one of the following
criteria:
·
worn out beyond economic repair
·
damaged beyond economic repair
·
unreliable through service history
·
clinically or technically obsolete
·
spare parts no longer available when a repair is required
·
unable to be cleaned effectively prior to disinfection and/or
sterilisation
·
a device identified in accordance with MMC local procedure
Once a Condemnation Certificate has been
issued under no circumstances must the device be brought back into service.
Disposal
Disposal of medical devices can be arranged
through BME department or supplier in line with the manufacturing guidance; however
the cost of disposal must be met by the Department. MMC will ensure that all
patient identifiable data is securely and correctly removed/deleted from the
equipment prior to disposal.
User responsibilities in equipment disposal
To ensure that equipment is disposed of in a timely and safe manner,
users are advised to:
Keep management informed of equipment status
·
report when parts are replaced, report when
equipment is unreliable
·
Be aware of hazards involved when equipment is
disposed
·
warn of the presence of mercury, asbestos etc
·
Assist in planning for replacements
·
comment on helpful or unhelpful features or
suppliers
·
Keep the asset register up to date
·
report when equipment arrives new or is replaced
·
Request regular maintenance work if it is delayed
·
send reminders to service / maintenance group
when work is due
·
Inform maintenance dept of any issue as soon as
possible
·
report promptly any work done or spares required
Report of surplus, Obsolete and Unserviceable Stores for Disposal
|
Item No. |
Particulars of Stores |
Quantity |
Book Value / Original Purchase Price |
Condition and year of purchase |
Mode of Disposal (Sale, open auction, advertised tender etc) |
Remarks |
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