Reprocessing of Single Use Medical Devices and Limited Reuse

Medical Devices

Definition:
The correct method of control and reprocessing for single-use medical devices, based on the
Spaulding classification risk category.
Objective:
1. To prevent transmission of infection from medical devices.
2. To ensure that equipment is in good quality and can be used again based on that function.
3. To ensure that all health care workers are responsible in using the correct method for
reprocessing the medical devices based on Spaulding risk category.
4. Cost consideration.
Policy:
1. If there is a request to reprocess a new single-use medical device, the related supervisor
should report this to the Infection Prevention Control Nurse (IPCN).
2. Healthcare Infection Control Management Resources (HICMR) approval is required before a
single-use medical device being reprocessed.
3. Approval/exemption form has to be completed for each device.
4. All single use devices that are approved for reprocessing must be listed in this policy.
5. All new medical devices must have manufacturers instructions. (e.g. limit of re-use
devices)
6. Original packaging for the single-use medical devices must be retained.
Medical
Level
of
Risk
Critica
l

Semi
Critica

equipment Spaulding classification

Application
Process

Equipments
that enter or
penetrate into
sterile tissue,
body cavity,
blood flow.

Steam
sterilization and
Sterrad

All equipment
that is in

Steam
sterilisation or

Storage

Examples

Maintain the
Sterilisation by:
1. Wrapping the
equipment only
when it is
completely dry.
2. Making sure there
is no tear or
leakage on the
wrap.
3. Making sure the
wrap can prevent
any biological
activity on the
equipment during
storage.
4. Always store the
equipment in
sterile area to
protect from
environment
contamination.

Harmonic scalpel
Arthroscopy incisor blade

Keep in clean and

dry area to protect

Equipment related to the

respiratory system such

contact with
mucosal
membrane

Thermal
disinfection using
high-level
disinfectant

from environmental
contamination

as:

Laryngeal Mask (LM)

Procedure and Tracking

1. Devices are inspected for any signs of damage and if so, the devices should not be
reprocessed and must be discarded.
2. For details of critical equipment reprocessing, refer to Manual of Central Sterile Supply
Department (CSSD).
3. For details of semi-critical equipment reprocessing, refer to Manual of Central Sterile
Supply Department (CSSD) for semi-critical equipment.
4. Two (2) batch tracking labels are adhered to the medical device package prior to
sterilisation. The following information is included on the label:

Date of sterilisation and cycle number

The name and unique identification of the device e.g. A,B, C

The number of times the device has been reprocessed. e.g. 1,2,3
5. Procedure in OT:

After the equipment being used, the first batch label is attached on patient
medical record file.

The OT nurse should complete the Check List of Single-use Device

Reprocessing form with patient ID label, item used (by name & unique
number), number of usage, and date of procedure.
6. All used equipment should be returned to CSSD with the second batch label still being
attached on the inside of equipment package.
7. Procedure in CSSD:

Used device is returned to CSSD, batch label (2) is attached on Check List of
Single-use Device Reprocessing form for each device, as proof of usage
frequency for each device.
8. Surveillance audit of patients listed on the register is held monthly for signs and
symptoms of infection and/or inflammatory response.
SINGLE USE DEVICES APPROVED FOR REUSE
No
Medical
Frequency
Exception
Control process
equipme
use & rent
process
1
Phaco set 10x /Sterrad
damaged,
1. Write down
malfunction,
frequency of
change in
use on check
shape, leak,
list card
blocked, or dull 2. Discard after
10x use
3. Discard if
damage before
10x use
2
Harmonic 1x / Sterrad
damaged
1. Write down
Scalpel
rubber, change
frequent of
in shape, dull
used at check
list card
2. Discard after
2x use

Related unit

OT
Ophthalmolog
y

Operating
Theatre
(Digestive)

Nasogastr
ic feed
syringe

Once a week
(replace
every
Monday)
a. Pasteurisati
on
b. Chemical
desinfectio
n

Damaged,
discolored,
blurred
measuring strip

No

Medical
equipme
nt
Connectin
g tube of
breast
pump

Frequency
use & reprocess
a. Pasteurisati
on
b. Chemical
desinfectio
n

Exception

Milk
bottle

a. Pasteurisati
on
b. Chemical
desinfectio
n

LIMITED REUSE DEVICES

No
Medical
Frequency
equipme
use & rent
process
1
Laryngeal 40x / Sterrads
Mask

3. Discard if
damaged
before 2x use
1. Label the
syringe with
starting date of
usage
2. Discard after
one week of
usage
3. Discard if
damaged
before one
week

Control process

CCU

Related unit

Damaged,
discolored,
brittle

Discard if any
damage occurs

Well-nursery
Room, NICU,
Merpati ward
(maternity
ward)

Damaged,
discolored,
blurred
measuring
strip.

Discard if any
damage occurs

CCU, NICU,
Penguin ward
(pediatric
ward).

Exception

Damaged
rubber

Control process

1. Write down
frequent of
used at
maintenance
card
2. Discarded after
40x used
3. Discarded if
damage before
40x used

Related unit

Operating
Theatre
(Anesthesia)

Attention
1. Use PPE during cleaning procedure
2. After each use, check equipment for any damage, colour change or malfunction.
3. If staff identifies an issue as in point 2 above, they should not use the equipment.
4. Make sure all the check list cards are filled in completely and consistently for all individual

items.