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Policy & Procedure for Reuse of single use devices Document No:

PURPOSE

To define set guidelines for the reprocessing of single use or disposable medical devices (SUD)

SCOPE

Hospital wide.

DEFINITION / ABBREVIATION

Single use or disposable devices: A devices that is marketed or labeled for single patient use or
single procedure use. It is not marketed or labeled with the intent of reusing the device on
another patient. The labeling identifies the device as single use or disposable and does not
include instruction for reprocessing.

Note: Some SUD’s are marketed and labeled as non-sterile and include appropriate pre use
sterilization or processing instructions to make the device patient ready. This is not considered as
“reprocessing”

Open but unused: An “Open but unused” product is a SUD whose sterility has been breached or
whose sterile package was opened but the device has not been used on a patient. This also
includes a device whose packaging has expired as identified by the label on the package.

Reuse: The repeated use or multiple use of any medical device on the same patient or different
patients with applicable reprocessing (cleaning, functionality verification, and or disinfecting /
sterilization) between uses.

Reprocessing : Reprocessing includes all operation performed to assure that a previously used
SUD is clean, sterile and will function as intended by the original equipment manufacturer
( OEM). The process includes, but is not limited to, disinfection, cleaning functional verification,
packaging and possibly sterilization.

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Re-sterilization: The repeated application of a terminal process designed to remove or destroy all
viable forms of microbial life, including bacterial spores, to an acceptable sterility level.

SUD: Single Use Device.

OEM: Original equipment manufacturer.

RESPONSIBILITY

 Infection control committee

 Medical and Emergency department
 Nursing department
 CSSD

POLICY

The hospital has adopted the following policy regarding the reprocessing of SUD.
 The hospital is committed to reprocess SUD’s in a manner so as to patient safety and
stringent quality control.
 SUD’s that may be reprocessed are listed. SUD’s not listed cannot be reprocessed and
should be discarded after single use.
 Authority :
Authority for the program is vested with the infection control committee. The infection
control committee will follow the policies set forth regarding the reprocessing of SUD’s.

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REPROCESSING OF SINGLE USE DEVICE:

DEFINITION: A medical device is intended to be used on an individual patient during a single procedure and then discarded. It is not
intended to be reprocessed and used on another patient.

PURPOSE: To established a safe guideline for reprocessing a single use device in healthcare organization.
PROCEDURE:
1. Single-use devices identified for reprocessing must be approved by the Food and Drug Administration (FDA)
for reprocessing.
2. Single-use devices identified for reprocessing must be further approved in writing by the both Medical
Director and Consultant Microbiologist.
3. How many times it will be reprocessed that have a written documentation to the user and CSSD.
4. After recommended reprocessing will over that particular single use device will be discarded.
Reused item:
Sl No Device Reuse number

CATH LAB
1 Catheter 04
2 Manifold 04
3 Y connector set 04
4 Introducer 04
5 Radial Sheath 04
6 Femoral Sheath 04
7 Puncture needle 04
8 Torka 04
9 ID Kit 04
10 Teramo wire 04
11 Teflon wire 04
12 Coronary wire 04
13 Balloon catheter 02
14 Butterfly and cannula 04
15 PMO Line 04
16 PPI Lead 04
17 Dilator 04
18 Crocodile cable 04

OT
01 Liga Clip 01
02 Plastic Proctoscope 04
03 Diathermy pencil 06
04 Plain sheet 01
05 TUR set 03
06 Vaccu suction 03

NICU
1 MR 290 Humidifier 03
2 HFNC Circuit 03
3 Ventilation Circuit 03
4 Suction Tube 03

WARD
1 Ambu Jet 04

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2 Laryngoscope blade 04
3 Bhujie 01
4 Bipap Mask 01
5 Brain Circuit 01

The process of single-use device reprocessing:

Single-use medical device reprocessing entails disinfecting, cleaning, sterilizing, packaging,
labelling, and storing a used or opened package of a medical device to be placed into service again.
The medical devices used today are engineering marvels, with intricate materials, parts, and
passageways. When a device is labelled as single use, the manufacturer is claiming its safety for use
only once. To reprocess such a device after it has been used, one must ensure that it is sufficiently
clean or sterile and properly functioning, and will not pose a risk to the patient for whom it is used.
Sanjiban Hospital will consider additional technical issues when deciding to reprocess single-use
medical device, such as the following:

■ What are the effects of cleaning, disinfecting, and sterilization on the function of the device?
■ Can reprocessing change the design specifications of the device?
■ How can the reprocessor confirm that reprocessing has not changed the device’s functionality or
performance?
■ If an issue is identified with a reprocessed device, is there a way to trace that device to the patient
on whom it was used?
■ If a patient experiences an adverse event that can be linked to a device, is it possible to trace the
device to the patient or vice versa to determine which device the patient received? And how are the
individual devices identified?

Difficult-to-Clean Devices are as follows:

• Cannula in septorhioplasty set
• Coronary suctions
• All ear trays, suctions, and very fine, delicate instruments
• Flexible scopes, gastroscopes, and bronchoscopes
• Defibrillator paddles
• Lenses
• Trivex system
• Drills
• Gamma nail sets
• Saws
• Extract All set
• Kerrison Rongeurs
• Spring-loaded drill guides
• Bipolar forceps with delicate tips
• Tympanomastoid set
• Orthopaedic reamers

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A quality system for reprocessing single-use devices should include the following components:
1. A reuse committee including members from the facility with responsibility for administration, risk
management, epidemiology, infection prevention and control, biomedical engineering, medical
device processing and procurement, medical departments and accounting.
The committee should establish policies, ensure that protocols exist for each reprocessed device, and
monitor adherence to approved procedures.
2. Written reprocessing procedures for each type of single-use device.
3. Validation of the effectiveness of reprocessing procedures to ensure both sterility and
functionality of the device.
4. Quality assurance. This includes monitoring of control points and quality indicators, regular
sampling and
inspection of devices, and a periodic review of external factors that could affect the safety or
function of reprocessed devices, such as changes in hospital use practices, changes in the supplier of
the device, or changes in the design or materials of the device.
The “decontamination” process is a combination of procedures that include transportation, cleaning,
disinfection and/ or sterilisation used to render a re-usable invasive medical device safe for further
episodes of use. The most important way of reducing the risk of transmission of infectious agents is
by ensuring that the decontamination of all instruments is as effective as possible. Decontamination
is performed in a suitable location, ideally external to the dental surgery.
Where this is not possible and instruments have to be decontaminated in the dental surgery refer to
Appendix IX.
 Cleaning is the process that physically removes soiling including large numbers of
microorganisms and the organic material on which they thrive.
 Disinfection describes a process that eliminates many or all pathogenic microorganisms on
inanimate objects, with the exception of bacterial spores.
 Sterilisation refers to a physical or chemical process that completely kills or destroys all forms of
viable microorganisms from an object, including spores. Sterility is an absolute condition - an item is
either sterile or not sterile.

Appropriate PPE must be worn at all stages of the decontamination process. New reusable
instruments should be decontaminated prior to first use.

Acquisition of RIMD: When procuring RIMD, it is essential that it is compatible with HSE
standards and recommended practices.

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Use and Transportation of RIMD

Remove instruments to the decontamination area in a safe leak proof transport box, where
appropriate, having ensured clinicians have disposed of single use sharps. The transport box should
be colour coded or identifiable as containing contaminated dental RIMD.
 It is essential not to contaminate the outer part of the transport box.
 The box must not be overfilled.
 The transport box needs to be cleaned using a dual detergent/disinfectant wipe.

Cleaning of RIMD
Cleaning must precede all disinfection and sterilization processes. If an instrument is not clean
it cannot be sterilized. It must involve the removal of organic and inorganic contamination.
Good working practice means that debris must be removed by the clinician/dental nurse at the
point of use (e.g. dental cement) from RIMD with a single handed technique.

 Washer disinfectors are the preferred method for cleaning/disinfecting RIMD. The use of
washer disinfectors will minimize handling of sharp instruments and the risk of sharps injury.
 In the absence of a washer-disinfector the next most appropriate method of cleaning of RIMD is
in an ultrasonic cleaner. An Ultrasonic Cleaner will not disinfect medical devices and thus devices
pre cleaned in an Ultrasonic Cleaner will still be contaminated and present a sharps injury risk.
 Each stage of the cleaning process must be reviewed and signed off before release to next stage of
decontamination process. Use manual sign offs to indicate that instruments have gone through sonic
cleaning where print outs are not available to sign.
 Instruments must not be allowed to dry out prior to cleaning. If instruments cannot be
decontaminated within 30 minutes of use, they should be kept moist. This can be achieved by using
a non linting absorbent pad/gauze and a few mls of water or enzymatic cleaner (no free liquid) in a
transport container or by using a product specifically intended for this purpose and in accordance
with manufacturer instructions. The container needs to be a secure box labelled “contaminated”.
 If instruments cannot be decontaminated within 24 hours, they should be cleaned in the Washer
Disinfector, bagged, clearly identified as contaminated and sterilised at the earliest opportunity.
o If instruments cannot be decontaminated within 24 hours, and no Washer Disinfector is available,
instruments should be cleaned in the Ultrasonic Cleaner, dried, bagged, clearly identified as
contaminated and sterilised at the earliest opportunity.
o Duck bags are also available, and must be used according to manufacturer’s instructions
10.2.1 Procedure: Cleaning of instruments in the ultrasonic cleaner
‐Ultrasonic Cleaner must conform to: EN 15883‐Part 1, 2 and 5.
 Staff must be trained in the correct use of the ultrasonic cleaning equipment.
 The ultrasonic cleaner is used for the removal of surface debris, prior to autoclaving. As stated
previously, an ultrasonic cleaner will not disinfect medical devices and thus devices pre cleaned in
an ultrasonic cleaner will still be contaminated and present a sharps injury risk to the user.
 Heavily soiled instruments when contained in the basket of the ultrasonic cleaner should be
immersed in water and not held under running water in the decontamination sink. This is done prior
to automated cleaning so as to avoid splashing. It is advisable to remove blood from surgical
instruments as quickly as possible as it is more difficult to remove when congealed.

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 Fill the ultrasonic cleaner with the correct dilution of recommended enzymatic solution according
to manufacturer’s instruction.
 The cleaning liquid must be degassed for 5 minutes prior to use and each time the solution is
changed. If there is no specific degas function then run a 5 minute cycle with no instrument load
ensuring manufacturer’s instructions are followed.
 All suitable RIMD must be immersed in the cleaning solution.
 The ultrasonic cleaner must not be overloaded.
 Hand pieces and ultrasonic scalers must not be placed in the ultrasonic cleaner.
 The ultrasonic cleaner must be located close to the instrument rinsing sink to facilitate filling and
emptying.
 The ultrasonic cleaning cycle must not be less than 5 minutes.
 Do not add instruments to the ultrasonic cleaner when a cycle is in progress.
 Do not interrupt the cycle once started.
 At the end of the ultrasonic cycle rinse the instruments under running water whilst contained in
the ultrasonic cleaner basket. At this stage, if visible debris is noticed on the instruments they should
be returned to the ultrasonic cleaner for reprocessing. If visible debris is not removed it will interfere
with microbial inactivation and compromise the sterilisation process.
 Dry the instruments with disposable, non-linting paper towels.
 Change liquid solution at least every 4 hours or more frequently if contaminated. Document the
change of solution.
 Drain, clean and dry the ultrasonic cleaner at the end of the day.
 The Ultrasonic Cleaner must be commissioned prior to initial use or undergo local acceptance test.
Only when all the above tests have been passed should the Ultrasonic Cleaner be accepted for use in
the decontamination process. These results should be used as a benchmark for on-going comparison.
 The Ultrasonic Cleaner must be validated at least annually to confirm functionality using the
standards EN 15883.

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