Reuse of single use items

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

REUSE OF SINGLE USE

REUSE OF SINGLE USE

DEVICES

DEVICES

Christina Bradley

Laboratory Manager

Hospital Infection Research Laboratory

City Hospital, Birmingham

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

INTERNATIONAL OPINION

INTERNATIONAL OPINION

Most national authorities, particularly in
wealthier countries, are against reuse in
principle but may accept reuse provided
strict reprocessing criteria are met

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

MEDICAL DEVICES

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In the European Union, the use of
medical devices is regulated by
European or national law

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Medical Devices Directive (1993)

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

UK GUIDANCE

UK GUIDANCE

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

UK : DB 2004(04)

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A medical device made for reuse must
work as well as it did on its first use
every time that is is reprocessed. The
manufacturer will validate the device for
reuse and provide adequate
reprocessing instructions when the
device is placed on the market.

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

UK : DB 2004(04)

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A single use device may be made in
such a way that any reprocessing may
damage it or alter it to the extent of
making it unsafe to reuse. If the device
has been designed for single use, the
manufacturer need not undertake any
reprocessing validation studies and is
therefore not required to provide such
information.

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

UK : DB 2006(04)

UK : DB 2006(04)

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Safety Issues

– Reprocessing single use devices may

compromise its intended function.

– Single use devices may not be designed to allow

thorough decontamination.

– Reprocessing a single use device may alter its

characteristics so that it no longer complies with
the original manufacturers specifications and
therefore the performance may be compromised.

– Single use devices have not undergone extensive

testing, validation and documentation to ensure
the device is safe to reuse

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

UK : DB 2004(04)

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Potential for cross infection

– Greatest concern

– Risk may increase due to inability to

access all micro-organisms

– May be due to design eg narrow lumens

and materials

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

UK : DB 2004(04)

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Inability to clean and decontaminate

– Access to all surfaces eg acute angles,

coils, long or narrow lumens, specialist
surface coatings

– Validation of complete removal of all micro-

organisms

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

UK : DB 2004(04)

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Residues for chemical decontamination
agents

– Materials may absorb or adsorb certain

chemicals eg glutaraldehyde, ethylene
oxide

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

UK : DB 2004(04)

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Material alteration

– Exposure to chemicals may cause

corrosion and/or changes in the device
materials

– Exposure to elevated temperatures may

alter the properties or cause degradation of
the device materials eg plastics may
soften, crack or become brittle

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

UK : DB 2004(04)

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Mechanical failure

– Devices may experience stress during

each cycle of reuse leading to fatigue
induced failure and fracturing eg single use
drill burrs, saw baldes, craniotomy knives

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

UK : DB 2004(04)

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Reaction to endotoxins

– Breakdown products of gram negative

bacteria

– May remain on instruments after cleaning

– Sterilization process will not inactivate

endotoxins

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

UK : DB 2004(04)

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Prion disease

– Health Service Circular 1999/178 states

that “devices designated for single
episodes of use must not be reused under
any circumstances whatsoever”

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

REUSE : OBJECTIVE

REUSE : OBJECTIVE

SAFETY

versus

COST

Reduce spending on non cost effective
single use items releasing more funds for
patient care, expensive reusable devices
and reducing the amount of clinical waste

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

CSC SURVEY 1996

CSC SURVEY 1996

79 replies received

54% acknowledged they were
reprocessing items labeled as single use

56 single use items were identified as
reused

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

CSC SURVEY (1996) : ITEMS

CSC SURVEY (1996) : ITEMS

REUSED

REUSED

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Cardiac catheters

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Pacemakers

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Pacemaker
electrodes

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Guide wires

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Eye shields

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Oxygen masks

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Airways

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Suction
tubing/catheters

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Anaesthetic tubing

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Tracheostomy tubes

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Endotracheal tubes

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Foetal scalp
electrodes

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

REUSE OF MEDICAL DEVICES

REUSE OF MEDICAL DEVICES

If a medical device is reused and causes
damage or injury, the re-processor and
the re-user are likely to be become
personally liable (civil and criminal
liability)

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

RISK ASSESSMENT

RISK ASSESSMENT

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

DEVICE ASSESSMENT GROUP

DEVICE ASSESSMENT GROUP

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Infection Control Doctor

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Infection Control Nurse

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Procurement Officer

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Member of the Ethical Committee

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Processor(s)

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Risk Management Officer (or equivalent)

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User

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

FACTORS TO BE CONSIDERED

FACTORS TO BE CONSIDERED

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Single use “reuse” category

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Infection risk

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Method of reprocessing

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Cost

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

SINGLE USE

SINGLE USE

REUSE

REUSE

CATEGORIES

CATEGORIES

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Unused items requiring sterilization
following damage to pack or opening in
error eg pacemaker

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Items used for more than one procedure
on the same patient eg insulin syringes

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Items used on more than one patient
after reprocessing

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

REUSE OF SINGLE USE ITEMS

REUSE OF SINGLE USE ITEMS

INFECTION RISK (1)

INFECTION RISK (1)

High

In contact with a break in the skin
or mucous membrane

Class 1

Very high risk – Intravascular,
intraventricular, intraoptic devices
Difficult to clean, heat labile,
sterilization necessary. Infections
may be severe and difficult to treat
eg endocarditis, meningitis

Class 2

Usually cleanable, heat tolerant,
sterilization necessary eg surgical
instruments

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

REUSE OF SINGLE USE ITEMS

REUSE OF SINGLE USE ITEMS

INFECTION RISK (2)

INFECTION RISK (2)

Intermediate
In contact with intact mucous membranes,
usually cleanable, disinfection is usually
adequate

Low
In contact with intact skin, usually cleanable,
disinfection (or often cleaning alone) is
adequate

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

CAN THE ITEM BE SUITABLY

CAN THE ITEM BE SUITABLY

REPROCESSED AND REUSED (1)

REPROCESSED AND REUSED (1)

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Can it be cleaned?

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Can it be adequately decontaminated ie
cleaned/disinfected/sterilized with
respect to the infection risk it poses to
the patient?

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

CAN THE ITEM BE SUITABLY

CAN THE ITEM BE SUITABLY

REPROCESSED AND REUSED (2)

REPROCESSED AND REUSED (2)

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Is the item structurally or functionally
damaged during reprocessing due to
pressure, high temperature or
chemicals?

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Are harmful residues present after
processing?

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

CAN THE ITEM BE SUITABLY

CAN THE ITEM BE SUITABLY

REPROCESSED AND REUSED (3)

REPROCESSED AND REUSED (3)

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Is the reprocessor put at any additional
or significant risk whilst processing (or
disposing of) the item eg exposure to
infectious material, hazardous
chemicals or sharps?

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Are suitable processing equipment,
facilities and expertise available?

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

CAN THE ITEM BE SUITABLY

CAN THE ITEM BE SUITABLY

REPROCESSED AND REUSED (4)

REPROCESSED AND REUSED (4)

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Is it possible to assess if the item is
suitable for reuse by visual inspection or
testing?

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If so can the number of reuses be
identified by tagging or bar coding?

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Is sterility important? Can this be
ensured by wrapping or processing at
point of use?

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

REUSE OF SINGLE USE ITEMS

REUSE OF SINGLE USE ITEMS

RISKS OTHER THAN INFECTION

RISKS OTHER THAN INFECTION

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Intravascular devices

– Breakage in situ

– Harm from release of toxic agents eg

ethylene oxide, endotoxins

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Respiratory equipment

– Harm from release of toxic agents eg

ethylene oxide, endotoxins

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

IS REPROCESSING COST

IS REPROCESSING COST

EFFECTIVE (1)

EFFECTIVE (1)

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Initial cost of the item

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Processing costs including labour

– Transport – to and from the processor
– Cleaning
– Disinfection/sterilization
– Packaging
– Documentation
– Testing/validation

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

IS REPROCESSING COST

IS REPROCESSING COST

EFFECTIVE (2)

EFFECTIVE (2)

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Recording/tracking

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Additional equipment (if required)

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Training of processing staff

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Additional safety measures

– Personal protective equipment
– Exhaust systems
– Health checks
– Monitoring devices

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Disposal of single use item as single use

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HIRL Birmingham

HIRL Birmingham

HIRL Birmingham

CONCLUSION

CONCLUSION

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The legal consequences should be

considered.

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Reprocessing will depend on careful costing

taking into account all the variables.

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Reprocessing should be validated

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Advice should be sought from a Device

Management Group and a risk assessment
carried out.


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