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
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
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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UK GUIDANCE
UK GUIDANCE
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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.
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.
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
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
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
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
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
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
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
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
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
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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
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
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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RISK ASSESSMENT
RISK ASSESSMENT
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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
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
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
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
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
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
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
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
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
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
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
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
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.