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Single Use Medical Devices Policy


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									         Single Use Medical Devices Policy

Document Reference:          Infection Control

Point of Reference:          Peter Walsh, Director for Infection Prevention and Control
Status:                      Final
Date of Issue:               May 2006
Date of review:              May 2008
Date of last review          Februaru 2008
Policy Reference:            IC 05
Ratified by:                 Clinical Governance Committee

            Approved at Clinical Governance Committee Meeting

Signed By
           Executive Director of Nursing
           Central and North West London Mental Health NHS Trust

Signed By
         Medical Director : Chair of Clinical Governance Committee.
           On Behalf of Chief Executive
           Central and North West London Mental Health NHS Trust

   This policy is based on previous work by the Infection Control team at Westminster and
                        Kensington and Chelsea Primary Care Trusts
Single use medical devices policy
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                                                    Page number

1.     Rationale                                         3

2.     Aim                                               3

3.     Definitions: categories of medical devices        3

4.     Legal issues                                      4

5.     Technical issues                                  5

6.     Prion diseases                                    5

7.     References                                        6

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1.     Rationale

The reuse of a single use device is associated with significant risk and is in
breach of the law (see section 4). Potential risks include that of cross-infection
through inadequate decontamination and mechanical damage due to
exposure of the device to heat or chemical decontamination agents. All
equipment must therefore be used strictly according to the manufacturer’s
instructions (Medical Devices Agency, 2000).

It is the policy of Central and North West London Foundation Trust that
single use devices must never be reused or reprocessed. More general
information on medical devices is in the Medical Devices Policy.

2.     Aim

To ensure that single use devices are never reused or reprocessed. This
policy draws the attention of managers and staff to the hazards and risks
associated with reprocessing and reusing single use medical devices, and the
legal issues involved.

3.     Definitions: categories of medical devices

Medical devices can be divided into 3 categories:

i)     Single Use
       The medical device is intended for use once, on an individual patient
       for a single procedure, and then should be discarded. It should not be
       reprocessed or reused on another patient. The following packaging
       symbol indicates that a medical device is single use and disposable.

ii)    Single Patient Use
       The medical device can be used for more than one episode of use on
       one patient only. The device will need to be decontaminated between
       each use. The manufacturer must state how the device should be
       decontaminated and how many times the device can be used prior to

iii)   Re-usable
       The medical device can be used for repeated episodes of use on
       different patients, but will need to be decontaminated appropriately

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       between each episode of use, according to the manufacturer’s

4.     Legal issues

European Council – Medical Devices Directive 93/42/EEC implemented
into UK law as the Medical Devices Regulations, 1998

Health Service Circular HSC 1999/179 – Controls assurance in infection
control: Decontamination of medical devices, 1999

The Health Act 2006 (revised 2008)

Key points
 devices designated for single use must not be reused under any
 the reuse of single use devices can affect their safety, performance and
  effectiveness, exposing patients to unnecessary risk
 anyone who reuses a device intended by the manufacturer for use on a
  single occasion takes full legal responsibility for its safety and
 anyone who reprocesses a single use device and passes it to a separate
  legal entity for use, has the same legal obligations under the Medical
  Devices Regulations as the original manufacturer of the device.

If a reprocessed device is supplied to another legal entity for use, and
the device is not fit for its intended purpose, the reprocessor and the
professional user may be committing an offence under one or more of
the following acts.

Health and Safety at Work etc Act, 1974

Consumer Protection Act, 1987
There may be exposure to civil liability, with payment of damages for any
injury caused to another person by the device.

General Product Safety Regulations, 1994

Medical Devices Regulations, 1994
Medical devices manufactured and put on to the market throughout the EU
are subject to specific regulation and required to carry a CE marking. This
denotes compliance with essential safety and performance requirements.

5.     Technical issues

 A medical device manufactured for reuse must work as well as it did on its
first use every time that it has been reprocessed. The manufacturer must

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extensively test and validate the device and the process for reuse and provide
adequate reprocessing instructions when the device is placed on the market.

A single use device will not be validated for reuse and may be made in such a
way that any reprocessing may damage or alter it to the extent of making it
unsafe to reuse. Most problems caused by inappropriate reuse of a single use
device fall into one or more of the following categories:

Potential for cross infection
Infection is one of the greatest patient safety concerns associated with reuse.
The risk of infection will increase if the device cannot be effectively

Inadequate cleaning and decontamination
The cleaning process must access all parts of the device to enable complete
decontamination and at the end of the process the cleaning agents must be
completely removed. This process should be validated, to establish that it will
consistently provide the required results. Examples of features of the device
that may make cleaning difficult are narrow lumens and specialist coatings.

Material alteration
Exposure to heat or chemical agents may cause corrosion, degradation or
other changes in the material of the device.

Mechanical failure
Some devices may experience stress if repeatedly reprocessed, leading to
fatigue-induced failure and fracturing, e.g. single use drill burs.

Residues from chemical decontamination agents
Plastic devices may absorb chemicals that may leach out over time, resulting
in chemical burns or sensitisation to the patient.

6.     Prion diseases

Prions are infectious agents, which contain no nuclear material. They replicate
by transforming normal cellular proteins into abnormal proteins, which then
accumulate in the central nervous system where they can trigger neurological
symptoms. Prion diseases are neuro-degenerative, with no known treatment.

The abnormal proteins associated with prion diseases are very resistant to all
conventional methods of decontamination. Most chemical and physical means
of cleaning, disinfection and sterilisation of medical devices are only partially
effective at inactivating prion proteins.

In order to reduce the risk of transmission of prion proteins during surgical
procedures, single use devices should be used whenever practicable and they
must not be reused under any circumstances (Medical Devices Agency, 2002;
Health Service Circular 1999/178).

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7.     References

CNWL Infection Control policies including Decontamination of equipment

Health Service Circular: HSC 1999/178. Variant Creutzfeldt-Jakob Disease
      (vCJD): Minimising the risk of transmission. 1999

Health Service Circular: HSC 1999/179. Controls assurance in infection
      control: Decontamination of Medical Devices. 1999

Medical Devices Agency. Single-use medical devices: implications and
      consequences of reuse. MDA DB 2000(04). 2000

Medical Devices Agency. Benchtop vacuum steam sterilizers – the “prion
      cycle”. MDA SN 2002(11). 2002

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