DECONTAMINATION OF EQUIPMENT PRIOR TO INSPECTION by xfa20788

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									           Clinical Guidelines




DECONTAMINATION OF EQUIPMENT PRIOR TO
    INSPECTION SERVICE OR REPAIR




               Version: 1




        Date approved: April 2007
Ref No:CICT009                                   v.1                                         April 2007




                                 Document Control


Document Reference                              CICT009
Title of document                               Decontamination of Equipment Prior to
                                                Inspection Service or Repair
Authors name(s)                                 Sally Webster
                                                Leasa Benson
Authors job title(s)                            Lead Clinician in Infection Control
                                                Infection Control Nurse

Directorate(s)                                  Public Health

Document status                                 V1
Supersedes

Clinical approval                               NHS Manchester Infection Control
                                                Committee
NHS Manchester (Committee)                      NHS Manchester Infection Control
approved by                                     Committee

Date of approval                                April 2007

Publication/issue date
                                                April 2007
Review date                                     April 2009

Distribution                                    NHS Manchester website
                                                NHS Manchester Infection Control
                                                Committee




DECONTAMINATION OF EQUIPMENT     Page 2 of 10                    Sally Webster and Leasa Benson
PRIOR TO INSPECTION SERVICE OR
REPAIR
Ref No:CICT009                                             v.1                                                   April 2007




                                                  Contents

1 Introduction.......................................................................................................... 4
2 Classification of infection risk .............................................................................. 4
3 Classification of infection risk associated with the decontamination of medical
devices and equipment ............................................................................................... 4
4 Manufacturer’s and suppliers responsibility ......................................................... 5
5 Procedure to be followed when sending items for service or repair .................... 5
6 Items that are the subject of a complaint or investigation .................................... 5
7 Appendix 1 Handling of equipment prior to inspection, service, repair, return to
lending organisation or investigation of adverse incident ........................................... 7
8 Declaration of contamination status .................................................................... 8




DECONTAMINATION OF EQUIPMENT             Page 3 of 10                              Sally Webster and Leasa Benson
PRIOR TO INSPECTION SERVICE OR
REPAIR
Ref No:CICT009                                   v.1                                     April 2007




1    Introduction

Safe systems of work should be implemented to protect all staff, including those not
employed within the Health Service, from the transmission of infection from medical
devices (medical and laboratory equipment, consumables and materials used in the
treatment, diagnosis and care of patients) and other equipment which comes into
contact with patients or their body fluids.

This is a legal requirement under The Health and Safety at Work Act 1974 and
COSHH Regulations 1988.

Anyone who inspects, services, repairs or transports medical, dental and laboratory
equipment, either on hospital premises or elsewhere, has a right to expect that
medical devices and other equipment have been appropriately treated so as to
remove or minimise the risk of infection or other hazards; appropriate documentation
is required to be provided to indicate the contamination status of the item.

This policy should be brought to the attention of all staff that need to be aware of its
contents. This will include general managers, scientific officers, sterile services
managers, medical, dental, laboratory and nursing staff, staff in pharmacy, medical
physics, audiology, physiotherapy, imaging, engineering and maintenance
departments, infection control personnel, supplies officers, safety officers and
surgical appliance officers.


2    Classification of infection risk

The following guidance will determine whether equipment needs sterilisation,
disinfection or cleaning prior to inspection, service or repair.
For further guidance on methods of sterilisation, disinfection or cleaning contact the
community infection control team.


3    Classification of infection risk associated with the decontamination of
     medical devices and equipment

Adapted from ‘sterilization, disinfection & cleaning of medical equipment: Guidance
on decontamination from Microbiology Advisory Committee to the Department of
Health Medical Devices Agency (MAC manual) [2]

Risk                             Application of Item         Recommendation
High                              in close contact with     Cleaning followed by
                                     broken skin or broken   sterilization*
                                     mucous membrane
                                  introduced into sterile
                                     body areas
Medium                            in close contact with     Cleaning followed by
                                     mucous membranes        sterilization or disinfection
DECONTAMINATION OF EQUIPMENT      Page 4 of 10               Sally Webster and Leasa Benson
PRIOR TO INSPECTION SERVICE OR
REPAIR
Ref No:CICT009                                      v.1                                        April 2007



                                       contaminated with
                                        particularly virulent or
                                        readily transmissible
                                        organisms
                                       prior to use on
                                        immunocompromised
                                        patients
Low                                    in contact with healthy    Cleaning only
                                        skin
                                       not in contact with
                                        patient

*Other factor to be taken into consideration when choosing a method of
decontamination include the nature of the contamination, the time required for
processing, the heat, pressure, moisture & chemical tolerance of the object, the
availability of the processing equipment & the quality & risks associated with the
decontamination method.
Note: Where sterilization will damage equipment, cleaning followed by high-level
disinfection may be used as an alternative.


4    Manufacturer’s and suppliers responsibility

Suppliers have a responsibility to provide information on the compatibility of their
particular medical devices or equipment with methods and agents for
decontamination. Some guidance on decontamination has been issued in HC
(91)33. Such general guidance will require to be interpreted in the light of particular
local situations.


5    Procedure to be followed when sending items for service or repair

All items intended for inspection, service, repair or transportation must be provided
with a declaration of contamination status from the owner of the item. For an
example of such a declaration which may be copied and used (see Appendix 1 & 2).

If items are dispatched to suppliers, or presented for service or inspection on Trust
premises without a declaration of contamination status and without prior agreement,
suppliers may refuse to handle such items until they have been decontaminated and
a declaration provided. This may result in delays and/or additional costs.


6    Items that are the subject of a complaint or investigation

In particular situations, for example when the condition of an item which is the subject
of complaint or investigation may be altered or influenced by a decontamination
process, the investigator may wish the item not to be decontaminated. In such
situations, the advice of the investigating body and the Community Infection Control
Team should be sought.
Prior warning should be given to the intended recipient.
DECONTAMINATION OF EQUIPMENT         Page 5 of 10                  Sally Webster and Leasa Benson
PRIOR TO INSPECTION SERVICE OR
REPAIR
Ref No:CICT009                                  v.1                                    April 2007




The condition of the item should be clearly labelled so that it can be determined prior
to opening of the inner package.

The packaging should be sufficiently robust to withstand transport.

The packaging should ensure that the content of the inner pack cannot contaminate
the outer one.

In addition, agreement of any carrier used to transport a contaminated item may be
required.

The above also applies to items, which are not subject to investigation but cannot be
decontaminated before inspection, service or repair (see Appendix 1 and 2).




DECONTAMINATION OF EQUIPMENT     Page 6 of 10              Sally Webster and Leasa Benson
PRIOR TO INSPECTION SERVICE OR
REPAIR
Ref No:CICT009                                    v.1                                   April 2007




7    Appendix 1 Handling of equipment prior to inspection, service, repair,
     return to lending organisation or investigation of adverse incident


Note: it is illegal to send contaminated items through the post


 Can the equipment be
                                                        Decontaminate item
 decontaminated without
 removing evidence important                     Yes
                                                           Label with contamination
 to a repair or an investigation?
                                                            status
                                                           Note fault/defect
                                                           Off site: pack and
                                                            despatch for
                                                            service/repair/investigation
                                                           On site: store in
                  No                                        preparation for
                                                            service/repair/investigation
    Inform repair
    organisation or
    investigating body




                                                           Label with contamination
    Repair organisation or                      Yes         status
    investigating body agrees
                                                           Note fault/defect
    despatch?
                                                           Pack and despatch for
                                                            service/repair/investigation
                  No



    Arrange visit by service/repair
    organisation or investigating body

        Label with contamination status
        Note fault/defect
        Quarantine in preparation for
         service/repair/investigation




DECONTAMINATION OF EQUIPMENT     Page 7 of 10               Sally Webster and Leasa Benson
PRIOR TO INSPECTION SERVICE OR
REPAIR
Ref No:CICT009                                  v.1                                     April 2007



8    Declaration of contamination status



    From (consignor): ……………………………                     To (consignee): …………………….………

    Address: ………………………………………                          Address: …………….………………………



    Reference: ………………………………….                         Reference: …………………………………

    Emergency Tel: ………………………                    ………




Type of equipment: …………………………………… Manufacturer: …..………

Description of equipment: ………………………..…………………………………………

Other identifying marks: ………………………………...……………………………………

Model No…………………………………………..…                              Serial No.………………………

Fault ………………………………………………………………………………………
………..
 Is the item contaminated? Yes/ No/ don’t know

 * State type of contamination: blood, body fluids, respired gases, pathological samples,
 chemicals (including cytotoxic drugs), radioactive material or any other hazard
 …………………………………

 Has the item been decontaminated? Yes/ No/ don’t know

 † What method of decontamination has been used? Please provide details

 Cleaning ………………………………………………………………………………………………

 Disinfection ……………………………………………………………………………………………

 Sterilization ……………………………………………………………………………………………

 ‡ Please explain why the item has not been decontaminated?
 ………………………………………………………………………………………………………
 ………………………………………………………………………………………………………


         Contaminated items should not be returned without prior
                       agreement of the recipient
DECONTAMINATION OF EQUIPMENT     Page 8 of 10               Sally Webster and Leasa Benson
PRIOR TO INSPECTION SERVICE OR
REPAIR
Ref No:CICT009                                  v.1                                    April 2007




 This item has been prepared to ensure safe handling and transportation:

 Name ………………………………………..                               Position ………………………………………

 Signature …………………………………………………………………………………………….

 Date ………………………………………………. Tel …………………………………………….




DECONTAMINATION OF EQUIPMENT     Page 9 of 10              Sally Webster and Leasa Benson
PRIOR TO INSPECTION SERVICE OR
REPAIR
Ref No:CICT009                                   v.1                                    April 2007




9    References and Sources of Information

Health and Safety Commission (1991) Safe working and the Prevention of infection
in clinical laboratories. HMSO.

The Health and Safety at Work etc. Act (1974).

The Control of Substances Hazardous to Health Regulations, 1988 (SI No. 1657).

Health and Safety Commission (1992) Management of Health and Safety at Work
Regulations: Approved Code of Practice. HMSO.

90/679/EEC Council Directive of 26 November 1990 on the protection of workers
from risks related to exposure to biological agents at work, Official Journal L374;
31.12.90.

Royal Mail guide: a comprehensive guide to mail services, October 1992.

HC (91)33 Decontamination of equipment, linen or other surfaces contaminated with
Hepatitis B and/or Human Immunodeficiency Virus.

HSG (93)13 Reporting adverse incidents and reactions and defective products
relating to medical and non-medical equipment and supplies, food, buildings and
plant and medicinal products.

The classification, Packaging and Labelling of Dangerous Substances Regulations.
1984 (SI No. 1244).

HSG (93)26 Decontamination of Equipment prior to Service or Repair.

MHRA DB2003 (03) management of Medical Devices Prior to Repair, service or
Investigation.




DECONTAMINATION OF EQUIPMENT     Page 10 of 10              Sally Webster and Leasa Benson
PRIOR TO INSPECTION SERVICE OR
REPAIR

								
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