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					       Decontamination of Equipment Policy


Document Reference:           Doris Thomson/Gillian Trainor
Point of Reference:           Infection Control/Medical Devices Group
Status:                       Active
Reference No                  C15 (Clinical Policy)




Signed: ___________________________________________

       Claire Murdoch. Chief Executive




Signed: ___________________________________________

       Dr Alex Lewis, Medical Director




 We would like to acknowledge Westminster and Kensington and Chelsea PCTs for allowing us to base this
 policy on their work.



                                                                                                ISSUE DATE
                                                                                               October
                                                                                                2007
                                                                                              REVIEW DATE
                                                                                               October
                                                                                                2010

                                                                                                    1
                               Contents Page


                                                               Page no

1. Introduction                                                     3

2. Aims of Policy                                                   3

3. Categories of Medical Devices and Equipment                      4

4. Methods of Decontamination                                       5

5. Facilities Required for Decontamination                          6

6. Equipment for decontamination                                    6

7.Management of medical devices prior to                            13
  repair, service and investigation

8.Purchases of medical devices and equipment                        13

9. Decommissioning and disposal of medical devices                  14
  and equipment

10. Preparations and agents currently available in the Trust        15

11. References/ Bibliography                                        17


Appendices

1. Relevant legislation                                             18
2. TBS Handling of equipment prior to inspection, service,          19
 repair, return to lending organisation, or investigation
 of an adverse incident
3. Alternative Declaration of contamination status                  20




                                                                         2
                                 1.Introduction

1.1 The Trust is committed to providing a safe and therapeutic environment for all
patients, staff and visitors.

All medical devices and equipment used in healthcare environments may
become contaminated with micro-organisms and present a risk to patients, as
well as to those subsequently handling or using them. Safe and effective
decontamination of all re-usable equipment between uses is therefore an
essential part of routine infection control practice.

Inadequate decontamination has been responsible for outbreaks of infection in
healthcare establishments, and can result in the transmission of a range of
micro-organisms from blood-borne viruses such as HIV or hepatitis B, to fungal
and common bacterial infections.

This policy describes the cleaning and disinfecting procedures that must be
followed to minimise these risks.

1.2 What constitutes a medical device?
Any equipment used in the course of the working day when delivering clinical
care or treatment is defined as a medical device. This can range from a fairly
complex piece of equipment such as a defibrillator or ECG (electro cardiogram)
to basic equipment such as a bed, bath or shower unit. Medical equipment
covers other items used in the clinical area that come into contact with clients or
their families, for example toys, where they are available.

Section 6 lists all the medical devices and equipment that might be used when
delivering care, and also describes how it can be decontaminated.

1.3 This policy should be read in conjunction with the following Trust Policies:
Blood Spillage Policy; Medical Devices Policy; Single Use Policy.


                            2. Aims of the Policy
By describing the actions required for safe decontamination of re-usable devices
and equipment, and by outlining the legislative requirements and national
guidance governing the decontamination of equipment, the policy aims to: -

   1 Protect staff and patients from any infection risks from medical devices
     and equipment


                                                                                   3
   2 Eradicate or significantly reduce the number of micro-organisms on
     medical devices and equipment
   3 Ensure a high standard of decontamination by providing a code of practice
     for cleaning and disinfecting medical devices and equipment.
   4 Ensure the Trust meets the legislative requirements and fulfils its
     legislative responsibility with regard to providing a safe environment.
   5 Ensure staff exercise their professional duty of care with regard to
     providing a safe environment.

Please see Appendix 1 for details of legislation and guidance governing the
decontamination of medical devices and equipment.


           3. Categories of medical devices and equipment
Medical devices and equipment can be divided into 3 categories:

   1 Those that are used only once and are then disposed of; eg single
     use

   2 Those that are used for one patient only during a course of treatment
     or an episode of care and are then disposed of; eg single patient use

   3    Those that are used repeatedly and used on different patients but are
        effectively cleaned in between each use to ensure decontamination.
        e.g. reusable


Any re-use of a device meant for single only use is in breach of the law and can
pose a significant risk through cross-infection. Indeed all equipment must be used
according to the manufacturer’s instructions (Medical Devices Agency, 2000).

The level of decontamination required depends on the risk of the item transmitting
micro-organisms. Any item can be categorised into one of three levels of risk. At
CNWL Mental Health Foundation Trust we do not have high-risk items that are not
for single use only, we therefore should not need to sterilise equipment.

 Risk                Application of item                     Recommendation

                      In contact with intact skin          CLEANING ONLY
 LOW                  Not in direct contact with patient
                      In contact with intact mucous        CLEANING    FOLLOWED
 MEDIUM              membranes                               BY DISINFECTION
                      Contaminated with blood / body
                     fluid
                      Penetrates skin or mucous
 HIGH                membranes                               CLEANING FOLLOWED


                                                                                 4
                      In contact with broken skin or BY STERILISATION
                     mucous membranes
                      Enters sterile body areas




                      4. Methods of decontamination

As can be seen in the above table there are 3 levels of decontamination.

1) Cleaning
Cleaning is a process that physically removes contaminants, e.g. dust, dirt,
grease and body fluids using general-purpose detergent (washing up liquid) and
hot water.

Cleaning is important for two reasons as: a method of decontaminating low risk
items and as an essential pre-requisite to any disinfection or sterilisation process.
Organic matter must first be removed in order for heat or chemicals to be able to
penetrate and therefore disinfect or sterilise effectively.

Detergent is essential for breaking down grease and dirt. It therefore improves
the ability of water to remove soiling. Approximately 80% of micro-organisms will
be removed by thorough cleaning. Careful drying is also essential to prevent any
remaining bacteria from multiplying. Protective clothing must be worn for all
cleaning procedures, i.e. gloves and aprons as a minimum, and where there is a
risk of splashing, goggles must be worn.

2) Disinfection
Disinfection is a process which reduces the number of micro-organisms to a level
at which they are not harmful. It will not, however, destroy bacterial spores.
Disinfection can be achieved either by heat or by chemical means. Heat
disinfection is preferable, as this is a more reliable method. Examples of heat
disinfection are bedpan washer-disinfectors, washing machines and
dishwashers. In order to achieve heat disinfection, the item must be heated to
81ºC for at least 1 minute, 71ºC for at least 3 minutes, or 65ºC for at least 10
minutes. Where heat disinfection is used, the process must be regularly
monitored to ensure that the correct parameters of temperature and time are
being met.

Where heat is not appropriate, chemical disinfectants may need to be used.
There are many problems inherent in the use of chemical disinfectants, such as:

   1 Many are chemically unstable
   2 Their effectiveness is dependent on the use of the correct concentration
     and exposure time
   3 Chemical disinfectants have no value as cleaning agents and are


                                                                                   5
     inactivated by organic matter
   4 Chemical disinfectants have varying levels of activity against micro-
     organisms

Disinfectants must only be used where heat disinfection is not possible, e.g. for
dealing with environmental contamination such as blood spillage or for the
decontamination of heat sensitive items.

3) Sterilisation
Sterilisation is a process that removes or destroys all micro-organisms, including
bacterial spores. There should not be any equipment used at CNWL that requires
sterilisation. All medical devices used with a high risk will be single use only.

Choosing an appropriate method of decontamination
The manufacturer of a medical device or item of equipment is required to provide
advice on how that item should be decontaminated. Their guidance must always
be followed. The table in section 6 gives the recommended methods of
decontamination for each item that will need to be cleaned or disinfected at
CNWL.


               5. Facilities required for decontamination
Wherever possible, the decontamination process should take place in a
dedicated dirty utility area. Any decontamination area will have specific design
requirements (e.g. floor / wall finishes / sanitary ware). Advice must always be
sought from the Infection Control Team when designing such facilities.
Contaminated and clean items must always be segregated and stored
separately. Where possible, medical devices and items of equipment should be
stored clean. If storage of contaminated items is necessary, these items must be
segregated and clearly labelled as contaminated. Within the decontamination
area, there must be a clear one-way flow of equipment, from entry of dirty items
into the area, to removal of the clean equipment following decontamination.


             6. Equipment for decontamination
The following is not intended to be an exhaustive list of all items of medical
equipment used within the Trust. The manufacturer’s instructions must always be
followed in regards to decontamination of a product. Where manufacturer’s
decontamination instructions are unclear, or alternative disinfection agents to
those described above are recommended, the Infection Control Team should be
contacted.




                                                                                6
ITEM                           ACTION/RECOMMENDED METHOD
Airways                        Disposable – single use only
Alcometer                      Wipe with hot water and detergent
                               Mouth pieces- single use only discard after use
Ambu-bag / Re-breathing bag    Dispose of filter and mask between uses
                               Bag single use disposable. Non–disposable bags
                               must be disposed of after use and new single use
                               type purchased
ANAESTHETIC EQUIPMENT          Disposable Single use.
   including Face Masks, Re-
   breathing bags,
   Connectors, Catheter
   Mounts.
Baby Changing Mats             Cover with disposable paper roll and change this
                               between each baby. Clean with hot water and
                               detergent at the end of each clinic session.
                               If contaminated with body fluid, mop up excess soiling
                               with paper towels, clean with hot water and detergent,
                               and follow this by wiping with 70% Isopropyl Alcohol
                               wipes.
                               If the plastic cover becomes torn or damaged, the mat
                               must be discarded.
Baby Cots                      Clean periodically or when dirty with detergent
                               solution and dry. On discharge. Clean with detergent
                               solution
Baby Scales                    Line with disposable paper roll and change this
                               between each baby. Clean with hot water and
                               detergent at the end of each clinic session.
                               If contaminated with body fluid, mop up excess soiling
                               with paper towels, clean with hot water and detergent,
                               and follow this by wiping with 70% Isopropyl Alcohol
                               wipes.
Baths, Shower Chairs and       Clean with hot water and detergent or cream cleaner
Seats and Non-slip Mats        after each patient. Hang bath mats up to dry. Material
                               bath mats should not be used
Bed Cradles                    Clean with hot water and detergent when soiled,
                               between patients, or at least weekly. Dry thoroughly.
Bed frames                     Periodically clean with hot water and detergent. If
                               contaminated with a body fluid follow this by wiping
                               with a solution of actichlor. On discharge clean with
                               hot water and detergent.
Bedpans and urinals (only      Wearing disposable gloves, place bedpan / urinal and
disposables recommended)       contents in macerator. Ensure contents contain only
                               body fluids and toilet paper. In the event of machine
                               failure, inform Estates Department immediately and
                               dispose of contents of bedpan / urinal into toilet or


                                                                                   7
                               sluice. Place bedpan / urinal in clinical waste bag.



ITEM                           ACTION/RECOMMENDED METHOD
Bedpan holders                 Disinfect in a washer / disinfector if available.
                               Alternatively, wearing disposable gloves and plastic
                               apron, dispose of contents into toilet, sluice or
                               macerator. Clean with hot water and detergent and
                               follow this by using a chlorine-releasing solution of
                               1,000 ppm, e.g. Actichlor. Dry thoroughly and store
                               dry. Do not soak.
Blood Glucose Monitoring Pen   Use single use retracting needles and clean in
                               between each patient use. Always follow the
                               manufacturers instructions. Wear gloves when taking
                               blood sample. Should pen become smeared with
                               blood clean as per the blood spillage policy.
Blood pressure                 Wipe with hot water and detergent after each use
sphygmomanometer and cuff
Bowls (washing)                Patients must have their own individual
                               washbowl. After each use, clean with hot water and
                               detergent, rinse and store dry in or behind patient’s
                               locker (not on the floor). Spare washbowls must be
                               stored inverted in a clean area.
Combs/Hair brushes             Patients must have their own individual comb/Hair
                               brushes. Wash weekly or when visibly soiled with hot
                               water and detergent and dry thoroughly. Discard on
                               patients discharge
Commodes                       Clean seat with hot water and detergent between
                               uses and clean commode thoroughly at least weekly.
                               If contaminated with body fluids, follow this by using a
                               chlorine-releasing solution of 1,000 ppm, e.g.
                               Actichlor. Rinse and dry thoroughly. Ensure
                               commodes are in a good state of repair with no tears
                               to covering or splits/satins in the plastic or rust. .
CROCKERY AND CUTLERY           - See FOOD HYGIENE POLICY
CURTAINS                       Send to Laundry when visibly soiled and every 3
                               months. Clean after use by patient infected e.g. with
                               MRSA,
Denture Pots                   Patients should have their own individual denture
                               pots. These must remain single patient use. Clean
                               with hot water and detergent. Store dry when not in
                               use. Discard in yellow clinical waste bag on patient’s
                               discharge.
Dosset Boxes                   Single patient use only
Dressing Scissors              For sterile procedures – use single use sterile
                               disposable scissors.
                               For non-sterile procedures – clean with hot water and
                               detergent then wipe with 70% Isopropyl Alcohol
                               wipes.



                                                                                       8
ITEM                               ACTION/RECOMMENDED METHOD
Dressing Trolley/ Dressing trays   Clean the whole trolley with hot water and detergent
                                   at the beginning of the session and when visibly
                                   soiled. Wipe with 70% Isopropyl alcohol wipes
                                   between each use. Ensure no items are left on the
                                   trolley when not in use
Duvets                             Must be enclosed in an impermeable cover. On
                                   patient discharge or when visibly soiled, clean with hot
                                   water and detergent and dry thoroughly.
                                   If contaminated with body fluid, clean with hot water
                                   and detergent and then disinfect with a solution of
                                   1,000 ppm Actichlor. (note Chlorine-releasing
                                   disinfectants will damage the cover if used routinely).
ECG Equipment (machine and         Wipe machine with 70% Isopropyl Alcohol wipes at
leads)                             least weekly and if dirty. (Wipe with hot water and
                                   detergent first if dirty).
                                   Electrodes must be disposed of after each use.
Endotracheal Tubes                 Disposable only – use single use and discard.
Enteral Feeding Equipment          See PCT Enteral Feeding Policy, and
                                   manufacturer’s instructions for each product.
Examination Couches                Cover with disposable paper roll. (Paper roll should be
                                   attached to either a holder on couch or a wall-
                                   mounted dispenser). Change paper between each
                                   patient. Avoid linen.

                                   Wash couch with hot water and detergent at the end
                                   of each session. If contaminated with body fluid, wipe
                                   with a solution of 1,000 ppm Actichlor following
                                   cleaning.

                                   If the plastic cover becomes torn or damaged, the
                                   couch should be re-upholstered or replaced.
Examination Lamps (in              Wipe with hot water and detergent daily and when
treatment rooms)                   visibly dirty.
                                   If contaminated with body fluid, follow this by wiping
                                   with a solution of 1,000 ppm Actichlor
FLOWER VASES                       Pour dirty water down sluice, wash with detergent
                                   solution. Dry thoroughly, store dry and inverted.
FURNITURE                          Damp dust with general purpose detergent
Glucometer                         Wipe with hot water and detergent
                                   Testing strips – single use only
Gym equipment                      Wash equipment with hot water and detergent at the
                                   end of each session. If contaminated with body fluid,
                                   wipe with a solution of 1,000 ppm Actichlor following
                                   cleaning.



                                                                                         9
ITEM                            ACTION/RECOMMENDED METHOD
Hoist Slings, Sliding Sheets    Patients should have either their own hoist sling or a
(Fabric)                        disposable sling until discharge from hospital, when
                                this should be laundered or disposed of, as
                                appropriate. Patients should have their own sliding
                                sheet if required, which should be laundered on
                                discharge from hospital. Where there is any soiling of
                                fabric items, they must be laundered immediately and
                                must not be washed by hand in the department.
Infusion pumps (PEG feed etc)   Wipe clean before and after use with hot water and
                                detergent. Keep clean and dry
Inhalation compliance devices   These will be labeled by pharmacy for individual
e.g. Volumatic, Nebuhaler       patient use, and must not be shared. If dirty, wash
                                with warm water and detergent. Rinse and dry
                                thoroughly.
Jugs (for non-sterile           Disposable urinals can be used for emptying catheter
procedures)                     bags. If fluid measurements are required, a plastic jug
                                can be used for this purpose and should be for single
                                patient use only (but must be kept in the sluice). A
                                washer-disinfector should be used if available.
                                Alternatively, the jug should be washed with hot water
                                and detergent after each use. Discard when patient is
                                discharged.
LIBRARY BOOKS                   No cleaning needed
Linen (Used)                    Put into clear/white bags.

Linen (Soiled/Infected          Put into red bags and then into a clear bag.
Locker tops and tables          Always ensure these are clean, dry and tidy. Clean
                                with hot water and detergent. If contaminated with a
                                body fluid, follow this by wiping with a solution of
                                1,000 ppm Actichlor
Mattresses                      Must be enclosed in an impermeable cover. On
                                patient discharge or when visibly soiled clean with hot
                                water and detergent and dry thoroughly.
                                If contaminated with body fluid, clean with hot water
                                and detergent and then disinfect with a solution of
                                Actichlor. If cover stained or damaged change
                                mattress.
Medicine Pots, Medicine         Disposable - single use only – discard after each
Spoons and Oral syringes.       use. nb liquid medication should be measured using a
                                oral syringe and discarded after use.




                                                                                    10
ITEM                            ACTION/RECOMMENDED METHOD
Nebulisers, Masks and Tubing    Single patient use. Each individual patient must have
                                his or her own nebuliser, mask and tubing, which are
                                discarded as clinical waste on discharge from
                                hospital. Clean nebuliser with hot water and
                                detergent and store dry inverted and covered between
                                therapies. Change mask and tubing when dirty.
Oxygen Mask and Tubing          Single patient use. Each individual patient must have
                                his or her own mask and tubing, which is changed
                                when dirty and discarded on discharge from hospital.
                                Store dry, invered and covered between therapies.
                                Dispose of as clinical waste on patient discharge.

PEAK FLOW METER                 Use Disposable Single patient Use - mouthpieces.
                                Filter change to manufacture’s guidance




Pillows                         Always ensure that pillows are protected with an
                                impermeable plastic cover.

                                On examination couches, the pillow should be wiped
                                with hot water and detergent at the end of the day.

                                Inpatient Services – wipe with hot water and detergent
                                     on patient discharge and when soiled.
Pressure Relieving Aids         Aids must be allocated to one user only. On discharge
e.g. mattresses, cushions and   or when soiled clean to manufacturer’s instructions. If
motors                          contaminated with body fluid, refer to manufacturer’s
                                instructions. Once on longer in user if on hire aids
                                must be returned to the hiring company and not
                                reassigned to another client.
Shaving Equipment               Razors and brushes – Patients must have their own
                                individual equipment.
                                Dispose of razors / blades in sharps bin after use.

                                Electric shavers – Patients must have their own
                                individual shavers; they must not be shared. Clean as
                                per manufacturer’s instructions.
Specula (Vaginal)               Disposable – single use. Plastic discard into yellow
                                clinical waste bag after use. Metal discard into sharps
                                bin
Sputum pots                     Disposable – change daily.
                                Discard into yellow clinical waste bag.
Sticks, Frames, Crutches        Clean with hot water and detergent between uses by


                                                                                    11
                                 different patients and when dirty.
Stethoscopes                     Wipe bell with 70% Isopropyl Alcohol between each
                                 use. Wipe earpieces with 70% Isopropyl Alcohol
                                 between staff use.
ITEM                             ACTION/RECOMMENDED METHOD
Suction Equipment – the          All new suction machines purchased must be of a
machines                         type that uses disposable collection bottle liners.
                                 Change liner daily when in use. Discard into yellow
                                 clinical waste bag.
                                 Accessories e.g. suction catheters – single use. Use
                                 once and discard.
                                 Filters –must be hydrophobic filters only– disposable -
                                 change every three months or when wet or visibly
                                 soiled.
                                 Tubing must be single patient use
                                 Machines – wipe weekly and when soiled with hot
                                 water and detergent. Dry thoroughly

Suction tubing                   Single patient use only
Thermometers                     Single use ‘TempaDot’ or Use disposable plastic
Oral                             cover after use wipe with 70% Alcohol.


Ear                              Single use plastic ear sheath/ Wipe unit with 70%
                                 alcohol between patients
Toilet seats (raised)            Clean with hot water and detergent. If soiled with a
                                 body fluid, follow this by wiping with a solution of
                                 1,000 ppm Actichlor. Rinse and dry.
Tourniquet                       Wipe with hot water and detergent after each use.
Toys                             Soft toys and those made of wood are not
                                 recommended. Only plastic toys that are in good
                                 condition and easy to clean are suitable for the clinical
                                 environment.
                                 All toys must be cleaned with hot water and detergent
                                 at the end of each clinic list. Those in waiting areas
                                 must be cleaned at least weekly and when soiled.
“Vacutainer” Needle Holders      Disposable - single-Use – discard after each
                                 procedure
Vomit Bowls / Kidney Dishes      Disposable – single use. Discard into macerator or
(only disposables                dispose of contents into toilet and then dispose of
recommended)                     receptacle in yellow clinical waste bag
Weighing scales (seated adult)   Line with disposable paper towels.
                                 Clean with hot water and detergent daily and keep
                                 dry.
Work surfaces                    Clean daily with hot water and detergent.
Wheelchairs                      Should be cleaned weekly and when visibly soiled.
                                 Wipe over with hot water and detergent. If soiled with
                                 a body fluid, follow this by wiping with a solution of
                                 1,000 ppm Actichlor. Rinse and dry.




                                                                                       12
7. Management of medical devices prior to repair, service and
investigation
If medical devices or equipment require repair, service or investigation, anyone
who handles equipment for these purposes has a right to expect that it has been
appropriately treated to minimise the risk of infection. Appendix 2 is to be used
when equipment is being decommissioned or repaired by TBS. Appendix 3 is to
be used when another company maybe repairing, transporting or
decommissioning equipment. A written declaration must accompany any item of
medical equipment when being transported within the Trust or outside of the
Trust for repair, service or investigation. Where decontamination of the
equipment could remove evidence of a fault or hinder any subsequent
investigation, advice on transportation arrangements should be sought from the
manufacturer, service / repair organisation or investigating body, as the use of a
specialist courier may be required. In this case:

   1.   The device must be double wrapped in appropriate packaging
   2.   Prior warning must be given to the intended recipient
   3.   The equipment must be clearly labelled to indicate that it is contaminated
   4.   The packaging should be sufficiently robust to withstand transport
   5.   The inner packaging should be suitable to ensure that the outer packaging
        does not become contaminated or breached during transit

(MHRA, 2003)

The Infection Control Nurse/ Medical Devices Liaison Officer may be contacted
for further advice.


             8. Purchase of medical devices or equipment

Those involved in the purchasing of medical devices and equipment must always
consider the suitability and compatibility of the item with the decontamination
processes available within the Trust. All new medical devices and equipment
must be ratified by the Medical Devices Committee before purchase. The
following issues should be taken into account:

   1 How easily can the item be cleaned?
   2 Does the item need dismantling before decontamination? If so, can this be
     performed by the clinician?
   3 Does the item have electrical components? If yes, does the Trust have the
     ability to decontaminate these?
   4 Does the product have a limited life / number of times that it can be


                                                                               13
        decontaminated?
    5   Are the recommended cleaning / disinfecting methods available within the
        Trust?
    6   What cleaning agents / disinfectants are recommended and do these
        comply with the Trust’s Infection Control Policies and health and safety
        requirements?
    7   Is the item heat labile? If so, does the Trust have the appropriate
        equipment to disinfect / sterilise at low temperatures?
    8   How long will the decontamination process take?
    9   Has a risk assessment process been undertaken to determine whether a
        single use product is more appropriate for the circumstances (i.e. would
        this pose significantly less risk of infection or be more cost effective?)

Where necessary, advice should be sought from the Infection Control Team.
See also: Medical Devices Agency. Checks and tests for newly delivered medical
devices. MDA DB9801, Suppl 1; 1999
Available at:www.mhra.gov.uk/mda/mdawebsitev2.nsf/webvwMDASafetyWarnings


    9. Decommissioning and disposal of medical devices and
                         equipment

The purpose of decommissioning is to make a medical device safe prior to
disposal. Any medical device deemed not re-usable, due to wear, damage,
breakdown or having become obsolete, must be decommissioned before
disposal. This should include:

   Decontamination
   Making safe
   Making unusable

This is to ensure that an inappropriate person does not use the medical device
and expose themselves to potential hazards. If the medical device cannot be
decontaminated prior to disposal, contact the Infection Control Team for advice.

The Estates Department should be contacted for advice on decommissioning
and disposal of medical devices. In addition, the original equipment manufacturer
should be contacted for information on any environmental, disposal, recycling or
structural requirements. If the manufacturer has ceased to trade, contact the
Medicines and Healthcare products Regulatory Agency (MHRA) on 020 7084
2000 for further information. This is particularly important if the device is likely to
contain substances classed as special waste, e.g. mercury, radioactive waste,
batteries, and for any electrical / electronic equipment.

For further information on the above, and for transfer of ownership of any
surplus or obsolete equipment, e.g. donation to charity, see:


                                                                                    14
Medical Devices Agency. Guidance on the sale, transfer of ownership and
disposal of used medical devices. MDA DB9801, Suppl 2; 2001
Available : www.mhra.gov.uk/mda/mdawebsitev2.nsf/webvwMDASafetyWarnings
     10. Preparations / agents currently available in the Trust
To provide a standard approach across the Trust, a limited number of products
are recommended by the Infection Control Team, Facilities and Pharmacy
Departments. No additional products should be introduced. Protective clothing
should be worn when using / handling any of the following agents, in accordance
with the outcome of COSHH assessment. Cleaning / decontamination agents
must never be mixed with other products or decanted into other containers.


Products To Be Used For Cleaning:

Product            Dilution                    Usage

General            Dilute in hot water.       General cleaning of environment,
Purpose            Concentration as       per furniture, trolleys and
Detergent (GPD)    manufacturer’s             wheelchairs Must be used with
e.g. Hospec        instructions.              disposable cloths / paper towels.
                                              Solution must be changed
                                              frequently. Following cleaning, all
                                              equipment must be dried and
                                              stored dry.



Products To Be Used For Disinfection:

Product            Dilution                 Usage
Chlorine-based     10,000 parts per million Decontamination of spillages of
disinfectant       (ppm)                    blood and blood-stained body
NaDCC              use granules             fluids only (Refer to Spillage of
                                            Blood and Body Fluid Policy ICC
NB. Corrosive to                            04)
metals         and
fabrics.           10,000ppm solution by Surface decontamination, e.g.
Inactivated     by adding 1.7g tablet per commodes.
organic matter.    100ml of water
                                            NB. Chlorine agents must not be
e.g. Actichlor                              used on urine or mixed with hot
                                            water or other cleaning agents,
                                            as toxic chlorine fumes are
                                            released.



                                                                              15
Alcohol

70%     Isopropyl Use as supplied        Surface      decontamination of
Alcohol wipes                            specific items such as dressing
                                         trolleys / baby scales

70% Methylated Available as a solution Surface      decontamination of
Spirit         spray, use with paper specific items such as dressing
               towels as appropriate.  trolleys / baby scales




PLEASE NOTE: Chlorhexidine based products must never be used for
environmental or equipment cleaning.




                                                                     16
                     11. References / Bibliography

Advisory Committee on Dangerous Pathogens / Spongiform Encephalopathy
Advisory Committee (ACDP / SEAC). Transmissible Spongiform Encephalopathy
Agents: safe working and the prevention of infection; 2001

Ayliffe GAJ, Coates D and Hoffman P. Chemical Disinfection in Hospitals. Public
Health Laboratory Service. London; 1993

Department of Health. Variant Creutzfeldt-Jakob Disease: Minimising the risk of
transmission. HSC 1999/178;1999

Department of Health. Decontamination of medical devices. HSC 2000/032; 2000

Medical Devices Agency. Checks and tests for newly delivered medical devices.
MDA DB 9801, Suppl 1; 1999
Available at:
www.mhra.gov.uk/mda/mdawebsitev2.nsf/webvwMDASafetyWarnings

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

Medical Devices Agency. Compatibility of medical devices and reprocessing
units with decontamination agents. MDA SN 2001(28); 2001

Medical Devices Agency. Guidance on the sale, transfer of ownership and
disposal of used medical devices. MDA DB 9801, Suppl 2; 2001
Available at:
www.mhra.gov.uk/mda/mdawebsitev2.nsf/webvwMDASafetyWarnings

Medical Devices Agency. Bench-top steam sterilisers: guidance on purchase,
operation and maintenance. MDA DB 2002(06); 2002

Medicines and Healthcare Products Regulatory Agency. Management of medical
devices prior to repair, service or investigation. MHRA DB 2003(05); 2003

Medicines and Healthcare Products Regulatory Agency. Community Equipment
Loan Stores – Guidance on Decontamination. MHRA DB 2003(06); 2003
Available                                                             at:
www.mhra.gov.uk/mda/mdawebsitev2.nsf/webvwMDASafetyWarnings

NHS Estates. A guide to the decontamination of re-usable surgical instruments;
2003.



                                                                            17
APPENDIX 1
Legal framework

Consumer Protection Act, 1987
There may be exposure to civil liability, with payments for damages, for any
injuries caused to another person by a defective product. This could include an
inadequately decontaminated item that causes an infection.

Control of Substances Hazardous to Health (COSHH) Regulations, 2002
Staff must be aware of these regulations that relate to biological and chemical
risks, including the risks from disinfectants. These regulations require a risk
assessment to be carried out of all potentially hazardous substances.

General Product Safety Regulations, 1994
These regulations apply when a product is intended for use by consumers. They
apply to both producers and distributors of a product. A producer includes those
who decontaminate products.

Health & Safety at Work etc Act, 1974
This Act establishes the employer’s responsibility for the health and safety of
employees and visitors to their premises, for providing safe equipment, safe
systems of work and training for staff, e.g. how to handle contaminated
equipment.

Management of Health and Safety at Work Regulations, 1999
These expand on the Health and Safety at Work etc Act, requiring employers to
make a systematic assessment of all the risks to the health and safety of their
employees and others, arising from work activities.

Medical Devices Regulations, 1994
Medical devices placed on the market within the UK after June 1998 must carry a
CE marking. This denotes compliance with a number of essential requirements
covering the safety and performance of the medical device.

Controls Assurance Standard: Decontamination of Re-usable Medical
Devices, 2002
This standard covers systems for proper decontamination of re-usable medical
devices and management of the risks associated with decontamination
processes.

The Health Act 2006. Code of practice for the Prevention and Control of
Health Care Infections. Department of Health (2006) and all documents
therein.
The purpose of the code is to help NHS bodies plan and implement how they can
prevent and control HCAI.




                                                                             18
APPENDIX 2


                                   EQUIPMENT CONDEMNATION CERTIFICATE
1. EQUIPMENT DETAILS                                            (for completion by Bio-Medical Dept)
Equipment Description
Manufacturer
Model Number
Serial Number
Asset Number
User Department
Approximate Age                                                                          (if known)
2. CONDEMNATION STATEMENT
The equipment detailed above has been certified as being Beyond Economical
Repair, for the following reasons;



3. DECONTAMINATION CERTIFICATE                                  (For completion by User Department)
* a) This equipment has been cleaned and disinfected by the following method;

OR
* b) I certify that this equipment has not been in contact with any blood, blood
products or other body fluids likely to be a potential source of infection
Name
Signed
Position
Date
4. AUTHORISING OFFICER
I have noted the statements above and give due authority for this equipment to be
disposed of
Name
Signed
Position
Date
5. BIOMEDICAL ENGINEER
The equipment has been checked for potential environmental contaminants;
* a) All internal batteries and battery packs have been removed
* b) All oils and other fluids have been drained off
(Note: these items are to be disposed of separately in accordance with current procedures)
The equipment is to be removed to (state destination):
Name
Signed
Position
Date


                                                                                             19
                Appendix 4 Trust Decontamination form

                        Date: …………………
                 Department/ Ward/ Clinic……:…………
                       Address:………………….
                       ……………………………..
                       …………………………….


Equipment Description:…………………..
Quantity:……………………..


Reason for decontamination: Disposal / transfer/ other…………


Destination of Equipment:……………………….



a)The equipment has been cleaned or disinfected by the following
method……………………………………………………..

b) The equipment is free from all potential environmental contaminants
Y/N

c) The equipment has been put in appropriate bags ( e.g. clinical waste)
Y/N



Departmental Authorizing officer: Name……………………….
Signature:………………………….
Designation:………………………..


Receiving Officer: Name…………………………..
Signature:……………………………..
Designation and Employer:…………………………………..




                                                                     20

				
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