Policy for Guidelines for the Decontamination of Equipment



|Policy for Decontamination of Equipment |

|(Including Prior to Inspection, Service or Repair) |

|IC08 |

|Version Number: |5 |

|Issue Date: |January 2014 |

|Review Date: |January 2017 |

|Sponsoring Directors: |Directors of Nursing |

| |NHS North Durham, NHS Darlington, NHS Durham Dales, Easington and Sedgefield (DDES) Clinical |

| |Commissioning Groups (CCGs) |

|Prepared By: |Lead Infection Prevention and Control Nurse |

|Consultation Process: |Members of Health and Social Care Health Care Associated Infection (HCAI) Assurance Group |

Document History

|Version |Date |Significant Changes |

|2 |Nov 2006 |* |

|3 |Nov 2008 |* |

|4 |Nov 2010 |* Removal of guidance on the use of benchtop sterilizers which has been superseded by HTM01-05 |

|5 |Jan 2014 |* None |

|POLICY VALIDATION STATEMENT |

| |

|This policy is due for review on the latest date shown about. |

|After this date, policy and process documents may become invalid. |

|Policy users should ensure that they are consulting the current valid version of the documentation. |

EQUALITY IMPACT ASSESSMENT STATEMENT

|Audit Assessment |Date |Result |

|Risk Audit |14.01.2014 |Risks identified and risk assessment included at Appendix 4 |

|Equality Audit |14.01.2014 |No or very low potential for discrimination |

|Human Rights Audit |14.01.2014 |No breach of Human Rights |

POLICY FOR DECONTAMINATION OF EQUIPMENT

(INCLUDING PRIOR TO INSPECTION, SERVICE OR REPAIR)

CONTENTS

|Section |Title |Page |

|1 |Introduction |4 |

|2 |Definitions |4 |

|3 |Decontamination of Equipment |5 |

|4 |Duties and Responsibilities |10 |

|5 |Implementation |11 |

|6 |Training Implications |11 |

|7 |Documentation |11 |

|8 |Monitoring, Review and Archiving |12 |

|9 |Equality Impact Assessment Statement |13 |

Appendices

|1 |Declaration of Contamination Status |17 |

|2 |Handling of Equipment Prior to Inspection, Service, Repair, Return to Lending |18 |

| |Organisation or investigation of Adverse Incident | |

|3 |Non-Compliance |19 |

POLICY FOR DECONTAMINATION OF EQUIPMENT

(INCLUDING PRIOR TO INSPECTION,

SERVICE OR REPAIR)

1 Introduction

NHS North Durham, NHS Darlington and NHS DDES CCGs aspire to the highest standard of corporate behaviour and clinical competence, to ensure that safe, fair and equitable procedures are applied to all organizational transactions, including relationships with patients, their carers, public, staff, stakeholders and the use of public resources. In order to provide clear and consistent guidance, NHS North Durham, NHS Darlington and NHS DDES CCGs will develop documents to fulfil all statutory, organizational and best practice requirements and support the principles of equal opportunity for all.

The aim of this policy is to provide a framework for the safe management and decontamination of medical devices and equipment.

This policy is in line with national guidance from the Department of Health (DH) and the National Patient Safety Agency (NPSA).

1.1 Status

This policy is an Infection Control policy.

1.2 Purpose and Scope

To ensure that equipment is decontaminated safely and effectively between patient use, and prior to inspection or repair.

This policy applies to all health care workers working within NHS North Durham, Darlington and DDES CCGs.

2 Definitions

Decontamination – a general term to cover methods of cleaning, disinfection and sterilization for removal of microbial contamination from medical equipment to render it safe.

Cleaning – a process which removes large numbers of micro-organisms and the organic material on which they thrive.

Disinfection – a process which reduces the number of viable micro-organisms but is not necessarily effective against bacterial spores and some viruses.

Sterilization – a validated process used to render a product free from viable micro-organisms, including bacterial spores.

Single Use Items – any device marked as single use should not be re-used under any circumstances.

Medical Devices and Equipment – all items of equipment which are connected with patient care and other equipment used in the analysis and delivery of patient treatment. ]

PPM – parts per million.

3 Decontamination of Equipment

Micro-organisms are normally present in the home, primary care establishments and hospital environments. Most are harmless and only a small proportion cause infections if transferred via inadequately decontaminated environment/equipment.

All health care workers are responsible for the effective decontamination of equipment to prevent cross infection.

The products choice and method of decontamination depends upon the type of material to be decontaminated, the type of contamination, the organisms involved and the risk to staff and patients.

The risks to patients are classified as:

HIGH RISK: Items in close contact with a break in the skin or mucous membranes, or introduced into a normally sterile body cavity/organ eg surgical instruments, catheters, needles etc. Sterilization is required.

MEDIUM RISK: Items in close contact with mucous membranes, contaminated with transmissible organisms or to be used on immuno-compromised patients, eg respiratory equipment and speculae. Disinfection is required, by heat where possible.

LOW RISK: Items in contact with normal and intact skin eg stethoscopes, environment, furniture etc. Cleaning and drying is adequate.

3.1 Equipment purchase

BEFORE ANY EQUIPMENT IS PURCHASED THE FOLLOWING CONDITION HAS TO BE SATISFIED

The manufacturer must provide guidelines for the safe decontamination/sterilization or disinfection of equipment. It is the responsibility of the buyer, before purchasing, to ensure that these guidelines can be met and that they are implemented. Failure to do this has legal implications.

SINGLE USE ITEMS: Any device marked as single use should not be re-used under any circumstances. (See signage below)

Some items are designated as single patient use and should be cleaned in accordance with manufacturer’s guidance.

3.2 Definitions/Methods of decontamination

3.2.1 Decontamination

Decontamination is a general term to cover methods of cleaning, disinfection and sterilization for removal of microbial contamination from medical equipment to render it safe.

Guidance on Decontamination

Staff handling used medical devices and equipment should assume that they are contaminated and take precautions to reduce the risk to themselves and others. The use of personal protective equipment is strongly recommended, e.g. all decontamination activities should be carried out in accordance with the manufacturer’s instructions by appropriately trained personnel who are provided with suitable equipment. Decontamination should be carried out in dedicated facilities.

Cleaning is an essential prerequisite for effective disinfection or sterilization. Where possible, use automated cleaning methods instead of washing by hand. In some cases cleaning alone may be sufficient. If after cleaning it is necessary to disinfect or sterilize the item, the chosen method must be compatible with the item and not damage it.

Decontamination should be carried out in accordance with the equipment manufacturer’s instructions. The user should seek guidance from the manufacturer if there is no reprocessing/decontamination information provided with the product.

Decontamination is the combination of processes used to make a reusable item safe for handling by staff and further use on or by patients. Processes can include cleaning, cleaning followed by disinfection or cleaning followed by sterilization. The effective decontamination of reusable items is essential in reducing the risk of transmission of infectious agents.

This guidance focuses on the aspects of reducing the microbiological risks. Other methods of decontamination may be necessary to remove chemical and radioactive material. The user should seek advice from the device manufacturer in these cases.

3.2.2 Cleaning

Cleaning is a process which removes large numbers of micro-organisms and the organic material on which they thrive. It also enables physical and chemical contact with the disinfecting/sterilizing agent.

Cleaning with neutral detergent and water will physically remove most contaminates/micro-organisms from a surface. A further reduction in numbers occurs through manual drying. A thorough cleaning and drying procedure will be an adequate routine treatment for most surfaces and furniture.

3.2.3 Disinfection

Disinfection is a process which reduces the number of viable micro-organisms but is not necessarily effective against bacterial spores and some viruses.

Cleaning before disinfection of equipment is required in order to remove organic material.

Disinfection either by automated washing or chemicals will destroy most non-sporing organisms.

Chemical disinfection should only be used if heat treatment is impractical or undesirable eg for skin or heat labile equipment eg endoscopes.

3.2.4 Sterilization

Sterilization is a validated process used to render a product free from viable micro-organisms. It achieves the complete destruction or removal of all types of micro-organisms, including bacterial spores.

3.2.5 Decontamination of Medical Devices and Equipment Prior to Investigation, Inspection, Service and Repair

All reusable medical devices and equipment to be inspected, serviced, repaired, disposed of or to be returned to the lending organisation, should first undergo decontamination. This process must only be carried out if it is safe to do so and will not hinder any investigation if there is a fault on the equipment. This is necessary to ensure that they are in a condition that makes them safe to be handled by all personnel who may come into contact with them during transit and subsequent handling. The devices and equipment should not expose the recipient to a biological, chemical or radioactive hazard.

Definition of Medical Devices and Equipment

The policy describes all items of equipment which are connected with patient care and other equipment used in the analysis and delivery of patient treatment.

3.3 Procedure to be followed

For each item intended for investigation, inspection, service or repair, a declaration of contamination status certificate (see Appendix 1) must be provided. This is necessary for items dealt within primary care and also applies to those items requiring transportation to the manufacturers /suppliers/agents, the Medicines and Healthcare Products Regulatory Agency or others. (See Appendix 2)

3.4 Guidelines for cleaning of equipment

Please note – for patients with known infections, refer to relevant policy).

When cleaning any equipment appropriate personal protective equipment must be worn.

AIRWAYS – Disposable/single use.

AMPOULES/VIALS – Wipe with 70% alcohol eg mediswab prior to use.

BABY SCALES – Place paper roll inside the scales and change between each baby. Clean with detergent or alcohol wipe between each baby. If the baby urinates or defecates clean with detergent and water follow up with alcohol wipe.

BLOOD SPILLAGE – Disposable gloves and apron must be worn. Cover the spillage with disposable paper towels soaked with hypochlorite 10,000 ppm, as per manufacturer’s instructions. Leave for 2 minutes, rinse clean and dry the area. Hypochlorite should not be used on urine spillages as large amounts of fumes are released. The area can finally be cleaned with detergent and water. If broken glass or any other sharps are included in the spill, they can be picked up using forceps and disposed of in a sharps container before the hypochlorite solution is used.

BODY FLUIDS (Management of) – This does not include blood spillages (see above). Clean with detergent and water, then disinfect with a solution of 1000 ppm of hypochlorite, as per manufacturer’s instructions. Rinse with water. Wear appropriate personal protective equipment, as determined by COSHH assessment.

EAR SYRINGING EQUIPTMENT- Follow manufacturers guidance.

ENT INSTRUMENTS – Follow manufacturers instructions if not single use.

EXAMINATION COUCH – Clean with detergent and water after use – and dry. Clean underneath couch weekly.

LARYNGOSCOPES – Disposable versions are available for single use only.

NEBULISER, MASK AND TUBING – Disposable. Dedicated for that patient use.

Follow manufacturer’s instructions for portable nebulisers for changing of filters and decontamination.

PEAK FLOW METER – Follow manufacturer’s instructions. Check for single patient use only.

PILLOWS – Must be enclosed in plastic cover. Clean with detergent and water and dry between patient use. If contaminated with blood refer to blood spillage section. If pillow has not been in a plastic cover and is blood stained destroy.

SPECULA – Vaginal speculum - disposable or reprocess through CSSD

Proctoscope } Disposable or re-process through

Sigmoidoscope } CSSD.

SUCTION APPARATUS (Respiratory) – Disposable catheter and tubing, use once then discard.

RE-USEABLE SURGICAL INSTRUMENTS – Return to CSSD Department.

THERMOMETERS – Electronic - Disposable plastic probe covers (single use only).

TROLLEYS (Dressing) – Wash with detergent and dry at the beginning and end of each procedure. If contaminated, clean first then use alcohol wipe.

TOYS – Soft-toys not to be available for communal use. Other toys should be cleaned with hot water and detergent and dried. If toys have been used by infected children, eg impetigo, use hypochlorite disinfectant, 1000 ppm, as per manufacturer’s instructions. Then rinse and dry.

VITALOGRAPH – Mouth pieces are disposable. For tubing and bellows follow manufacturer’s instructions.

4 Duties and Responsibilities

4.1 Accountable Officer

The Accountable Officer has overall responsibility for the strategic direction and operational management, including ensuring that CCG process documents comply with all legal, statutory and good practice guidance requirements.

4.2 Director of Nursing

As the nominated director responsible for Infection Prevention and Control the Director of Nursing has delegated responsibility for ensuring that arrangements are in place to manage Infection Prevention and Control including the risks from decontamination of medical devices and equipment.

In addition the Director of Nursing is responsible for ensuring that the policy is drafted, approved and disseminated in accordance with ‘Writing Policy Documents’.

The necessary training and education needs and methods to implement this document are identified and resourced. Mechanisms are in place for the regular evaluation of the implementation and effectiveness of this document.

4.3 Lead Infection Prevention and Control Nurse

The Lead Infection Prevention and Control Nurse will:

• generate and formulate this policy, identifying appropriate processes for regular evaluation of, and the implementation and effectiveness of, this policy;

• notify the Policy Coordinator of any revisions to this document;

• ensure the policy is taken to members of Health and Social Care HCAI Group for comment;

• arrange for superseded version of this document to be retained in line with national guidance.

4.4 All staff

All staff, including temporary and agency staff, are responsible for:

• Compliance with relevant process documents. Failure to comply may result in disciplinary action being taken.

• Co-operating with the development and implementation of polices and procedures as part of their normal duties and responsibilities.

• Identifying the need for a change in policy or procedure as a result of becoming aware of changes in practice, changes to statutory requirements, revised professional or clinical standards and local/national directives, and advising their line manager accordingly.

• Identifying training needs in respect of policies and procedures and bringing them to the attention of their line manager.

Attending training/awareness sessions when provided.

5 Implementation

5.1 This policy will be available to all staff for use in decontamination of equipment.

5.2 All managers are responsible for ensuring that relevant staff within their departments have read and understood this document and are competent to carry out their duties in accordance with the procedures described.

6 Training Implications

The sponsoring director will ensure that the necessary training or education needs and methods required to implement the policy or procedure(s) are identified and resourced or built into the delivery planning process. This may include identification of external training providers or development of an internal training process.

7 Documentation

7.1 Other related policy documents

NHSCDD (2009) Policy for the Safe Use and Management of Medical Devices in the Clinical Environment

7.2 Legislation and statutory requirements

None.

7.3 Best practice documents

None.

7.4 References

Ayliffe, G.A.J., Coates, D., Hoffman, P.N. (1993) Chemical Disinfection in Hospitals, Public Health Laboratory Services

Community Infection Control Nurses Network (2003) Infection Control Guidelines for General Practice, Royal College of General Practitioners

Department of Health (2010) The Health and Social Care Act 2008 Code of Practice on the prevention and control of infections and related guidance. London, DH

Lawrence, J. and May, D (2004) Infection Control in the Community, Churchill Livingstone

McCulloch, J. (2000) Infection Control Science, Management and Practice, Whurr Publishers

Medical Devices Agency (2003) Management of Medical Devices prior to repair, service or investigation 2003(05), London, MHRA

Medical Devices Agency (2006) Single Use Medical Devices: Implications and Consequences of Reuse 2006(04), London:MDA ( MHRA)

Microbiology Advisory Committee to Department of Health, Medical Devices Agency (2006) Sterilization, Disinfection and Cleaning of Medical Equipment: Guidance on Decontamination, London

NHS Estates (2003) A guide to the decontamination of reusable surgical instruments, London: NHS Estates

National Patient Safety Agency (2010) The national specifications for cleanliness in the NHS. Guidance on setting and measuring performance outcomes in primary care medical and dental premises, DoH

Royal College of Paediatrics and Child Health (2002) Position Statement on Injection Technique, London, RCPCH

8 Monitoring, Review and Archiving

8.1 Monitoring

The Director of Nursing, as sponsor director, will agree with the Lead Infection Prevention and Control Nurse a method for monitoring the dissemination and implementation of this policy. Monitoring information will be recorded in the policy database.

8.2 Review

8.2.1 The Director of Nursing will ensure that each policy document is reviewed in accordance with the timescale specified at the time of approval. No policy or procedure will remain operational for a period exceeding three years without a review taking place.

8.2.2 Staff who become aware of changes in practice, changes to statutory requirements, revised professional or clinical standards and local/national directives that affect, or could potentially affect policy documents, should advise the sponsoring director as soon as possible, via line management arrangements. The sponsoring director will then consider the need to review the policy or procedure outside of the agreed timescale for revision.

8.2.3 If the review results in changes to the document, then the initiator should inform the policy manager who will renew the approval and re-issue under the next ‘version’ number. If, however, the review confirms that no changes are required, the title page should be renewed indicating the date of the review and date for the next review and the title page only should be re-issued.

8.2.4 For ease of reference for reviewers or approval bodies, changes should be noted in the ‘document history’ table on the front page of this document.

NB If the review consists of a change to an appendix or procedure document, approval may be given by the sponsor director and a revised document may be issued. Review to the main body of the policy must always follow the original approval process.

8.3 Archiving

The Policy Manager will ensure that archived copies of superseded policy documents are retained in accordance with Records Management: NHS Code of Practice 2008.

9 Equality Impact Assessment Statement

The tables below summarise reviews with respect to:

( Strategic and operational risks, including risks to health and safety.

( Current equality and diversity legislation.

( Rights under the European Convention on Human Rights.

9.1 Risk Audit

|Risk Audit for |

|RISK CATEGORIES |Significant Risks |

| |Identified Yes/No |

|1 Risks relating to organisational objectives |Yes |

|2 Risks to patient experience/outcome |Yes |

|3 Risk to or from service/business interruption |No |

|4 Risks relating to staffing and competence |Yes |

|5 Financial risks |No |

|6 Risks to compliance with inspection/audit standards |Yes |

|7 General risks to organisational reputation |Yes |

|8 Specific health and safety (inc fire) risks to persons (staff, patients, public, etc) | |

| a Location (access, environment, working |No |

|conditions) | |

| b Equipment (medical, electrical, other) |No |

| c Hazardous substances | |

| d Lone working |No |

| e Moving and handling |No |

| f Potential to cause undue stress |No |

| g Anti-social behaviour (violence, harassment, |No |

|theft) | |

|OUTCOME (tick appropriate box) |ACTION |

|No significant risks identified | |Proceed with ratification process. |

|Significant risks identified |( |Complete a full risk assessment form and action plan for all risks |

| | |identified. Include in the Appendices – see Appendix 3. |

|There is some doubt about whether risks are | |Take further advice from appropriate directorate or department. If |

|significant or relevant. | |unresolved, refer to Governance and Assurance Committee. |

9.2 Equality Audit

|Equality Audit for |

|QUESTION |RESPONSE |

|What is the purpose of the proposed policy document (or changes to policy document)? |Decontamination of equipment (including prior|

| |to inspection, service or repair) |

|Who is intended to benefit, and how? |Correct patient management and safety |

|Will the proposals involve, or have consequences for, the people the CCGs serve and employ?|No |

|Is there any reason to believe that people could be affected differently by the proposals, |No |

|for example in terms of access to a service, or the ability to take advantage of proposed | |

|opportunities? | |

|Is there any evidence that any part of the proposals could discriminate unlawfully, |No |

|directly or indirectly, against any section of the population? | |

|Is the proposed policy likely to affect relations between certain groups of people, for |No |

|example because it is seen as favouring a particular group or denying opportunities to | |

|another? | |

|Is the proposed policy likely to damage relations between any particular group(s) of people|No |

|and the CCG? | |

|OUTCOME (tick appropriate box) | |

|Potential for discrimination is very low or |( |Proceed with ratification process. |

|non-existent | | |

|Potential for discrimination exists | |Amend the document as appropriate to clarify exceptions or remove |

| | |potential. If this is not possible, take further advice from Corporate |

| | |Services Manager and/or the Equality Lead Manager (HR Department) |

|There is doubt about the potential for | | |

|discrimination | | |

9.3 Human Rights Audit

|Human Rights Audit for |

|QUESTION |RESPONSE |

|Does the policy document interfere with a Convention right? |No |

|Could the actions described in the policy document touch on one of the Convention rights? |No |

|Is there a victim? |No |

|Are there circumstances where the right can legitimately be limited or interfered with? |No |

|Does the interference meet the general criteria established by the Strasbourg authorities, |No |

|ie: | |

|( The action is prescribed by law | |

|( It pursues a legitimate aim. | |

|( It is necessary in a democratic society. | |

|OUTCOME (tick appropriate box) | |

|No rights affected |( |Proceed with ratification process. |

|Potential to affect a right has been identified| |Amend the document as appropriate to clarify exceptions or remove |

| | |potential. If this is not possible, take further advice from Corporate |

| | |Services Manager/Legal Advisers. |

|There is doubt about the potential to affect a | | |

|right. | | |

Appendix 1

Declaration of Contamination Status

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

Description of equipment ……………………………………………………………………

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

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

Fault ………………………………………………………………………………………….

Contaminated items should not be returned without prior agreement of the recipient

Appendix 2

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

Yes

No

Yes

No

Appendix 3

There is a risk of non-compliance with all infection control policies which would in turn increase the risk of patients acquiring healthcare associated infections (HCAI), the organisation not achieving national targets on HCAI and not complying with inspection audits.

These policies are designed to provide a framework to reduce those risks.

-----------------------

From: …………………………………….… To: ………………………………………….

Address: …………………………………… Address: ……………………………………

…………………………………… ……………………………………

…………………………………… ……………………………………

Reference ………………………………… Reference …………………………………...

Is this item contaminated? Yes* No Don’t know

*State type of contamination: blood, body fluids, respired gases, pathological samples, chemical (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 …………………………………………………………………………………………….

Sterilisation……………………………………………………………………………………………..

‡ Please explain why the item has not been decontaminated?

…………………………………………………………………………………………………………..

…………………………………………………………………………………………………………..

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

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

Signature ………………………………………………………………………………………………

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

Repair organisation or investigating body agrees dispatch?

Decontaminate Item

• Label with contamination status

• Note fault/defect

• Off site: pack and dispatch for service/repair/investigation

• On site: store in preparation for service/repair/investigation

Can the equipment be decontaminated without removing evidence important to a repair or an investigation?

Inform repair organisation or investigating body

• Label with contamination status

• Note fault/detect

• Pack and dispatch for service/repair/investigation

Arrange visit by service/repair organisation or investigating body

• Label with contamination status

• Note fault/defect

• Quarantine in preparation for service/repair/investigation

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