Decontamination of Reusable Medical Devices

DECONTAMINATION OF REUSABLE MEDICAL DEVICES

TRUST POLICY

Version Tracking

CONTENTS

1.  Introduction

2.  Purpose

3.  Scope

4.  Definitions

5.  Duties and responsibilities

6.  Process

-  Risk Assessment and Choice of decontamination methods

-  Compatibility

-  Regulatory framework for medical device decontamination

-  Decontamination Committee and the Management of Decontamination Services

-  Decontamination of invasive medical devices

-  Decontamination of non-invasive medical devices

-  Decontamination of Endoscopes

-  Record Keeping

-  Devices suspected of contamination with prions

-  Single Use medical devices

-  Decontamination of Equipment Prior to Service or Repair

-  Loan/Lease devices

7.  Training Requirements

8.  References and associated documentation

9.  Equality Impact Statement

10.  Monitoring compliance with procedural documents

11.  Appendix A: Approved list of cleaning agents

12.  Appendix B: Example of a Decontamination Certificate

13.  Appendix C: Decontamination Committee Terms of Reference

14.  Appendix D: Regulatory Framework for Medical Device Decontamination

QUICK REFERENCE GUIDE

This policy must be followed in full when developing or reviewing and amending Trust procedural documents.

For quick reference the guide below is a summary of actions required. This does not negate the need for the document author and others involved in the process to be aware of and follow the detail of this policy. The quick reference can take the form of a list or a flow chart, if the latter would more easily explain the key issues within the body of the document

1.  Decontamination is a combination of processes (cleaning, disinfection and/or sterilisation) which removes or destroys contamination so that infectious agents cannot reach a susceptible site in sufficient quantities to cause harm to a patient or device user. Differing levels of decontamination are used depending on the device and the procedure involved.

2.  The choice of the decontamination method (cleaning, disinfection and/or sterilisation) centres around the infection risk associated with the use of the device, the type of device, the nature of the contamination, the organisms involved, the risk to patients and staff.

3.  Medical devices must be checked for compatibility with the proposed decontamination method.

4.  Invasive medical devices, such as surgical instruments, must be decontaminated in a compliant environment with validated processes such as the Hospital Sterilisation and Disinfection Unit (HSDU)

5.  Non-invasive medical devices must be subjected to a suitable level of decontamination based on the use and type of device involved.

6.  The decontamination of flexible endoscopes is to include cleaning and disinfection. These processes must be undertaken in dedicated Endoscope Decontamination Areas within the Trust.

7.  If equipment is believed to be contaminated with prions then the equipment should not be decontaminated and should be quarantined. Seek advice from the Consultant Microbiologist, Decontamination Lead or the Infection Control Team

8.  The reuse of ‘single-use’ devices has legal implications. It is the policy of the Portsmouth Hospitals NHS Trust that medical devices designated for a single episode of use are not to be reused under any circumstances

1.  INTRODUCTION

High standards of cleanliness and hygiene related to equipment and medical devices are essential for the prevention of cross infection in the healthcare environment. The cleanliness of the environment and equipment used in patient care is the responsibility of all staff.

The Health and Social Care Act 2008 requires the Trust to ensure that appropriate standards are maintained for the decontamination of equipment and reusable medical devices. This policy provides an explanation of the processes, responsibilities and requirements relating to the decontamination of medical devices.

Whilst the advice contained within this policy relates particularly to microbiological hazards, equipment may also become contaminated with hazardous chemicals. The same requirements of decontamination to provide safe equipment apply and should be included in safe systems of work.

2.  PURPOSE

The purpose of this policy is

·  To provide staff with the necessary information to decontaminate patient equipment safely in order to protect patients, public, members of staff from infection, injury or harm whilst maintaining the integrity and purpose for which each item of equipment was intended

·  To promote the safest possible environment for patients through the identification and application of best practice in the decontamination of re-usable medical devices.

·  To provide compliant guidance to all staff who undertake the decontamination of medical devices within Portsmouth Hospitals NHS Trust.

·  To promote consistency in Decontamination practices across the Trust incorporating essential quality requirements and best practice.

The principles of this policy are:

·  That the Trust will continually review and develop practices in order to comply with all present and future medical device legislation within resources available.

·  That equipment will be adequately cleaned, disinfected or sterilised according to its function so as to protect as far as reasonably practical the health, safety and welfare of its staff, patients and those recipients who are involved in inspection, service, repair or transportation of medical devices or equipment.

·  That the Trust will ensure adequate provision of disinfectants, cleaning agents and equipment necessary to achieve the required standard of decontamination.

3.  SCOPE

This policy applies to direct employees of Portsmouth Hospitals NHS Trust and employees of other organizations managed by the Trust.

‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety’

4.  DEFINITIONS

Decontamination;

The decontamination of re-usable medical devices is the combination of processes, which if not correctly undertaken, individually or collectively, may increase the likelihood of microorganisms being transferred to patients or staff. Decontamination is a process, which removes or destroys contamination and thereby prevents microorganisms or other contaminants reaching a susceptible site in sufficient quantities to initiate infection or any other harmful response. Three processes of decontamination are commonly used;

-  Cleaning

-  Disinfection

-  Sterilisation

Cleaning;

Cleaning is the mechanical process which physically removes soiling but does not necessarily destroy microorganisms. The reduction of microbial contamination is not routinely measured and will depend upon many factors, including the efficiency of the cleaning process and the initial bioburden. Cleaning removes micro-organisms and the organic material on which they thrive.

Disinfection;

Disinfection is a process intended to kill, reduce or remove, pathogenic micro-organisms but which may not necessarily inactivate some microbial agents, such as certain viruses and bacterial spores. Disinfection may not achieve the same reduction in microbial contamination levels as sterilisation.

Sterilisation;

Sterilisation is the process of rendering an article completely free from all living microorganisms including viruses. Standard sterilisation methods will not destroy abnormal prion proteins thought to be the causative agents of Creutzfeldt-Jakob disease (CJD).

Bioburden;

The population of viable infectious agents contaminating a medical device

Single-use device;

A medical device which is intended to be used on an individual patient during a single procedure and then discarded. It is not intended to be used on another patient. Staff who disregard this information and allow further use of these items, will transfer legal liability for the safe performance of the product from the manufacturer to themselves, or to the Trust

HSDU;

The Hospital Sterilisation and Disinfection Unit (HSDU) is a centralized department specifically designed and equipped to reprocess reusable medical devices. The department uses a range of decontamination equipment such as ultrasonic washers, washer-disinfectors and sterilisers to achieve medical device decontamination.

CJD and vCJD;

Creutzfeldt–Jakob disease and variant Creutzfeldt–Jakob disease (vCJD) are degenerative neurological disorders that are incurable and invariably fatal. Brain tissue develops holes and takes on a sponge-like texture. This is due to a type of infectious protein called a prion. Prions are misfolded proteins which replicate by converting their properly folded counterparts. Standard sterilisation methods will not destroy these abnormal prion proteins.

5.  DUTIES AND RESPONSIBILITIES

The Chief Executive

The Chief Executive is ultimately accountable for ensuring that there are effective arrangements in place for the decontamination of medical devices, including the provision of adequate decontamination facilities.

The Chief Executive has authorized the delegation of these responsibilities to the Director of Infection Prevention and Control (DIPC) and the Trust Decontamination Lead.

Director of Infection Prevention and Control (DIPC)

The Director of Infection Prevention and Control (DIPC) is responsible for overseeing local control of infection policies (including decontamination) and their implementation. The DIPC nominates a Decontamination Lead to be responsible for the implementation of an operational policy for decontamination.

The Decontamination Lead

The Decontamination Lead reports to board level through the DIPC. The Decontamination Lead is responsible for the effective, and technically compliant, provision of decontamination services. The Decontamination Lead is responsible for the implementation of an operational policy for decontamination. He/she will ensure that the operational policy clearly defines the roles and responsibilities of all personnel who may be involved in the use, installation and maintenance of decontamination equipment. The Decontamination Lead is also responsible for monitoring the implementation of the policy and will form and chair a Decontamination Committee.

The Decontamination Committee

The Decontamination Committee is chaired by the Decontamination Lead. The Committee’s function is to provide direction to the Clinical Service Centres of the Trust. Representation on this committee includes the operational leads of those departments involved in decontamination of medical devises (i.e. HSDU, Endoscopy, Clinical Engineering).

Authorising Engineer (Decontamination) - AE(D)

The role of the AE(D) is fully independent of the healthcare facilities’ structure for maintenance, testing and management of the decontamination equipment. The AE(D) is defined as a person designated by Management to provide independent auditing and technical advice on decontamination procedures, washer-disinfectors, sterilisers and sterilisation and to review and witness documentation on validation.

The AE(D) is appointed under the authorisation and direction of the Decontamination Lead. The AE(D) must be IHEEM registered and offer impartial advice to the Trust Management on all matters relating to medical device decontamination.

Senior Operational Manager (Estates)

The Senior Operational Manager is technically, professionally and managerially responsible (and accountable to the Decontamination Lead) for the engineering aspects of decontamination plant and environment. This function includes the management of the maintenance and testing programmes for decontamination machinery and physical environments. The Senior Operational Manager (Estates) has defined Competent Persons (Decontamination) to undertake repairs, maintenance, validation and testing of washers, sterilisers and associated decontamination equipment.

Authorised Person (Decontamination) AP(D)

An internally appointed person who has undertaken specialist training and possesses technical knowledge relating to the engineering aspects of decontamination. The person will manage the practical implementation of policy and procedure.
Competent Person(s)

Designated by management to carry our maintenance, validation and periodic testing of decontamination plant and equipment.

Users

The User is defined as the person designated by Management to be responsible for the management of decontamination processes. The User is also responsible for the Operators.

Within Portsmouth Hospitals NHS Trust the User includes the HSDU Manager, Endoscopy Manager and Lead Clinical Engineer.

The principal responsibilities of the User are as follows:

·  to certify that the decontamination equipment is fit for use;

·  to hold all documentation relating to the decontamination equipment, including the names of other key personnel;

·  to ensure that decontamination equipment is subject to periodic testing

·  and maintenance;

·  to appoint operators where required and ensure that they are adequately trained;

·  to maintain production records;

·  to establish procedures for product release in line with the quality management system;

·  to ensure that procedures for production, quality control and safe working are documented and adhered to in the light of statutory requirements and accepted best practice.

The User may seek the advice of the Decontamination Lead, infection control teams, AE(D) or Microbiologist (Decontamination).

Operators

The Operator is defined as any person with the authority to operate decontamination equipment, including the noting of instrument readings and simple housekeeping duties.

Operators have their tasks clearly defined in their job description. Operators have documented training records to demonstrate that they are competent at undertaking their assigned tasks.

HSDU

The HSDU provides a decontamination service to all operating theatres, wards, outpatients, clinics etc. and some external customers. The principle responsibilities of the HSDU are to;

·  Provide decontamination which will comply with current legislation and guidelines processing surgical instrument sets, supplementary instruments, loan instrument sets, anaesthetic devices and rigid endoscopes.

·  Provide specialist advice on decontamination and sterilisation as appropriate.

·  Report any significant or major decontamination incidents to the Decontamination Lead, liaise with Infection Prevention and Control, and where appropriate Health and Safety.

Endoscopy Decontamination Areas

These areas are responsible for the safe and effective decontamination of flexible endoscopes to support the clinical activity of endoscopy units. The responsibility of these areas are to undertake endoscope reprocessing in accordance with Department of Health guidance.

Infection Prevention and Control Team

The IPC Team will provide specialist advice for the decontamination of equipment prior to purchase and during use.

General Managers, Heads of Nursing, Department Managers

Ensure that this policy and its associated procedures are fully adhered to within their area of responsibility.

Employees