Infection Control and Cleanliness: Single-use Medical Devices and Equipment in Care Homes Policy

Policy Statement

Infection control is a critical element in the running and management of any care home as serious infections can easily be spread if inadequate controls are in place.

The protection of people who use services from such diseases is a key aim of {{org_field_name}}, which expects all of its staff and volunteers to adhere strictly to a range of policies relating to the control of infection, including this one, which is designed to protect people from the risks of infection associated with medical devices.

The policy is in line with all statutory requirements for care services to maintain high standards of cleanliness of facilities and equipment and health and safety laws.

Legal Considerations

This care service will adhere to all relevant legislation, including:

the Health and Safety at Work, etc Act 1974
the Public Health Infectious Diseases Regulations 1988
the Control of Substances Hazardous to Health Regulations 2002 (COSHH)
the applicable national standards, regulations and guidance for health and social care services.

Under the above legislation, and associated codes of practice, {{org_field_name}} understands its legal and moral duty to ensure the health and safety of both staff and people who use services and to protect them, wherever practicable, from dangerous substances in the workplace, including the risk of transmission of infections.

This policy should be read and used in relation to other cleanliness and infection control policies.

Applicable best practice infection control guidance includes:

NICE CG139: Healthcare-associated Infections: Prevention and Control in Primary and Community Care (2017), NICE
NICE PH36: Healthcare-associated Infections: Prevention and Control (2011), NICE
HSE HSG220 Health and Safety in Care Homes (2nd edition) (2014), HSE.

Specialist advice and support will be obtained from the local public health protection team and from relevant primary healthcare teams.

Regulation

{{org_field_name}} recognises that it must comply with the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 in order to meet its legal requirement for registration with the Care Quality Commission (CQC).

With respect to infection control, the home understands that a range of regulations may apply, including:

Regulation 12: Safe Care and Treatment — this requires providers to assess the risk of, and prevent, detect and control the spread of, infections, including those that are healthcare associated
Regulation 15: Premises and Equipment — this states that premises and equipment must be clean, suitable for the purpose for which they are being used, properly used and properly maintained.

Guidance for Providers on Meeting the Regulations, published by the CQC in March 2015, provides guidance on how this service should comply with the regulations.

Under regulation 15(2) the guidance states that:

where applicable, premises must be cleaned or decontaminated in line with current legislation and guidance, and equipment must be cleaned, decontaminated and/or sterilised in line with current legislation and guidance and manufacturers’ instructions
equipment must be cleaned or decontaminated after each use and between use by different people who use the service
multiple-use equipment and devices must be cleaned or decontaminated between use
single-use and single-person devices must not be reused or shared
all staff must understand the risk to people who use services if they do not adhere to these requirements.

Definitions and Theory

{{org_field_name}} understands the term “single-use medical devices” to refer to a device that is intended to be used on an individual person during a single procedure and then discarded. In this respect, the home interprets the expression “single-use” on the packing of a medical device (or an equivalent statement, such as “not for re-use”) to mean that the manufacturer:

intends the device to be used once and then discarded
considers the device is not suitable for use on more than one occasion
has evidence to confirm that re-use would be unsafe.

The Medical Devices Regulations 2002 require that all medical devices placed on the market carry a CE marking.

The rationale behind the use of such equipment is that in certain circumstances the use of disposable sterile equipment may present a lower infection control risk than the sterilisation or disinfection of reusable equipment.

The use of single-use equipment is covered by guidelines issued by the Medicines and Healthcare Products Regulatory Authority (MHRA). These are primarily contained within Single-use medical devices: implications and consequences of reuse, published in October 2019.

The guidance represents an update of Device Bulletin DB2006 Single-use Medical Devices: Implications and Consequences of Re-use and Equipped to Care.

The guidance states the following.

Devices designated for single use must not be re-used under any circumstances.
The re-use of single-use devices can affect their safety, performance and effectiveness, exposing patients and staff to unnecessary risk.
Single-use devices are not designed to allow thorough decontamination and resterilisation processes.
Reprocessing single-use devices may alter the nature of the materials from which the device is made and therefore its performance to an extent that makes it unsafe to re-use.
The re-use of single-use devices has legal implications, eg the manufacturer’s warranty may not apply or the item may fail.

The MHRA warns that the following problems may be caused by inappropriate re-use.

The safety, performance and effectiveness of single-use items might be affected.
Devices not intended for re-use might simply not stand up to the reprocessing or decontamination process, which often involves high levels of heat and pressure. Inadequate cleaning or decontamination might result.
Devices not intended for re-use might not be properly decontaminated by the reprocessing or decontamination process and thus increase potential for cross-infection.
Exposure to chemical cleansing agents might cause corrosion or material damage to a device that could render the device or equipment more likely to mechanical or structural failure.

These problems will be exacerbated through prolonged and repeated re-use.

The home understands “re-use” to apply to medical devices that are not single-use and which can safely be used again following some form of reprocessing between use, ranging from a simple washing of the item to a full cleaning and sterilisation process.

Note:

Single-use devices should not be confused with “single-patient use” devices, which may be used more than once on the same person and may undergo reprocessing as advised by the manufacturer.

Procedure

To fully protect people who use services from the risks associated with single-use medical devices, in {{org_field_name}} the following applies.

The relevant MHRA guidelines will be followed by all staff at all times.
Single-use devices are not designed to allow thorough decontamination and resterilisation processes and therefore should be discarded after use and no attempt should be made to re-sterilise or decontaminate them.
Any member of staff who re-uses or reprocesses a device intended for single use bears full responsibility for their actions and may be liable for disciplinary action according to the home’s disciplinary policy.
All single-use medical devices should be disposed of in compliance with the home’s disposal of clinical waste policy.

Covid-19 Infection and Prevention Measures

{{org_field_name}} understands that key guidance for care homes in England includes:

Infection Prevention and Control (IPC): Resource for Adult Social Care (2022), DHSC
Infection Prevention and Control in Adult Social Care: Covid-19 Supplement (2022), DHSC
Covid-19 PPE Guide for Adult Social Care Services and Settings (October 2022), DHSC.

{{org_field_name}} is aware of the danger of Covid-19 being transmitted from one person to another via contaminated equipment. The appropriate use of single-use sterile equipment and the effective cleaning and decontamination of reusable equipment is therefore of extreme importance.

In {{org_field_name}}:

where possible, during outbreaks of Covid-19, single-use devices should be used wherever practicable (for example, thermometers, blood pressure cuffs, pulse oximeters, etc)
where equipment is re-used it should be cleaned and disinfected (including mobility aids) before re-use with another person who uses the service in accordance with manufacturer’s instructions
particular attention should be paid to cleaning of any reusable equipment taken between the people who use the service’s bedrooms.

Low-risk equipment can be cleaned sufficiently with hot water and detergent.

Implementation

All staff are responsible for the implementation of this policy.

Overall responsibility for ensuring that the policy is implemented, monitored and reviewed rests with the Infection Control Lead for the home.

The Infection Control Lead will work closely with the manager of the home to ensure that all infection control policies are effectively implemented and that the home has adequate supplies of handwashing materials and facilities, personal protective equipment and sterile clinical equipment, including single-use medical devices.

The procurement strategy for these products will be led by the Infection Control Lead and will be based upon sound best practice principles.

Individual staff practitioners are responsible for ensuring that they implement this policy wherever necessary and exercise adequate infection control precautions at all times, seeking further advice from the Infection Control Lead as required.

Information on the policy will be:

circulated to all staff
provided to all new employees
included in the infection control policy, the clinical waste policy, and the disinfection of medical devices policy.

Training

All new staff should read this policy as part of their induction. Those staff who are required to work with single-use medical devices will be expected to be appropriately trained, qualified and competent to do so. The home will ensure that appropriate access to ongoing infection control refresher training will be provided to all persons with clinical or cleaning roles.

Audit

The use of single-use medical devices within the organisation will be subject to regular audit to monitor compliance with this policy.

The Infection Control Lead for the home is responsible for ensuring that evidence-based policies and procedures in relation to the control of infection are developed and their implementation monitored.

The Infection Control Lead for the home will monitor carefully any incident reports relating to infection control matters in order to identify any trends or patterns.

Responsible Person: {{org_field_registered_manager_first_name}} {{org_field_registered_manager_last_name}}

Reviewed on: {{last_update_date}}

Next Review Date: {{next_review_date}}

WCH151. Infection Control and Cleanliness: Single-use Medical Devices and Equipment in Care Homes