1. Purpose

This policy sets out how valid consent is obtained, documented, and respected for all microsuction ear wax removal procedures, ensuring patients are fully informed, empowered, and treated lawfully and ethically.

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2. Scope

This policy applies to all patients receiving microsuction ear wax removal via the practitioner’s mobile service and covers:
    •    Consent to examination and treatment
    •    Consent to data collection, storage, photography and video recording
    •    Capacity, best interests decisions, and refusal of treatment

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3. Legal & Professional Framework

This policy is informed by:
    •    Mental Capacity Act 2005
    •    Health and Social Care Act 2008 (Regulated Activities) Regulations
    •    CQC Fundamental Standards (Regulation 11 – Need for Consent)
    •    General Data Protection Regulation (UK GDPR)
    •    Data Protection Act 2018
    •    NMC Code (2018) – principles applied where relevant
    •    Department of Health: Reference Guide to Consent for Examination or Treatment

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4. Principles of Consent

Consent must be:
    •    Voluntary – given freely without pressure
    •    Informed – patient understands the procedure, risks, and alternatives
    •    Capacity-based – patient has capacity to make the decision
    •    Ongoing – can be withdrawn at any time

Consent may be verbal, written, or electronic, but must always be documented.

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5. Consent Process

5.1 Information Provision

Before the procedure, patients are provided with:
    •    A verbal explanation of the microsuction procedure
    •    A paper copy outlining the risks and benefits
    •    Opportunity to ask questions, all of which are welcomed and answered
    •    Signposting to the practitioner’s website for further information

Patients are given adequate time to consider the information before consenting.

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5.2 Electronic Consent (TYMPA System)

The TYMPA system is used to obtain and document consent electronically, including:
    •    Acknowledgement of risks
    •    Consent to the microsuction procedure
    •    Consent for data management
    •    Consent for photography and video recording of the ear canal

All consent forms are electronically signed by the patient and securely stored on the TYMPA cloud-based clinical system.

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5.3 Documentation

The following are documented within the TYMPA system:
    •    Confirmation that risks were explained verbally and in writing
    •    Electronic consent signatures
    •    Any questions asked and responses provided
    •    Capacity assessment where relevant
    •    Details of any refusal or withdrawal of consent

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6. Consent to Photography & Video Recording
    •    Images and videos of the ear canal are taken for clinical assessment, documentation, and monitoring.
    •    Patients provide explicit consent via the TYMPA system.
    •    Images and videos form part of the patient’s clinical record and are stored securely in accordance with GDPR.

Patients may refuse consent for photography/video recording without affecting their right to receive care.

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7. Capacity to Consent

7.1 Assessing Capacity

Capacity is assessed in line with the Mental Capacity Act 2005. A patient is presumed to have capacity unless there is reason to believe otherwise.

A patient must be able to:
    •    Understand the information
    •    Retain the information
    •    Weigh the information
    •    Communicate their decision

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7.2 Patients Unable to Sign for Themselves

If a patient is unable to sign electronically:
    •    A Power of Attorney (POA), carer, or family member may sign with the patient’s consent.
    •    The patient’s agreement to this arrangement is documented.

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7.3 Best Interests Decisions

If a patient lacks capacity:
    •    A best interests decision may be made in consultation with the Next of Kin (NOK) or POA.
    •    The decision must be the least restrictive option and clinically appropriate.
    •    If the patient shows any signs of distress, discomfort, or objection, the procedure is immediately stopped, regardless of third-party consent.

All best interests decisions are fully documented within the TYMPA system.

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8. Right to Refuse or Withdraw Consent
    •    Patients have the absolute right to refuse treatment.
    •    Patients may stop the procedure at any time, for any reason.
    •    Withdrawal of consent does not affect future care or professional conduct.

Any refusal or withdrawal is documented in the clinical record.

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9. Ongoing Consent

Consent is treated as an ongoing process:
    •    Consent is reconfirmed throughout the procedure.
    •    The practitioner monitors verbal and non-verbal cues.
    •    Treatment is paused or stopped if consent is unclear.

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10. Confidentiality & Data Protection

All patient information, including consent records, images, and videos, is:
    •    Stored securely within the TYMPA cloud system
    •    Accessed only by authorised users
    •    Managed in line with UK GDPR and the Data Protection Act 2018

Patients may request access to their data in accordance with data protection legislation.

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11. Training & Review
    •    The practitioner is trained in consent, capacity, and best interests decision-making.
    •    This policy is reviewed annually or sooner if legislation or guidance changes.

Updated on 02/02/2026*