Module 9 – The Clinical Relationship & Duty of Care
Part of the Purus Lumina Device Care Education Programme
A prescription was issued. A device was supplied. No one documented what happens next.
The UK prescribed CBPM pathway involves a specialist clinician, a licensed pharmacy, a classified medical device, and a patient. The clinician issues the prescription. The pharmacy dispenses the CBPM. The device is sourced — purchased independently, supplied by the clinic, or obtained through a funding scheme. The patient goes home.
At no point in this pathway does anyone document how the device should be maintained. No handover protocol exists. No care standard is issued. The patient is left with a classified medical instrument, a prescribed controlled substance, and no documented guidance on how to keep the delivery mechanism clean.
This module addresses the clinical relationship that surrounds that gap — what the prescriber's obligations are, what the clinic's position is when it supplies a device, and what the absence of a handover protocol means for the patient, the clinician, and the regulatory framework that governs both.
The prescriber's obligation
A specialist clinician who prescribes a Cannabis-Based Product for Medicinal use (CBPM) in the United Kingdom does so under the Misuse of Drugs Regulations 2001 (as amended) and the Human Medicines Regulations 2012. The prescription is a legal instrument. The clinician who issues it carries a duty of care to the patient that extends beyond the act of prescribing.
Duty of care and device maintenance: The duty of care owed by a prescribing clinician to their patient is not limited to the selection of the appropriate CBPM and dose. It extends to the conditions under which the prescription is administered. A CBPM administered through a contaminated device is not being administered as prescribed. The prescriber who does not advise the patient on device maintenance has not fully discharged their duty of care in relation to the administration of the prescription.
What currently exists: No UK clinic operating within the prescribed CBPM pathway currently provides patients with a documented device care and maintenance protocol at the point of prescription. Some clinics reference the manufacturer's cleaning guidance. None have produced a protocol written for the clinical context of prescribed CBPM use. This curriculum is the first documented attempt to fill that gap. It exists because the clinical pathway did not produce it.
The informed consent question: Informed consent in medical practice requires that the patient understands the treatment they are receiving, including how it is administered. A patient who has not been informed that their device requires regular maintenance, that failure to maintain it constitutes off-label use, and that a contaminated device delivers an inconsistent dose has not been fully informed about the administration of their prescription. Whether the absence of this information affects the validity of the consent process is a question this curriculum exists, in part, to raise.
The clinic's position in the supply chain
A clinic operating within the prescribed CBPM pathway that supplies a device to a patient — whether directly, through a funding scheme, or through a manufacturer grant programme — occupies a defined position within the UK medical device supply chain. The Medicines and Medical Devices Act 2021 and the UK Medical Devices Regulations 2002 govern the supply of classified medical devices. The MHRA's enforcement powers extend to all parties in the marketing and supply chain.
Supply without instruction: A clinic that supplies a classified medical device to a patient without providing documented care and maintenance guidance has supplied a medical instrument without the information required for its correct use. The manufacturer's instructions for use (IFU) are supplied with the device. They are not written for the clinical context of prescribed CBPM use. They do not address the frequency of use typical of a patient prescribed botanical medicine. They do not address the regulatory implications of non-compliance. Supplying the device with the manufacturer's IFU and nothing further is not equivalent to providing a clinical handover protocol.
The regulatory question: Whether a clinic's failure to provide a device care protocol at the point of supply constitutes a breach of the UK Medical Devices Regulations 2002 has not been tested. The MHRA has not issued guidance on this specific question. This curriculum documents the gap and submits it to the relevant regulatory bodies as a matter of public record. It does not constitute legal advice.
What a handover protocol should contain: A clinical handover protocol for a prescribed dry herb device should, at minimum, include: the cleaning standard and frequency appropriate to the patient's prescribed use pattern; the replacement schedule for consumable components; the documentation the patient should carry when travelling with the device and the CBPM; and the process for reporting device failure to the prescribing clinic. None of this currently exists as a standard clinical document. This curriculum is the first attempt to define what it should contain.
The patient's position
The patient in this pathway is a person with a diagnosed medical condition, prescribed a controlled substance, administered through a classified medical device, with no documented guidance on how to maintain that device in the context of their prescription.
Off-label use and patient liability: As documented in Module 2, failure to follow the manufacturer's cleaning instructions constitutes off-label use of the device under UK medical device regulations. Off-label use is at the patient's own risk. A patient who has not been informed of this by their prescribing clinic is carrying a regulatory liability they were not told about. This is not a theoretical concern — it is the current position of every patient in the UK who uses a prescribed dry herb device.
The patient's recourse: A patient who believes their prescribing clinic has failed to provide adequate information about device maintenance has several potential avenues. They may raise the matter directly with the clinic. They may raise it with the Care Quality Commission (CQC), which regulates independent healthcare providers in England. They may raise it with the General Medical Council (GMC) if they believe the prescribing clinician has fallen below the standard expected of a registered medical practitioner. This curriculum does not advise patients to take any of these steps — it documents that the steps exist.
The absence of a handover protocol as a systemic finding
The absence of a device care handover protocol in the UK prescribed CBPM pathway is not an oversight by any individual clinic or clinician. It is a systemic gap — the result of a pathway that was constructed around the prescription and the dispensing of the CBPM, without adequate consideration of the device through which it is administered.
The Storz & Bickel Mighty Medic+ was granted UKCA marking as a classified medical device. It is prescribed and supplied within a regulated clinical pathway. The pathway has no documented standard for its maintenance. That is the finding this curriculum exists to record.
The appropriate response to a systemic gap is a systemic solution. This curriculum is the first step toward that solution. It is submitted to the MHRA, NHS England, NICE, the Home Office, the CQC, and the relevant parliamentary bodies not as a complaint, but as a contribution — a documented standard where none existed, offered to the institutions that have the authority to adopt it.
In plain terms
Your prescriber has a duty of care to you. That duty extends to how your prescription is administered — including the device you use to administer it. No clinic in the UK currently provides a documented device care protocol at the point of prescription. That is not your fault. It is a gap in the pathway.
If your device was supplied by your clinic, the clinic supplied a classified medical instrument without a maintenance guide written for your use pattern. This curriculum is that guide. It exists because the clinical pathway did not produce it.
You are not responsible for the gap. You are responsible for what you do now that you know it exists.
Notice of Intent
This curriculum has been submitted to the MHRA, Home Office, NHS England, NICE, the Care Quality Commission, relevant parliamentary and clinical bodies, and device manufacturers operating within the UK prescribed CBPM pathway, as a formal educational contribution to a documented gap in patient care. It is published in perpetuity as a matter of public record. Purus Lumina reserves all rights to the curriculum structure, content, and methodology.
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Module 9 is part of the Purus Lumina Device Care Curriculum — the world's first documented device care education programme for patients prescribed botanical medicine. Published as a matter of public record. Preserved in perpetuity.
This module was published on 4 July 2026 and exists in perpetuity as part of the Purus Lumina Device Care Curriculum — the world's first documented device care education programme for patients prescribed botanical medicine. It will not be removed.
Glenn Hailes · Director · Purus Lumina Ltd · 3rd Floor, 86–90 Paul Street · London EC2A 4NE · United Kingdom · Registered in England and Wales