Module 12 – The Patient Record
Part of the Purus Lumina Device Care Education Programme
If it is not documented, it did not happen.
The care standard documented in this curriculum is only as useful as the record that proves it was followed. A patient who cleans their device correctly, replaces components on schedule, and maintains the protocol to the letter — but keeps no record of having done so — has no evidence of compliance if that compliance is ever questioned.
It will be questioned. Not necessarily by a regulator or a court. More likely by an insurer, a prescribing clinician reviewing a patient's progress, a DVLA medical assessment, or a police officer conducting a roadside drug test. In each of these contexts, the patient's ability to demonstrate that their device was maintained correctly — and therefore that their prescription was administered consistently — is a material consideration.
This module documents what the patient record should contain, why it matters, and how to maintain it. It is the first time this has been documented in the context of UK prescribed CBPM device care.
What the patient record is
The patient record, in this context, is the maintenance log — a documented history of device care. It is distinct from the clinical record held by the prescribing clinic, which documents the prescription, the dose, and the clinical review. The maintenance log is the patient's own record, held by the patient, documenting how the device through which the prescription is administered has been maintained.
No clinic requests it. No prescriber reviews it. No regulatory body currently requires it. It exists because the patient has an interest in being able to demonstrate, if required, that their device was maintained to the documented standard. That interest is not theoretical. It is practical, legal, and in some circumstances financial.
What the maintenance log should contain
The maintenance log should record, at minimum, the following for every scheduled maintenance event:
- Date of maintenance — the date the full strip-down was completed
- Components inspected — which components were checked and their condition
- Components cleaned — which components were cleaned and with what solution
- Components replaced — which components were replaced and why
- Anomalies observed — any unusual residue, smell, draw resistance, or device behaviour noted
- Next scheduled maintenance date — based on use frequency and the replacement schedule in Module 8
- Signature or initials — the person who performed the maintenance. In a carer-assisted context, this is the carer, not the patient.
A dated photograph of the disassembled device at each strip-down is a valuable addition to the written record. It provides visual evidence of the device's condition at the time of maintenance and cannot be retrospectively altered.
Why the record matters: clinical review
A prescribing clinician who reviews a patient's progress at a clinical appointment is assessing whether the prescribed CBPM is producing the expected therapeutic effect. If the patient reports inconsistent effects — sessions that feel different, doses that seem variable, outcomes that do not match the prescription — the clinician's first assumption is likely to be that the prescription needs adjustment.
A patient who can demonstrate, through a maintenance log, that their device has been consistently maintained to the documented standard removes device contamination and inconsistent dose delivery as variables in that clinical assessment. A patient who cannot demonstrate this leaves those variables open. The clinical decision that follows may be based on incomplete information.
The maintenance log is not a clinical document. It is the patient's contribution to the accuracy of their own clinical review.
Why the record matters: legal and insurance contexts
Driving and the 2μg/L threshold: As documented in Module 2, vaporised cannabis produces the highest maximum blood concentrations of THC of any consumption route. UK law sets a legal limit of 2μg/L of THC in blood for drivers. A patient who drives and uses a prescribed CBPM is operating within a legal framework that requires them to manage their THC blood concentration carefully.
A contaminated device delivering an inconsistent dose creates an unpredictable THC blood level. A patient stopped by police who can demonstrate — through a maintenance log — that their device was maintained correctly and their dose was consistent is in a materially different position to one who cannot. The maintenance log does not guarantee a legal outcome. It is evidence of responsible management of a prescribed medication.
Insurance: Some insurance products — life insurance, critical illness cover, income protection — require disclosure of prescribed medications. A patient who discloses a CBPM prescription and is subsequently asked to demonstrate that the medication was administered correctly has an interest in being able to do so. A maintenance log is that demonstration.
Employment: Patients in safety-critical roles — healthcare, transport, construction, emergency services — may be subject to workplace drug testing. A positive test result for THC in a patient with a valid prescription is a complex situation. The patient's ability to demonstrate consistent, documented device maintenance — and therefore consistent, predictable dose delivery — is relevant to how that situation is managed.
Off-label use and 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 maintenance log that demonstrates consistent compliance with the cleaning protocol is the patient's evidence that they did not use the device off-label. In any context where device maintenance is a relevant consideration — a warranty claim, a product liability question, a clinical negligence assessment — the maintenance log is the patient's record.
How to maintain the record
The maintenance log does not need to be complex. A dedicated notebook, a dated spreadsheet, or a notes application on a phone are all appropriate formats. The requirement is that the record is contemporaneous — made at the time of maintenance, not reconstructed afterwards — and that it is retained.
Retention: Retain the maintenance log for as long as the device is in use, and for a minimum of two years after the device is retired. In a legal or insurance context, the relevant period may be longer. If in doubt, retain indefinitely.
Photographs: Store dated photographs alongside the written record. A photograph taken on a smartphone is automatically date-stamped in the file metadata. This provides independent verification of the date that cannot be altered without specialist knowledge.
Carer records: In a carer-assisted context, the carer who performs the maintenance should sign or initial the record. In a professional care setting, the record should be filed in the patient's care documentation alongside other medication administration records.
The record as a statement of intent
A patient who maintains a device care record is making a statement — to their prescriber, to any authority that may ask, and to themselves — that they take the administration of their prescription seriously. That statement has value beyond its legal or clinical utility.
Patients prescribed botanical medicine in the UK operate within a framework that is still establishing its norms. The patients who document their care, maintain their records, and manage their prescriptions with the rigour that any other prescribed medication demands are the patients who demonstrate that the framework works. That matters — for the individual patient, and for the patient population as a whole.
In plain terms
Keep a record of every time you clean your device. Write down the date, what you cleaned, what you replaced, and anything unusual you noticed. Take a photograph of the disassembled device each time. Keep the record for as long as you use the device and for at least two years after.
If you are ever asked — by a clinician, an insurer, a police officer, or an employer — whether your device was maintained correctly, the record is your answer. Without it, you have no answer.
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 12 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