We have become aware that the adequacy of important information being supplied to patients and/or their carers who are provided with a medical device, either from a clinic or on discharge from hospital, may be variable. For this reason we have produced information that may be helpful to consider as a checklist in such circumstances.
In this section...
General considerations
- Is the device suitable for home use (have, for example, robustness, back-up systems, alarms been considered if appropriate, modifications needed, patient care and instructions)?
- Has the person responsible for use of the device been identified, i.e. is it patient and/or carer?
- Is the loan equipment scheduled maintenance status compatible with the loan?
- Has the device been fully tested with confirmed full functionality and fitness for purpose?
Patient/carer instructions
- Does the patient/carer know the name of the device?
- Does the patient/carer know how to set up the device in the home?
- Has the patient/carer been trained in the use and functions of the device?
- Has the patient/carer been provided with written instructions specifically about the device?
- Has the patient/carer been trained in how to deal with fail-safe features, e.g. alarms?
- Has the patient/carer been trained in the care of the device?
- Does the patient/carer require accessories? If so, does the patient/carer know where to obtain these and how often?
- Is maintenance required? If so, is the patient/carer aware and in possession of instructions about how this will be achieved?
- Does the patient/carer have a point of contact in the Trust for any queries?
- If relevant, does the patient/carer have a contact point in case of emergency?
Return
- Does the patient/carer know when to return the device?
- Does the patient/carer know where to return the device once treatment is complete, to whom and at what time?
Ownership of implants
The MHRA continues to receive enquiries about the ownership of implantable medical devices after they have been removed from patients when:
- the implant has reached the end of it's useful life; or
- the implant is no longer functioning as intended; or
- the patient has died and the death may be related to the implant; or
- the patient has died for reasons unrelated to the implant.
Department of Health guidance on the ownership of implants is given in Department of Health and Social Security Heallth Notice HN(83)6
(168Kb), which was published in March 1983. This states that "on implantation, an implant becomes the property of the person in whom it has been implanted and it remains his or her property even if it is subsequently removed. Following the patient's death, it forms part of his or her estate unless there is any specific provision to the contrary."
Further enquiries about this policy and its implications should be addressed to the MHRA Central Enquiry Point telephone number 020 3080 6000 or email dts@mhra.gov.uk
