NatPSA/2026/005/MHRA clarification on compatibility assessments
Following publication of the Patient Safety Alert, National Back Exchange contacted the MHRA to clarify the terms “qualified person” and “competent person”, and what evidence organisations should retain when compatibility cannot be confirmed from the manufacturer’s instructions for use.
The MHRA’s response is reproduced below.
It explains that competence to carry out a LOLER thorough examination does not automatically mean someone is qualified to assess hoist and sling compatibility.
The MHRA does not prescribe a specific qualification or evidence format; the organisation must decide whether the person has appropriate knowledge and experience, and record the basis for that decision.
Dear National Back Exchange
Thank you for your enquiry of 26 September regarding Action 2 of NatPSA/2026/005/MHRA.
The LOLER Approved Code of Practice, L113, sets out at paragraph 296 the competence required of a person carrying out a thorough examination.
This includes having sufficient practical and theoretical knowledge and experience of the lifting equipment concerned to identify defects or weaknesses and assess their significance for its safety and continued use. HSE guidance on LOLER in health and social care also states that, for slings, the examiner should be able to identify wear, deterioration or damage.
However, neither document describes assessing whether a sling is compatible with a hoist as part of a thorough examination. Therefore, a person who is competent to carry out LOLER examinations should not automatically be assumed to be qualified to assess hoist and sling compatibility.
Questions about the scope of a LOLER examination, or the competence of the person carrying one fall within the remit of the Health and Safety Executive who can be contacted here: Contact the Health and Safety Executive
Compatibility information is primarily a manufacturer responsibility.
The Medical Devices Regulations 2002 (as amended) require the instructions for use of a device that must be connected to other devices to provide, where appropriate, sufficient details of its characteristics to identify the correct devices for a safe combination.
Where an alternative accessory to that specified by the manufacturer is considered to offer improved benefits, section 3.4 of the MHRA guidance Managing Medical Devices (Managing medical devices - GOV.UK) advises that a risk assessment should be carried out to ensure that all components are compatible and can be used safely, as part of a documented risk management process.
This route should only apply in exceptional circumstances, where the manufacturer’s instructions do not confirm compatibility, rather than as a routine approach.
There is no specific definition of “qualified person” in the alert, and the MHRA leaves it to the organisation to decide who is appropriately qualified to carry out the compatibility assessment.
MHRA would expect the person undertaking it to have appropriate knowledge and experience of the specific hoist and sling designs concerned, including their attachment arrangements and safe working loads.
The organisation should also record the basis on which it considers that person appropriately qualified to make the assessment.
The alert does not specify a particular form of technical evidence that must be produced.
However, records should clearly document the manufacturer information relied upon, the safe working loads and relevant markings of the hoist and sling, the assessment conclusion and supporting rationale, who carried out the assessment, the basis for considering that person appropriately qualified, and the date of the assessment.