The Medicine and Healthcare Products and Regulatory Agency
Other
Noted
MHRA acknowledges the concerns about support belts lacking warnings and guidance, provides background on its regulatory role, and explains existing device regulations and post-market surveillance activities, including Yellow Card scheme and collaborations. It highlights manufacturer responsibilities for safety and labeling. The response includes details on the product and its instructions for use. (AI summary)
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Dear Miss Thistlethwaite,
Regulation 28: Inquest to investigate the death of Mrs Susan Marion LAKIN. We acknowledge your Regulation 28 prevention of future death report, received by MHRA on 11 April 2025, relating to the conclusions of the inquest investigating the sad death of Susan Marion Lakin. We would like to offer our sincere condolences to her family.
Your report raises the following concerns:
• The sale of Support Belts that contain no warnings in relation to the risks of physical restraint, tissue viability risks and finally the risk of strangulation.
• The sale of Support Belts that contain no suggestion that the product should be used or fitted under the guidance/supervision of a therapist or medical professional.
• Support Belts, and other seemingly basic pieces of healthcare equipment, are readily available for people to purchase online without them being appraised of the risks that come with their use.
I have taken the opportunity to provide you with some supporting information below, before providing comments to your matters of concern.
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care (“DHSC”). We are the regulator of medicines, medical devices and blood components for transfusion in the UK.
With respect to medical devices, one major area of the MHRA’s responsibilities is the investigation of adverse incidents. An adverse incident is an event involving a medical device, which produces, or has the potential to produce, unwanted effects involving the safety of patients, users and other persons.
The MHRA operates a voluntary reporting scheme, called the Yellow Card scheme1, where health professionals and members of the public can report adverse incidents to us directly. Additionally, manufacturers of medical devices are required to report details of all serious incidents involving medical devices to the MHRA as part of their mandatory vigilance reporting.
Where serious incidents involving medical devices have been reported to other authorities including the police and coroners, the MHRA provides input if required. The MHRA will then ensure any concerns raised from these investigations, if required, are disseminated to either healthcare professionals directly or to healthcare institutions to help to prevent further incidents and take up the concerns directly with the manufacturer of the medical device.
Manufacturers placing a medical device on the market are required to identify the potential hazards associated with the use of the medical device, evaluate the related risks and eliminate or reduce these risks as far as possible; finally users of the device must be informed of any residual risks. Manufacturers are expected to follow the principles set out in BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices. This approach aims to also ensure that any new risks are incorporated into risk management process therefore facilitating ongoing improvement throughout the product’s lifecycle.
Manufacturers should also demonstrate how their devices meet the relevant Designated/Harmonized Standards. If they have not applied these standards, then they must provide a description of the solutions adopted to fulfil the requirements which apply to the devices. This information should be included within their technical documentation for the devices.
It is important to note that the MHRA does not conduct inspections of medical devices, nor do we directly authorise or certify medical devices for placement onto the market. However, all medical devices are required to be registered with the MHRA prior to selling them in the UK.
Each medical device is assigned a classification (I, IIa, IIb or III) based largely upon its considered “risk” factor to the patient according to medical device classification rules in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)2. To place a medical device on the market, manufacturers must obtain certification that demonstrates their conformity to the regulatory requirements3. This certification is represented as a CE or UKCA mark and is displayed on the medical device itself. To gain CE or UKCA
1 Yellow Card | Making medicines and medical devices safer (mhra.gov.uk) 2 The Medical Devices Regulations 2002 (legislation.gov.uk) 3 Regulating medical devices in the UK - GOV.UK (www.gov.uk)
marking, the higher risk (class IIa, IIb and III) devices need to be certified by an approved conformity assessment body. Whereas manufacturers of the lowest risk/class devices (class I) self-certify against the requirements in relevant legislation.4
Background
In April 2015 the MHRA released Medical Device Alert (MDA/2015/018), for all posture or safety belts fitted to supportive seating5. The Alert stated, “Using the wrong type of belt or a belt that isn’t fitted or adjusted properly can lead to serious injury or death of the person using the equipment.”
The Alert goes on to explain that all users and carers need to have received training on how to check, adjust, clean, and maintain each device; and individuals need to be reviewed to check that the right type of belt is used and adjusted correctly.
Finally, the alert clarifies that the problems associated with these devices include “the person in the seat slipping down and suffering positional asphyxiation or strangulation...”. The targeted audience was those involved in the provision, prescription, use and maintenance of the belts and it was cascaded through the Central Alerting System (CAS). This was withdrawn in 2022 as the number of reports had reduced to zero and the actions should have been incorporated into good practice within the NHS.
Action undertaken by MHRA to date
Establishment of the appropriate Regulator On receipt of the regulation 28 letter we sought further confirmation that the support belt purchased by Mrs Lakin’s family was the ORTONES Wheelchair and Geriatric Armchair Belt Restraint, reference D2100 (henceforth referred to the ORTONES belt).
Through our investigations, the manufacturer Eurobaston S.L, confirmed that the ORTONES belt is marketed as a class I medical device in Spain, however they had not registered the ORTONES belt with the MHRA, which is a legal requirement for all medical devices sold in the UK. They informed us that they were unaware that their distributor, Comercial Nespral S.L, was selling the product in the UK. Comercial Nespral S.L, has confirmed that the ORTONES belt is no longer marketed in the UK.
The MHRA’s Borderline team have reviewed the intended use and claims of the ORTONES belt and concluded that wheelchair belts are unlikely to meet the definition of a medical device in their own right, as the intended purpose is to prevent accidents and falls, which is not considered to be a medical purpose.
We also considered whether the belt would meet the definition of an accessory to a medical device. An “accessory” to a medical device, as defined by regulation 5(1) of the UK MDR, means a product which, whilst not itself a medical device, is intended specifically by its manufacturer to be used together with a medical device, to enable that device to be used in accordance with its intended use. Wheelchair belts are considered accessories if they are specifically designed by the manufacturer for use in conjunction with a specific wheelchair,
4 Guidance on Class I medical devices - GOV.UK (www.gov.uk) 5 Medical Device Alert
and the manufacturer of the wheelchair has evidenced in their instructions for use that their wheelchair cannot fulfil its intended purpose without the belt.
In considering the Instructions for Use for the ORTONES belt (Annex A), we do not consider it would be classified as an accessory to a medical device based on the following:
1. There are no claims that the belt is intended to be used with a specific wheelchair
2. The belt seems to be designed for general use as it is also promoted for use on non- medical products (armchairs)
3. The intended use is stated to provide “maximum support and safety: It is designed to bring maximum comfort to the user of a wheelchair. Provides extra support to prevent accidents and falls”, which is not a medical purpose
It is worth noting that in the UK, not all products which are used in a healthcare environment, by a disabled person, or by a healthcare professional or carer, qualify as medical devices.
It should be noted that wheelchairs may come already supplied with a belt, and in these cases, the belt is a component of the wheelchair and the wheelchair as a whole, including the belt, is regulated as a medical device.
In addition to the concerns regarding the ORTONES belt, we have identified several other supportive belts that are sold online that do not appear to be registered with the MHRA. However, they also make general claims, similar to the ORTONES belt, and are therefore unlikely to qualify as medical devices or accessories to a medical device.
Given this, the MHRA has advised the relevant regulator, the Office of Product Safety and Standards (OPSS), to ensure that they are aware of your concerns.
Warnings. We have reviewed the ISO standard for Selection, placement and fixation of flexible postural support devices in seating (part 15 of the wheelchair seating series): ISO/TS 16840‑15:2024. The purpose of this standard is to specify the criteria to be applied to positioning supports when used in seating systems and chairs.
According to ISO/TS 16840‑15:2024, flexible postural support devices (PSD) shall be prescribed for safety when the primary purpose is to protect the occupant from injury (e.g. to prevent falling from the seat), and occupants should be assessed as to the correct style and size of PSD to be prescribed. The standard also covers the safety information to be included in the user instructions for use; for example “any special requirements as to who can prescribe and fit a postural support”, the “need for any periodic checking the occupant’s skin for associated pressure injuries” and “the risks of strangulation due to poor positioning”.
The MHRA reviewed the instructions for use for the ORTONES belt (see attached document). While they did not contain the warnings required in the standard, as the belt is not considered a medical device or accessory to a medical device, addressing this is outside the MHRA’s remit. However, this information will be highlighted to OPSS as the relevant regulator.
Prevalence of the problem
There are many other supportive belt devices that are registered with the MHRA as medical devices. We reviewed the MHRA’s adverse incident database for cases involving support belts that were reported to us between 1 April 2015 to 23 April 2025 following the release of the alert in 2015. The broad device code ‘Wheelchair accessory’ was used in the search, which includes types of wheelchair/chair/stander occupant restraint/support devices.
This search generated 398 reports, twenty-nine (29) of which specifically detailed the use of a support belt, one of which resulted in a fatality. See Table 1 for a breakdown of these incident reports.
Table 1: Breakdown of reported incidence reports
Incident themes Total number of reports Reported year of incident* User slipping under the support belt resulting in an injury
Three (3)
One in 2017 One in 2016 One in 2018
Failure of postural support, or the unbuckling/detachment of the belt leading to a fall
Nine (9) One in 2014 Two in 2015 Two in 2016 Two in 2017 One in 2018 One in 2023 Belt not fastened appropriately - resulting in a fall Three (3) One in 2016 One in 2017 One in 2023 Failure of postural support where the belt had either become loose, unbuckled or detached/broken (no injury reported) Nine (9) Three in 2015 One in 2016 One in 2018 Three in 2024 One in 2025 Report raising a safety concern relating to support belts namely misuse of belts and lack of guidance
Two (2) Two in 2015 User misunderstanding the belt’s fitting instructions
One (1) One in 2017 Exposure of a sharp edge of the belt - resulting in an injury (cut on hand)
Two (2) One in 2015 One in 2023
Total: Twenty nine (29)
* Where the date of incident has not been provided, the date of the report has been used.
Twenty-two (22) out of twenty-nine (29) reported incidents took place between 2014 and
2018. We note that Mrs Lakin’s case had not been reported to us prior to receiving the Regulation 28 report, and recognise that adverse incident reports for products not regulated as medical devices, would not be reported to the MHRA.
Further action to be undertaken by MHRA
Eurobaston S.L has committed to the re-evaluation of the ORTONES belt design, labelling and instructions for use. Eurobaston S.L have informed us that they will be working with Comercial Nespral S.L to determine what corrective actions can be implemented for ORTONES belts that have been distributed in the UK. The MHRA will inform OPSS of this ongoing investigation into the sale of support belts without the appropriate warnings, including the ORTONES belt. In addition, we will include OPSS in our communications with the Eurobaston S.L, to assess the appropriateness of their corrective actions.
Any wheelchair belts which would fall under the definition of a medical device or accessory and are not registered with the MHRA will be referred to the MHRA’s compliance team.
Conclusion
Pending the conclusion of the investigation and actions detailed above, we will continue to monitor all adverse incidence reports we receive and take any necessary action as appropriate.
Regulation 28: Inquest to investigate the death of Mrs Susan Marion LAKIN. We acknowledge your Regulation 28 prevention of future death report, received by MHRA on 11 April 2025, relating to the conclusions of the inquest investigating the sad death of Susan Marion Lakin. We would like to offer our sincere condolences to her family.
Your report raises the following concerns:
• The sale of Support Belts that contain no warnings in relation to the risks of physical restraint, tissue viability risks and finally the risk of strangulation.
• The sale of Support Belts that contain no suggestion that the product should be used or fitted under the guidance/supervision of a therapist or medical professional.
• Support Belts, and other seemingly basic pieces of healthcare equipment, are readily available for people to purchase online without them being appraised of the risks that come with their use.
I have taken the opportunity to provide you with some supporting information below, before providing comments to your matters of concern.
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care (“DHSC”). We are the regulator of medicines, medical devices and blood components for transfusion in the UK.
With respect to medical devices, one major area of the MHRA’s responsibilities is the investigation of adverse incidents. An adverse incident is an event involving a medical device, which produces, or has the potential to produce, unwanted effects involving the safety of patients, users and other persons.
The MHRA operates a voluntary reporting scheme, called the Yellow Card scheme1, where health professionals and members of the public can report adverse incidents to us directly. Additionally, manufacturers of medical devices are required to report details of all serious incidents involving medical devices to the MHRA as part of their mandatory vigilance reporting.
Where serious incidents involving medical devices have been reported to other authorities including the police and coroners, the MHRA provides input if required. The MHRA will then ensure any concerns raised from these investigations, if required, are disseminated to either healthcare professionals directly or to healthcare institutions to help to prevent further incidents and take up the concerns directly with the manufacturer of the medical device.
Manufacturers placing a medical device on the market are required to identify the potential hazards associated with the use of the medical device, evaluate the related risks and eliminate or reduce these risks as far as possible; finally users of the device must be informed of any residual risks. Manufacturers are expected to follow the principles set out in BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices. This approach aims to also ensure that any new risks are incorporated into risk management process therefore facilitating ongoing improvement throughout the product’s lifecycle.
Manufacturers should also demonstrate how their devices meet the relevant Designated/Harmonized Standards. If they have not applied these standards, then they must provide a description of the solutions adopted to fulfil the requirements which apply to the devices. This information should be included within their technical documentation for the devices.
It is important to note that the MHRA does not conduct inspections of medical devices, nor do we directly authorise or certify medical devices for placement onto the market. However, all medical devices are required to be registered with the MHRA prior to selling them in the UK.
Each medical device is assigned a classification (I, IIa, IIb or III) based largely upon its considered “risk” factor to the patient according to medical device classification rules in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)2. To place a medical device on the market, manufacturers must obtain certification that demonstrates their conformity to the regulatory requirements3. This certification is represented as a CE or UKCA mark and is displayed on the medical device itself. To gain CE or UKCA
1 Yellow Card | Making medicines and medical devices safer (mhra.gov.uk) 2 The Medical Devices Regulations 2002 (legislation.gov.uk) 3 Regulating medical devices in the UK - GOV.UK (www.gov.uk)
marking, the higher risk (class IIa, IIb and III) devices need to be certified by an approved conformity assessment body. Whereas manufacturers of the lowest risk/class devices (class I) self-certify against the requirements in relevant legislation.4
Background
In April 2015 the MHRA released Medical Device Alert (MDA/2015/018), for all posture or safety belts fitted to supportive seating5. The Alert stated, “Using the wrong type of belt or a belt that isn’t fitted or adjusted properly can lead to serious injury or death of the person using the equipment.”
The Alert goes on to explain that all users and carers need to have received training on how to check, adjust, clean, and maintain each device; and individuals need to be reviewed to check that the right type of belt is used and adjusted correctly.
Finally, the alert clarifies that the problems associated with these devices include “the person in the seat slipping down and suffering positional asphyxiation or strangulation...”. The targeted audience was those involved in the provision, prescription, use and maintenance of the belts and it was cascaded through the Central Alerting System (CAS). This was withdrawn in 2022 as the number of reports had reduced to zero and the actions should have been incorporated into good practice within the NHS.
Action undertaken by MHRA to date
Establishment of the appropriate Regulator On receipt of the regulation 28 letter we sought further confirmation that the support belt purchased by Mrs Lakin’s family was the ORTONES Wheelchair and Geriatric Armchair Belt Restraint, reference D2100 (henceforth referred to the ORTONES belt).
Through our investigations, the manufacturer Eurobaston S.L, confirmed that the ORTONES belt is marketed as a class I medical device in Spain, however they had not registered the ORTONES belt with the MHRA, which is a legal requirement for all medical devices sold in the UK. They informed us that they were unaware that their distributor, Comercial Nespral S.L, was selling the product in the UK. Comercial Nespral S.L, has confirmed that the ORTONES belt is no longer marketed in the UK.
The MHRA’s Borderline team have reviewed the intended use and claims of the ORTONES belt and concluded that wheelchair belts are unlikely to meet the definition of a medical device in their own right, as the intended purpose is to prevent accidents and falls, which is not considered to be a medical purpose.
We also considered whether the belt would meet the definition of an accessory to a medical device. An “accessory” to a medical device, as defined by regulation 5(1) of the UK MDR, means a product which, whilst not itself a medical device, is intended specifically by its manufacturer to be used together with a medical device, to enable that device to be used in accordance with its intended use. Wheelchair belts are considered accessories if they are specifically designed by the manufacturer for use in conjunction with a specific wheelchair,
4 Guidance on Class I medical devices - GOV.UK (www.gov.uk) 5 Medical Device Alert
and the manufacturer of the wheelchair has evidenced in their instructions for use that their wheelchair cannot fulfil its intended purpose without the belt.
In considering the Instructions for Use for the ORTONES belt (Annex A), we do not consider it would be classified as an accessory to a medical device based on the following:
1. There are no claims that the belt is intended to be used with a specific wheelchair
2. The belt seems to be designed for general use as it is also promoted for use on non- medical products (armchairs)
3. The intended use is stated to provide “maximum support and safety: It is designed to bring maximum comfort to the user of a wheelchair. Provides extra support to prevent accidents and falls”, which is not a medical purpose
It is worth noting that in the UK, not all products which are used in a healthcare environment, by a disabled person, or by a healthcare professional or carer, qualify as medical devices.
It should be noted that wheelchairs may come already supplied with a belt, and in these cases, the belt is a component of the wheelchair and the wheelchair as a whole, including the belt, is regulated as a medical device.
In addition to the concerns regarding the ORTONES belt, we have identified several other supportive belts that are sold online that do not appear to be registered with the MHRA. However, they also make general claims, similar to the ORTONES belt, and are therefore unlikely to qualify as medical devices or accessories to a medical device.
Given this, the MHRA has advised the relevant regulator, the Office of Product Safety and Standards (OPSS), to ensure that they are aware of your concerns.
Warnings. We have reviewed the ISO standard for Selection, placement and fixation of flexible postural support devices in seating (part 15 of the wheelchair seating series): ISO/TS 16840‑15:2024. The purpose of this standard is to specify the criteria to be applied to positioning supports when used in seating systems and chairs.
According to ISO/TS 16840‑15:2024, flexible postural support devices (PSD) shall be prescribed for safety when the primary purpose is to protect the occupant from injury (e.g. to prevent falling from the seat), and occupants should be assessed as to the correct style and size of PSD to be prescribed. The standard also covers the safety information to be included in the user instructions for use; for example “any special requirements as to who can prescribe and fit a postural support”, the “need for any periodic checking the occupant’s skin for associated pressure injuries” and “the risks of strangulation due to poor positioning”.
The MHRA reviewed the instructions for use for the ORTONES belt (see attached document). While they did not contain the warnings required in the standard, as the belt is not considered a medical device or accessory to a medical device, addressing this is outside the MHRA’s remit. However, this information will be highlighted to OPSS as the relevant regulator.
Prevalence of the problem
There are many other supportive belt devices that are registered with the MHRA as medical devices. We reviewed the MHRA’s adverse incident database for cases involving support belts that were reported to us between 1 April 2015 to 23 April 2025 following the release of the alert in 2015. The broad device code ‘Wheelchair accessory’ was used in the search, which includes types of wheelchair/chair/stander occupant restraint/support devices.
This search generated 398 reports, twenty-nine (29) of which specifically detailed the use of a support belt, one of which resulted in a fatality. See Table 1 for a breakdown of these incident reports.
Table 1: Breakdown of reported incidence reports
Incident themes Total number of reports Reported year of incident* User slipping under the support belt resulting in an injury
Three (3)
One in 2017 One in 2016 One in 2018
Failure of postural support, or the unbuckling/detachment of the belt leading to a fall
Nine (9) One in 2014 Two in 2015 Two in 2016 Two in 2017 One in 2018 One in 2023 Belt not fastened appropriately - resulting in a fall Three (3) One in 2016 One in 2017 One in 2023 Failure of postural support where the belt had either become loose, unbuckled or detached/broken (no injury reported) Nine (9) Three in 2015 One in 2016 One in 2018 Three in 2024 One in 2025 Report raising a safety concern relating to support belts namely misuse of belts and lack of guidance
Two (2) Two in 2015 User misunderstanding the belt’s fitting instructions
One (1) One in 2017 Exposure of a sharp edge of the belt - resulting in an injury (cut on hand)
Two (2) One in 2015 One in 2023
Total: Twenty nine (29)
* Where the date of incident has not been provided, the date of the report has been used.
Twenty-two (22) out of twenty-nine (29) reported incidents took place between 2014 and
2018. We note that Mrs Lakin’s case had not been reported to us prior to receiving the Regulation 28 report, and recognise that adverse incident reports for products not regulated as medical devices, would not be reported to the MHRA.
Further action to be undertaken by MHRA
Eurobaston S.L has committed to the re-evaluation of the ORTONES belt design, labelling and instructions for use. Eurobaston S.L have informed us that they will be working with Comercial Nespral S.L to determine what corrective actions can be implemented for ORTONES belts that have been distributed in the UK. The MHRA will inform OPSS of this ongoing investigation into the sale of support belts without the appropriate warnings, including the ORTONES belt. In addition, we will include OPSS in our communications with the Eurobaston S.L, to assess the appropriateness of their corrective actions.
Any wheelchair belts which would fall under the definition of a medical device or accessory and are not registered with the MHRA will be referred to the MHRA’s compliance team.
Conclusion
Pending the conclusion of the investigation and actions detailed above, we will continue to monitor all adverse incidence reports we receive and take any necessary action as appropriate.