The British Association of Prosthetists and Orthotists

Archives for February 2021

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AHP’s Listen Event

The Current Allied Health Professionals (AHPs) strategy ‘AHPs into Action is coming to an end in 2022 and so our CAHPO (Chief Allied Health Professionals Officer) is now starting a consultation period for its successor.

The aim is for the content to be crowed sourced from both professionals and ‘citizens’ and will be split into 3 sections to allow views to be sourced from all parties

The first group ‘citizen’s’ can register now to have there say at the AHPListens website please share this link amongst colleagues, patients, family and friends.

Prosthetists and Orthotists can also sign up to the first national conversation in their capacity as citizens who also use health care services but the second conversation in may will be aimed at capturing your views as a professional

For more information see the attached covering letter from the campaign:

AHPsListen-Covering-LetterDownload

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MHRA Updates: BAPO Guidance on MDR regulations post Brexit

The Medical and Health care products Regulatory Agency MHRA published an update on the UK.Gov website at the end of December 2020 ( https://www.gov.uk/government/publications/in-house- manufacture-of-medical-devices/in-house-manufacture-of-medical-devices ) concerning in-house manufacture of medical devices and exemptions from the Medical Devices Regulations (MDR). There has been some discussion as to what, if any, exemptions are applicable for prosthetics and orthotics.

There is a line in the text of the update that reads: These regulations don’t apply if your device is only being used for patients within the institute it was made, even if the product is made in one part of a healthcare establishment. For example, if it is made in an NHS Trust laboratory and moved to another part of the hospital, as this means you are not placing it on the market (GOV.UK, 2020).

BAPO have been in direct discussion with the MHRA to clarify if this meant the exemption only applied whilst the patient wearing the device was on the premises of the healthcare establishment and not when the patient had left the establishment. i.e. only whilst they were an in-patient and once they were discharged to out-patient care the exemption ceased.

The answer we got was concise and unambiguous: “We can confirm that the in house exemption for medical devices manufactured by in-house units and supplied to patients within the same healthcare institutions applies to both in-patients and out-patients.” Once devices are placed on the market or transferred to another establishment (a transfer refers to a sale, loan, hire, lease, gift, or any other type of legal transfer), the exemption no longer applies. Should the patient move to another healthcare establishment, the onus for taking on responsibility of the second-hand device is on the receiving establishment. The receiving establishment would need assurance that the product was manufactured to the appropriate requirements. The original manufacturer will have the records in place to show that the product was manufactured to the appropriate requirements. In–House manufacturing units should have a quality manufacturing system in place regardless of this exemption.
This exemption does NOT mean that these in-house units should not have a Quality Management System in place. For patient safety, they should be closely aligned with the MDR regulations, e.g. technical data provided, device types, process systems, traceability records, CE component batch/lot number recorded etc.

If further information is required BAPO recommends departments contact the MHRA direct. Contact details for queries specific to medical devices devices.regulatory@mhra.gov.uk and for general enquiries info@mhra.gov.uk

Reference
GOV.UK. (2020, December 31). In-house manufacture of medical devices in Great Britain. Retrieved February 2, 2021, from http://www.gov.uk: https://www.gov.uk/government/publications/in-house-manufacture-of-medical-devices/in-house-manufacture-of-medical-devices

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New position statement for children’s services

We would like to draw attention to the need for prosthetic and orthotic intervention to continue for children and young people. We ask that prosthetic and orthotic services are protected to enable this aspect of the service to continue throughout the pandemic and ensuing winter pressures.

The impact of COVID-19 on children and young people, especially those with special educational needs and disabilities (SEND), has been significant. Access to prosthetic and orthotic services in the UK is vital in supporting children’s physical health, mental health and development. With orthotics, access to timely treatment ensures the effectiveness of some therapy treatment which relies on orthotic intervention for optimum results. It is important that children have access to prosthetic treatment to ensure that the prosthetic devices they use for daily activities are revised appropriately to prevent mobility issues and potential physical damage due to ill fitting devices.
As the COVID-19 pandemic continues, we need to protect families, children and young people who rely on prosthetic and orthotic treatment as an adjunct to surgery, medical intervention, serial casting or therapy treatment, to be able to function at their best. Children are growing, conditions changing constantly and with targeted input from our services when they are required, long term disability and harm can be avoided.

We therefore ask that services remain open and an appropriate number of Prosthetists and Orthotists are protected from redeployment, to ensure that families with children and young people, have access to the support they sorely need.

We recognise the need for flexibility in areas where acute pressures are high, where individual discussions may be appropriate, however, we ask that the impact of the lack of access to prosthetic and orthotic services are discussed and understood from a multi-disciplinary perspective. Prosthetic and orthotic services should not be left without the staff or facilities to deliver essential treatment as occurred earlier in 2020.

British Association of Prosthetists and Orthotists

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Feedback Survey

As a volunteer-run organization serving the prosthetic and orthotic community, we actively use feedback to improve our membership program.

If you can spare ten minutes for a quick survey we’d love to get your thoughts and ideas to help us make BAPO better. You do not have to be a member to complete this

Click here to take part:  https://baposurvey.typeform.com/to/j5Gsbh6c

Thank you for your time and input.

The Team at BAPO