The British Association of Prosthetists and Orthotists

Executive

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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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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

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AGM

The Annual General Meeting (AGM) of the British Association of Prosthetists and Orthotists is scheduled to take place virtually on Thursday 18 March 2021 at 7pm. The Executive Committee invites all members to attend this meeting.

Agenda items are requested from all members of the Association and should be submitted in writing, no later than 11 February 2021 to the Secretariat. This will provide time for a detailed answer from the EC and membership during the AGM and will be answered even if you are unable to attend. A submitted question may be read by the member raising the issue or a member of the EC if preferred by the questioner. Where necessary, all Agenda items will be voted upon in the AGM. If any member not able to attend wishes to make representations to the AGM regarding an Agenda item, they may do so in writing up to 10 days before the meeting.


Non-Agenda questions raised in the AGM which, after discussion develop into voting issues, may be voted on in the AGM or, depending on their importance, may be placed before the whole membership with supporting information from the AGM. The EC under the Chair will decide if a vote must be placed before the whole membership or may be voted upon in the AGM.

Past AGMs have provided a time for constructive discussion of key issues concerning BAPO members and the EC hope that this AGM will be no exception.

There will be 10 Full & 2 Associate vacant seats at the time of the AGM.

Nominations for all available places require a proposer and seconder: if you would like to be considered for election please complete the Nomination Form and return together with a 100 word profile, to the Secretariat Manager no later than 11 February 2021.

I look forward to hearing from you in due course and hope you are able to attend the meeting.

Yours sincerely,

Kate Spiller
Secretary

Return Email/Post: enquiries@bapo.com
BAPO Secretariat, Unit 3011, Mile End Mill, Abbey Mill Business Centre, Paisley, Renfrewshire PA1 1JS

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UK Assistive Products List

BAPO are a stakeholder partner for a new survey launched by the British Assistive Technology Association in collaboration with the WHO-GATE programme. The UK Assistive Products List survey follows on from the original global survey developed by GATE, to which you may have been asked to contribute.

 

Using the original Assistive Products List as a starting template, we are looking to establish a Priority Assistive Products List specific to the UK. We are therefore asking all BAPO members to respond to the simple survey below to highlight which assistive products you feel are of greatest importance to you and your patients.

 

We would really value your input in this collaborative project and welcome your expertise in what we hope will help improve access to quality assistive products and services in the UK.

 

The UK APL survey can be found here: https://bit.ly/UKAPL

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Workforce Survey

Thanks to those who have responded to our ‘Workforce Survey’. This poll has been designed to get a perspective on members experiences and, through comments, their views on the current Covid-19 crisis; providing the opportunity to explain how this has affected them, the services where they work and patients they treat.

In responding to the crisis BAPO are engaging with patient/user groups and stakeholder bodies, and are seeking out concerns raised by their members. In addition we are also reaching out to the national P&O managers groups and employers to clarify if there is a shared position in response to the crisis.

Initial issues which have been raised include:-

  1. Unclear position on urgent care being offered
  2. Unclear provision for growth in children who depend on an orthosis or prosthesis
  3. What pathways will be available to those not be able to obtain a prothesis or orthosis?
  4. What are the plans to manage access once services resume (including how will the backlog be prioritised and will social distancing impact on capacity)?
  5. How can parents/users access advice (including access to remote advice and information)?

 

We aim to collate the returned initial views and opinions by Friday and then draw on those to produce initial guidelines for all stakeholders. This is so that they can be used to advise and signpost clinicians, managers, carers, parents and service users.

As a follow up we plan to organise a webinar for the week of May 4th to communicate with service users and stakeholders; to share those guidelines. BAPO will now aim to develop a consensus on the best way to manage the current challenges and those which will emerge as P&O clinical services reboot.

 

Best wishes

Lynne

Lynne Rowley

Chair BAPO

 

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SIHED Outreach officer

The Strategic Interventions in Health Education Disciplines (SIHED) project is designed to support small specialist health careers. it launched in March 2018 and aims to:

  • increase awareness of allied health disciplines
  • increase understanding of and demand for small specialist allied health disciplines
  • strengthen and diversify the delivery of the small and specialist disciplines covered by this initiative
  • develop a better understanding of the mature student market for nursing, midwifery and allied health.

The project is looking for a new part time P&O outreach officer  to work on an exciting programme which aims to inspire the next generation of students for specialist health careers. FMI: click here for job advert

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Postcode Lottery

Postcode lottery for NHS orthotics patients

Specialist orthotics care for patients with mobility issues varies significantly depending on where they live, new research by Staffordshire University reveals.

The findings, published on BMJ Open, have uncovered major differences across orthotics services at various NHS trusts and health boards.

Problems within orthotic service provision in the UK have been the focus of a number of reports by the NHS and other organisations.  An NHS report from 2014 highlighted that many patients experienced long waiting times which could lead to the development of secondary health complications.

Professor Chockalingam and colleagues at Staffordshire University based their research on Freedom of Information (FOI) requests sent to all NHS trusts and Health Boards in the UK. The survey scrutinises information on Finance, Service Provision, Staffing, Complaints, and Outcome measures and key performance indicators (KPIs).

The results highlight large variances in the length of appointments, appointment waiting times, product entitlements for patients, and product lead times. Certain geographical areas were found to provide shorter waiting times and wider access to assistive devices. The findings also reflect there is more information available on the quantity of service above the quality of service.

The findings showed that:

  • average and maximum waiting times for adult appointments were 7 and 34 weeks, respectively.
  • Scotland seems to fair better in all of the reported measures. Patients in Scotland have longer appointment times and the average waiting times are lower.
  • some Trusts are not fully accommodating the needs of children

Nachiappan Chockalingam, Professor of Clinical Biomechanics at Staffordshire University, explained: “Within the NHS, the Orthotics Service is poorly understood and low in priority lists. Therefore, it is essential to evaluate the current state of provision to ensure that services are capable of meeting future demands.

“In 2011, a report estimated there were 2m orthotics users in England and assistive devices including wrist splints, custom footwear, foot and ankle support, back and neck braces are needed to alleviate pain, help patients recovering from injury and those with chronic conditions.

“In future, there will be an increased demand for orthotics services because of the projected population growth, the aging population and the rising prevalence of obesity, diabetes, cardiovascular and peripheral vascular diseases.”

Dr Aoife Healy who co-authored this study added: “Our results highlight that some of the Trusts appeared to not accommodate the needs of children fully. Waiting times of 20 weeks for routine and 8.2 weeks for urgent appointments are unacceptable”.

The researchers hope that these findings will prompt the NHS to instigate its own evaluation of services across the country.  Ms Lynne Rowley, Chair of British Association of Prosthetists and Orthotists (BAPO) said: “We welcome this study, which clearly showcases the inequalities across orthotic service provision in the UK. BAPO has been aware of this issue and has been working with NHS England. However, this study is timely and provides a push in the right direction.”

However, the combination of the number of Trusts and Health Boards who declined to reply to the FOI request and those who replied with limited information hindered the team’s ability to provide a national picture of Orthotic Service provision.

Professor Chockalingam added: “The UK NHS needs to establish appropriate processes to record the quality of service provision since this will enable improvements in clinical management and ensure good value for money.”

Read the full paper http://dx.doi.org/10.1136/bmjopen-2018-028186 here.

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National Associations for Orthotist/Prosthetists

BAPO has represented British Prosthetists and Orthotists at the inaugural meeting of National Associations for Orthotist/Prosthetists. We are proud to be working alongside some wonderful other P&O societies from across the world to improve P&O!

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Social Prescribing

RSPH have just launched a new framework for social prescribing for AHPs

Social prescribing, sometimes referred to as community referral, is a means of enabling people to be referred to a range of local, non-medical services. 

Recognising that people’s health is determined primarily by a range of social, economic and environmental factors, social prescribing seeks to address people’s needs in a holistic way. It also aims to support people to take greater control of their own health.

Social prescribing can meet a wide range of needs, with many schemes aiming to improve mental health and physical wellbeing. It can be used to support adults, young people and children as well as people with learning disabilities or mental health problems. It can take place in primary and secondary care. Social prescribing can also help to address social issues such as debt, unemployment, gambling and loneliness.

Social prescribing and community-based support is part of the NHS Long-Term Plan’s commitment to make personalised care[i] business as usual across the health and care system in England. The NHS Long Term Plan[ii] published in January 2019 has a commitment to personalised care and increasing access to social prescribing for the whole population. 

This approach to holistic care is not new to allied health professionals who frequently have conversations and provide support related to the wider factors influencing the health of the people they work with. 

To illustrate the way AHPs already support this agenda and to provide a framework to support them to do more; a new social prescribing framework for AHPs[iii] has been developed by the Royal Society for Public Health, Public Health England, NHS Improvement and NHS England along with AHP professional bodies and voluntary sector partners.

The framework is divided into 4 sections to reflect the varying intensity of AHP interventions, these include:

  • Active signposting – a light-touch approach where staff provide information and choice to signpost people to services, using local knowledge and resource directories.  This works best for clients who are confident and skilled enough to find their own way to services after a brief conversation. 
  • Referral to a link worker – In cases where a person needs more support than active signposting can provide, it may be appropriate to refer them to non-medical link workers who can provide more time to understand what matters to the individual and connect them to relevant community groups and other agencies for practical and emotional support.
  • Undertaking social prescribing – AHPs are likely to undertake social prescribing themselves when they are already providing long-term intensive support to a person as part of their job role. It will involve supporting people to work out which local groups and services would be beneficial to them and helping them to access them in a variety of ways. You may need to work through multiple options with a client and accompany them on first visits. Some AHPs are likely to do this than others because of the nature of their role.
  • Supporting the development of social prescribing – for example by providing community groups and services and providing guidance, supervision and training to link workers.

Over 2500 AHPs engaged with the development of this framework by completing a survey, joining a twitter chat, providing feedback on early drafts and submitting case studies.  This shows the enthusiasm for this agenda amongst the professions.  We hope the framework will support all AHPs to articulate their current role in social prescribing and consider how they could do more.

Click here to access the site

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[i] https://www.england.nhs.uk/personalisedcare/

[ii] https://www.england.nhs.uk/long-term-plan/

[iii] https://www.rsph.org.uk/our-work/resources/ahp-social-prescribing-frameworks/ahps-promoting-growing-and-developing-social-prescribing.html

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One Year On – The SIHED programme and I See The Difference campaign

                                      

The SIHED (Strategic Interventions in Health Education Disciplines) programme is a £3m, three-year initiative to help build the sustainability of the allied health professions (AHPs). A big part of the programme, the I See the Difference campaign, has been developed to include lots of helpful information about AHPs on the website, currently alongside social media channels such as @icthedifference Twitter, Facebook and Instagram. The digital campaign is also backed up by a large amount of outreach activities at schools and careers events across England.

More programme updates include:

  • The Challenge Fund – In year one, six higher education projects were funded which focus on supporting the recruitment and retention of existing and new students of podiatry and therapeutic radiography. Find out more about the providers and projects here. As we begin year two, we have launched a second challenge fund with a wider remit and a budget of £400,000. Successful bid winners will be announced in the coming months.
  • The British and Irish Orthoptic Society (BIOS) are working on a project to facilitate work shadowing opportunities in orthoptics.
  • A funded fixed-term role to increase capacity for prosthetics and orthotics work placements, allowing more students to study the subject.
  • Two research projects. The first report looked into the barriers to mature student engagementin healthcare, and how to address them. See report here
  • We are currently working with another research company who are completing a study of male participation in nursing and allied health (NMAH). The report will seek to understand current differences in male participation to different NMAH disciplines to help understand and overcome barriers.

Some of our achievements in Year One of the campaign and programme include:

  • More than 11,000 people visited the campaign website, 90% were new users. This equated to 19,637 page views
  • A direct email campaign to 2500 secondary schools was undertaken, with 772 emails opened, equated to an open rate of 30.9%
  • Attending more than 100 events including presentations to schools and smaller career fairs. Reaching 1700 students, families, teachers and careers advisors at large scale events and receiving 236 requests for school outreach at these events.

Also, visit the I See The Difference website for more information about the campaign.

Get in touch with the team, info@iseethedifference.co.uk, Twitter, Instagram, Facebook