BAPO

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