Manufacture of equipment or medical devices for individuals within healthcare

This standard covers the manufacture of customised and/or rehabilitation equipment, medical devices and assistive technology. It relates to working with individual users, their carers and other members of a multi-disciplinary team in the production of prescribed equipment and medical devices and assistive technology.

Manufacture will utilise suitable materials and methods to meet the specification within the prescription.  The capacity or social interaction needs of the individual may require a prototype or trial use of the equipment or medical assistive device in the user environment

Equipment and medical devices are manufactured to fitting stage; this is to allow a certain amount of adjustment to be made to the fit of the equipment or device for the individual user.

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1. access and accurately interpret all relevant work instructions and information
2. work safely at all times and in accordance with all relevant legislation, guidelines, policies, procedures and protocols
3. deal promptly and effectively with any problems within your control and report those which cannot be solved
4. identify and minimise hazards and risk in the workplace
5. communicate with the individual and key people at a pace, in a manner and at a level appropriate to the individual's understanding, preferences and needs
6. respect the individual's rights and wishes relating to their privacy, beliefs, and dignity
7. provide support to the individual and carers and ensure health and safety measures are implemented at all times
8. gain valid, informed consent from the individual in accordance with specific procedures
9. liaise and work with relevant stakeholders or agencies involved in the manufacture process
10. correctly interpret the specification for the manufacture of the rehabilitation or customised equipment, assistive technology or medical device
11. identify existing manufacturing components for suitability
12. select the appropriate range of tools and techniques to produce the working/prototype model
13. select the appropriate materials to meet the prescribed manufacturing specification
14. determine those aspects of specification which relate to an adaptation of existing equipment and/or device to meet the prescribed customised solution
15. apply health and safety measures, standard precautions for infection prevention and control and personal protective equipment appropriate to the manufacturing process
16. manufacture and assembly the component parts to specification
17. monitor environmental conditions and maintain them at the correct levels during the manufacturing process as required by the procedure
18. incorporate relevant testing, inspection and risk assessment for the operation of equipment and materials within the manufacturing process
19. monitor the operation of equipment regularly and take appropriate action where faults or breakdowns occur in equipment during use
20. test the working model or prototype with the individual
21. make the required adaptations to the working model or prototype within the prescribed specification
22. confirm that final product meets design specification, prescription and required performance parameters
23. test the final product with the individual against the prescription and specification and confirm performance within expected parameters and/or make appropriate adjustments
24. confirm that the product is suitable for the individuals needs and where appropriate offer the prototype for a trial in their home environment
25. compile user information for the product and make arrangements to review the completed product or prototype with the individual and relevant others
26. dispose of waste in accordance with organisational procedures
27. complete and store all relevant documentation in accordance with organisational requirements

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1. the current legislation, guidelines, policies, procedures and protocols which are relevant to your work practice and to which you must adhere
2. the scope and limitations of your own competence, responsibilities and accountability as it applies to your job role
3. how to access and interpret all relevant work instructions and information
4. specific procedures for reporting issues which are beyond your competence, responsibilities and accountability
5. the duty to report any acts or omissions that could be unsafe/detrimental to you or others
6. the hazards and risks which may arise during the execution of your work role and how you can minimise these
7. how to adapt communication styles in ways which are appropriate to the needs of the individual  
8. the correct use of any equipment and PPE to protect the health and safety of you and others
9. the needs of individuals and carers including issues relating to dignity, confidentiality, and privacy
10. the range of stakeholders, their information needs, roles, responsibilities and capabilities involved in the manufacture of the rehabilitation or customised equipment, assistive technology or medical devices
11. the importance of and how to ensure that the prescription requirement is integrated in the manufacture of the equipment or medical device
12. the methods for selection, approval and contracting with external suppliers appropriate to the prescription for the equipment or medical device
13. the range, extent, format and level of detail required within manufacturing information and how to turn the specification into a manufactured product
14. the range of health and safety measures, infection prevention and control and relevant personal protective equipment, their importance and their application within the manufacturing process
15. why it is important to know how to assess and manage risks within the manufacturing environment and for the item under construction
16. the principles of manufacturing techniques, electronic and mechanical engineering and/or biomechanics and their application relevant to the component manufacture
17. the range of design specifications, purpose and application of the range of equipment or medical devices within your work practice
18. the range and types of tools required for the manufacture process and how to operate these
19. the type, range, purpose and properties of materials used in manufacture of equipment and medical devices and the indications and contra-indications for use
20. the range and types of environmental controls and devices used in assistive technology and their application within your work practice
21. how to conduct the relevant procedures involving direct interaction with the individual and/or relevant others during the manufacturing process
22. the range of materials available for impression taking and the contra-indications for their use
23. the use of prototypes and when and where to apply them
24. how to fabricate equipment and materials and other components to meet the prescription
25. the requirements for assembly, testing and inspection of relevant components to meet specification
26. how to communicate effectively in the appropriate medium to meet the individuals needs and preferences
27. the need to test whether any interim and the completed model meets the individual's requirements and how to adapt the model as necessary within the prescription specification parameters
28. how to check the completed product meets the individuals needs and prescribed specifications 
29. how to dispose of waste in accordance with organisational procedures
30. how to complete and safely store all relevant documentation in accordance with organisational requirements

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2

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2026

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Current

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Original

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Skills for Health

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SFHCHS205

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Health and Social Care, Health and Social Services Officers, Health Associate Professionals, Health Professionals, Health, Public Services and Care, Healthcare and Related Personal Services

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2259

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Manufacture, equipment, medical, devices, healthcare

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