Training activity: 5

Details

Plan design and manufacture a custom made deep buried implant for a body contour defect (bone or soft tissue) or a custom implant to support facial palsy/weakness/paralysis

Type

Developmental training activity (DTA)

Evidence requirements

Evidence the activity has been undertaken by the trainee​.

Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.

An action plan to implement learning and/or to address skills or knowledge gaps identified.

Considerations

• Patient centred care and support
• Information required prior to manufacture
• Pre surgical planning using imaging and digital printed models
• 3D data acquisition and use of CAD/CAM for implant manufacture
• Data manipulation using design tools to accurately represent the missing anatomy
• Communication with surgical team
• Information guidance on local quality management system alignment with NHS higher level medical device governance
• Medical device regulations
• Ideal requirements for an implant
• Regulatory requirements affecting class IIb and III custom medical implants
• Selection and use of materials
• Manufacture protocols and device risk assessment
• Manufacturing technique employed depending upon the material selection
• Post processing of implants to improve biocompatibility
• Sterilisation and decontamination procedures
• Methods of device fixation
• Patient safety, dignity and confidentiality
• Impact of plan/design on patient quality of life
• Innovative or alternative commercially sourced options, e.g. PEEK
• Complications and onward referral

Relevant learning outcomes

#	Outcome
# 1	Outcome Deliver quality patient centred care with the best interests of patients in all elements of practice.
# 2	Outcome Practice in accordance with local and national health and safety policies, regulatory requirements and overall service governance.
# 3	Outcome Communicate effectively with patients, relatives, healthcare professionals and other stakeholders.
# 4	Outcome Identify patients who need further specialist support and refer to the appropriate healthcare specialist.
# 5	Outcome Analyse and interpret patient investigations, multimodal imaging and information.
# 6	Outcome Perform clinical investigations, formulate treatment plans and manufacture medical devices to a safe clinical standard.
# 7	Outcome Prepare surgical treatment plans for complex head and neck surgery.
# 8	Outcome Select appropriate biomedical materials and components/instrumentation used in the treatment of patients and the manufacture of custom-made medical devices.
# 9	Outcome Practice in partnership with other clinical specialisms as part of a multidisciplinary team and understand their roles and their impact on patient care and pathway.
# 10	Outcome Apply the principals of a quality management system to their professional practice.
# 12	Outcome Assess and interpret patients’ needs to provide customised treatment dependent on medical, physical, social and psychological requirements.