Training activity: 11

Details

Plan design and manufacture a custom alloplastic cranioplasty implant

Support the surgical team fitting the implant in the operating theatre

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 the multidisciplinary team
• Information guidance on local quality management system alignment with NHS higher level medical device governance
• Medical device regulations
• Ideal requirements for a cranial 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
• New innovative materials being marketed for cranioplasty manufacture

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 Apply the principals of a quality management system to their professional practice.
# 5	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.
# 6	Outcome Perform clinical investigations, formulate treatment plans and manufacture medical devices to a safe clinical standard.
# 7	Outcome Analyse and interpret patient investigations, multimodal imaging and information.
# 8	Outcome Select appropriate biomedical materials and components used in the treatment of patients and the manufacture of custom-made medical devices.
# 9	Outcome Assess and interpret patients’ needs to provide customised treatment dependent on medical, physical, social and psychological requirements.