Craniofacial and Trauma Rehabilitation —
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

Reflective practice guidance

The guidance below is provided to support reflection at different time points, providing you with questions to aid you to reflect for this training activity. They are provided for guidance and should not be considered as a mandatory checklist. Trainees should not be expected to provide answers to each of the guidance questions listed.

Before action

• What are the key considerations for biocompatibility and implant stability?
• What is your current understanding of cranioplasty procedures and the properties of alloplastic materials used for cranial implants?
• What do you hope to learn about the CAD/CAM planning process, the specific manufacturing techniques for these implants, and the practicalities of supporting the surgical team in the operating theatre?
• Have you reviewed the pre-surgical imaging and planning for the cranioplasty?
• Have you discussed the surgical procedure and the fitting process with the surgical team?
• What potential challenges might arise during the fitting, and how can you best support the surgical team?

In action

• Given the specific requirements of this specialist device, what key design principles are you actively focusing on during planning and manufacture?
• What unique challenges are you encountering due to the novel nature of this device? How are you adapting your usual processes?
• What critical decisions are you making regarding materials and construction techniques as you progress with the manufacture? What is informing these decisions?
• When using Ti are you able to specify different Titanium etching mechanisms and why would you use a specific one for the material that is selected?

On action

• Describe the specific specialist device you planned, designed, and manufactured. What were the unique requirements and challenges of this particular device?
• What specific problem was this device intended to solve? What new knowledge or skills did you need to acquire or apply during this process? What challenges did you overcome in the planning, design, or manufacturing stages? How effective was the final device in meeting its intended purpose?
• How will this experience inform your approach to future specialist device projects? What specific areas of your skills or knowledge were highlighted as needing further development? What resources would be beneficial for future learning in this area?
• Discuss the differences of the various manufacturing techniques and the limitations of each.

Beyond action

• Reflecting on this more involved activity, how has your understanding of planning and manufacturing custom alloplastic implants evolved?
• How did the experience of supporting the surgical team in the operating theatre enhance your appreciation of the clinical application of laboratory work?
• How might this experience contribute to your future involvement in complex surgical cases and the application of cranioplasty implants?
• How are the skills and knowledge you gain in this activity transferable to different surgical reconstruction cases?

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.