Module - Medical Devices for Maxillofacial Trauma and Craniofacial Deformities (SPE420)

STP

Aim of this module

This module will enable trainees to gain the knowledge and understanding that  will be applied as they develop their specialist practice. They will continue to learn and gain new work based skills to enable them to competently perform a range of treatments, interact with patients, and demonstrate safe, patient centred practice. Trainees will be expected to build on the competence gained during rotational training developing technical expertise in planning, interpreting and communicating the design and manufacture of dental and medical devices and surgical plans. The module aims to integrate the manufacturing and clinical aspects of reconstructive science as part of a multidisciplinary team approach to treatment and a leadership role in the management of patients requiring prosthetic rehabilitation. Trainees will gain wider experience of the role and application of reconstructive science in supporting patients requiring prosthetic and surgical treatment for congenital craniofacial deformities.

Work-based learning outcomes


  1. Observe informed consent and assist in planning the treatment of the patient who has experienced maxillofacial trauma in accordance with local/professional guidelines, adapting techniques as necessary to reflect possible outcomes and influencing factors.
  2. Observe informed consent and assist in clinical assessment of a patient who has a craniofacial deformity in accordance with local/professional guidelines, adapting techniques as necessary to reflect possible outcomes and influencing factors.
  3. Record a comprehensive and contemporaneous patient history recognising the significance of changes in the patient’s reported health status and taking appropriate action.
  4. Write a treatment plan for patients who have experienced maxillofacial trauma or have a craniofacial deformities in partnership with the patient, supporting the patient to manage their fear and anxiety, and referring to other support services for advice or alternative/adjunct treatment where appropriate.
  5. Discuss and agree treatment plans for a range of patients referred to the unit with maxillofacial trauma or craniofacial deformities with clinical colleagues, the patient and, if appropriate, relatives or carers.
  6. Plan, design, manufacture and evaluate dental devices for patients with fractures involving the mandible, maxilla and middle third of the facial skeleton.
  7. Discuss treatment options, design, plan, manufacture, fit and evaluate a range of auricular (ear) prostheses for patients with congenital absence of pinna (external part of the ear) prosthesis with the patient, their carers or relatives, and colleagues, as appropriate.
  8. Discuss treatment options and plans with patients, their carers or relatives, and colleagues for bimaxillary orthognathic (jaw) surgery and generate pre- surgical plan.
  9. Manipulate, analyse and interpret 3D digital imaging data of the head and neck for patients requiring orthognathic surgery.
  10. Manufacture medical implants for patients requiring surgical repair.
  11. Assist in the routine maintenance, calibration and quality assurance procedures on the equipment used to plan and make medical devices.

Work-based Competencies


Learning outcome Title Knowledge
1 1, 3, 4, 5

Explain to a patient the procedure for the provision of a prosthesis to treat their deformity, address any procedure-related questions and provide information on how to manage their prosthesis.

  • The importance of explaining the procedures to the patient.
  • Common questions and concerns of patients about procedures.
  • Risks and benefits of a prosthesis.
  • The information needs of the patient following investigations.
  • Different levels of authority level for provision of information and treatment to patients in relation to your professional competency level, professional boundaries and experience.
  • The range of treatment pathways and their relevance/applicability to the patient.
  • Factors affecting selection of treatment option.
2 1, 3, 4, 5

Gain informed consent and plan the clinical examination of the patient in accordance with local/professional guidelines, adapting techniques as necessary to reflect possible outcomes and influencing factors.

  • The importance of introducing yourself to the patient, including your role and experience as a Clinical Scientist.
  • The importance of introducing yourself to the patient, including your role and experience as a Clinical Scientist.
  • The importance of checking patient identity.
  • The importance of explaining the procedure for each investigation to the patient and gaining informed consent.
  • Clinical indications for and contraindications to each investigation.
  • Principles, guidance and the law with respect to informed consent.
3 1, 3, 4, 5

Treat patients in a way that respects their dignity, rights, privacy and confidentiality.

  • The rights of the patient with regard to consent for treatment and confidentiality of consultation and medical records.
  • Requirements of patients with disabilities and special needs.
  • Key factors influencing dignity, rights, privacy and confidentiality, including age, gender, culture and beliefs.
4 1, 2, 3, 4, 5, 6, 7, 11

Minimise risks and hazards in compliance with health and safety policies, performing contamination control and infection prevention.

  • Protocols and requirements for hygiene and infection control related to the relevant range of investigations, including preparation, conduct and completion of investigation. Protocol for hand washing and how effective hand washing contributes to control of infection.
5 3

Record a comprehensive and contemporaneous patient history, recognising the significance of changes in the patient’s reported health status and taking appropriate action.

  • Clinical history-taking frameworks.
  • Patient-centred history taking, including how to build up a picture of the patient’s problems from their perspective of their physical complaints, the impact of these complaints on their lives and any psychosocial issues that are also active.
  • The importance of an accurate and complete patient history and the potential implications of missing or incorrect information.
  • Factors relevant to the range of investigations to be undertaken.
  • How to listen, interpret and act on the information provided.
  • How to communicate with patients in ways that facilitate cooperation and an understanding of requirements, including patients with special needs.
6 4

Plan the treatment with the patient, referring patients for advice or alternative/adjunct treatment where appropriate.

  • Potential for different treatment plans and surgical options.
  • Clinical episodes in difficult situations.
  • Enhance communication skills with senior surgical and scientist colleagues.
  • Patient-centred communication skills.
  • Referral pathways.
  • How to support and advise patients, helping them to manage their fear and anxiety and referring to other support services as necessary.
  • Clinical indications for and contraindications to each prosthetic option.
  • Explore ethical issues of treating patients in vulnerable situations (not conscious, disabilities, or children).
  • MHRA and national guidelines for treatment.
  • Identify difficulties in relation to incomplete planning information and how to access further information, whether with surgical colleagues or electronic hospital systems (Patient Administration Systems; PAS).
  • Relevant legal, professional and ethical requirements of treating patients requiring prescribed devices to treat maxillofacial trauma and craniofacial deformities.
7 5

Discuss possible treatment plans for patients with maxillofacial trauma with senior clinical colleagues, recognising the impact on the patient, relatives and carers.

  • Potential for different treatment plans and surgical options.
  • Clinical episodes in difficult situations.
  • Enhance communication skills with senior surgical and scientist colleagues.
  • Patient-centred communication skills.
  • Referral pathways.
  • How to support and advise patients, helping them to manage their fear and anxiety and referring to other support services as necessary.
  • Clinical indications for and contraindications to each prosthetic option.
  • Explore ethical issues of treating patients in vulnerable situations (not conscious, disabilities, or children).
  • MHRA and national guidelines for treatment.
  • Identify difficulties in relation to incomplete planning information and how to access further information, whether with surgical colleagues or electronic hospital systems (Patient Administration Systems; PAS).
  • Relevant legal, professional and ethical requirements of treating patients requiring prescribed devices to treat maxillofacial trauma and craniofacial deformities.
8 5

Discuss possible treatment plans for patients  with  craniofacial deformities with clinical colleagues, recognising the impact on the patient relatives and carers.

  • Potential for different treatment plans and surgical options.
  • Clinical episodes in difficult situations.
  • Enhance communication skills with senior surgical and scientist colleagues.
  • Patient-centred communication skills.
  • Referral pathways.
  • How to support and advise patients, helping them to manage their fear and anxiety and referring to other support services as necessary.
  • Clinical indications for and contraindications to each prosthetic option.
  • Explore ethical issues of treating patients in vulnerable situations (not conscious, disabilities, or children).
  • MHRA and national guidelines for treatment.
  • Identify difficulties in relation to incomplete planning information and how to access further information, whether with surgical colleagues or electronic hospital systems (Patient Administration Systems; PAS).
  • Relevant legal, professional and ethical requirements of treating patients requiring prescribed devices to treat maxillofacial trauma and craniofacial deformities.
9 6

Plan, design, manufacture and evaluate dental devices for patients with fractures involving the mandible, maxilla and middle third of the facial skeleton.

  • Follow local laboratory procedures and protocols.
  • Identify different methods of treatment.
  • Infection control standards for possibly infective situations (blood and body fluids).
  • The relevant, current health and safety regulations specific to procedures in maxillofacial prosthetics and reconstruction.
  • Potential hazards and risks and the actions to be taken to minimise these.
  • Expected treatment outcomes and assessment of quality, audit of outcomes.
10 6

Discuss treatment options with respect to devices for patients with dentoalveolar trauma.

  • Follow local laboratory procedures and protocols.
  • Identify different methods of treatment.
  • Infection control standards for possibly infective situations (blood and body fluids).
  • The relevant, current health and safety regulations specific to procedures in maxillofacial prosthetics and reconstruction.
  • Potential hazards and risks and the actions to be taken to minimise these.
  • Expected treatment outcomes and assessment of quality, audit of outcomes.
11 6

Plan and manufacture devices for a patient with a single avulsed tooth.

  • Head and neck anatomy.
  • Fracture sites of the mandible.
  • Displacement of mandibular fractures.
  • Principles of treatment of mandibular fractures.
  • Dental trauma, displacement injuries, splinting of traumatised teeth.
  • Interpretation of prescriptions, where, how and when to seek advice and information from colleagues and relevant agencies,
  • Dental impression materials, techniques and the factors affecting the clinical choice for dental fractures.
  • Design factors for laboratory constructed fracture fixation devices.
12 6

Plan and manufacture devices for a patient with multiple dental alveolar injuries.

  • Head and neck anatomy.
  • Fracture sites of the mandible.
  • Displacement of mandibular fractures.
  • Principles of treatment of mandibular fractures.
  • Dental trauma, displacement injuries, splinting of traumatised teeth.
  • Interpretation of prescriptions, where, how and when to seek advice and information from colleagues and relevant agencies,
  • Dental impression materials, techniques and the factors affecting the clinical choice for dental fractures.
  • Design factors for laboratory constructed fracture fixation devices.
13 6

Plan and manufacture devices for a patient requiring soft bite guards for concussed teeth.

  • Head and neck anatomy.
  • Fracture sites of the mandible.
  • Displacement of mandibular fractures.
  • Principles of treatment of mandibular fractures.
  • Dental trauma, displacement injuries, splinting of traumatised teeth.
  • Interpretation of prescriptions, where, how and when to seek advice and information from colleagues and relevant agencies,
  • Dental impression materials, techniques and the factors affecting the clinical choice for dental fractures.
  • Design factors for laboratory constructed fracture fixation devices.
14 6

Plan and manufacture arch bars for dentate patients with mandibular fractures.

  • Head and neck anatomy.
  • Fracture sites of the mandible.
  • Displacement of mandibular fractures.
  • Principles of treatment of mandibular fractures.
  • Dental trauma, displacement injuries, splinting of traumatised teeth.
  • Interpretation of prescriptions, where, how and when to seek advice and information from colleagues and relevant agencies,
  • Dental impression materials, techniques and the factors affecting the clinical choice for dental fractures.
  • Design factors for laboratory constructed fracture fixation devices.
15 6

Plan and manufacture arch bars for dentate patients with mandibular fractures and edentulous saddles.

  • Arch bars, cast splints, gunning splints.
  • Materials selection.
  • Metal-joining techniques (e.g. soldering, laser welding).
  • Type and extent of records required for individual assessment and how to complete them.
16 6

Plan and manufacture splints for edentulous patients with mandibular fractures.

  • Arch bars, cast splints, gunning splints.
  • Materials selection.
  • Metal-joining techniques (e.g. soldering, laser welding).
  • Type and extent of records required for individual assessment and how to complete them.
17 7

Explain and discuss treatment options for patients with congenital absence of pinna (ears) that require an auricular (ear) prosthesis with patients, their carers or relatives and colleagues as appropriate.

  • Reconstruction options for the patient in relation to autogenous or alloplastic materials. Identify the pros and cons of each in relation to different patient circumstance.

Medical Legal Aspects

  • Medical legal aspects of treating patients, patients’ complaints procedures, carers.
  • Personal Protective Equipment regulations.
  • Medical history and records, patient and professional communication.
  • Medical ethics.
  • Informed choice/consent/negligence and maxillofacial prosthetics practice.
  • Clinical indications for and contraindications to each prosthetic option.
  • Principles of the clinical management of facial prostheses.
18 7

Prepare the patient and take impressions of patients to generate analogues for a range of defects.

Patient Management

  • Patient evaluation and understand referral sources.
  • Theories of health-related behaviour and effects of drugs, allergies and lifestyle factors on patient health and rehabilitation.
  • Management of patient’s fears/anxiety.
  • Common psychosocial disorders associated with congenital facial deformities (abnormal psychology, anxiety, depression, psychoses).
  • Basic counselling and communication skills.
  • Support groups (physical and internet).
  • Management of patient during impression procedures.
19 7

Design, plan, manufacture, fit and evaluate an adhesive retained auricular (ear) prosthesis for a patient with congenital absence of pinna (external part of the ear).

  • Principles of treatment planning.
  • Sculptured anatomical form to match patients missing anatomical facial/body parts (i.e. ocular, auricular, nasal digital and nipple prostheses).
  • Colour science.
  • Introduction to silicone elastomers.
  • Processing prostheses.
  • Skin contact adhesives: pressure-sensitive adhesives.
  • Main types of tissue conditioners, adhesives and removers used to attach prostheses to both the normal and impaired anatomy.
20 7

Plan alternative types of auricular (ear) prostheses for patients with congenital absence of pinna (external part of the ear).

  • Principles of the clinical management of auricular prostheses:
    • pre-treatment assessment
    • treatment planning
    • pre-prosthetic surgery.
  • Principles of auricular prosthesis design.
  • Implant retention for auricular prostheses, materials selection for one-piece stud/implant-retained prostheses.
  • Integration of colour technology, material and colour stability.
  • Impression techniques and materials.
  • Main types of mechanical retention options.
  • Basic understanding of types of implant system and attachment options.
21 7

Fit a range of auricular (ear) prostheses for patients with congenital (external part of the ear).

Discuss prosthesis management with the patient, carer, or relative.

  • Why informed consent is necessary for each treatment event/episode.
  • Utilise extrinsic colour systems for adapting a prosthesis to match surrounding structures.
  • Patient education in relation to skin preparation for prosthetic application, self-care as part of the recovery of the patient and care for the prosthesis.
22 8

Discuss treatment options and plans with senior surgical and scientific colleagues for bi-maxillary orthognathic surgery (jaw surgery). Observing discussions with patients, their carers or relatives, and outline the procedures and complications related to the treatment options.

  • The relevant, current health and safety regulations specific to laboratory procedures in planning.
  • Potential hazards and risks and the actions to be taken to minimise these.
  • Possible complications for the patient of the treatment (morbidity).
  • Expected treatment outcomes and assessment of quality, audit of outcomes.
23 8

Generate pre-surgical plans for patients requiring bi-maxillary orthognathic surgery (jaw surgery).

  • Patterns of craniofacial growth and common dentofacial deformities/syndromes.
  • Applied head and neck anatomy.
  • Surgical techniques for bimaxillary osteotomies.
  • Model-based pre-operative planning systems, computer-aided planning systems.
  • Design principles for operative wafers for mandibular osteotomies.
  • Disinfection procedures for use in the clinical and operating theatre environment.

Orthognathic Surgery Planning

  • Craniofacial and jaw deformities:
  • cleft lip and palate, incidence, aetiology, treatment
  • surgical techniques for orthognathic surgery
  • distraction osteogenesis.
  • Model based pre-operative planning systems, computer-aided planning systems.
  • Design principles for devices and surgical aids for orthognathic surgery.

Surgical Procedures and Devices

  • Theatre protocols.
  • Surgical procedures relevant to orthognathic and craniofacial surgery.
24 8

Complete, interpret and analyse a two-dimensional surgical plan for a bimaxillary osteotomy (cephalometric analysis and plan).

  • Patterns of craniofacial growth and common dentofacial deformities/syndromes.
  • Applied head and neck anatomy.
  • Surgical techniques for bimaxillary osteotomies.
  • Model-based pre-operative planning systems, computer-aided planning systems.
  • Design principles for operative wafers for mandibular osteotomies.
  • Disinfection procedures for use in the clinical and operating theatre environment.

Orthognathic Surgery Planning

  • Craniofacial and jaw deformities:
  • cleft lip and palate, incidence, aetiology, treatment
  • surgical techniques for orthognathic surgery
  • distraction osteogenesis.
  • Model based pre-operative planning systems, computer-aided planning systems.
  • Design principles for devices and surgical aids for orthognathic surgery.

Surgical Procedures and Devices

  • Theatre protocols.
  • Surgical procedures relevant to orthognathic and craniofacial surgery.
25 8

Complete, interpret and analyse a three-dimensional surgical plan for a bi-maxillary orthognathic surgery (model analysis and plan).

  • Patterns of craniofacial growth and common dentofacial deformities/syndromes.
  • Applied head and neck anatomy.
  • Surgical techniques for bimaxillary osteotomies.
  • Model-based pre-operative planning systems, computer-aided planning systems.
  • Design principles for operative wafers for mandibular osteotomies.
  • Disinfection procedures for use in the clinical and operating theatre environment.

Orthognathic Surgery Planning

  • Craniofacial and jaw deformities:
  • cleft lip and palate, incidence, aetiology, treatment
  • surgical techniques for orthognathic surgery
  • distraction osteogenesis.
  • Model based pre-operative planning systems, computer-aided planning systems.
  • Design principles for devices and surgical aids for orthognathic surgery.

Surgical Procedures and Devices

  • Theatre protocols.
  • Surgical procedures relevant to orthognathic and craniofacial surgery.
26 8

Plan and manufacture a surgical inter-occlusal wafer for bi-maxillary orthognathic surgery.

  • Patterns of craniofacial growth and common dentofacial deformities/syndromes.
  • Applied head and neck anatomy.
  • Surgical techniques for bimaxillary osteotomies.
  • Model-based pre-operative planning systems, computer-aided planning systems.
  • Design principles for operative wafers for mandibular osteotomies.
  • Disinfection procedures for use in the clinical and operating theatre environment.

Orthognathic Surgery Planning

  • Craniofacial and jaw deformities:
  • cleft lip and palate, incidence, aetiology, treatment
  • surgical techniques for orthognathic surgery
  • distraction osteogenesis.
  • Model based pre-operative planning systems, computer-aided planning systems.
  • Design principles for devices and surgical aids for orthognathic surgery.

Surgical Procedures and Devices

  • Theatre protocols.
  • Surgical procedures relevant to orthognathic and craniofacial surgery.
27 8

Recognise and classify malocclusions and bi-deformities.

  • Patterns of craniofacial growth and common dentofacial deformities/syndromes.
  • Applied head and neck anatomy.
  • Surgical techniques for bimaxillary osteotomies.
  • Model-based pre-operative planning systems, computer-aided planning systems.
  • Design principles for operative wafers for mandibular osteotomies.
  • Disinfection procedures for use in the clinical and operating theatre environment.

Orthognathic Surgery Planning

  • Craniofacial and jaw deformities:
  • cleft lip and palate, incidence, aetiology, treatment
  • surgical techniques for orthognathic surgery
  • distraction osteogenesis.
  • Model based pre-operative planning systems, computer-aided planning systems.
  • Design principles for devices and surgical aids for orthognathic surgery.

Surgical Procedures and Devices

  • Theatre protocols.
  • Surgical procedures relevant to orthognathic and craniofacial surgery.
28 8

Recognise and classify malocclusions and apply this to the planning for the surgical treatment of dentofacial defomities.

  • Developmental/Embryological malformation that leads to various types of dentofacial deformity, including clefts.
  • Basic principles of multidisciplinary treatment for these patients.
  • The principles of laboratory-based procedures to correct deformity.
29 8

Appreciate and apply the technical management of the cleft palate patient.

  • Developmental/Embryological malformation that leads to various types of dentofacial deformity, including clefts.
  • Basic principles of multidisciplinary treatment for these patients.
  • The principles of laboratory-based procedures to correct deformity.
30 9

Manipulate, analyse and interpret three-dimensional data of the head and neck for patients requiring orthognathic surgery.

  • Methodology of the different modalities of obtaining digital data (CT, MRI, surface data acquisition).
  • Be able to identify principle anatomical structures on X-rays, CT, MRI and surface data scans.
  • Methods of obtaining volumetric and surface 3D data.

Three-Dimensional Data

  • Different modalities of obtaining digital data (CT, MRI, surface data acquisition) and new developments in imaging.
  • 3D volumetric and 3D surface data acquisition.
  • Comparative analysis of methods of obtaining 3D data and accuracy.
  • Identification of principle anatomical structures on X-rays, CT, MRI and surface data scans.
  • Principles of image-guided surgery and its applications in maxillofacial and craniofacial surgery.
  • Dicom data, conversion to a 3D data set and 3D images.
  • Anatomical landmarks and artefacts for the different methods of data collection.
  • Accuracy of 3D reconstructed images.
  • 3D software programmes available for pre-operative planning and image manipulation and assessment in pre/postoperative outcomes.
  • 3D software systems to predict ideal implant locations.
  • 3D templates to locate implants at surgery.

Anatomical Models

  • Anatomical models from 3D data, i.e. CNC (computerised numerical controlled) milling, rapid prototyping techniques.
  • Manufacture and accuracy of 3D models used to create facial prostheses, cranioplasties and templates.
31 9

Use Dicom data to reconstruct 3D images and apply methods of image manipulation to 3D data sets.

  • Methodology of the different modalities of obtaining digital data (CT, MRI, surface data acquisition).
  • Be able to identify principle anatomical structures on X-rays, CT, MRI and surface data scans.
  • Methods of obtaining volumetric and surface 3D data.

Three-Dimensional Data

  • Different modalities of obtaining digital data (CT, MRI, surface data acquisition) and new developments in imaging.
  • 3D volumetric and 3D surface data acquisition.
  • Comparative analysis of methods of obtaining 3D data and accuracy.
  • Identification of principle anatomical structures on X-rays, CT, MRI and surface data scans.
  • Principles of image-guided surgery and its applications in maxillofacial and craniofacial surgery.
  • Dicom data, conversion to a 3D data set and 3D images.
  • Anatomical landmarks and artefacts for the different methods of data collection.
  • Accuracy of 3D reconstructed images.
  • 3D software programmes available for pre-operative planning and image manipulation and assessment in pre/postoperative outcomes.
  • 3D software systems to predict ideal implant locations.
  • 3D templates to locate implants at surgery.

Anatomical Models

  • Anatomical models from 3D data, i.e. CNC (computerised numerical controlled) milling, rapid prototyping techniques.
  • Manufacture and accuracy of 3D models used to create facial prostheses, cranioplasties and templates.
32 9

Prepare the manufacture of model analogues from 3D data sets.

  • Methodology of the different modalities of obtaining digital data (CT, MRI, surface data acquisition).
  • Be able to identify principle anatomical structures on X-rays, CT, MRI and surface data scans.
  • Methods of obtaining volumetric and surface 3D data.

Three-Dimensional Data

  • Different modalities of obtaining digital data (CT, MRI, surface data acquisition) and new developments in imaging.
  • 3D volumetric and 3D surface data acquisition.
  • Comparative analysis of methods of obtaining 3D data and accuracy.
  • Identification of principle anatomical structures on X-rays, CT, MRI and surface data scans.
  • Principles of image-guided surgery and its applications in maxillofacial and craniofacial surgery.
  • Dicom data, conversion to a 3D data set and 3D images.
  • Anatomical landmarks and artefacts for the different methods of data collection.
  • Accuracy of 3D reconstructed images.
  • 3D software programmes available for pre-operative planning and image manipulation and assessment in pre/postoperative outcomes.
  • 3D software systems to predict ideal implant locations.
  • 3D templates to locate implants at surgery.

Anatomical Models

  • Anatomical models from 3D data, i.e. CNC (computerised numerical controlled) milling, rapid prototyping techniques.
  • Manufacture and accuracy of 3D models used to create facial prostheses, cranioplasties and templates.
33 10

Identify different material options in relation to surgical repair of the skull from alloplastic (not human tissues, i.e. metal) and autogenous (patient’s own tissue) sources.

  • Repair of defects using the patient’s own skin and bone, autogenous reconstruction.
  • The advantages and disadvantages of both autogenous (own skin) or alloplastic (non human) materials.

Deep-Buried Implants

  • Physiological and immunological responses to alloplastic implants.
  • Cellular response to implants, systemic effects of implants.
  • Blood compatibility, non-thrombogenic surfaces.
  • Testing of carcinogenicity, risk assessment.

Metallic Implant Materials

  • Titanium and titanium-based alloys.
  • Types and composition.
  • Structure and properties.
  • Implant manufacture with titanium and titanium-based alloys.

Ceramic Implant Materials

  • Calcium phosphate, structure, properties of hydroxyapatite.
  • Manufacturing of hydroxyapatite.

Polymeric Implant Materials

  • Polymeric implant materials, rubbers.
  • Deterioration of polymers, chemical effects, sterilisation effects, mechano-chemical effects, in vivo environmental effects, stability and toxicity.

Failure of Materials

  • Behaviour of materials when stressed.
  • Different ways in which materials can fail (wear, fatigue, degradation by corrosion).
  • Corrosion of metallic implants.
  • Electrochemical aspects.
  • Pourbaix diagrams in corrosion.
  • Rates of corrosion and polarisation curves.
  • Corrosion of available metals.
  • Minimisation of corrosion.
  • Relationship of failure to the macro and microstructure of a material.
  • Role of defects in metals and the effect on an appliance.

Soft Tissue Replacement

  • Percutaneous devices.
  • Maxillofacial implants.
  • Ear and eye implants.
  • Space-filling implants.

New Developments in Biomedical Materials and Manufacturing

  • Surface coatings of implant materials, e.g. plasma coatings, hydroxyapetite coatings.
  • Physical and vapour deposition of thin films.
  • Evaluation of chemical and mechanical properties of new materials and their application.
  • Principles of tissue engineering and stem cell research and its application to hard and soft tissue reconstruction.
  • 3D printing of substrate structures, materials for scaffolds
  • Hard tissue growth, soft tissue growth.
  • Comparisons with alloplastic materials and manufacture.
  • 3D printing of metallic implants, laser sintering.
34 10

Discuss material selection for the surgical repair based on patient aetiology, laboratory choices, surgical choices and accessibility of materials for manufacture.

  • Repair of defects using the patient’s own skin and bone, autogenous reconstruction.
  • The advantages and disadvantages of both autogenous (own skin) or alloplastic (non human) materials.

Deep-Buried Implants

  • Physiological and immunological responses to alloplastic implants.
  • Cellular response to implants, systemic effects of implants.
  • Blood compatibility, non-thrombogenic surfaces.
  • Testing of carcinogenicity, risk assessment.

Metallic Implant Materials

  • Titanium and titanium-based alloys.
  • Types and composition.
  • Structure and properties.
  • Implant manufacture with titanium and titanium-based alloys.

Ceramic Implant Materials

  • Calcium phosphate, structure, properties of hydroxyapatite.
  • Manufacturing of hydroxyapatite.

Polymeric Implant Materials

  • Polymeric implant materials, rubbers.
  • Deterioration of polymers, chemical effects, sterilisation effects, mechano-chemical effects, in vivo environmental effects, stability and toxicity.

Failure of Materials

  • Behaviour of materials when stressed.
  • Different ways in which materials can fail (wear, fatigue, degradation by corrosion).
  • Corrosion of metallic implants.
  • Electrochemical aspects.
  • Pourbaix diagrams in corrosion.
  • Rates of corrosion and polarisation curves.
  • Corrosion of available metals.
  • Minimisation of corrosion.
  • Relationship of failure to the macro and microstructure of a material.
  • Role of defects in metals and the effect on an appliance.

Soft Tissue Replacement

  • Percutaneous devices.
  • Maxillofacial implants.
  • Ear and eye implants.
  • Space-filling implants.

New Developments in Biomedical Materials and Manufacturing

  • Surface coatings of implant materials, e.g. plasma coatings, hydroxyapetite coatings.
  • Physical and vapour deposition of thin films.
  • Evaluation of chemical and mechanical properties of new materials and their application.
  • Principles of tissue engineering and stem cell research and its application to hard and soft tissue reconstruction.
  • 3D printing of substrate structures, materials for scaffolds
  • Hard tissue growth, soft tissue growth.
  • Comparisons with alloplastic materials and manufacture.
  • 3D printing of metallic implants, laser sintering.
35 10

Explore material choice in relation to different types of tissue to be replaced, either bone (hard), or muscle or skin (soft).

  • Repair of defects using the patient’s own skin and bone, autogenous reconstruction.
  • The advantages and disadvantages of both autogenous (own skin) or alloplastic (non human) materials.

Deep-Buried Implants

  • Physiological and immunological responses to alloplastic implants.
  • Cellular response to implants, systemic effects of implants.
  • Blood compatibility, non-thrombogenic surfaces.
  • Testing of carcinogenicity, risk assessment.

Metallic Implant Materials

  • Titanium and titanium-based alloys.
  • Types and composition.
  • Structure and properties.
  • Implant manufacture with titanium and titanium-based alloys.

Ceramic Implant Materials

  • Calcium phosphate, structure, properties of hydroxyapatite.
  • Manufacturing of hydroxyapatite.

Polymeric Implant Materials

  • Polymeric implant materials, rubbers.
  • Deterioration of polymers, chemical effects, sterilisation effects, mechano-chemical effects, in vivo environmental effects, stability and toxicity.

Failure of Materials

  • Behaviour of materials when stressed.
  • Different ways in which materials can fail (wear, fatigue, degradation by corrosion).
  • Corrosion of metallic implants.
  • Electrochemical aspects.
  • Pourbaix diagrams in corrosion.
  • Rates of corrosion and polarisation curves.
  • Corrosion of available metals.
  • Minimisation of corrosion.
  • Relationship of failure to the macro and microstructure of a material.
  • Role of defects in metals and the effect on an appliance.

Soft Tissue Replacement

  • Percutaneous devices.
  • Maxillofacial implants.
  • Ear and eye implants.
  • Space-filling implants.

New Developments in Biomedical Materials and Manufacturing

  • Surface coatings of implant materials, e.g. plasma coatings, hydroxyapetite coatings.
  • Physical and vapour deposition of thin films.
  • Evaluation of chemical and mechanical properties of new materials and their application.
  • Principles of tissue engineering and stem cell research and its application to hard and soft tissue reconstruction.
  • 3D printing of substrate structures, materials for scaffolds
  • Hard tissue growth, soft tissue growth.
  • Comparisons with alloplastic materials and manufacture.
  • 3D printing of metallic implants, laser sintering.
36 10

Manufacture medical implants for patients requiring titanium cranioplasty (surgical repair of a defect or deformity of a skull).

  • Repair of defects using the patient’s own skin and bone, autogenous reconstruction.
  • The advantages and disadvantages of both autogenous (own skin) or alloplastic (non human) materials.

Deep-Buried Implants

  • Physiological and immunological responses to alloplastic implants.
  • Cellular response to implants, systemic effects of implants.
  • Blood compatibility, non-thrombogenic surfaces.
  • Testing of carcinogenicity, risk assessment.

Metallic Implant Materials

  • Titanium and titanium-based alloys.
  • Types and composition.
  • Structure and properties.
  • Implant manufacture with titanium and titanium-based alloys.

Ceramic Implant Materials

  • Calcium phosphate, structure, properties of hydroxyapatite.
  • Manufacturing of hydroxyapatite.

Polymeric Implant Materials

  • Polymeric implant materials, rubbers.
  • Deterioration of polymers, chemical effects, sterilisation effects, mechano-chemical effects, in vivo environmental effects, stability and toxicity.

Failure of Materials

  • Behaviour of materials when stressed.
  • Different ways in which materials can fail (wear, fatigue, degradation by corrosion).
  • Corrosion of metallic implants.
  • Electrochemical aspects.
  • Pourbaix diagrams in corrosion.
  • Rates of corrosion and polarisation curves.
  • Corrosion of available metals.
  • Minimisation of corrosion.
  • Relationship of failure to the macro and microstructure of a material.
  • Role of defects in metals and the effect on an appliance.

Soft Tissue Replacement

  • Percutaneous devices.
  • Maxillofacial implants.
  • Ear and eye implants.
  • Space-filling implants.

New Developments in Biomedical Materials and Manufacturing

  • Surface coatings of implant materials, e.g. plasma coatings, hydroxyapetite coatings.
  • Physical and vapour deposition of thin films.
  • Evaluation of chemical and mechanical properties of new materials and their application.
  • Principles of tissue engineering and stem cell research and its application to hard and soft tissue reconstruction.
  • 3D printing of substrate structures, materials for scaffolds
  • Hard tissue growth, soft tissue growth.
  • Comparisons with alloplastic materials and manufacture.
  • 3D printing of metallic implants, laser sintering.
37 10

Manufacture and provide a deep- buried implant recognising the use of 3D data, correct anatomical shape, production of the defect bone analogue, post processing the surface for improved biocompatibility, placement and fixation.

Patient Selection and Management

  • The implant patient: aetiology and assessment of condition.
  • Medicolegal implications of implantable prostheses. EU, US and UK legislation for implantable prostheses.
  • Sterilisation techniques:
  • effects of sterilisation techniques upon physical and chemical properties of implants
  • microbial contamination
  • effects of contamination.

Manufacturing

  • Manufacturing techniques of custom made alloplastic implants:
  • 3D modelling
  • 3D patient analogue of the defect bone
  • custom mould manufacture to form the correct contour
  • post processing of the materials to achieve the best bio- compatibility
  • different sterilisation procedures.
  • Effects of manufacturing techniques on the properties of implants.
  • Calculation of physical dimensions of alloplastic implants relating to mechanical and chemical properties of the material selected.
  • Effect of bone density on fixation design.

Fixation

  • Interface problems, bone cement, porous ingrowth, direct bonding, interface and passive fixation.
  • Effects of fixation on implant function.

Three-Dimensional Data

  • Different modalities of obtaining digital data (CT, MRI, surface data acquisition) and new developments in imaging.
  • 3D volumetric and 3D surface data acquisition.
  • Comparative analysis of methods of obtaining 3D data and accuracy.
  • Identification of principle anatomical structures on X-rays, CT, MRI and surface data scans.
  • Principles of image-guided surgery and its applications in maxillofacial and craniofacial surgery.
  • Dicom data, conversion to a 3D data and 3D images.
  • Anatomical landmarks and artefacts for the different methods of data collection.
  • Accuracy of 3D reconstructed images.
  • 3D software programs available for pre-operative planning and image manipulation and assessment in pre/postoperative outcomes.
  • 3D software systems to predict ideal implant locations (i.e. Simplant). 3D templates to locate implants at surgery.
38 10

Manufacture alloplastic implants to a standard suitable for implantation.

  • Risk management procedures locally.
  • In-house manufacture guidelines from the MHRA.
  • NICE guidance on implants.
39 10

Evaluate the fitness for use of implanted devices used in craniofacial surgery and attend operating theatre to see the use of the implant.

40 10

Apply the regulatory factors affecting the recording and provision of deep-buried implants.

Risk Management and Governance

  • National and international standards and guidance particularly in relation to in-house (within the same hospital as the device is to be fitted) and commercial manufacture.
  • Compliance with the requirements of the Medical Devices Directive (MDD).
  • The requirements of the MDD and the application of these and technical standards to the safety and performance of medical devices.
  • Device classifications.
  • Clinical Governance framework.
  • Current standards and compliance in the healthcare environment including Standards for Better Health, NHS Litigation Authority.
  • Management of innovation and prototypes.
41 11

Identify and navigate the standards that underpin or are used within the organisation’s medical device management strategy and associated service delivery.

  • Existence of, and ability to navigate key prevailing standards, including:
    • legal requirements, health and safety at work legislation
    • medical device elements of prevailing NHS standards, e.g. Care Quality Commission and NHS Litigation Authority
    • electromedical safety standards, IEC60601, part one, collaterals and family of particular part 2 standards
    • ISO 9001 quality management standards
    • risk management standards
    • best practice standards.
  • The philosophy, hierarchy of IEC 60601 and key differences from other standards, i.e. single fault condition. Understand how these standards are used by the practising clinical engineer.
  • The Clinical Governance framework and corporate objectives of the organisation.
  • Local healthcare environment and range of services offered by the institution and the existence of relevant policies and procedures.
42 11

Assist in the routine maintenance and calibration of equipment used to plan and make medical devices producing accurate records in accordance with relevant legislation and guidance.

  • Routine equipment maintenance and calibration procedures and schedules.
  • Expected performance, limitations and calibration of equipment.
  • The appropriate selection, operation, calibration and quality assurance of equipment.
  • National guidance and legislation.
  • The importance, application and relevance of routine quality assurance to patient care and treatment and implications of unsafe performance for staff and patients.
  • Current national quality assurance guidance.
  • Reporting systems.
  • Repairs, decontamination and record keeping.
43 11

Assist in the routine quality assurance procedures on the equipment used to plan and make medical devices producing accurate records in accordance with relevant legislation and guidance.

  • Routine equipment maintenance and calibration procedures and schedules.
  • Expected performance, limitations and calibration of equipment.
  • The appropriate selection, operation, calibration and quality assurance of equipment.
  • National guidance and legislation.
  • The importance, application and relevance of routine quality assurance to patient care and treatment and implications of unsafe performance for staff and patients.
  • Current national quality assurance guidance.
  • Reporting systems.
  • Repairs, decontamination and record keeping.

Work-based assessment


Complete 5 Case-Based Discussion(s)
Complete 5 of the following DOPS and/or OCEs
Type Title
DOPS Fabricate custom made metal arch bar splints.
DOPS Fabricate custom made arch bar splints with Gunning type extension.
DOPS Position models of dental arches in ideal post operative position for bimaxillary orthognathic surgery planning.
DOPS Pack silicone into mould to produce and ear prosthesis.
OCE Take relevant medical history, discuss a treatment plan with a patient and obtain informed consent.
OCE Trial fit intermediate and final position PMMA occlusal splints prior to surgery
OCE Fit an ear prosthesis and instruct patient in use of fixation system.