Biomedical Materials and Engineering

Module details

Title

Biomedical Materials and Engineering

Type

Rotation

Module code

SPE402

Credits

10

Requirement

Compulsory

Aim of this module

This rotation will provide trainees with the knowledge and understanding of the scope of practice of biomedical engineering, radiotherapy oncology modalities, and the development of effective interface techniques to enhance patient care. The study of the principles of materials science and the introduction to new and innovative materials and tissue engineering will provide the trainees with the skills to develop evidence-based analytical skills in a rapidly changing area. The interaction with therapeutic radiography is key in the students’ understanding of other treatment modalities for neoplastic disease and the factors affecting device manufacture and use in this area. This module provides the trainee with an introduction to evidence-based decision making associated with the selection of materials and techniques used in the manufacture of common medical devices. They will gain experience of a range of current and potential future techniques and materials, and the advantages and applications of each in clinical care.

Competencies

#	Learning outcome	Competency	Action
# 1	Learning outcome 1,2	Competency Apply relevant legal, professional and ethical requirements of making devices for patients with oral cancer.	Action View
# 2	Learning outcome 1	Competency Design reference specimens of silicone elastomers to replicate required mechanical properties.	Action View
# 3	Learning outcome 1	Competency Manufacture reference specimens of silicone elastomers to replicate required mechanical properties.	Action View
# 4	Learning outcome 1	Competency Manufacture reference specimens of silicone elastomers to replicate colorimetric data.	Action View
# 5	Learning outcome 2	Competency Select, justify and use a range of biomedical materials in the manufacture of a medical device.	Action View
# 6	Learning outcome 1	Competency Evaluate a range of biomedical materials used in the manufacture of a medical device.	Action View
# 7	Learning outcome 2	Competency Work safely in radiation areas.	Action View
# 8	Learning outcome 2	Competency Design devices to support therapeutic radiography, considering the safety and comfort of patients.	Action View
# 9	Learning outcome 2	Competency Manufacture devices to support therapeutic radiography, considering the safety and comfort of patients.	Action View
# 10	Learning outcome 1,2	Competency Apply relevant legal, professional and ethical requirements of making devices for patients undergoing radiotherapy.	Action View

Assessments

You must complete:

• 1 case-based discussion(s)
• 1 of the following DOPS/ OCEs:

Vacuum forming a large thermoplastic sheet.	DOPS
Preparation and colour matching of silicone in the clinic.	OCE

Learning outcomes

1. Select, justify, use and evaluate a range of biomedical materials in the manufacture of a variety of custom-made medical devices.
2. Design and manufacture devices to support radiotherapy in accordance with appropriate quality systems and work safely in radiation areas.

Learning outcomes

1. Describe the scientific principles underpinning the use of materials and biomaterials and critically evaluate their limitations and selection.
2. Discuss the composition, structure, processing and behaviour of metallic, polymeric and ceramic biomedical materials and their use in Reconstructive Science.
3. Discuss and evaluate the properties of silicone elastomers and their use in Reconstructive Science.
4. Describe the principles of tissue engineering and the application and their use in Reconstructive Science.
5. Discuss the role of rehabilitation engineering, medical, prosthetics and orthotics in the treatment of patients and the relationship with Reconstructive Science.
6. Describe the radiobiological basis and principles of radiotherapy, the effects of radiotherapy on tissues, treatment planning and simulation.
7. Explain the patient pathway in radiotherapy and the associated risks.
8. Discuss the physics of radiotherapy treatment machines and dosimetry equipment.
9. Describe the devices (e.g. body moulds, head masks) used to maximise treatment of the cancer cells while minimising damage to normal cells.
10. Describe and evaluate the role of quality assurance in the maintenance of equipment used in the manufacture of medical devices.
11. Critically evaluate the underlying risks, legal and ethical requirements in the manufacture and use of medical devices.

Indicative content

Colour

• Colour science: colour and methods of colour measurement
• Principles and techniques used in shade taking and colour matching in Reconstructive Science
• Methods of skin colour reproduction
• Effects of surface finish on colour perception
• Effects of light source on colour measurement
• Skin pigmentation, racial variation, changes in skin colour due to physiological responses

Silicone polymers

• Silicone polymer chemistry: introduction to synthesis of silicone polymers and routes for cross-linking, including condensation and addition mechanisms
• Deformation of silicone elastomers, definition of resilience, modulus of resilience
• Silicone elastomers for use as resilient liners, requirements, systems, advantages and limitations
• Silicone elastomers as impression materials, requirements, systems, assessment

Tissue response to biomaterials

• Biocompatibility; soft and hard tissue response to biomaterials; hypersensitisation; blood–material interactions

Microbial interactions

• Microbial adhesion and biofilm formation, locations, incidence of device- related infection, consequences, diagnosis and control strategies
• Typical microorganisms associated with device-related infections

Degradation of materials in the biological environment

• Characteristics of the biological environment, factors leading to deterioration of materials
• Corrosion mechanisms for metallic materials: corrosion in aqueous solutions, effect of mechanical factors, approaches to corrosion control
• Degradation of polymeric and composite materials

Alloys

• Austenitic stainless steels, unalloyed titanium
• Titanium alloys: constitution, structure and properties, influence of processing on properties
• Examples of alloy selection for dental applications

Quality management systems

• Background to quality management systems
• Quality management principles applied to quality management system standards
• The ISO 9000 series of standards
• Interpretation of quality management system standards: examples of generic standards and standards for organisations associated with medical devices

Product liability

• Introduction to product liability legislation, UK and European remedies
• European law, types of EU law, new approach standards

Introduction to clinical engineering

• Role of medical physics and clinical engineering
• Basis of medical electronics and the medical device life cycle
• Basis of rehabilitation engineering and biomechanical assessment
• Basis of clinical measurement

Introduction to radiation physics

• X-rays, electrons (betas), neutrons, alpha and other particles
• Radioactivity units and relationships
• X-ray production
• Physical effects of radiation
• Interaction processes with matter
• Measurement and instrumentation
• Basic principles of imaging
• X-ray, CT, MR, nuclear medicine, ultrasound
• Non-ionising radiations, including ultraviolet (UV), radiofrequency (RF) and microwaves, lasers, infrared, magnetic fields and ultrasound
• Radiation safety: dose limits. principles of protection, safe practice
• Ionising radiation, U V, m icrowave, R F and ultrasound

 Effects of irradiation on tissues

• Biological effects of ionising radiation
• Mechanisms and effects of irradiation damage of tissues, with emphasis on the head and neck
• Types of malignant lesions for which radiotherapy is likely to be effective
• Lesions for which radiotherapy is indicated and those for which it is inappropriate
• Practical procedures involved in radiotherapy appropriate for explanation to patients

Custom-made devices in radiotherapy

• Historical device design and provision
• Intra-oral applicators, screens
• Design of radiotherapy masks
• Vacuum-forming techniques and materials
• Impression and body scanning techniques

Activities

• Observe the process of making a custom-made device for a range of patients, comparing and contrasting the process and decisions made, and discuss these with your training officer.
• Observe a range of radiotherapy treatments and, with permission, talk to a patient(s) about their experience of radiotherapy.
• With permission, follow a patient who has been referred with a head or neck cancer from diagnosis, treatment and if possible the early stages of recovery, and reflect on how your learning will impact on your future practice as a Clinical Scientist.
• Observe the routine maintenance, calibration and quality assurance procedures on the equipment used in radiotherapy, imaging and clinical engineering, and discuss the importance of planned preventative maintenance with your training officer.
• Attend a meeting where the results from a clinical audit are presented and discuss the role of clinical audit in contributing to service improvement.