REHABTech conducts clinical, technical, engineering and information technology services with a number of collaborative centres.
It does this with the financial assistance of
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Site updated : 26th August, 2008
Material Science - Maximising Patient Safety - Resource Page - resource page
Material Science and P&O design
- Maximising Patient Safety

RESOURCE PAGE

This resource page is constantly being compiled - please return frequently
These resources are only intendeed for those who have attended this course or have access to support from REHAB Tech.
Please do not use any of the information contained here without the express permission and explanation of REHAB Tech.
common failures are analysed    Requirements for maintenance are discussed   failure at point of intervention

If you are interested in this course, please download a flyer and return with your details to register your interest. This will ensure we keep you in contact for when the course is running next.


This course has been held in a number of places around the world including the USA, Hong Kong and Australia.
It has been conducted in part using videoconferencing and has also been customised for single facilities, Technician programs and Prosthetic and Orthotic tertiary programs.

Aim Engineering Analysis of failures
The aim of this workshop was to provide prosthetic and orthotic practitioners  as well as technicians with a clear overview of the material science that governs aspects of clinical & technical principles.
This will give an understanding of what can go wrong and how to avoid it !
By understanding the clear scientific reasons behind these practices, patient safety can be maximised and failures can be minimised.
This course is part of the overall quality process that is in place to ensure the best outcomes for your clients.

What you will learn:

Faculty:A wide variety of devices and failure types

   Bill Contoyannis, MBE - REHAB Tech
  John Michael, MEd, CPO, FISPO, FAAOP
 

Program
If you are a supporter or have attended this course, and cannot access these presentations, please email here!


TOPIC
Content
Resource


Introduction to Course
What are course objectives and the delegates expectations?
The course will address the material science aspects of ensuring quality practice as well as cover the some system aspects of the quality practice.
We then focus on material science and issues affected by material considerations.
This includes:
  • Manufactured components
  • Custom fabricated devices
What's the theory behind what the P&/or O does? 
We will simply cover / explain some of the theory behind what the clinicians "intuitively" know.
Finally. . this course will focus on the details of the device, both the bits we use and the bits we make and how we can influence what we do with these to minimise failure and litigation.
Introduction
    Systems that we have in place in P&O to maximize Patient safety  

Introduction to Quality Management in P&O Design
This looks at overall Prosthetic and Orthotics practice and design. 
Are we including principles of quality management of overall systems? 
How they are applied, what  do they involve? We cover breifly CQI -Continuous Quality Improvement and / or (TQM) Total Quality Management. 
Are we thinking about what we are doing in all aspects of the treatment/ service cycle. - from scheduling the client visit through to training the client with their device back through to scheduling the client visit! (a complete cycle) Why do we do things a certain way?
Is it because that's the way we've always done them?, or is it because we are improving on how we used to do it? ....or because we were sued and therefore have to change?!?! 
We can cover other aspects of the system (info management, recall notice, benchmarking of the other aspects of practice  another time, but may touch on them briefly.
Introduction to Quality Management

Contemporary Standards for P&O Design
What standards are relevant to P & O practice?
[ISO 9000, ISO 10328, K-levels] 
Systems and standards covering P&O including 
ISO 10328, ISO 9000 (series)- K0 -K4 activity levels. 
(Terminology) Do we know the standards covering the components we use? 
Can we know how they are used, can we predict what will happen, how often they should be reviewed? 
We know what they've been designed for and for what conditions of use, so how do we apply this?
Standards
  • a list of standards relevant in P&O

When Things Break: Malpractice Litigation
Live presentations on malpractice cases.
Questions - (Good thought provokers!) 
Has anyone been sued?
Yes - EVERYONE is affected indirectly due to -premiums etc 
Does anyone die due to poor P or O practice? 
Yes - indirectly 
Does something need to fail for a client to take action? - Not structurally, only a failure of system. 
ABCD
Most commonly, a lack of information/understanding seems to be the reason for new lawsuits.
When Things break
  •  Failure review report
  •  Cases Fracture (Pyramid) Functional
  • Hazard alerts

Avoiding & Defending Malpractice Suits
Principles for avoiding and defending!! Systems that help, 
Avoiding and defending
  • Maximizing component service life 
  • Sample acknowledgment form
  • Protocols for use of Unknown or beyond weight limit components
  •  
  •   The science behind maximizing patient safety.  

    Introduction to Materials Science: Prosthetic & Orthotic Components
    What's the theory behind what the P&/or O does. We will simply cover explain some of the theory behind what the clinicians "intuitively" know. The first session looks mostly at the components we use (and we will do the theory and then apply it to the practical situation)
    Introduction to Material Science


    Custom Made Structures in Prosthetics & Orthotics
    The second session looks mostly at the practices that we have, particularly at the custom made/designed aspects of the devices (and again we will do the theory and then apply it to the practical situation)
    Custom Manufacturing

    [Mechanical & Structural Theory]
    Brief overview and the practical application. A refresh of fundamental structural theory and material properties. How are things designed and applied. 
    Elastic deformation, plastic deformation, yield point, ultimate tensile strength.
    Mechanical & Structural Theory

    [Types of Stress]
    What are the overall stresses involved in the use of these devices. Which are the critical ones. Can they be avoided? How can we maximise use, while minimising the potential of failure.
    Stress, strain, shear forces, shear strain, torque.
    (as above)

    [Moments of Inertia]
    What is the moment of Inertia (second moment of area) and how do we apply it to maximise the efficiency of what we do in terms of improving strength, durability etc of the devices we design. 
    This is the shape strength factor. It defines the strength of the device based on shape rather material.
    Moment of Inertia
        The science of mass produced commercial components.  

    [Stress Concentrations]
    What are they and again how do they influence. 
    Stress Concentrations

    [Types of Failures]
    In terms of the material science, (not system failures)The types of things that go wrong - structural and functional 
    Failures
    • Process for checking
    • Service fault and Breakdown form
    • Failure reviews on line

    [Fatigue]
    What is the influence of fatigue on failures. How do we determine this influence and how does it relate to the common activities of our clients. 
    Fatigue
        The science behind custom fabricated components.  

    [Composites Theory]
    Applying the theory specific to these combined with the mechanical theory of the first day, how should we be doing the custom designed parts of any device.
    Composite Theory

    [Thermoplastic Theory]
    Applying the theory specific to these combined with the mechanical theory of the first day, how should we be doing the custom designed parts of any device.
    Thermoplastics

    [Common Failures in Custom P&O Structures]
    Alignment, work hardening, mix and match, and general assembly and disassembly techniques. Why the practice contributes to the problem and how we can make it such that the practice improves it! 
    Common Failures and practices
        Putting the science into practice  


    Assembly & Disassembly Theory
    A critical overview of things to consider from assembling a new device, to reviewing an existing, to pulling apart and discarding a device. Inspection techniques
    as above

    Common Failures in Custom P&O Structures]
    Alignment, work hardening, mix and match, and general assembly and disassembly techniques. Why the practice contributes to the problem and how we can make it such that the practice improves it! 
    •  failure review
    • failure database

    Case Studies: Failures of P&O Devices - Part I
    Practical application of material science theory, how it helps avoid problems.
    Cases

    Case Studies: Failures of P&O Devices - Part II
    Cover component failures that have been brought in (cases can come in any way!) Hopefully a lot of what we discussed can already be applied. HOWEVER it is now hoped that intelligent questions will get asked!. Service fault and breakdown report forms 
    • Service fault form

    Fatigue
    How do we avoid fatigue failure! uhmmm how does the TechGUIDE help??? How do we determine the fatigue influence and how does it relate to the common activities of our clients. How can we set parameters for it. CAn we measure it using things like the StepWatch
    • Inspection Interval Calculation

    The Practical Role of the material science

    Part I

    Basically an overview of what's been covered theoretically and how we translate that practically, particularly in mass produced devices. Looks at using metals, alloys. Drilling bending etc
    Practical Role of material science -overview

    The Practical Role of the material science part II
    Basically an overview of what's been covered theoretically and how we translate that practically, particularly in custom fabricated devices. Looks at using thermoplastics and fibre/resin laminations. Practical review of custom manufacturing techniques and processes


    The Practical Role of Quality Management
    Quality Management - device considerations, client considerations, 'tools' for a quality practice - Basically an overview of what's been covered and how it should fit into the overall quality management process you should have in place.
    Practical Quality application for patient safety - overview

    Dual Issues Amputee obesity and the current popularity of lightweight prostheses
    Presented at the 2004 AAOP meeting, this  presentation  investigates the obesity trend and how best to manage it whilst considering the safest  options for the patient.
        Recommended reading and resources  
        Must read: 
    • Bo Klasson article - P&O Int Aug 1995 vol 19 No 2 pg 74- 91 
    • Strength of Materials in O&P design - Thomas R Lunsford - AAOP 
      • Must read:Chapter 1, 5, 6,8,9
      • Recommended: Chapter 7 
      • Not vital: Chapter 2,3,4
    Other reading:
    • "Lawsuits against Practitioners are on the rise" Graff,J. O&P Almanac, September 1998 p33
    • "Preventing Patient Lawsuits" Chasen, A., O&P Almanac, September 1997 p49
    • "How to minimise Claim exposure" Grosse E., O&P Almanac, June 1992 p61
    • "Outcome Measures: Moving from Theory to practice" Polliack A., September 1997 p85
    Web References:

    Medical Devices Directorate (UK)

     maximising patient safety






     

    This course was brought to you through the collaboration of


     REHAB Tech and The American Academy of Orthotists and Prosthetists






     
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    REHABTech - Centre for Biomedical Engineering
    Dept. of Electrical And Computer Systems Engineering
    Monash University

    Building 35 Room G19
    Clayton Vic AUSTRALIA 3800
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    E-mail: rehab.tech@eng.monash.edu.au
    Internet: http://www.monash.edu.au/rehabtech