Device Risk Management Overview

Details

Title

Device Risk Management Overview

Type

Stage One

Module code

HPE306

Requirement

Compulsory

Module objective

By the end of this module the Clinical Scientist in HSST will develop their understanding of the history, principles and practice of  a  medical  device  management service within a healthcare environment. The Clinical Scientist in HSST will also be expected to analyse and synthesise their understanding of the current guidance,  regulations and policy from which medical device  management  strategies are developed and electromedical and risk management standards with emphasis on how standards are developed, used and revised. They will also be able to analyse, synthesise and critically apply their expert knowledge whilst performing a range of activities as part of the device risk management programme whilst critically evaluating their own response to both normal and complex situations using the professional attributes and insights required of a Consultant Clinical Scientist.

Knowledge and understanding

By the end of this module the Clinical Scientist in HSST will be able to analyse, synthesise and critically apply their expert knowledge with respect to medical equipment management including:

• current national standards underpinning medical device risk management and governance services.
• the institution’s key polices related to risk  management,  device  management and decontamination.
• the range of services delivered within the institution to achieve the effective management of medical devices, ensuring risks associated with the acquisition and use of medical devices are minimised.
• the organisational level arrangements i n place to strategically  manage  medical devices including policies and organisational arrangements relating to medical device management.
• the content and structure of IEC 60601 family of  standards:
  • Part 1 General standard
  • Part 1 Collateral standards
  • Part 2 Particular standard
  • Part 3 Performance standard.
  • The horizontal nature of part 1 and collaterals, contrasted with the specific nature of particular standards.
• the typical engineering content.
• the standards development process  and crucial role of the healthcare  scientist  in acting as the patient’s ambassador in developing  standards.
• how the standards are used by different parties, e.g. the manufacturer, the regulators and the healthcare scientist.
• the  existence  of  alternative  publications  where  a standard  is not  appropriate, e.g. a rapidly changing technology leading to a technical report or publically available specification.
• the local institution’s arrangements for risk management and the range and type of medical device risks in the organisation and actions undertaken to mitigate them.
• how to conduct a medical device-related risk assessment.

Technical and clinical skills

By the end of this module the Clinical Scientist in HSST will be able to demonstrate  a critical understanding of current research and its application to the performance and mastery of the following technical skills and will:

• perform risk based assessments of the organisational compliance with national standards and best practice.
• use and evaluate standards to support maintenance regime development.
• perform a wide range of medical device risk assessments.

By the end of this module the Clinical Scientist in HSST will be expected to critically reflect and apply in practice a range of clinical and communication skills to advise and communicate effectively with patients, relevant clinicians, patients and the public and other healthcare professionals and will:

• operate a range of commonly encountered medical devices in the typical ward or clinical  environment, namely
  • volumetric infusion pumps and syringe drivers
  • defibrillators
  • suction equipment
  • nebulisers
  • oxygen therapy
  • vital signs monitoring equipment
  • hospital beds
  • humidifiers
  • diathermy
  • various patient ventilators
  • anaesthesia equipment
  • ECG recorders
  • light sources
    • Lasers
    • Phototherapy
    • UV equipment
  • physiotherapy equipment
  • incubators
  • pressure relieving mattresses
  • POCT devices
  • computer systems integrated to medical devices
  • lung function equipment
  • warming systems
  • plaster saws

Attitudes and behaviours

By the end of this module the Clinical Scientist in HSST will be expected to evaluate their own response to both normal and complex situations demonstrating the professional attributes and insights required of a Consultant Clinical Scientist working within the limits of professional competence referring as appropriate to senior staff and will:

• show respect and behave in accordance with Good Scientific Practice.
• establish and influence the culture of health and safety in the work place promoting the importance of patient safety.
• ensure the safe and effective use of medical devices supporting colleagues to ensure all devices are used safely at all times.
• respond appropriately to issues if they arise.
• lead by example including the effective use of Personal Protective Equipment.
• have a clear focus on effective patient centred service delivery, minimising risk and promoting patient safety.