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Supporting Guidance Standard 2.9

Health and Care Standards

Supporting Guidance

Standard 2.9:  Medical Devices, Equipment and Diagnostic Systems


What is the Standard about?

The standard is about the safe and effective procurement, use and disposal of medical equipment, devices and diagnostic systems.  It covers issues such as appropriate selection, procurement, maintenance, calibration, reprocessing, disposal and training.


Who is it for?

All health services in all settings.

In relation to the standard criteria (in bold) the following key questions need to be considered:

There is compliance with health, safety and environmental legislation, regulation and guidance.

  • How do you ensure you conform to health, safety and environmental legislation, standards and guidance?
    • For example, if you claim compliance with standards such as ISO 15189 or ISO 13485, inspections by a Notified Body would demonstrate compliance.
  • Do you liaise with local experts/advisers in each sphere – for example, Health and Safety Officers to ensure that needle-stick injury prevention devices comply with the European Directive; Estates Officers for compliance with environmental legislation?

Processes ensure that equipment, and devices are maintained, cleaned and calibrated in accordance with manufacturer’s guidelines, ensuring they are appropriate for their intended use and for the environment in which they are used.

  • What processes do you have in place to ensure that equipment and devices are maintained, cleaned and calibrated in accordance with manufacturers’ guidelines and the relevant EN (European) Standard?
  • Do you have systems in place to manage and monitor this activity?
  • What standards or systems do the manufacturers specify, and how can you demonstrate compliance?
    • For example, if manufactures require particular methods and standards of calibration, is this documented internally, specified in local equipment databases/registers, and undertaken at appropriate intervals as required by the NHS guidance documentation or National Standards/UKAS?
  • How do you know you are compliant with National standards or guidelines such as the Medical Device Regulations or Welsh Health Technical Memoranda?
  • How do you ensure you have the right environment and conditions for secure and safe storage?
    • For example, if you are storing endoscopes after decontamination, how can you be sure that they are suitably stored so that they do not become contaminated before their next use?  Full guidance and storage methods and test requirements are given in WHTM 01.06 Part E
  • What records do you keep regarding maintenance, cleaning and calibration? 
  • Do you have performance requirements for the organisation undertaking these activities, and are you able to demonstrate they meet these requirements?
    • For example, if calibration is required to national traceable standards, how do you select an appropriate calibration laboratory, testing ranges and requirements for that equipment, and how do you document satisfactory completion of the process?
  • What arrangements do you have for safe and effective procurement? 
  • Are there appropriate healthcare staff involved in specifying the requirements, and selecting appropriate devices for the clinical procedures in question?
  • Have you also liaised with local advisers such as Health &Safety, Estates, Infection Prevention Officers / Authorising Engineer [Decontamination], Sterile Services management, Decontamination Lead and Electro-Biomedical Engineer (EBME)?
  • Do you have a planned replacement programme for equipment?
  • How do you ensure that the right device is used by the right staff in the right place for the right patient at the right time?
  • What arrangements are in place for decommissioning and disposal?
  • Do you liaise with NWSSP Procurement to ensure that potential suppliers are in compliance with relevant legislation and standards?

An ongoing programme of training and competence assessment covers staff and users.

  • How do you identify the educational and training needs?
  • What arrangements do you have in place for providing and recording educational standards and training?
  • How do you assess competency of staff members? 
  • Do you have a records system which is well maintained and allows identification of staff who are within their education/training window, or who have lapsed?
  • Do you have procedure for staff to follow if they are outside their education/training window?

Timely reporting and management arrangements exist to address any device, equipment or system faults in use or in stock, including any alert or warning notices issued by appropriate agencies such as MHRA.

  • What arrangements and protocols do you have in place for the timely reporting, management and communication of faults, breakdowns and incidents?
  • Do you have an identified or nominated person in the organisation with responsibility for reporting medical device issues to external organisations such as the MHRA, NRLS, SMTL and HIW?
  • Many Welsh organisations use their local procurement officer or risk management team as the first point of contact.
  • Are staff educated and trained in the use of a local risk management system (such as DATIX) to record clinical incidents associated with device and equipment failure?
  • Can you demonstrate appropriate review and identification of whether the notice or alert affects your organisation?
  • Do you have a records system which records which actions were undertaken, by whom and when?
  • Have you identified a local Medical Device Safety Officer to coordinate this activity?

Suitable and sustainable systems, policies and procedures are in place for medical device decontamination by competent staff in an appropriate environment.

  • How do you ensure safe reprocessing and decontamination of medical devices and equipment, such as manual cleaning procedures, automated cleaning via washer disinfectors, disinfection requirements, and sterilization procedures?
  • Decontamination and sterilization is a scientific discipline of increasing importance as the complexity of medical devices increases. 
  • How do you ensure that Individuals carrying out decontamination are appropriately trained and educated as recommended by the MHRA?
  • Can you demonstrate that your staff have the appropriate competencies and ongoing education and training to ensure that relevant regulations and standards are met?
    • For example, you may be able to demonstrate that you use an in-house Sterile Services Department which is accredited to ISO 13485.


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