The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published a guidance document dedicated to the in-vitro diagnostic (IVD) point-of-care test devices. Aside from other aspects, the guidance highlights the management and organization of point-of-care test (POCT) service.
Responsibility and Accountability
The MHRA emphasizes the importance of the appointment of the POCT coordinator – a person in charge of the implementation of a point of care test service, as well as for further communications with the regulating authority. According to the document, a senior professional should be appointed to carry out these responsibilities. This person would be also responsible for the results obtained when using the medical devices in question. The MHRA additionally emphasizes that under the Consumer Protection Act (1987), the medical device manufacturer or supplier would be responsible for the erroneous result if the user can demonstrate that the equipment has been used in strict accordance with the manufacturer`s instructions.
Furthermore, the responsibilities should be outlined in detail and cover such aspects as:
- Training,
- Instructions for use,
- Standard operating procedures,
- Health and safety,
- Quality assurance,
- Maintenance,
- Accreditation,
- Recordkeeping,
- Audit,
- Adverse incident reporting.
When assessing the related aspects, the medical device manufacturer shall consider the way the service quietly should be maintained, the management structure in terms of responsible persons, and also the availability of a laboratory providing support for the point of care test service. In order to confirm the latter, it would be necessary to provide the appropriate service level agreement.
Moreover, in case if the point of care test service being used in the clinical environment (hospital setting), a POCT committee should be established in addition to the appointment of a POCT co-ordinator. Such a committee should comprise of the representatives of all stakeholders, including healthcare professionals, industry representatives, and laboratory staff. According to the present guidance, the POCT committee shall:
- Determine whether the use of a point of care test is justified by demonstrating a significant increase in clinical evidence,
- Implement a consulting audit and assessment system with regard to the POCT service,
- Ensure the POCT services are being used only upon confirmation from a POCT committee,
- Ensure the use of POCT devices in the appropriate way,
- Expand the inclusion of community and healthcare professionals,
- Ensure the correct implementation of the quality control and external quality assessment schemes.
POCT and Staff Requirements
Another important aspect addressed in the guidance relates to the training of the staff operating the point of care test systems. According to the document, only staff whose training and competence has been established and recorded should be permitted to carry out POCT, they should also receive continued support and regular updates.
At the moment, an accreditation service for point-of-care tests is currently under development. Later it would include such core elements as accreditation, competence, and development of learning materials. The MHRA also states that the e-learning materials would be also used.
According to the document, it is important to ensure that:
- Core competencies are being assessed by a competent person,
- An entity responsible for a medical device provides the necessary training,
- Healthcare professionals using medical devices in question could dedicate the time sufficient to participate in training,
- The appropriate continuing professional development (CPD) program is being implemented.
The regulating authority additionally emphasizes the importance of familiarising with the instructions for use provided by the medical device manufacturer, especially in terms of such aspects as:
- The intended purpose of the device,
- Performance characteristics,
- Interpretation of results,
- Limitations of use,
- Sampling requirements, inducing sample type,
- Storage of reagents and samples,
- Expiry dates,
- Quality assurance procedures,
- Health and safety issues.
As it is stated by the MHRA, the persons using the point of care test devices should be familiar with the instructions for use provided by the medical device manufacturer. The information regarding the way the device should be used, as well as the details on contradictions associated thereto, should be incorporated into a training program.
According to the present MHRA guidance, the standard operating procedures (SOP) should be developed and implemented in order to prescribe the way the POCT devices should be used in order to ensure safety and effectiveness. The SOP should be based on the instructions for use provided by the medical device manufacturer and also incorporate a copy thereof. These SOPs should be available for all persons using POCT devices. They should be also subject to review on a regular basis to ensure the latest instructions for use provided by the medical device manufacturer are incorporated. The MHRA also recommends prescribing the actions to be taken on the basis of the result, as well as in case of a fault or breakdown.
Additional Aspects to be Considered
The guidance also covers additional important points the parties involved should take into consideration. This includes, inter alia, the health- and safety-related aspects associated with the point of care test devices. In particular, it is important to consider the hazards associated with the use of test devices outside the laboratory environment. For instance, it is important to determine whether the use of POCT devices complies with the applicable health and safety policy.
The healthcare professionals and other persons using point of care test devices should pay attention to the following safety-related aspects:
- Standard (universal) infection control precautions,
- The prevention of occupational exposure to blood-borne viruses, the wearing of gloves and other protective clothing, and the prevention of sharps injuries,
- Prevention of cross-infection with blood-borne viruses, including a selection of appropriate lancing devices,
- Safe handling and disposal of healthcare waste, including sharps,
- Safe medical device use, including decontamination of reusable devices.
In terms of other safety-related aspects associated with medical devices, the MHRA refers to the Health and Social Care Act 2008: Code of Practice of the NHS on the prevention and control of healthcare-associated infection and related guidance.
Under the general rule, in the case of taking samples from more than one patients, one of the following approaches should be applied:
- The use of disposable single-use lancing devices, providing that such a device is being used only once, or
- The use of a reusable lancing device, providing that such use is initially prescribed by the medical device manufacturer.
The MHRA also emphasizes the importance of quality assurance (QA). According to the guidance, QA stands for the measures to be implemented in order to ensure the reliability of the results obtained by the means of a point of care test. It includes such aspects as:
- Identification of a patient subject to examination,
- Use of the appropriate test,
- Collection of a specimen in a way prescribed by the medical device manufacturer to ensure it would be satisfactory,
- Carrying out the analysis and ensuring its results are duly documented,
- Interpretation of the test results in a correct way,
- Ensuring that all necessary actions are taken on the basis of the results obtained,
- Duly documenting and sustaining compliance with the regulatory requirements in terms of record keeping.
Summarizing the information provided here above, the present MHRA guidance outlines the regulatory requirements for the point of care test devices and also provides additional clarifications and recommendations in this regard. In particular, the document emphasizes the most important aspects to be considered by all the parties involved in operations with POCT services, including medical device manufacturers and healthcare professionals.
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