The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published updated guidance on in vitro diagnostic (IVD) medical devices intended for point of care use. The initial version of the guidance was published earlier in 2002. The present version of the document already incorporates the changes resulting from the end of the transition period with the European Union.
Regulatory Background
The present MHRA guidance is intended to provide additional clarifications and recommendations with regard to the regulatory requirements for point-of-care testing (POCT) IVD devices. First of all, the agency outlines the main points covered by the guidance, namely:
- A clinical need must be identified before the implementation of a POCT service.
- Consider involving the local hospital laboratory in the management of POCT services.
- Lines of accountability for POCT management must be clear.
- Managers of POCT services must be aware of their responsibilities under clinical governance.
- Arrangements for training, management, quality assurance (QA) and quality control (QC), health and safety policy, and the use of standard operating procedures (SOPs) must be made and reviewed at frequent specified intervals.
- Assessment of the service by an external accreditation body is recommended.
- You should consider the available evidence for the performance of the test.
- Adverse incidents must be reported to the MHRA.
- Clear, comprehensive record-keeping and documentation are vital.
- Everyone involved in POCT should know what to do in the event of any abnormal result or unsatisfactory QC result.
The guidance is addressed mostly to healthcare professionals directly operating POCT services and advising patients on the use of self-testing devices. However, the main points outlined therein should be also taken into consideration by other parties involved.
The MHRA states that medical technologies have improved dramatically from the date the initial version of the present guidance was released. The regulating authority acknowledges that due to the general technological advancement the effectiveness of IVD test devices has increased significantly, while the actual accuracy and reliability of the results depends also on the way they are being used.
According to the document, the most important features of POCT are:
- They could be used in different locations;
- They should be used by healthcare professionals having necessary knowledge and skills, while training and competence of such healthcare professionals should be duly recorded;
- The main concepts associated with POCT are quality assurance (QA), interpretation of test results, and limitations for use. The information on all these aspects should be properly communicated to the healthcare professionals using them.
The MHRA acknowledges that similar guidance documents have already been issued by various institutions and organizations, so it is important to focus on the most important aspects to be considered by ones actually using POCT. The present guidance complements the appropriate guidelines on the regulatory requirements for in vitro diagnostic devices.
POCT Regulatory Requirements in Detail
According to the present MHRA guidance, POCT could be defined as any analytical test performed for a patient by a healthcare professional outside the conventional laboratory setting. Other applicable terms include, inter alia, the following ones:
- Near patient testing (NPT);
- Bedside testing;
- Extra-laboratory testing;
- Disseminated / decentralized laboratory testing.
As it was already mentioned before, the use of POCT provides additional flexibility – such IVD test devices could be used in secondary care facilities (e.g. ambulance service, dental clinics, neonatal units), and well as in primary care facilities (e.g. community clinics, GP surgeries, dental surgeries, mobile units). The document also provides examples of POCT including such devices as bilirubin meters, coagulometers, pregnancy tests, and urinalysis test strips.
In general, all POCT systems could be divided into the following categories:
- Non-instrumental systems, disposable systems, or devices. For instance, this category includes multi-analyte reagent strips.
- Small analyzers.
- Desktop analyzers.
POCT Implementation: Key Aspects
The MHRA outlines the most important aspects to be considered before the implementation of a POCT solution. However, the same approach and similar regulatory requirements could be applied in the case of already existing POCT services.
According to the document, the local hospital pathology laboratory should play a key role in the development and management of a POCT service. For instance, the pathology laboratory can provide advice on a wide range of questions such as the ones related to purchasing medical devices, training of healthcare staff, quality assessment and control, as well as any other important safety-related matters.
The MHRA states that when considering the implementation of a POCT service, an interested party shall pay attention to the following aspects:
- Existing clinical need in such a solution, and
- Benefits to the patients associated with the potential use of a POCT service.
Under the general rule, the implementation of a POCT solution should be at least as effective, as existing options.
In order to identify whether there are benefits to patients, the following aspects should be considered:
- The way the service is being provided at the present time,
- The attempts that have been already made to address the needs,
- The particular groups of patients that need testing, as well as the type of testing these patients need,
- The current situation with the availability of laboratory service,
- The way the POCT solution to be implemented could provide additional clinical benefit,
- The extent to which a POCT solution would accelerate the diagnosis or treatment, or make them more effective,
- Benefits to patients in case of the alternative approach are applied.
The regulating authority also emphasizes the importance of rigorous evaluation of all the advantages and disadvantages associated with the use of POCT. The document provides some examples of both advantages and disadvantages, namely:
- Potential advantages: reduction of the turnaround time, reduction of need in sample and reagent volumes, easier access to service for certain categories of patients or in remote areas, potential economic benefits, and also the general improvement of the patient experience.
- Potential disadvantages: decrease in the quality of analysis, lower effectiveness of the record-keeping, unnecessary or inappropriate testing performed by the patients due to the expanded availability of testing, incompatibly with laboratory results, additional expenses – in some cases, they could exceed the ones associated with the usual testing.
Summarizing the information provided here above, the updated MHRA guidance on in vitro diagnostic point of care test devices contains important recommendations and clarifications to be considered by all the parties involved. In particular, the document provides a kind of checklist based on the current regulatory requirements for POCT services. The guidance describes in detail the main aspects to be considered before implementation of a POCT solution, as well as the issues arising when using such systems on a daily basis. Additionally, the document provides a general overview of the existing regulatory framework, including the definitions of the core concepts and terms. The information provided therein would be useful for healthcare professionals using in vitro diagnostic point-of-care test devices as an alternative to usual laboratory testing in cases when such substitution is admissible and justified with regard to the benefits to patients. According to the document, such benefits could include the expanded availability of testing, as well as the significant reduction in the time the testing takes.
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