The UK Medicines & Healthcare products Regulatory Agency (MHRA), the country’s regulating authority in the sphere of medicinal products and medical devices, has published a guidance document dedicated to the equipment for temperature screening intended to be used in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus.”
In particular, the document issued by the MHRA:
- Provides the definition of “temperature screening equipment” covered by the scope of the respective regulatory policy;
- Describes the applicable classification;
- Highlights the most important aspects associated with the use of such equipment during the pandemic;
- Outlines the core points to be considered by the parties involved in operations with temperature screening equipment;
- Provides additional clarifications regarding the obligations and responsibilities of the medical device manufacturers and supplies;
- Explains how the parties involved should report any issues associated with such devices.
Temperature Screening Equipment: Definition
The authority acknowledges the increasing use of equipment intended for contact-less temperature screening, including thermal cameras and infrared thermometers. In particular, such equipment is used to monitor the temperature of people in order to identify individuals who could be infected and thus cause hazards to others. However, the authority also states this category actually covers two types of products: those initially intended to be used for such purpose (and thus subject to regulation under medical device framework), and also those initially intended for other, non-medical purpose, for which the scope of use was then extended to medical application. Nowadays, such products could be used, for example, for preliminary temperature screening in public places.
Regarding the definition of a medical device, the guidance refers to Regulation 2(1) of the UK Medical Device Regulations 2002, stating that medical devices are products with an intended medical purpose that is achieved through physical or mechanical means and not by pharmacological, immunological or metabolic means. The authority further expresses the position that any and all products initially intended to be used to measure the body temperature of people in order to identify individuals with a temperature above the normal threshold fall within the scope of the definition of a medical device. Consequently, such products should be subject to regulation under the medical devices framework and comply with all applicable regulatory requirements. The determination of whether the product in question should be regulated as a medical device is actually based on the claims made by its manufacturer. If the product is regulated as a medical device with measuring functions, the manufacturer shall have in place all necessary documentation indicating the level of accuracy of the measurements provided by such devices. The authority additionally emphasizes that such products should be marked with CE, CE UKNI, UKCA marks.
It is also important to mention that some of the products that are used nowadays for temperature screening were initially intended for non-medical purposes. Such products include the following:
- Thermal cameras for:
- Premises security,
- Fire and Rescue services,
- Military use;
- Infrared thermometers and thermal cameras designed to measure temperatures during industrial manufacturing processes.
The authority states that measurements performed with the use of such equipment are not accurate enough to be used for medical purposes. Hence, such products fall outside the scope of medical devices regulations.
Temperature Screening During the Pandemic
According to the information available, fever constitutes one of the easily identifiable symptoms of Coronavirus Disease, facilitating the identification of people who are suspected to be infected. Thus, temperature screening is widely used to prevent access of people who are potentially infected to public places in order to prevent exposure to others. The medical devices usually used for such purposes are intended for performing measurements without close physical contact. This allows them to cover a large number of people within a short period of time. At the same time, this should not be treated as the only or the most important way of identifying people who are infected. The authority mentions that in certain cases, the accuracy level of measurement is not sufficient for its results to be reliable. This mostly depends on the specifications of the products used for such purposes. It is stated that there are certain limitations associated with the use of temperature screening equipment for identifying people who are potentially infected.
For instance, this approach could be ineffective if the people infected:
- Are asymptomatic (people who do not feel or look ill and may not realize they are infected at all);
- Are at an early stage of infection and have not yet begun to display any signs or symptoms;
- Display other symptoms such as a cough, but never develop a fever;
- Develop a fever during the course of their infection, but do not have a raised temperature at the moment their temperature is checked.
Aspects to be Considered
The present MHRA guidance also highlights the most important aspects to be considered by those purchasing temperature screening equipment or performing such screening in the context of COVID-19. The use of temperature screening equipment should not rely significantly on the results it provides, as it could lead to exposure to additional risks. Nowadays, it is not forbidden to perform temperature screening when using products initially intended for non-medical purposes. At the same time, those using such equipment should be fully aware of the risks associated with the potential inaccuracy of the results of such screening. As it is stated by MHRA, such off-label use could create a false sense of security.
The authority provides the following recommendations to be taken into consideration by the entities using temperature screening equipment:
- Temperature screening performed with the use of non-contact products should not be construed as a replacement to any additional preventive measures;
- The instructions for use provided by the product’s manufacturer should be strictly followed;
- The staff using the equipment should be familiar with how it should be used to ensure correct performance and accurate results;
- There should be the appropriate instructions describing the actions to be taken in case there is a person with a raised temperature identified;
- Apart from temperature screening, additional testing methods could be employed, including ones based on the use of approved diagnostic medical devices.
The MHRA additionally emphasizes that there are no “MHRA approved” temperature screening products.
When purchasing non-contact temperature screening equipment, an interested party shall rigorously check the specifications provided by its manufacturer, especially in terms of the level of accuracy of measurements the product performs. According to the guidance, this should be plus or minus 0.5°C (or better) for thermal cameras or plus or minus 0.3°C (or better) for thermometers.
In summary, the present MHRA guidance outlines the most important aspects to be considered with regard to the use of temperature screening equipment in the context of the COVID-19 outbreak. The authority describes the main risks associated with such use, mostly associated with the potential inaccuracy of measurements.
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