Thermidas Thermal Imaging System

The Thermidas system is based on infrared thermal imaging conducted by a health care professional. Its purpose is to measure the surface temperature of the skin in a non-invasive manner, providing information to support diagnostics and the monitoring of treatment. Due to the nature of the thermal imaging method, the temperature readings are to be understood proportionally. They should not be interpreted as absolute values or used to measure fever. Infrared imaging should not be used as the sole examination method, so it is not possible to make a diagnosis based on infrared imaging alone. ¹

The clinical assessment Report (CER) produced by the manufacturer contains a literature review on the safety, benefits and suitability of the solution based on scientific knowledge.^2-9 The clinical applicability of infrared thermal imaging has been studied as a means of supporting patient self-care and as a tool for diagnostics and the monitoring of treatment provided by a professional. Evidence exists of the utility of infrared thermal imaging and theoretical cost savings, particularly in the monitoring of diabetic podiatric conditions and inflammatory rheumatoid arthritis, as well as in support of diagnostics.^10-15

The manufacturer has demonstrated through a clinical study that their solution is able to detect temperature differences in the feet of a group of patients at high risk due to diabetes¹³. 118 diabetic patients and 93 healthy individuals were sampled in the study. For all participants, ankle brachial index and toe pressure measurements were conducted along with infrared temperature imaging using a standardised temperature measurement protocol across five regions of the foot. Infrared thermal imaging was analysed using Thermidas Imager and FLIR ResearchIR software. Patients with diabetes were found to generally had warmer feet and had a significantly higher temperature difference between their feet (p < 0.001) than controls.  The average temperatures were highest in patients suffering from neural ischemia. Toe pressure (TP) correlates with temperatures: the average temperatures at all measuring sites were significantly higher with an abnormal TP than with a normal TP (p < 0.001). The study thus concluded that infrared thermal imaging was able to reveal local temperature differences in high-risk diabetic feet. Normal skin surface temperature varies from one individual to another, but infrared thermal imaging together accompanied by other methods may be useful for clinical screening.¹³

Clinical  studies have shown that the method provides diagnostic added value in monitoring temperature differences. It can indicate e.g. changes in the circulatory index, subclinical infections, the severity of vascular disease, and specific complications of Charcot neuro-osteoarthropathy, but there is still little evidence of these available^14-15. Through a cross-sectional study, it has also been shown that combined thermal and ultrasound imaging provides better information about the area under examination than either imaging method used alone in assessing arthritis in rheumatoid arthritis cases¹² .

Literature review

Thermometry has been shown to have beneficial effects in monitoring the incidence of diabetic foot ulcers compared to traditional methods². Referring to the systematic literature review containing a meta-analysis by Araújo et al., evidence of the effectiveness of home thermometry is reasonable in the prevention of diabetic foot ulcers (RR 0.53; 95% CI 0.29-0.96; p = 0.02)¹⁶.

As a specific method, thermometric infrared thermal imaging has been shown to be a reliable and reproducible method for measuring temperature across areas, compared to traditional point-like temperature measurements in healthy adults^17-18.

A systematic overview of the effectiveness of infrared thermal imaging has been published ¹⁹, which shows the method can be used to assess the development of the inflammatory process and whether specific treatments are having an effect, as well as pinpointing the exact locus of a given pathology for the purposes of targeted procedures ^{19, 20, 21}.^. Benefits can be demonstrated in situations where the temperature of the anatomic areas to be imaged is sufficiently different from the background, such when supporting the diagnostics and monitoring of the treatment of foot complications in diabetic patients^{22, 23.}

There is also evidence to support effectiveness in monitoring the treatment of a patient group diagnosed with Charcot’s foot ⁴. The method may be useful for the monitoring of rheumatoid arthritis in the hands and wrists²⁴, for monitoring the treatment of pressure wounds²⁵ and for the prevention of ulcers in high-risk diabetic feet²⁶.

The evidence of effectiveness as it pertains to the sensitivity of the method is partly contradictory. The method has been found to be sufficiently sensitive to reliably identify a large number of “hot spots”, but there is little evidence in the studies as they have not reported actual negative values related to “cold spots”. ²⁷

Recommendations and previous assessments

The current Finnish national care recommendation for diabetic foot issues considers both skin temperature measurements and thermal imaging in the monitoring of patient groups diagnosed with Charcot foot.⁹

The manufacturer has a risk management system in place in accordance with ISO 14971:2019, which is regularly updated. The design of the solution has identified possible risks and a risk management plan has been drawn up to prevent or to minimise such risks. Risks have been comprehensively mapped and documented during the development phase of the product as part of the CE conformity assessment process, both theoretically and on the basis of usability testing. The comments, limitations and warnings regarding use are clearly described in the user manual provided by the manufacturer.¹

The manufacturer has processes and a responsible person for handling adverse events. Incidents that occurred in the use of the solution and were reported to the company, as well as customer complaints, have been reported and handled appropriately. No adverse events have been reported for the solution.¹

The costs related to the solution consist of one-off procurement as well as maintenance and life-cycle costs. The purchase price includes deployment training. Post-acquisition product and maintenance support is subject to a fee.¹

The manufacturer can demonstrate theoretical evidence of the benefits of the solution in relation to costs. With reference to the cost analyses by Kurkela et al. 2022 and Kurkela et al. 2023: the theoretical cost of the solution is reasonable and, on a case-by-case basis, lower compared to similar traditional methods for treating diabetic-centred foot problems.^10-11 Cost analysis modelling demonstrated a potential for significant long-term savings. However, when assessing the potential for savings, it should be taken into account that indirect costs were not included in the calculation criteria: thermal examination alone does not indisputably support a diagnosis, but recommends additional examinations that would increase hypothetical costs.^10-11

The information security and data protection requirement database for purchases by the social care and health care services, as well as response material delivered by Thermidas Oy, have been used in the evaluation¹.

The Thermidas solution meets the essential requirements of data security and protection. However, the client organisation should pay attention to the responsibilities imposed on the client organisation under the Hardware and Other Considerations headings.

Risk management and data security testing

The development of the service has taken into account the security risks and a comprehensive risk assessment has been drawn up for the service.

Log management

The Remote Imager and Thermidas Imager software included in the service provide technical logs of usage. The service database solution also provides technical log of usage. The log data generated by the service is under the control of the client organisation and tracing logs are collected from professional data processing.

User management

The user credentials of the software included in the service are managed manually by either the client organisation or Thermidas Oy. User management does not support role-based user rights management. User access and activity may be further restricted by the client organisation through the user rights management interface included in the Windows operating system.

The service does not support two-step authentication.

Hardware

The client organisation is responsible for defining the security of the product’s operating environment and for maintaining the operating system components. In addition, the client organisation is responsible for storing, archiving, and backing up the data generated by the service. Thermidas Oy is responsible for updating and maintaining the software included in the service through a remote connection to be defined with the customer organization.

The service requires an internal network within the organization and the ability to assign a fixed IP address to components of the service.

Data protection

User and patient data stored in the software are to be stored encrypted on the database servers under the control of the client organisation. A data protection impact assessment has been prepared for the service by Thermidas Oy.

Other Considerations

The service is only available as an On-Premises solution.

The client organisation should ensure that the organisation has sufficient professional skills to maintain the servers and systems required by the service and is aware of the maintenance burden and impact on the organization’s data security and protection. In addition, the client organisation should investigate the archiving or retention time requirements of the data produced by the service together with the organization’s data protection expert.

An AI-based cloud computing service is an additional feature that may be utilised in the analyses produced by the product, but it and any other additional features or integrations that may be related to the product are not included in this evaluation. When employing such additional features, the client organisation should assess and be aware of their impact on data security and protection.

General guidance on procurement

During the purchase phase it is always important to contact the IT management, data security specialist and data protection specialist of the organisation. Please discuss with them whether the product in question fulfils your requirements. In addition, we recommend that health care districts utilise the European Union Agency for Cybersecurity’s (ENISA) data security manual for purchases.²⁸

The solution is intended for use by a health care professional. According to the manufacturer, the development of the usability of the product is a continuous process and the manufacturer has a channel for feedback.¹

According to the manufacturer, the solution complies with IEC 62366-1:2015 and IEC 60601-1-6:2010 and has been subjected to IEC/TR 62366-2:2016 usability tests. In the development process the solution, formative usability testing involving end-users of the solution has been carried out. On the basis of the usability testing, changes have been made to the risk management plan, and the final functionality of the system has been verified in the operating environment through summary user testing.¹

The use of the solution is supported by a user manual containing instructions on the operating environment, patient preparation, maintenance and cleaning, among other things. The terminology of the product is consistent with that generally used in the health care field and does not include hard-to-understand jargon¹.  User feedback is processed systematically and the trends and procedures related to it are reviewed every month.¹

The solution is not covered by the Digital services Act.^{29, 30} Its accessibility has been investigated and the accessibility limitations related to the solution described in the accessibility statement³¹, taking into account noticeability, manageability, intelligibility and operational reliability. The prerequisites, considerations, limitations, and warnings pertaining to the use of the solution are described in the user manual provided by the manufacturer, assuming that the system will be operated by persons without limitations related to the interpretation of colours. This assumption is based on the presentation of thermal images, which rely heavily on the use and interpretation of a full spectrum of colour.¹

General guidance on procurement

The purchasing organisation shall take into account the accessibility requirements set out in the legislation in force at the time.³²

Interoperability

The solution is an On-Premises software solution provided on the Microsoft Windows platform. The solution does not contain interfaces with any external systems. All data transfer to external systems shall be made manually by the user. It is possible to produce patient-specific reports in the PDF, PNG, and JPEG formats through the operating system.

The system is compatible with the following  Series A and Series T thermal imager models made by FLIR Inc.: E6xt, E8xt, E86, E96, T540, T560, and T1020. In addition, the system is compatible with the IRT-384 camera certified under US FDA Class I. Images captured with a third party thermal camera can also be imported into Thermidas Imager through a USB port. The factory setting for the image format is PNG. If a JPEG image format is desired instead, the manufacturer must be contacted.¹

Technical functionality

The manufacturer complies with IEC 62304:2015 with regard to the management of medical device software lifecycle processes. The solution has not been out of use for the past six months due to a failure. The manufacturer provides prior notification of product updates, and furthermore, it is possible to roll back to earlier versions of the product. The device manufacturer recommends conducting a maintenance of the solution every three years. The user is responsible for the periodic maintenance of the computer.¹

Training and product support

The system may only be used by a health care professional certified by the manufacturer as a thermographer and granted credentials to the operating system on the basis of operational training. The intended professional groups include doctors, nurses, and podiatric therapists. Advanced education in thermography and the granting of a competence-based qualification are part of the implementation of the solution. The use of the system is supported by a user manual containing e.g. operating environment, patient preparation, maintenance and cleaning instructions.¹

Distribution of the product

The solution is locally implemented in Finland in public and private health care as well as in an international trial in Europe, the United States and the United Arab Emirates.¹

1. The Digi-HTA questionnaire filled out by the company, not public information.
2. Bus SA, Lavery LA, Monteiro‐Soares M, Rasmussen A, Raspovic A, Sacco ICN, et al. 2020.Guidelines on the prevention of foot ulcers in persons with diabetes (IWGDF 2019 update). Diabetes Metab Res Rev. 2020;36:e3269.
3. Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Armstrong DG, et al. 2004. Home monitoring of foot skin temperatures to prevent ulceration. Diabetes Care. 2004;27(11):2642–7.
4. Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Athanasiou KA, et al.2007. Preventing diabetic foot ulcer recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool. Diabetes Care. 2007;30(1):14–20.
5. Armstrong DG, Holtz-Neiderer K, Wendel C, Mohler MJ, Kimbriel HR, Lavery LA. 2007. Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. Am J Med. 2007;120(12):1042–
6. Skafjeld A, Iversen M, Holme I, Ribu L, Hvaal K, Kilhovd B. 2015 A pilot study testing the feasibility of skin temperature monitoring to reduce recurrent foot ulcers in patients with diabetes–a randomized controlled trial. BMC Endocr Disord. 2015;15(1):1–7.
7. Petrova NL, Donaldson NK, Tang W, MacDonald A, Allen J, Lomas C. 2020. Infrared thermography and ulcer prevention in the high‐risk diabetic foot: data from a single‐blind multicentre controlled clinical trial. Diabet Med. 2020;37(1):95–104.
8. Bus SA, Wouter B, van Baal JG, Busch-Westbroek TE, Nollet F, van Netten JJ. 2021. Effectiveness of at-home skin temperature monitoring in reducing the incidence of foot ulcer recurrence in people with diabetes: a multicenter randomized controlled trial (DIATEMP). BMJ Open Diabetes Res Care. 2021;9(1):e002392.
9. Diabeetikon jalkaongelmat (Foot issues of diabetics) Käypä hoito Current Care Guidelines Working group appointed by the Finnish Medical Society Duodecim and the Diabetes Current Care Guidelines Advisory Board. Helsinki: Finnish Medical Society Duodecim, 2021. Available: kaypahoito.fi Accessed 31 October 2022.
10. Kurkela, O. ; Nevalainen, J. ; Arffman, M. ; Lahtela, J. & Forma, L. 2022. Foot-related diabetes complications: care pathways, patient profiles and costs. Referenced 30 January 2023. Available at https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-022-07853-2
11. Kurkela O, Lahtela J, Arffman M, Forma L. 2023. Infrared Thermography Compared to Standard Care in the Prevention and Care of Diabetic Foot: A Cost Analysis Utilizing Real-World Data and an Expert Panel. Clinicoecon Outcomes Res. 2023 Feb 22;15:111-123. doi: 10.2147/CEOR.S396137. PMID: 36855751; PMCID: PMC9968423.
12. Tan et al 2021. Tan YK, Hong C, Li H, Allen JC Jr, Thumboo J. 2021. A novel use of combined thermal and ultrasound imaging in detecting joint inflammation in rheumatoid arthritis. Eur J Radiol. 2021 Jan;134:109421. doi: 10.1016/j.ejrad.2020.109421. Epub 2020 Nov 20. PMID: 33254064.
13. Ilo, A., Romsi, P., & Mäkelä, J. 2020. Infrared thermography and vascular disorders in diabetic feet. Journal of Diabetic Science and Technology, 14(1), 28–36. https://doi.org/10.1177/1932296819871270
14. Ilo, A., Romsi, P., Pokela, M., & Mäkelä, J. 2020. Infrared thermography follow-up after lower limb revascularization. Journal of Diabetic Science and Technology. https://doi.org/10.1177/1932296820912311
15. Ilo, A., Romsi, P., & Mäkelä, J. 2020. Infrared Thermography as a Diagnostic Tool for Peripheral Artery Disease. Advances in skin & wound care, 33(9), 482–488. https://doi.org/10.1097/01.ASW.0000694156.62834.8b
16. Araújo AL, Negreiros FDDS, Florêncio RS, Oliveira SKP, Silva ARVD, Moreira TMM. 2022. Effect of thermometry on the prevention of diabetic foot ulcers: a systematic review with meta-analysis. Rev Lat Am Enfermagem. 2022;30:e3567. doi: 10.1590/1518-8345.5663.3567. Erratum in: Rev Lat Am Enfermagem. 2022;30:e3751. PMID: 35584410; PMCID: PMC9109465.
17. Petrova NL, Donaldson NK, Tang W, MacDonald A, Allen J, Lomas C, Leech N, Ainarkar S, Bevans J, Plassmann P, Kluwe B, Ring F, Whittam A, Rogers L, McMillan J, Simpson R, Donaldson ANA, Machin G, Edmonds ME. 2020. Infrared thermography and ulcer prevention in the high-risk diabetic foot: data from a single-blind multicentre controlled clinical trial. Diabet Med. 2020 Jan;37(1):95-104. doi: 10.1111/dme.14152. Epub 2019 Nov 13. PMID: 31629373
18. Alfieri FM, Battistella LR. 2018. Body temperature of healthy men evaluated by thermography: A study of reproducibility. Technol Health Care. 2018;26(3):559-564. doi: 10.3233/THC-171164. PMID: 29578493.
19. Kumar P, Gaurav A, Rajnish RK, Sharma S, Kumar V, Aggarwal S, Patel S. 2021. Applications of thermal imaging with infrared thermography in Orthopaedics. J Clin Orthop Trauma. 2021 Nov 29;24:101722. doi: 10.1016/j.jcot.2021.101722. PMID: 34926152; PMCID: PMC8646160.
20. Chanmugam A, Langemo D, Thomason K, Haan J, Altenburger EA, Tippett A, Henderson L, Zortman TA. 2017. Relative Temperature Maximum in Wound Infection and Inflammation as Compared with a Control Subject Using Long-Wave Infrared Thermography. Adv Skin Wound Care. 2017 Sep;30(9):406-414. doi: 10.1097/01.ASW.0000522161.13573.62. PMID: 28817451.
21. Fidut-Wrońska J, Chołuj K, Chmiel J, Pikto-Pitkiewicz K, Majcher P. 2019. Observation using thermography of post-operative reaction after fascial manipulation®. Ann Agric Environ Med. 2019 Sep 19;26(3):468-471. doi: 10.26444/aaem/103456. Epub 2019 Feb 25. PMID: 31559805.
22. Zhang S, Liu Y, Liu X, Liu T, Li P, Mei W. 2021. Infrared thermography for assessment of thoracic paravertebral block: a prospective observational study. BMC Anesthesiol. 2021 Jun 11;21(1):168. doi: 10.1186/s12871-021-01389-4. PMID: 34116642; PMCID: PMC8194215.
23. Sardjoe Mishre ASD, Straat ME, Martinez-Tellez B, Mendez Gutierrez A, Kooijman S, Boon MR, Dzyubachyk O, Webb A, Rensen PCN, Kan HE. 2022. The Infrared Thermography Toolbox: An Open-access Semi-automated Segmentation Tool for Extracting Skin Temperatures in the Thoracic Region including Supraclavicular Brown Adipose Tissue. J Med Syst. 2022 Nov 2;46(12):89. doi: 10.1007/s10916-022-01871-7. PMID: 36319877; PMCID: PMC9626432.
24. Gatt A, Mercieca C, Borg A, Grech A, Camilleri L, Gatt C, Chockalingam N, Formosa C. 2019. A comparison of thermographic characteristics of the hands and wrists of rheumatoid arthritis patients and healthy controls. Sci Rep. 2019 Nov 25;9(1):17204. doi: 10.1038/s41598-019-53598-0. PMID: 31767935; PMCID: PMC6877528.
25. Bilska A, Stangret A, Pyzlak M, Wojdasiewicz P, Szukiewicz D. 2020. Skin surface infrared thermography in pressure ulcer outcome prognosis. J Wound Care. 2020 Dec 2;29(12):707-718. doi: 10.12968/jowc.2020.29.12.707. PMID: 33320753.
26. Aliahmad B, Tint AN, Poosapadi Arjunan S, Rani P, Kumar DK, Miller J, Zajac JD, Wang G, Ekinci EI. 2018. Is Thermal Imaging a Useful Predictor of the Healing Status of Diabetes-Related Foot Ulcers? A Pilot Study. J Diabetes Sci Technol. 2019 May;13(3):561-567. doi: 10.1177/1932296818803115. Epub 2018 Sep 26. PMID: 30255722; PMCID: PMC6501524.
27. Berner JE, Pereira N, Troisi L, Will P, Nanchahal J, Jain A. 2021. Accuracy of infrared thermography for perforator mapping: A systematic review and meta-analysis of diagnostic studies. J Plast Reconstr Aesthet Surg. 2021 Jun;74(6):1173-1179. doi: 10.1016/j.bjps.2020.12.093. Epub 2021 Jan 11. PMID: 33573886.
28. The European Union Agency for Cybersecurity Procurement Guidelines for Cybersecurity in Hospitals. Available at: https://www.enisa.europa.eu/publications/good-practices-for-the-security-of-healthcare-services Accessed 25 October 2022.
29. Act on the Provision of Digital Services 306/2019. Available at: https://www.finlex.fi/fi/laki/alkup/2019/20190306 Accessed 25 October 2022
30. Regional State Administrative Agency of Southern Finland, Accessibility supervision unit. The requirements of the Act on Provision of Digital Services. Available at: https://www.saavutettavuusvaatimukset.fi/digipalvelulain-vaatimukset/ Accessed 25 October 2022
31. Thermidas accessibility report 2023. Available https://thermidas.fi/fi/ohjelmistojen-saavutettavuusselvitys/ Accessed 23 March 2023.
32. Act on Public Procurement and Concession Contracts 1397/2016. Available at: https://www.finlex.fi/fi/laki/alkup/2016/20161397 Accessed 25 October 2022

Jarno Suominen, Senior Planning Officer, FinCCHTA

Joni Liljeblad, Information Security Expert, Oulu University

Jari Haverinen, Senior Planning Officer, FinCCHTA

Petra Falkenbach, Head of Assessment, FinCCHTA