Credibility assessment of in silico clinical trials for medical devices.

In silico clinical trials (ISCTs) are an emerging method in modeling and simulation where medical interventions are evaluated using computational models of patients. ISCTs have the potential to provide cost-effective, time-efficient, and ethically favorable alternatives for evaluating the safety and effectiveness of medical devices. However, ensuring the credibility of ISCT results is a significant challenge. This paper aims to identify unique considerations for assessing the credibility of ISCTs and proposes an ISCT credibility assessment workflow based on recently published model assessment frameworks. First, we review various ISCTs described in the literature, carefully selected to showcase the range of methodological options available. These studies cover a wide variety of devices, reasons for conducting ISCTs, patient model generation approaches including subject-specific versus 'synthetic' virtual patients, complexity levels of devices and patient models, incorporation of clinician or clinical outcome models, and methods for integrating ISCT results with real-world clinical trials. We next discuss how verification, validation, and uncertainty quantification apply to ISCTs, considering the range of ISCT approaches identified. Based on our analysis, we then present a hierarchical workflow for assessing ISCT credibility, using a general credibility assessment framework recently published by the FDA's Center for Devices and Radiological Health. Overall, this work aims to promote standardization in ISCTs and contribute to the wider adoption and acceptance of ISCTs as a reliable tool for evaluating medical devices.

Implications of variability on medical device chemical equivalence assessment.

Chemical equivalence testing can be used to assess the biocompatibility implications of a materials or manufacturing change for a medical device. This testing can provide a relatively facile means to evaluate whether the change may result in additional or different toxicological concerns. However, one of the major challenges in the interpretation of chemical equivalence data is the lack established criteria for determining if two sets of extractables data are effectively equivalent. To address this gap, we propose a two-part approach based upon a relatively simple statistical model. First, the probability of a false positive conclusion, wherein there is an incorrectly perceived increase for a given analyte in the comparator relative to the baseline device, can be reduced to a prescribed level by establishing an appropriate acceptance criterion for the ratio of the observed means. Second, the probability of a false negative conclusion, where an actual increase in a given analyte cannot be discerned from the test results, can be minimized by specifying a limiting value of applicability based on the margin of safety (MoS) of the analyte. This approach provides a quantitative, statistically motivated method to interpret chemical equivalence data, despite the relatively high intrinsic variability and small number of replicates typically associated with a chemical characterization evaluation.

Is read-across for chemicals comparable to medical device equivalence and where to use it for conformity assessment?

Novel medical devices must conform to medical device regulation (MDR) for European market entry. Likewise, chemicals must comply with the Registration, Evaluation, Authorization and Restriction of Chemicals (REACh) regulation. Both pose regulatory challenges for manufacturers, but concordantly provide an approach for transferring data from an already registered device or compound to the one undergoing accreditation. This is called equivalence for medical devices and read-across for chemicals. Although read-across is not explicitly prohibited in the process of medical device accreditation, it is usually not performed due to a lack of guidance and acceptance criteria from the authorities. Nonetheless, a scientifically justified read-across of material-based endpoints, as well as toxicological assessment of chemical aspects, such as extractables and leachables, can prevent failure of MDR device equivalence if data is lacking. Further, read-across, if applied correctly can facilitate the standard MDR conformity assessment. The need for read-across within medical device registration should let authorities to reconsider device accreditation and the formulation of respective guidance documents. Acceptance criteria like in the European Chemicals Agency (ECHA) read-across assessment framework (RAAF) are needed. This can reduce the impact of the MDR and help with keeping high European innovation device rate, beneficial for medical device patients.

Lifecycle evaluation of medical devices: supporting or jeopardizing patient outcomes? A comparative analysis of evaluation models.

OBJECTIVES: Lack of evidence regarding safety and effectiveness at market entry is driving the need to consider adopting a lifecycle approach to evaluating medical devices, but it is unclear what lifecycle evaluation means. This research sought to explore the tacit meanings of "lifecycle" and "lifecycle evaluation" as embodied within evaluation models/frameworks used for medical devices. METHODS: Drawing on qualitative evidence synthesis methods and using an inductive approach, novel methods were developed to identify, appraise, analyze, and synthesize lifecycle evaluation models used for medical devices. Data was extracted (including purpose; audience; characterization; outputs; timing; and type of model) from key texts for coding, categorization, and comparison, exploring embodied meaning across four broad perspectives. RESULTS: Fifty-two models were included in the synthesis. They demonstrated significant heterogeneity of meaning, form, scope, timing, and purpose. The "lifecycle" may represent a single stage, a series of stages, a cycle of innovation, or a system. "Lifecycle evaluation" focuses on the overarching goal of the stakeholder group, and may use a single or repeated evaluation to inform decision-making regarding the adoption of health technologies (Healthcare), resource allocation (Policymaking), investment in new product development or marketing (Trade and Industry), or market regulation (Regulation). The adoption of a lifecycle approach by regulators has resulted in the deferral of evidence generation to the post-market phase. CONCLUSIONS: Using a "lifecycle evaluation" approach to inform reimbursement decision-making must not be allowed to further jeopardize evidence generation and patient safety by accepting inadequate evidence of safety and effectiveness for reimbursement decisions.

Assessing medical devices: a qualitative study from the validate perspective.

OBJECTIVES: Our objective was to explore procedures and methods used at health technology assessment (HTA) agencies for assessing medical devices and the underlying views of HTA practitioners about appropriate methodology to identify challenges in adopting new methodologies for assessing devices. We focused on the role of normative commitments of HTA practitioners in the adoption of new methods. METHODS: An online survey, including questions on procedures, scoping, and assessments of medical devices, was sent to members of the International Network of Agencies for Health Technology Assessment. Interviews were conducted with survey respondents and HTA practitioners involved in assessments of transcatheter aortic valve implantation to gain an in-depth understanding of choices made and views about assessing medical devices. Survey and interview questions were inspired by the "values in doing assessments of health technologies" approach towards HTA, which states that HTA addresses value-laden questions and information. RESULTS: The current practice of assessing medical devices at HTA agencies is predominantly based on procedures, methods, and epistemological principles developed for assessments of drugs. Both practical factors (available time, demands of decision-makers, existing legal frameworks, and HTA guidelines), as well as commitments of HTA practitioners to principles of evidence-based medicine, make the adoption of a new methodology difficult. CONCLUSIONS: There is a broad recognition that assessments of medical devices may need changes in HTA methodology. In order to realize this, the HTA community may require both a discussion on the role, responsibility, and goals of HTA, and resulting changes in institutional context to adopt new methodologies.

Suitability of the Current Health Technology Assessment of Innovative Artificial Intelligence-Based Medical Devices: Scoping Literature Review.

BACKGROUND: Artificial intelligence (AI)-based medical devices have garnered attention due to their ability to revolutionize medicine. Their health technology assessment framework is lacking. OBJECTIVE: This study aims to analyze the suitability of each health technology assessment (HTA) domain for the assessment of AI-based medical devices. METHODS: We conducted a scoping literature review following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methodology. We searched databases (PubMed, Embase, and Cochrane Library), gray literature, and HTA agency websites. RESULTS: A total of 10.1% (78/775) of the references were included. Data quality and integration are vital aspects to consider when describing and assessing the technical characteristics of AI-based medical devices during an HTA process. When it comes to implementing specialized HTA for AI-based medical devices, several practical challenges and potential barriers could be highlighted and should be taken into account (AI technological evolution timeline, data requirements, complexity and transparency, clinical validation and safety requirements, regulatory and ethical considerations, and economic evaluation). CONCLUSIONS: The adaptation of the HTA process through a methodological framework for AI-based medical devices enhances the comparability of results across different evaluations and jurisdictions. By defining the necessary expertise, the framework supports the development of a skilled workforce capable of conducting robust and reliable HTAs of AI-based medical devices. A comprehensive adapted HTA framework for AI-based medical devices can provide valuable insights into the effectiveness, cost-effectiveness, and societal impact of AI-based medical devices, guiding their responsible implementation and maximizing their benefits for patients and health care systems.

Nursing care bundles in the prevention of medical device related pressure ulcers: An integrative review.

The aim of this integrative review was to explore the effect of care bundles in the prevention of Medical Device Related Pressure Ulcers (MDRPU). An MDRPU is a wound that occurs on the skin or mucosal membranes because of pressure or pressure in combination with shear. Like other types of pressure ulcers, they will have negative consequences for patients and healthcare organisations alike. Many MDRPU's are preventable. A literature search was undertaken from computerised databases using key search terms, Pressure Ulcer* Pressure Injur* and Medical Device*. Databases included CINAHL; Medline and SocIndex. A total of seven studies were found that met the criteria for inclusion in this review. When compared to the widely recognised and trusted international guidelines there was variation found between the individual interventions selected within each study for inclusion within the bundle. Skin assessment and device repositioning were the most frequently included interventions in the bundles, followed by use of prophylactic dressings, appropriate device selection and fitting. The least common intervention was monitoring the tension of the device and/or its securements. All studies reported a reduction in the number of MDRPU's when care bundles were used in clinical practice. However, there is variation in bundle designs and study methodologies employed. This review has demonstrated the potential benefit of care bundles in reducing MDRPU. However, due to heterogeneity in the study methods employed and the interventions within the care bundles, further, more robust research is required to establish which interventions show the most clinical and patient benefit.

Medical device-related pressure injuries prevention practices of intensive care unit nurses: A cross-sectional study in Turkey.

AIM: Medical device-related pressure injuries (MDRPIs) are becoming increasingly common across all healthcare services and age groups in terms of both incidence and severity. It is crucial for nurses to be aware that MDRPI is a potential complication of healthcare services. This study aimed to assess the preventive practices of intensive care unit (ICU) nurses in relation to MDRPIs. MATERIALS AND METHODS: This cross-sectional and descriptive study was conducted with 96 nurses between March 10 and April 31, 2021. The "Nurse Information Form" and the "MDRPIs Prevention Practices Questionnaire" form were used for the data collection. RESULTS: The overall practice scores of ICU nurses in preventing MDRPIs were 50.83 ± 12.93. Out of the participants, 57.3% (n = 55) achieved a total practice score of 51 and above out of 68 (considered an acceptable score indicating proficiency in positive practice). The items with the most negative practice levels among nurses were related to statements such as 'I apply hydrocolloid, thin foam, or a silicone-type dressing to prevent MDPRI' (2.86 ± 0.85) and 'I use the normal pressure injury staging when staging the MDRPI' (2.88 ± 0.86). No significant difference was observed between the mean scores of MDRPI prevention practices and the characteristics of ICU nurses, such as education level, years working in the unit, and years of experience in the profession (p > 0.05). Furthermore, a positive correlation was found between age and practice levels in preventing MDRPIs (p < 0.05). CONCLUSION: The study results indicate that the practice levels of ICU nurses in preventing MDRPIs were insufficient. We believe that regular in-service training programs, grounded in clinical practice, are necessary to enhance nurses' awareness and management of MDRPIs.

Evaluation of final-year nursing students' attitudes towards preventing medical device-related pressure ulcers using a ABC model of affect, behavior and cognitive dimensions.

INTRODUCTION: Half of the hospital-acquired pressure ulcers are associated with the use of medical devices. Nursing students provide care services to patients in clinical settings and intensive care units who have or are at risk for medical device-related pressure ulcers (MDRPUs). In the prevention and care of MDRPUs, the attitudes of nursing students towards preventing of pressure ulcers are as crucial as their knowledge level and clinical skills. AIM: The aim of this descriptive study is to assess the attitudes of final-year nursing undergraduate students towards preventing MDRPUs across cognitive, affective, and behavioral dimensions of ABC model. MATERIALS AND METHODS: Data of the study was handed between April 1 and December 31, 2021, with 147 final-year nursing students. Data were collected using the Student Information Form and the Attitude Towards Preventing Medical Device-Related Pressure Ulcers Questionnaire (ATP-MDRPUsQ). RESULTS: The mean attitude score towards preventing MDRPUs was 3.98 ± 0.45 on a 5-point Likert scale. The mean scores for the cognitive, affective, and behavioral sub-dimensions were 3.88 ± 0.57, 4.15 ± 0.51, and 4.00 ± 0.672, respectively. A moderate positive relationship was found between the cognitive sub-dimension and both the affective and behavioral sub-dimensions (r = 0.451; r = 0.302; p < 0.01, respectively). Based on cluster analysis, the mean attitude scores of students towards MDRPU prevention were grouped into two clusters. The students in Cluster-2 and female students had higher mean attitude scores (p < 0.01). The item with the lowest mean score in the questionnaire pertained to the item, "I believe that I need training on the etiology and prevention of medical device-related pressure ulcers." CONCLUSION: The general attitudes of final-year nursing students towards prevention MDRPU were satisfactory. However, their cognitive attitudes were less positive compared to their affective and behavioral attitudes. It is recommended to incorporate theoretical and practical courses focusing on the prevention of these injuries into nursing curricula to enhance students' knowledge and attitudes.

Medical device-related pressure injuries in intensive care patients: A prospective and descriptive study.

BACKGROUND: Treatment and care of patients in intensive care units require the use of many medical and technological instruments. Pressure injuries occur when medical devices, which are used more in intensive care patients and are in direct or indirect contact with the skin, cause focal and localized forces on the superficial or deep tissues. OBJECTIVE: In this study, it was aimed to examine the risk factors, incidence and characteristics of medical device-related pressure injuries in intensive care patients. METHODS: This study has a prospective and descriptive design. The study was carried out in the adult intensive care unit of a healthcare institution located in the western Turkey. 138 intensive care patients treated in the level 3 adult intensive care unit were enrolled in the study. The first observations and evaluations of intensive care patients in terms of pressure injuries were made within the first 24 h after admission to the clinic. Observations continued daily during the hospitalization period of the patient. Data were collected with the Intensive Care Patient Information Form, Glasgow Coma Scale, Braden Pressure Ulcer Risk Assessment Scale and Identification Form for Medical device-related Pressure Ulcers. Analysis of data was performed with descriptive statistical methods, Shapiro-Wilk Test, Mann-Whitney U Test and Chi-Square analysis. RESULTS: Medical device-related pressure injury developed in 11.6% (n = 16) of intensive care patients. Anatomically, pressure injury occurred most frequently on the lip (37.5%) and most frequently due to the intubation tube (37.5%). Most of the developed wounds (75.0%) were found to be stage 2. Multinominal logistic regression analysis, which was performed to determine the effect of independent variables on medical device-related pressure injuries in intensive care patients, was found to be statistically significant (X2 = 37.098, p < 0.001). When the regression coefficients were examined, it was found that total hospitalization time in the intensive care unit (ß = 0.948, p < 0.01) and PaCO2 level (ß = 0.923, p < 0.01) had a positive, and duration of aerobic respiration with nasal cannula or mask (ß = -0.920, p < 0.01) and Braden score (ß = -0.948, p < 0.01) had a negative and significant effect on medical device-related pressure injuries. CONCLUSIONS: In this study found that the MDRPIs development rate was lower than other studies. It was observed that pressure injuries due to medical devices developed more frequently in patients with longer hospitalization days, higher PaCO2 levels, shorter duration of oxygenated breathing with nasal cannula or mask, and lower Braden scores.

[Several Aspects Worthy of Attention in the Pre-research of Medical Device Standards].

The pre-research of medical device standards is of great significance for the enactment and amendment of standards. This study discusses four aspects and explores how to promote more scientific and reasonable pre-research. Based on the pre-research practice of medical device standards project, this study puts forward relevant work ideas and suggestions.

[Exploration of Application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices: Take Artificial Joint Products as Example].

Through the effective application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (EP), to continuously improve the corresponding management tools to ensure the safety and effectiveness of medical device in the quality management system, risk management system, evaluation of safety and effectiveness for the supervision departments and manufacturers. The current status of the application of EP and the application issues are analyzed in the study. Take artificial joint products for example, the idea of using EP in quality management system, risk management system and evaluation of safety and effectiveness is investigated, and several thoughts are proposed. Supervision departments should strengthen the unified understanding of EP, develop requirements according to the classification of medical device，and refine specific execution requirements.

[The problems and prospects of import substitution in medical industry].

The achievement of economic sustainability and assurance of national security through activation of production sectors, medical industry in particular, is the integral component of successful strategy of state development. The importance of achieving autonomy in production of medical technique is targeted to reducing dependence of external factors, ensuring continuity of supply of critically important equipment and increasing level of technical characteristics of production. Besides it, expansion of medical production positively impact on innovative development, organization of new work places and level of scientific research in this industry. The development of national medical industry contributes to improvement of quality of medical care that directly affect population health. The necessity to maintain stability of health care through import substitution of medical products is indisputable fact in modern conditions, determined by strategically important direction from national security point of view. The article considers measures within the framework of import substitution plan in medical industry of the Russian Federation for period up to 2024. The analysis of volume of national production of medical equipment in dynamics over 5 years was carried out. The main problems of production of medical devices at the present stage were considered. The measures of state support targeted to development of national production of medical equipment and innovative medical technologies were discussed.

[The issues of development and functioning of common market of medical equipment and articles within the framework of the Eurasian Economic Union].

The market of medical devices within the framework of the Eurasian Economic Union is regulated by special legislation that ensures formation of common market and compliance of products with all necessary requirements. This allows to ensure high level of quality of medical equipment and articles that contributes into improving safety and efficiency of medical procedures. The development of uniform requirements, considering world practices, is an important step, since it allows to guarantee high standards not only at level of single states, but also at level of the entire Union. This approach facilitates reinforcement of confidence to medical production of manufacturers from he Eurasian Economic Union countries. The article examines normative legal base regulating issues of formation and functioning of common market of medical equipment and articles within the framework of the Eurasian Economic Union. The analysis of normative legal base of the Russian Federation in section related to medical articles market was carried out. The analysis of the regulatory framework of the Russian Federation in terms of issues related to the market of medical devices was also carried out. The corresponding conclusions were made based on the study results.

Clinical evidence requirements according to the IVDR 2017/746: practical tools and references for underpinning clinical evidence of IVD-MDs.

In May 2022, the European Regulation 2017/746 (IVDR) came into force. It changes the approach of in vitro medical devices (IVD-MDs) for industry and institutions. It reinforces the clinical evidence requirements to improve performance, safety and transparency. Despite extended transition periods and existing guides, IVDR remains difficult to interpret and bringing devices into compliance requires efforts. The generation of clinical evidence is essential to demonstrate compliance with IVDR, and encompasses scientific validity, analytical performance and clinical performance. It is required to demonstrate, per intended use in the target population and clinical care pathway, IVD-MDs clinical performance (compared to a predefined clinical performance). Thus, there is a need for IVD-manufacturers and end-users in health care institutions, to obtain guidance on how to generate this clinical evidence. This article aims industrials and clinicians to identify key steps imposed by the IVDR for bringing IVD-MDs to the EU-market. We propose a general view of performance evaluation requirements for IVD-MDs and provide key references, including how to establish study design that will enable to document clinical performance of existing, refined or emerging medical tests. Finally, we propose a roadmap to address the relevant questions and studies in relation to the documents requested in the IVDR.

Which value aspects are relevant for the evaluation of medical devices? Exploring stakeholders' views through a Web-Delphi process.

BACKGROUND: Implementation and uptake of health technology assessment for evaluating medical devices require including aspects that different stakeholders consider relevant, beyond cost and effectiveness. However, the involvement of stakeholders in sharing their views still needs to be improved. OBJECTIVE: This article explores the relevance of distinct value aspects for evaluating different types of medical devices according to stakeholders' views. METHODS: Thirty-four value aspects collected through literature review and expert validation were the input for a 2-round Web-Delphi process. In the Web-Delphi, a panel of participants from five stakeholders' groups (healthcare professionals, buyers and policymakers, academics, industry, and patients and citizens) judged the relevance of each aspect, by assigning a relevance-level ('Critical', 'Fundamental', 'Complementary', or 'Irrelevant'), for two types of medical devices separately: 'Implantable' and 'In vitro tests based on biomarkers'. Opinions were analysed at the panel and group level, and similarities across devices were identified. RESULTS: One hundred thirty-four participants completed the process. No aspects were considered 'Irrelevant', neither for the panel nor for stakeholder groups, in both types of devices. The panel considered effectiveness and safety-related aspects 'Critical' (e.g., 'Adverse events for the patient'), and costs-related aspects 'Fundamental' (e.g., 'Cost of the medical device'). Several additional aspects not included in existing frameworks' literature, e.g., related to environmental impact and devices' usage by the healthcare professional, were deemed as relevant by the panel. A moderate to substantial agreement across and within groups was observed. CONCLUSION: Different stakeholders agree on the relevance of including multiple aspects in medical devices' evaluation. This study produces key information to inform the development of frameworks for valuing medical devices, and to guide evidence collection.

Tool Condition Monitoring for High-Performance Machining Systems-A Review.

In the era of the "Industry 4.0" revolution, self-adjusting and unmanned machining systems have gained considerable interest in high-value manufacturing industries to cope with the growing demand for high productivity, standardized part quality, and reduced cost. Tool condition monitoring (TCM) systems pave the way for automated machining through monitoring the state of the cutting tool, including the occurrences of wear, cracks, chipping, and breakage, with the aim of improving the efficiency and economics of the machining process. This article reviews the state-of-the-art TCM system components, namely, means of sensing, data acquisition, signal conditioning and processing, and monitoring models, found in the recent open literature. Special attention is given to analyzing the advantages and limitations of current practices in developing wireless tool-embedded sensor nodes, which enable seamless implementation and Industrial Internet of Things (IIOT) readiness of TCM systems. Additionally, a comprehensive review of the selection of dimensionality reduction techniques is provided due to the lack of clear recommendations and shortcomings of various techniques developed in the literature. Recent attempts for TCM systems' generalization and enhancement are discussed, along with recommendations for possible future research avenues to improve TCM systems accuracy, reliability, functionality, and integration.

Development status and prospects of international standardization of medical devices of Traditional Chinese Medicine.

As Traditional Chinese Medicine (TCM) becomes widely used in many countries around the world, global demand for intelligent and modernized medical devices of TCM is increasing. Medical devices of TCM have played an important role in diagnosis and treatment of disease. Standardization on medical devices of TCM cannot only be beneficial to ensuring the life safety of patients, but also to enhancing the effectiveness of diagnosis and treatment. This paper includes (1) classification and trends in medical devices of TCM; (2) status review on international standardization of medical devices of TCM; (3) key technical factors in developing international standards for medical devices of TCM and (4) prospects for international standardization development of medical devices of TCM.

Technical and biological review of authorized medical devices for platelets-rich plasma preparation in the field of regenerative medicine.

Platelet-rich plasma (PRP) has seen increased interest and utilization over the past decade, particularly in the field of musculoskeletal disease. This growth has been accompanied by the development of medical devices to realize PRP preparation which includes blood collection, centrifugation, and PRP isolation. The final PRP composition is directly influenced by this preparation step and absence of biological quality control led to a lack of comparability between PRP products that could explain the large variability in the clinical benefit of PRP reported in literature. To circumvent this issue, the scientific community developed different PRP classifications but none of them have been adopted. The goal of this review is to furnish both technical and biological characteristics from PRP commercial systems. On review of 1379 studies, 105 studies were selected according to inclusion criteria for technical analysis and led to the identification of 50 commercial systems that have been classified in three technical categories based on the blood harvesting technique (tubes, syringes or bags). Twelve studies were selected and sufficiently describe biological characteristics from only 14 commercial systems from the 50 identified in the technical analysis. Inclusion of duplicates characterization from a same PRP system lead to the final analysis of 36 PRP preparations that met the inclusion criteria of the biological analysis. All these PRP preparations have been classified among the seven existing classifications. Comparison from all biological parameters and classifications revealed a large heterogeneity among the available current PRP commercial systems. Index of biological sensitivity of classifications to distinguish PRP preparations were also variable. Although these findings should help clinicians in selecting a system that meets their specific needs, this also raises the question to standardize the parameters to biologically define PRP preparation among users and to systematically performed PRP qualification when used.

Does a short intervention with vibration foam roller recover lifeguards better after a water rescue? A pilot study.

PURPOSE: The aim of this study was to analyze the effects of a recovery program based on foam roller with and without vibration on blood lactate clearance and perceived fatigue after a water rescue. METHODS: A quasi-experimental crossover design was carried out to compare passive (PR) recovery and a short protocol of foam roller (FR) and vibration foam roller (VFR) recovery after a 100 m water rescue in 7 volunteer lifeguards. Blood lactate and perceived exertion were measured before and after the rescue, and also after the 5-min recovery intervention. RESULTS: Blood lactate levels decrease significantly with foam roller (p = 0.013; effect size = 0.97) and vibration foam roller recovery (p < 0.001; effect size = 1.62). Passive recovery did not show significant differences clearing out blood lactate. Fatigue perceived decrease significantly with all the recovery methods, but foam roller has higher effects on the global fatigue and VFR on the legs. CONCLUSION: FR and VFR clear out more blood lactate and decrease fatigue more than PR, with the subsequently increase of the physical conditioning to perform another effort.