AI as a Medical Device Adverse Event Reporting in Regulatory Databases: Protocol for a Systematic Review.

BACKGROUND: The reporting of adverse events (AEs) relating to medical devices is a long-standing area of concern, with suboptimal reporting due to a range of factors including a failure to recognize the association of AEs with medical devices, lack of knowledge of how to report AEs, and a general culture of nonreporting. The introduction of artificial intelligence as a medical device (AIaMD) requires a robust safety monitoring environment that recognizes both generic risks of a medical device and some of the increasingly recognized risks of AIaMD (such as algorithmic bias). There is an urgent need to understand the limitations of current AE reporting systems and explore potential mechanisms for how AEs could be detected, attributed, and reported with a view to improving the early detection of safety signals. OBJECTIVE: The systematic review outlined in this protocol aims to yield insights into the frequency and severity of AEs while characterizing the events using existing regulatory guidance. METHODS: Publicly accessible AE databases will be searched to identify AE reports for AIaMD. Scoping searches have identified 3 regulatory territories for which public access to AE reports is provided: the United States, the United Kingdom, and Australia. AEs will be included for analysis if an artificial intelligence (AI) medical device is involved. Software as a medical device without AI is not within the scope of this review. Data extraction will be conducted using a data extraction tool designed for this review and will be done independently by AUK and a second reviewer. Descriptive analysis will be conducted to identify the types of AEs being reported, and their frequency, for different types of AIaMD. AEs will be analyzed and characterized according to existing regulatory guidance. RESULTS: Scoping searches are being conducted with screening to begin in April 2024. Data extraction and synthesis will commence in May 2024, with planned completion by August 2024. The review will highlight the types of AEs being reported for different types of AI medical devices and where the gaps are. It is anticipated that there will be particularly low rates of reporting for indirect harms associated with AIaMD. CONCLUSIONS: To our knowledge, this will be the first systematic review of 3 different regulatory sources reporting AEs associated with AIaMD. The review will focus on real-world evidence, which brings certain limitations, compounded by the opacity of regulatory databases generally. The review will outline the characteristics and frequency of AEs reported for AIaMD and help regulators and policy makers to continue developing robust safety monitoring processes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48156.

Detecting Algorithmic Errors and Patient Harms for AI-Enabled Medical Devices in Randomized Controlled Trials: Protocol for a Systematic Review.

BACKGROUND: Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have shown potential for a range of clinical tasks such as diagnostics, prognostics, and therapeutic decision-making such as drug dosing. There is, however, an urgent need to ensure that these technologies remain safe for all populations. Recent literature demonstrates the need for rigorous performance error analysis to identify issues such as algorithmic encoding of spurious correlations (eg, protected characteristics) or specific failure modes that may lead to patient harm. Guidelines for reporting on studies that evaluate AI medical devices require the mention of performance error analysis; however, there is still a lack of understanding around how performance errors should be analyzed in clinical studies, and what harms authors should aim to detect and report. OBJECTIVE: This systematic review will assess the frequency and severity of AI errors and adverse events (AEs) in randomized controlled trials (RCTs) investigating AI medical devices as interventions in clinical settings. The review will also explore how performance errors are analyzed including whether the analysis includes the investigation of subgroup-level outcomes. METHODS: This systematic review will identify and select RCTs assessing AI medical devices. Search strategies will be deployed in MEDLINE (Ovid), Embase (Ovid), Cochrane CENTRAL, and clinical trial registries to identify relevant papers. RCTs identified in bibliographic databases will be cross-referenced with clinical trial registries. The primary outcomes of interest are the frequency and severity of AI errors, patient harms, and reported AEs. Quality assessment of RCTs will be based on version 2 of the Cochrane risk-of-bias tool (RoB2). Data analysis will include a comparison of error rates and patient harms between study arms, and a meta-analysis of the rates of patient harm in control versus intervention arms will be conducted if appropriate. RESULTS: The project was registered on PROSPERO in February 2023. Preliminary searches have been completed and the search strategy has been designed in consultation with an information specialist and methodologist. Title and abstract screening started in September 2023. Full-text screening is ongoing and data collection and analysis began in April 2024. CONCLUSIONS: Evaluations of AI medical devices have shown promising results; however, reporting of studies has been variable. Detection, analysis, and reporting of performance errors and patient harms is vital to robustly assess the safety of AI medical devices in RCTs. Scoping searches have illustrated that the reporting of harms is variable, often with no mention of AEs. The findings of this systematic review will identify the frequency and severity of AI performance errors and patient harms and generate insights into how errors should be analyzed to account for both overall and subgroup performance. TRIAL REGISTRATION: PROSPERO CRD42023387747; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=387747. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/51614.

Pattern of Medical Device Adverse Events in a Tertiary Care Hospital in Northern India: An Ambispective Study.

BACKGROUND: Knowledge about the pattern of adverse events caused by medical devices (MDs) is limited in India. We aimed to assess the pattern of MD adverse events (MDAEs) in a tertiary hospital in Northern India. MATERIALS AND METHODS: This descriptive study was conducted ambispectively at various clinical departments of PGIMER, Chandigarh. We followed the guidelines edged by the Materiovigilance Program of India (MvPI) to conduct this study. The prospective study (PS) was done from January to December 2020, with a concurrent retrospective study (RS) proceeding to 3 years to learn more about the reporting culture, demographics, notification status, risk class of defective devices, and the type of adverse events. RESULTS: We received 224 MDAE in the PS and identified 413 MDAE in the RS. Reporting of adverse events to the national MvPI was negligible in the RS. In the PS, nurses reported the majority of MDAEs (65%), followed by doctors (30%). The occurrence of MDAE was higher in males (PS; 52%, RS; 57%) and age groups between 21 and 30 years (PS; 19.1%, RS; 23.2%) in both studies. MDAEs were frequent in low- to moderate-risk devices (class B: 66%) in the PS, while it was documented only for high-risk devices (class C: 51% and class D: 49%) in the RS. Most of the serious adverse events (SAEs) were reported among moderate to high-risk devices, and an increased frequency of SAE (60.4%) was observed among nonnotified MDs. The overall incidence of near-miss events was 14%. CONCLUSION: Knowledge of MDAEs and reporting of defective devices to regulatory authorities is essential to prevent further incidence. Adverse events caused by MDs are ubiquitous irrespective of their risk classification, notification status, and patient demographic factors. Accelerated reporting of MDAE by all cadre of healthcare professionals is urgently required to safeguard the health of Indians.

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.

Incidence and Risk Factors for Medical Device-Related Pressure Injury in Hemodynamically Unstable Intensive Care Unit Patients: A Prospective Cohort Study.

PURPOSE: The purpose of this study was to determine the incidence and identify potential risk factors for medical device-related pressure injury (MDRPI) in critically ill and hemodynamically unstable adults (patients classified class III or IV on the Therapeutic Intervention Scoring System-28; TISS-28). DESIGN: Prospective cohort study. SUBJECTS AND SETTING: The target population was critically ill adults who were using one or more medical devices and categorized as class III or IV on the TISS-28. The study sample comprised 77 participants followed daily until discharge, death, transfer, or lesion development. Data were collected from January to March 2020. The study setting was an intensive care unit with 40 beds in a large hospital in a municipality in the state of Minas Gerais, Brazil. METHODS: Sociodemographic and pertinent clinical data, pressure injury (PI) risk assessed using the Braden Scale for Pressure Sore Risk, and head-to-toe skin inspections were completed. The incidence rate of MDRPIs was calculated, and survival analyses were completed via the Kaplan-Meier method and Cox regression model. RESULTS: Forty-nine of 77 participants developed an MDRPI, reflecting an incidence rate of 63.6%. Collectively, 71 MDRPIs occurred in these 49 participants. Univariate analysis indicated significant associations between MDRPI occurrences and level of consciousness ( P = < .001), use of tube holder for ventilation devices ( P = .013), nasal cannula ( P = .034), nasogastric cannula ( P = .034), presence of edema ( P = .001), infection ( P = .007), higher TISS score ( P = .047), and greater number of medical devices ( P = .022). Survival analysis indicated that a high or very high-risk score on the Braden Scale for Pressure Sore Risk ( P = .043) and edema ( P = .030) are risk factors for MDRPI occurrences in this vulnerable population. CONCLUSIONS: The incidence rate of MDRPIs was 63.6%. The categories with the highest high or very high risk scores on the Braden Scale for Risk of Pressure Pain and Edema emerged as risk factors for MDRPI in this critically ill and vulnerable population.

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 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.

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.

Analysis of preservatives and fragrances in topical medical devices: The need for more stringent regulation.

INTRODUCTION: Medical devices (MDs) have a long history of use, and come with regulatory frameworks to ensure user safety. Although topically applied MDs in the form of gels and creams might be used on damaged skin, their composition is often similar to that of cosmetic products applicable to intact skin, especially in terms of preservatives and fragrances. However, unlike cosmetics, these products are not subject to compound-specific restrictions when used in MDs. OBJECTIVE: This study aimed to identify and quantify preservatives and fragrances in topically applied MDs and assess their safety towards the Cosmetic Regulation (EC) 1223/2009. METHOD: Sixty-nine MDs available on the EU market were subjected to previously validated liquid chromatography tandem mass spectrometry (LC-MS/MS) and gas chromatography-mass spectrometry (GC-MS) methods to identify and quantify occurring preservatives and fragrances. RESULTS: Findings revealed that 32% of the examined MDs did not provide comprehensive ingredient lists, leaving users uninformed about potential risks associated with product use. Furthermore, 30% of these MDs would not meet safety standards for cosmetic products and, most significantly, 13% of the analysed samples contained ingredients that are prohibited in leave-on cosmetics. CONCLUSION: Results highlight the pressing demand for more stringent requirements regarding the labelling and composition of MDs to enhance patient safety. Improved regulation and transparency can mitigate potential risks associated with the use of topically applied MDs.

Medical device report analyses from MAUDE: Device and patient outcomes, adverse events, and sex-based differential effects.

Post-market medical device-associated failures and patient problems are reported in Medical Device Reports (MDRs) to the US Food and Drug Administration. Reports are accessible through Manufacturer and User Facility Device Experience (MAUDE), a database including both required and voluntary submissions. We present an overview of >10 million MDRs received from 2011 to 2021. Approximately 92% of reporting issues represent medical device physical or functional failures, categorized from 1704 codes related to medical device integrity or function. ∼8% were coded adverse events (AEs). Patient outcomes are reported via 998 patient codes in 19 medical specialties (cardiovascular, orthopedic, etc.). ∼40% of patient reports indicated "no health consequences"; however, a small number of devices had consistently high AE reports. While overall reports did not exhibit a sex-based dichotomy, ∼9% of the reported AEs occurred more frequently in females, many of which were related to immune effects. The analyses are subject to uncertainties and potential bias based on data available and data selected for analysis. However, such an overview of post-market MDR data, not previously published, fills a gap in understanding medical device issues and patient-based outcomes related to medical device use. Trends identified may be subjects of additional hypotheses, analysis, and research.

Balancing pediatric device utility and harm: navigating the challenges for safer healthcare.

This article discusses the challenges in balancing the utility and harm associated with pediatric medical devices. Takashima et al. explored the prevalence and complications of invasive devices across three Australian pediatric tertiary hospitals and reported a high prevalence of complications, particularly with vascular access devices. We also highlight the need to pay attention to the use of these devices, particularly intravenous catheters, and the importance of a culture of patient safety in healthcare systems. We emphasize the need for a nuanced approach that carefully weighs the benefits against potential risks and encourages collaboration among stakeholders to establish robust regulatory frameworks and prioritize the safety and well-being of pediatric patients. Finally, we conclude by advocating the involvement of parents and families in gathering information about hospital safety incidents and fostering a culture of safety that supports reporting, flexibility, and learning. IMPACT: Reporting adverse events and their consequences is essential in the strategy to prevent them, allowing comparison with national or international standards, and identifying indicators to optimize and harbor the possibility of determining improvement measures that pursue a multifactorial approach and are cost-effective. Our comment advocates limiting the prevalence of medical invasive devices and their consequences by reviewing their epidemiology. Although advancements in medical technology have undoubtedly improved the diagnostic and therapeutic possibilities, the delicate balance between device utility and potential harm necessitates careful consideration.

Incidence, severity and characteristics of medical device-related pressure injuries in adult intensive care patients: A single-centre, cross-sectional study.

AIM: This study aimed to determine the incidence, severity and characteristics of medical device-related pressure injuries in intensive care units. METHODS: This is a cross-sectional study. Data were collected from 187 patients admitted to the Anaesthesia and Reanimation intensive care unit of a university hospital between January and May 2023. The skin of the patients enrolled in the study was assessed for the presence of medical device-related pressure injuries, and all medical devices used were recorded. Data were collected using the Patient Identification Form, the Medical Device-Related Pressure Injury Follow-up Form, and the Braden Scale for Predicting Pressure Ulcer Risk. RESULTS: It was found that 30.6% of the patients developed medical device-related pressure injuries; of these, 73.7% had stage I pressure injuries. We found that 36.8% of the patients were diagnosed with medical device-related pressure injuries within 8-11 days. The results showed that endotracheal tube (61.4%), non-invasive ventilation/oxygen mask (52.6%), Foley catheter (49.1%), and nasogastric tube (36.8%) devices were the most common causes of the development of medical device-related pressure injuries. Patients' demographic characteristics were found to have a significant effect on the development of medical device-related pressure injuries (p < .05). CONCLUSION: The study found that the incidence of medical device-related pressure injuries was relatively high and that a relationship was observed between the patients' demographic characteristics and medical device-related pressure injuries. It is crucial that ICU nurses, who are more likely to encounter medical device-related pressure injuries, consider these factors when caring for their patients and take appropriate preventive measures to reduce the incidence of these injuries.

Medical device-related pressure injuries in paediatric patients: An incidence study in a children's hospital.

AIM: To determine the incidence of pressure injuries from medical devices in children. BACKGROUND: Medical devices can cause pressure injuries on skin and soft tissues. DESIGN: A prospective, descriptive study adhering to STROBE guidelines. METHODS: This study was conducted in the third-level Paediatric Intensive Care Unit of Ege University Hospital in Izmir, Türkiye between April 2019 and October 2019 in Türkiye. Patients aged between 1 month and 18 years with medical devices were observed for pressure injuries using Braden scales and a specific monitoring form. RESULTS: In this study, we followed 522 medical devices applied to 96 patients. The three most commonly used medical devices were the ECG probe (21%), the blood pressure cuff (16%) and the saturation probe. Out of the 522 medical devices followed, 36 caused pressure injuries (6.8%). CONCLUSION: The incidence of medical device-related pressure injuries was found to be high. Effective training and implementation strategies need to be devised for paediatric nurses to prevent pressure injuries associated with medical devices. RELEVANCE TO CLINICAL PRACTICE: The results of this study reveal that pressure injuries related to medical devices are an important health problem in paediatric hospitals. Therefore, awareness-raising and educational activities among health professionals and nurses should be accelerated. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution in the study.

The attitude towards Medical Device-Related Pressure Injuries Questionnaire: a Turkish validity and reliability study.

BACKGROUND: The attitudes of nurses should be measured using valid and reliable tools to develop effective nursing care strategies for the prevention of medical device-related pressure injuries and to organize necessary training programs. PURPOSE: This study was planned to conduct the Turkish validity and reliability study of the Attitude towards Medical Device-Related Pressure Ulcers/Injuries Questionnaire (MDRPU/I Questionnaire (the English-language version)) in nurses. METHODS: This methodological study included 134 nurses working in hospitals of different sizes and characteristics (public hospitals, training and research hospitals, and university hospitals) in Turkey. The validity and reliability of the Attitude Towards Medical Device-Related Pressure Injuries (MDRPI Questionnaire (the Turkish-language version)) Questionnaire were tested using language validity, content validity, face validity, construct validity, and reliability analyses. RESULTS: The final version of the questionnaire had a content validity index of 98.03%, sufficient construct validity, and a Cronbach α value of 0.92 for the total questionnaire. CONCLUSIONS: The Turkish version of the MDRPI Questionnaire is valid, reliable, and suitable for measuring the attitudes of nurses in Turkey toward the prevention and care of medical device-related pressure injuries.

Reporting serious incidents in medical devices used in intraocular surgery: Proposing ideas.

The entry into force of the regulation on medical devices obliges clinicians to identify and report to the Health Authorities possible serious incidents arising from their use. In view of the doubts that may arise as to whether or not it may be considered a serious incident, a working group, set up by members of the Spanish Society of Retina and Vitreo and the cluster of ophthalmology and vision sciences (Cluster4Eye) have prepared a document that aims to guide ophthalmologists about some of the incidents that, in the experience of the work team, are not common or can cause serious damage to the patient's function.

The FDA and Ensuring Safety and Effectiveness of Devices, Biologics, and Technology.

Orthopaedic devices account for nearly 20% of all devices on the market, with more than 600 novel orthopaedic devices cleared or approved by the FDA for marketing in the United States annually. Advances in technology and biologic therapies offer tremendous potential for patients with musculoskeletal ailments; however, it is important that the safety and effectiveness of these products be assessed to safeguard the public health. The FDA uses multiple different premarket pathways for devices, biologics, and combination products based on perceived risk of the novel product. More than 97% of orthopaedic devices go through the FDA's 510(k) pathway, which does not require clinical trials. The remaining high-risk devices must receive premarket approval and submit clinical trial data demonstrating safety and effectiveness. Similarly, high-risk biologics must obtain a biologics license application by submitting clinical trial data. Postmarketing surveillance strategies, including extended clinical trials or real-world evidence from registries, are increasingly being relied on by the FDA to expedite approval while also improving its capacity to identify problematic products.

Materiovigilance in health centers: The role of notifiers to ensure safer use of medical devices.

BACKGROUND: The implementation of efficient health and vigilance strategy is one of the essential aspects of the health policy of public and private health establishments, in order to reduce the risk of incidents due to medical devices. AIM: The objective of this study is to demonstrate the importance of user notification and to recognize the role of nursing staff in the materiovigilance process. METHODS: This is a retrospective study of materiovigilance cases notified for three years (2016, 2017, and 2018) at the National Institute of Oncology. The evaluation of the incidents was carried out with the aim of taking the necessary measures to prevent and minimize risk. RESULTS: Seven thousand three hundred and eight cases of materiovigilance during the 3 years were collected. A spontaneous collection of reports was predominant (70%). The distribution of the number of incidents by the profile of notifiers shows that reports come from surgeons and much more from nurses. The surgical block (35.7%) and medical oncology services (14.3%) were the services that reported more; the majority of the observed adverse events were attributed to infusion sets (n=7105). Four serious cases of materiovigilance. reported during these 3 years at the level of the vigilance unit considered the most relevant were detailed with examples of immediate actions taken and risk minimization actions. CONCLUSION: This study highlights the characteristics of incidents reported. The role of the nursing staff and the strong presence of nurses in the vigilance system has been well demonstrated, thus reducing the risk of side effects due to medical devices.

Streptomyces sp.-A Treasure Trove of Weapons to Combat Methicillin-Resistant Staphylococcus aureus Biofilm Associated with Biomedical Devices.

Biofilms formed by methicillin-resistant S. aureus (MRSA) are among the most frequent causes of biomedical device-related infection, which are difficult to treat and are often persistent and recurrent. Thus, new and effective antibiofilm agents are urgently needed. In this article, we review the most relevant literature of the recent years reporting on promising anti-MRSA biofilm agents derived from the genus Streptomyces bacteria, and discuss the potential contribution of these newly reported antibiofilm compounds to the current strategies in preventing biofilm formation and eradicating pre-existing biofilms of the clinically important pathogen MRSA. Many efforts are evidenced to address biofilm-related infections, and some novel strategies have been developed and demonstrated encouraging results in preclinical studies. Nevertheless, more in vivo studies with appropriate biofilm models and well-designed multicenter clinical trials are needed to assess the prospects of these strategies.

The aetiology of medical device-related pressure ulcers and how to prevent them.

This article provides an introduction to the aetiology of medical device-related pressure ulcers (MDRPUs), describes the vicious cycle that leads to these injuries and highlights bioengineering methodologies and findings that connect the aetiology to the clinical practice of preventing MDRPUs. Specifically, the vicious cycle of MDRPUs is triggered by the sustained tissue deformations induced by a skin-contacting device. The primary, deformation-inflicted cell damage leads to a secondary inflammatory-oedema-related damage and then to tertiary ischaemic damage. Each of these three factors contributes to cumulative cell death and tissue damage under and near the applied device. The damage therefore develops in an escalated manner, as a result of the added contributions of the above three factors. This phenomenon is exemplified through two common clinical scenarios. First, through the use of continuous positive airway pressure (CPAP) masks, which are being applied extensively in the current COVID-19 pandemic, and, second, through the use of doughnut-shaped head positioners, which are applied to surgical patients and sometimes to bedridden individuals who receive intensive care in a supine position. These two medical devices cause intense, localised mechanical loads in the facial skin and underlying tissues (CPAP mask) and at the occipital scalp (doughnut-shaped positioner), where the soft tissues cannot swell in response to the inflammatory oedema as, in both cases, the tissues are sandwiched between the device and the skull. Accordingly, the two device types result in characteristic MDRPUs that are avoidable through appropriate prophylactic interventions, that is, preventive dressings under the CPAP mask and replacement of the doughnut device by a soft, shape-conforming support aid to alleviate and disperse the localised soft tissue deformations. Hence, understanding the aetiology of MDRPUs targets and focuses effective clinical interventions.