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.

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.

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.

Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death.

Importance: In the US, most postmarket medical device safety data are obtained through adverse event reports that are submitted to the US Food and Drug Administration (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database. Adverse event reports are classified by the reporter as injury, malfunction, death, or other. If the device may have caused or contributed to a death, or if the cause of death is unknown, the FDA requires that the adverse event be reported as a death. Objective: To determine the percentage of medical device adverse event reports submitted to the MAUDE database that were not classified as death even though the patient died. Design, Setting, and Participants: In this study, a natural language processing algorithm was applied to the MAUDE database, followed by manual text review, to identify reports in the injury, malfunction, other or missing categories that included at least 1 term that suggested a patient death, such as patient died or patient expired, from December 31, 1991, to April 30, 2020, for any medical device. Exposures: Manual review of a random sample of 1000 adverse event reports not classified as death and of selected reports for 62 terms that are associated with deaths but were not classified as death. Main Outcomes and Measures: Percentage of adverse event reports in which the patient was said to have died in the narrative section of the report but the reporter classified the report in a category other than death. Results: The terms in the natural language processing algorithm identified 290 141 reports in which a serious injury or death was reported. Of these, 151 145 (52.1%) were classified by the reporter as death and 47.9% were classified as malfunction, injury, other, or missing. For the overall sample, the percentage of reports with deaths that were not classified as deaths was 23% (95% CI, 20%-25%), suggesting that approximately 31 552 reports in our sample had deaths that were classified in other categories. The overall percentage of missed deaths, defined as the percentage of deaths that were classified in other categories, was 17% (95% CI, 16%-19%). Conclusions and Relevance: Many of the findings of this study suggest that many medical device adverse event reports in the FDA's MAUDE database that involved a patient death are classified in categories other than death. As the FDA only routinely reviews all adverse events that are reported as patient deaths, improving the accuracy of adverse event reporting may enhance patient safety.

Incidence and risk factors of medical device-related pressure injuries among patients undergoing prone position spine surgery in the operating room.

AIM: We aimed to investigate the incidence rate and risk factors of medical device-related pressure injuries (MDRPIs) among patients undergoing prone position spine surgery. MATERIALS AND METHODS: This was a prospective observational study of 147 patients who underwent spine surgery in an orthopaedic hospital in Korea. The incidence of MDRPI according to intrinsic and extrinsic factors was assessed using the independent t-, χ2 -, or Fisher's exact tests. A logistic regression analysis was performed exclusively for MDRPI areas with an incidence rate >5%. RESULTS: The mean incidence rate of overall MDRPI was 27.4%, while that of MDRPI by Wilson frame, bi-spectral index, and endotracheal tube (ETT) was 56.5%, 52.4%, and 9.5%, respectively. The risk factors under Wilson frame were operation time and body mass index classification. Compared to their normal weight counterparts, those who were underweight, overweight, and obese had a 46.57(95% CI: 6.37-340.26), 3.96 (95% CI: 1.13-13.86), and 5.60 times (95% CI: 1.62-19.28) higher risk of developing MDRPI, respectively. The risk factors by bi-spectral index were sex, operation time, and the American Society of Anaesthesiologists classification. Compared to ETT intubation of <2 h, the risk of MDRPI increased by 7.16 times (95% CI: 1.35-38.00) and 7.93 times (95% CI: 1.45-43.27) for<3 and ≥3 h' duration, respectively. CONCLUSION: The difficulty of device repositioning can increase the incidence of MDRPI, and prolonged surgery was a significant risk factor. Thus, appropriate planning and correct equipment utilization is needed during prone position spine surgeries.

Varied-shaped gold nanoparticles with nanogram killing efficiency as potential antimicrobial surface coatings for the medical devices.

Medical device-associated infections are a serious medical threat, particularly for patients with impaired mobility and/or advanced age. Despite a variety of antimicrobial coatings for medical devices being explored to date, only a limited number have been introduced for clinical use. Research into new bactericidal agents with the ability to eradicate pathogens, limit biofilm formation, and exhibit satisfactory biocompatibility, is therefore necessary and urgent. In this study, a series of varied-morphology gold nanoparticles in shapes of rods, peanuts, stars and spherical-like, porous ones with potent antibacterial activity were synthesized and thoroughly tested against spectrum of Candida albicans, Pseudomonas aeruginosa, Staphylococcus aureus clinical strains, as well as spectrum of uropathogenic Escherichia coli isolates. The optimization of gold nanoparticles synthesis allowed to develop nanomaterials, which are proved to be significantly more potent against tested microbes compared with the gold nanoformulations reported to date. Notably, their antimicrobial spectrum includes strains with different drug resistance mechanisms. Facile and cost-efficient synthesis of gold nanoparticles, remarkable bactericidal efficiency at nanogram doses, and low toxicity, underline their potential for development as a new coatings, as indicated by the example of urological catheters. The presented research fills a gap in microbial studies of non-spherical gold nanoparticles for the development of antimicrobial coatings targeting multidrug-resistant pathogens responsible for device-associated nosocomial infections.

Descripción de las lesiones relacionadas con la dependencia en una clínica cardiovascular / Dependence-related lesions in a cardiovascular clinic

Objetivos: Describir las lesiones relacionadas con la dependencia en una clínica cardiovascular de alto nivel de atención, de la Ciudad de Medellín, Colombia, en el año 2018. Metodología: Estudio descriptivo retrospectivo con una muestra no probabilística a conveniencia. A las variables de naturaleza cuantitativa, previa prueba de normalidad de Shapiro Wilk, se les calcularon la mediana con sus respectivos rangos intercuartílicos y los valores mínimo y máximo. Las variables de naturaleza cualitativa se presentan con frecuencias absolutas y relativas. Resultados: Se presentaron 167 pacientes con lesiones para una incidencia global del 2,8%; las lesiones más frecuentes fueron causadas por dispositivos médicos (50,9%). Las lesiones por apoyo fueron del 28,7%; por adhesivo, del 18,6%; y por humedad, del 1,8%. No se presentaron lesiones por fricción. El 73,1% de las lesiones se presentaron en pacientes adultos. El 77,2% tenía clasificación de riesgo alto; el 60,5% de las lesiones fueron de categoría 1. De acuerdo con el sitio anatómico, la mayoría de las lesiones se presentaron en cara y cuello (47,9%), seguido de pelvis y miembros inferiores (40,1%). En el análisis de calidad se encontró que el 60,5% fue evitable. Conclusiones: La mayoría de las lesiones relacionadas con la dependencia fueron secundarias al uso de dispositivos médicos. Es necesario continuar haciendo estudios que brinden información sobre los diferentes tipos de lesiones por dependencia, ya que las medidas de prevención y los cuidados de estas varían de acuerdo con el mecanismo de producción (AU)

Aim: To describe dependence-related lesions in a high level of care cardiovascular clinic in the city of Medellin, Colombia, in 2018. Method: Retrospective descriptive study with a non-probabilistic sample. Quantitative data were calculated with median and their respective interquartile ranges, minimum and maximum values. Qualitative data is presented with absolute and relative frequencies. Results: 167 patients suffered dependence-related lesions, incidence 2.8%. The most frequent lesions were caused by medical devices (50.9%), by pressure (28.7), by Medical Adhesive-Related Skin Injury (18.6), and by humidity (1.8%). There were not friction injuries. 73.1% of the lesions occurred in adult patients. % had a high risk classification; 60.5% of the injuries were category 1. According to the anatomical site, most lesions were presented in the face and neck (47.9%), followed by the pelvis and lower limbs (40.1%). In the quality analysis it was found that 60.5% were avoidable. Conclusions: The majority of dependence-related lesions were secondary to the use of medical devices. It is necessary to make more researches that show the different type of dependence-related lesions, since caring and prevention measures vary according to the production mechanism (AU)

Development and Testing of the Psychometric Properties of the Attitude Towards Medical Device-related Pressure Ulcers/Injuries Questionnaire.

BACKGROUND: Medical device-related pressure ulcers/injuries (MDRPU/Is) are a serious concern in health care. PURPOSE: To develop and assess the psychometric testing of a questionnaire to measure nursing students' attitudes about the care and prevention of MDRPU/Is. METHODS: Based on a review of the literature, a 26-item questionnaire was developed; face validity was assessed by ten (10) nursing students. The modified Lawshe's model was used, and both the content validity index (CVI) and content validity ratio were calculated. Items with a CVI more than 0.63 were retained. The minimum optimal CVI for the new instrument was 79%. Qualitative assessments were performed by 10 experienced faculty members. One-hundred-and-eighty seven (187) nursing students participated in the construct validity testing of the 11-item questionnaire. The Kaiser-Meyer-Olkin test of sampling adequacy and Bartlett's test of sphericity were performed. Following analysis of the main components and the varimax rotation, the factor analysis was determined. Internal consistency (Cronbach's alpha) and test-retest were determined using Pearson's correlation and intraclass correlation coefficient to evaluate reliability. RESULTS: During the face validity phase of the initial 26 items, 7 items had impact scores less than 1.5. After calculating the CVI and content validity ratio for all items, 8 items did not achieve the desirable score. After performing exploratory factor analysis on the remaining 11 items, the Kaiser-Meyer-Olkin test value was 0.789, and Bartlett's test of sphericity was 0.0001, which was statistically significant. Internal consistency of items (Cronbach's alpha of 0.77) showed that all items had a high correlation. The reliability of test-retest was significant using an intraclass correlation coefficient of 0.75 and Pearson's correlation coefficient of 0.86 at P < .005. CONCLUSION: In this sample of nursing students, the Attitude Towards Medical-device Related Pressure Ulcers/Injuries Questionnaire was valid and reliable. Studies including licensed clinicians are needed to confirm these results.

How sensitive does chemical characterization of medical devices need to be? Calibration of analytical evaluation thresholds with the carcinogenic potency database.

Chemical characterization is a component of the safety evaluation of medical devices. An analytical evaluation threshold (AET) is recommended to calculate the required analytical sensitivity. There is a lack of consensus whether to use 1.5 or 120 µg/day in calculating the AET with the lower value often requiring sensitivities beyond analytical capabilities. The Carcinogenic Potency Database (CPDB) was reviewed to compare risks associated with using either value to calculate an AET. The TD50s for non-Cohort of Concern (non-COC) substances in the CPDB were used to extrapolate the doses to an excess cancer risk of 10-5 and calculate the total doses. The number of non-COC substances that would exceed this risk using an AET calculated using 1.5 µg/day or 120 µg/day were then compared. From the 199 substances evaluated, only two posed an excess risk at an AET calculated with 1.5 µg/day and only seven more with 120 µg/day. Furthermore, over 95 percent of non-COC substances would not pose an excess cancer risk using an AET calculated with 120 µg/day. Based on our evaluation, an AET based on 120 µg/day is protective and practical for chemical characterization of short and long-term medical devices.

Effectiveness and safety of reduced-port laparoscopic surgery vs conventional multi-port laparoscopic surgery in the treatment of gastric diseases: A meta-analysis.

ABSTRACT: This study aimed to compare the effectiveness and safety of reduced-port laparoscopic surgery (RPLS) and conventional multi-port laparoscopic (CMPLS) surgery in the treatment of gastric diseases.The PubMed, Embase, Cochrane Library, Web of Science, and Chinese Biomedical Literature databases were systematically searched for randomized controlled trials, cohort studies, and case control studies on the use of RPLS vs conventional multi-port laparoscopic surgery in treating gastric diseases from their inception until March 10, 2019. The evaluated outcomes were the operative time, blood loss, length of hospital stay, number of dissected lymph nodes, postoperative complications, and conversions. All of these were compared using Stata software version 12.0.A total of 18 studies were included, which involved 2938 patients. In studies referring to the comparison between RPLS and CMPLS in treating gastric diseases, the former showed significantly inferior in terms of operative time (P = .011) and number of dissected lymph nodes (P = .031); but superior results in terms of the estimated blood loss (P = .000) and length of hospital stay (P = .001) than the latter did; however, the rates of postoperative complications (P = .830) and conversions (P = .102) were not statistically significant between the 2 groups.RPLS and CMPLS showed comparable effectiveness and safety in the treatment of gastric diseases in our meta-analysis. Based on the current evidence, we believe that RPLS is an efficacious surgical alternative to CMPLS in the management of gastric diseases because of the shorter hospital stay and reduced blood loss. However, large-scale, well-designed, multicenter studies are needed to further confirm the results of this study.

The mechanobiology theory of the development of medical device-related pressure ulcers revealed through a cell-scale computational modeling framework.

Pressure ulcers are localized sites of tissue damage which form due to the continuous exposure of skin and underlying soft tissues to sustained mechanical loading, by bodyweight forces or because a body site is in prolonged contact with an interfacing object. The latter is the common cause for the specific sub-class of pressure ulcers termed 'medical device-related pressure ulcers', where the injury is known to have been caused by a medical device applied for a diagnostic or therapeutic purpose. Etiological research has established three key contributors to pressure ulcer formation, namely direct cell and tissue deformation, inflammatory edema and ischemic damage which are typically activated sequentially to fuel the injury spiral. Here, we visualize and analyze the above etiological mechanism using a new cell-scale modeling framework. Specifically, we consider here the deformation-inflicted and inflammatory contributors to the damage progression in a medical device-related pressure ulcer scenario, forming under a continuous positive airway pressure ventilation mask at the microarchitecture of the nasal bridge. We demonstrate the detrimental effects of exposure to high-level continuous external strains, which causes deformation-inflicted cell damage almost immediately. This in turn induces localized edema, which exacerbates the cell-scale mechanical loading state and thereby progresses cell damage further in a nonlinear, escalating pattern. The cell-scale quantitative description of the damage cascade provided here is important not only from a basic science perspective, but also for creating awareness among clinicians as well as industry and regulators with regards to the need for improving the design of skin-contacting medical devices.

The Effectiveness of the SKINCARE Bundle in Preventing Medical-Device Related Pressure Injuries in Critical Care Units: A Clinical Trial.

OBJECTIVE: To examine the impact of a medical device-related pressure injury (MDRPI) prevention bundle/mnemonic on the incidence of acquired MDRPIs in critically ill patients. METHODS: This study used a prospective, single-arm, open-label clinical design and was carried out from January to April 2020 in CCUs in a Saudi Arabian tertiary hospital. All participants received the SKINCARE bundle intervention, which is based on the best available evidence for MDRPI prevention in CCUs. The primary outcome was the development of MDRPI. RESULTS: The MDRPI cumulative incidence was significantly lower after the implementation of the SKINCARE bundle (0.89%, 90% lower than historic incidence). CONCLUSIONS: The SKINCARE bundle demonstrates significant improvement of skin care through decreased cumulative incidence of acquired MDRPI.

Using the monocyte activation test as a stand-alone release test for medical devices.

Monocyte activation tests (MAT) are widely available but rarely used in place of animal-based pyrogen tests for safety assessment of medical devices. To address this issue, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods and the PETA International Science Consortium Ltd. convened a workshop at the National Institutes of Health on September 18-19, 2018. Participants included representatives from MAT testing laboratories, medical device manufacturers, the U.S. Food and Drug Administration's Center for Devices and Radiologic Health (CDRH), the U.S. Pharmacopeia, the International Organization for Standardization, and experts in the development of MAT protocols. Discussions covered industry experiences with the MAT, remaining challenges, and how CDRH's Medical Device Development Tools (MDDT) Program, which qualifies tools for use in evaluating medical devices to streamline device development and regulatory evaluation, could be a pathway to qualify the use of MAT in place of the rabbit pyrogen test and the limulus amebocyte lysate test for medical device testing. Workshop outcomes and follow-up activities are discussed.

Preventing and managing device-related pressure ulcers in oncology.

There is growing evidence that medical device-related pressure ulcers (MDRPUs) are an increasing healthcare concern in all aspects of care. It is especially important to develop an individualised care plan for people at the end of life to prevent pressure ulceration and to treat this if it occurs. Tissue viability nurses have a responsibility to review and assess new prophylactic devices and dressings, to ensure a high standard of care is provided. This article describes the use of a soft silicone dressing, Kliniderm foam silicone lite, in combination with best practice, to prevent MDRPUs in the oncology setting. Three case studies show that the dressing helped avoid the occurrence of ulceration on the ears and nose in patients receiving oxygen through a nasal cannula.

Bacterial strains colonizing the sensor electrodes of a continuous glucose monitoring system in children with diabetes.

INTRODUCTION: The higher frequency of infections in diabetic patients is caused by a hyperglycemic environment, which promotes immune dysfunction. People with diabetes are more prone to skin infections. A continuous glucose monitoring (CGM) system provides information on changes in blood glucose (BG) levels throughout the day. Its use facilitates optimal therapeutic decisions for a diabetic patient. One of the factors limiting the use of CGM is inflammation at the insertion site. AIM OF THE STUDY: The aim of the study was the microbiological identification of the bacterial strains which are found on CGM sensor electrodes. MATERIAL AND METHODS: We performed microbiological tests on patients' CGM Enlite Medtronic electrodes, which were removed after 6 days of usage according to the manufacturer's instructions. 31 sensors were examined from 31 children (14 girls) aged from 0.5 to 14.6 years. The microbiological analysis was routinely performed at the Department of Children's Diabetology Medical University of Silesia in Katowice, Poland. RESULTS: 12 (39%) of the electrodes were colonized. In 11 (92%) cases the electrodes were colonized by one bacteria strain. 7 times methicillin-sensitive coagulase negative staphylococcus (MSCNS) was detected. We also found one case of Klebsiella pneumoniae, Ochrobactrum tritici, Bacillus sonorensis and methicillin-resistant coagulase-negative Staphylococci (MRCNS) colonization. One electrode was colonized by the mixed flora Enterococcus faecalis, methicillin-susceptible coagulase-negative Staphylococci (MSCNS), Pseudomonas stutzeri, methicillin-susceptible Staphylococcus aureus (MSSA). The median HbA1c in the group with colonization of electrodes was 6, 85% (6, 3-7, 6%) versus 6, 3% (5, 8-7, 5%) in the group without colonization. The median BMI in the group with colonization of the electrodes was 17.10 kg/m2 (16.28-18.62 kg/m2) versus 15.98 kg/m2 (15.14-17.96 kg/m2) in the group without colonization. Statistically, significantly more frequently electrodes are colonized in older children (median age in the group with colonization of electrodes 11.43 years (6.52-12.27 years), without colonization 8.42 years. (3.098-9.375 years); (p = 0.033). CONCLUSIONS: It seems that older children are more likely to have their sensor electrode colonized by bacterial strains.