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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., Competing Interests: All authors declare no conflict of interest., (Copyright © 2024 by the Wound, Ostomy and Continence Nurses Society.)

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 (X 2  = 37.098, p < 0.001). When the regression coefficients were examined, it was found that total hospitalization time in the intensive care unit (β = 0.948, p < 0.01) and PaCO 2 level (β = 0.923, p < 0.01) had a positive, and duration of aerobic respiration with nasal cannula or mask (β = -0.920, p < 0.01) and Braden score (β = -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 PaCO 2 levels, shorter duration of oxygenated breathing with nasal cannula or mask, and lower Braden scores., Competing Interests: Declaration of competing interest The authors declare no conflict of interest., (Copyright © 2024 Tissue Viability Society / Society of Tissue Viability. Published by Elsevier Ltd. All rights reserved.)

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., Competing Interests: Declaration of competing interest We have no conflicts of interest on the subject and during the process of the paper., (Copyright © 2024 Tissue Viability Society / Society of Tissue Viability. Published by Elsevier Ltd. All rights reserved.)

The existing fuzzy assistant cognition system has the problem of imperfect retrieval function, which leads to long execution time. This paper designs a fuzzy assistant cognition system of international economic and trade information under supply chain management. Hardware Part . Optimize wireless sensor and connect power interface and related accessories. In the software part, the dynamic characteristics of international economic and trade information elements are extracted, the flexible operation model of supply chain management is constructed, the demand-oriented organizational structure is established, the output set is determined by the product reasoning, and the retrieval function of fuzzy assistant cognitive system is designed by using the fuzzy association algorithm. Experimental Results . The average execution time of the fuzzy assistant cognitive system and the other two systems is 123.593 s, 165.733 s, and 169.506 s, which proves that the cognitive system integrated with supply chain management has a higher practical application value., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2022 Donghong Ren and Zamira Madina.)

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-, χ 2 -, 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., (Copyright © 2021 Tissue Viability Society. Published by Elsevier Ltd. All rights reserved.)

The coordination of different container-handling equipment is an important method for improving the overall efficiency of automated container terminals. In the real terminal, we should consider many real-life issues, such as the equipment capacity, the equipment collision, changing lanes in the multi-lane road, and choosing one of container-handling lanes for each container. This paper proposes the integrated scheduling problem of three container-handling equipment with the capacity constraint and the dual-cycle strategy, for simultaneously solving the equipment scheduling problem, the assignment problem of the container-handling lane and the conflict-free route planning problem of automated guided vehicles (AGVs). With the objective of minimizing the ship's berth time, we propose a mixed-integer programming model based on the space-time network representation method and two bilevel optimization algorithms based on conflict resolution rules. Finally, numerical experiments are conducted to verify the effectiveness of the proposed model and two bilevel optimization algorithms., Competing Interests: The authors have declared that no competing interests exist.

Importance: Home modification through seemingly mundane equipment, such as grab bars and shower seats, mitigates injury, dependence, and reduced quality of life in older adults coping with increasing disability. However, whether these interventions are underused in the US is unclear., Objective: To estimate how many older adults who need equipment to help with bathing and toileting do not have it, describe factors associated with not having equipment, and describe how many who did not initially have equipment acquired equipment over time., Design: This observational cohort study of participants 65 years or older used secondary data from the 2015 to 2019 waves of the US National Health and Aging Trends Study. Participants included community-dwelling older adults who would unequivocally benefit from equipment, defined as those with poor physical performance or substantial difficulty bathing, toileting, transferring, or walking. Respondents were representative of the US population 65 years and older. Data were collected from May 2015 to October 2019 and analyzed from August 1, 2019, to February 24, 2021., Exposures: Population characteristics (eg, age, sex, income, health conditions, and physical performance), environmental factors (eg, home ownership and living arrangement), and health behaviors (eg, prior knee and/or hip surgery)., Main Outcomes and Measures: Prevalence of any unmet need for equipment, defined as either needing bathing equipment (bath grab bars and shower seat) but having none or needing toileting equipment (toilet grab bars and raised toilet seat) but having none and the cumulative incidence of equipment acquisition during 4 years of follow-up., Results: A total of 2614 participants representing 12 million US individuals would benefit from equipment. The mean (SD) age was 80.5 (8.2) years, and 1619 individuals (62%) were women. Of these, an estimated 5 million individuals (42%; 95% CI, 39%-44%) had an unmet need. After adjustment for age, sex, and race/ethnicity, unmet need was associated with younger age (49% if aged 65-74 years, 37% if aged 75-84 years, and 29% if aged ≥85 years; P < .001), having fewer health conditions (55% if none vs 39% if ≥3; P = .002), non-White race/ethnicity (40% if White vs 51% if Black, 54% if Hispanic, and 55% if other; P < .001), no recent hospitalization (46% vs 37% if hospitalized; P = .001), and no prior knee and/or hip fracture or surgery (46% vs 35% if prior fracture or surgery; P < .001). After 4 years of follow-up, 35% of those with bathing equipment needs and 52% of those with toileting equipment needs never received equipment., Conclusions and Relevance: This cohort study suggests that in the US, 42% of older adults with impairments that would make bathing or toileting difficult lack equipment to assist. This situation is a missed opportunity to help 5 million individuals live independently and safely.

In recent times, there has been a significant growth in networks known as the wireless body area networks (WBANs). A WBAN connects distributed nodes throughout the human body, which can be placed on the skin, under the skin, or on clothing and can use the human body's electromagnetic waves. An approach to reduce the size of different telecommunication equipment is constantly being sought; this allows these devices to be closer to the body or even glued and embedded within the skin without making the user feel uncomfortable or posing as a danger for the user. These networks promise new medical applications; however, these are always based on the freedom of movement and the comfort they offer. Among the advantages of these networks is that they can significantly increase user's quality of life. For example, a person can carry a WBAN with built-in sensors that calculate the user's heart rate at any given time and send these data over the internet to user's doctor. This study provides a systematic review of WBAN, describing the applications and trends that have been developed with this type of network and, in addition, the protocols and standards that must be considered., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (Copyright © 2021 Carlos A. Tavera et al.)

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/m 2 (16.28-18.62 kg/m 2 ) versus 15.98 kg/m 2 (15.14-17.96 kg/m 2 ) 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.

Efforts towards slowing down coronavirus (COVID-19) transmission and reducing mortality have focused on timely case detection, isolation and treatment. Availability of laboratory COVID-19 testing capacity using reverse-transcriptase polymerase chain reaction (RT-PCR) was essential for case detection. Hence, it was critical to establish and expand this capacity to test for COVID-19 in Ethiopia. To this end, using a three-phrased approach, potential public and private laboratories with RT-PCR technology were assessed, capacitated with trained human resource and equipped as required. These laboratories were verified to conduct COVID-19 testing with quality assurance checks regularly conducted. Within a 10-month period, COVID-19 testing laboratories increased from zero to 65 in all Regional States with the capacity to conduct 18,454 tests per day. The success of this rapid countrywide expansion of laboratory testing capacity for COVID-19 depended on some key operational implications: the strong laboratory coordination network within the country, the use of non-virologic laboratories, investment in capacity building, digitalization of the data for better information management and establishing quality assurance checks. A weak supply chain for laboratory reagents and consumables, differences in the brands of COVID-19 test kits, frequent breakdowns of the PCR machines and inadequate number of laboratory personnel following the adaption of a 24/7 work schedule were some of the challenges experienced during the process of laboratory expansion. Overall, we learn that multisectoral involvement of laboratories from non-health sectors, an effective supply chain system with an insight into the promotion of local production of laboratory supplies were critical during the laboratory expansion for COVID-19 testing. The consistent support from WHO and other implementing partners to Member States is needed in building the capacity of laboratories across different diagnostic capabilities in line with International Health Regulations. This will enable efficient adaptation to respond to future public health emergencies., Competing Interests: The authors declare no competing interests., (Copyright: Adisu Kebede et al.)

Aims: Uptake of continuous subcutaneous insulin infusion (CSII) by people with diabetes (PwD) in Ireland is low and exhibits regional variation. This study explores barriers and facilitators to accessing CSII by adults with Type 1 diabetes mellitus., Research Design and Methods: A qualitative study employing focus groups with adults with Type 1 diabetes mellitus (n = 26) and semi-structured interviews with health care professionals (HCP) and other key stakeholders (n = 21) was conducted. Reflexive thematic analysis was used to analyze data, using NVivo., Results: Four main themes comprising barriers to or facilitators of CSII uptake were identified. These included: (1) awareness of CSII and its benefits, (2) the structure of diabetes services, (3) the capacity of the diabetes service to deliver the CSII service, and (4) the impact of individuals' attitudes and personal characteristics-both PwD, and HCP. Each of these themes was associated with a number of categories, of which 18 were identified and explored. If the structure of the health-service is insufficient and capacity is poor (e.g., under-resourced clinics), CSII uptake appears to be impacted by individuals': interest, attitude, willingness and motivation, which may intensify the regional inequality in accessing CSII., Conclusions: This study identified factors that contribute to gaps in the delivery of diabetes care that policy-makers may use to improve access to CSII for adult PwD.

Background: Acceleromyometry is the clinical standard for quantitative neuromuscular monitoring, mostly using the stimulation pattern train-of-four (TOF). TOF-Cuff®, a recently introduced neuromuscular monitor with stimulating electrodes integrated within a blood pressure cuff, assesses the muscular response in the upper arm., Methods: The time from administration of a neuromuscular blocking agent to TOF-ratio 0% during modified rapid sequence induction was compared between TOF-Cuff® and acceleromyometry (TOF-Scan®). Included were 26 adults with body mass index <35 kg/m 2 . TOF-Scan® and TOF-Cuff® were simultaneously fitted on patients' opposite arms. The mean difference to TOF-ratio 0% was compared using the one sample t-test (p < 0.05) and Bland-Altman plots., Results: After anesthesia induction, atracurium 0.9 mg/kg (±0.08) i.v. was administered. The mean time to TOF ratio 0% for TOF-Scan® was 140.4 s (±34.3), and 132.7 s (±32.5) for TOF-Cuff®, with a mean difference of 5.4 (95% CI: -9.9 to 20.7, p = 0.472). The maximum difference between the two modalities was 135 s when the TOF-Cuff® was faster and 60 s when the TOF-Scan® was faster., Conclusions: No statistically significant systematic difference was found between TOF-Scan® and TOF-Cuff®. However, there was high variability and wide limits of agreement. The two devices cannot be used interchangeably., (Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Electronic devices (eDevices) may have positive or negative influences on family communication and well-being depending on how they are used., Objective: We examined eDevice use during family time and its association with the quality of family communication and well-being in Hong Kong Chinese adults., Methods: In 2017, a probability-based 2-stage random sampling landline telephone survey collected data on eDevice use in daily life and during family time (eg, family dinner) and the presence of rules banning eDevice use during family dinner. Family communication quality was rated from 0 to 10 with higher scores being favorable. Family well-being was calculated as a composite mean score of 3 items each using the same scale from 0 to 10. The associations of family communication quality and well-being with eDevice use in daily life and during family time were estimated using beta-coefficient (β) adjusting for sociodemographics. The mediating role of family communication quality in the association between eDevice use and family well-being was analyzed., Results: Of the 2064 respondents (mean age 56.4 [SD 19.2] years, 1269/2064 [61.48%] female), 1579/2059 (76.69%) used an eDevice daily for a mean of 3.6 hours (SD 0.1) and 257/686 (37.5%) used it for 30+ minutes before sleep. As much as 794/2046 (38.81%) often or sometimes used an eDevice during family time including dinner (311/2017, 15.42%); 713/2012 (35.44%) reported use of an eDevice by family members during dinner. Lower family communication quality was associated with hours of eDevice use before sleep (adjusted β=-.25; 95% CI -0.44 to -0.05), and often use (vs never use) of eDevice during family dinner by oneself (adjusted β=-.51; 95% CI -0.91 to -0.10) and family members (adjusted β=-.54; 95% CI -0.79 to -0.29). Similarly, lower family well-being was associated with eDevice use before sleep (adjusted β=-.26; 95% CI -0.42 to -0.09), and often use during family dinner by oneself (adjusted β=-.48; 95% CI -0.83 to -0.12) and family members (adjusted β=-.50; 95% CI -0.72 to -0.28). Total ban of eDevice use during family dinner was negatively associated with often use by oneself (adjusted odds ratio 0.49; 95% CI 0.29 to 0.85) and family members (adjusted odds ratio 0.41; 95% CI 0.28, 0.60) but not with family communication and well-being. Lower family communication quality substantially mediated the total effect of the association of eDevice use time before sleep (61.2%) and often use at family dinner by oneself (87.0%) and by family members (67.8%) with family well-being., Conclusions: eDevice use before sleep and during family dinner was associated with lower family well-being, and the association was substantially mediated by family communication quality. Our results suggest that interventions on smart use of eDevice may improve family communication and well-being., (©Sheng Zhi Zhao, Ningyuan Guo, Man Ping Wang, Daniel Yee Tak Fong, Agnes Yuen Kwan Lai, Sophia Siu-Chee Chan, Tai Hing Lam, Daniel Sai Yin Ho. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 14.10.2020.)

Purpose: The purpose of this study was to describe medical device-related pressure injuries (MDRPIs) in hospitalized pediatric patients., Design: A prospective, descriptive study., Sample/subjects and Setting: The sample comprised 625 patients cared for in 8 US pediatric hospitals. Participants were aged preterm to 21 years, on bed rest for at least 24 hours, and had a medical device in place., Methods: Two nursing teams, blinded to the other's assessments, worked in tandem to assess pressure injury risk, type of medical devices in use, and preventive interventions for each medical device. They also identified the presence, location, and stage of MDRPI. Subjects were observed up to 8 times over 4 weeks, or until discharge, whichever occurred first., Results: Of 625 enrolled patients, 42 (7%) developed 1 or more MDRPIs. Two-thirds of patients with MDRPIs were younger than 8 years. Patients experiencing MDRPIs had higher acuity scores on hospital admission, were more frequently cognitively and/or functionally impaired, or were extreme in body mass index. Respiratory devices caused the most injuries (6.19/1000 device-days), followed by immobilizers (2.40/1000 device-days), gastric tubes (2.24/1000 device-days), and external monitoring devices (1.77/1000 device-days). Of the 6336 devices in place, 36% did not have an MDRPI preventive intervention in place. Clinical variables contributing to MDRPI development included intensive care unit care (odds ratio [OR] 8.9, 95% confidence interval [CI] 1.9-43.6), use of neuromuscular blockade (OR 3.7, 95% CI 1.7-7.8), and inotropic/vasopressor medications (OR 2.7, 95% CI 1.7-4.3). Multivariable analysis indicated that Braden QD scores alone predicted MDRPI development., Conclusion: Medical devices are common in hospitalized infants and children and these medical devices place patients at risk for MDRPI.

Background: Over the past years, several emergency medical service providers have introduced mechanical chest compression devices (MCDs) in their protocols for cardiopulmonary resuscitation (CPR). Especially in helicopter emergency medical systems (HEMS), which have limitations regarding loading weight and space and typically operate in rural and remote areas, whether MCDs have benefits for patients is still unknown. The aim of this study was to evaluate the use of MCDs in a large Swiss HEMS system., Materials and Methods: We conducted a retrospective observational study of all HEMS missions of Swiss Air rescue Rega between January 2014 and June 2016 with the use of an MCD (Autopulse®). Details of MCD use and patient outcome are reported from the medical operation journals and the hospitals' discharge letters., Results: MCDs were used in 626 HEMS missions, and 590 patients (94%) could be included. 478 (81%) were primary missions and 112 (19%) were interhospital transfers. Forty-nine of the patients in primary missions were loaded under ongoing CPR with MCDs. Of the patients loaded after return of spontaneous circulation (ROSC), 20 (7%) experienced a second CA during the flight. In interhospital transfers, 102 (91%) only needed standby use of the MCD. Five (5%) patients were loaded into the helicopter with ongoing CPR. Five (5%) patients went into CA during flight and the MCD had to be activated. A shockable cardiac arrhythmia was the only factor significantly associated with better survival in resuscitation missions using MCD (OR 0.176, 95% confidence interval 0.084 to 0.372, p < 0.001)., Conclusion: We conclude that equipping HEMS with MCDs may be beneficial, with non-trauma patients potentially benefitting more than trauma patients.

Radiographs of the abdomen and pelvis are routinely obtained as a standard part of clinical care for the abdomen and pelvis. Brisk advances in technology over the last few decades have resulted in a multitude of medical devices and materials. Recognizing and evaluating these devices on abdominal and pelvic radiographs are critical, yet increasingly a difficult endeavor. In addition, multiple devices serving different purposes may have a similar radiographic appearance and position causing confusion for the interpreting radiologist. The role of the radiologist is to not only identify accurately these medical objects, but also to confirm for their accurate placement and to recognize any complications that could affect patient care, management or even be potentially life threatening. An extensive online search of literature showed our review article to be the most comprehensive work on medical devices and materials of the abdomen and pelvis, and in this second part of our two-part series, we discuss in depth about the neurologic and genitourinary devices seen on abdominal and pelvic radiographs.

Objectives: Severe sepsis is a significant cause of healthcare utilization and morbidity among pediatric patients. However, little is known about how commonly survivors acquire new medical devices during pediatric severe sepsis hospitalization. We sought to determine the rate of new device acquisition (specifically, tracheostomy placement, gastrostomy tube placement, vascular access devices, ostomy procedures, and amputation) among children surviving hospitalizations with severe sepsis. For contextualization, we compare this to rates of new device acquisition among three comparison cohorts: 1) survivors of all-cause pediatric hospitalizations; 2) matched survivors of nonsepsis infection hospitalizations; and 3) matched survivors of all-cause nonsepsis hospitalization with similar organ dysfunction., Design: Observational cohort study., Setting: Nationwide Readmission Database (2016), including all-payer hospitalizations from 27 states., Patients: Eighteen-thousand two-hundred ten pediatric severe sepsis hospitalizations; 532,738 all-cause pediatric hospitalizations; 16,173 age- and sex-matched nonsepsis infection hospitalizations; 15,025 organ dysfunction matched all-cause nonsepsis hospitalizations; and all with live discharge., Measurements and Main Results: Among 18,210 pediatric severe sepsis hospitalizations, 1,024 (5.6%) underwent device placement. Specifically, 3.5% had new gastrostomy, 3.1% new tracheostomy, 0.6% new vascular access devices, 0.4% new ostomy procedures, and 0.1% amputations. One-hundred forty hospitalizations (0.8%) included two or more new devices. After applying the Nationwide Readmissions Database sampling weights, there were 55,624 pediatric severe sepsis hospitalizations and 1,585,194 all-cause nonsepsis hospitalizations with live discharge in 2016. Compared to all-cause pediatric hospitalizations, severe sepsis hospitalizations were eight-fold more likely to involve new device acquisition (6.4% vs 0.8%; p < 0.001). New device acquisition was also higher in severe sepsis hospitalizations compared with matched nonsepsis infection hospitalizations (5.1% vs 1.2%; p < 0.01) and matched all-cause hospitalizations with similar organ dysfunction (4.7% vs 2.8%; p < 0.001)., Conclusions: In this nationwide, all-payer cohort of U.S. pediatric severe sepsis hospitalizations, one in 20 children surviving severe sepsis experienced new device acquisition. The procedure rate was nearly eight-fold higher than all-cause, nonsepsis pediatric hospitalizations, and four-fold higher than matched nonsepsis infection hospitalizations.

Objective: The objective of this study was to develop a French value set for the EQ-5D-5L, for academic and clinical research, and for regulatory requirements for price-setting of drugs and medical devices., Method: This study used the standardized valuation protocol developed by EuroQol, using computer-assisted personal interview software. A representative sample of 1048 French residents were interviewed by a market research company, under the supervision of the research team. Health states were valued using composite time trade-off and a discrete choice experiment. Modeling was used to create values for the 3125 possible health states. The composite time trade-off data were modeled using a Tobit model with censored observations at -1 and correcting for heteroscedasticity. A conditional logit model was used for the discrete choice results, and both models were combined using a hybrid model. An adjusted hybrid model was tested to correct for imbalance in the sample on age and sex compared with the general population. A comparison with the 3-level (3L) value set was performed., Results: The adjusted model was preferred to comply with the representativeness of the general population. It provided a value set for which all coefficients were logically consistent. Values ranged from - 0.525 to 1. The distribution of values presented a shift towards higher values versus the 3L value set. Ranking of dimensions changed. Pain and discomfort and mobility were the dimensions with the highest potential for disutility compared with mobility and self-care for the 3L instrument., Conclusions: This study provides a value set based on societal preferences of the French population, using an improved descriptive instrument of health-related quality-of-life health states. It will contribute to improve the quality of cost-effectiveness analysis in the French context and help stimulate disease-specific quality-of-life references for academic-, institutional-, and industry-promoted studies.

Problem: Rapid growth in the use of medical devices has drawn attention to gaps in the systematic monitoring of medical device-associated adverse events in India., Approach: Implementation of national regulations on medical devices started in January 2018. Supported by a nationwide network of monitoring centres, the Indian Pharmacopoeia Commission coordinates adverse event reports from manufacturers, legal representatives and patients or users. The commission follows-up and reviews reports with subject expert groups and sends recommendations on necessary action to the national regulatory authority., Local Setting: Before 2015, no systematic structure was in place to collate adverse events associated with medical devices. Several reports of deaths and hospitalization due to faulty hip implants, cardiac stents and poor-quality devices prompted the health ministry to launch the materiovigilance programme., Relevant Changes: From July 2015 to October 2019, the commission received 1931 adverse event reports, mostly from marketing authorization holders; 1277 were serious events. Reporting increased markedly after 2017. Cardiac stents were the most reported device (926 events; 47.95%). To encourage a culture of reporting, the commission has raised awareness about the programme among stakeholders, developed user-friendly reporting tools and guidelines, and conducted training for hospital personnel on medical device adverse event reporting., Lessons Learnt: Regular training to stakeholders develops a sense of responsibility towards reporting medical device adverse events and ensures quality data reporting. Reporters must be assured that reporting adverse events does not have any legal implications for them and given acknowledgement of their role in high-quality device associated adverse event reporting., ((c) 2020 The authors; licensee World Health Organization.)

Background: Continuous glucose monitoring (CGM)/flash glucose monitoring (FGM) use in diabetes management is increasing. Cutaneous complications associated with these devices were reported. We conducted a systematic review to provide an overview of cutaneous complications with CGM/FGM use., Methods: We identified observational studies and intervention trials that report on cutaneous complications with CGM/FGM use up to January 14, 2019. Studies were identified through Medline, Embase, and PubMed, or with hand searching of the previous publications. Screening was duplicated and data extracted to consider four main themes: incidence rate and severity, participant perspectives of cutaneous complications, potential solutions, and future directions in diabetic technology relevant to reducing cutaneous complications., Results: A total of 54 eligible studies were identified. The overall event rate of cutaneous complications reported from 19 trials was one event per eight weeks of sensor wear-time of which 1.5% were considered severe. The most common cutaneous complications were wear-related erythema, itching, and induration. Although skin irritations were the most common cause of CGM/FGM discontinuation, most users experienced less pain or discomfort with CGM/FGM than capillary blood glucose testing. Future technological advances may reduce, but not eliminate cutaneous complications., Conclusion: The incidence rate of reported cutaneous complications with CGM/FGM use from the available literature is low, with one event per eight weeks of sensor wear-time. Reported complication severity was also low, leading to low rates of CGM/FGM discontinuation. However, there appear to be discrepancies between reporting in trial and observational data. Greater constancy in reporting is necessary to understand the frequency of this issue.

Objective: In 2016, nationwide reimbursement of intermittently scanned continuous glucose monitoring (isCGM) for people living with type 1 diabetes treated in specialist diabetes centers was introduced in Belgium. We undertook a 12-month prospective observational multicenter real-world study to investigate impact of isCGM on quality of life and glycemic control., Research Design and Methods: Between July 2016 and July 2018, 1,913 adults with type 1 diabetes were consecutively recruited in three specialist diabetes centers. Demographic, metabolic, and quality of life data were collected at baseline, 6 months, and 12 months of standardized clinical follow-up. The primary end point was evolution of quality of life from baseline to 12 months. Secondary outcome measures were, among others, change in HbA 1c , time spent in different glycemic ranges, occurrence of acute diabetes complications, and work absenteeism., Results: General and diabetes-specific quality of life was high at baseline and remained stable, whereas treatment satisfaction improved ( P < 0.0001). Admissions for severe hypoglycemia and/or ketoacidosis were rare in the year before study ( n = 63 out of 1,913; 3.3%), but decreased further to 2.2% ( n = 37 out of 1,711; P = 0.031). During the study, fewer people reported severe hypoglycemic events ( n = 280 out of 1,913 [14.6%] vs. n = 134 out of 1,711 [7.8%]; P < 0.0001) or hypoglycemic comas ( n = 52 out of 1,913 [2.7%] vs. n = 18 out of 1,711 [1.1%]; P = 0.001) while maintaining HbA 1c levels. Fewer people were absent from work ( n = 111 out of 1,913 [5.8%] vs. n = 49 out of 1,711 [2.9%]; P < 0.0001). Time spent in hypoglycemia significantly decreased in parallel with less time in range and more time in hyperglycemia. Eleven percent ( n = 210) of participants experienced skin reactions, leading to stopping of isCGM in 22 participants (1%)., Conclusions: Nationwide unrestricted reimbursement of isCGM in people with type 1 diabetes treated in specialist diabetes centers results in higher treatment satisfaction, less severe hypoglycemia, and less work absenteeism, while maintaining quality of life and HbA 1c ., (© 2019 by the American Diabetes Association.)

Objective: Around a quarter of older occupants use some type of comfort or orthopedic aftermarket accessory on the vehicle seat while traveling in a vehicle. The aim of this study was to investigate the effect of comfort accessories on the performance of the seat belt restraint system in a frontal crash in terms of potential injury implications for older occupants. Methods: Eight frontal sled tests (43 km/h, 32  g ) were carried out on a deceleration sled fitted with a three-point lap-sash seat belt and a front passenger seat from a common Australian passenger car for each test. A 5 th percentile Hybrid III anthropometric test device (ATD) was positioned in the seat and measurements were recorded for head center of gravity acceleration, chest acceleration, neck forces and moments and sternal deflection. Tests were carried out in a baseline condition and with seven comfort accessories. Each comfort accessory was inserted between the ATD and vehicle seat as it is intended to be used, with the ATD otherwise positioned as close as possible to the baseline test position. Results: Initial distance between the seat belt anchor and ATD hip was associated with a statistically significant decrease in Head Injury Criterion and increase in sternal deflection. Submarining was related to the ATD torso recline angle and angle of the lap belt from the seat belt anchor. Conclusions: Accessories placed between the seat back and the lumbar region of an occupant have the potential to increase the risk of submarining due to a change in posture and should be avoided if such a change in posture when seated with an accessory is excessive. Sitting on seat cushions resulted in the greatest increase in seat belt anchor to hip distances and hence largest increase in sternal deflection. Given the fragility, frailty and particular importance of chest injuries among older vehicle occupants, further investigation is needed to determine whether these changes in ATD sternal deflection observed with seat cushion use results in injury threshold limits being exceeded and whether pretensioners and load limiters would ameliorate these effects without causing other negative changes in occupant response or kinematics.

Background: Hospitals in many countries do not record and analyze artificial hip and knee joint surgeries systematically, leading to a lack of reliable quality assurance data. Arthroplasty registers have the potential to alleviate this and improve quality of care and health care expenditures. In Germany, the current introduction of the Arthroplasty Register acts as a prototype for various medical device registers. However, participation is voluntary for hospitals in most countries, leading to problems with nonadoption., Purpose: Implementing successful registers requires adoption by most relevant hospitals. Therefore, we assess variables influencing medical device register adoption., Methodology: We collect longitudinal data from 343 hospitals that are potential adopters of the German Arthroplasty Register in two surveys. The first survey on the implementation process is conducted in 2014; the second survey is conducted in 2016 to collect data on actual adoption of the surveyed hospitals in 2014. The survey data are matched with published hospital characteristics and administrative data. The hypotheses are tested with a mediated regression model, using partial least squares structural equation modeling., Findings: Hospital specialization positively affects adoption, directly and indirectly, depending on top management support and user involvement. Quality benefits and hospital size impact adoption positively; economic benefits impact adoption negatively., Conclusion: Important factors influencing adoption of medical device registers for the first time were revealed in this study, providing a starting point to influence adoption proactively and avoid nonadoption., Practice Implications: The results provide important guidelines for decision-makers at hospitals, registers, and health insurance companies and policy makers about how to foster register adoption and encourage hospitals toward adopting medical device registers.

Identifying the needs of dementia caregivers is critical for supporting dementia home care. This study identified a typology of expert interventions delivered to dementia caregivers during an innovative telehealth trial that used in-home video recordings to directly observe care challenges. Qualitative content analysis was used to analyze narrative notes describing interventions that were developed based on video data submitted by 33 caregiver-care recipient dyads. Two major themes emerged: education and skills for dementia care and caregiver support. Ten subthemes included education and skills related to: behavioral and psychological symptoms of dementia, disease expectations, safety, activities of daily living, medical care optimization, and medication utilization and caregiver support related to: respite, positive reinforcement, social and financial support, and self-care. Families providing in-home dementia care experience a wide range of care challenges. By using video data, dementia care experts were able to witness and evaluate challenging care situations and provide individualized feedback.

A medevac involves the transport of a critically ill patient, usually by plane or helicopter, to access necessary and at times life-saving care, most often only accessible in urban centres. Medevacs are commonly used in resource-limited and geographically isolated areas in Canada. The objective of this study was to explore the determinants of medevac decision-making from the perspective of frontline care providers and decision-makers in Nunavut. For this purpose, we conducted a secondary analysis of 90 in-depth interviews. Findings indicate that medevacs can be the result of a number of intersecting factors, including the referring and receiving provider's experience, insufficient staffing in health centres, lack of access to diagnostic or treatment-related, and challenges related to recruitment and retention. An expanded scope of practice for frontline care providers, and a related lack of training and/or confidence in skills, only add to these challenges. Medevacs play an important role related to managing shifting community nursing workloads, which expands and contracts in response to local needs. Attention to structural issues, putting in place virtual peer support systems, resolving vacancies left by the lag between attrition and recruitment, increasing access to training, and local diagnostic and treatment equipment, might decrease reliance of medevacs.

Online pharmacies are an important part of the modern healthcare system. They interact with customers through well-designed web interfaces to deliver the healthcare customers need. In addition to well-designed web interfaces, online pharmacies rely on an effective supply chain system to provide medical supplies and services, and especially effective inventory management for supply systems. As green supply chain management (GSCM) becomes increasingly considered by countries, how to develop a sustainable inventory model that takes into account the revenue growth of an online pharmacy while preventing waste and reducing energy costs has become very important. In line with this trend, the study develops a sustainable inventory model that focuses on both economic aspect (profit) and environmental aspect (losses from excessive inventory) within a framework of a single period multi-product inventory model. Specifically, the sustainable inventory model applies the visual-attention-dependent demand (VADD) rate to characterize customer demand in an online trading environment, thereby seeking a profitable marketing strategy and reducing losses due to excessive inventory. Since the complexity of model optimization will drastically increase due to the inclusion of many products in the problem, a Genetic Algorithm (GA) based solution procedure is proposed to increase the feasibility of the proposed model in solving real problems. The sustainable inventory model and the solution procedure are illustrated, compared, and discussed with an online pharmacy example. Additionally, a sensitivity analysis is formulated to study the influence of model parameters on the model solution, the loss of unsold inventory that results in a waste of resources and energy, and the profit of online pharmacies.

Aim: To explore the impact of using electronic data in performance management to improve nursing compliance with a protocol., Background: Electronic data are increasingly used to monitor protocol compliance but little is known about the impact on nurses' practice in hospital wards., Method: Seventeen acute hospital nursing staff participated in semi-structured interviews about compliance with an early warning score (EWS) protocol delivered by a bedside electronic handheld device., Results: Before electronic EWS data was used to monitor compliance, staff combined protocol-led actions with clinical judgement. However, some observations were missed to reduce noise and disruption at night. After compliance monitoring was introduced, observations were sometimes covertly omitted using a loophole. Interviewees described a loss of autonomy but acknowledged the EWS system sometimes flagged unexpected patient deterioration., Conclusions: Introducing automated electronic systems to support nursing tasks can decrease nursing burden but remove the ability to record legitimate reasons for missing observations. This can result in covert resistance that could reduce patient safety., Implications for Nursing Management: Providing the ability to log legitimate reasons for missing observations would allow nurses to balance professional judgement with the use of electronic data in performance management of protocol compliance., (© 2019 The Authors. Journal of Nursing Management published by John Wiley & Sons Ltd.)

Background: Objectively derived search filters for adverse drug effects and complications in surgery have been developed but not for medical device adverse effects., Objective: To develop and validate search filters to retrieve evidence on medical device adverse effects from ovid medline and embase., Methods: We identified systematic reviews from Epistemonikos and the Health Technology Assessment (hta) database. Included studies within these reviews that reported on medical device adverse effects were randomly divided into three test sets and one validation set of records. Using word frequency analysis from one test set, we constructed a sensitivity maximising search strategy. This strategy was refined using two other test sets, then validated., Results: From 186 systematic reviews which met our inclusion criteria, 1984 unique included studies were available from medline and 1986 from embase. Generic adverse effects searches in medline and embase achieved 84% and 83% sensitivity. Recall was improved to over 90%, however, when specific adverse effects terms were added., Conclusion: We have derived and validated novel search filters that retrieve over 80% of records with medical device adverse effects data in medline and embase. The addition of specific adverse effects terms is required to achieve higher levels of sensitivity., (© 2019 The Authors. Health Information and Libraries Journal published by John Wiley & Sons Ltd on behalf of Health Libraries Group.)

Background: Healthcare-associated infection (HAI) is the most frequent adverse event in healthcare settings. It is associated with increased mortality and antimicrobial resistance, leading to prolonged hospital stays and consistent financial loss for healthcare systems. The objective of this study was to estimate the burden of HAIs and antimicrobial use in the Teaching Hospital Policlinico Umberto I (THPUI) of Rome and to identify the most critical areas for intervention., Methods: Data were collected according to the most recent ECDC point prevalence survey protocol in November 2018. Descriptive statistics for all variables were calculated. Univariate analysis was used to assess possible associations between variables and HAIs. Variables with a significance level of p<0.25 were included in a multiple logistic regression model., Results: A total of 799 patients were included in the analysis; of these, 13.3% presented with at least one HAI. Bloodstream infection was the most common, accounting for 30.9% of total infections. Overall, 125 microorganisms were isolated, with Enterobacteriaceae being the most frequent (32%). At the time of the survey, 49.1% patients were receiving antimicrobial therapy. The multivariate analysis showed a significant association between HAI and use of medical devices (OR=34.30; 95% CI:3.69-318.66), length of stay (OR=1.01; 95% CI:1.00-1.02) and exposure to prophylactic antimicrobial therapy (OR=0.23; 95% CI:0.11-0.47)., Conclusions: The ECDC methodology proved to be applicable to THPUI, where HAI prevalence was higher than the European standard (6.7%). This highlights the need to implement targeted measures to prevent and control HAIs, including continuous monitoring to evaluate the effectiveness of such interventions.

Background and Objectives : Gait training with body weight-support has been shown to improve the walking speed of individuals with movement disorders. The AccesSportAmerica Gait Trainer is a low-cost, pre-market gait rehabilitation device that alters the stride characteristics of participants walking on a standard treadmill. The purpose of this study was to examine the biomechanical outcomes that training on this device has for people with brain injuries that affect motor functioning. It was hypothesized that there would be an increase in walking speed post-intervention, and that there would be an increase in step length and joint range-of-motion. Materials and Methods : An intervention study was conducted with 11 people with ambulatory difficulty caused by post-stroke hemiparesis ( n = 7), traumatic brain injury ( n = 3), and cerebral palsy ( n = 1). The average time using the AccesSportAmerica Gait Trainer was 34.5 (SD = 6.0) minutes per session for 36.9 (SD = 21.8) sessions. Gait speed, step length and time, and joint flexion were measured during the 10 Meter Walk Test. Results : From pre- to post-intervention, there was a mean increase in walking speed of 0.19 m/s (SD = 0.06, p = 0.016, d = 0.40) and a decrease in step time of both affected and unaffected legs (affected: p = 0.011, d = 0.37; unaffected: p = 0.004, d = 0.67). There was no significant change in stride length or joint angles. Conclusions : The AccesSportAmerica Gait Trainer has the potential to improve the walking speed of people with ambulatory difficulty., Competing Interests: The authors declare no conflicts of interest.

Background: Medical supplies and equipment are unevenly distributed throughout the world., Objective: Our aim was to describe, quantify, and monetize unused supplies suitable for recovery produced from two urban emergency departments (EDs)., Methods: We trained ED staff to place opened, unused, uncontaminated medical supplies in strategically located bins located in two urban EDs for 30 days. We sorted and quantified collected supplies, then used hospital-specific supply catalogs to determine the total cost of recovered medical supplies during the 30-day study period. We extrapolated the amount of collected medical supplies and associated costs to yearly estimates., Results: We recovered 39.9 kg ($6,096) from the trauma center and 3.4 kg ($539) from the academic center during the 30-day study period. The most commonly collected supplies included open but unused procedure kits ($1,776), catheter needles ($1,009), and sutures ($698). We estimated that the trauma center produces $73,158 of unused medical supplies per year and the academic center produces $6,467 of unused medical supplies per year., Conclusions: We present a novel approach to decreasing waste and recovering usable medical supplies, in which we found that substantial, valuable medical supplies can be recovered in two urban EDs., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: The use of health information technology (IT) is rapidly increasing to support improvements in the delivery of care. Although health IT is delivering huge benefits, new technology can also introduce unique risks. Despite these risks, evidence on the preventability and effects of health IT failures on patients is scarce. In our study we therefore sought to evaluate the preventability and effects of health IT failures by examining patient safety incidents in England and Wales., Methods: We designed our study as a retrospective analysis of 10 years of incident reporting in England and Wales. We used text mining with the words "computer", "system", "workstation", and "network" to explore free-text incident descriptors to identify incidents related to health IT failures following a previously described approach. We then applied an n-gram model of searching to identify contiguous sequences of words and provide spatial context. We examined incident details, recorded harm, and preventability. Standard descriptive statistics were applied. Degree of harm was identified according to standardised definitions and preventability was assessed by two independent reviewers., Findings: We identified 2627 incidents related to health IT failures. 2557 (97%) of 2627 incidents were assessed for harm (70 incidents were excluded). 2106 (82%) of 2557 health IT failures caused no harm to patients, 331 (13%) caused low harm, 102 (4%) caused moderate harm, 14 (1%) caused severe harm, and four (<1%) contributed to the death of a patient. 1964 (75%) of 2627 incidents were deemed to be preventable., Interpretation: Health IT is fundamental to the delivery of high-quality care, yet there is a poor understanding of the effects of IT failures on patient safety and whether they can be prevented. Failures are complex and involve interlinked aspects of technology, people, and the environment. Health IT failures are undoubtedly a potential source of substantial harm, but they are likely to be under-reported. Worryingly, three-quarters of IT failures are potentially preventable. There is a need to see health IT as a fundamental tenet of patient safety, develop better methods for capturing the effects of IT failures on patients, and adopt simple measures to reduce their probability and mitigate their risk., Funding: The National Institutes of Health Research Imperial Patient Safety Translational Research Centre at Imperial College London., (Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background/objective: The effect of economic assistance to underprivileged families with type 1 diabetes has never been described. Such a study is relevant as logistic and cultural factors may preclude an anticipated good outcome. The objective of the study is to determine the impact of economic and educational intervention on hemoglobin A1c (HbA1c) and diabetes knowledge., Methods: Eighty-five consecutive participants were prospectively provided insulin and glucose strips for 1 year. From the 6th to 12th month, patients were randomized such that half of them (telephone group) received proactive telephonic advice by a diabetes educator, while the non-telephone group received usual care. HbA1c and diabetes knowledge were measured at baseline, 6 and 12 months., Results: Significant improvement was seen in HbA1c with provision of free diabetes supplies, when patients were compared with their own HbA1c values during the prior 36 months (baseline [8.38 ± 2.0%], at 3 months [8.0 ± 1.6%] and at 6 months [8.1 ± 1.5%, P = 0.0106]). Knowledge score increased from baseline (48 ± 15) to 6 months (58 ± 13, P < 0.001). No difference was seen between the telephone and non-telephone groups in HbA1c from the 6th to 9th and 12th month. The knowledge score showed significant improvement in the telephone group during the proactive telephonic advice study compared with the non-telephone group (P = 0.002)., Conclusions: The provision of free medical supplies improved HbA1c and diabetes knowledge. Intensive telephone contact improved knowledge, not HbA1c. These results provide important background for policy makers and diabetes management teams., (© 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Objective: To determine the nature and extent of misappropriation of medications and equipment from the ED., Methods: We undertook a retrospective audit of medications procured and administered, and equipment replaced, in 2016, within a tertiary referral ED. Medication procurement and administration data were obtained from our MERLIN ® pharmacy system and CERNER ® electronic prescribing system, respectively. A medication 'discrepancy rate' was defined as the percentage of a medication procured that could not be accounted for by electronic administrations. The study also comprised a nested intervention sub-study where, from July 1, 2016, all Panadeine Forte tablets were stored in a locked facility. Victorian Hospital Healthcare Equipment invoices were audited to determine which major non-disposable equipment items most commonly needed resupply., Results: Discrepancy rates for paracetamol 500mg and 665mg tablets were 23.3% and 54.9%, respectively. Following the Panadeine Forte intervention, the discrepancy rate for this medication fell from 70.5% to 8.8%. Orally administered medications with the potential for misappropriation had high discrepancy rates: caffeine (90.6%), cephalexin (62.9%), ondansetron (50.1%), pantoprazole (42.9%), amoxicillin (41.1%), metoclopramide (41.0%) and the 'morning after pill' (levonorgestrel) (36.4%). Parenterally administered medications had lower discrepancy rates: ceftriaxone (7.9%) and ampicillin (3.4%). The largest equipment replacement rates were for tourniquets and crutches., Conclusion: Discrepancy rates for many medications, especially those administered orally, are high. Further research is required to determine how these medications 'go missing'. Placing a medication with a high discrepancy rate in a locked facility with a 'logbook' substantially reduces this rate. Misappropriation of non-disposable equipment items is uncommon., (Copyright © 2019 College of Emergency Nursing Australasia. Published by Elsevier Ltd. All rights reserved.)

Most of the industrial sectors of India have undergone major changes in the post-liberalization period. During this period, India has become self-reliant in drugs; however, still, 75% of the medical devices are imported in India. According to WHO, almost all devices present in the developing countries have been designed for use in the industrialized countries. With the increase in incidence of non-communicable diseases and decrease in communicable diseases; increase in survival rates and decrease in mortality rates, and increase in ageing population, the healthcare demands have changed in the last decade. In addition to these parameters, aware patients and healthcare professionals, requirement of achieving national targets of healthcare and close proximity to the developed world, is giving a push to the development of indigenous medical device industry. However, the rules and regulations governing medical devices are ambiguous and vague. The Health Ministry of India has notified Medical Devices Rules, 2016, for regulating manufacturing/import/sale/clinical investigation and other related matters concerning medical devices. In addition, the government is funding the start-up industries in medical devices sector. Furthermore, government has taken the initiative of inverted duty structure in India. Also, special med tech zones are being set-up, which will enhance the production at local levels for the local population and will also generate employment for local people., (Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

The present study aimed to identify plasticizers present in indwelling plastic medical devices commonly used in the pediatric intensive care unit (PICU). We have analyzed a wide range of medical devices (n = 97) daily used in the PICUs of two academic hospitals in Belgium and the Netherlands. Identified compounds varied between the samples. Most of the indwelling medical devices and essential accessories were found to actively leach phthalates and alternative plasticizers. Results indicated that DEHP was predominantly present as plasticizer (60 of 97 samples), followed by bis(2-ethylhexyl) adipate (DEHA, 32 of 97), bis(2-ethylhexyl) terephthalate (DEHT, 24 of 97), tris(2-ethylhexyl) trimellitate (TOTM, 20 of 97), and tributyl-O-acetyl citrate (ATBC, 10 of 97). Other plasticizers, such as di-isononyl-cyclohexane-1,2-dicarboxylate (DINCH, 2 of 97), di-isononyl phthalate (DiNP, 4 of 97), di(2-propylheptyl) phthalate (DPHP, 4 of 97) and di-isodecyl phthalate (DiDP, 2 of 97) were detected in < 5% of the investigated samples. Several devices contained multiple plasticizers, e.g. devices containing TOTM contained also DEHP and DEHT. Our data indicate that PICU patients are exposed to a wide range of plasticizers, including the controversial DEHP. Future studies should investigate the exposure to APs in children staying in the PICU and the possible health effects thereof., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Setting: Dakshina Kannada District, coastal South India, under the Revised National Tuberculosis Control Programme (RNTCP)., Objective: To identify the potential and practices at primary health centres (PHCs) for the assessment of nutritional status of patients with tuberculosis (TB), the basic tools used to measure height and weight and the type of nutritional counselling provided., Design: A cross-sectional study was conducted with physical verification of availability of height and weight measuring equipment. Information was collected on the method used by medical officers for assessing nutritional status in PHCs, action taken in case the patient is undernourished and any formal training in nutritional assessment and counselling., Results: Of 37 PHCs assessed, weighing machines were available in all and stadiometers in 38%. Medical officers were not calculating body mass index for nutritional assessment even when height and weight were being uniformly measured. Nutritional classification was mostly based on the appearance and physique of the patient. Counselling included advice to take milk, eggs and protein powders with efforts to arrange funds from village health, sanitation and nutrition committees., Conclusion: There is a need to equip the PHCs and their medical officers with necessary tools and training for nutritional assessment and counselling of patients with tuberculosis.

A question that routinely arises in medical device clinical studies is the homogeneity across demographic subgroups, geographical regions, or investigational sites of the enrolled patients in terms of treatment effects or outcome variables. The main objective of this paper is to discuss statistical concepts and methods for the assessment of such homogeneity and to provide the practitioner a statistical framework and points to consider in conducting homogeneity assessment. Demographic subgroups, geographical regions, and investigational sites are discussed separately as each has its unique issues. Specific considerations are also given to randomized controlled trials, non-randomized comparative studies, and single-arm studies. We point out that judicious use of statistical methods, in conjunction with sound clinical judgment, is essential in handling the issue of homogeneity of treatment effect in medical device clinical studies.

Objectives: Children with medical complexity (CMC) are commonly assisted by medical devices to support essential body functions, although complications may lead to preventable emergency department (ED) and hospital use. Our objective was to identify predictors of device-complicated ED visits and hospitalizations., Methods: This single-center retrospective cohort study included patients referred to a Pediatric Complex Care Program between April 1, 2014, and April 30, 2016, assisted by at least 1 medical device. Hospitalizations and ED visits in the year before enrollment were rated for likelihood for being due to device complications. Interrater reliability among 3 independent reviewers was assessed. Bivariate followed by multivariate logistic regression clustered by patient helped us identify associations between demographic, clinical, and device characteristics associated with device-complicated ED or hospital encounters., Results: Interrater reliability was high (κ = 0.92). Among 98 CMC, device-complicated encounters represented 17% of 258 hospitalizations and 31% of 228 ED visits. Complications of 3 devices (central venous catheters, enteral tubes, and tracheostomy tubes) accounted for 13% of overall hospitalizations and 28% of overall ED visits. Central venous catheter presence (adjusted odds ratio [aOR] 3.2 [95% confidence interval (CI) 1.1-9.5]) was associated with device-complicated ED visits. Gastrojejunostomy/jejunostomy tube presence (aOR 3.3 [95% CI 1.5-7.5]) or tracheostomies with (aOR 8.1 [95% CI 2.3-28.5]) or without (aOR 4.5 [95% CI 1.7-7.5]) ventilator use was associated with device-complicated hospitalizations. Clinical variables were poor predictors of device-complicated encounters., Conclusions: Device-complicated ED visits and hospitalizations comprised a substantial proportion of total hospital and ED use. Developing interventions to prevent device complications may be a promising strategy to reduce overall CMC use., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2019 by the American Academy of Pediatrics.)

Importance: Pediatric hospital medicine is a relatively new and growing specialty. However, research remains inconclusive on outcomes for inpatients cared for by pediatric hospitalists compared with those cared for by general pediatricians., Objective: To analyze outcomes, adverse events (AEs), and types of AEs associated with care provided for pediatric patients by hospitalists vs general pediatricians., Design, Setting, and Participants: This cross-sectional study used data from the medical records of a US urban academic children's hospital comprising 1423 hospitalizations between January 1, 2009, and August 31, 2015, for 57 diagnoses of patients cared for by either a hospitalist or general pediatrician. General pediatricians worked primarily in the hospital's outpatient clinic, serving a few inpatient weeks per year, and were not the patients' primary care physician. Data analysis was performed from July 1, 2017, to October 10, 2018., Main Outcomes and Measures: Outcomes were length of stay, total costs, 30-day readmission rates, and AEs. Adverse events were documented by International Classification of Diseases, Ninth Revision, Clinical Modification codes determined by review of medical records. Adverse event categories were drug events, infections, and device-related AEs. Generalized linear models were used to analyze patient outcomes, with standard errors clustered by physician. Models were adjusted for patient characteristics, including Chronic Condition Indicators. Models were estimated with and without adjustment for physician characteristics., Results: The data set contained 1423 hospitalizations among 726 female patients and 697 male patients (mean [SD] age, 6.1 [6.3] years). Hospitalists cared for 870 patients, and general pediatricians cared for 553 patients. Among the physicians, there were 57 women and 38 men; physicians were a mean (SD) 11.1 (8.1) years out of medical school. Patients cared for by general pediatricians were younger than those cared for by hospitalists (mean [SD] age, 5.4 [6.0] vs 6.5 [6.4] years; P = .001) but had similar mean (SD) Chronic Condition Indicator scores (1.5 [1.0] vs 1.5 [1.0]). A total of 33 of 56 general pediatricians (58.9%) and 24 of 39 hospitalists (61.5%) were women (P = .006), and general pediatricians were in practice twice as long as hospitalists on average (mean [SD], 16.0 [10.3] vs 7.9 [3.8] years out of medical school; P < .001). In multivariate models adjusting for patient-level features, there were no significant differences between general pediatricians and hospitalists for mean length of stay (4.7 vs 4.6 days), total costs ($14 490 vs $15 200), and estimated 30-day readmission rate (8.9% vs 6.4%), and results were similar with adjustments for physician characteristics. Device-related AEs were higher among hospitalists (3.0% vs 1.1%; odds ratio, 0.34; 95% CI, 0.12-1.00); this association became nonsignificant after adjusting for physician experience., Conclusions and Relevance: General pediatrician and hospitalist inpatient care had similar length of stay, total costs, and readmission rates. However, AEs differed between hospitalists and general pediatricians, with device-related AEs more common among hospitalists, which may be associated with hospitalists' fewer years in practice. Such findings can inform hospitals in planning their inpatient staffing and patient safety oversight.

Over recent years there has been an explosion in availability of technical devices to support diabetes self-management. But with this technology revolution comes new hurdles. On paper, the available diabetes technologies should mean that the vast majority of people with type 1 diabetes have optimal glycemic control and are using their preferred therapy choices. Yet, it does not appear to be universally the case. In parallel, suboptimal glycemic control remains stubbornly widespread. Barriers to improvement include access to technology, access to expert diabetes health care professionals, and prohibitive insurance costs. Until access can be improved to ensure the technologies are available and usable by those that need them, there are many people with diabetes who are still losing out.