Medical Device Safety Training by Using Quick Response Codes and Extended Reality-Based Technologies.

This article describes the results of three different study settings where the use of QR codes and XR technologies were tested for medical device training among 132 social and health care professionals. Data from three types of learning events and different contents of training indicated that the professionals considered these novel technologies both beneficial for learning and useful in their working environments for training safe use of medical devices. Based on the collected data, these technologies can be considered prospective options for medical device training.

Extended Reality Is Underutilized in Medical Device Training: A Descriptive Literature Review.

This descriptive review provides a synthesis of existing literature about the use of extended reality (XR) including virtual (VR) and augmented reality (AR) technology solutions for competence assurance, training and orientation regarding digital skills and medical device training. From the literature, only few original studies were recognized with a study question or aim to assess medical device training as the target of virtual training modalities. XR methods could provide potential useful solutions to improve medical device competence. Based on the literature, it was evident that further studies are required to research the possibilities of XR technologies to improve medical device training.

Medical Device Incident Reports by Professional Users in Finland 2014-2021.

Medical Device incident reporting is a legal obligation for professional users in Finland. We analyzed all medical device incident reports recorded into the national incident repository from January 2014 to August 2021. Among the total 5,897 records, annual numbers of incident reports varied between 463 and 1,190. Approximately 80% of the medical device incident reports were near misses, 18.7% were person injuries and 1.3% deaths. The number of annual medical device incident reports between hospital districts varied more than expected when related to the population of catchment area. There was a tendency towards lesser reports per population from smaller hospital districts. In conclusion, medical device incident reporting activity of the professional user varied both annually and geographically. A high number of incidents caused person injuries or even death, which arouses safety concerns. A further analysis is required to explore the causes behind our findings.

Electronic Health Records on the Top of Medical Device Incident Reports.

Medical Device incident reporting is a legal obligation for professional users in Finland. We analyzed all medical device incident reports recorded into the national incident repository from January 2014 to August 2021. Almost 30% of the total of 5,897 recorded incidents were caused by top ten devices, of which electronic health records were the most common (332 incidents). High number of incidents caused by electronic health records arouses safety concerns. A further analysis is required to explore the causes of findings.

The Need for Surgical Safety Checklists in Neurosurgery Now and in the Future-A Systematic Review.

Safety checklists have been studied among various surgical patient groups, but evidence of their benefits in neurosurgery remains sparse. Since the implementation of the World Health Organization's Surgical Safety Checklist, their use has become widespread. The aim of this review was to systematically review the state of the literature on surgical safety checklists in neurosurgery. Also, in the new era of robotics and artificial intelligence, there is a need to re-evaluate patient safety procedures in neurosurgery. A systematic review was conducted on PubMed, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials, Embase, and MEDLINE for articles published between 2008 and 2016 using MeSH (medical subject heading) terms and keywords describing postoperative complications and surgical adverse events, and some additional searches were carried out until January 2019. Twenty-six original studies or reviews were eligible for this review. They were categorized into studies with patient-related outcomes, personnel-related outcomes, or previous reviews. Checklist use in neurosurgery was found to reduce hospital-acquired infectious complications and to enhance operating room safety culture. Checklists seem to improve patient safety in neurosurgery, although the amount of evidence is still limited. Despite their shortcomings, checklists are here to stay, and new research is required to update checklists to meet the requirements of the transforming working environment of the neurosurgery operating room.

SUCCESSFUL IMPLEMENTATION OF LEAN AS A MANAGERIAL PRINCIPLE IN HEALTH CARE: A CONCEPTUAL ANALYSIS FROM SYSTEMATIC LITERATURE REVIEW.

PURPOSE: The aim of this study was to identify and analyze the characteristics of leadership and management associated with a successful Lean thinking adaptation in healthcare. DESIGN: A systematic literature review was undertaken using electronic databases: PubMed, PubMed Systematic Review, ABI/INFORM, Business Source Complete, Emerald, JBI, and Cinahl. Inclusion criteria were: (i) a description of Lean management or leadership in health care, (ii) a reference to Lean thinking, (iii) a peer-reviewed original research article or a literature review, and (iv) a full text article available in English. Among the 1,754 peer-reviewed articles identified, nine original articles and three systematic reviews met the inclusion criteria. Data on informants, methods, and settings were extracted and collated. Content analysis was used to conduct a review of the nine original studies describing and analyzing the success factors of Lean adaptation. The characteristics of leadership and management were analyzed by using the concept of a managerial windshield that divides leadership and management into four ontological dimensions: activities, style, focus, and purpose, each with typical developmental stages of skills and capabilities. The current study has some limitations: some papers from the journals not indexed in the searched databases may have been overlooked and the literature searches were carried out only for a 5-year period. FINDINGS: Considering the results using the windshield concept emphasizes the philosophy, principles, and tools of Lean thinking. Lean leadership and management factors in health care were mainly conceptualized as skills and capabilities such as problem solving, making changes occur, empowering, communicating, coaching, supporting, facilitating, being democratic, organizational learning, and organizational success, all of which represented middle-stage or advanced managerial skills and capabilities. PRACTICAL IMPLICATIONS: A conceptual analysis of systematically reviewed studies of Lean leadership and management point to certain traits as being typical when adapting Lean thinking to health care. The concept of a managerial windshield is useful when categorizing and analyzing essential managerial skills and capabilities for Lean implementation. Findings are beneficial when learning and educating the skills required for Lean transformation in healthcare organizations.

Analysis of neurosurgical reoperations: use of a surgical checklist and reduction of infection-related and preventable complication-related reoperations.

OBJECT: Use of the WHO surgical checklist has been proven to reduce surgical morbidity and mortality, but its effect on surgical complications requiring reoperation has not been previously studied. The aim of this study was to determine whether the use of the WHO surgical checklist would have an impact on the number and causes of neurosurgical complications leading to a reoperation. METHODS: The authors retrospectively gathered information on all neurosurgical reoperations using hospital discharge data as well as the operations and procedures registry, and tracked all primary neurosurgical operations (n = 175) preceding a complication-related reoperation from 2007 to 2011. There were a total of 5418 neurosurgical operations during the study period. For further analysis of electronic patient records, the primary operations were divided into 2 groups based on the time of the WHO surgical checklist implementation in the authors' unit: 103 operations before and 72 after the introduction of the checklist. Observed adverse events and reoperations were categorized as preventable or unpreventable, and the actual use of the checklist during each operation was recorded. RESULTS: The overall rate of preventable complication-related neurosurgical reoperations decreased from 3.3% (95% CI 2.7%-4.0%) to 2.0% (95% CI 1.5%-2.6%) after the checklist implementation. The reoperations were mainly due to wound infections, 46% before and 39% after the checklist. All infection-related reoperations proportioned to all neurosurgical operations (2.5% before vs 1.6% after checklist implementation) showed a significant reduction (p = 0.02) after the implementation of the checklist. In particular, there was a significant decrease (p = 0.006) in the rate of preventable infections associated with reoperations, i.e., 2.2% before versus 1.2% after checklist implementation. The overall adherence to checklist use (the "time out" phase) in neurosurgical operations was 78%, and adherence was 70% in primary operations preceding a complication-related reoperation regarded as preventable. CONCLUSIONS: The implementation of the WHO surgical checklist in neurosurgery was associated with a decrease in complication-related reoperations, especially those due to preventable infection complications, the majority of which were wound infections. The adherence to checklist use in individual operations after the checklist implementation did not appear to have an impact on the results.

A systematic review and cost analysis of robot-assisted hysterectomy in malignant and benign conditions.

In order to assess the effectiveness and costs of robot-assisted hysterectomy compared with conventional techniques we reviewed the literature separately for benign and malignant conditions, and conducted a cost analysis for different techniques of hysterectomy from a hospital economic database. Unlimited systematic literature search of Medline, Cochrane and CRD databases produced only two randomized trials, both for benign conditions. For the outcome assessment, data from two HTA reports, one systematic review, and 16 original articles were extracted and analyzed. Furthermore, one cost modelling and 13 original cost studies were analyzed. In malignant conditions, less blood loss, fewer complications and a shorter hospital stay were considered as the main advantages of robot-assisted surgery, like any mini-invasive technique when compared to open surgery. There were no significant differences between the techniques regarding oncological outcomes. When compared to laparoscopic hysterectomy, the main benefit of robot-assistance was a shorter learning curve associated with fewer conversions but the length of robotic operation was often longer. In benign conditions, no clinically significant differences were reported and vaginal hysterectomy was considered the optimal choice when feasible. According to Finnish data, the costs of robot-assisted hysterectomies were 1.5-3 times higher than the costs of conventional techniques. In benign conditions the difference in cost was highest. Because of expensive disposable supplies, unit costs were high regardless of the annual number of robotic operations. Hence, in the current distribution of cost pattern, economical effectiveness cannot be markedly improved by increasing the volume of robotic surgery.

Ethical issues of obesity surgery--a health technology assessment.

New surgical technologies may challenge societal values, and their adoption may lead to ethical challenges. Despite proven cost-effectiveness, obesity (bariatric) surgery and its public funding have been questioned on ethical arguments relating to, for example, the self-inflicted or non-disease nature of obesity. Our aim was to analyze the ethical issues relevant to bariatric surgery. A comprehensive health technology assessment was conducted on bariatric surgery for morbid obesity using the EUnetHTA method, including a fully integrated ethical analysis. The ethical arguments suggesting that obesity should not be surgically treated because it is self-inflicted were rejected. Medicalization of obesity may have both positive and negative effects that impact the various stakeholders differently, thus being difficult to balance. Informing bariatric surgery patients and actively supporting their autonomy is exceptionally important, as the benefits and harms of both obesity and bariatric surgery are complex, and the outcome depends on how well the patient understands and adheres to the life-long changes in eating habits required. Justice considerations are important in organizing surgical treatment of obesity, as the obese are discriminated against in many ways and obesity is more common in socioeconomically disadvantaged populations who might have problems of access to treatments. Obesity should be treated like other diseases in health care, and obesity surgery rationed like other cost-effective treatments. Positive actions to ensure patient autonomy and just access to surgical treatments may be warranted.

Fewer major amputations among individuals with diabetes in Finland in 1997-2007: a population-based study.

OBJECTIVE: Complications occur in diabetes despite rigorous efforts to control risk factors. Since 2000, the National Development Programme for the Prevention and Care of Diabetes has worked to halve the incidence of amputations in 10 years. Here we evaluate the impact of the efforts undertaken by analyzing the major amputations done in 1997-2007. RESEARCH DESIGN AND METHODS: All individuals with diabetes (n = 396,317) were identified from comprehensive national databases. Data on the first major amputations (n = 9,481) performed for diabetic and nondiabetic individuals were obtained from the National Hospital Discharge Register. RESULTS: The relative risk for the first major amputation was 7.4 (95% CI 7.2-7.7) among the diabetic versus the nondiabetic population. The standardized incidence of the first major amputation decreased among the diabetic and nondiabetic populations (48.8 and 25.2% relative risk reduction, respectively) over 11 years, and the time from the registration of diabetes to the first major amputation was significantly longer, on average 1.2 years more. The cumulative five-year postamputation mortality among diabetic individuals was 78.7%. CONCLUSIONS: In our nationwide diabetes database, the duration from the registration of diabetes to the first major amputation increased, and the incidence of major amputations decreased almost 50% in 11 years. Approximately half of this change was due to the increasing size of the diabetic population. The risk for major amputation is more than sevenfold that among the nondiabetic population. These results pose a continuous challenge to improve diabetes care.

Introducing new technology safely.

AIM: This report considers the introduction of new technology and the implications for patient safety. METHODS AND DISCUSSION: A distinction is made between 'conceptually' new and 'contextually' new technology. The life cycle of technology from development to routine use is discussed and the key role for regulation, health technology assessment, clinical engineering and surveillance in this life cycle considered. The limitations of each of these disciplines are also discussed. Special consideration is given to the needs of developing countries. Case study examples of particular challenges in the safe introduction of technology are presented.

Chlamydial lipopolysaccharide (cLPS) is present in atherosclerotic and aneurysmal arterial wall--cLPS levels depend on disease manifestation.

BACKGROUND: The role of Chlamydia pneumoniae in peripheral atherosclerosis disease and abdominal aortic aneurysm (AAA) remains unclear. Chlamydial lipopolysaccharide (cLPS) detection is a method used conventionally in routine chlamydial diagnosis of gynecological or ophthalmic samples. METHODS: We compared cLPS concentrations, as well as other markers of bacterial load, in plaques and sera of patients operated on for carotid artery stenosis (n=110), aorto-occlusive disease (n=22), or AAAs (n=50) at the Helsinki University Central Hospital. RESULTS: The median levels of cLPS in plaques were 2.28, 0.80, and 0.29 ng/ml in AAA, aorto-occlusive disease, and carotid artery stenosis patients, respectively (P<.001, Kruskal-Wallis). cLPS in serum correlated with LPS binding protein levels (Spearman's rho=0.52, P<.001), suggesting that the presence of chlamydiae is sufficient to produce an innate immune response reaction in these patients. Serum inflammatory markers interleukin 6 and highly sensitive C-reactive protein also correlate with cLPS (Spearman's rho=0.42 and 0.51, respectively, P<.001). CONCLUSIONS: cLPS is present in arterial disease, and the potential role of C. pneumoniae in the pathogenesis of both peripheral atherosclerosis disease and AAA should not be forgotten. cLPS has a positive correlation with serum inflammatory markers, but this is no proof of a causal association.

[Where does obesity stand in health care--every alternative into use]. / Lihavuuden asema terveydenhuollossa-- kaikki vaihtoehdot käyttöön.

Although intervention in obesity on a consultation visit, i.e. brief intervention, will only affect a portion of patients, it can reach large numbers of patients. Basic care of obesity, i.e. patient education in a group, leads to an average weight loss of 3 to 5 kg within one to two years. Basic care should be offered to patients having a condition that requires weight reduction during the treatment. In morbid obesity, surgical treatment should be promoted in Finland, although it can only be applied to a minor fraction of those requiring antiobesity treatment. Self-motivated weight control should thus be encouraged.

[Effectiveness and safety of bariatric surgery]. / Lihavuuskirurgian vaikuttavuus ja turvallisuus.

Evidence for the effectiveness of surgical treatment of morbid obesity on life span, quality of life and associated diseases proves it an applicable alternative for the morbidly obese in cases where other means of controlling obesity have remained ineffective. The operation causes significant weight reduction even within a 15-year follow-up. Surgical mortality after an endoscopic operation is usually less than 0.5%. After the operation, patients fairly often experience various symptoms of the digestive tract. Common complications include various infections and functional disturbances associated with the band.

[Provision of surgical treatment for the morbidly obese in Finland]. / Sairaalloisen lihavien leikkaushoidon järjestäminen Suomessa.

The number of and demand for surgical treatments of morbid obesity are quickly increasing in Finland. The resources and action models differ regionally. The position of antiobesity surgery among antiobesity treatments should be defined more clearly than is now the case in Finland. Also a decision should be made how these operations are included in the patient's treatment guarantee. There should be a public discussion on how to centralise the operations into sufficiently large units of expertise and availability of the treatment in various parts of Finland must be guaranteed. Treatment chains should be standardized, at the same time ascertaining adequate expertise of various health care providers.

[Ethical aspects of bariatric surgery]. / Lihavuuden leikkaushoitoon liittyviä eettisiä näkökohtia.

Attitude to obesity determines the attitude to antiobesity surgery: is obesity a disease among other diseases belonging to the public health care, or a characteristic resulting from living habits, remaining under the person's own responsibility? Antiobesity surgery requires supporting the patients' right to self-determination. Other treatments for obesity should be available, and this procedure necessitating permanent adjustments of living habits requires sufficient advance preparation. The patient's guarantee governing the treatment of obesity as a whole seems relevant. Assessment of the need for surgery is, however, difficult and the benefits and disadvantages differ among the various stakeholders.

[Effects of bariatric surgery on mental and social well-being]. / Lihavuusleikkauksen vaikutukset psyykkiseen ja sosiaaliseen hyvinvointiin.

Morbid obesity is associated with severely invalidizing symptoms and a strong stigma, which restrict the management of daily life. The handicaps of morbid obesity are so severe that patients are ready to accept even inconvenient adverse effects or high risks from the treatment. Seeking antiobesity surgery is mainly done for health reasons, but is perceived to have a broad effect on functional capacity, self-image as well as on mental and social well-being. By the help of anti-obesity surgery, many patients not only gain control over eating, but also over other fields of life.

Ligation of ameroid-stenosed coronary artery leads to reproducible myocardial infarction--a pilot study in a porcine model.

OBJECTIVE: Myocardial gene and cellular therapies have revived the use of porcine ischemic heart models. Commonly applied ameroid-obstruction produces inconsistent coronary stenoses and myocardial lesions, whereas abrupt coronary occlusion causes arrhythmias and sudden death. To produce a constant myocardial lesion after adaptation to ischemia, we surgically modified the ameroid-model by ligation. As a pilot study for further cell therapy research, the spontaneous myocardial response is described. MATERIALS AND METHODS: Simultaneously with ameroid application, a loose loop of nonabsorbable thread was placed around the left circumflex artery (LCx) on 11 domestic piglets. Three weeks later, the loop was tightened. Coronary arteriograms with Rentrop collateral grading from 0 to 3, and 99mTc-single photon emission computerized tomography studies were performed 1 to 5 wk after ligation. At autopsy, the hearts were analyzed macroscopically, histologically, and with von Willebrandt factor-staining. RESULTS: LCx-banding was well-tolerated in nine animals, of which angiographic occlusion was gained in eight. Postmortem analysis revealed a 5 to 10 cm(2) transmural or subendocardial lateral myocardial infarction in all except one heart. One week after occlusion, LCx showed well-developed collateral filling (Rentrop-grade 2.7 +/- 0.4), which remained unchanged at 5 wk. On single photon emission computerized tomography-scans, lateral wall perfusion increased spontaneously between 1 and 5 wk (P = 0.02), and von Willebrandt factor revealed clusters of neovascularization at the borders of infarct areas. CONCLUSIONS: This new modification of ameroid model standardizes myocardial lesion, which might reduce animal number in preclinical studies, thus having ethical aspect. The remarked potential for spontaneous recovery in ischemic porcine myocardium should be considered in preclinical therapeutic studies.