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

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

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

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

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

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

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

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

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

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

Preventing and managing device-related pressure ulcers in oncology.

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

Comparison of Hysteroscopic Cesarean Scar Defect Repair with 26 Fr Resectoscope and 16 Fr Mini-resectoscope: A Prospective Pilot Study.

STUDY OBJECTIVE: Several studies have been published on hysteroscopic treatment of cesarean scar defect using the 26 Fr resectoscope. This study compared the effects of the 26 Fr resectoscope with those of the 16 Fr mini-resectoscope in terms of efficacy, safety profile, and peri- and postoperative complications. DESIGN: A prospective cohort study. SETTING: Tertiary care university hospital (S. Orsola-Malpighi, Bologna, Italy). PATIENTS: Three hundred and nine women having symptoms and with a cesarean scar defect diagnosis were divided into 2 groups according to a temporal criterion: from March 2012 to March 2015, 155 consecutive women (control group) underwent isthmoplasty with the 26 Fr resectoscope (Karl Storz, Tuttlingen, Germany), whereas from April 2015 to March 2018, 154 consecutive women (study group) underwent isthmoplasty with the 16 Fr mini-resectoscope (Gubbini system, Tontarra Medizintechnik, Tuttlingen, Germany). INTERVENTIONS: One hundred and fifty-five women (control group) underwent isthmoplasty with the 26 Fr resectoscope, and 154 women (study group) underwent isthmoplasty with the 16 Fr mini-resectoscope. The so-called "channel-like" 360° endocervical resection technique was applied. MEASUREMENTS AND MAIN RESULTS: The isthmoplasty time with the 2 resectoscopes, excluding cervical dilatation, was similar (p = .25), whereas the overall surgical time was shorter in the case of the mini-resectoscope. The use of the 16 Fr mini-resectoscope was significantly associated with a reduced volume of distension medium used (p <.001) and a lower fluid absorption (p <.001). A significant increase (p = .01) in postoperative complications in the control group (9/155; 5.8%) compared with the study group (1/154; 0.7%) was also found. No significant reduction in discharge time was observed between the 2 groups (p = .13). Patient satisfaction immediately after surgery was significantly higher (p <.001) in the study group than in the control group. CONCLUSION: Isthmoplasty with a 16 Fr mini-resectoscope seems to be as effective as isthmoplasty with a 26 Fr resectoscope in reducing postmenstrual abnormal uterine bleeding and suprapubic pelvic pain. It is associated with a significant reduction in overall surgical time owing to the non-necessity of performing cervical dilatation. The 16 Fr mini-resectoscope facilitates surgery in small anatomical spaces such as the cervical canal and reduces the complication rate linked to blind maneuvers not respecting the uterine anatomy.

Fake gunshot wounds in the skull-post-mortem artifact caused by steel probe during police search for a missing body.

The paper presents a case of a forensic autopsy of a young woman who was murdered and her dismembered body was hidden in soil and water. In the skull of the deceased, in the temporal and occipital regions, the autopsy revealed 3 round, almost identical holes, which looked like small caliber gunshot wounds. Doubts about the cause of these injuries were raised by the fact that despite the decomposition of the body, the continuity of the dura at the site of these holes remained undamaged and the absence of any trace of a bullet's wound track in the brain, the absence of a foreign body in the cranial cavity, as well as the absence of wounds on the opposite side of the skull that could be exit wounds. A thorough analysis of the investigation and the activities carried out during the search for the missing body allowed to adopt and finally confirm the hypothesis that the above mentioned skull damage occurred during the search for the cut-off head of the deceased in shallow water by means of special tapered conical steel probes used by the rescue/search teams. Due to the structure of such a spike, i.e., a sharp end and then a wide cone, only a superficial puncture of the steel probe tip three times into the skull had taken place, which caused regular, rounded bone damage without damaging the dura and brain. The presented case indicates that sometimes post-mortem artifacts may suggest a completely different origin of wounds, which emphasizes the need for a comprehensive analysis of all possible causes of their occurrence, particularly data concerning the handling of the corpse before it is delivered to the morgue, so as not to make a diagnostic error during autopsy.

Medical device-related pressure injuries in critical patients: prevalence and associated factors / Lesiones por presión relacionadas con dispositivos médicos en pacientes críticos: prevalencia y factores asociados / Lesões por pressão relacionadas a dispositivos médicos em pacientes críticos: prevalência e fatores associados

ABSTRACT Objective: To determine the prevalence of medical device-related pressure injuries in critical patients and analyze the associated factors. Method: Epidemiological, cross-sectional study. Sociodemographic, clinical and medical device data were collected. Inspection of the skin/mucous membranes was performed to identify and classify the injuries. Analysis using descriptive statistics, Poisson regression and the Spearman correlation coefficient. Results: Ninety-three patients were evaluated and 58 developed injuries, with a prevalence of 62.4%. Injuries by the orotracheal tube (50%), nasogastric tube (44.1%) and urinary catheter (28.6%) were the most prevalent, and the most affected regions were, respectively, the auricular (79.5%), nasal ala (86.7%) and urethral meatus (76.9%). Factors associated with injuries were severe edema (p = 0.005), low Braden (p<0.001) and Glasgow (p = 0.008) scores, length of stay in intensive care (p<0.001) and hospitalization diagnosis classified as other causes (p<0.001). The use of more than one device (p<0.001) and a longer time of use (p<0.001) were correlated. Conclusion: The high prevalence of injuries and the associated factors indicate the need for preventive measures and risk monitoring.

RESUMEN Objetivo: Determinar la prevalencia de lesiones por presión relacionadas con dispositivos médicos en pacientes críticos y analizar los factores asociados. Método: Estudio epidemiológico, transversal. Se recogieron datos sociodemográficos, clínicos y de dispositivos médicos. Se realizó una inspección de la piel/membranas mucosas para identificar y clasificar las lesiones. Análisis mediante estadística descriptiva, regresión de Poisson y coeficiente de correlación de Spearman. Resultados: Se evaluaron 93 pacientes y 58 desarrollaron lesiones, con una prevalencia del 62.4%. Las lesiones por sonda orotraqueal (50%), sonda nasogástrica (44.1%) y sonda vesical (28.6%) fueron las más prevalentes, y las regiones más afectadas fueron, respectivamente, la auricular (79.5%), el ala de la nariz (86.7%) y el meato uretral (76.9%). Los factores asociados a las lesiones fueron edema severo (p = 0.005), puntuaciones bajas de Braden (p < 0,001) y Glasgow (p = 0.008), tiempo de estancia en cuidados intensivos (p < 0.001) y diagnóstico de hospitalización clasificado como otras causas (p < 0.001). Se correlacionó el uso de más de un dispositivo (p < 0.001) con un mayor tiempo de uso (p < 0.001). Conclusión: La alta prevalencia de lesiones y los factores asociados indican la necesidad de medidas preventivas y monitoreo de riesgos.

RESUMO Objetivo: Determinar a prevalência das lesões por pressão relacionadas a dispositivos médicos em pacientes críticos e analisar fatores associados. Método: Estudo epidemiológico, transversal. Dados sociodemográficos, clínicos e dos dispositivos médicos foram coletados. Realizou-se inspeção da pele/mucosas para identificação e classificação das lesões. Análise mediante estatística descritiva, regressão de Poisson e coeficiente de correlação de Spearman. Resultados: Foram avaliados 93 pacientes e 58 desenvolveram lesões, com prevalência de 62.4%. Lesões pelo tubo orotraqueal (50%), cateter nasogástrico (44.1%) e vesical (28.6%) foram as mais prevalentes, e as regiões mais afetadas foram, respectivamente: auricular (79.5%), asa do nariz (86.7%) e meato uretral (76.9%). Fatores associados às lesões: edema acentuado (p = 0.005), baixo escore de Braden (p < 0.001) e de Glasgow (p = 0.008), tempo de internação em terapia intensiva (p < 0.001) e diagnóstico de internação classificado como outras causas (p < 0.001). Correlacionou-se o uso de mais de um dispositivo (p < 0.001) e maior tempo de utilização destes (p < 0.001). Conclusão: A elevada prevalência de lesões e os fatores associados indicam a necessidade de medidas preventivas e da monitorização de risco.

Percepção de profissionais de enfermagem sobre lesões por pressão relacionadas a dispositivos médicos / Percepción de los profesionales de enfermería sobre la evidencia por áreas relacionadas con dispositivos médicos / Perception of Nursing professionals on medical device-related pressure injuries

Resumo Objetivo Conhecer a percepção de profissionais de enfermagem atuantes em unidade de terapia intensiva acerca das lesões por pressão relacionadas a dispositivos médicos. Método Pesquisa qualitativa, descritiva, realizada com 12 profissionais de enfermagem de um hospital público de ensino de Santa Catarina. A coleta de dados se deu por entrevista semiestruturada, e análise pela técnica do discurso do sujeito coletivo com o emprego do software QualiQuantiSoft®. Resultados Emergiram cinco Ideias Centrais: tipos de dispositivos e ocorrência das lesões por pressão relacionadas a dispositivos médicos; (in)visibilidade e (des)valorização destas lesões no cuidado ao paciente crítico; lesões por pressão relacionadas a dispositivos médicos podem ser inevitáveis; perfil do paciente crítico e risco para desenvolver a lesão; e (des)conhecimento profissional sobre o impacto da lesão na vida das pessoas após alta da terapia intensiva. Conclusão e implicações para a prática A percepção da enfermagem acerca das lesões por pressão relacionadas a dispositivos médicos está vinculada aos tipos de dispositivos, a ocorrência das lesões na terapia intensiva, ao cuidado ofertado e ao impacto das lesões na vida das pessoas.

Resumen Objetivo Conocer la percepción de los profesionales de Enfermería que trabajan en unidades de cuidados intensivos acerca de las lesiones por presión relacionadas con dispositivos médicos. Método Investigación cualitativa y descriptiva, realizada con 12 profesionales de Enfermería de un hospital escuela público Santa Catarina. Los datos se recolectaron por medio de una entrevista semiestructurada, y el análisis tuvo lugar a través de la técnica de discurso del sujeto colectivo utilizando el software QualiQuantiSoft®. Resultados Surgieron cinco Ideas Centrales: tipos de dispositivos y frecuencia de las lesiones por presión relacionadas con dispositivos médicos; la (in)visibilidade y (des)valorización de estas lesiones en la atención al paciente en estado crítico; las lesiones por presión relacionadas con dispositivos médicos pueden ser inevitables; perfil del paciente en estado crítico y riesgo de desarrollar una lesión; y (des)conocimiento profesional sobre el efecto de la lesión en la vida de las personas después del alta de la unidad de cuidados intensivos. Conclusión e implicaciones para la práctica La percepción del personal de Enfermería acerca de las lesiones por presión relacionadas con dispositivos médicos está vinculada a los tipos de dispositivos, a la frecuencia de las lesiones en la unidad de cuidados intensivos, a la atención prestada y al efecto de las lesiones en la vida de las personas.

Abstract Objective To know the perception of Nursing professionals working in intensive care units regarding medical device-related pressure injuries related. Method A qualitative and descriptive research, carried out with 12 Nursing professionals from a public teaching hospital in Santa Catarina. Data collection took place through semi-structured interviews, and the analysis was performed using the collective subject discourse technique by means of the QualiQuantiSoft® Software. Results Five Central Ideas emerged: types of devices and the occurrence of medical device-related pressure injuries; (in)visibility and (de)valuation of these injuries in the care of critical patients; medical device-related pressure injuries can be inevitable; critical patient profile and risk to develop the injury; and (lack of) professional knowledge about the impact of the injury on people's lives after discharge from intensive care. Conclusion and implications for the practice The perception of Nursing about medical device-related pressure injuries is linked to the types of devices, the occurrence of injuries in intensive care, the care offered and the impact of injuries on people's lives.

[Study of No Observed Adverse Effect Level of Nickel and Its Preliminary Evaluation Biocompatibility].

The purpose of this study was to investigate the NOAEL of the nickel ion and provide with basic data for the biological evaluation of those medical devices containing nickel. Five groups SD rats were repeatedly exposed during 14 d respectively to nickel at first stage doses of 4.9, 3.7, 2.5 mg/(kg.d), and the second stage doses of 1.2, 0.25 mg/(kg.d) by the intravenous route. The results showed that the NOAEL of nickel ion is 0.25 mg/(kg.d) for SD rats, and the result was verified by subchronic systemic toxicity test of nickel alloy. The threshold of toxicological concern (TTC) of nickel is 150 µg/d (based on application of 100-fold uncertainty factor and a body weight of 60 kg)deduced by these data.

A Systematic Review of the National Breast Implant Registry for Application in Korea: Can We Predict "Unpredictable" Complications?

Background and Objectives: Since silicone breast implants were introduced to the market several decades ago, the safety of breast implants has remained controversial. Recently, several studies have explored breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) and breast implant illness (BII). Several countries have developed national breast implant registries to improve the safety and quality of breast implant surgery. We performed a systematic review of the current status of national breast implant registries and propose a pilot form of an appropriate breast implant registry model for Korea. Materials and Methods: The systematic review was conducted in accordance with the "preferred reporting items for systematic reviews and meta-analyses (PRISMA) pro forma". PubMed and Google Scholar databases were searched to identify all articles containing information on national breast implant registries. We limited the search to articles written in the English language from 2010 to 2020. Articles were reviewed by two independent authors. Results: A total of 63 articles related to national breast implant registries, registry principles and national breast implant registry annual reports were identified. After reviewing the literature, 25 national breast implant registry-related articles were included in the full-text synthesis. Currently, four countries, The Netherlands, Australia, Sweden, and the UK, have breast implant registries with well-formed sources for big data. Overall, similarities in data points were detected for three categories: implant-related complications, operation details, and device information. However, there were differences for each registry in terms of governance, funding, and capture rate. Conclusion: After reviewing other countries' experiences, tentative datasets for the Korean Breast Implant Registry (K-BIR) were developed. The K-BIR can improve the quality of breast implant surgery in Korea by providing datasets on overall processes and outcome measures with quality indicators and risk adjustment factors. This approach will register characteristics of patients and monitor breast implants, complications, and surgical procedures to improve the outcomes of breast implant surgery in Korea. In addition, it can be used as a track-and-trace system with automated notifications to patients in the event of a product recall or other safety concerns related to a specific type of implant.

Device profile of the Vici venous stent for chronic iliofemoral venous obstruction recanalization: overview of its safety and efficacy.

Introduction: Endovenous stenting is being increasingly used for the management of iliofemoral venous outflow obstruction due to thrombotic or non-thrombotic iliac vein lesions (NIVL). Dedicated venous stents have replaced re-purposed arterial stents but there are limited data on their relative safety and efficacy.Areas covered: This review looks at the available literature on the safety and efficacy of the Veniti Vici Venous stent (Boston Scientific), a specific venous stent, and compares its outcomes with the other venous stents that are currently available. Reported outcomes include patency, clinical efficacy, and the number of adverse events.Expert opinion: The initial clinical trials of the Vici venous stent have shown both good clinical and safety outcomes at 12-24 months follow-up. Longer follow-up data are pending and further trials comparing available stents are required. Current evidence supports its use in the management of deep venous reconstruction, especially in occlusive post-thrombotic disease. Patients should, however, be made aware of the paucity of long-term data and the need for monitoring within a dedicated surveillance program following stent placement.

Banding the Pouch with a Non-adjustable Ring as Revisional Procedure in Patients with Insufficient Results After Roux-en-Y Gastric Bypass: Short-term Outcomes of a Multicenter Cohort Study.

BACKGROUND: After laparoscopic Roux-en-Y gastric bypass (RYGB), approximately 10-35% of patients with morbid obesity regain weight after an initial good result or fail to achieve a sufficient amount of weight loss. Patients in which conservative measures are not successful may potentially benefit from revisional surgery. OBJECTIVE: To evaluate the effect of a non-adjustable ring placed around the gastric pouch in patients with insufficient weight loss or weight regain after RYGB. SETTING: Four specialized bariatric hospitals in The Netherlands, Germany, and Switzerland. METHODS: From 2011 to 2017, 79 patients underwent revisional surgery using a non-adjustable silicone ring because of insufficient results after RYGB. Data on weight loss and complications up to 2 years after revisional surgery was collected and analyzed retrospectively. RESULTS: A follow-up percentage of 86% after 1 year and 61% after 2 years was achieved. In 75% of patients, further weight regain was prevented. Percentage total body weight loss improved by 7 to 26% 1 year after revisional surgery and remained stable during 2 years of follow-up. The additional weight loss effect of placing a non-adjustable ring was more pronounced in patients with an initial good result after primary RYGB. Eighteen (23%) rings were removed, most often due to dysphagia. CONCLUSION: Especially for patients who experience weight regain after initial good weight loss, placing a non-adjustable silicone ring around the gastric pouch results in modest improvements in weight loss. To prevent the risk of ring removal due to dysphagia, surgeons should take notice not to place the ring too tight around the gastric pouch during revisional surgery.

Novel Incision-free Device for Transvaginal Apical Pelvic Organ Prolapse Repair.

STUDY OBJECTIVE: The purpose of this study was to present the feasibility and potential clinical advantages of Apyx (Escala Medical, Israel), a minimally invasive incision-free anchoring device, for apical prolapse repair. DESIGN: An experimental prospective animal and cadaver study. SETTING: Animal facility and a cadaver laboratory of a tertiary care teaching hospital. PATIENTS: Included in this study were 7 ovine models, 2 porcine specimens, and 3 fresh unembalmed female human cadavers. INTERVENTIONS: The Apyx device for sacrospinous ligament (SSL) suspension was tested on ovine and porcine models. The pullout force needed to detach the Apyx anchor from the SSL was measured. Safety, reliability, and feasibility of this new incision-free procedure were also tested on an ovine model and human cadavers. The precision in deployment of the Apyx device to the SSL was tested via palpation by the surgeon, tissue dissection, and x-ray imaging. The efficacy was tested both by pullout forces and histologic analysis of the vaginal attachment to the SSL. MEASUREMENTS AND MAIN RESULTS: Forty-two anchors were inserted into the SSLs on ovine and porcine models and on cadaver SSLs. No abnormalities or malfunctions were noted in the functional performance of the anchors or the retrieval device. Mean pullout force for the ovine animal model was 38.64 ± 2.80 N. Pullout force in the porcine model was found to be in correlation with the values observed in the ovine model. None of the measured forces was below 20 N. Accuracy and safety tests showed good consistency when deploying the Apyx device to the SSL with no damage to surrounding organs in the ovine or the human cadaver model. Histology demonstrated biologic adhesion characterized by a gross assessment of a newly formed, firm fibrotic tissue 12 weeks after anchor deployment. CONCLUSION: The Apyx anchoring system, a novel incision-free minimally invasive prolapse repair device, demonstrated an anatomically feasible, easy-to-use procedure for suspending the vaginal apex to the SSLs. Its clinical safety, efficacy, and impact on patient symptoms and quality of life should be further studied.

Eventos adversos relacionados ao uso de equipamentos e materiais na assistência de enfermagem a pacientes hospitalizados / Eventos adversos relacionados con el uso de equipos y materiales en la asistencia de enfermería a pacientes hospitalizados / Adverse events associated to the use of equipment and materials in nursing care of hospitalized patients

RESUMO Objetivo Analisar a ocorrência de eventos adversos relacionados ao uso de equipamentos e materiais na assistência de enfermagem. Método Estudo quantitativo, descritivo, com consulta às fichas informatizadas de notificação de eventos adversos de um hospital acreditado. Resultados Foi constatada a notificação de 1.065 eventos adversos, 180 (16,9%) deles relacionados ao uso de equipamentos e materiais, sendo os mais frequentes: perda de sonda de alimentação (45,0%), perda de catéter venoso central (15,5%), lesão de pele (10,5%) e extubação acidental (10,0%). As principais causas e ações imediatas registradas foram, respectivamente: perda de sonda de alimentação - retirada da sonda pelo paciente (53,1%) e repassado o dispositivo (83,9%); perda de catéter venoso central - paciente agitado ou desorientado (32,1%) e puncionado catéter venoso periférico (46,2%); lesão de pele - paciente agitado ou desorientado (26,3%) e realizado curativo oclusivo (73,7%); e extubação acidental - paciente em desmame da sedação ou com sedação desligada/inadequada (50,0%) e reintubação (50,0%). Os graus de danos encontrados foram: ligeiro (23,3%), grave (62,2%), muito grave (13,9%) e gravíssimo (0,6%). Conclusão A investigação da ocorrência de eventos adversos relacionados ao uso de equipamentos e materiais na assistência pode prevenir e minimizar danos ao paciente.

RESUMEN Objetivo Analizar la ocurrencia de eventos adversos relacionados con el uso de equipos y materiales en la asistencia de enfermería. Método Estudio cuantitativo, descriptivo, con consulta a las fichas informatizadas de notificación de eventos adversos de un hospital acreditado. Resultados Fue constatada la notificación de 1.065 eventos adversos, 180 (16,9%) de ellos relacionados con el empleo de equipos y materiales, siendo los más frecuentes: pérdida de sonda de alimentación (45,0%), pérdida de catéter venoso central (15,5%), lesión de piel (10,5%) y extubación accidental (10,0%). Las principales causas y acciones inmediatas registradas fueron, respectivamente: pérdida de sonda de alimentación - retirada de la sonda por el paciente (53,1%) y reintroducido el dispositivo (83,9%); pérdida de catéter venoso central - paciente agitado o desorientado (32,1%) y puncionado el catéter venoso periférico (46,2); lesión de piel - paciente agitado o desorientado (26,3%) y realizado apósito oclusivo (73,7%); y extubación accidental - paciente en discontinuación de la sedación o bajo sedación desconectada/inadecuada (50,0%) y reintubación (50,0%). Los grados de daños encontrados fueron: ligero (23,3%), severo (62,2%), muy severo (13,9%) y severísimo (0,6%). Conclusión La investigación de la ocurrencia de eventos adversos relacionados con el uso de equipos y materiales en la asistencia puede prevenir y minimizar los daños al paciente.

ABSTRACT Objective To analyze the occurrence of adverse events associated to the use of equipment and materials in nursing care. Method Quantitative, descriptive study, using the electronic records of adverse events notifications in an accredited hospital. Results A total of 1,065 adverse events were reported, of which 180 (16.9%) were related to the use of equipment and materials. The most frequent events were: loss of feeding tube (45.0%), loss of central venous catheter (15.5%), skin injury (10.5%) and accidental extubation (10.0%). The main causes and immediate actions recorded were: loss of feeding tube - removal of the tube by the patient (53.1%) and reinsertion of the device (83.9%); loss of central venous catheter - agitated or disoriented patient (32.1%) and insertion of peripheral venous catheter (46.2%); skin injury - agitated or disoriented patient (26.3%) and application of occlusive dressing (73.7%); and accidental extubation - weaning from sedation, disconnected sedation or inadequate doses of sedation (50.0%) and reintubation (50.0%). The degrees of harm were: mild (23.3%), severe (62.2%), very severe (13.9%) and extremely severe (0.6%). Conclusion The investigation of the occurrence of adverse events related to the use of equipment and materials in care can prevent and minimize harm to the patient.

Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital.

Intensive care units (ICU) rely on multiple technical resources with extensive use of different medical devices, such as ventilators, vital sign monitors, infusion, and injection pumps. This study explored how ICU nurses approach adverse events related to medical devices in a single tertiary center and identify their level of awareness of the national reporting system for adverse events related to medical devices beside their source for risk information updates. Totally, 297 nurses working in the ICU at King Saud University Medical City completed a survey on medical devices and adverse events reporting and 198 reported experiencing an adverse event related to equipment failure. However, 195 nurses were unaware of an official national reporting system for reporting such events. It is important to develop a framework of safe operation of medical devices based on international standards. This reporting system should include the national patients' safety authorities, and should be anonymous, confidential, and non-punitive.

The Antibiofilm Effect of a Medical Device Containing TIAB on Microorganisms Associated with Surgical Site Infection.

Surgical site infections (SSIs) represent the most common nosocomial infections, and surgical sutures are optimal surfaces for bacterial adhesion and biofilm formation. Staphylococcus spp., Enterococcus spp., and Escherichia coli are the most commonly isolated microorganisms. The aim of this research was to evaluate the antibiofilm activity of a medical device (MD) containing TIAB, which is a silver-nanotech patented product. The antibacterial effect was evaluated against Staphylococcus aureus ATCC 29213, Enterococcus faecalis ATCC 29212, and E. coli ATCC 25922 by assessing the minimum inhibitory concentration (MIC) by the Alamar Blue® (AB) assay. The antibiofilm effect was determined by evaluation of the minimum biofilm inhibitory concentration (MBIC) and colony-forming unit (CFU) count. Subsequently, the MD was applied on sutures exposed to the bacterial species. The antimicrobial and antibiofilm effects were evaluated by the agar diffusion test method, confocal laser scanning microscopy (CLSM), and scanning electron microscopy (SEM). The MIC was determined for S. aureus and E. faecalis at 2 mg/mL, while the MBIC was 1.5 mg/mL for S. aureus and 1 mg/mL for E. faecalis. The formation of an inhibition zone around three different treated sutures confirmed the antimicrobial activity, while the SEM and CLSM analysis performed on the MD-treated sutures underlined the presence of a few adhesive cells, which were for the most part dead. The MD showed antimicrobial and antibiofilm activities versus S. aureus and E. faecalis, but a lower efficacy against E. coli. Surgical sutures coated with the MD have the potential to reduce SSIs as well as the risk of biofilm formation post-surgery.

[Risk Factors of Medical Device-Related Pressure Ulcer in Intensive Care Units].

PURPOSE: The purpose of this study was to identify the characteristics of and risk factors for medical-device-related pressure ulcer (MDRPU) development in intensive care units. METHODS: A prospective cohort study design was used, and the participants were 253 adult patients who had stayed in medical and surgical intensive care units. Data were collected regarding the application of medical devices and MDRPU-related characteristics over a period of six months from June to November, 2017. Data were analyzed using independent t-test, χ²-test, Fisher's exact test, and binary logistic regression analysis with the SPSS 21.0 program. RESULTS: Among the 253 participants, MDRPUs occurred in 51 (19.8%) participants. The results of the logistic regression analysis showed that the risk factors for MDRPUs were the use of endotracheal tubes (OR=5.79, 95% CI: 1.66~20.20), having had surgery (OR=2.95, 95% CI: 1.11~7.77), being in a semi-coma/coma (OR=5.79, 95% CI: 1.04~32.05), and sedation (OR=5.54, 95% CI: 1.39~22.19). CONCLUSION: On the basis of the study results, it is effectively facilitated by nurses when they care for patients with MDRPUs in intensive care units and the results are expected to be of help in preventive education for MDRPU development as well as preparing the base data for intervention studies.

A 12-Month Clinical Durability of Effectiveness and Safety Evaluation of a Vaginal Bowel Control System for the Nonsurgical Treatment of Fecal Incontinence.

OBJECTIVE: The aim of this study was to characterize clinical success, impact on quality of life, and durability up to 1 year in women with fecal incontinence (FI) responsive to an initial test period with a trial vaginal bowel control system. METHODS: This was a prospective open-label study in subjects with FI and successfully fit who underwent an initial 2-week trial period. Those achieving 50% or greater reduction in FI episodes were provided the long-term system. Primary outcome was success at 3 months defined as 50% or greater reduction in baseline FI episodes, also assessed at 6 and 12 months. Secondary outcomes included symptom impact measured with Fecal Incontinence Quality of Life scale, symptom severity by the St Mark's (Vaizey) questionnaire, Patient Global Impression of Improvement, and satisfaction. Adverse events were collected. Primary analysis was intention to treat (ITT). RESULTS: Seventy-three subjects with baseline mean of 14.1 ± 12.15 FI episodes over 2 weeks entered the treatment period. Success rate at 3 months was 72.6% (53/73, P < 0.0001); per-protocol, 84.1% (53/63, P < 0.0001). Significant improvement in all Fecal Incontinence Quality of Life subscales and St Mark's questionnaire meeting minimally important differences was noted. Satisfaction was 91.7%, 89.7%, and 94.4% at 3, 6, and 12 months, respectively; 77.4%, 77.6%, and 79.6% were very much/much better on the Patient Global Impression of Improvement at 3, 6, and 12 months, respectively. Most common adverse event was vaginal wall injury, with most adverse events (90/134, 67%) occurring during fitting period. CONCLUSIONS: In women with successful fitting and initial treatment response, durable efficacy was seen at 3, 6, and 12 months by objective and subjective measures, with favorable safety.