Intravenous Medication Administration Safety with Smart Infusion Pumps in the Neonatal Intensive Care Unit: An Observational Study.

INTRODUCTION: Infants in the neonatal intensive care unit (NICU) are among the most vulnerable patient populations and medication errors are a significant source of risk and harm to neonates. Smart infusion pumps have been implemented to support the safe medication administration process; however, the effect of using smart infusion pumps on medication safety in the NICU is still unclear. METHODS: We conducted an observational study with a prospective point-prevalence approach to investigate intravenous (IV) medication administration errors in the NICU at one academic medical center in the USA. Observations were conducted in 48 days in a 3-month data collection period in 2019. RESULTS: We observed a total of 441 patients with 905 IV medication administrations during the data collection period. The total number of errors was 130 (14.4 per 100 administrations). Of these, the most frequent errors were selecting the wrong drug library entry (5.3 per 100 administrations), unauthorized medication (0.7 per 100 administrations), and wrong dose (0.6 per 100 administrations). Sixty-eight errors (7.5 per 100 administrations) were unlikely to cause harm despite reaching the patient (category C errors), while the rest did not reach the patient. CONCLUSION: We identified the medication errors, which was unique to NICU populations, but no harm to the patients were identified. Most errors occurred due to a lack of compliance of using smart pump technology; therefore, potential exists to maximize safety related to medication administration practices in the NICU through hospital policy change and increasing adherence to appropriate use of smart pump technology.

Chemotherapy induced phlebitis experienced by women with breast cancer following administration of epirubicin using a volumetric infusion pump: an observational study.

OBJECTIVE: To establish the incidence and severity of chemotherapy-induced phlebitis (CIP) following administration of epirubicin chemotherapy using a volumetric infusion pump (Hospira Plum 360), compared to a previous study of manual injection of epirubicin. Also the study aimed to gain insight into staff perceptions of ease of use and safety of infusion pump administration. METHODS: An observational study of women with breast cancer (n = 47) receiving epirubicin via volumetric infusion pump. Phlebitis was reported through a participant self-assessment questionnaire and graded by clinical assessment three weeks after each chemotherapy cycle. Staff perceptions were explored using questionnaires. RESULTS: Infusion pump administration delivered a significantly higher concentration of epirubicin (p < 0.001), a significantly higher rate of grade 3 and 4 participant reported CIP between cycles (p = 0.003) but demonstrated no significant difference in grade 3 and 4 CIP when assessed clinically three weeks after treatment (p = 0.157). CONCLUSION: Peripheral epirubicin administration will result in severe CIP being experienced by a proportion of patients irrespective of whether infusion pump or manual injection method is used. Those at high risk of severe CIP should be informed of the risk and offered a central line. For those with a lower risk of severe phlebitis use of the infusion pump appears to be a safe option.

Developing Strategic Recommendations for Implementing Smart Pumps in Advanced Healthcare Systems to Improve Intravenous Medication Safety.

Avoidable harm associated with medication is a persistent problem in health systems and the use of preprogrammed infusion devices ('smart pumps') and data monitoring is seen as a core approach to mitigating and reducing the incidence of these harms. However, smart pumps are costly to procure, configure and maintain (in both human and financial terms) and are often poorly implemented. Variation in the manner in which medicines are prepared and used within complex modern healthcare systems exacerbates these challenges, and a strategic human-centred approach is needed to support their implementation. A symposium of 36 clinical and academic medication safety experts met virtually to discuss the current 'state of the art' and to propose strategic recommendations to support the implementation of medication administration technology to improve medication safety. The recommendations were that health systems (1) standardise infusion concentrations to facilitate the development of ready-to-administer formulations of frequently used medicines, and support 'out of the box' programming of infusion devices; (2) develop and implement drug libraries using human-centred approaches and the aforementioned standard concentrations, with a theoretical understanding of how devices are used in practice; (3) develop standardised metrics and outcomes to support the interpretation of data produced by infusion devices; (4) involve all stakeholders in the development of drug libraries and metrics to ensure broad understanding of the devices, their benefits and limitations; and (5) leverage input into device design, working with manufacturers and users. Using this strategic approach, it is then possible to envisage and plan real-world implementation studies using a uniform approach to quantify improvements in safety, efficiency and cost effectiveness.

Influence of transport conditions on infusion pumps performance and triggering alarms: A simulation-based research.

BACKGROUND: Critical care transport is an essential component of care system. Inadequacies in equipment, during the interhospital transport can lead to adverse event. OBJECTIVES: To verify the influence of physical transport conditions in the infusion pumps (IPs) performance and alarm activation. METHODS: Simulation-based study about IPs use during interhospital ground transportation. There were 54 simulations (18 flowmetric, 18 volumetric, 18 syringe IPs). The equipment were tested at 01, 05 and 50mL/h infusion flow. Descriptive and inferential statistical analysis, with a 5% significance level was performed. RESULTS: The effectively infused volume was lower than the expected volume for the 3 IPs types. Vibration was the variable with highest correlation in volume difference. Flowmetric IPs showed higher alarm frequency (50.0%), followed by syringe IPs (27.8%). Free flow predominated in flowmetric IP and airline and occlusion alarms in volumetric and syringe IP. Error percentage of delivered fluid ranged from 2.8% to 25.9% being more evident in flowmeter IPs. CONCLUSION: The infusion pumps showed infusion misfunctioning when subjected to physical transport conditions. Syringe IPs were more accurate for low flow administration, while for the administration of solutions at higher flow rate, the volumetric IP showed the highest accuracy.

Vesicant infusates are not associated with ultrasound-guided peripheral intravenous catheter failure: A secondary analysis of existing data.

BACKGROUND: Intravenous vesicants are commonly infused via peripheral intravenous catheters (PIVC) despite guidelines recommending administration via central route. The impact of these medications on PIVC failure is unclear. We aimed to assess dose-related impact of these caustic medications on ultrasound-guided (US) PIVC survivorship. METHODS: We performed a secondary analysis of a randomized control trial that compared survival of two catheters: a standard long (SL) and an ultra-long (UL) US PIVC. This study involved reviewing and recording all vesicants infusions through the PIVCs. Type and number of vesicants doses were extracted and characterized as one, two or multiple. The most commonly used vesicants were individually categorized for further analysis. The primary outcome was PIVC failure accounting for use and timing of vesicant infusates. RESULTS: Between October 2018 and March 2019, 257 subjects were randomized with 131 in the UL group and 126 in the SL group. Vesicants were infused in 96 (37.4%) out of 257 study participants. In multivariable time-dependent extended Cox regression analysis, there was no significant increased risk of failure due to vesicant use [adjusted hazard ratio, aHR 1.71 (95% CI 0.76-1.81) p = 0.477]. The number of vesicant doses was not significantly associated with the increased risk of PIVC failure [(1 vs 0) aHR 1.20 (95% CI 0.71-2.02) p = 0.500], [(2 vs 0) aHR 1.51 (95% CI 0.67-3.43) p = 0.320] and [(≥ 3 vs 0) aHR 0.98 (95% CI 0.50-1.92) p = 0.952]. CONCLUSION: Vesicant usage did not significantly increase the risk of PIVC failure even when multiple doses were needed in this investigation. Ultrasound-guided PIVCs represent a pragmatic option when vesicant therapy is anticipated. Nevertheless, it is notable that overall PIVC failure rates remain high and other safety events related to vesicant use should be considered when clinicians make vascular access decisions for patients.

Strategies for intra-amniotic administration of fetal therapy in a rabbit model of intrauterine growth restriction.

Intrauterine growth restriction affects up to 10% of all pregnancies, leading to fetal programming with detrimental consequences for lifelong health. However, no therapeutic strategies have so far been effective to ameliorate these consequences. Our previous study has demonstrated that a single dose of nutrients administered into the amniotic cavity, bypassing the often dysfunctional placenta via intra-amniotic administration, improved survival at birth but not birthweight in an intrauterine growth restriction rabbit model. The aim of this study was to further develop an effective strategy for intra-amniotic fetal therapy in an animal model. Intrauterine growth restriction was induced by selective ligation of uteroplacental vessels on one uterine horn of pregnant rabbits at gestational day 25, and fetuses were delivered by cesarean section on GD30. During the five days of intrauterine growth restriction development, three different methods of intra-amniotic administration were used: continuous intra-amniotic infusion by osmotic pump, multiple intra-amniotic injections, and single fetal intraperitoneal injection. Technical feasibility, capability to systematically reach the fetus, and survival and birthweight of the derived offspring were evaluated for each technique. Continuous intra-amniotic infusion by osmotic pump was not feasible owing to the high occurrence of catheter displacement and amnion rupture, while methods using two intra-amniotic injections and one fetal intraperitoneal injection were technically feasible but compromised fetal survival. Taking into account all the numerous factors affecting intra-amniotic fetal therapy in the intrauterine growth restriction rabbit model, we conclude that an optimal therapeutic strategy with low technical failure and positive fetal impact on both survival and birthweight still needs to be found.

Intravenous prostacyclin-analogue therapy in pulmonary arterial hypertension - A review of the past, present and future.

Therapy with intravenous prostacyclin analogues in patients with pulmonary arterial hypertension (PAH) has been established for decades and is an integral component of the current guidelines for the treatment of pulmonary hypertension. Initially, these drugs were infused by external pump systems via tunnelled right atrial catheters with the need for cooling and frequent exchange of drug reservoirs. Associated complications included, among others, catheter-related infections. More recently, fully implantable pump systems have been developed with drug reservoirs that are filled transcutaneously, allowing intervals between refills of several weeks. This technique results in a low rate of infections. Epoprostenol, iloprost and treprostinil have all been used intravenously in PAH, but titration, dosing and dose escalation in long-term therapy are not standardized. Intravenous prostacyclin analogues are still under-used, despite available data suggesting that early and broad application of these therapies as part of risk-oriented, guideline-directed combination therapy for patients with PAH may lead to a survival benefit. This review provides a detailed overview of the drugs, infusion systems and dosing strategies used for intravenous therapy in patients with PAH.

Safety and Tolerability of Subcutaneous IgPro20 at High Infusion Parameters in Patients with Primary Immunodeficiency: Findings from the Pump-Assisted Administration Cohorts of the HILO Study.

PURPOSE: To evaluate the safety and tolerability of subcutaneous IgPro20 (Hizentra®, CSL Behring, King of Prussia, PA, USA) administered at high infusion parameters (> 25 mL and > 25 mL/h per injection site) in patients with primary immunodeficiency. METHODS: The Hizentra® Label Optimization (HILO) study was an open-label, parallel-arm, non-randomized study (NCT03033745) of IgPro20 using a forced upward titration design for infusion parameters. Patients experienced with pump-assisted IgPro20 infusions received weekly IgPro20 infusions at a stable dose in the Pump-Assisted Volume Cohort (N = 15; 25-50 mL per injection site) and in the Pump-Assisted Flow Rate Cohort (N = 18; 25-100 mL/h per injection site). Responder rates (percentage of patients who successfully completed ≥ 75% of planned infusions), safety outcomes, and serum immunoglobulin G (IgG) trough levels were evaluated. RESULTS: Responder rates were 86.7% (13/15, 25 mL) and 73.3% (11/15, 40 and 50 mL) in the Volume Cohort, and 77.8% (14/18, 25 and 50 mL/h), 66.7% (12/18, 75 mL/h), and 61.1% (11/18, 100 mL/h) in the Flow Rate Cohort. Infusion compliance was ≥ 90% in all patients in the Volume Cohort and in 83.3% of patients in the Flow Rate Cohort. The number of injection sites (Volume Cohort) and the infusion duration (Flow Rate Cohort) decreased with increasing infusion parameters. The rate of treatment-emergent adverse events per infusion was low (0.138 [Volume Cohort] and 0.216 [Flow Rate Cohort]). Serum IgG levels remained stable during the study. CONCLUSION: Pump-assisted IgPro20 infusions are feasible at 50 mL and 100 mL/h per injection site in treatment-experienced patients, which may result in fewer injection sites and shorter infusion times. TRIAL REGISTRATION: NCT03033745 ; registered January 27, 2017.

The Impact of Rapid Infuser Use on the Platelet Count, Platelet Function, and Hemostatic Potential of Whole Blood.

BACKGROUND: Rapid infusion pumps employing filters, roller pumps, and heat exchangers for the administration of blood products are not approved for platelets or cryoprecipitate. This technology may decrease platelet count and degrade coagulation proteins. The effect of rapid infusers on the hemostatic potential of whole blood is unknown. METHODS: Five units of low titer O+ whole blood were obtained from anonymous donors. Each unit was subjected to infusion by five different techniques: (1) gravity infusion without a filter, (2) gravity infusion with a filter, (3) Belmont rapid infuser at 70 mL/min, (4) Belmont at 100 mL/min, and (5) pressurized infusion with a pneumatic pressure bag and filter. After infusion, platelet count, platelet function, thrombin generation, and hemostatic potential were measured for each aliquot. Infusion techniques were compared, using gravity infusion without a filter as the control. RESULTS: There was a significant decrease in platelet count from baseline (168,000) in the BELMONT70 (97,000) and BELMONT100 (94,000) groups (P < 0.05). However, there were no differences in platelet function (all P > 0.20). While there were no differences in thromboelastography parameters between control and infusion models (all P > 0.20), there were significant increases in thrombin generation parameters by CAT in both the BELMONT70 and BELMONT100 groups (all P < 0.05). CONCLUSIONS: The use of a rapid infuser decreases the platelet count of WB but does not decrease platelet function or overall hemostatic potential. In fact, thrombin generation and thrombin potential are actually increased. Rapid infusers are safe for the transfusion of WB.

Behavioral changes in preterm children during nasogastric tube feeding. Comparative study of manual administration by parents versus mechanical administration via electric syringe pump.

INTRODUCTION: Manual feeding by parents using a syringe, a widespread practice in Sweden since the 1980s, favors parents' involvement in childcare tasks. This approach is used in our neonatal unity since 2007. OBJECTIVE: To study the behavioral changes of preterm children during nasogastric tube feeding: manual milk administration by parents (MAP) versus electric syringe administration (ESA) over a 30-minute period. METHOD: This is a randomized, crossover study conducted in the neonatology unit of Toulouse. Preterm children under 33 weeks of age and over 7 days of life were included. A video recording was performed to assess the children's behavioral response, using the Dsilna score. The reviewer was blinded. RESULTS: 15 preterm children with a median gestational age of 30.1 weeks and a median birth weight of 1.210 g were included from March to October 2012. The facility, environment, and state of alertness of children were similar in both groups. Signs of well-being were significantly more prevalent in the MAP group versus the ESA group (36.2 (±8.0) versus 30.7 (±9.5)), (p = 0.04), particularly "hand-to-mouth, mouth gestures, seeking suction and sucking". Although not significant, motor withdrawal signs were more apparent and fluctuating in the ESA group. Qualitative analysis of NIDCAP observations confirms this data. CONCLUSION: There are behavior changes of preterm children during nasogastric tube feeding. This pilot study showed previously undescribed results: MAP is associated with more common well-being signs and could be more widely used in neonatal units.

Intracerebroventricular Cerliponase Alfa for Neuronal Ceroid Lipofuscinosis Type 2 Disease: Clinical Practice Considerations From US Clinics.

BACKGROUND: Neuronal ceroid lipofuscinosis type 2 or CLN2 disease is a rare, autosomal recessive, neurodegenerative lysosomal storage disorder caused by tripeptidyl peptidase 1 deficiency. Cerliponase alfa, a recombinant human tripeptidyl peptidase 1 enzyme, is the first and only approved treatment for CLN2 disease and the first approved enzyme replacement therapy administered via intracerebroventricular infusion. METHODS: A meeting of health care professionals from US institutions with experience in cerliponase alfa treatment of children with CLN2 disease was held in November 2018. Key common practices were identified, and later refined during the drafting of this article, that facilitate safe chronic administration of cerliponase alfa. RESULTS: Key practices include developing a multidisciplinary team of clinicians, pharmacists, and coordinators, and institution-specific processes. Infection risk may be reduced through strict aseptic techniques and minimizing connections and disconnections during infusion. The impact of intracerebroventricular device design on port needle stability during extended intracerebroventricular infusion is a critical consideration in device selection. Monitoring for central nervous system infection is performed at each patient contact, but with flexibility in the degree of monitoring. Although few institutions had experienced positive cerebrospinal fluid test results, the response to a positive cerebrospinal fluid culture should be determined on a case-by-case basis, and the intracerebroventricular device should be removed if cerebrospinal fluid infection is confirmed. CONCLUSIONS: The key common practices and flexible practices used by institutions with cerliponase alfa experience may assist other institutions in process development. Continued sharing of experiences will be essential for developing standards and patient care guidelines.

Hypothermic Oxygenated New Machine Perfusion System in Liver and Kidney Transplantation of Extended Criteria Donors:First Italian Clinical Trial.

With the aim to explore innovative tools for organ preservation, especially in marginal organs, we hereby describe a clinical trial of ex-vivo hypothermic oxygenated perfusion (HOPE) in the field of liver (LT) and kidney transplantation (KT) from Extended Criteria Donors (ECD) after brain death. A matched-case analysis of donor and recipient variables was developed: 10 HOPE-ECD livers and kidneys (HOPE-L and HOPE-K) were matched 1:3 with livers and kidneys preserved with static cold storage (SCS-L and SCS-K). HOPE and SCS groups resulted with similar basal characteristics, both for recipients and donors. Cumulative liver and kidney graft dysfunction were 10% (HOPE L-K) vs. 31.7%, in SCS group (p = 0.05). Primary non-function was 3.3% for SCS-L vs. 0% for HOPE-L. No primary non-function was reported in HOPE-K and SCS-K. Median peak aspartate aminotransferase within 7-days post-LT was significantly higher in SCS-L when compared to HOPE-L (637 vs.344 U/L, p = 0.007). Graft survival at 1-year post-transplant was 93.3% for SCS-L vs. 100% of HOPE-L and 90% for SCS-K vs. 100% of HOPE-K. Clinical outcomes support our hypothesis of machine perfusion being a safe and effective system to reduce ischemic preservation injuries in KT and in LT.

Effects of Tubing Type, Formulation, and Postpumping Agitation on Nanoparticle and Microparticle Formation in Intravenous Immunoglobulin Solutions Processed With a Peristaltic Filling Pump.

The main goal of this study was to use state-of-the-art instruments for nanoparticle (nanoparticle tracking analysis and resonant mass measurement) and microparticle counting (flow imaging) to assess the effects of peristaltic filling pump operation on particle formation in formulations of intravenous immunoglobulin. Microparticle levels were also measured with light obscuration. Postpumping agitation was studied as an accelerated degradation method, 3 different commercial peristaltic tubing types were tested, and the effects of formulation pH and inclusion of polysorbate 80 were determined. Overall, the results documented that nanoparticle measurements, as well as microparticle determinations with flow imaging, were essential to gain rigorous insights into impacts of processing and formulation parameters on pumping- and agitation-induced particle formation. In addition, light obscuration was a relatively insensitive method and failed to detect large increases in protein particles caused by pumping and postpumping agitation. Formulation studies showed that the presence of polysorbate 80 or increasing protein colloidal stability with appropriate choice of buffer generally reduced particle formation. The results highlight the need for filling pump assessments in formulation development studies. Combining such assessments with appropriate analytical methods should help assure that particle levels are controlled during filling pump operation and that the highest quality products are manufactured.

Dexmedetomidine infusion overdose during anesthesia: A case report.

A 12-kg infant was given intravenous dexmedetomidine 0.2 µg kg-1  min-1 as an adjunct for general anesthesia. The 60-fold increase in dexmedetomidine infusion rate caused a biphasic response with initial hypertension followed by bradycardia and hypotension requiring inotropic support. No postoperative or long-term sequelae were noted. Dexmedetomidine infusion is usually delivered as µg kg-1  h-1 .

Safety and effectiveness of levodopa-carbidopa intestinal gel for advanced Parkinson's disease: A large single-center study.

BACKGROUND: Treatment with levodopa-carbidopa intestinal gel (LCIG) can effectively relieve motor and non-motor symptoms in advanced Parkinson's disease (PD). However, adverse events (AEs) are frequent. OBJECTIVE: To describe AEs associated with LCIG treatment and the main reasons for treatment discontinuation. We also looked for factors that were potentially predictive of serious AEs and assessed the effectiveness of and satisfaction with LCIG. METHOD: We retrospectively analyzed data on AEs in patients treated with LCIG at a French university medical center. For patients still receiving treatment at last follow-up, effectiveness was assessed according to the Clinical Global Impression (CGI) scale and the Movement Disorders Society - Unified Parkinson's Disease Rating Scale motor score. RESULTS: Of the 63 patients treated with LCIG for a mean (range) of 19 months (8-47), 57 (90%) experienced at least one AE (340 AEs in total). Most of the AEs (in 69.8% of the patients) were related to percutaneous endoscopic gastrostomy with a jejunal tube (PEG-J) or affected the gastrointestinal tract (granuloma, leakage, or a local infection). Device-related AEs (such as PEG-J removal and device occlusion) were frequent (in 63.5% of patients). Forty-three patients (68%) required at least one additional endoscopic procedure. Dopatherapy-related AEs occurred in 30 patients (48%). Most of the AEs occurred long after treatment initiations, and only a small proportion led to discontinuation. On the CGI scale, 53 patients (84.4%) considered that their condition had improved during LCIG treatment. CONCLUSION: Despite the high frequency of AEs, patients with advanced PD gain clinical benefit from treatment with LCIG. This treatment requires a competent, multidisciplinary team on site.

Fluid Infusion Through Chest Tube to Facilitate Pleural Procedures: A Feasibility Study.

BACKGROUND: Most pleural procedures need the presence of a moderate effusion to allow safe access to the pleural space. We propose a technique to allow safe access in patients with a drained pleural space who require further pleural evaluation or treatment during the same hospital stay. METHODS: This was a retrospective study. All patients who underwent any pleural intervention with a prior infusion of fluid in the pleural space using a pre-existing chest tube (≤14 Fr) were included. Before the pleural intervention, warm saline was infused into the pleural space through the small-bore chest tube until enough fluid was detected on thoracic ultrasound to allow pleural access. Data on patient demographics, indication for the pleural procedure, and patient outcome was analyzed. RESULTS: A total of 22 patients with pleural disease underwent definitive pleural procedure facilitated by fluid infusion. Median volume of fluid infused was 1000 mL (850, 1500 mL). The median time between the initial chest tube insertion and the subsequent definitive pleural procedure was 3 days (2, 7 d). All procedures were completed successfully. One patient had a hemothorax secondary to fluid infusion. CONCLUSION: Fluid infusion through a chest tube is a feasible technique for patients that require a pleural procedure and have minimal fluid after initial pleural drainage. This approach may facilitate pleural procedures, reduce incidence of complications, and expedite the diagnosis and treatment of patients with pleural diseases. Pressure infusers should not be used during this procedure as there is a theoretical increased risk of complications.

Intrathecal Baclofen Infusion Pumps in the Treatment of Spasticity: A Retrospective Cohort Study in a Portuguese Centre.

INTRODUCTION: Spasticity is a complex problem in patients with neurological disorders and may distress their quality of life. Intrathecal baclofen infusion pumps reduce spasticity with low doses and minimal side effects but are not free from complications. We aimed to evaluate the efficacy and safety of intrathecal baclofen infusion pumps as well as patients' satisfaction. MATERIAL AND METHODS: Retrospective cohort study including all intrathecal baclofen infusion pumps placed up to December 2015. Demographic characteristics, clinical diagnoses, date of placement or withdrawal/replacement of intrathecal baclofen infusion pumps, baclofen dosage and complications of intrathecal baclofen infusion pumps were collected. Assessments from the Ashworth and Penn's scales, Katz index and patients' global satisfaction were analysed. RESULTS: In 19 years we placed 251 intrathecal baclofen infusion pumps in 155 patients. The mean age was 41.1 ± 15.8 years. The most frequent conditions were: trauma (34%), cerebral palsy (14%), multiple sclerosis (12%) and stroke (12%). Eighty-five patients (55%) required a second pump, and eleven (7%) a third one. The lifetime of the first pump was 72 (36 - 89) and the total follow-up time was 96 (9 - 132) months. The causes of withdrawal/replacement were: battery failure (57%), catheter migration/kinking (24%), infection (14%) and pump displacement/exteriorization (7%). The complication rate was 0.21 events/month. There was a significant improvement in the Ashworth and Penn's scales after the placemen of intrathecal baclofen infusion pumps (p < 0.001 for all diagnoses) and the patients were satisfied with the treatment. DISCUSSION: The incidence of complications was within range of other international studies despite our long follow-up time. Events per month, loss to follow-up, re-intervention rate, incidence of infection and mortality were similar to other studies. CONCLUSION: Intrathecal baclofen infusion pumps are safe and effective in the treatment of spasticity. Infusion pumps provide a high level of satisfaction regarding treatment and quality of life.

Introdução: A espasticidade é um problema complexo em doentes com distúrbios neurológicos influenciando a sua qualidade de vida. As bombas perfusoras intratecais de baclofeno reduzem a espasticidade com doses baixas e efeitos laterais mínimos, mas não estão livres de complicações. Pretendemos avaliar a eficácia, segurança e satisfação dos doentes com bombas perfusoras intratecais de baclofeno. Material e Métodos: Estudo de coorte retrospetivo, incluindo todas as bombas perfusoras intratecais de baclofeno colocadas até dezembro de 2015. Foram avaliadas as características demográficas, diagnósticos, data de colocação ou retirada/substituição e complicações das bombas perfusoras intratecais de baclofeno. Analisaram-se as escalas Ashworth, Penn, Katz e satisfação dos doentes. Resultados: Durante 19 anos colocaram-se 251 bombas perfusoras intratecais de baclofeno em 155 doentes. A idade média foi 41,1 ± 15,8 anos. As patologias mais freqüentes foram: traumatismo (34%), paralisia cerebral (14%), esclerose múltipla (12%) e acidente vascular cerebral (12%). Oitenta e cinco doentes (55%) precisaram de uma segunda e onze (7%) de uma terceira bomba. A semi-vida da primeira bomba foi 72 (36 ­ 89) e o tempo total de seguimento 96 (9 ­ 132) meses. As causas de retirada/substituição foram: falha de bateria (57%), migração/kinking do cateter (24%), infeção (14%) e deslocamento/exteriorização da bomba (7%). A taxa de complicações foi 0,21 eventos/mês. Houve uma melhoria significativa nas escalas de Ashworth e Penn após colocação das bombas perfusoras intratecais de baclofeno (p < 0,001 para todos os diagnósticos) e os doentes ficaram satisfeitos com o tratamento. Discussão: A incidência de complicações situou-se dentro do intervalo reportado por outros estudos internacionais, apesar do longo tempo de seguimento. Número de eventos por mês, perda de seguimento, taxas de re-intervenção ou infecção e mortalidade foram semelhantes a outros estudos. Conclusão: As bombas perfusoras intratecais de baclofeno são seguras e eficazes no tratamento da espasticidade e oferecem um alto nível de satisfação quanto ao tratamento e qualidade de vida.

Allergic contact dermatitis caused by isobornyl acrylate in the Enlite glucose sensor and the Paradigm MiniMed Quick-set insulin infusion set.

BACKGROUND: The FreeStyle Libre glucose sensor has caused many cases of allergic contact dermatitis, and isobornyl acrylate (IBOA) in this sensor has been identified as one of the culprit allergens. OBJECTIVES: To report on the presence of IBOA in devices produced by Medtronic, namely, the Enlite sensor and the insulin infusion set Paradigm MiniMed Quick-set. PATIENTS AND METHODS: Five patients reacting to the glucose sensor Enlite and/or the insulin infusion set Paradigm MiniMed Quick-set observed in three clinics (two Belgian and one Swedish) were patch tested with the baseline and other series, as well as with IBOA; four of them also with pieces of adhesive patches from the devices, and two with a thin layer chromatogram of Enlite glucose sensor extracts. Gas chromatography-mass spectrometry (GC-MS) analyses were performed. RESULTS: Four patients reacted to IBOA and one to colophonium, a known allergen in Enlite, and three to the adhesive part of the sensor or the insulin infusion set. IBOA was identified in the sensor by GC-MS, and its presence was indicated in the infusion set. CONCLUSIONS: IBOA is a contact allergen in Enlite glucose sensor, and likely also in the infusion set. Therefore, these devices are not suitable alternatives for patients sensitized to the FreeStyle Libre sensor.

A resistance-sensing mechanical injector for the precise delivery of liquids to target tissue.

The precision of the delivery of therapeutics to the desired injection site by syringes and hollow needles typically depends on the operator. Here, we introduce a highly sensitive, completely mechanical and cost-effective injector for targeting tissue reliably and precisely. As the operator pushes the syringe plunger, the injector senses the loss-of-resistance on encountering a softer tissue or a cavity, stops advancing the needle and delivers the payload. We demonstrate that the injector can reliably deliver liquids to the suprachoroidal space-a challenging injection site that provides access to the back of the eye-for a wide range of eye sizes, scleral thicknesses and intraocular pressures, and target sites relevant for epidural injections, subcutaneous injections and intraperitoneal access. The design of this simple and effective injector can be adapted for a broad variety of clinical applications.

Device-Related Error in Patient-Controlled Analgesia: Analysis of 82,698 Patients in a Tertiary Hospital.

BACKGROUND: Patient-controlled analgesia (PCA) is one of the most popular and effective methods for managing postoperative pain. Various types of continuous infusion pumps are available for the safe and accurate administration of analgesic drugs. Here we report the causes and clinical outcomes of device-related errors in PCA. METHODS: Clinical records from January 1, 2011 to December 31, 2014 were collected by acute pain service team nurses in a 2715-bed tertiary hospital. Devices for all types of PCA, including intravenous PCA, epidural PCA, and nerve block PCA, were included for analysis. The following 4 types of infusion pumps were used during the study period: elastomeric balloon infusers, carbon dioxide-driven infusers, semielectronic disposable pumps, and electronic programmable pumps. We categorized PCA device-related errors based on the error mechanism and clinical features. RESULTS: Among 82,698 surgical patients using PCA, 610 cases (0.74%) were reported as human error, and 155 cases (0.19%) of device-related errors were noted during the 4-year study period. The most common type of device-related error was underflow, which was observed in 47 cases (30.3%). The electronic programmable pump exhibited the high incidence of errors in PCA (70 of 15,052 patients; 0.47%; 95% confidence interval, 0.36-0.59) among the 4 types of devices, and 96 of 152 (63%) patients experienced some type of adverse outcome, ranging from minor symptoms to respiratory arrest. CONCLUSIONS: The incidence of PCA device-related errors was <0.2% and significantly differed according to the infusion pump type. A total of 63% of patients with PCA device-related errors suffered from adverse clinical outcomes, with no mortality. Recent technological advances may contribute to reducing the incidence and severity of PCA errors. Nonetheless, the results of this study can be used to improve patient safety and ensure quality care.