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.

ElectroMotive drug administration (EMDA) of Mitomycin C as first-line salvage therapy in high risk "BCG failure" non muscle invasive bladder cancer: 3 years follow-up outcomes.

BACKGROUND: In case of high grade non-muscle invasive bladder cancer (HG-NMIBC), intravesical BCG represents the first-line treatment; despite the "gold" standard therapy, up to 50% of patients relapse, needing radical cystectomy. Hence, alternative therapeutic strategies have been developed. The aim of the study was to evaluate a first-line salvage treatment with EMDA®-MMC in patients with HGNMIBC unresponsive to BCG. METHODS: We carried out a prospective, single-center, single-arm Phase II study in order to evaluate the efficacy (in terms of recurrence and progression) and the safety of the EMDA®-MMC treatment in 26 (21 male, 5 female) consecutive patients with "BCG refractory" HGNMIBC on a 3 years follow-up. EMDA®-MMC treatment consisted of 40 mg of MMC diluted in 100 ml of sterile water retained in the bladder for 30 min with 20 mA pulsed electric current. EMDA®-MMC regimen consisted of an induction course of 6 weekly instillations followed by a maintenance course of 6 monthly instillations. Follow-up was performed with systematic mapping biopsies of the bladder (with sampling in the prostatic urethra for men), voiding and washing urinary cytology, radiological study of the upper urinary tract. We performed Survival Kaplan-Meier curves and Log-rank test in order to analyze high grade disease-free survival. RESULTS: At the end of follow-up, 16 patients (61.5%) preserved their native bladder; 10 patients (38.4%) underwent radical cystectomy, in 6 patients (23.1%) for recurrent HGNMIBC and in 4 patients (15.4%) for progression to muscle-invasive disease. At the end of follow-up, stratifying patients based on TNM classification (TaG3, T1G3, Cis, TaT1G3 + Cis), disease-free rates were 75, 71.4, 50 and 25%, respectively; survival curves showed statistically significant differences (p value < 0.05). Regarding toxicity, we reported severe adverse systemic event of hypersensitivity to the MMC in 3 patients (11.5%), and local side effects in 6 patients (26.1%). CONCLUSIONS: In the field of alternative strategies to radical cystectomy, the EMDA®-MMC could be considered safe and effective in high-risk NMIBC unresponsive to BCG, as a "bladder sparing" therapy in selected patients. Multicenter studies with a larger number of patients and a longer follow-up might confirm our preliminary results. TRIAL REGISTRATION: EudraCT2017-002585-43. 17 June 2017 (retrospectively registered).

Local anesthetic infusion pump for pain management following total knee arthroplasty: a meta-analysis.

BACKGROUND: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) were to evaluate the effect and safety of local anesthetic infusion pump versus placebo for pain management following total knee arthroplasty (TKA). METHODS: In September 2016, a systematic computer-based search was conducted in the Pubmed, ISI Web of Knowledge, Embase, Cochrane Database of Systematic Reviews. Randomized controlled trials of patients prepared for primary TKA that compared local anesthetic infusion pump versus placebo for pain management following TKA were retrieved. The primary endpoint was the visual analogue scale (VAS) with rest or mobilization at 24, 48 and 72 h and morphine consumption at 24 and 48 h. The second outcomes are range of motion, length of hospital stay (LOS) and complications (infection, deep venous thrombosis (DVT), prolonged drainage and postoperative nausea and vomiting (PONV)). RESULTS: Seven clinical studies with 587 patients were included and for meta-analysis. Local anesthetic infusion pump are associated with less pain scores with rest or mobilization at 24 and 48 h with significant difference. However, the difference was likely no clinical significance. There were no significant difference between the LOS, the occurrence of DVT, prolonged drainage and PONV. However, local anesthetic infusion pump may be associated with more infection. CONCLUSION: Based on the current meta-analysis, we found no evidence to support the routine use of local anesthetic infusion pump in the management of acute pain following TKA. More RCTs are still need to identify the pain control effects and optimal dose and speed of local anesthetic pain pump.

Patient safety, error reduction, and pediatric nurses' perceptions of smart pump technology.

Patient safety and error reduction are essential to improve patient care, and new technology is expected to contribute to such improvements while reducing costs and increasing care efficiency in health care organizations. The purpose of this study was to assess the relationships among pediatric nurses' perceptions of smart infusion pump (SIP) technology, patient safety, and error reduction. Findings revealed that RNs' perceptions of SIP correlated with patient safety. No significant relationship was found between RNs' perceptions of SIP and error reduction, but data retrieved from the pumps revealed 93 manipulations of the pumps, of which error reduction was captured 65 times.

Implementation of a new CSF dynamic device: a multicenter feasibility study in 562 patients.

OBJECTIVES: The cerebrospinal fluid (CSF) infusion test is frequently used when selecting hydrocephalus patients for shunt surgery. Very little has been reported regarding adverse events. We present a prospective feasibility study. METHODS: Standardized devices for measuring CSF dynamics were built and 562 patients investigated: Needles were placed by lumbar puncture (LP). An automatic CSF infusion protocol was performed. Course of events during the investigation as well as adverse events were registered. RESULTS: Preoperative evaluation of normal-pressure hydrocephalus was the most common indication (63%), followed by evaluation of shunt function (23%) and intracranial pressure recordings (14%). The LP was successfully performed in all but nine cases with 24 patients (4.3%) reporting major discomfort. Ringer infusion was performed in 474 investigations, and a valid measurement of the outflow resistance was received in 439 (93%). During the infusion phase, 17 (4%) patients reported severe headache. Infusion volume was significantly higher in patients having subjective symptoms during the infusion phase compared with those without adverse events. During 269 preoperative CSF tap tests, six (2%) patients had severe headache. Post-investigational headache was reported by 83 (15%) patients at the 24-h follow-up. No serious adverse events were observed. CONCLUSION: Infusion testing was safe and without serious adverse events with a high rate of successful procedures. The investigation was associated with expected mild to moderate discomfort.

Analysis of nationwide multimodal complex treatment and drug pump therapy in Parkinson's disease in times of COVID-19 pandemic in Germany.

INTRODUCTION: During the first peak phase of the COVID-19 pandemic, the German Ministry of Health recommended that elective treatments should be postponed to increase hospital capacities. This has also compromised the capacity for application of specialized Parkinson's disease (PD) therapies to an unknown extent. METHODS: We conducted a nationwide cross-sectional study using administrative database of all hospitalized patients with main diagnosis of PD receiving multimodal complex treatment (PD-MCT), initial setup of levodopa/carbidopa intestinal gel (LCIG) or continuous subcutaneous apomorphine infusion (CSAI) in Germany. We compared case numbers and clinical characteristics of the pandemic (March 16th - May 15th, 2020) and post-lockdown (July 16th - September 15th, 2020) period with the pre-pandemic (January 16th - March 15th, 2020) and historical control period (March 16th - May 15th, 2019). RESULTS: We identified a strong decline for PD-MCT(-62.8%) and for the application of drug pump-based therapies (-69.4%) during the first peak phase of the pandemic as compared to the pre-pandemic period while specialized PD treatment procedures increased again in the post-lockdown phase. Advanced disease was a marker for PD-MCT patients during the pandemic period. CONCLUSION: Besides the marked decline in specialized PD treatments during the first peak phase of the COVID-19 pandemic, we found recuperative effects for these procedures in the post-lockdown period without reaching pre-pandemic levels. Strengthening treatment capacities for PD patients, even in the event of a persistent pandemic, is urgently needed in order to maintain the quality of care.

Impact of reperfusion pump power on technical and clinical outcomes after direct aspiration thrombectomy (ADAPT).

INTRODUCTION: Higher aspiration forces using larger bore catheters in direct aspiration thrombectomy (ADAPT) have been associated with shorter procedure time and better outcomes in patients treated for acute ischemic stroke (AIS). However, the effect of using reperfusion pumps of higher aspiration power on outcomes of ADAPT has not been investigated. We evaluated the effect of using pumps with different aspiration powers on technical and clinical outcomes after ADAPT. METHODS: We reviewed a retrospective database of AIS cases between January 2018 and February 2019, while comparing technical and clinical outcomes between patients undergoing ADAPT using the MAX pump (28.5 inHg power) vs the ENGINE pump(29.2 inHg power). RESULTS: Among 194 patients (48% females, age 69±15 years) included in the study, 73 patients undergoing ADAPT using the ENGINE pump were age-, gender-, comorbidities-, and operator-matched to 118 patients treated using the MAX pump. The ENGINE group had shorter procedure time (20±17 vs 27±21 mins, p=0.017), lower number of aspiration attempts (2.2±1.6 vs 2.8±1.9, p=0.047), and similar rates of favorable 90 day modified Rankin Scale. Using multivariate linear regression, the use of the ENGINE reperfusion pump with higher vacuum power was independently and inversely correlated with procedure time (coefficient -2.23, p=0.027). While controlling for confounders, there was a trend toward an inverse correlation between use of the ENGINE pump and the number of attempts on linear regression (coefficient -1.04, p=0.09) and lower odds of PH2/intracranial (ICH) hemorrhages on logistic regression (OR 0.227, p=0.075). CONCLUSION: Our findings suggest that the use of the ENGINE reperfusion pump of higher aspiration power during ADAPT decreases procedure time, without increasing complications and post-procedural hemorrhage rates.

Impact of interoperability of smart infusion pumps and an electronic medical record in critical care.

PURPOSE: To describe the benefits of smart infusion pump interoperability with an electronic medical record (EMR) system in an adult intensive care unit (ICU) setting. SUMMARY: In order to assess the impact of smart infusion pump and EMR interoperability, we observed whether there were changes in the frequency of electronic medication administration record (eMAR) documentation of dose titrations in epinephrine and norepinephrine infusions in the ICU setting. As a secondary endpoint, we examined whether smart pump/EMR interoperability had any impact on the rate of alerts triggered by the dose-error reduction software. Pharmacist satisfaction was measured to determine the impact of smart pump/EMR interoperability on pharmacist workflow. In the preimplementation phase, there were a total of 2,503 administrations of epinephrine and norepinephrine; 13,299 rate changes were documented, for an average of 5.31 documented rate changes per administration. With smart pump interoperability, a total of 13,024 rate changes were documented in association with 1,401 administrations, for an average of 9.29 documented rate changes per administration (a 74.9% increase). A total of 1,526 dose alerts were triggered in association with 76,145 infusions in the preimplementation phase; there were 820 dose alerts associated with 48,758 autoprogammed infusions in the postimplementation phase (absolute difference, -0.32%). ICU pharmacists largely agreed (75% of survey respondents) that the technology provided incremental value in providing patient care. CONCLUSION: Interoperability between the smart pump and EMR systems proved beneficial in the administration and monitoring of continuous infusions in the ICU setting. Additionally, ICU pharmacists may be positively impacted by improved clinical data accuracy and operational efficiency.

[The development tendencies of infusion pumps/syringe pumps].

Through the investigation about the current infusion pumps, the development tendencies of the next generation infusion pumps/Syringe Pumps with regarding to human-factors, practicality and application under MRI (Magnetic resonance imaging) were put forward.

The effect of local anesthetic continuous wound infusion for the prevention of postoperative pneumonia after on-pump cardiac surgery with sternotomy: the STERNOCAT randomized clinical trial.

PURPOSE: Postoperative pain after cardiac surgery, exacerbated by cough and sternal mobilization, limits clearance of bronchopulmonary secretions and may predispose to postoperative pneumonia. In this study, we tested the ability of local anesthetic continuous wound infusion to prevent pneumonia after cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) owing to better analgesia and bronchopulmonary drainage. METHODS: In this randomized, double-blind, placebo-controlled trial conducted in five academic centers, patients undergoing cardiac surgery with sternotomy and CPB were enrolled from February 2012 until November 2014, and were followed over 30 days. Patients were assigned to a 48-h infusion (10 ml h-1) of L-bupivacaine (12.5 mg h-1) or placebo (saline) via a pre-sternal multiperforated catheter. Anesthesia and analgesia protocols were standardized. The primary end point was the incidence of pneumonia during the study period, i.e., until hospital discharge or 30 days. We hypothesized a 30% reduction in the incidence of pneumonia. RESULTS: Among 1493 randomized patients, 1439 completed the trial. Pneumonia occurred in 36/746 patients (4.9%) in the L-bupivacaine group and in 42/739 patients (5.7%) in the placebo group (absolute risk difference taking into account center and baseline risk of postoperative pneumonia, - 1.3% [95% CI - 3.4; 0.8] P = 0.22). In the predefined subgroup of patients at high risk, L-bupivacaine decreased the incidence of pneumonia (absolute risk difference, - 5.6% [95% CI - 10.0; - 1.1], P = 0.01). CONCLUSIONS: After cardiac surgery with sternotomy, continuous wound infusion of L-bupivacaine failed to decrease the incidence of pneumonia. These findings do not support the use of local anesthetic continuous wound infusion in this indication. Further study should investigate its effect in high-risk patients. TRIAL REGISTRATION: EudraCT Number: 2011-003292-10; Clinicaltrials.gov Identifier: NCT01648777.

Programmable infusion pumps in ICUs: an analysis of corresponding adverse drug events.

BACKGROUND: Patients in intensive care units (ICUs) frequently experience adverse drug events involving intravenous medications (IV-ADEs), which are often preventable. OBJECTIVES: To determine how frequently preventable IV-ADEs in ICUs match the safety features of a programmable infusion pump with safety software ("smart pump") and to suggest potential improvements in smart-pump design. DESIGN: Using retrospective medical-record review, we examined preventable IV-ADEs in ICUs before and after 2 hospitals replaced conventional pumps with smart pumps. The smart pumps alerted users when programmed to deliver duplicate infusions or continuous-infusion doses outside hospital-defined ranges. PARTICIPANTS: 4,604 critically ill adults at 1 academic and 1 nonacademic hospital. MEASUREMENTS: Preventable IV-ADEs matching smart-pump features and errors involved in preventable IV-ADEs. RESULTS: Of 100 preventable IV-ADEs identified, 4 involved errors matching smart-pump features. Two occurred before and 2 after smart-pump implementation. Overall, 29% of preventable IV-ADEs involved overdoses; 37%, failures to monitor for potential problems; and 45%, failures to intervene when problems appeared. Error descriptions suggested that expanding smart pumps' capabilities might enable them to prevent more IV-ADEs. CONCLUSION: The smart pumps we evaluated are unlikely to reduce preventable IV-ADEs in ICUs because they address only 4% of them. Expanding smart-pump capabilities might prevent more IV-ADEs.

Convection-enhanced delivery: targeted toxin treatment of malignant glioma.

Historically, malignant gliomas are perhaps the most difficult intracranial neoplasms to treat. Surgery, radiation therapy, and traditional chemotherapy have not been able to significantly alter the course of this disease. By definition, these tumors are located in the protected space of the cranial vault, where the blood-brain barrier prevents most therapies from gaining access. Because of the difficulty in treating this disease, new, innovative treatments and alternative delivery techniques for those therapies are needed. Targeted toxins are fusion proteins that represent a novel medical treatment for these cancers that is under development. However, the efficacy of these agents is dependent on the method of delivery to the tumor. The administration of targeted toxins requires image-guided placement of catheters, either within the tumor or into the adjacent infiltrated brain, and positive pressure infusion. The term that has been applied to this microinfusion technique is convection-enhanced delivery (CED). This infusion method was first attempted via direct intratumoral infusion in nude mouse flank tumor models of human malignant glioma. After significant development of this delivery technique in animal models, the successful demonstration of in vivo efficacy of targeted toxins in Phase I and II clinical trials was reported. Currently, ongoing targeted toxin trials are being conducted at academic health centers to define the best clinical practice for CED. This work involves refining the details of delivery such as infusion rate, duration of treatment, and drug dosing. The early results of CED of targeted toxins supports their continued investigation, as few other treatment modalities have produced durable results in the fight against gliomas.

Convection-enhanced delivery of immunotoxins and radioisotopes for treatment of malignant gliomas.

The treatment of malignant gliomas has advanced significantly in the past 15 years. The simultaneous development of new targeting agents and techniques to deliver these high-molecular-weight compounds has led to improved efficacy and promising results in Phase III trials. Convection-enhanced delivery (CED) of macromolecules has emerged as the leading delivery technique for the treatment of malignant gliomas. A summary of the basic principles of CED and a review of the current human trials of protein targeting agents are provided.

Safety of intraparenchymal convection-enhanced delivery of cintredekin besudotox in early-phase studies.

OBJECT: Convection-enhanced delivery (CED) is an increasingly used novel local/regional delivery method targeted directly to tissue. It relies on a continuous pressure gradient for distribution of therapeutic agents into the interstitial space, with administration of the infusate over a few days. Cintredekin besudotox (also known as IL13- PE38QQR) is a recombinant chimeric cytotoxin consisting of interleukin-13 and a truncated exotoxin produced by the Pseudomonas aeruginosa bacterium, which targets malignant glioma cells. METHODS: Cintredekin besudotox was administered via intraparenchymal CED after resection of supratentorial recurrent malignant glioma. The safety and toxicity profile was reviewed for 53 patients in whom infusion catheters had been placed; 51 of them received CED of the study drug. Adverse events were categorized based on time of onset in relation to CED, and the causal relationship with catheter placement or delivery of cintredekin besudotox. Catheters were placed in 53 patients, although only 51 of them received cintredekin besudotox. Most adverse events related to catheter placement or the study drug originated from the central nervous system. Three symptomatic windows were defined: the first one was between surgical procedure and CED; the second was during CED and up to 1 week after its completion; and the third window was 2 to 10 weeks after treatment. Those windows generally reflected adverse events related to surgical procedures, mass effect from infusate, and drug effect on tumor-infiltrated and normal brain parenchyma, respectively. CONCLUSIONS: The symptomatic windows identified in this study apply to any CED clinical trials, particularly those in which chimeric cytotoxins are used, and will help to determine the most likely underlying pathophysiological process causing symptoms. This information, in turn, will help to prevent adverse events or minimize their severity. Those events also have implications for dose escalation and outcome measures.

Changes in preconception treatment and glycemic control in women with type 1 diabetes mellitus: a 15­year single­center follow­up.

INTRODUCTION    Pregnancy in women with type 1 diabetes mellitus (T1DM) is associated with higher risk of complications. Strict glycemic control before conception reduces the risk of unfavorable outcomes. OBJECTIVES    The aim of the study was to assess changes in clinical characteristics, preconception treatment, and glycemic control of women with T1DM at the first antinatal visit. PATIENTS AND METHODS    We analyzed the records from the first antenatal visit of 524 women with T1DM in the years 1998-2012. The follow­up period was divided into 3 5­year periods. RESULTS    Differences in the age of patients between the 3 follow­up periods were observed (28.2 ±5.7 years for 1998-2002; 27.3 ±4.5 years for 2003-2007; and 29.4 ±4.8 years for 2008-2012; P <0.0001). The number of women planning pregnancy did not change and reached 32.1% in the first, 44.4% in the second, and 40.4% in the third period (P = 0.2). The use of rapid­acting insulin analogues increased from 2.6% to 46.5% and then to 95.6% (P <0.001). The rate of therapy with personal insulin pumps before pregnancy increased from 4.6% in the first, through 23.5% in the second, to 33.3% in the third period (P <0.001). Over the subsequent periods, we observed a decrease in hemoglobin A1c (HbA1c) levels at the first antenatal visit (from 7.4% ±1.6%, through 6.9% ±1.4%, to 7.0% ±1.4%; P = 0.06), as well as a decrease in HbA1c levels between the subgroups of women planning pregnancy (6.8% ±1.4%, 6.6% ±1.2%, and 6.1% ±0.8%, P = 0.015). CONCLUSIONS    In the years 1998-2012, an increase in the use of insulin analogues and personal insulin pumps by women with T1DM before conception was observed, and these changes were accompanied by a slight improvement in glycemic control, particularly among women planning pregnancy. The percentage of women planning pregnancy did not change during the follow­up.

Implementation of smart pump technology in a paediatric intensive care unit.

Patient safety is a matter of major concern that involves every health professional. Nowadays, emerging technologies such as smart pumps can diminish medication errors as well as standardise and improve clinical practice with the subsequent benefits for patients. The aim of this paper was to describe the smart pump implementation process in a paediatric intensive care unit (PICU) and to present the most relevant infusion-related programming errors that were prevented. This was a comparative study between CareFusion Alaris Guardrails(®) and Hospira MedNet(®) systems, as well as a prospective and intervention study with analytical components carried out in the PICU of Gregorio Marañón General and Teaching Hospital. All intravenous infusions programmed with a pump in the eleven beds of the unit were analyzed. A drug library was developed and subsequently loaded into CareFusion and Hospira pumps that were used during a three month period each. The most suitable system for implementation was selected according to their differences in features and users' acceptance. Data stored in the pumps were analyzed to assess user compliance with the technology, health care setting and type of errors intercepted. The implementation process was carried out with CareFusion systems. Compliance with the technology was 92% and user acceptance was high. Vacation substitution and drug administration periods were significantly associated with a greater number of infusion-related programming errors. High risk drugs were involved in 48% of intercepted errors. Based on these results we can conclude that implementation of smart pumps proved effective in intercepting infusion-related programming errors from reaching patients. User awareness of the importance of programming infusions with the drug library is the key to succeed in the implementation process.