Heuristic evaluation and simulated use testing of infusion pumps to inform pump selection.

BACKGROUND: Poorly designed infusion pumps can lead to user errors and adverse incidents. Therefore, assessments of their usability and performance that can inform managerial decisions about the selection of appropriate medical devices are essential. OBJECTIVE: This study aimed to identify design deficiencies and evaluate the usability and performance of four infusion pump models and thus inform decisions about infusion pump selection. METHODS: Four evaluators evaluated the interface designs of the pumps according to a series of design principles in a heuristic evaluation in order to identify pump design deficiencies. Additionally, 60 registered nurses participated in simulated use testing to perform a series of tasks using the pumps in order to examine the pump performances. Outcome measures included task completion time, frequency of deviations, frequency of requests for assistance, and nurses' perceptions. RESULTS: Design issues identified included system status visibility, information access, and error prevention. The results of simulated use testing favored some pumps over others, depending on which outcome measures were considered. CONCLUSIONS: Heuristic evaluations and simulated use testing can provide information about the basic usability of medical devices and related operational issues. However, practitioners should select appropriate evaluation principles, testing tasks, and outcome measures based on the tested medical devices and contexts.

Bedside Usability Surveys: Adding Authentic User Detail to the Assessment.

Errors in healthcare are a leading cause of death in the United States. Equipment usability and user interfaces remain an area not fully elucidated. Infusion pumps play a vital role in care delivery, often essential for critical therapies. While pump function is comparatively simple, their programming, configuration, and form provide opportunity for error. Our purpose was to assess qualities nurses identified as important to pump operation by electronic survey. A self-developed usability survey was distributed to a random sample of 500 nurses, stratified by unit type and employed at the large academic quaternary care hospital. The overall response rate was 48% (n = 240). Descriptive and inferential statistics describe the responses and represent more than 5500 weekly infusions. Nurses described confident use of the system with some differences by unit type. Ninety percent of respondents indicated they have omitted use of the dose error reduction system, which should raise safety concerns. Users reported issues with the user interface and error prevention systems. Qualitative items elicited suggestions for improving aspects of the pump. Employing a usability survey in a clinical area proved to be a simple, inexpensive way to gather more information on the use and potential improvements of infusion pumps.

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.

The Effect of On-Pump and Off-Pump Bypass Operations on Oxidative Damage and Antioxidant Parameters.

OBJECTIVE: The aim of the study is to determine the oxidative status in on-pump and off-pump coronary artery surgery and contribute to possible surgical choices in clinical practices in accordance with the information obtained as a result of this study. METHODS: 52 patients undergoing open heart surgery (26 patients in on-pump group and 26 patients in off-pump group) were included in the study. MDA, GPx, GSH, CAT, and SOD were investigated in blood samples. RESULTS: In the on-pump group, it was determined that there were a significant increase in MDA level in the peroperative period compared to the preoperative and postoperative periods and a significant increase in GSH level in the postoperative period than in the preoperative period. Additionally, while there was a significant decrease in CAT activity in the postoperative period than in the peroperative period, there was a statistically significant increase in SOD enzyme activity in the postoperative period compared to the preoperative and peroperative periods. A statistically significant increase was observed in SOD enzyme activity in the postoperative period in on-pump compared to off-pump group. CONCLUSION: It is thought that this oxidative damage can be suppressed by administering a suitable antioxidant supplement in the preoperative and peroperative periods among patients undergoing the on-pump operation.

Hyperbaric programs in the United States: Locations and capabilities of treating decompression sickness, arterial gas embolisms, and acute carbon monoxide poisoning: survey results.

Hyperbaric oxygen therapy is the primary treatment for arterial gas embolism, decompression sickness and acute carbon monoxide poisoning. Though there has been a proliferation of hyperbaric centers throughout the United States, a scarcity of centers equipped to treat emergency indications makes transport of patients necessary. To locate and characterize hyperbaric chambers capable of treating emergency cases, a survey of centers throughout the entire United States was conducted. Using Google, Yahoo, HyperbaricLink and the UHMS directory, a database for United States chambers was created. Four researchers called clinicians from the database to administer the survey. All centers were contacted for response until four calls went unreturned or a center declined to be included. The survey assessed chamber readiness to respond to high-acuity patients, including staff availability, use of medical equipment such as ventilators and intravenous infusion devices, and responding yes to treating hyperbaric emergencies within a 12-month period. Only 43 (11.9%, N = 361) centers had equipment, intravenous infusion pumps and ventilators, and staff necessary to treat high-acuity patients. Considering that a primary purpose of hyperbaric oxygen therapy is the treatment of arterial gas embolism and decompression sickness, more hyperbaric centers nationwide should be able to accommodate these emergency cases quickly and safely.

Review of epinephrine solution use in 400 consecutive cases of burn reconstruction. Are infusion pumps safe?

Infiltration of diluted epinephrine solutions is often used in reconstructive surgery to produce local vasoconstriction and minimize bleeding. A total of 400 burn reconstruction procedures were performed with the aid of epinephrine solution between July 2008 and July 2011. We used to consider this practice very safe, but after encountering several complications, we decided to perform a retrospective review to look at all complications in detail and identify opportunities to improve safety. We encountered nine complications including one case of flash pulmonary edema and one patient with acute carpal tunnel syndrome. All severe complications were seen when the epinephrine solution was infiltrated with the aid of an electric infusion pump. Infusion pumps do not allow for reliable control of the amount of infiltration of epinephrine solutions. We conclude that infusion pumps may unnecessarily increase the risk for complications. This has resulted in a change in our practice. We now use infusion pumps only in selected cases.

Efficacy of scheduled time ketorolac administration compared to continuous infusion for post-operative pain after abdominal surgery.

BACKGROUND: Ketorolac tromethanime is a non steroidal anti inflammatory drug and its efficacy on acute pain control after abdominal surgery has been well documented. It has a rapid onset and it can be given both for intra operative and for post operative pain management. AIM: In this study we aimed to evaluate if there were any differences in relieving post operative pain when Ketorolac was administered with continuous infusion or if it was given at prearranged times. PATIENTS AND METHODS: 80 ASA I patients, scheduled for major gynecological surgery, were randomly assigned to 2 groups: group A patients were connected after surgical incision with a 24h analgesic infusor (2 ml/h) containing morphine (0.02 mg/kg/h) and Ketorolac (90 mg). Group B patients were connected after surgical incision with a 24h analgesic infusor (2 ml/h) containing morphine (0.02 mg/kg/h) at first and Ketorolac was then given in bolus after surgical incision and then every 8 hours for the first 24 hours. Post-operative pain scores were assessed using the Visual Analogue Scale (VAS) every 8 hours for 24 h. For a VAS value greater than 6, patients received Tramadol 100 mg. RESULTS: Post-operative pain scores showed a better pain relief for patients in the group B. Furthermore, the requirements of rescue analgesic were less in the group B [Tramadol was used for only 8 patients] than in the group A [Tramadol was used for 31 patients]. No adverse effects were registered in both groups. CONCLUSIONS: For post-operative pain Ketorolac administration at prearranged times, every 8 hours, offers greater benefits in respect to its continuous infusion.

Enhanced notification of infusion pump programming errors.

Hospitalized patients receive countless doses of medications through manually programmed infusion pumps. Many medication errors are the result of programming incorrect pump settings. When used appropriately, smart pumps have the potential to detect some programming errors. However, based on the current use of smart pumps, there are conflicting reports on their ability to prevent patient harm without additional capabilities and interfaces to electronic medical records (EMR). We developed a smart system that is connected to the EMR including medication charting that can detect and alert on potential pump programming errors. Acceptable programming limits of dose rate increases in addition to initial drug doses for 23 high-risk medications are monitored. During 22.5 months in a 24 bed ICU, 970 alerts (4% of 25,040 doses, 1.4 alerts per day) were generated for pump settings programmed outside acceptable limits of which 137 (14%) were found to have prevented potential harm. Monitoring pump programming at the system level rather than the pump provides access to additional patient data in the EMR including previous dosage levels, other concurrent medications and caloric intake, age, gender, vitals and laboratory results.

A baseline review of medication provided to older people in nursing care homes in the last month of life.

AIM: Increasing numbers of older people are dying in the nursing care home setting. Little is known about the medication needs of the very old and frail in the last weeks of life and how they might differ from a model of care developed for people dying from cancer. METHOD: A baseline review of medication in the last month of life was undertaken to try and establish current practice of prescribing for this population. The notes of 48 deceased residents in seven nursing care homes were examined, alongside a questionnaire sent to 67 trained nurses. RESULTS: Subcutaneous prescribing only occurred where specialist palliative care teams had been involved with the residents' care. Syringe drivers were used in 23% of cases; however, only three residents required a syringe driver for more than a day and a half. Nurses' confidence and competence in setting up syringe drivers was varied. CONCLUSIONS: The use of syringe drivers may not be the most appropriate way of managing symptoms during the dying phase in very frail and old people.

The benefits and drawbacks of syringe drivers in palliative care.

This article will outline the use of continuous subcutaneous infusion pumps, known as syringe drivers, including their benefits and drawbacks in a palliative care context. There have been over 5000 articles published globally describing syringe drivers in the medical and nursing literature within the last decade. Many provide guidance on their use, although much of the data are repetitious, disease or age-group specific, and focused on pragmatic issues to do with clinical application. Several trusts and hospices across the UK are carrying out trials of the recently launched McKinley T34 syringe driver. Therefore, it seems timely to consider their wider use internationally. Globally, practitioners in palliative care are very familiar with their use, although the literature lacks specific guidance and, at times, the information is ambiguous. Having briefly reviewed their benefits, the article considers the limitations of using syringe drivers and comments on some of the lesser known/reported practical and patient-focused drawbacks associated with their use. We conclude by considering why, when so much education and training exists to help practitioners use these devices effectively, so many human errors occur.

Thinking about nursing practice and culture: syringe drivers.

We recently set up a new inpatient unit and this involved making various decisions about our philosophy and approach to nursing practice (Shaw et al, 2007). One of the clinical issues we had to deal with was how to manage syringe drivers. Syringe drivers had been used within the community for many years, and local guidelines about their use along with various policies and procedures existed. We considered all of this information and asked some critical questions about it. One of the most practical issues we explored was the volume (or length) of infusions. This single issue and our response to it caused a significant amount of reaction among colleagues. We have written this article in an attempt to explain some of the issues relating to nursing practice and culture as we perceive them and to raise questions about why and how professionals sometimes respond to changes in practice.

Postoperative pain significantly influences postoperative blood loss in patients undergoing total knee replacement.

BACKGROUND AND OBJECTIVES: Although hypertension has long been recognized as a factor that might increase intraoperative blood losses in major orthopedic surgery, the effects of postoperative pain-induced hypertension on blood losses have not so far been evaluated. The aim of this study was to evaluate the effect of pain on perioperative blood losses of patients undergoing primary total knee replacement (TKR). METHODS: Data from patients participating in a randomized clinical trial comparing intravenous patient-controlled analgesia (PCA) (N = 20) with PCA plus continuous femoral nerve (three-in-one) block (N = 20) or PCA plus continuous posterior lumbar plexus (psoas compartment) block (N = 20) were prospectively and retrospectively collected. Correlations between relevant variables and measured and calculated blood loss, number of transfused unit, and late (96 hours) postoperative hemoglobin were tested by linear regressions. Stepwise regressions for each of the four above-mentioned goals were constructed using a probability to enter of 0.25 and to leave of 0.1. A P < 0.05 was considered significant. RESULTS: At the stepwise regressions there was a significant positive correlation between measured blood losses and morphine consumption from 12 to 18 hours (P = 0.006); between calculated blood loss and preoperative mean arterial blood pressure (P = 0.01) and preoperative hemoglobin value (P = 0.02); and between late postoperative hemoglobin and body weight (P = 0.047). CONCLUSION: In patients undergoing TKR, there is a significant correlation between measured blood loss and morphine consumption from 12 to 18 hours. It is concluded that postoperative pain significantly influences postoperative blood loss in patients undergoing TKR.

Drugs given by a syringe driver: a prospective multicentre survey of palliative care services in the UK.

The use of a syringe driver to administer drugs by continuous subcutaneous infusion is common practice in the UK. Over time, drug combinations used in a syringe driver are likely to change and the aim of this survey was to obtain a more recent snapshot of practice. On four separate days, at two-week intervals, a questionnaire was completed for every syringe driver in use by 15 palliative care services. Of 336 syringe drivers, the majority contained either two or three drugs, but one-fifth contained only one drug. The median (range) volume of the infusions was 15 (9.5-48) mL, and duration of infusion was generally 24 hours. Only one combination was reported as visually incompatible, and there were 13 site reactions (4% of total). Laboratory physical and chemical compatibility data are available for less than half of the most frequently used combinations.

A comparison of epidural analgesia with combined continuous femoral-sciatic nerve blocks after total knee replacement.

Epidural analgesia remains the "gold standard" of pain relief after total knee replacement. However, peripheral nerve block is gaining popularity because the incidence of side effects may be reduced. Our study tests this postulate. Sixty patients were prospectively randomized to receive either epidural infusion or combined continuous femoral and sciatic nerve blocks. Ropivacaine 2 mg/mL plus sufentanil 1 mug/mL was given either epidurally or through the femoral nerve catheter, and ropivacaine 0.5 mg/mL was given through the sciatic nerve catheter using elastomeric infusers (delivering 5 mL/h for 55 h). The primary outcome measure was the total incidence of side effects (urinary retention and moderate to severe degrees of dizziness, pruritus, sedation, and nausea/vomiting on the first postoperative day). Intensity of motor blockade, pain at rest and on mobilization, and rehabilitation indices were also registered for 72 h. One or more side effects were present in 87% of patients in the epidural group whereas only 35% of patients in the femoral and sciatic block groups were affected on the first postoperative day (P = 0.0002). Motor blockade was more intense in the operated limb on the day of surgery and the first postoperative day in the peripheral nerve block group (P = 0.001), whereas the non-operated limb was more blocked in the epidural group on the day of surgery (P = 0.0003). Pain on mobilization was well controlled in both groups and there were no differences in the length of hospital stay. Rehabilitation indices were similar. The results demonstrate a reduced incidence of side effects in the femoral/sciatic nerve block group than in the epidural group on the first postoperative day.

[Present status of home therapy cancer patients using an infusor].

We started a department of medical oncology and the risk management system of cancer chemotherapy since April in 2004. After that, chemotherapy administration increased steadily in numbers, especially on an outpatient basis. For reliable venous access, we made active use of a central venous Port (more than 60% of cases) as a rout of administration. Fifty five patients with advanced colorectal cancer were treated by FOLFIRI or FOLFOX regimen from April 2005 to June 2006. Two hundred sixty four cycles of FOLFIRI and 276 cycles of FOLFOX were administered. One hundred sixteen cycles (44%) and 117 cycles (42%) were performed through home therapy, respectively. Twenty five out of 55 patients could shift to home therapy using an infusor. Nine out of 30 patients wanted to continue on an inpatient basis, because their private insurance for medical care did not support the outpatient chemotherapy.

Identification of priorities for medication safety in neonatal intensive care.

BACKGROUND: Although neonates are reported to be at greater risk of medication error than infants and older children, little is known about the causes and characteristics of error in this patient group. Failure mode and effects analysis (FMEA) is a technique used in industry to evaluate system safety and identify potential hazards in advance. The aim of this study was to identify and prioritize potential failures in the neonatal intensive care unit (NICU) medication use process through application of FMEA. METHODS: Using the FMEA framework and a systems-based approach, an eight-member multidisciplinary panel worked as a team to create a flow diagram of the neonatal unit medication use process. Then by brainstorming, the panel identified all potential failures, their causes and their effects at each step in the process. Each panel member independently rated failures based on occurrence, severity and likelihood of detection to allow calculation of a risk priority score (RPS). RESULTS: The panel identified 72 failures, with 193 associated causes and effects. Vulnerabilities were found to be distributed across the entire process, but multiple failures and associated causes were possible when prescribing the medication and when preparing the drug for administration. The top ranking issue was a perceived lack of awareness of medication safety issues (RPS score 273), due to a lack of medication safety training. The next highest ranking issues were found to occur at the administration stage. Common potential failures related to errors in the dose, timing of administration, infusion pump settings and route of administration. Perceived causes were multiple, but were largely associated with unsafe systems for medication preparation and storage in the unit, variable staff skill level and lack of computerised technology. CONCLUSION: Interventions to decrease medication-related adverse events in the NICU should aim to increase staff awareness of medication safety issues and focus on medication administration processes.

Oligodeoxynucleotides induce brain inflammation in rats when infused intracerebroventricularly.

Antisense oligodeoxynucleotides (ODNs) can inhibit gene expression in a specific manner. However, several studies described problems with cerebral ODN application. Here, we investigated the immune effects (interleukin-6 (IL-6) release, cell invasion into cerebrospinal fluid (CSF) and brain parenchyma) of 'non-sense' randomized ODNs with different counterions (NH(4)(+), Na(+)) and modifications (with or without thioat-backbone) which were administered intracerebroventricularly for 48 h using osmotic mini-pumps in a rat model. All animals receiving ODNs showed increased IL-6 levels in the CSF as well as cell invasion into the CSF and brain parenchyma (P<0.05). However, the use of thioat-backbone and ammonium as the counterion induced the highest IL-6 levels (7210+/-1696 pg/ml, P<0.05) and the highest cell numbers in the CSF (31.6+/-15.5x10(5)/ml, P<0.05) as well as brain parenchyma (268.1+/-143.2 HIS-48+ cells/mm(2), P<0.01; and 31.3+/-10.7 OX-6+cells/mm(2), P<0.05) compared with the other groups.

An update on perfusion safety: does the type of perfusion practice affect the rate of incidents related to cardiopulmonary bypass?

Cardiopulmonary bypass (CPB) techniques vary among adult and pediatric patients undergoing cardiac surgery. This may result in a differential conduct of CPB between various aged patients. The present study reports on perfusion incidents occurring in hospitals using extracorporeal circulation. An 80 question survey was mailed to chief perfusionists at all 1030 US cardiac surgical centers. Respondents were asked to report on device use and incidents occurring during a 2-year period from July 1996 to June 1998. Five hundred and twenty-four completed surveys were returned with the age of surgical patients operated on at each hospital defined as either an adult (n=407), pediatric (n=17), or combined-adult and pediatric (n=100). Centrifugal pumps were used as the primary systemic pumps in 54% of adult, 12% of pediatric, and 36% of combined centers. In-line blood gas monitoring was used in 76% of all pediatric hospitals, but in only 30% of adult facilities. Incident rates occurred once per every 120.9, 83.9, and 220.2 cases in adult, pediatric, and combined centers, respectively. Mortality rates related to CPB occurred 2.7 times higher in adult and pediatric centers as compared to combined hospitals. Arterial dissection was the number one cause of death in both pediatric and combined hospitals, while coagulation disturbances resulted in the highest mortality for adult procedures. Results of this study show that the lowest incident rates occur at hospitals performing combined adult and pediatric CPB.