Capturing Essential Information to Achieve Safe Interoperability.

In this article, we describe the role of "clinical scenario" information to assure the safety of interoperable systems, as well as the system's ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, workflow, hazards, and device interactions in the clinical environment. Key user (clinician and clinical engineer) needs and system requirements can be derived from this information, therefore, improving the communication from clinicians to medical device and information technology system developers. This methodology is intended to assist the health care community, including researchers, standards developers, regulators, and manufacturers, by providing clinical definition to support requirements in the systems engineering process, particularly those focusing on development of Integrated Clinical Environments described in standard ASTM F2761. Our focus is on identifying and documenting relevant interactions and medical device capabilities within the system using a documentation tool called medical device interface data sheets and mitigating hazardous situations related to workflow, product usability, data integration, and the lack of effective medical device-health information technology system integration to achieve safe interoperability. Portions of the analysis of a clinical scenario for a "patient-controlled analgesia safety interlock" are provided to illustrate the method. Collecting better clinical adverse event information and proposed solutions can help identify opportunities to improve current device capabilities and interoperability and support a learning health system to improve health care delivery. Developing and analyzing clinical scenarios are the first steps in creating solutions to address vexing patient safety problems and enable clinical innovation. A Web-based research tool for implementing a means of acquiring and managing this information, the Clinical Scenario Repository™ (MD PnP Program), is described.

[Cost minimization analysis in postoperative pain management : economic efficiency and effectiveness of two infusion pump systems]. / Kostenminimierungsanalyse in der postoperativen Schmerztherapie : Wirtschaftlichkeit und Effektivität von 2 Schmerzpumpensystemen.

BACKGROUND: Besides reliable efficacy and patient satisfaction, economic efficiency is becoming increasingly more important in postoperative pain management. AIM: The present study investigated the effectiveness of two pain pump systems and compared the running costs in treatment. MATERIAL AND METHODS: In this study 40 patients received an interscalene catheter prior to shoulder surgery. Postoperative pain management was provided via an electronic pump with patient-controlled analgesia (PCA) or a mechanical pump without PCA. Patients kept a pain log. After treatment they were interviewed about their satisfaction with the pump. In addition drug consumption, nursing material, staff time for handling and maintenance of the pumps and preparation of medications pro re nata were assessed. RESULTS: Postoperative pain levels and patient satisfaction were comparable in both groups. Economically, the electronic pump was more cost-effective than the electronic model for a duration of treatment of 1 and 2 days. With treatment duration of 2 days the costs of both pumps were equivalent; however, the PCA feature of the electronic pump allowed a reduced intake of systemic analgesics on demand. CONCLUSION: Both pain pump systems provide equally effective pain management, while the electronic model caused less costs. Both pumps offer advantages and disadvantages that should be considered based on local circumstantial demands.

[Direct cost of connecting, maintaining and disconnecting patient-controlled analgesia pump]. / Custo direto da instalação, manutenção e desligamento da bomba de analgesia.

Quantitative research that aimed to identify the mean total cost (MTC) of connecting, maintaining and disconnecting patient-controlled analgesia pump (PCA) in the management of pain. The non-probabilistic sample corresponded to the observation of 81 procedures in 17 units of the Central Institute of the Clinics Hospital, Faculty of Medicine, University of Sao Paulo. We calculated the MTC multiplying by the time spent by nurses at a unit cost of direct labor, adding the cost of materials and medications/solutions. The MTC of connecting was R$ 107.91; maintenance R$ 110.55 and disconnecting R$ 4.94. The results found will subsidize discussions about the need to transfer money from the Unified Health System to hospitals units that perform this technique of analgesic therapy and it will contribute to the cost management aimed at making efficient and effective decision-making in the allocation of available resources.

Direct cost of connecting, maintaining and disconnecting patient-controlled analgesia pump / Custo direto da instalacao, manutencao e desligamento da bomba de analgesia / Costo directo de la instalacion, mantenimiento y detencion de la bomba de analgesia controlada por el paciente

Quantitative research that aimed to identify the mean total cost (MTC) of connecting, maintaining and disconnecting patient-controlled analgesia pump (PCA) in the management of pain. The non-probabilistic sample corresponded to the observation of 81 procedures in 17 units of the Central Institute of the Clinics Hospital, Faculty of Medicine, University of Sao Paulo. We calculated the MTC multiplying by the time spent by nurses at a unit cost of direct labor, adding the cost of materials and medications/solutions. The MTC of connecting was R$ 107.91; maintenance R$ 110.55 and disconnecting R$ 4.94. The results found will subsidize discussions about the need to transfer money from the Unified Health System to hospitals units that perform this technique of analgesic therapy and it will contribute to the cost management aimed at making efficient and effective decision-making in the allocation of available resources.

Estudio cuantitativo cuyo fue objetivo identificar el costo total promedio (CTM) de la instalación, mantenimiento y detención de la bomba de analgesia controlada por el paciente (PCA) para el manejo del dolor. La muestra no probabilística correspondió a la observación de 81 procedimientos en 17 unidades del Instituto Central del Hospital de las Clínicas de la Facultad de Medicina de la Universidad de São Paulo. Se calculó el CTM multiplicándose el tiempo dedicado por las enfermeras por el costo unitario de la mano de obra directa más el costo de los materiales y medicamentos/soluciones. El CTM de la instalación fue de R$107,91, el del mantenimiento fue de R$ 110,55 y el de la detención de la bomba fue de R$ 4,94. Los resultados pueden contribuir a las discusiones sobre la necesidad de transferir dinero del Sistema Nacional de Salud a las unidades hospitalarias que realizan esta técnica de terapia analgésica y a la gestión de los costos con el fin de favorecer la toma de decisiones eficientes y eficaces respecto al destino de los recursos disponibles.

Pesquisa quantitativa que objetivou identificar o custo total médio (CTM) da instalação, manutenção e desligamento da bomba de analgesia controlada pelo paciente (PCA) no manejo da dor. A amostra não probabilística correspondeu à observação de 81 procedimentos em 17 Unidades do Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo. Calculou-se o CTM multiplicando-se o tempo despendido pelas enfermeiras pelo custo unitário da mão de obra direta, somando-se ao custo dos materiais e medicamentos/soluções. O CTM da instalação foi de R$ 107,91; da manutenção R$ 110,55 e do desligamento R$ 4,94. Os resultados obtidos subsidiarão discussões acerca da necessidade de repasse monetário do Sistema Único de Saúde às unidades hospitalares que realizam essa técnica de terapia antálgica e contribuirão para o gerenciamento de custos visando à tomada de decisão eficiente e eficaz na alocação dos recursos disponíveis.

[Home care treatment of cancer pain patients with patient-controlled analgesia (PCA)]. / Häusliche Behandlung von Tumorschmerzpatienten mit patientenkontrollierter Analgesie (PCA).

BACKGROUND: Only limited data and experience with patient-controlled analgesia (PCA) in outpatients for palliative home care, related to organization, effectiveness and costs are available. PATIENTS AND METHODS: In our retrospective study we analyzed the effectiveness, care intensity and pain reduction of 108 palliative cancer pain patients with PCA, included in a palliative home care system. RESULTS: After equivalent conversion of the opioid doses from oral/transcutaneus to parenteral administration a dose increase was necessary in 12.9% of the patients. The pain therapy was effective until death for an average of 38.9 days (median 21 days). During 3,889 days of PCA therapy there were 76 unscheduled visits based on technical problems. CONCLUSION: In cases of cancer pain patients with failed oral or transcutaneous opioid medication, sufficient pain reduction can be achieved with parenteral drug administration by PCA. Domestic PCA requires a lot of human and financial resources, with trained nursing services and regular house visits by physicians experienced in palliative medicine but this method is sufficient and safe to use.

Patient-controlled analgesic infusion pumps. Making a painless purchase.

Patient-controlled analgesic infusion pumps give patients the ability to self-administer pain-relieving medication as needed within the limits set by a physician. The most significant risk associated with these pumps is the possibility of oversedation, potentially leading to life-threatening narcotic-induced respiratory depression. We examine nine pumps, basing our ratings on safety and ease of use.

[A national survey of postoperative pain management in Lebanon]. / Enquête nationale sur la prise en charge de la douleur aiguë postopératoire dans les hôpitaux libanais.

INTRODUCTION: Postoperative pain relief in Lebanon is a public health problem because its coverage is insufficient. STUDY DESIGN: A survey was performed with a questionnaire distributed to anaesthesiologists during the Lebanese national meeting of anaesthesia in May 2006. RESULTS: A total of 106 out of the 230 distributed questionnaires were collected. The coverage of the postoperative pain is different in the university hospitals and others. A preoperative information and postoperative evaluation of pain are only performed by 26% of anesthesiologists. A multimodal analgesia is begun in the operative room or in postanaesthesist care unit for 92% of the patients. Only 71% of the anaesthesiologists have pumps for patient-controlled analgesia. Written protocols for postoperative analgesia are available in only 58% of the centres. Among anaesthesiologists, only 36% have an initial and/or continuous formation to treat the postoperative pain. The major obstacle for improvement of postoperative pain is the cost of such treatments, which must be supported by the patients. CONCLUSION: Even if there is a good awareness of the importance to relieve the postoperative pain, important efforts must be done in this domain in Lebanon.

Pain control in augmentation mammaplasty: safety and efficacy of indwelling catheters in 644 consecutive patients.

BACKGROUND: In an effort to give patients an additional effective form of analgesia, indwelling catheters for the instillation of a long-acting local anesthetic have been used to alleviate postoperative pain in patients undergoing augmentation mammaplasty. OBJECTIVE: This prospective study analyzes the safety and efficacy of this form of pain control in a consecutive series of 644 patients. METHODS: Patients were given a choice of intermittent bolus or continuous flow catheters for pain control. Prior to discharge, 20 mL of 0.25% bupivicaine with 1:400,000 epinephrine was instilled by a nurse into catheters for those patients receiving bolus self-administration. Pain scores for each side were recorded both before and 30 minutes after instillation. Patients then instilled 1 to 2 additional doses of bupivicaine during the first 24 hours and continued to record pain scores in the evening and following morning. For patients using continuous flow catheters, 0.25% bupivicaine without epinephrine was used to fill pumps that allowed up to 2 days of continuous flow at a rate of 2 mL per hour per side. Patients recorded pain at time intervals similar to those of patients using bolus self-administration. Questionnaires were given to all patients to determine the extent of pain reduction following the instillation of local anesthesia. More than 200 complete questionnaires were gathered, and pain scores from each of these were analyzed to gauge the efficacy of the instillation regimen. RESULTS: Eighty-nine percent of the patients who self-administered a bolus of bupivacaine reported pain reduction on the evening of surgery, and 78% reported a reduction on the following morning, before implant mobility exercises. Catheters were maintained for 1 day postoperatively by 544 patients (84%) and for 2 days by 100 patients (16%). One patient developed an infection of unknown etiology that ultimately resulted in the loss of a unilateral implant. CONCLUSIONS: A prospective study of 644 consecutive augmentation mammaplasty patients shows that indwelling catheters for the postoperative instillation of bupivacaine are both safe and effective in the management of postoperative pain. This gives the patient an additional form of analgesia, limited to the operative site, which is helpful in a multimodal pain management program. Both continuous flow and intermittent bolus self-administration systems are effective and their patient ratings are indistinguishable.

[Cost benefit analysis of portable disposable patient-controlled epidural analgesia pump under the diagnosis procedure combination based payment system].

BACKGROUND: The aim of this study was to assess how portable disposable patient-controlled epidural analgesia (PCEA) pumps (P group) affect the total costs of postoperative pain management compared with ordinary continuous epidural analgesia pumps without patient-controlled analgesia(C group). METHODS: The hospital income, material costs and costs of drugs for postoperative analgesia were analyzed in 446 surgical patients (C group) between April 2005 and November 2005 and in 417 surgical patients (P group) between April 2006 and November 2006, respectively. RESULTS: Considerable cost savings were achieved when PCEA pumps was used (C group--1300 yen/per patient; P group + 1950 yen/per patient). CONCLUSIONS: PCEA pumps itself work out as designated insured medical materials and additional drugs for postoperative analgesia in the ward is cleared under the diagnosis procedure combination (DPC)-based payment system. Clearance of PCEA pumps under the DPC-based payment system and cost savings of additional drugs for postoperative analgesia in the ward contributed to increases in the profit of the hospital. The DPC-based payment system may offer an economic incentive to introduction of PCEA.

Ergonomics, patient safety, and engineering ethics: a case study and cautionary tale.

Poor ergonomic design of complex medical equipment can lead to patient morbidity and mortality while still operating correctly. For example, patient controlled analgesia (PCA) machines are used extensively for postoperative pain, and can be programmed to give intravenous morphine every time the patient pushes the demand button. Unfortunately, such devices sometimes have poorly designed user interfaces. As an example, ergonomic flaws in the design of the Abbott Lifecare 4100 PCA Plus II machine have been held to be ultimately responsible for a number of deaths. However, despite being notified of this problem, the manufacturer was unwilling to upgrade the unit to a safer design, claiming that there was no problem with the unit in the first place that could not be handled with proper user training. This case draws attention to two important points, namely, (i) ergonomic studies on medical equipment may be abandoned in favor of early market penetration, and (ii) even when potential improvements are developed, they may be ignored by manufacturers, who may sometimes take a completely amoral approach to business decision making, focusing entirely on what is legal and expedient rather than being driven by any particular moral or ethical principles.

Patient-controlled analgesic infusion pumps.

Patient-controlled analgesic (PCA) infusion pumps allow patients to self-administer doses of pain-relieving medication as needed, rather than having to summon a caregiver. The most significant risk when using these pumps is overmedication leading to narcotic-induced respiratory depression. Several current PCA pumps offer advanced error-reduction features designed to minimize the odds of an accidental overdose: dose error reduction systems, bar-code readers, and computer-based pump-programming systems that entail downloading infusion protocols via a hardwired connection to a PC. The availability of these features plays a dominant role in our ratings. We tested 11 pumps from seven suppliers. Two pumps are rated Preferred because they offer easy-to-use advanced error-reduction features that have been proven effective in a hospital setting. Two other pumps offer computer-based programming and are rated Acceptable, although we note that not all facilities may be able to accommodate the workflow necessary to use the computer-based programming. The remaining pumps are rated Not Recommended because they lack advanced error-reduction features; although most of these pumps perform acceptably, better choices are available.

Recent developments in patient-controlled analgesia.

Patient-controlled analgesia (PCA) has become the gold standard for acute pain management since it was first introduced 20 years ago, and its merits have been discussed in quite a large number of publications. This review summarizes the more recent developments, such as new application devices and strategies, including intranasal, spinal, and regional PCA; patient-controlled sedation; experience with children and elderly people; and some data from chronic pain situations. Analyzing PCA literature from 2001 onwards confirms the author's long belief that the PCA principle ("WYNIWYG": what you need is what you get) was the most important aspect of a patient-controlled strategy, more or less independent of the type of drug or machine. Discovering this principle has changed the understanding of pain and suffering.

JCAHO's National Patient Safety Goal for infusion pump free-flow protection: ECRI's assessment of the protection offered by general-purpose, PCA, and ambulatory pumps.

One of the U.S. National Patient Safety Goals promulgated by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is to "improve the safety of using infusion pumps" by ensuring that pumps are protected against free-flow. In this Guidance Article, we provide ECRI's updated guidance for achieving this goal. Free-flow refers to the uncontrolled delivery of an infusion to a patient when a controlled or metered delivery was intended. For more than 20 years--in numerous articles presented in Health Devices and its sister publication Health Devices Alerts--ECRI has offered guidance to help hospitals avoid the dangers of free-flow. The current article is the latest in a series of reports addressing JCAHO's goal; it describes the dangers, provides updated guidance for interpreting JCAHO's goal, and categorizes the available pump models according to the level of free-flow protection offered. This report supersedes Health Devices Alerts Special Reports S0008 (August 23, 2002), S0018 (March 21, 2003), and S0029 (November 14, 2003).

What does it take? A case study of radical change toward patient safety.

BACKGROUND: Adopting a human factors engineering approach to patient safety requires a radical behavioral shift from "blame and shame," which emphasizes further training, to systems thinking, which also emphasizes improved system design. A medical device manufacturer appeared to initiate this radical shift after exhibiting the traditional approach for years. METHODOLOGY: The research focused on a patient-controlled analgesia device. A qualitative case study methodology was used to study events in the period from the device's introduction (1988) until the start of the behavioral change (May 2001). Data on 50 relevant events were analyzed. The tabular summary was analyzed for evidence of the prerequisites predicted by punctuated equilibrium theory, and the graphical time line was analyzed for evidence of vertical alignment across levels. RESULTS: Radical behavioral change was preceded by a critical 9.5-month period with three characteristics: new corporate leadership, perceived poor corporate performance, and aligned disruptions occurring within a relatively short time at almost every level in the external environment in which the company operated. DISCUSSION: These findings are consistent with punctuated equilibrium theory, according to which organizations can experience long periods of resistance to change followed by fast revolutionary change (approximately two years). The findings also have implications for when and how to introduce patient safety policy interventions to "tilt the playing field" and thereby increase the likelihood that such reforms will succeed.

Patient-controlled analgesic infusion pumps. Evaluating the Deltec CADD-Prizm PCS II.

Patient-controlled analgesic (PCA) infusion devices allow patients to self-administer narcotic analgesics within the limits prescribed by the physician. They deliver solutions intravenously, subcutaneously, or epidurally and allow patient activation by means of a pendant button on a cord connected to the pump or a button directly on the pump. PCA therapy is typically used for postoperative, obstetric, terminally ill, and trauma patients. In the May 2001 issue of Health Devices, we evaluated nine PCA pumps from six suppliers. In this Update Evaluation, we present our findings on an additional pump, the Deltec CADD-Prizm PCS II. Like most of the previously evaluated pumps, this pump does not stand out as ideal but nonetheless meets most of our criteria and is rated Acceptable.

Patient-controlled analgesic infusion pumps.

Patient-controlled analgesic (PCA) infusion devices allow patients to self-administer narcotic analgesics within the limits prescribed by the physician. PCA therapy is typically used for postoperative, obstetric, terminally ill, and trauma patients. PCA pumps deliver solutions intravenously, subcutaneously, or epidurally and allow patient activation by means of a pendant button on a cord connected to the pump or a button directly on the pump. We evaluated nine PCA pumps from six suppliers. Three of these pumps are syringe-type, while the others use cassette-based fluid delivery. Because PCA pumps have often been cited as examples of devices that contribute to medical error (the most significant risk connected with PCA infusion is overmedication), the accident resistance of each device weighed heavily in our testing. The pumps we tested exhibit varying levels of performance, resistance to accidents and tampering, and ease of use. We rate six of them Acceptable. While none of the six units stands out as ideal, they meet most of our criteria, and we consider them somewhat better choices than the rest. We rate one other pump Acceptable (with Conditions) because, in one of its operating modes, it has a drawback that could be dangerous to patients; we consider its use acceptable only if the hospital doesn't employ the operating mode in question. Finally, we rate two pumps Not Recommended because they both have a significant number of disadvantages.

[The examination of usefulness of the disposable pump in case of cancer pain relaxation and the economic problem].

Recently, an increasing number of cancer patients being taken care of at home has been able to use morphine to treat their pain by themselves. The most suitable administration method for individual patients-oral, intravenous, subcutaneous or depository--is being investigated. When oral intake becomes difficult, the subcutaneous via of administration is best option because it is the less dangerous and easier to use compared with the other two options. These are also thought to be less useful because it is difficult to judge the exact dosage. The use of pumps might be an economic problem to some patients. We will examine this problem.

[Postoperative pain assessment in head and neck cancer surgery: benefit of patient controlled analgesia (PCA)]. / Evaluation de la douleur post-opératoire en chirurgie carcinologique cervico-faciale. Intérêt de l'analgésie auto-contrôlée.

Acute postoperative pain has seldom been assessed in head and neck cancer surgery. The estimation of actual pain is more difficult when communication is impaired by tracheotomy or tracheostomia. The aim of the present prospective study was the assessment of analgesia level during the first 48 postoperative hours after head and neck cancer surgery. The analgesic procedure involved intra-venous morphine injected by means of a PCA pump (Patient controlled analgesia). Thirty patients were thus treated after cancer surgery of the larynx or the oropharynx. The protocol included during 48 hours the assessment of pain, using a visual analogic scale (VAS) every fourth hour, while recording the total injected dose of morphine, the localisation of pains, as well as the occurrence of side-effects. The control of postoperative pain was shown to be satisfactory, with a VAS grade smaller than 3 at time zero and kept below this value during 48 hours. At the end of this period, the mean total dose of morphine injected was 38 mg. No case of respiratory depression was even seen. It can be concluded that PCA seems to be an efficient procedure for controlling postoperative pain in head and neck cancer surgery. This technique proved to be better than delivering analgesia on requirement.

Infusion pumps.

Infusion pumps are used to deliver drugs and other substances to patients at a pre-set rate. Infusion pumps are classified according to their application, whether ambulatory, patient controlled, anaesthesia or general purpose units.