Failure mode and effects analysis of the universal anaesthesia machine in two tertiary care hospitals in Sierra Leone.

BACKGROUND: Anaesthesia care in developed countries involves sophisticated technology and experienced providers. However, advanced machines may be inoperable or fail frequently when placed into the austere medical environment of a developing country. Failure mode and effects analysis (FMEA) is a method for engaging local staff in identifying real or potential breakdowns in processes or work systems and to develop strategies to mitigate risks. METHODS: Nurse anaesthetists from the two tertiary care hospitals in Freetown, Sierra Leone, participated in three sessions moderated by a human factors specialist and an anaesthesiologist. Sessions were audio recorded, and group discussion graphically mapped by the session facilitator for analysis and commentary. These sessions sought to identify potential barriers to implementing an anaesthesia machine designed for austere medical environments-the universal anaesthesia machine (UAM)--and also engaging local nurse anaesthetists in identifying potential solutions to these barriers. RESULTS: Participating Sierra Leonean clinicians identified five main categories of failure modes (resource availability, environmental issues, staff knowledge and attitudes, and workload and staffing issues) and four categories of mitigation strategies (resource management plans, engaging and educating stakeholders, peer support for new machine use, and collectively advocating for needed resources). CONCLUSIONS: We identified factors that may limit the impact of a UAM and devised likely effective strategies for mitigating those risks.

[Interdisciplinary training opportunities for residents in occupational medicine: the experience of the ERC Tour 2012]. / Nuove opportunità formative interdisciplinari per i medici specializzandi: l'esperienza dell'ERC Tour 2012.

This paper describes the experience of the School of Occupational Medicine of the University of Brescia at the current edition of the New York and New Jersey Education and Research Center--Historical Perspectives Tour on Occupational Safety and Health, that involved 5 different industrial and environmental sites, appropriate for understanding the complex occupational health and safety problems. In every site, the participants have interacted with workers and professionals and discussed about the specific work processes, to better understand the risk faced by the workers, occupational pathologies that can occur, personal protective equipment used and preventive measures adopted. This experience has been successful in provide interdisciplinary educations to occupational safety and health professionals in training in order to prepare them for the collaboration and cooperation required to solve the complex occupational health and safety problems they will face in their future careers.

A human prostatic epithelial model of hormonal carcinogenesis.

The effects of stromal and hormonal environment on the immortalized but nontumorigenic human prostatic epithelial cell line BPH-1 were investigated in an in vivo model. BPH-1 cells were recombined with rat urogenital sinus mesenchyme (UGM), and the tissue recombinants were grafted to the renal capsule of adult male athymic mouse hosts. BPH-1 + UGM recombinants formed solid branching epithelial cords with a well-defined basement membrane. The cords canalized to form ductal structures. The mesenchymal cells formed thick sheets of well-differentiated smooth muscle surrounding the epithelium, reinforcing the idea that the epithelium dictates the patterning of prostatic stromal cells. When hosts carrying BPH-1 + UGM tissue recombinants were exposed to testosterone propionate and 17-beta-estradiol (T + E2), the tissue recombinants responded by forming invasive carcinomas, demonstrating mixed, predominantly squamous as well as adenocarcinomatous (small acinar and mucinous) differentiation. When either untreated or T + E2-treated hosts were castrated, epithelial apoptosis was observed in the grafts. When tumors were removed and regrafted to fresh hosts they grew rapidly. Tumors were serially regrafted through six generations. Histologically these tumors consisted largely of focally keratinizing squamous cell carcinoma with high-grade malignant cytological features. BPH-1 cells grown in the absence of UGM survived at the graft site but did not form tumors or organized structures. This behavior was not influenced by the presence or absence of T + E2 stimulation. These data show that an immortalized, nontumorigenic human prostatic epithelial cell line can undergo hormonal carcinogenesis in response to T + E2 stimulation. In addition, the data demonstrate that the stromal environment plays an important role in mediating hormonal carcinogenesis.

Characterization of calcitonin- and adrenocorticotropin-producing human cloned cell lines.

We have developed three human cloned cell lines that produce immunoreactive human calcitonin (ihCT) and ACTH (iACTH) as well as exhibit characteristics of cultured neural cells. Clones HMS-41/I, -78/2, and -98/2 were developed from cell lines HeLa AV3, MBA 9812 (bronchogenic carcinoma), and SW 267 (pheochromocytoma), respectively. Karyological analysis of both the parent and the cloned cell lines confirmed the identity of HeLa AV3 and MBA 9812. When grown in serum-free media designed for culturing neural cells, the patterns of production for both ihCT and iACTH varied among the clones. The multiple patterns of hormone production suggest that the mechanisms involved in the biosynthesis, processing, and secretion of these hormones differ among the clones. The clones contain neuron-specific enolase and the putative neurotransmitters beta-alanine and gamma-amino butyric acid, and they respond to cAMP analogs by differentiating, as noted by the extension of neurites (except the HeLa-derived HMS-41/I). The iACTH extracted from cells and synthetic ACTH exhibited equivalent profiles upon isoelectric focusing. The forms of ihCT noted in cell extracts were similar to those observed in extracts of human tumor tissue. Our rabbit antiserum to hCT failed to detect ihCT in those cell extracts prepared for ACTH determination or in extracts of rat pituitaries, but it did detect CT in rat thyroids by both RIA and immunofluorescent procedures. We concluded that our antisera to hCT do not detect the precursor form of ACTH. The availability of these cloned cell lines provides model systems for examining the production of these peptide hormones and the concomitant expression of neural and endocrine characteristics.

Carbon-11 choline: synthesis, purification, and brain uptake inhibition by 2-dimethylaminoethanol.

We report an improved method for the synthesis and purification of [11C]methylcholine from the precursors [11C]methyliodide and 2-dimethylaminoethanol (deanol). Preparation time, including purification, is 35 min postbombardment. Forty millicuries of purified injectable [11C]choline were produced with a measured specific activity of greater than 300 Ci/mmol and a radiochemical purity greater than 98%. The decay corrected radiochemical yield for the synthesis and purification was approximately 50%. Residual precursor deanol, which inhibits brain uptake of choline, is removed by a rapid preparative high performance liquid chromatography (HPLC) method using a reverse phase cyano column with a biologically compatible 100% water eluent. Evaporation alone did not completely remove the deanol precursor. Brain uptake of the [11C]choline product was six times greater after HPLC removal of deanol because doses of less than 1 microgram/kg significantly inhibit [14C]choline brain uptake.

Epidural morphine analgesia after cesarean delivery.

The effectiveness and safety of 5 mg of epidurally administered morphine for postoperative analgesia was determined in 276 healthy women undergoing cesarean delivery. Overall pain relief, time to administration of additional analgesic medications, and adverse side effects were evaluated. Epidural injection of 5 mg of morphine provided good to excellent pain relief lasting 24 to 36 hours for 83% of patients. Also, review of hospital records for a subset of 34 patients revealed that requirements for additional systemic analgesics were markedly less when postoperative pain relief was provided by epidural administration of morphine than by conventional analgesia therapy. Pruritus, nausea, and vomiting occurred frequently, but were easily treated. Although late respiratory depression did not occur in this group, the authors continue to observe patients closely and monitor respiratory rates for 24 hours.

Transitional cell carcinoma of fossa navicularis in a man with three other synchronous malignancies.

Transitional cell carcinoma arising from the anterior portion of the male urethra is rare, with less than 10 cases reported in the literature. Our patient had a high-grade, highly invasive transitional cell carcinoma originating in the fossa navicularis and extending proximally along the corpus spongiosum, the corpora cavernosa, and blood and lymphatic vessels. In addition, the patient had a concurrent low-grade prostatic adenocarcinoma, a large basal cell carcinoma of the nose, and a squamous cell carcinoma of the penile skin. The previously reported cases are reviewed, with particular reference to the possible association of these tumors with human papillomavirus infection.

Current indications for cutaneous ureterostomy.

OBJECTIVE: To assess the current indications for cutaneous ureterostomy in children. METHOD: A total of 32 children underwent cutaneous ureterostomy at Texas Children's Hospital from 1975 to 1990. Medical records were reviewed to determine the urologic diagnosis, the indication for urinary diversion, the type of ureterostomy performed, and the outcome for each patient. RESULTS: Twenty patients underwent loop cutaneous ureterostomy (LCU) or pyelostomy and 12 patients underwent end cutaneous ureterostomy (ECU). The main indication for LCU was obstructive uropathy unresponsive to lower urinary tract drainage, and the most common cause was posterior urethral valves. Other indications for LCU included obstruction requiring delayed surgical correction, high-grade reflux into a solitary kidney, and obstruction with infection. The children who required ECU were an older, more diverse group than those who underwent LCU. The main indication for ECU was poor bladder function secondary to a variety of congenital anomalies, including prune-belly syndrome, posterior urethral valves, bladder exstrophy, and urogenital sinus defect. CONCLUSION: LCU is easy to perform and is an excellent method for achieving temporary upper urinary tract drainage. ECU is suited for long-term or permanent urinary diversion in children with at least one dilated ureter, and can provide a socially acceptable stoma when delayed reconstruction is necessary. Many children who were "permanently" diverted by ECU may be undiverted using newer reconstructive techniques.

Significant interaction between clozapine and cocaine in cocaine addicts.

Because clozapine may be prescribed to cocaine abusing patients with schizophrenia, we studied cocaine-clozapine interactions in a controlled setting. Eight male cocaine addicts underwent four oral challenges with ascending doses of clozapine (12.5, 25 and 50 mg) and placebo followed 2 h later by a 2-mg/kg dose of intranasal cocaine. Subjective and physiological responses, and serum cocaine levels were measured over a total 4-h period. Clozapine pretreatment increased cocaine levels during the study and significantly increased the peak serum cocaine levels in a dose dependent manner. In spite of this elevation in blood levels, clozapine pretreatment had a significant diminishing effect upon subjective responses to cocaine, including 'expected high', 'high' and 'rush', notably at the 50 mg dose. There was also a significant effect upon 'sleepiness', 'paranoia' and 'nervous'. Clozapine caused a significant near-syncopal episode in one subject in the study, requiring his removal from the study. Clozapine had no significant effect on baseline pulse rate and systolic blood pressure, but it attenuated the significant pressor effects of the single dose of intranasal cocaine. These data suggested a possible therapeutic role for clozapine in the treatment of cocaine addiction in humans, but also suggests caution due to the near-syncopal event and the increase in serum cocaine levels.

Survival of cells after intra-articular transplantation of fresh allografts of the patellar and anterior cruciate ligaments. DNA-probe analysis in a goat model.

The fate of donor cells in fresh allografts of the patellar and anterior cruciate ligaments was assessed after transplantation of the allografts as substitutes for the anterior cruciate ligament in goats. DNA-probe analysis was used to distinguish between the DNA of individual goats. Donor DNA was completely replaced by recipient DNA in both the transplanted patellar and anterior cruciate ligaments within a four-week period. Simultaneous full-thickness skin transplants in the same animals were not rejected during the interval of rapid loss of donor DNA from the allografts. The absence of rejection of the skin grafts at the one-week interval suggests that no pre-existing antibody associated with an immune reaction was responsible for the rapid loss of DNA in the allografts.

The efficacy of continuous passive motion in the rehabilitation of anterior cruciate ligament reconstructions.

Seventy-five patients undergoing arthroscopically-assisted anterior cruciate ligament reconstruction by the same surgeon were divided into three random subgroups. All of the anterior cruciate ligament reconstructions used the middle third of the ipsilateral patellar tendon autograft. Patients undergoing meniscal repair, extraarticular procedures, or repair of other ligaments were excluded. The 75 patients were divided into subgroups to assess the benefits or disadvantages of early active motion (25 patients), continuous passive motion (25 patients), and a combination of both (25 patients) during the first 30 days after surgery. All patients were evaluated at specific intervals for 6 months after surgery. Data recorded included drain output, medication usage, tourniquet time, leg involved, hospital stay length, KT-1000 testing (before surgery in the anesthetized patient, after the procedure was completed, and 2 and 6 months after surgery), and range of motion. Radiographs and the International Knee Evaluation Form were also used to evaluate the results. No statistically significant differences were found between the three groups. Side-to-side anterior-posterior differences, stability, and restoration of full range of motion were similar in each subgroup at each evaluated interval. In this prospective study of motion, started immediately after anterior cruciate ligament reconstruction, passive and active methods were shown to have identical results. A supervised active and passive motion program during the 1st month had the same results as either one used individually.

A comparison of patellar tendon autograft and allograft used for anterior cruciate ligament reconstruction in the goat model.

Similar-sized patellar tendon autografts and fresh-frozen allografts were used to reconstruct the anterior cruciate ligament of one knee in 40 female goats. Evaluations of the reconstructions and contralateral controls at the 6-week and 6-month postoperative periods included anterior-posterior translation, mechanical properties determined during tensile failure tests, measurement of cross-sectional area, histology, collagen fibril size and area distribution, and associated articular cartilage degenerative changes. Six months after anterior cruciate ligament reconstruction, the autografts demonstrated a smaller increase in anterior-posterior displacement, values of maximum force to failure two times greater, a significant increase in cross-sectional area, a more rapid loss of large-diameter collagen fibrils, and an increased density and number of small-diameter collagen fibrils compared to the allografts. Clinical significance. More surgeons are allowing their patients to return to running and sports 6 months after anterior cruciate ligament reconstruction. While the structural and material properties of autografts and allografts at time zero are similar, in the goat model during the first 6 months they differ. The allografts demonstrate a greater decrease in their implantation structural properties, a slower rate of biologic incorporation, and the prolonged presence of an inflammatory response. At 6 months the autograft demonstrates a more robust biologic response, improved stability, and increased strength to failure values.

The INSURE project on lifecycle preventive health services.

The INSURE Project on Lifecycle Preventive Health Services is a 3-year study to determine the feasibility of implementing preventive services in primary medical care as a health insurance benefit and to assess the short-term impact of this implementation on providers and consumers. Initiated by the life and health insurance companies, the project has received additional support from private philanthropic foundations. Preventive services, which will be provided under a lifecycle approach according to the age and sex of the patient and include education of patients on health-related behavior, will range from prenatal care through geriatrics. A quasi-experimental design will be used in which three study (experimental) group practice sites are matched with three control group practice sites. At the study sites, the primary care physicians will participate in orientation sessions on recommended preventive services and patient education procedure; they will also examine and counsel the study patients. The study and control physicians and patients will be surveyed before and after the program of intervention is conducted at the study sites to assess their knowledge, attitudes, and behavior toward health behavior practices.

Fetal surgery in the primate I. Anesthetic, surgical, and tocolytic management to maximize fetal-neonatal survival.

There are compelling physiologic arguments for correcting certain malformations before birth. Although fetal surgery has been successful in sheep and lower animals, it has proven difficult in primates because the gravid uterus is exquisitely sensitive to induction of preterm labor and abortion. Because the feasibility of fetal intervention can be determined only in a primate model, we have investigated the variables affecting fetal-neonatal survival after fetal surgery in 25 monkeys. As we improved our anesthetic and surgical techniques and refined our tocolytic therapy, mortality fell from 73.3% (11/15) to 20% (2/10). Since spontaneous perinatal loss in 56 controls was 21.4% we can now operate on the late second and early third trimester fetal monkey without increasing maternal or fetal-neonatal mortality. Success in this rigorous model is a requisite for attempted correction of human malformations in utero.

Operating on placental support: the ex utero intrapartum treatment procedure.

While treating eight fetuses with predictable airway obstruction, the authors developed a systematic approach, the ex utero intrapartum treatment procedure, to secure the airway during delivery. Six patients had their trachea plugged or clipped in utero for treatment of congenital diaphragmatic hernia, and two patients had prenatally diagnosed cystic hygroma of the neck and oropharynx. The ex utero intrapartum treatment procedure was performed by using high doses of inhaled halogenated agents to facilitate uterine relaxation during cesarean section, securing the fetal airway while feto-placental circulation remained intact, and then dividing the umbilical cord. A variety of procedures were performed during the ex utero intrapartum treatment procedure including bronchoscopy, orotracheal intubation, tracheostomy, tracheostomy with retrograde orotracheal intubation, tracheoplasty, removal of internal tracheal plug, removal of external tracheal clip, central line placement, and instillation of surfactant. There were minimal maternal or fetal complications during the procedure. This approach requires the coordinated efforts of pediatric surgeons, obstetricians, anesthesiologists, sonographers, and neonatologists. The combination of intensive maternal-fetal monitoring, cesarean section with maximal uterine relaxation, and maintenance of intact feto-placental circulation provides a controlled environment for securing the airway in babies with prenatally diagnosed airway obstruction.

Correction of congenital diaphragmatic hernia in utero VIII: Response of the hypoplastic lung to tracheal occlusion.

Most fetuses with congenital diaphragmatic hernia (CDH) diagnosed before 24 weeks' gestation die despite optimal postnatal care. In fetuses with liver herniation into the chest, prenatal repair has not been successful. In the course of exploring the pathophysiology of CDH and its repair in fetal lambs, the authors found that obstructing the normal egress of fetal lung fluid enlarges developing fetal lungs, reduces the herniated viscera, and accelerates lung growth, resulting in improved pulmonary function after birth. They developed and tested experimentally a variety of methods to temporarily occlude the fetal trachea, allow fetal lung growth, and reverse the obstruction at birth. The authors applied this strategy of temporary tracheal occlusion in eight human fetuses with CDH and liver herniation at 25 to 28 weeks' gestation. With ongoing experimental and clinical experience, the technique of tracheal occlusion evolved from an internal plug (two patients) to an external clip (six patients), and a technique was developed for unplugging the trachea at the time of birth (Ex Utero Intrapartum Tracheoplasty [EXIT]). Two fetuses had a foam plug placed inside the trachea. The first showed dramatic lung growth in utero and survived; the second (who had a smaller plug to avoid tracheomalacia) showed no demonstrable lung growth and died at birth. Two fetuses had external spring-loaded aneurysm clips placed on the trachea; one was aborted due to tocolytic failure, and the other showed no lung growth (presumed leak) and died 3 months after birth. Four fetuses had metal clips placed on the trachea. All showed dramatic lung growth in utero, with reversal of pulmonary hypoplasia documented after birth. However, all died of nonpulmonary causes. Temporary occlusion of the fetal trachea accelerates fetal lung growth and ameliorates the often fatal pulmonary hypoplasia associated with severe CDH. Although the strategy is physiologically sound and technically feasible, complications encountered during the evolution of these techniques have limited the survival rate. Further evolution of this technique is required before it can be recommended as therapy for fetal pulmonary hypoplasia.

Correction of congenital diaphragmatic hernia in utero, V. Initial clinical experience.

Review of our experience with 45 cases of prenatally diagnosed congenital diaphragmatic hernia (CDH) confirms that most fetuses (77%) will not survive despite optimal pre- and postnatal care. Polyhydramnios, associated anomalies, early diagnosis, and a large volume of herniated viscera (including liver) are associated with a particularly dismal prognosis. After extensive experimental work demonstrated the efficacy, feasibility, and safety of repair in utero, we attempted to salvage six highly selected fetuses with severe CDH by open fetal surgery. Five had liver incarcerated in the chest: three died at operation because attempts to reduce the liver compromised umbilical venous return. In one, a Goretex diaphragm was constructed around the liver, but the baby died after birth. The last two fetuses, one with incarcerated liver, were successfully repaired. Both demonstrated rapid growth of the lung in utero, had surprisingly good lung function after birth despite prematurity, had the abdominal patch removed at 2 weeks, and subsequently died of nonpulmonary problems (an unrelated nursery accident in one and intestinal complications in the other). The only maternal complication was amniotic fluid leak and preterm labor. All six women are well and four have had subsequent normal children. From this phase I experience, we conclude that fetal surgery appears safe for the mother and her reproductive potential, that fetal CDH repair is feasible in selected cases, and that the fetal lung responds quickly after decompression. However, fetal repair remains a formidable technical challenge.

Correction of congenital diaphragmatic hernia in utero VII: a prospective trial.

BACKGROUND: Congenital diaphragmatic hernia (CDH) remains an unsolved problem. Despite optimal postnatal care, up to 60% of CDH babies die. Experimental evidence and clinical experience have shown that in utero repair of CDH is feasible and can reverse pulmonary hypoplasia, but only in fetuses without liver herniation. For this subgroup, the safety and efficacy of repair before birth has not been compared with standard care after birth. METHODS: Four fetuses in whom CDH without liver herniation was diagnosed underwent open fetal surgery for repair of the CDH. Seven comparison fetuses were treated conventionally. Neonatal mortality was the principle outcome variable. Secondary outcome variables included death of all causes until 2 years of age, number of days of ventilatory support, length of hospital stay, requirement for extracorporeal membrane oxygenation (ECMO), and total hospital charges. RESULTS: There was no difference in survival between the fetal surgery group and the postnatally treated comparison group (75% v 86%). Fetal surgery patients were born more prematurely than the comparison group (32 weeks v 38 weeks' gestation). Length of ventilatory support and requirement for ECMO were equivalent in the fetal surgery group and the postnatally treated comparison group. Length of hospital stay and hospital charges did not differ between the groups. CONCLUSIONS: Open fetal surgery is physiologically sound and technically feasible, but does not improve survival over standard postnatal treatment in the subgroup of CDH fetuses without liver herniation, primarily because overall survival in this subgroup is favorable with or without prenatal intervention. These data suggest that fetuses who have prenatally diagnosed CDH and without evidence of liver herniation should be treated postnatally.

Anesthesia for fetal procedures and surgery.

Many of the anesthetic considerations for fetal procedures and surgery are identical to those for nonobstetric surgery during pregnancy, including concern for maternal safety, avoidance of both teratogenic drugs and fetal asphyxia, and the prevention of preterm labor and delivery. Anesthesia is required for the mother and quite often the fetus to perform many fetal procedures. Fetal procedures and surgery can be divided into subgroups according to their anesthetic requirements. For example: procedures that only require a needle insertion into the uterus but not into the fetus, such as intrauterine infusions; laser surgical photocoagulation of the communicating placental circulation for twin-twin transfusion syndrome (TTTS) and radio-frequency umbilical cord ablation for managing twin reversed arterial perfusion (TRAP), which are not really fetal procedures, rather they are placental or cord procedures; surgical procedures performed directly on the fetus; and the EX-utero Intrapartum Treatment (EXIT) procedure. Anesthetic considerations also depend on other factors, such as the location of the placenta. Unlike maternal surgery, for fetal procedures, the fetus is not an innocent bystander for whom the least anesthetic interference is used. Instead, the fetus can be the primary patient and may benefit from anesthesia, with close monitoring of the anesthetic effects to ensure well-being. Fetal asphyxia, hypoxia, or distress can be most effectively recognized, predicted, and avoided by fetal monitoring. Monitoring is also crucial for assessing the fetal response to corrective maneuvers.

The INSURE Project on Lifecycle Preventive Health Services: cost containment issues.

The INSURE Project on Lifecycle Preventive Health Services (LPHS) is a three-year feasibility study to determine whether preventive health services can be implemented in the primary medical care setting as a covered health insurance benefit and what the short-term behavioral effects will be on physicians and their patients. Thus far, the negotiated reasonable and customary fees that have been paid are lower than anticipated. Patients have expressed a willingness to pay extra for preventive care insurance coverage if it were available. The positive reactions of providers and consumers and the reasonable cost of LPHS may prove to be more crucial than broader cost containment issues in determining the extent of health insurance coverage for preventive care in the future.