Abstract: Medication dispensing system is a life-critical system whose failure may result in preventable adverse events leading to longer patient stays in hospitals or patient death. Automation has led to great improvements in life-critical systems as it increased safety, efficiency, and comfort. However, critical risks related to medical organization complexity and automated solutions integration can threaten drug dispensing security and performance. Knowledge about the system’s complexity aspects and human machine parameters to control for automated equipment’s security and performance will help operators to secure their automation process and to optimize their system’s reliability. In this context, this study aims to document the operator’s situation awareness about automation risks and parameters involved in automation security and performance. Our risk management approach has been deployed in the North Luxembourg hospital center’s pharmacy, which is equipped with automated drug dispensing systems since 2009. With more than 4 million euros of gains generated, North Luxembourg hospital center’s success story was enabled by the management commitment, pharmacy’s involvement in the implementation and improvement of the automation project, and the close collaboration between the pharmacy and Sinteco’s firm to implement the necessary innovation and organizational actions for automated solutions integration security and performance. An analysis of the actions implemented by the hospital and the parameters involved in automated equipment’s integration security and performance has been made. The parameters to control for automated equipment’s integration security and performance are human aspects (6.25%), technical aspects (50%), and human-machine interaction (43.75%). The implementation of an anthropocentric analysis system before automation would have prevented and optimized the control of risks related to automation.
Abstract: Associations between life events and various forms of cancers have been identified. The purpose of a recent random-effects meta-analysis was to identify studies that examined the association between adverse events associated with changes to financial status including decreased income and breast cancer risk. The same association was studied in four separate studies which displayed traits that were not consistent between studies such as the study design, location, and time frame. It was of interest to pool information from various studies to help identify characteristics that differentiated study results. Two random-effects Bayesian meta-analysis models are proposed to combine the reported estimates of the described studies. The proposed models allow major sources of variation to be taken into account, including study level characteristics, between study variance and within study variance, and illustrate the ease with which uncertainty can be incorporated using a hierarchical Bayesian modelling approach.
Abstract: Innovative medical technologies offer more effective medical care, with less risk to patient and healthcare personnel. Medical technology and devices when properly used provide better data, precise monitoring and less invasive treatments and can be more targeted and often less costly. The Intensive Care Unit (ICU) equipped with patient monitoring, respiratory and cardiac support, pain management, emergency resuscitation and life support devices is particularly prone to medical errors for various reasons. Many people in the developing countries now wonder whether their visit to hospital might harm rather than help them. This is because; clinicians in the developing countries are required to maintain an increasing workload with limited resources and absence of well-functioning safety system. A team of experts from the medical, biomedical and clinical engineering in Sweden and Bangladesh have worked together to study the incidents, adverse events at the ICU in Bangladesh. The study included both public and private hospitals to provide a better understanding for physical structure, organization and practice in operating processes of care, and the occurrence of adverse outcomes the errors, risks and accidents related to medical devices at the ICU, and to develop a ICT based support system in order to reduce hazards and errors and thus improve the quality of performance, care and cost effectiveness at the ICU. Concrete recommendations and guidelines have been made for preparing appropriate ICT related tools and methods for improving the routine for use of medical devices, reporting and analyzing of the incidents at the ICU in order to reduce the number of undetected and unsolved incidents and thus improve the patient safety.
Abstract: Background: Seborrheic dermatitis is a common chronic skin condition affecting the face, scalp, chest, and trunk. The cause of seborrheic dermatitis is still unknown. Sebum production, lipid composition, hormone levels, and Malassezia species have been suggested as important factors in the development of seborrheic dermatitis. Curcuma aeruginosa Roxb. extract-containing cream with anti-inflammatory and anti-androgenic properties may be beneficial for treating mild to moderate facial seborrheic dermatitis. Objectives: We evaluated the efficacy and safety of 2% C. aeruginosa Roxb. extract-containing cream in the treatment of mild to moderate seborrheic dermatitis. Methods: This was a prospective, open-label, and non-comparative study. Ten adult patients clinically diagnosed with mild to moderate seborrheic dermatitis were enrolled in a four-week study. The 2% C. aeruginosa Roxb. cream was applied twice daily to a lesional area on the face for four weeks. The Scoring Index (SI) ranking system on days 14 and 28 was compared with that at baseline to determine the efficacy of treatment. The adverse events (burning sensation and erythema) were evaluated on days 14 and 28 to determine the safety of the treatment. Results: Significant improvement was observed in the reduction of the mean SI at day 14 (2.9) and 28 (1.4) compared to that at baseline (4.9). An adverse reaction was observed on day 14 (mild erythema 20% and mild burning sensation 10%) and was resolved by the end of the study. Conclusion: This open-label pilot study has shown that there was a significant improvement in the severity in these seborrheic patients and most reported they were satisfied with it. Reported adverse events were all mild.
Abstract: Introduction: The process to build a better safety
culture, methods of error analysis, and preventive measures, starts
with an understanding of the effects when human factors engineering
refer to remote microscopic diagnosis in surgery and specially in
organ transplantation for the remote evaluation of the grafts. It has
been estimated that even in well-organized transplant systems an
average of 8% to 14% of the grafts (G) that arrive at the recipient
hospitals may be considered as diseased, injured, damaged or
improper for transplantation. Digital microscopy adds information on
a microscopic level about the grafts in Organ Transplant (OT), and
may lead to a change in their management. Such a method will
reduce the possibility that a diseased G, will arrive at the recipient
hospital for implantation. Aim: Ergonomics of Digital Microscopy
(DM) based on virtual slides, on Telemedicine Systems (TS) for
Tele-Pathological (TPE) evaluation of the grafts (G) in organ
transplantation (OT). Material and Methods: By experimental
simulation, the ergonomics of DM for microscopic TPE of Renal
Graft (RG), Liver Graft (LG) and Pancreatic Graft (PG) tissues is
analyzed. In fact, this corresponded to the ergonomics of digital
microscopy for TPE in OT by applying Virtual Slide (VS) system for
graft tissue image capture, for remote diagnoses of possible
microscopic inflammatory and/or neoplastic lesions. Experimentation
included: a. Development of an OTE-TS similar Experimental
Telemedicine System (Exp.-TS), b. Simulation of the integration of
TS with the VS based microscopic TPE of RG, LG and PG applying
DM. Simulation of the DM based TPE was performed by 2
specialists on a total of 238 human Renal Graft (RG), 172 Liver Graft
(LG) and 108 Pancreatic Graft (PG) tissues digital microscopic
images for inflammatory and neoplastic lesions on four electronic
spaces of the four used TS. Results: Statistical analysis of specialist‘s
answers about the ability to diagnose accurately the diseased RG, LG
and PG tissues on the electronic space among four TS (A,B,C,D)
showed that DM on TS for TPE in OT is elaborated perfectly on the
ES of a Desktop, followed by the ES of the applied Exp.-TS. Tablet
and Mobile-Phone ES seem significantly risky for the application of
DM in OT (p
Abstract: Advances in the use of health care technology have
resulted in increased adverse events (AEs) related to the use of
medical devices. The study focused on the existing reporting systems.
This study was conducted in a tertiary care public sector hospital.
Devices included Syringe infusion pumps, Cardiac monitors, Pulse
oximeters, Ventilators and Defibrillators. A total of 211 respondents
were recruited. Interviews were held with 30 key informants. Medical
records were scrutinized. Relevant statistical tests were used.
Resident doctors reported maximum frequency of AEs, followed
by nurses; and least by consultants. A significant association was
found between the cadre of health care personnel and awareness that
the patients and bystanders have a risk of sustaining AE. Awareness
regarding reporting of AEs was low, and it was generally done
verbally. Other critical findings are discussed in the light of the
barriers to reporting, reasons for non-compliance, recording system,
and so on.
Abstract: The management of Helicobacter pylori (H. pylori)
eradication is still a matter of discussion, full effectiveness is rarely
achieved, and it has many adverse effects. The use of probiotics may
be associated with better eradication rates and possibly prevention of
adverse events due to antibiotic therapy. The present clinical study
was undertaken to evaluate the efficacy of a specially designed
fermented milk product, containing Bifidobacterium lactis B420, on
the eradication of H. pylori infection in a prospective, randomized,
double-blind, controlled study in humans. Four test fermented milks
(FM) were specially designed in which counts of viable cells in all
products were 10^10 Log CFU. 100 mL-1 for Bifidobacterium lactis -
Bifidobacterium species 420. 190 subjects infected with H. pylori,
with previous diagnosis of functional dyspepsia according to Rome
III criteria entered the study. Bifidobacterium lactis B420,
administered twice a day for 90 days was not able to eradicate H.
pylori in Brazilian patients with functional dyspepsia.
Abstract: Background and aim: It has not been well studied
whether fentanyl-thiopental (FT) is effective and safe for PSA in
orthopedic procedures in Emergency Department (ED). The aim of
this trial was to evaluate the effectiveness of intravenous FT versus
fentanyl-midazolam (FM) in patients who suffered from shoulder
dislocation or distal radial fracture-dislocation.
Methods: In this randomized double-blinded study, Seventy-six
eligible patients were entered the study and randomly received
intravenous FT or FM. The success rate, onset of action and recovery
time, pain score, physicians’ satisfaction and adverse events were
assessed and recorded by treating emergency physicians. The
statistical analysis was intention to treat.
Results: The success rate after administrating loading dose in FT
group was significantly higher than FM group (71.7% vs. 48.9%,
p=0.04); however, the ultimate unsuccessful rate after 3 doses of
drugs in the FT group was higher than the FM group (3 to 1) but it
did not reach to significant level (p=0.61). Despite near equal onset
of action time in two study group (P=0.464), the recovery period in
patients receiving FT was markedly shorter than FM group
(P