scholarly journals Ticking time bomb: Poorly managed product safety

1969 ◽  
Vol 12 (4) ◽  
Author(s):  
Greg Meline ◽  
Chris Albani
Keyword(s):  
Medical Devices ◽  
Safety Management ◽  
Safety Data ◽  
Pharmaceutical Products ◽  
Data Handling ◽  
Safety Issues ◽  
Handling Practices ◽  
High Level ◽  
A Company

A key paradigm of the pharmaceutical industry has changed. With increased attention towards ensuring the safety of drugs and medical devices, the ability of firms to conduct risk management based on high-quality pharmacovigilance (PV) – starting early on in clinical development – is becoming increasingly important to the successful marketing of pharmaceutical products. Indeed, the repercussions of recent litigation regarding the Cox-II class of compounds are just an example of how safety management will continue to impact the marketability of both existing and future drugs and medical devices. Firms without satisfactory safety data handling and reporting operations in place are now vulnerable to significant business risks with potential long-term drug safety issues. While this has often been considered a necessity, a small proportion of companies have actively pursued excellence in this area. Companies are taking different approaches to address the increasing demands in this area – from focusing on efficiency to driving higher levels of rigorousness in their PV practices. PRTM various has identified a number of key practices common among firms demonstrating excellence within PV. Results of a pioneering study of 23 top Western and Japanese pharmaceutical companies confirm that, overall, the industry has yet to achieve both a high-level of quality and productivity in firms' PV operations. As the burden for conducting efficient, effective PV becomes increasingly difficult, senior management will seek targeted improvement strategies in order to balance a high level of efficiency with a high level of rigorousness among their safety data handling practices. With this in mind, this article seeks to demonstrate how a company can most effectively comply with ever-changing requirements, strategically improve the thoroughness of the practices within their PV operations and achieve greater efficiency. In addressing these challenges, top management will be focusing a greater amount of attention on one more thing – pharmacovigilance.

Best data handling practices in water-related research

2013 ◽  
Vol 8 (3-4) ◽  
pp. 390-398
Author(s):  
H. Sonnenberg ◽  
M. Rustler ◽  
M. Riechel ◽  
N. Caradot ◽  
P. Rouault ◽  
...  
Keyword(s):  
Data Collection ◽  
Data Processing ◽  
Point Of View ◽  
Data Handling ◽  
Quality Of Data ◽  
Related Research ◽  
Long Run ◽  
Handling Practices

Data play an important role in water-related research. Based on experiences in data collection and data processing in water-related research this paper proposes – both from a computer scientist's and an environmental engineer's point of view – a set of rules for data handling: Rule 1: Protect raw data; Rule 2: Save metadata; Rule 3: Use databases; Rule 4: Separate data from processing; Rule 5: Use programming; Rule 6: Avoid redundancy; Rule 7: Be transparent; Rule 8: Use standards and naming conventions. Applying these rules (i) increases the quality of data and results, (ii) allows to prepare data for long-term usage and make data accessible to different people, (iii) makes data processing transparent and results reproducible, and (iv) saves – at least in the long run – time and effort. With this contribution the authors would like to start a discussion about best data handling practices and present a first checklist of data handling and data processing for practitioners and researchers working in the water sector.

scholarly journals ANALISIS TERHADAP PERMASALAHAN HUKUM PENGUASAAN TANAH DENGAN HAK GUNA USAHA DI KALIMANTAN (STUDI PUTUSAN: PUTUSAN MAHKAMAH AGUNG NOMOR 121 K/TUN/2017)

2019 ◽  
Vol 2 (2) ◽  
pp. 1266
Author(s):  
Nadhil Rifqi Izhhar ◽  
Hasni Hasni
Keyword(s):  
Oil Palm ◽  
Agricultural Land ◽  
Forest Damage ◽  
District Government ◽  
The Republic ◽  
High Level ◽  
The Village ◽  
A Company

The law of the land Indonesia in the act of no. 5 1960 basic provisions concerning this agrarian law based on article 33 paragraph 3 constitution of the Republic of Indonesia 1945. In long-term development the role of land to meet various purposes will increase, good as a live and for business activities.  The high level of demand will ground , present us on various problems quaint and still unsolved in an unsatisfactory manner for all parties. Usage rights business have had the use as agricultural land, fisheries, or farmers usage rights a business are also was in directly controlled by the state with a term 25 years or 35 years old and if necessary it could be prolonged 25 years, the broad at least usage rights business at least 5 acres. The various kinds of problems land around land and land together have a Cultivation Rights Title itself such a delicate and complicated it feels conflict land that is just keep on coming from the opening of the land and forest , damage to the customary overlapping permission and many other conflict certain harming other parties. The results of the investigations and analysis Forest Watch Indonesia has indicated the occurrence of violations of related to the licensing of some companies by the district government Long Bentuq area. Forest watch indonesia found the existence of overlapping permission between companies the oil palm with a company from various sectors which are all active operating in the same location but it happened to the forest customary, eviction cemetery land and sengon and cocoa plantations belonging to society is in the village Long Bentuq. The approach used by the writer among others is the approach comparative and law.

scholarly journals Research of safety management indicators

2020 ◽  
Vol 8 ◽  
pp. 552-557
Author(s):  
Zdeněk Dvořák ◽  
Nikola Chovančíková
Keyword(s):  
Safety Management ◽  
Environmental Safety ◽  
City Region ◽  
Safety Issues ◽  
Effective Evaluation ◽  
Management Indicators ◽  
Safety And Health ◽  
Operational Safety ◽  
Security Information

Safety is one of the basic needs of every citizen, company, city, region, and state. Long-term solutions to safety issues have brought 6 pillars to this area (ie physical security, fire safety, safety and health at work, environmental safety and security, operational safety and security, information security). The mentioned safety/security pillars comprehensively cover the area of safety within the company, region, etc. In today's society, it is necessary to focus on the effective evaluation of individual pillars of safety/security. By evaluating them, it is possible to identify places with deficiencies that may be sources of risk in the future. Sources of risk could be identified through a tool that could comprehensively assess all pillars. The result of the evaluation would be the level of safety of the evaluated pillar. Depending on the level of the safety pillar, adequate measures could be taken to address the shortcomings.

Xerostomia

2021 ◽  
pp. 60-107
Keyword(s):  
Medical Devices ◽  
Treatment Guidelines ◽  
Treatment Options ◽  
Nutritional Deficiencies ◽  
Menopausal Women ◽  
Standard Treatment Guidelines ◽  
High Level ◽  
Systemic Agents ◽  
Common Manifestation

Xerostomia is most commonly observed in patients treated with certain medications, those subjected to radiotherapy of the head and neck, or in individuals with Sjogren's syndrome. Although it mostly affects geriatric patients, xerostomia can be also observed in young individuals. This condition not only results from the physiological process of aging but is also associated with the number and type of medications administered in the treatment of various systemic conditions. Xerostomia is also a common manifestation in menopausal women due to estrogen deficiency. If it remains untreated, xerostomia can lead to nutritional deficiencies, decreased mood, and finally, depression. Treatment is long-term and requires a high level of patient motivation. Although no standard treatment guidelines are available, many treatment options exist: topical agents to alleviate and/or prevent xerostomia, systemic therapy, or newer devices. While systemic agents (pilocarpine or cevimeline) have been largely studied, new medical devices require large well-designed clinical trials.

Vivid Imagers Are Better at Detecting Salient Changes

2006 ◽  
Vol 27 (4) ◽  
pp. 218-228 ◽  
Author(s):  
Paul Rodway ◽  
Karen Gillies ◽  
Astrid Schepman
Keyword(s):  
Individual Differences ◽  
Change Detection ◽  
Visual Imagery ◽  
Detection Task ◽  
Level Of Detail ◽  
Detection Accuracy ◽  
Change Detection Task ◽  
Term Change ◽  
High Level

This study examined whether individual differences in the vividness of visual imagery influenced performance on a novel long-term change detection task. Participants were presented with a sequence of pictures, with each picture and its title displayed for 17  s, and then presented with changed or unchanged versions of those pictures and asked to detect whether the picture had been changed. Cuing the retrieval of the picture's image, by presenting the picture's title before the arrival of the changed picture, facilitated change detection accuracy. This suggests that the retrieval of the picture's representation immunizes it against overwriting by the arrival of the changed picture. The high and low vividness participants did not differ in overall levels of change detection accuracy. However, in replication of Gur and Hilgard (1975) , high vividness participants were significantly more accurate at detecting salient changes to pictures compared to low vividness participants. The results suggest that vivid images are not characterised by a high level of detail and that vivid imagery enhances memory for the salient aspects of a scene but not all of the details of a scene. Possible causes of this difference, and how they may lead to an understanding of individual differences in change detection, are considered.

BIM-Based Quality Control for Safety Issues in the Design and Construction Phases

2015 ◽  
Vol 9 (3) ◽  
pp. 111 ◽  
Author(s):  
Seunghwa Park ◽  
Inhan Kim
Keyword(s):  
Decision Making ◽  
Traditional Method ◽  
Building Information Modeling ◽  
Safety Management ◽  
Information Modeling ◽  
Use Case ◽  
Safety Issues ◽  
Building Information ◽  
Building Safety

Today’s buildings are getting larger and more complex. As a result, the traditional method of manually checking the design of a building is no longer efficient since such a process is time-consuming and laborious. It is becoming increasingly important to establish and automate processes for checking the quality of buildings. By automatically checking whether buildings satisfy requirements, Building Information Modeling (BIM) allows for rapid decision-making and evaluation. In this context, the work presented here focuses on resolving building safety issues via a proposed BIM-based quality checking process. Through the use case studies, the efficiency and usability of the devised strategy is evaluated. This research can be beneficial in promoting the efficient use of BIM-based communication and collaboration among the project party concerned for improving safety management. In addition, the work presented here has the potential to expand research efforts in BIM-based quality checking processes.

Methodical approaches to managing economic safety of tourism enterprises

2020 ◽  
pp. 160-164
Author(s):  
Leonid Tsubov ◽  
Oresta Shcherban
Keyword(s):  
Safety Management ◽  
Integrated Approach ◽  
Small Enterprise ◽  
Complex Nature ◽  
Efficient Management ◽  
Tourism Enterprises ◽  
High Level ◽  
Functional Components ◽  
Stimulation Control

The set of scientific-methodological tools to secure the mechanism of economic safety management of tourism entrepreneurship is examined as an aggregate of methods, tools, and conceptual activities directed at maintaining the high level of economic safety of tourism entrepreneurship. The features of managing the tourism enterprise and economic safety are analyzed. The basic valuation principles of the reliability and efficiency of the economic safety of the tourism enterprise are determined. The basic tasks of ensuring the economic safety of a small enterprise are outlined. The need to use the integrated approach that secures more opportunities to avoid threats and limits the danger of their emergence is emphasized. The most important principles for securing the economic safety of the tourism enterprise on the microeconomic level are described. Possible practical methods of risk management for the implementation of adopted decisions are proposed. The paper proves the fact that the complex nature of the management of the economic safety of the tourism enterprise and securing the sufficiently efficient management system of detecting and eliminating the threats are provided by the establishment of the management of the economic safety system of the tourism enterprise and its functional components. Research of the methodical approaches to the management of the tourism enterprises’ economic safety allows building and describing the functional structure of the mechanism of management of the tourist enterprise’s economic safety (it is formalized and described by 5 functions: determination of aims; planning; organization and adjusting; motivation and stimulation; control and monitoring).

scholarly journals Surface Immobilization of Nano-Silver on Polymeric Medical Devices to Prevent Bacterial Biofilm Formation

Pathogens ◽  
2019 ◽  
Vol 8 (3) ◽  
pp. 93 ◽  
Author(s):  
Riau ◽  
Aung ◽  
Setiawan ◽  
Yang ◽  
Yam ◽  
...  
Keyword(s):  
Medical Devices ◽  
Biofilm Formation ◽  
Culture Media ◽  
Silver Ions ◽  
Bacterial Biofilm ◽  
Surface Immobilization ◽  
Nano Silver ◽  
Gram Positive Bacteria ◽  
Tissue Microenvironment

: Bacterial biofilm on medical devices is difficult to eradicate. Many have capitalized the anti-infective capability of silver ions (Ag+) by incorporating nano-silver (nAg) in a biodegradable coating, which is then laid on polymeric medical devices. However, such coating can be subjected to premature dissolution, particularly in harsh diseased tissue microenvironment, leading to rapid nAg clearance. It stands to reason that impregnating nAg directly onto the device, at the surface, is a more ideal solution. We tested this concept for a corneal prosthesis by immobilizing nAg and nano-hydroxyapatite (nHAp) on poly(methyl methacrylate), and tested its biocompatibility with human stromal cells and antimicrobial performance against biofilm-forming pathogens, Pseudomonas aeruginosa and Staphylococcus aureus. Three different dual-functionalized substrates—high Ag (referred to as 75:25 HAp:Ag); intermediate Ag (95:5 HAp:Ag); and low Ag (99:1 HAp:Ag) were studied. The 75:25 HAp:Ag was effective in inhibiting biofilm formation, but was cytotoxic. The 95:5 HAp:Ag showed the best selectivity among the three substrates; it prevented biofilm formation of both pathogens and had excellent biocompatibility. The coating was also effective in eliminating non-adherent bacteria in the culture media. However, a 28-day incubation in artificial tear fluid revealed a ~40% reduction in Ag+ release, compared to freshly-coated substrates. The reduction affected the inhibition of S. aureus growth, but not the P. aeruginosa. Our findings suggest that Ag+ released from surface-immobilized nAg diminishes over time and becomes less effective in suppressing biofilm formation of Gram-positive bacteria, such as S. aureus. This advocates the coating, more as a protection against perioperative and early postoperative infections, and less as a long-term preventive solution.

Pooling Raw Shell Eggs: Salmonella Contamination and High Risk Practices in the United Kingdom Food Service Sector

2010 ◽  
Vol 73 (3) ◽  
pp. 574-578 ◽  
Author(s):  
F. J. GORMLEY ◽  
C. L. LITTLE ◽  
N. MURPHY ◽  
E. de PINNA ◽  
J. MCLAUCHLIN
Keyword(s):  
United Kingdom ◽  
Food Safety ◽  
High Risk ◽  
Service Sector ◽  
Safety Management ◽  
Food Service ◽  
Control Measures ◽  
Hygiene Practices ◽  
Risk Practices ◽  
Handling Practices

Salmonella contamination of pooled raw shelled egg mix (RSEM) used as an ingredient in lightly cooked or uncooked foods and high-risk kitchen hygiene practices in United Kingdom food service establishments using RSEM were investigated. Samples were collected from 934 premises. Salmonella was found in 1 (0.13%) of 764 RSEM samples, 2 (0.3%) of 726 samples from surfaces where ready-to-eat foods were prepared, and 7 (1.3%) of 550 cleaning cloths. Poor RSEM storage and handling practices were highlighted. Workers in 40% of the premises sampled failed to use designated utensils when RSEM was added to other ingredients, workers in 17% of the premises did not clean surfaces and utensils thoroughly after use with RSEM and before preparing other foods, only 42% of workers washed and dried their hands after handling eggs or RSEM, workers in 41% of the premises did not store RSEM at refrigeration temperature before use, and workers in 8% of the premises added RSEM to cooked rice at the end of cooking when preparing egg fried rice. Take-away premises, especially those serving Chinese cuisine, were least likely to have a documented food safety management system and awareness of the key food safety points concerning the use of RSEM compared with other food service premises (P < 0.0001). Food service businesses using RSEM must be aware of the continuing hazard from Salmonella, must adopt appropriate control measures, and must follow advice provided by national food agencies to reduce the risk of Salmonella infection.

scholarly journals Review on Perioperative and Oncological Outcomes of Robotic Gastrectomy for Cancer

2021 ◽  
Vol 11 (7) ◽  
pp. 638
Author(s):  
Giuseppe Giuliani ◽  
Francesco Guerra ◽  
Lorenzo De Franco ◽  
Lucia Salvischiani ◽  
Roberto Benigni ◽  
...  
Keyword(s):  
English Language ◽  
Length Of Hospital Stay ◽  
Radical Gastrectomy ◽  
Robotic Gastrectomy ◽  
Relevant Evidence ◽  
Relative Paucity ◽  
Duration Of Surgery ◽  
High Level ◽  
Standard Laparoscopic Surgery

Background. Minimally invasive gastrectomy is currently considered a valid option to treat gastric cancer and is gaining increasing acceptance. Recent reports have suggested that the application of robots may confer some advantages over conventional laparoscopy, but the role of robotic surgery in clinical practice is still uncertain. We aimed to critically review the relevant evidence comparing robotic to standard laparoscopic surgery in performing radical gastrectomy. Methods. The Pubmed/Medline electronic databases were searched through February 2021. Paper conference and the English language was the only restriction applied to our search strategy. Results. According to the existing data, robotic gastrectomy seems to provide some benefits in terms of blood loss, rate of conversion, procedure-specific postoperative morbidity, and length of hospital stay. Robotic gastrectomy is also associated with a longer duration of surgery and a higher economic burden as compared to its laparoscopic counterpart. No significant differences have been disclosed in terms of long-term survivals, while the number of lymph nodes retrieved with robotic gastrectomy is generally higher than that of laparoscopy. Conclusions. The current literature suggests that robotic radical gastrectomy appears as competent as the conventional laparoscopic procedure and may provide some clinical advantages. However, due to the relative paucity of high-level evidence, it is not possible to draw definitive conclusions.

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