scholarly journals Evaluating the Presence of Software-as-a-Medical-Device in the Australian Therapeutic Goods Register

Prosthesis ◽  
2021 ◽  
Vol 3 (3) ◽  
pp. 221-228
Author(s):  
Aaron Ceross ◽  
Jeroen Bergmann
Keyword(s):  
Adverse Events ◽  
Medical Device ◽  
Descriptive Analysis ◽  
Positive Trend ◽  
Significant Positive Trend ◽  
Distinct Subgroup ◽  
Global Challenges ◽  
Regulatory Bodies ◽  
Fit For Purpose ◽  
Digital Healthcare

In recent years, medical device regulatory bodies have recognised software-as-a-medical-device (SaMD) as a distinct subgroup of devices. The field of SaMD has been rapidly evolving and encompasses a range of different digital solutions. Many organisations have now started to look into digital healthcare, as a way to solve key global challenges. However, there remains uncertainty regarding how many of these SaMD products are entering the market and to what extent these systems achieve a desired level of general safety once they are in the market. In this study, we utilise data collected from publicly available databases. The data are evaluated for trends and a descriptive analysis is performed of the recall and adverse events associated specifically with SaMD. We find that there is a significant positive trend (p < 0.05) of SaMD registrations, although the number of SaMD registrations remains relative low compared to non-SaMD. This rise in SaMD registrations coincides with increasing levels of recalls and adverse events. More importantly, it becomes apparent that adverse events notification is not yet fit for purpose with regards to SaMD.

scholarly journals Penentuan Klaster Wilayah Kecamatan Berdasarkan Pusat Pelayanan Masyarakat di Wilayah Kepulauan Kabupaten Maluku Tengah Provinsi Maluku

2021 ◽  
Vol 7 (3) ◽  
pp. 314-325
Author(s):  
Ilham Marasabessy ◽  
Abdullah Marasabessy ◽  
Oki Nurul Asma Tualeka ◽  
Desmi Insu Tualeka
Keyword(s):  
Descriptive Analysis ◽  
Survey Method ◽  
Positive Trend ◽  
Quantitative Descriptive Analysis ◽  
Centrality Index ◽  
Banda Islands ◽  
Regional Service ◽  
Quantitative Descriptive ◽  
Centrality Analysis ◽  
Regional Development Bank

The connectivity of a region is an indicator the growth of service centers. Community service is carried out with a team from PT. Maluku and North Maluku Regional Development Bank Central Maluku Branch during 2018. Data were collected in 18 districts in Central Maluku Regency through the Rapid Survey Method for regional potential and socio-economic dynamics of the community. Central Maluku Regency BPS data support 2018 is a complementary input in the centrality analysis. The data were processed using quantitative descriptive analysis using Guttman scale/Marshall Centrality Index and spatial analysis tools using ArcmapGIS 10.3.1 software, to obtain a map of the regional service center. Central Maluku Regency is an archipelago, having district clusters spread over Seram Island, Ambon, Lease Islands and Banda. The district cluster is divided into 4 regions with the highest level of regional service being in Amahei District (11.14) and the lowest in Nusa Laut (2.50). Economic growth in sub-districts in the archipelago experienced a positive trend, concentrated on Ambon Island and Banda Islands, while the Lease Islands centrality index was in the lower middle category.

scholarly journals Analysis of Development of Archiving Regulation from Time to Time in Indonesia

2019 ◽  
Vol 5 (1) ◽  
pp. 90
Author(s):  
Rhoni Rodin
Keyword(s):  
Descriptive Analysis ◽  
Positive Trend ◽  
Literature Study ◽  
Reform Era ◽  
Colonial Era ◽  
Dutch Colonial

Background of the study: This research belongs to the literature study since it is carried out by exploring information and documentation relating to archiving regulationsPurpose: This study aims to analyze the development of archiving regulations in Indonesia from time to time.Method: Analyzing data using descriptive analysis methods.Findings: The results showed that the development of archiving regulations in Indonesia showed a positive trend, as this was shown by the issuance of several regulations relating to archival issues from the Dutch colonial era and the independence of Indonesia in 1945 up until the issuance of Law No. 43 of 2009 during the reform era recently.Conclusion: All archiving laws or regulations are basically for the existence of archives and archives very important for society, government and the Indonesian Nation.

scholarly journals Methods for measuring venous peripherally inserted central catheters in newborns

2022 ◽  
Vol 75 (2) ◽  
Author(s):  
Andreia Tomazoni ◽  
Patrícia Kuerten Rocha ◽  
Mavilde da Luz Gonçalves Pedreira ◽  
Elisa da Conceição Rodrigues ◽  
Bruna Figueiredo Manzo ◽  
...  
Keyword(s):  
Adverse Events ◽  
Neonatal Intensive Care ◽  
Descriptive Analysis ◽  
Institutional Review Board ◽  
Central Catheter ◽  
Peripherally Inserted Central Catheters ◽  
Institutional Review ◽  
Significant Difference ◽  
Catheter Tip ◽  
Central Catheters

ABSTRACT Objective: to analyze the results of insertion procedures of Peripherally Inserted Central Catheters in newborns using two measurement methods. Methods: this is a randomized clinical trial, presenting descriptive and exploratory results of variables. It was held at a Neonatal Intensive Care Unit. Data were collected between September 2018 and 2019. The sample analyzed was 88 catheter insertion procedures, distributed in two groups. Study approved by an Institutional Review Board and obtained registration in the country and abroad. Descriptive analysis and logistic regression of data. Results: modified measurement obtained a significant difference for the central catheter tip location. Elective removals and adverse events were not significant between groups; however, poor positioning was related to adverse events. Conclusions: between the two methods analyzed, the modified measurement obtained better results in the proper catheter tip positioning and, consequently, less risk to patients.

scholarly journals Are Regulations Safe? Reflections From Developing a Digital Cancer Decision-Support Tool

2021 ◽  
pp. 353-363
Author(s):  
Ciarán D. McInerney ◽  
Beverly C. Scott ◽  
Owen A. Johnson
Keyword(s):  
Risk Assessment ◽  
Primary Care ◽  
Patient Safety ◽  
Medical Device ◽  
Assessment Tool ◽  
Risk Assessment Tool ◽  
Cancer Risk Assessment ◽  
The European Union ◽  
Standards And Regulations ◽  
Fit For Purpose

PURPOSE Informatics solutions to early diagnosis of cancer in primary care are increasingly prevalent, but it is not clear whether existing and planned standards and regulations sufficiently address patients' safety nor whether these standards are fit for purpose. We use a patient safety perspective to reflect on the development of a computerized cancer risk assessment tool embedded within a UK primary care electronic health record system. METHODS We developed a computerized version of the CAncer Prevention in ExetER studies risk assessment tool, in compliance with the European Union's Medical Device Regulations. The process of building this tool afforded an opportunity to reflect on clinical concerns and whether current regulations for medical devices are fit for purpose. We identified concerns for patient safety and developed nine practical recommendations to mitigate these concerns. RESULTS We noted that medical device regulations (1) were initially created for hardware devices rather than software, (2) offer one-shot approval rather than supporting iterative innovation and learning, (3) are biased toward loss-transfer approaches that attempt to manage the fallout of harm instead of mitigating hazards becoming harmful, and (4) are biased toward known hazards, despite unknown hazards being an expected consequence of health care as a complex adaptive system. Our nine recommendations focus on embedding less-reductionist and stronger system perspectives into regulations and standards. CONCLUSION Our intention is to share our experience to support research-led collaborative development of health informatics solutions in cancer. We argue that regulations in the European Union do not sufficiently address the complexity of healthcare information systems with consequences for patient safety. Future standards and regulations should continue to follow a system-based approach to risk, safety, and accident avoidance.

Real-world risk of anosmia with cancer directed systemic therapy: A pharmacovigilance assessment using FDA Adverse Events Reporting System (FAERS) database.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18790-e18790
Author(s):  
Anahat Kaur ◽  
Shuai Wang ◽  
Arlene Yu ◽  
Tarek N. Elrafei ◽  
Lewis Steinberg ◽  
...  
Keyword(s):  
Adverse Events ◽  
Reporting System ◽  
Case Reports ◽  
Descriptive Analysis ◽  
Package Insert ◽  
Case Series ◽  
The United States ◽  
Chemotherapeutic Agents ◽  
United States Food ◽  
Pharmacovigilance Database

e18790 Background: Anosmia is a rare and under-reported adverse event associated with the use of several oncologic drugs. Instances of olfactory disturbances following administration of chemotherapeutic agents have been sporadically documented in case reports and case series. We aimed to conduct a more comprehensive study to generate signal for anosmia as adverse effect of drugs used for oncologic indications. Methods: The United States Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) database, a pharmacovigilance database, was used to extract data. All reported cases of anosmia in the database were filtered for an indication of cancer. Descriptive analysis was conducted using SPSS 26. Results: Total 10250 cases of anosmia were extracted from FAERS database. Out of these, cancer as an indication for medication use was noted in 139 cases. Some of the most common suspect medications exclusively associated with more than one case of anosmia were palbociclib (n=16), enzalutamide (13), pazopanib (8), cabozantinib (8), letrozole (6), leuprolide (5), niraparib (5), rucaparib (4), tamoxifen (4), capecitabine (3), everolimus (3), anastrazole (2), exemestane (2), zoledronic acid (2), vandetanib (2) and vismodegib (2). Detailed description of medications with highest number of reported cases is listed in Table. Median age at diagnosis was 66 years (interquartile range 58-71). Anosmia was reported more commonly in females (64% ) as compared to males (33.8%). Reactions were reported to the FDA more commonly by consumers (56.8%) as compared to healthcare professionals (40.3% cases). Out of 139 patients with anosmia, 93 (66.9%) had concomitant ageusia, 8 (5.7 %) had dysgeusia and 6 (4.3%) patients had neuropathy. Conclusions: This study demonstrates a signal for anosmia as side effect in patients receiving select oncologic medications based on the FAERS database. It is worth noting that none of the suspect medications identified in this study have anosmia listed as known adverse reaction on accompanying package insert. Further studies need to be conducted to confirm if causal relationship exists between use of these drugs and olfactory function compromise. [Table: see text]

scholarly journals An Analysis of FDA Adverse Event Reporting Data for Trends in Medical Device Use Error

2020 ◽  
Vol 9 (1) ◽  
pp. 130-134
Author(s):  
Benjamin M. Knisely ◽  
Camille Levine ◽  
Kush C. Kharod ◽  
Monifa Vaughn-Cooke
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Medical Device ◽  
Medical Devices ◽  
Product Life Cycle ◽  
Risk Mitigation ◽  
Adverse Event Reporting ◽  
Mitigation Strategies ◽  
Event Reporting ◽  
Device Use

Humans can contribute to error at all stages of the medical device product life-cycle. Use error associated with medical devices can result in catastrophic consequences for end users and inefficient use of healthcare system resources. Industry-wide statistics about medical device use error has the potential to aid in identifying opportunities for human factors intervention, however publicly available statistics are sparse. The Food and Drug Administration (FDA) requires medical device manufactures, importers, and device user facilities to track and report adverse events for post-market surveillance through medical device reports (MDRs). This data is available in an online database: Manufacturer and User Facility Experience (MAUDE). This study provides a comprehensive evaluation of use error adverse events in MAUDE (2010-2018) based on device class, device operator, and event outcome, to address the lack of industry-wide statistics on medical device use error. Results indicate that use error is significantly represented in adverse event reporting, constituting 28.1% of reports labeled with device problem codes. Events associated with patient device operators were predominately associated with diabetes-related medical devices, while provider operators were associated with a wider array of devices. Additionally, it was found that most use error reports were attributed to issues with device output; using the device in accordance with manufacturer expectations; and physically activating, positioning, or separating device components. This work demonstrates the viability of using MAUDE to attain industry wide statistics on medical device use error for later integration in industry-wide or device-specific risk mitigation strategies.

scholarly journals Estimates of Medical Device-Associated Adverse Events

2006 ◽  
Vol 163 (suppl_11) ◽  
pp. S171-S171
Author(s):  
B Hefflin ◽  
T Gross ◽  
T Schroeder
Keyword(s):  
Adverse Events ◽  
Medical Device

scholarly journals The Greening and Wetting of the Sahel Have Leveled off since about 1999 in Relation to SST

2020 ◽  
Vol 12 (17) ◽  
pp. 2723
Author(s):  
Tiexi Chen ◽  
Shengjie Zhou ◽  
Chuanzhuang Liang ◽  
Daniel Fiifi Tawia Hagan ◽  
Ning Zeng ◽  
...  
Keyword(s):  
Piecewise Linear ◽  
Vegetation Indices ◽  
Positive Trend ◽  
Causality Analysis ◽  
Area Index ◽  
Piecewise Linear Regression ◽  
Significant Positive Trend ◽  
Tropical Oceans ◽  
Regression Approach

The Sahel, a semi-arid climatic zone with highly seasonal and erratic rainfall, experienced severe droughts in the 1970s and 1980s. Based on remote sensing vegetation indices since early 1980, a clear greening trend is found, which can be attributed to the recovery of contemporaneous precipitation. Here, we present an analysis using long-term leaf area index (LAI), precipitation, and sea surface temperature (SST) records to investigate their trends and relationships. LAI and precipitation show a significant positive trend between 1982 and 2016, at 1.72 × 10 −3 yr −1 (p < 0.01) and 4.63 mm yr−1 (p < 0.01), respectively. However, a piecewise linear regression approach indicates that the trends in both LAI and precipitation are not continuous throughout the 35 year period. In fact, both the greening and wetting of the Sahel have been leveled off (pause of rapid growth) since about 1999. The trends of LAI and precipitation between 1982 and 1999 and 1999–2016 are 4.25 × 10 − 3 yr −1 to − 0.27 × 10 −3 yr −1, and 9.72 mm yr −1 to 2.17 mm yr −1, respectively. These declines in trends are further investigated using an SST index, which is composed of the SSTs of the Mediterranean Sea, the subtropical North Atlantic, and the global tropical oceans. Causality analysis based on information flow theory affirms this precipitation stabilization between 2003 and 2014. Our results highlight that both the greening and the wetting of the Sahel have been leveled off, a feature that was previously hidden in the apparent long-lasting greening and wetting records since the extreme low values in the 1980s.

scholarly journals DESCRIPTIVE ANALYSIS OF QUALITY OF INFORMATION OF DRUGS ON ANDROID-BASED INDIAN ONLINE PHARMACY APPLICATIONS: A PRELIMINARY ANALYSIS

2020 ◽  
pp. 93-96
Author(s):  
SHAIKH SANA PERVEEN ◽  
SHWETA SURVE ◽  
NERURKAR RP
Keyword(s):  
Adverse Events ◽  
Descriptive Analysis ◽  
Medical Specialties ◽  
Flesch Reading Ease ◽  
Android Apps ◽  
Related Information ◽  
Online Pharmacy ◽  
Barriers To Access ◽  
Ease Score

Objectives: The objectives of the study were as follows: 1) To analyze the completeness of drug-related information of various Indian pharmacy online android applications and its readability. 2)To analyze the ease of availability of drugs and barriers to access them on these apps. Methods: A total of five popular pharmacy android apps in India (1mg, Netmeds, MedPlus, Pharmeasy, and Medikova) were chosen to analyze the prescribing information (PI) regarding five drugs, metformin, atenolol, ranitidine, ibuprofen, and alprazolam. Display of PI in these apps was compared with standard sources, i.e., National Formulary of India, Current Index of Medical Specialties, and package inserts of respective drugs. Drug-related information under 11 categories (indication, dose, contraindications, adverse events, etc.) was analyzed in these apps as complete/ incomplete. Readability of information was assessed using Flesch Reading Ease Score (FRES). These five drugs were ordered from all the apps to know the exact process to access them. Results: Categories such as indication and dose were mentioned in most apps. While, precautions and adverse events were given for few drugs in few apps. Least score was for categories like precautions in special population. FRES was minimum in Pharmeasy (30.82) and maximum in MedPlus (70.51). Valid prescriptions were demanded by all apps while one app had the facility of providing prescription from their own consultant. Only one app provided “Ask a Pharmacist” option. Conclusion: We found lots of inconsistency in the information provided by these apps. Our results are based on only five apps and provide a framework for future studies to scrutinize online apps.

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