scholarly journals A Descriptive Analysis of Capsule Endoscopy Events in the FDA Manufacturer and User Facility Device Experience (MAUDE) Database

2021 ◽  
Vol 12 (02) ◽  
pp. 071-077
Author(s):  
Hangyu Ji ◽  
Shaoli Wang ◽  
Yang Gong
Keyword(s):  
Patient Safety ◽  
Medical Device ◽  
Capsule Endoscopy ◽  
Descriptive Analysis ◽  
Brand Names ◽  
Capsule Endoscope ◽  
Narrative Texts ◽  
Search Terms ◽  
Patency Capsule ◽  
User Facility

Abstract Introduction The malfunction of capsule endoscopy (CE) devices is a significant reason for the failure of CE procedures, which could hinder and prevent diagnosis. Unfortunately, malfunction-related adverse events (AEs) caused by CE devices are rarely reported in publications. Although most malfunction-related AEs could not lead to physical harm, they could reduce the efficiency of medical care and increase medical costs. The manufacturer and user facility device experience (MAUDE) database, a publicly accessible resource for patient safety, contains not only the common complications of CE but also valuable malfunction-related AEs, which have been underutilized. Therefore, the study aims to discover and analyze the possible AEs associated with CE and demonstrate the utility of the MAUDE reports to promote patient safety. Materials and Methods We acquired MAUDE reports of CE systems from January 01, 2008, to July 31, 2020, through a systematic search strategy. We utilized the manufacturers, brand names, and product codes as search terms from which medical device reports including structured data and narrative texts were extracted, followed by a manual review of the narrative texts, reporter occupation, device involved, event type and the phase of the event; finally, patient outcomes were recorded and analyzed as per CE categories and characteristics. Results A total of 377 CEs medical device reports were retrieved, and 342 reports were included after reviewing. There were 327 mandatory reports (96%) and 15 voluntary reports (4%). These reports referred to capsule endoscope (n = 213), sensing system (n = 66), patency capsule (n = 38), and capsule delivery device (n = 26). A total of 349 CE-related AEs were identified, including complications (n = 228), malfunction-related AEs (n = 109), and other events (n = 12). The composition of AEs was not the same for the CE devices. Complications were major AEs of capsule endoscope and patency capsule, but malfunction-related AEs were the most common in AEs of sensing systems and capsule delivery devices. Conclusion MAUDE serves as an invaluable data source for investigating malfunction-related AEs. In addition to common complications, malfunction of CE devices could threaten patient safety in CE procedures. Improving awareness of the malfunction of CE devices and raising adequate training for staff working in gastrointestinal (GI) endoscopic units could be critical and beneficial in preventing malfunction-related AEs.

scholarly journals The Impact of COVID-19 on Medical Device Reporting and Investigation

2021 ◽  
pp. 28-35
Author(s):  
Zoe Pruitt ◽  
Christian Boxley ◽  
Seth Krevat ◽  
Srijan Sengupta ◽  
Raj Ratwani ◽  
...  
Keyword(s):  
Patient Safety ◽  
Medical Device ◽  
Medical Devices ◽  
Current Time ◽  
Safety Issues ◽  
User Facility ◽  
Future Harm ◽  
Clinically Significant ◽  
The Impact ◽  
The U.S

Introduction The Manufacturer and User Facility Device Experience (MAUDE) database houses medical device reports submitted to the U.S. Food and Drug Administration (FDA). In May 2020, the FDA released guidance about medical device reporting during a pandemic, anticipating delays in reporting and investigating events involving medical devices. Methods We aimed to understand how the COVID-19 pandemic impacted medical device reporting by analyzing reports in the MAUDE database that mention COVID-19. Results From the 816,470 reports submitted between January 1 and July 31, 2020, 3,500 (0.43%) included phrases related to COVID-19. Of these reports, 4.8% (167/3,500) described adverse events during COVID-19 patients’ treatment, and 90.3% (3,161 /3,500) described barriers manufacturers faced investigating malfunctioning devices during the pandemic. 4.9% (172/3,500) of reports were not related to COVID-19. Malfunctions were clinically significant in 85.8% (3,004/3,500) of reports. Discussion Reports indicate challenges some manufacturers had when investigating medical devices during the pandemic. The pandemic made investigating implants uniquely difficult, as restrictions to person-to-person contact limited the type of care patients could receive. Because full-scale investigations into malfunctioning devices may be difficult to perform during the pandemic, safety issues may go unaddressed and result in future harm to patients. Conclusion The COVID-19 pandemic and the myriad of healthcare, travel, and shipping challenges it created impacted how manufacturers reported and investigated medical devices. At the current time, it is unclear how manufacturers will address delayed clinical management of implant devices and other uninvestigated malfunctions after the pandemic and how this will impact patient safety.

scholarly journals Capsule Endoscope Aspiration after Repeated Attempts for Ingesting a Patency Capsule

2015 ◽  
Vol 9 (3) ◽  
pp. 347-352 ◽  
Author(s):  
Tomohiko Mannami ◽  
Genyo Ikeda ◽  
Satoru Seno ◽  
Hiroshi Sonobe ◽  
Nobukiyo Fujiwara ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Respiratory Tract ◽  
Iron Deficiency Anemia ◽  
Capsule Endoscopy ◽  
Potential Risk ◽  
Rare Complication ◽  
Deficiency Anemia ◽  
Capsule Endoscope ◽  
Documented Case ◽  
Patency Capsule

Capsule endoscope aspiration into the respiratory tract is a rare complication of capsule endoscopy. Despite the potential seriousness of this complication, no accepted methods exist to accurately predict and therefore prevent it. We describe the case of an 85-year-old male who presented for evaluation of iron deficiency anemia. He complained of dysphagia while ingesting a patency capsule, with several attempts over a period of 5 min before he was successful. Five days later, he underwent capsule endoscopy, where he experienced similar symptoms in swallowing the capsule. The rest of the examination proceeded uneventfully. On reviewing the captured images, the capsule endoscope was revealed to be aspirated, remaining in the respiratory tract for approximately 220 s before images of the esophagus and stomach appeared. To our knowledge, this is the first documented case of a patient who experienced capsule endoscope aspiration after ingestion of a patency capsule. This case suggests that repeated attempts required for ingesting the patency capsule can predict capsule endoscope aspiration. We presume that paying sufficient attention to the symptoms of a patient who ingests a patency capsule could help us prevent serious complications such as aspiration of the capsule endoscope. In addition, this experience implies the potential risk for ingesting the patency capsule. We must be aware that the patency capsule could also be aspirated and there may be more unrecognized aspiration cases.

Twitter Analysis of the Nonmedical Use and Side Effects of Methylphenidate, and User Sentiment about the Drug (Preprint)

2019 ◽  
Author(s):  
Jungu Kim ◽  
Su Cheol Kim ◽  
Jaegwon Jeong ◽  
Myeong Gyu Kim
Keyword(s):  
Side Effects ◽  
Social Networking ◽  
Brand Names ◽  
Social Networking Services ◽  
Hyperactivity Disorder ◽  
Search Terms ◽  
Nonmedical Use ◽  
Twitter Analysis ◽  
Sentiment Score ◽  
The Cost

BACKGROUND Methylphenidate, a stimulant used to treat attention deficit hyperactivity disorder (ADHD), has the potential for nonmedical uses such as study and recreation. In the era of active use of social networking services (SNSs), experience with the nonmedical use or side effects of methylphenidate might be shared on Twitter. OBJECTIVE To analyze monthly tweets about methylphenidate, its nonmedical use and side effects, and user sentiments about methylphenidate. METHODS Tweets mentioning methylphenidate from August 2018 to July 2019 were collected using search terms for methylphenidate and its brand names. Only tweets written in English were included. The monthly number of tweets about methylphenidate and the number of tweets containing keywords related to the nonmedical use and side effects of methylphenidate were analyzed. Precision was calculated as the number of true nonmedical use or side effects divided by the number of tweets containing each keywords. Sentiment analysis was conducted using the text and emoji in tweets, and tweets were categorized as very negative (less than -3), negative (-3 to -1), neutral (0), positive (1 to 3), or very positive (more than 3), depending on the sentiment score. RESULTS A total of 4,169 tweets were ultimately selected for analysis. The number of tweets per month was lowest in August (n=264) and highest in May (n=435). There were 292 (7.0%) tweets about nonmedical uses of methylphenidate. Among those, 200 (4.8%) described use for studying, and 15 (0.4%) described use for recreation. In 91 (2.2%) tweets, snorting methylphenidate was mentioned. Side effects of methylphenidate, mainly poor appetite (n=74, 1.8%) and insomnia (n=54, 1.3%), were reported in 316 (7.6%) tweets. The average sentiment score was 0.027 ± 1.475, and neutral tweets were the most abundant (n=1,593, 38.2%). CONCLUSIONS Tweets about methylphenidate were most abundant in May, mentioned nonmedical use for study or recreation, and contained information about side effects. Analysis of Twitter has the advantage of saving the cost and time needed to conduct a survey, and could help identify nonmedical uses and side effects of drugs.

scholarly journals Analysis of medication therapy discontinuation orders in new electronic prescriptions and opportunities for implementing CancelRx

2018 ◽  
Vol 25 (11) ◽  
pp. 1516-1523 ◽  
Author(s):  
Yuze Yang ◽  
Stacy Ward-Charlerie ◽  
Nitu Kashyap ◽  
Richelle DeMayo ◽  
Thomas Agresta ◽  
...  
Keyword(s):  
Patient Safety ◽  
Alternative Therapy ◽  
Electronic Prescribing ◽  
Electronic Prescription ◽  
User Training ◽  
Medication Therapy ◽  
Search Terms ◽  
Medication Discontinuation ◽  
Representative Random Sample ◽  
Nationally Representative

Abstract Objective To illustrate the need for wider implementation of the CancelRx message by quantifying and characterizing the inappropriate usage of new electronic prescription (NewRx) messages for communicating discontinuation instructions to pharmacies. Materials and Methods A retrospective analysis on a nationally representative random sample of 1 400 000 NewRx messages transmitted over 7 days to identify e-prescriptions containing medication discontinuation instructions in NewRx text fields. A vocabulary of search terms signifying cancellation instructions was formulated and then iteratively refined. True-positives were subsequently identified programmatically and through manual reviews. Two independent reviewers identified incidences in which these instructions were associated with high-alert or look-alike-sound-like (LASA) medications. Results We identified 9735 (0.7% of the total) NewRx messages containing prescription cancellation instructions with 78.5% observed in the Notes field; 35.3% of identified NewRxs were associated with high-alert or LASA medications. The most prevalent cancellation instruction types were medication strength or dosage changes (39.3%) and alternative therapy replacement orders (39.0%). Discussion While the incidence of prescribers using the NewRx to transmit cancellation instructions was low, their transmission in NewRx fields not intended to accommodate such information can produce significant potential patient safety concerns, such as duplicate or inaccurate therapies. These findings reveal the need for wider industry adoption of the CancelRx message by electronic health record (EHR) and pharmacy systems, along with clearer guidance and improved end-user training, particularly as states increasingly mandate electronic prescribing of controlled substances. Conclusion Encouraging the use of CancelRx and reducing the misuse of NewRx fields would reduce workflow disruptions and unnecessary risks to patient safety.

scholarly journals Scoping review protocol: the use of telemedicine in providing opioid agonist treatment and related psychosocial supports

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040556
Author(s):  
Des Crowley ◽  
Robyn Homeniuk ◽  
Ide Delargy
Keyword(s):  
Scoping Review ◽  
Psychosocial Support ◽  
Descriptive Analysis ◽  
Cochrane Library ◽  
Opioid Use ◽  
Opioid Agonist ◽  
Opioid Agonist Treatment ◽  
Search Terms ◽  
Medical Librarian ◽  
The Cochrane Library

IntroductionThe global opioid-related disease burden is significant. Opioid agonist treatment (OAT) can be effective in reducing illicit opioid use and fatal overdose, and improving multiple health and social outcomes. Despite evidence for its effectiveness, there are significant deficits in OAT globally. COVID-19 has required rapid adaptation of remote models of healthcare. Telemedicine is not used routinely in OAT, and little is known about the current levels of use and effectiveness. The objective of this review is to describe models of telemedicine and their efficacy.Methods and analysisThis scoping review uses the review methodology described by Arksey and O’Malley and adapted by Levac et al. The search strategy developed by the medical librarian at the Irish College of General Practitioners in conjunction with the research team will involve five databases (PubMed, EMBASE, the Cochrane Library, PsycInfo and OpenGrey) and the hand searching of reference lists. A limited initial search of two databases will be completed to refine search terms, followed by a second comprehensive search using newly refined search terms of all databases and finally hand searching references of included studies. To be included, studies must report on remote ways of providing OAT (including assessment, induction and monitoring) or related psychosocial support; be published in English after 2010. Two researchers will independently screen titles, abstracts and full-text articles considered for inclusion. Data will be extracted onto an agreed template and will undergo a descriptive analysis of the contextual or process-oriented data and simple quantitative analysis using descriptive statistics.Ethics and disseminationResearch ethics approval is not required for this scoping review. The results of this scoping review will inform the development of a national remote model of OAT. The results will be published in peer-reviewed journals and presented at relevant conferences.

scholarly journals Patient safety may be compromised if study conclusions are generalized to products that make similar claims but have no equivalent research evidence

2018 ◽  
Vol 24 (1) ◽  
pp. 37-45 ◽  
Author(s):  
Amit Gefen ◽  
Nick Santamaria ◽  
Sue Creehan ◽  
Joyce Black
Keyword(s):  
Patient Safety ◽  
Medical Device ◽  
Cost Benefit ◽  
Well Being ◽  
Product Selection ◽  
Specific Product ◽  
Medical Claims ◽  
Published Evidence ◽  
Pressure Injury ◽  
Pressure Injury Prevention

This paper addresses a fundamentally important issue in health care, namely how to make informed decisions on product selection when two products, from different manufacturers, appear to be similar and have medical claims that sound comparable. In such cases, manufacturers of competing products often use each other’s evidence. They argue that the published evidence is generally applicable even if the original bioengineering tests and clinical trials were performed on a specific product, and no equivalence was obtained for their product that has similar medical claims. In this work, we use prophylactic dressings for pressure injury prevention as a good demonstrative example on how patient safety may be compromised if study conclusions are generally projected to such unstudied products. The medical device industry is regulated differently than the pharmaceutical industry, and consequently, voids in current medical device regulation are sometimes used to promote commercial interests. This paper analyzes gaps and potential pitfalls that occur where guiding documentations (e.g. guidelines, standards) do not cope well with medical technology. We explain how that can eventually lead to potential compromises to the well-being of patients, primarily if nurses are unaware of the aforementioned pitfalls. We conclude that currently, there is no alternative to rigorousness: Clinicians and decision-makers need to scrutinize up-to-date literature, decide which products have the best portfolio of bioengineering and clinical research to support the claims made, and which products have the best cost–benefit models. This is fundamentally different from simply buying the least expensive product because of appealing sale arguments.

scholarly journals Evaluasi Safety Attitude Culture pada Perawat di Ruang Operasi PKU Muhammadiyah Gamping

2020 ◽  
Vol 20 (1) ◽  
pp. 253
Author(s):  
Irma Wulandari ◽  
Titih Huriah ◽  
Sri Sundari
Keyword(s):  
Patient Safety ◽  
Medical Error ◽  
Mixed Methods Research ◽  
Safety Climate ◽  
Descriptive Analysis ◽  
Sampling Technique ◽  
Research Approach ◽  
Safety Attitudes ◽  
High Category ◽  
Safety Attitude

In Indonesia, the incidence of medical error is quite high as evidenced by the existence of hospital incident reports, where in 2010 there were 75% of unexpected events and in 2011 as many as 60% of cases of surgical cases or patients with surgery. Medical error is one of the unwanted events, which occurred in various countries. Therefore it begins to develop a patient safety system. In order to carry out these functions, hospital should be able to carry out management based on customer oriented and patient safety by implementing a safety attitude culture. The purpose of this study was to determine the safety attitude culture evaluation of nurses in surgery rooms of PKU Muhammadiyah Gamping. This research was a research using a mixed methods research approach; namely a quantitative method with a descriptive approach and qualitative methods with a case study approach. The population in this study was nurses in surgery room with a total sampling technique of 20 people. The questionnaire in this study referred to the Surgery room Version of Safety Attitudes Questionnaire. Quantitative data analysis used descriptive analysis; while qualitative analysis was performed by data reduction, data presentation, and drawing conclusions/verification. The results shows that overall evaluation of safety culture attitude of nurses in the surgery room summed up in the high category (75,0 %). Meanwhile based on the safety attitude culture component, namely safety climate is in the high category (85,0%), team working climate is in the high category (90,0%), stress recognition is in the high category (65,0%), management perceptions is in the moderate category ( 75,0%), working conditions is in the high category (60,0%), job satisfaction is in the high category (90,0%).

scholarly journals A questionnaire based study to assess the interns’ knowledge about the brand names of drugs routinely prescribed in a tertiary care hospital in Kerala, India

2018 ◽  
Vol 7 (10) ◽  
pp. 2042
Author(s):  
Divya G. Krishnan ◽  
Shaikh Ubedulla ◽  
Anukesh Vasu Keloth
Keyword(s):  
Patient Safety ◽  
Correct Response ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Brand Names ◽  
Care Hospital ◽  
Ensure Patient Safety ◽  
Clinical Consequences ◽  
Good Percentage

Background: The gap in the knowledge of interns between brand names, generic name and indication of a drug can lead to unwanted clinical consequences. This study was conducted to assess the knowledge of interns at a tertiary care hospital regarding the generic name and indications of the routinely prescribed brand names of drugs.Methods: In this study, interns were required to write whether they prescribed the brand names mentioned in the questionnaire in the preceding six months, their generic name and the indication for their use. Results were expressed using descriptive statistics.Results: All brands except Zovobact SB was prescribed by more than 50% of interns in the preceding six months. The generic equivalents were correctly identified by good percentage of interns for Hicet (100%), Asthalin (95%), Cifran (90%) but the percentage of correct answers was low for other brands. For combination brands, correct generic names of all components were identified by more than 50% of interns for oflox TZ (93%), Septid D (68%) and Losar H (68%). The percentage of correct response for the indication of the brands was satisfactory for Hicet (100%), Asthalin (98%), Cifran (98%), Zerodol P (100%), Cyclopam (100%), oflox TZ (100%), Losar H (98%), Septid D (98%) but was inadequate for Taxim O (48%), Betaloc (33%), Valium (23%), Diamox (0%), Quadriderm (31%) and Zovobact SB (31%).Conclusions: This study identified lacunas in the knowledge of interns regarding generic equivalents and indications of brand names. Strategies to overcome the problem should be devised to ensure patient safety.

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.

scholarly journals A Prototype Therapeutic Capsule Endoscope for Ultrasound-Mediated Targeted Drug Delivery

2018 ◽  
Vol 03 (02) ◽  
pp. 1840001 ◽  
Author(s):  
Fraser Stewart ◽  
Antonella Verbeni ◽  
Yongqiang Qiu ◽  
Ben F. Cox ◽  
Jan Vorstius ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Crohn’S Disease ◽  
Side Effects ◽  
Capsule Endoscopy ◽  
Targeted Drug Delivery ◽  
Capsule Endoscope ◽  
Proof Of Concept ◽  
Gi Tract ◽  
Preliminary Results ◽  
Targeted Drug

The prevalence of gastrointestinal (GI) diseases such as Crohn’s disease, which is chronic and incurable, are increasing worldwide. Treatment often involves potent drugs with unwanted side effects. The technological–pharmacological combination of capsule endoscopy with ultrasound-mediated targeted drug delivery (UmTDD) described in this paper carries new potential for treatment of these diseases throughout the GI tract. We describe a proof-of-concept UmTDD capsule and present preliminary results to demonstrate its promise as an autonomous tool to treat GI diseases.

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