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Journal of Investigative Medicine High... 2015Introduction. In December 2014, the Food and Drug Administration issued a recall of all Wallcur simulation products due to reports of their use in clinical practice. We...
Introduction. In December 2014, the Food and Drug Administration issued a recall of all Wallcur simulation products due to reports of their use in clinical practice. We present a case of septic shock and multiorgan failure after the accidental intravenous infusion of a nonsterile Wallcur simulation product. Case. The patient presented with symptoms of rigors and dyspnea occurring immediately after infusion of Wallcur Practi-0.9% saline. Initial laboratory evidence was consistent with severe septic shock and multiorgan dysfunction. His initial lactic acid level was 9 mmol/L (reference range = 0.5-2.2), and he had evidence of acute kidney injury and markers of disseminated intravascular coagulation. All 4 blood culture bottles isolated multidrug-resistant Empedobacter brevis. The patient recovered from his illness and was discharged with ciprofloxacin therapy per susceptibilities. Discussion. This patient represents the first described case of severe septic shock associated with the infusion of a Wallcur simulation product. Intravenous inoculation of a nonsterile fluid is rare and exposes the patient to unusual environmental organisms, toxins, or unsafe fluid characteristics such as tonicity. During course of treatment, we identified the possible culprit to be a multidrug-resistant isolate of Empedobacter brevis. We also discuss the systemic failures that led to this outbreak.
PubMed: 26668812
DOI: 10.1177/2324709615618980 -
Nutrients Sep 2023The range of gluten-free food products available to consumers is steadily expanding. In recent years, recalls of food products have highlighted the importance of...
The range of gluten-free food products available to consumers is steadily expanding. In recent years, recalls of food products have highlighted the importance of accurate labeling of food products for the presence of wheat, other gluten-containing cereals, or gluten itself as refined ingredient. The purpose of this study was to gain more insights into recent food recalls related to undeclared gluten/wheat contamination and consumer experiences with these recalls. Recalls of products triggered by gluten contamination are relatively scarce and are not often triggered by a consumer complaint. The impact of these recalls on consumer trust was evaluated through an online survey that was distributed among supporters of Celiac Canada (CCA) and covered (i) strategies to adhere to a gluten-free diet, (ii) experiences with gluten-free recalls and their impact on consumer trust, and (iii) demographic information. Consumer concern regarding gluten-free product recalls is significant, but the concern regarding recalls is not heightened after experiencing a recall. Companies pursuing transparency in the process, identification of the source of contamination, and mitigation strategies going forward are likely to retain consumer trust in their product and brand. Based on the survey results, further efforts focusing on consumer education regarding interpreting nutrient labels, identifying sources of information on product recalls, and understanding procedures to follow upon suspected gluten contamination of a gluten-free product are recommended.
Topics: Humans; Diet, Gluten-Free; Food Labeling; Trust; Glutens; Product Recalls and Withdrawals; Celiac Disease
PubMed: 37836454
DOI: 10.3390/nu15194170 -
Orthopaedics & Traumatology, Surgery &... Feb 2016Patient safety requires speedy detection of any medical device malfunction; this is known as "materials vigilance". It entails the need to be able to trace back the... (Review)
Review
Patient safety requires speedy detection of any medical device malfunction; this is known as "materials vigilance". It entails the need to be able to trace back the life-long pathway of a device; this is "traceability". European regulations enact free circulation of medical devices throughout the European Union, with each member state being responsible for safety within its own territory. Medical devices are divided into 3 categories of increasing risk. CE marking mandatory for medical devices distributed within the EU, and count as market authorizations. They are delivered with 5-year validity by what is known as a "notified body". Health authorities are responsible for monitoring the market and any incidents. New regulations are presently being drawn up to improve efficiency and transparency. Materials vigilance is founded on mandatory declaration of medical device incidents. At local level, it comprises local reporters responsible for informing the National Health Products Safety Agency (Agence nationale de sécurité du médicament et des produits de santé [ANSM]) of any incidents and taking all necessary precautions. At national level, the ANSM assesses the safety, efficacy and quality of healthcare products; it centralizes and assesses materials vigilance reports and takes the requisite decisions. Materials vigilance is further organized at the European and international levels, to harmonize legislation regarding medical devices. Traceability is intended to rapidly identify medical device bearers in case of product recall. Each center is to organize the traceability of its devices; manufacturers' obligation of traceability ceases with the healthcare establishment or user. CE marking involves strict labeling rules to ensure safety of use. A change in the organization of traceability is presently underway, in the form of international Unique Device Identifiers, with harmonized label data, barcodes and standardized terminology. A European and later international database will be set up. The objective is to make Unique Device Identifiers mandatory within the EU by 2017.
Topics: Equipment Failure; Equipment and Supplies; European Union; Humans; Patient Safety; Product Labeling; Prostheses and Implants; Reference Standards
PubMed: 26822532
DOI: 10.1016/j.otsr.2015.05.013 -
Nicotine & Tobacco Research : Official... Apr 2020We examined the effect of visual optimizations on warning text recall. (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
We examined the effect of visual optimizations on warning text recall.
METHODS
We used Amazon's Mechanical Turk to recruit 1854 young adult (18-34 years) electronic cigarette (e-cigarette) users or susceptible nonusers. We conducted a between-subjects 3 × 2 × 2 experiment to examine the influence of color (black text on white background [BW] vs. black on yellow [BY] vs. yellow on black [YB]), shape (rectangle vs. novel), and signal word (presence vs. absence of the word "warning"). We randomized participants to view one of 12 warnings on a fictional e-cigarette advertisement. We coded open-ended recall responses into three categories: (1) recalled nothing, (2) recalled something, (3) recalled the concept. We examined main effects on warning text recall using multinomial regression. We examined differences in attention, perceived message effectiveness, and appeal.
RESULTS
Those exposed to BW or BY warnings were more likely than those exposed to YB to recall something (AOR = 1.6, AOR = 1.5, respectively) or the concept (OR = 1.4, BW). Those exposed to novel shape (44.7% novel vs. 37.9% rectangle; p = .003) or color (44.5% BY vs. 41.9% YB vs. 37.5% BW; p = .04) warnings were more likely to report attention to the warning. In aided recall, those exposed to the signal word were more likely than those not exposed to select the correct response (64.0% vs. 31.3%; p < .0001). We did not find differences for message effectiveness or appeal.
CONCLUSIONS
Visual optimizations such as color may influence warning text recall and should be considered for new warnings. Research should continue exploring variations for advertisement warnings to maximize attention to warning text.
IMPLICATIONS
This study examines the impact of visual optimizations on recall of the US Food and Drug Administration-mandated e-cigarette advertisement warning text. We found that color might influence warning text recall, but we did not find effects for shape or signal word. It is possible the newly mandated e-cigarette advertisement warnings, which are required to occupy at least 20% of the advertisement, are currently novel enough to attract attention. Future research should examine optimizations following implementation of the new advertisement warnings.
Topics: Adolescent; Adult; Advertising; Attention; Electronic Nicotine Delivery Systems; Female; Humans; Male; Mental Recall; Product Labeling; Smokers; United States; United States Food and Drug Administration; Young Adult
PubMed: 31132095
DOI: 10.1093/ntr/ntz091 -
Medicine Access @ Point of Care 2021The entry of falsified and substandard medicines into the legitimate pharmaceutical supply chain has negative impacts on healthcare systems, patient safety, and patient...
The entry of falsified and substandard medicines into the legitimate pharmaceutical supply chain has negative impacts on healthcare systems, patient safety, and patient access to medicine. The COVID-19 pandemic has highlighted the importance of access to safe medicine through legitimate pharmaceutical supply chains and the willingness of criminals to target medical products such as PPE (personal protective equipment) and COVID-19 treatments. In this article, we analyse data from the United Kingdom (UK) national medicine alert and recall database to identify and understand recent cases of substandard and falsified medicine in the UK's healthcare systems. Using the UK as a case study, we describe that national drug alert and recall data are useful in their current form to record and understand cases of substandard and falsified medicines in the supply chain. However, if regulatory agencies published further data, these drug recall databases may be useful to support longitudinal and international comparative medicine quality studies. We suggest that regulatory agencies publish the number of affected medicine packs in each recalled batch, as part of the recall process. This will help policy makers, practitioners, and researchers to better understand, monitor and compare the quality of medicines within legitimate supply chains.
PubMed: 36204504
DOI: 10.1177/23992026211052272 -
Lakartidningen Dec 2018
Topics: Anticoagulants; Antithrombins; Atrial Fibrillation; Azetidines; Benzylamines; Dabigatran; Factor Xa Inhibitors; Humans; Safety-Based Drug Withdrawals; Stroke; Warfarin
PubMed: 30512138
DOI: No ID Found -
The Journal of Thoracic and... Nov 2012In 2008, we saw the withdrawal of aprotinin from the US markets after preliminary results from a large, randomized clinical trial in Canada. This drug, a potent... (Review)
Review
In 2008, we saw the withdrawal of aprotinin from the US markets after preliminary results from a large, randomized clinical trial in Canada. This drug, a potent antifibrinolytic, was used primarily in complex and/or redo cardiac surgery as an adjunct to decrease postoperative bleeding and complications. The Canadian study raised questions previously brought up in similar studies-does aprotinin increase the risk of mortality and renal failure after cardiac surgery? Recently, a re-review of the Canadian data noted flaws in the study, as well as in the interpretation of the results. The present review revisits the aprotinin controversy.
Topics: Antifibrinolytic Agents; Aprotinin; Cardiac Surgical Procedures; Evidence-Based Medicine; Humans; Patient Selection; Postoperative Hemorrhage; Randomized Controlled Trials as Topic; Renal Insufficiency; Research Design; Risk Assessment; Risk Factors; Safety-Based Drug Withdrawals; Treatment Outcome
PubMed: 22795461
DOI: 10.1016/j.jtcvs.2012.06.035 -
International Journal of Pharmaceutical... 2015There has been an increasing trend in the number of prescribed and over-the-counter drug recall over the last few years. The recall is usually due to company's... (Review)
Review
There has been an increasing trend in the number of prescribed and over-the-counter drug recall over the last few years. The recall is usually due to company's discovery, customer's complaint or Food and Drug Administration (FDA) observation. The process of recall involves a planned specific course of action, which addresses the depth of recall, need for public warning, and the extent of effectiveness checks for the recall. The FDA review and/or recommend changes to the firm's recall strategy, as appropriate. The critical recall information list includes the identity of the product; summary of the failure; amount of product produced in the distribution chain and direct account. Product recalls clashes thousands of companies every year affecting: sales, testing customer relationships and disrupting supply chains. Drug recall is incubus for pharmaceutical companies. It effects the reputation of the company. The reason for the recall can be divided into two categories: manufacturing affined and safety/efficacy affined. It is essential to follow all the guidelines related to drug development and manufacturing procedure so as to minimize drug recall.
PubMed: 25599028
DOI: 10.4103/2230-973X.147222 -
Journal of the American Pharmacists... 2021Our objective was to review recent drug and medical device recalls, categorize recall types based on the free text descriptions posted within the recall announcements,...
OBJECTIVE
Our objective was to review recent drug and medical device recalls, categorize recall types based on the free text descriptions posted within the recall announcements, and conduct exploratory analyses for researchers interested in pharmaceutical supply chain challenges.
METHODS
A cross-sectional study of all current recalls, market withdrawals, and safety alerts published by the United States Food and Drug Administration pertaining to drugs was conducted. A manual review of all the recalls was also conducted to extract additional information including company details, recall type (labeling or quality), and location of failure in the pharmaceutical supply chain (manufacturing or distribution). Descriptive statistics and exploratory bivariate analyses were conducted to test any potential differences between drug and device recalls.
RESULTS
Most recalls issued between January 2017 and September 2019 were pharmaceutical drug recalls (85.2%), while 34 (14.8%) medical device recalls were issued for the same period. For drug recalls, 85.1% (166/195) were because of quality, while 14.9% (29/195) were because of labeling issues. Of the quality issues for drug recalls, lack of sterility was the most frequent issue (139/166, 83.7%). There was no difference between drug or device recalls based on recall type (P = 0.16), top 20 pharmaceutical company (P = 0.62), or location of the supply chain failure (P = 0.20).
CONCLUSIONS
This study provides a process to categorize and evaluate drug and device recalls by recall type and location of the supply chain. By categorizing the free text provided in public recall data it would be easier to monitor trends over time.
Topics: Cross-Sectional Studies; Humans; Medical Device Recalls; Pharmaceutical Preparations; United States; United States Food and Drug Administration
PubMed: 32753251
DOI: 10.1016/j.japh.2020.07.005 -
JAMA Dermatology May 2021In February 2019, the US Food and Drug Administration issued a proposed rule (84 FR 6204), an amendment to the Sunscreen Innovation Act of 2014, that would require...
IMPORTANCE
In February 2019, the US Food and Drug Administration issued a proposed rule (84 FR 6204), an amendment to the Sunscreen Innovation Act of 2014, that would require listing active ingredients on the principal display panel of sunscreens to allow consumers to "more readily compare products and either select or avoid a given product accordingly."
OBJECTIVE
To understand consumers' perceived importance of active ingredients in sunscreen and their ability to recall these ingredients when comparing, avoiding, or selecting sunscreen products.
DESIGN, SETTING, AND PARTICIPANTS
In this qualitative study, participants were recruited from Fors Marsh Group and User Works, Inc consumer panels and interviewed in person in November and December 2019. Eligible participants were 18 years or older, reported sunscreen use in the past 12 months, and were residents of the Washington, DC, area. After viewing 2 mock sunscreen labels (1 that meets current US Food and Drug Administration requirements and 1 designed to meet proposed requirements), participants were asked questions to assess their perceived importance of active ingredients in sunscreen products, whether they could recall any of the active ingredients on the labels, and whether they typically looked for active ingredients on a sunscreen label.
MAIN OUTCOMES AND MEASURES
The main outcomes were the sunscreen label information used by participants to select a sunscreen and their ability to recall the active ingredients after viewing 2 mock sunscreen labels.
RESULTS
The mean (SD) age of the 47 participants was 42.8 (13.6) years, 32 (68%) were women, and 40 (85%) had a bachelor's or graduate degree. Of the total, 13 (28%) participants stated that sunscreen ingredients influenced their sunscreen selection, but only 5 (11%) said it was the most important information. Instead, 34 (72%) participants stated that the sun protection factor rating was the most important information. After viewing the mock sunscreen labels, only 5 (11%) participants recalled any of the active ingredients, although 10 (21%) reported typically looking at active ingredients when choosing a sunscreen.
CONCLUSIONS AND RELEVANCE
This qualitative study investigated the US Food and Drug Administration's proposed new rule requiring that active ingredients be listed on the front of sunscreen labels to facilitate product comparison for consumers. However, active ingredients were not reported to be a primary reason for consumers' sunscreen selection. Recall of active ingredients was low, and few consumers reported typically looking at the active ingredients, which were more commonly used to avoid ingredients rather than to select a sunscreen. Therefore, listing active ingredients on the front label alone may not have the intended usefulness for consumers.
Topics: Adult; Consumer Behavior; Female; Health Knowledge, Attitudes, Practice; Humans; Male; Mental Recall; Middle Aged; Product Labeling; Self Concept; Skin Neoplasms; Sun Protection Factor; Sunscreening Agents
PubMed: 33760056
DOI: 10.1001/jamadermatol.2020.5394