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FEMS Microbiology Letters Dec 2019Preventing microbial contamination of non-food products is a major area of industrial microbiology where preservatives are used to stop microbial growth. However,... (Review)
Review
Preventing microbial contamination of non-food products is a major area of industrial microbiology where preservatives are used to stop microbial growth. However, microorganisms occasionally overcome product preservation, causing recalls and the implementation of multiple procedures to prevent further contamination. Correct reporting of microbial contamination in non-food industrial products is vital, especially if spoilage organisms are antimicrobial resistant and pose a health threat. Gram-negative bacteria such as Pseudomonas, Burkholderia and Enterobacteriaceae are frequently reported as non-food product contaminants, including species that overlap current antimicrobial resistance priorities. Historical analysis of recall databases highlighted that for greater than 15% of contamination incidents, the causative microbial agents are reported as unidentified. Here we review the current antimicrobial resistant bacterial species associated with non-food product contamination and evaluate recall reporting in Europe from 2005 to 2018. Our review shows that 49% of microbial contaminants are reported as unidentified despite frequent detection of antimicrobial resistant pathogens; in contrast, 98% of food-related microbial contaminants are classified. Recommendations to fill this microbial identification gap in non-food product recalls are made. Overall, reporting standards for microbial contamination in non-food products must be improved to enable surveillance and for understanding the risks associated with antimicrobial resistant microorganisms.
Topics: Bacteria; Bacterial Physiological Phenomena; Drug Resistance, Bacterial; Equipment Contamination
PubMed: 31977006
DOI: 10.1093/femsle/fnaa010 -
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 -
Public Health Nutrition Nov 2022To evaluate the utility of three validated food responsiveness scales in measuring recall of, and responsiveness to, food marketing exposure on social media.
Associations between adolescent and young adult External Food Cue Responsiveness (EFCR) and brand recall, product craving and product purchasing in the livestreaming food marketing environment.
OBJECTIVE
To evaluate the utility of three validated food responsiveness scales in measuring recall of, and responsiveness to, food marketing exposure on social media.
DESIGN
Cross-sectional survey among adolescents and adults who used the social media platform Twitch.tv (Twitch). Responsiveness to food marketing was self-reported as craving or purchasing any brands participants observed on Twitch. Participants completed three validated scales of food responsiveness: the revised 18-question Three Factor Eating Questionnaire (TFEQ), the external eating subscale of the Dutch Eating Behavior Questionnaire (DEBQ) and the External Food Cue Responsiveness (EFCR) scale. Adjusted linear regression models assessed the predictive ability of each scale on recall and responsiveness outcomes.
SETTING
Online survey.
PARTICIPANTS
Five hundred and sixty-eight Twitch users (90·1 % male, 60·6 % White, 43·7 % aged 18-24, 25·9 % under 18).
RESULTS
In separate adjusted linear regression models, scores on the TFEQ were not related to any outcome, while DEBQ scores related to product cravings (OR: 1·10, 95 % CI 1·01, 1·19, = 0·02). In contrast, scores on the EFCR scale were significantly associated with higher brand recall (incident rate ratio: 1·42, 95 % CI 1·20, 1·68, < 0·001), product craving (OR: 3·93, 95 % CI 2·22, 7·17, < 0·001) and purchasing behaviour (OR: 3·97, 95 % CI 1·99, 8·26, < 0·001). A subset of three EFCR scale items related to influencer marketing were similarly associated with each outcome with greater precision in the point estimates than the overall EFCR.
CONCLUSIONS
The EFCR scale predicted recall of and responsiveness to food marketing via Twitch, suggesting its utility in monitoring the effects of food marketing on social media.
Topics: Adolescent; Craving; Cross-Sectional Studies; Cues; Female; Food; Humans; Male; Marketing; Young Adult
PubMed: 35920082
DOI: 10.1017/S1368980022001628 -
Epidemiologia E Prevenzione 2015
Topics: Autism Spectrum Disorder; Causality; Conflict of Interest; Consumer Organizations; Dissent and Disputes; Drug Recalls; Humans; Influenza Vaccines; Informed Consent; Italy; Marketing of Health Services; Parents; Public Policy; Vaccination; Vaccines
PubMed: 25855539
DOI: No ID Found -
JAMA Internal Medicine Feb 2020Timely and complete disclosure of medical device defects is necessary to manage patient care safely and effectively.
IMPORTANCE
Timely and complete disclosure of medical device defects is necessary to manage patient care safely and effectively.
OBJECTIVES
To determine if the manufacturer's recommendations following the recall of a medical device were timely and complete, the follow-up information and data provided to patients and physicians were adequate for managing patient care, and the actions taken by the US Food and Drug Administration (FDA) regarding the recall were appropriate.
DESIGN, SETTING, AND PARTICIPANTS
This single-center retrospective case series included 90 of 448 patients who were implanted with a cardiac resynchronization therapy pacemaker at the Minneapolis Heart Institute from May 2003 through January 2011; this pacemaker was recalled in November 2015. In addition, returned product reports submitted by the manufacturer to the FDA via the Manufacturer and User Facility Device Experience (MAUDE) database from January 2008 through December 2018 were analyzed.
MAIN OUTCOMES AND MEASURES
Clinical outcomes were serious adverse clinical events that occurred before and after the November 2015 recall notifying physicians and patients that the device's battery could fail unexpectedly because of high internal impedance. Technical outcomes were signs and causes of failure.
RESULTS
Five of 90 patients observed during 2015 experienced syncope when their pacemakers stopped pacing owing to battery or wire connection defects prior to the recall. Of the 90 patients, 37 (41%) were men, and the median (interquartile range) age at implantation was 71.3 (66.1-78.2) years. Analysis of the MAUDE data revealed that battery failures prior to the recall were associated with serious adverse events that included 1 death, 1 cardiac arrest, 5 syncopal attacks, and 6 heart failure exacerbations; 3 additional prerecall syncopal events were caused by wire connection defects. The manufacturer and the FDA were aware of the battery and wire connection defects for 19 months before issuing the recall, yet the wire connection problem was not included in the advisory and physicians were not informed that interrogating the pacemaker could result in loss of pacing. The FDA classified the recall as class II rather than the more critical class I.
CONCLUSIONS AND RELEVANCE
This case series study of patients implanted with a defective pacemaker found that the pacemaker recall was delayed and that subsequent communications did not include all critical information needed for safe and effective patient care. These findings should prompt reforms in how the medical device industry and the FDA manage future medical device recalls.
Topics: Aged; Cardiac Resynchronization Therapy Devices; Disclosure; Disease Progression; Equipment Failure; Female; Heart Arrest; Heart Failure; Humans; Information Dissemination; Male; Medical Device Recalls; Mortality; Retrospective Studies; Syncope; Time Factors; United States; United States Food and Drug Administration
PubMed: 31860011
DOI: 10.1001/jamainternmed.2019.5171 -
BMJ Open Jul 2022To evaluate the pattern of substandard and falsified pharmaceutical products recall in Nepal. (Review)
Review
OBJECTIVES
To evaluate the pattern of substandard and falsified pharmaceutical products recall in Nepal.
SETTING
We analysed drug recall notices issued by the Department of Drug Administration (DDA), Nepal, and systematically reviewed peer-reviewed research articles during January 2010 to December 2020.
PARTICIPANTS
This study did not include human participants. However, data were collected from 72 drug recall notices issued by DDA and four research papers.
RESULTS
A total of 346 pharmaceutical products were recalled during the reported period. The number of recalled pharmaceutical products has increased significantly over the past decade in Nepal. The most frequently recalled drugs were antimicrobials followed by gastrointestinal medicines, vitamins and supplements and pain and palliative medicines among others. Number of imported recalled drugs were slightly higher (42.2%) than domestic recalled drugs (40.7%). Sixty-two percentage of recalled drugs were substandard, 11% were falsified and remaining 27% were not registered at the DDA. Similarly, higher number of modern drugs (62%) were recalled than traditional ones (35%). Hand sanitisers used to minimise COVID-19 transmission contributed significantly to the list of recalled pharmaceutical products in 2020. Most of these sanitisers contained significant amounts of methanol (as high as 75% v/v) instead of appropriate amount of ethyl or isopropyl alcohol. The peer-reviewed research papers reported issues with labelling, unregistered drugs and drugs failed in several laboratory testing.
CONCLUSION
Our analysis showed that number of recalls of substandard and falsified drugs are increasing in Nepal. Since the recall data in this paper did not include number of samples tested and location of samples collected, more studies to understand the prevalence of substandard and falsified drugs in Nepal is recommended.
Topics: COVID-19; Counterfeit Drugs; Drug Recalls; Humans; Nepal; Pharmaceutical Preparations
PubMed: 35788073
DOI: 10.1136/bmjopen-2021-053479 -
Frontiers in Microbiology 2018High mortality and hospitalization rates have seen as a foodborne pathogen of public health importance for many years and of particular concern for high-risk population... (Review)
Review
High mortality and hospitalization rates have seen as a foodborne pathogen of public health importance for many years and of particular concern for high-risk population groups. Food manufactures face an ongoing challenge in preventing the entry of into food production environments (FPEs) due to its ubiquitous nature. In addition to this, the capacity of strains to colonize FPEs can lead to repeated identification of in FPE surveillance. The contamination of food products requiring product recall presents large economic burden to industry and is further exacerbated by damage to the brand. Poor equipment design, facility layout, and worn or damaged equipment can result in hotspots and biofilms where traditional cleaning and disinfecting procedures may be inadequate. Novel biocontrol methods may offer FPEs effective means to help improve control of and decrease cross contamination of food. Bacteriophages have been used as a medical treatment for many years for their ability to infect and lyse specific bacteria. Endolysins, the hydrolytic enzymes of bacteriophages responsible for breaking the cell wall of Gram-positive bacteria, are being explored as a biocontrol method for food preservation and in nanotechnology and medical applications. Antibacterial proteins known as bacteriocins have been used as alternatives to antibiotics for biopreservation and food product shelf life extension. Essential oils are natural antimicrobials formed by plants and have been used as food additives and preservatives for many years and more recently as a method to prevent food spoilage by microorganisms. Competitive exclusion occurs naturally among bacteria in the environment. However, intentionally selecting and applying bacteria to effect competitive exclusion of food borne pathogens has potential as a biocontrol application. This review discusses these novel biocontrol methods and their use in food safety and prevention of spoilage, and examines their potential to control within biofilms in food production facilities.
PubMed: 29666613
DOI: 10.3389/fmicb.2018.00605 -
Blood Jul 2013Gene therapy products for the treatment of genetic diseases are currently in clinical trials, and one of these, an adeno-associated viral (AAV) product, has recently... (Review)
Review
Gene therapy products for the treatment of genetic diseases are currently in clinical trials, and one of these, an adeno-associated viral (AAV) product, has recently been licensed. AAV vectors have achieved positive results in a number of clinical and preclinical settings, including hematologic disorders such as the hemophilias, Gaucher disease, hemochromatosis, and the porphyrias. Because AAV vectors are administered directly to the patient, the likelihood of a host immune response is high, as shown by human studies. Preexisting and/or recall responses to the wild-type virus from which the vector is engineered, or to the transgene product itself, can interfere with therapeutic efficacy if not identified and managed optimally. Small-scale clinical studies have enabled investigators to dissect the immune responses to the AAV vector capsid and to the transgene product, and to develop strategies to manage these responses to achieve long-term expression of the therapeutic gene. However, a comprehensive understanding of the determinants of immunogenicity of AAV vectors, and of potential associated toxicities, is still lacking. Careful immunosurveillance conducted as part of ongoing clinical studies will provide the basis for understanding the intricacies of the immune response in AAV-mediated gene transfer, facilitating safe and effective therapies for genetic diseases.
Topics: Antibodies, Viral; Dependovirus; Genetic Diseases, Inborn; Genetic Therapy; Genetic Vectors; Humans
PubMed: 23596044
DOI: 10.1182/blood-2013-01-306647 -
Experimental Psychology Jan 2022Reading some words aloud during presentation, that is, producing them, and reading other words silently generate a large memory advantage for words that are produced....
Reading some words aloud during presentation, that is, producing them, and reading other words silently generate a large memory advantage for words that are produced. This robust within-list production effect is in contrast with the between-lists condition in which all words are read aloud or silently. In a between-lists condition, produced items are better recognized, but not better recalled. The lack of a between-lists production effect with recall tasks has often been presented as one of its defining characteristics and as a benchmark for evaluating models. Recently, Cyr et al. (2021) showed that this occurs because item production interacts with serial positions: Produced items are less well recalled on the first serial positions than silently read items, while the reverse pattern is observed for the recency portion of the curve. However, this pattern was observed with a repeated-measures design, and it may be a by-product of compensatory processes under the control of participants. Here, using a between-participants design, we observed the predicted interaction between production and serial positions. The results further support the Revised Feature Model (RFM) suggesting that produced items are encoded with more modality-dependent distinctive features, therefore benefiting recall. However, the production of the additional distinctive features would disrupt rehearsal.
Topics: Humans; Learning; Mental Recall; Reading; Serial Learning
PubMed: 35272478
DOI: 10.1027/1618-3169/a000540