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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 -
The American Journal of Gastroenterology Sep 2019
Review
Topics: Adverse Drug Reaction Reporting Systems; Drug Labeling; Drug-Related Side Effects and Adverse Reactions; Gastroenterology; Humans; Safety-Based Drug Withdrawals; United States; United States Food and Drug Administration
PubMed: 31464745
DOI: 10.14309/ajg.0000000000000374 -
The Veterinary Record Jan 2017
PubMed: 28062772
DOI: 10.1136/vr.j11 -
The Veterinary Record Mar 2017
PubMed: 28255042
DOI: 10.1136/vr.j1016 -
Plastic and Reconstructive Surgery May 2021Proper management of symptomatic textured implant patients is critical to identify and treat associated oncologic disease. Textured surface breast implants were first... (Review)
Review
Proper management of symptomatic textured implant patients is critical to identify and treat associated oncologic disease. Textured surface breast implants were first introduced more than 50 years ago in an effort to decrease high rates of capsular contracture and implant malposition observed with first-generation smooth surface breast implants. Textured implants were dominant over smooth devices in the United States in the late 1990s, but they fell out of favor for newer-generation smooth implants, while texture remained the dominant selling implants worldwide until recently. A class I device recall by the US Food and Drug Administration in 2019 precipitated a removal of the highest selling implant worldwide, Allergan Biocell, due to a disproportionately increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Operative strategies, such as bacterial control at the time of textured implant insertion, have not been credibly shown to affect or prevent the future development of BIA-ALCL. BIA-ALCL patients require complete surgical excision of their disease, whereas textured implant patients who are otherwise asymptomatic do not require surgical removal. For suspicious cases, diagnostic testing with CD30 immunohistochemistry should be performed before any surgical intervention. Capsules are evaluated with 12 strategic regional biopsies in a standardized approach. If surgeons are revising or exchanging textured implants, they may reasonably consider a total capsulectomy, though this is not advocated by the Food and Drug Administration or national societies, and has not been shown to mitigate future risk of BIA-ALCL. The purpose of this article is to review data on and outcomes for textured surface implants, disease-associated risk, and the management strategy for revisionary surgery and device surveillance.
Topics: Breast Implantation; Breast Implants; Breast Neoplasms; Device Removal; Disease Management; Equipment Failure; Female; Humans; Lymphoma, Large-Cell, Anaplastic; Mammaplasty; Medical Device Recalls; Patient Education as Topic; Postoperative Complications; Prosthesis Design; Retrospective Studies; Risk; Silicone Gels; Surface Properties; Triage; Truth Disclosure
PubMed: 33890882
DOI: 10.1097/PRS.0000000000008047 -
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 -
The Journal of Medicine Access 2022Substandard and falsified (SF) medical products are removed from circulation through a process called 'product recall' by medicines regulatory agencies. In Zambia, the...
BACKGROUND
Substandard and falsified (SF) medical products are removed from circulation through a process called 'product recall' by medicines regulatory agencies. In Zambia, the Zambia Medicines Regulatory Authority (ZAMRA) is responsible for recalling SF medical products from the Zambian market through passive and active surveillance methods. This study aimed to describe the prevalence of recalls of SF medical products and to analyse the frequently recalled therapeutic categories, dosage forms, categories of defects that led to the recalls and their sources with respect to the country of the marketing authorisation holder (MAH) or manufacturer.
METHODS
We conducted a descriptive cross-sectional review of the product recalls issued by ZAMRA between January 2018 and December 2021. A search for all medical product alerts and recalls issued by ZAMRA was carried out by reviewing the internal post-marketing surveillance database kept at ZAMRA headquarters. Data were extracted using a structured Excel database and analysed using Microsoft Excel.
RESULTS
A total of 119 alerts were received during the review period, of which 83 (69.7%) were product recalls. Oral solid dosage forms were the most recalled dosage form (53%). Furthermore, the number of recalls increased in 2020 (44.6%) and 2021 (22.9%), with the majority (20.5%) of the recalled products being substandard products classified as antiseptics and disinfectants and were attributed to the high demand during the COVID-19 pandemic. Manufacturing laboratory control issues were the reason for product recall in almost half (47.4%) of the cases. Most of the products recalled originated from India (38.6%), followed by Zambia (25.3%). Only one suspected falsified product was recalled between 2018 and 2021. A total of 66 recalls of the 83 products were initiated by ZAMRA, with only 17 voluntarily by foreign MAHs. No product recall was initiated by the local representatives of foreign manufacturers or MAH.
CONCLUSION
The majority of the pharmaceutical product recalls in Zambia were substandard products. Manufacturing laboratory control issues lead to most recalls and require investigation of the root causes, preventive action, and strict compliance with the good manufacturing practices guidelines by manufacturers.
PubMed: 36601496
DOI: 10.1177/27550834221141767