Outbreak of Listeriosis in South Africa Associated with Processed Meat.

BACKGROUND: An outbreak of listeriosis was identified in South Africa in 2017. The source was unknown. METHODS: We conducted epidemiologic, trace-back, and environmental investigations and used whole-genome sequencing to type Listeria monocytogenes isolates. A case was defined as laboratory-confirmed L. monocytogenes infection during the period from June 11, 2017, to April 7, 2018. RESULTS: A total of 937 cases were identified, of which 465 (50%) were associated with pregnancy; 406 of the pregnancy-associated cases (87%) occurred in neonates. Of the 937 cases, 229 (24%) occurred in patients 15 to 49 years of age (excluding those who were pregnant). Among the patients in whom human immunodeficiency virus (HIV) status was known, 38% of those with pregnancy-associated cases (77 of 204) and 46% of the remaining patients (97 of 211) were infected with HIV. Among 728 patients with a known outcome, 193 (27%) died. Clinical isolates from 609 patients were sequenced, and 567 (93%) were identified as sequence type 6 (ST6). In a case-control analysis, patients with ST6 infections were more likely to have eaten polony (a ready-to-eat processed meat) than those with non-ST6 infections (odds ratio, 8.55; 95% confidence interval, 1.66 to 43.35). Polony and environmental samples also yielded ST6 isolates, which, together with the isolates from the patients, belonged to the same core-genome multilocus sequence typing cluster with no more than 4 allelic differences; these findings showed that polony produced at a single facility was the outbreak source. A recall of ready-to-eat processed meat products from this facility was associated with a rapid decline in the incidence of L. monocytogenes ST6 infections. CONCLUSIONS: This investigation showed that in a middle-income country with a high prevalence of HIV infection, L. monocytogenes caused disproportionate illness among pregnant girls and women and HIV-infected persons. Whole-genome sequencing facilitated the detection of the outbreak and guided the trace-back investigations that led to the identification of the source.

Recall of Point-of-Sale Marketing Predicts Cigar and E-Cigarette Use Among Texas Youth.

Introduction: While research has documented associations between recall of point-of-sale (POS) tobacco marketing and youth tobacco use, much of the research is cross-sectional and focused on cigarettes. The present longitudinal study examined recall of tobacco marketing at the POS and multiple types of tobacco use 6 months later. Methods: The Texas Adolescent Tobacco Advertising and Marketing Surveillance System (TATAMS) is a large-scale, representative study of 6th, 8th, and 10th graders in 79 middle and high schools in five counties in Texas. Weighted logistic regression examined associations between recall of tobacco advertisements and products on display at baseline and ever use, current use, and susceptibility to use for cigarette, e-cigarette, cigar, and smokeless products 6 months later. Results: Students' recall of signs marketing e-cigarettes at baseline predicted ever e-cigarette use and increased susceptibility to use e-cigarettes at follow-up, across all store types. Recall of e-cigarette displays only predicted susceptibility to use e-cigarettes at follow-up, across all store types. Both recall of signs marketing cigars and cigar product displays predicted current and ever cigar smoking and increased susceptibility to smoking cigars at follow-up, across all store types. Recall of cigarette and smokeless product marketing and displays was not associated with tobacco use measures. Conclusion: The POS environment continues to be an important influence on youth tobacco use. Restrictions on POS marketing, particularly around schools, are warranted. Implications: Cross-sectional studies have shown that exposure to POS cigarette marketing is associated with use of cigarettes among youth, though longitudinal evidence of the same is sparse and mixed. Cross-sectional studies have found that recall of cigars, smokeless product, and e-cigarette tobacco marketing at POS is associated with curiosity about tobacco use or intentions to use tobacco among youth, but limited longitudinal research has been conducted. Findings from the present longitudinal study suggest that recall of tobacco marketing at retail POS predicts ever use of e-cigarettes and cigars, current use of cigars, and susceptibility to cigar and e-cigarette use among youth.

After the Recall: Reexamining Multiple Magnet Ingestion at a Large Pediatric Hospital.

OBJECTIVES: To evaluate the effectiveness of a mandatory product recall on the frequency of multiple mini-magnet ingestion at a large tertiary pediatric hospital, and to examine the morbidity and mortality associated with these ingestions. STUDY DESIGN: In this retrospective chart review, we searched our institution's electronic patient record for patients aged <18 years who had been diagnosed with ingested magnetic foreign bodies between 2002 and 2015, a period that included the mandatory product recall. We compared the frequency and character of ingestions before and after the recall. RESULTS: Comparing the postrecall years (January 1, 2014, to December 31, 2015) with the 2 years immediately preceding the recall year (January 1, 2011, to December 31, 2012) yields an incidence rate ratio of 0.34 (95% CI, 0.18-0.64) for all magnet ingestions and 0.20 (95% CI, 0.08-0.53) for ingestion of multiple magnets. Based on the Fisher exact test, the incidence of both magnet ingestion (P < .001) and multiple magnet ingestion (P < .001) decreased, and the morbidity associated with magnet ingestion decreased. There were no deaths in either study period. CONCLUSION: There was a significant decrease in multiple mini-magnet ingestion following a mandatory product recall. This study supports the effectiveness of the recall, which should bolster efforts to keep it in place in jurisdictions where it is being appealed. More broadly, the result provides general evidence of a recall helping decrease further harm from a product that carries a potential hazard.

Virologic Monitoring of Poliovirus Type 2 after Oral Poliovirus Vaccine Type 2 Withdrawal in April 2016 - Worldwide, 2016-2017.

The Global Polio Eradication Initiative (GPEI) has made substantial progress since its launch in 1988; only 37 wild poliovirus type 1 (WPV1) cases were detected in 2016, the lowest annual count ever. Wild poliovirus type 3 has not been detected since November 2012, and wild poliovirus type 2 was officially declared eradicated in September 2015. This success is attributable to the wide use of live oral poliovirus vaccines (OPVs). Since 2001, numerous outbreaks were caused by the emergence of genetically divergent vaccine-derived polioviruses (VDPVs) whose genetic drift from the parental OPV strains indicates prolonged replication or circulation (1). In 2015, circulating VDPV type 2 (cVDPV2) outbreaks were detected in five countries worldwide (Nigeria, Pakistan, Guinea, Burma, and South Sudan), and VDPV2 single events were reported in 22 countries. These events prompted the GPEI to withdraw the type 2 component (Sabin2) of trivalent OPV (tOPV) in a globally coordinated, synchronized manner in April 2016 (2,3), at which time all OPV-using countries switched to using bivalent OPV (bOPV), containing Sabin types 1 and 3. This report details for the first time the virologic tracking of elimination of a live vaccine that has been withdrawn from routine and mass immunization systems worldwide (3). To secure elimination, further monitoring is warranted to detect any use of tOPV or monovalent OPV type 2 (mOPV2).

Tracing and inhibiting growth of Staphylococcus aureus in barbecue cheese production after product recall.

Staphylococcal food poisoning is one of the most prevalent causes of foodborne intoxication worldwide. It is caused by ingestion of enterotoxins formed by Staphylococcus aureus during growth in the food matrix. Following a recall of barbecue cheese due to the detection of staphylococcal enterotoxins in Switzerland in July 2015, we analyzed the production process of the respective dairy. Although most cheese-making processes involve acidification to inhibit the growth of pathogenic bacteria, barbecue cheese has to maintain a pH >6.0 to prevent undesired melting of the cheese. In addition, the dairy decided to retain the traditional manual production process of the barbecue cheese. In this study, therefore, we aimed to (1) trace Staph. aureus along the barbecue cheese production process, and (2) develop a sustainable strategy to inhibit growth of Staph. aureus and decrease the risk of staphylococcal food poisoning without changing the traditional production process. To this end, we traced Staph. aureus in a step-wise blinded process analysis on 4 different production days using spa (Staphylococcus protein A gene) typing, DNA microarray profiling, and pulsed-field gel electrophoresis analysis. We subsequently selected a new starter culture and used a model cheese production including a challenge test assay to assess its antagonistic effect on Staph. aureus growth, as well as its sensory and technological implications. We detected Staph. aureus in 30% (37/124) of the collected samples taken from the barbecue cheese production at the dairy. This included detection of Staph. aureus in the final product on all 4 production days, either after enrichment or using quantitative detection. We traced 2 enterotoxigenic Staph. aureus strains (t073/CC45 and t282/CC45) colonizing the nasal cavity and the forearms of the cheesemakers to the final product. In the challenge test assay, we were able to show that the new starter culture inhibited growth of Staph. aureus while meeting the sensory and technological requirements of barbecue cheese production.

Very late follow-up of a passive defibrillator lead under recall: do failure rates increase during long-term observation.

BACKGROUND: The Medtronic Sprint Fidelis lead (SFL; Medtronic Inc., Minneapolis, MN, USA) has a significantly impaired long-term survival, and active fixation leads fare worse than passive leads. The goal of this study was to present data of a series of passive SFL only with very long mean follow-up of more than 6 years. METHODS: Patients in whom a passive SFL was implanted in two large Swiss centers were followed. We excluded eight (5.5%) patients with a follow-up of <6 months. Patients who died or were lost during follow-up were censored at death or last device check, all others on January 31, 2014. We employed two different definitions of failure: strict = fracture with inappropriate discharge; sudden increase in impedance >1,500 or high-voltage impedance >100 Ohm; >300 nonphysiological short interventricular-intervals. Lenient = any of the above plus a linear increase in impedance >1,500 Ohm or a linear decrease in sensing to a level that treating cardiologists considered inappropriate. RESULTS: We included 137 patients. Age was 60 ± 12 years. Mean and median follow-up were 6.2 ± 2.1 and 6.8 (interquartile range 4.8-7.8) years. Applying the strict definition, 12 leads (8.8%) were replaced after 4.9 ± 2.4 years (range 1.2-8.1). Applying the lenient definition, 14 leads (10.2%) failed. Cumulative lead survival was 98.5% at 3, 96.9% at 4, 94.2% at 5, and 93.1% at 6 years. Leads "at risk" were: n = 122 (89%), 115 (84%), 101 (74%), and 88 (64%). CONCLUSIONS: In this population with passive SFLs, 5-year lead survival is impaired with 94.2% based on 74% of leads "at risk" at this time point.

The perceived value of dairy product traceability in modern society: An exploratory study.

The current study assessed the perceived value of food traceability in modern society by young consumers. After experiencing numerous recalls and food safety-related incidences, consumers are increasingly aware of the tools available to mitigate risks. Food traceability has been associated with food safety procedures for many years, but recent high-profile cases of food fraud around the world have given traceability a different strategic purpose. Focusing solely on dairy products, our survey results offer a glimpse of consumer perceptions of traceability as a means to preserve food integrity and authenticity. This study explored the various influences that market-oriented traceability has had on dairy consumers. For example, results show that if the dairy sector could guarantee that their product is in fact organic, 53.8% of respondents who often purchase organic milk would consider always purchasing traceable organic milk. This research produced a quantitative set of information related to the perceived value of food traceability, which could be useful for the creation and development of improved guidelines and better education for consumers. We discuss limitations and suggest areas for new research.

Assessment of Shiga Toxin-Producing Escherichia coli O157 Illnesses Prevented by Recalls of Beef Products.

Beef product recall data from 2005 through 2012 associated with Shiga toxin-producing Escherichia coli (STEC) O157 contamination were used to develop quantitative models to estimate the number of illnesses prevented by recalls. The number of illnesses prevented was based on the number of illnesses that occurred relative to the number of pounds consumed, then extrapolated to the number of pounds of recalled product recovered. A simulation using a Program Evaluation and Review Technique (PERT) probability distribution with illness-related recalls estimated 204 (95% credible interval, 117-333) prevented STEC O157 illnesses from 2005 through 2012. Recalls not associated with illnesses had more recalled product recovered and prevented an estimated 83 additional STEC O157 illnesses. Accounting for underdiagnosis resulted in an estimated total of 7500 STEC O157 illnesses prevented over 8 years. This study demonstrates that recalls, although reactive in nature, are an important tool for averting further exposure and illnesses.

Evaluation of U.S. Poison Center Data for Surveillance of Foodborne Disease.

INTRODUCTION: Enhancing foodborne disease (FBD) surveillance and improving the timeliness of outbreak detection have been identified as public health priorities. Consumer complaint data have become increasingly useful for FBD surveillance and the detection of outbreaks. Calls to poison centers are a potential source of consumer complaint data. A retrospective analysis of data from the National Poison Data System (NPDS) (2000-2011) was undertaken to evaluate the value of data collected through the United States poison centers for detection of large national outbreaks and recalls. METHODS: Demographic and clinical data were summarized. Prevalences of FBD calls were calculated and analyzed for time trends. Significant increases in daily call prevalences were identified, and dates of the increases were compared to the announcement of 18 national outbreaks/recalls. RESULTS: Over the 12-year period, there were 433,788 unique calls self-reporting a suspected FBD exposure in humans. Overall, daily call prevalences decreased over time. Only about half of callers reported common gastrointestinal clinical effects. Of the 42 identified significant increases in call prevalences, none occurred within 14 days before an outbreak announcement; 7 occurred within 14 days after an outbreak announcement. CONCLUSIONS: Based on this analysis, there are significant limitations to using self-reported FBD exposures to NPDS as a source of information for FBD surveillance of large national outbreaks and recalls; however, a syndromic approach may yield different results and should be explored. Improved data collection and coordination with public health agencies may improve the ability to use NPDS data to monitor FBD in near real-time, identify potential outbreaks, and improve situational awareness.

Discontinuation of memantine standard release and its impact on patient therapy.

The recently announced discontinuation of Namenda (memantine HCl) and consequent shortage of Namenda XR (memantine HCl extended-release) is a matter that affects physicians, patients with Alzheimer's disease, caregivers, and consultant pharmacists. The manufacturer's announcement to discontinue standard-release product came eight months after the extended-release formulation became available in June 2013. The manufacturer planned to discontinue the standard-release tablets to focus on XR capsules by August 2014, giving patients and their caregivers-who prefer immediate-release formulations-no other options except the oral solution formulation. This article updates pharmacists with the current development on the various pharmacy and therapeutic issues on memantine products. Consultant pharmacists play an important role in educating prescribers and caregivers of the recent changes on this matter. They shall help to ensure proper dosage switching among various formulations. Consultant pharmacists can also help caregivers to identify the most cost-effective options when generic memantine becomes available in the future.

Media actors' perceptions of their roles in reporting food incidents.

BACKGROUND: Previous research has shown that the media can play a role in shaping consumer perceptions during a public health crisis. In order for public health professionals to communicate well-informed health information to the media, it is important that they understand how media view their role in transmitting public health information to consumers and decide what information to present. This paper reports the perceptions of media actors from three countries about their role in reporting information during a food incident. This information is used to present ideas and suggestions for public health professionals working with media during food incidents. METHODS: Thirty three semi-structured interviews with media actors from Australia, New Zealand and the United Kingdom were conducted and analysed thematically. Media actors were recruited via purposive sampling using a sampling strategy, from a variety of formats including newspaper, television, radio and online. RESULTS: Media actors said that during a food incident, they play two roles. First, they play a role in communicating information to consumers by acting as a conduit for information between the public and the relevant authorities. Second, they play a role as investigators by acting as a public watchdog. CONCLUSION: Media actors are an important source of consumer information during food incidents. Public health professionals can work with media by actively approaching them with information about food incidents; promoting to media that as public health professionals, they are best placed to provide the facts about food incidents; and by providing angles for further investigation and directing media to relevant and correct information to inform such investigations. Public health professionals who adapt how they work with media are more likely to influence media to portray messages that fit what they would like the public to know and that are in line with public health recommendations and enable consumers to engage in safe and health promoting behaviours in response to food incidents.

Population diversity of Listeria monocytogenes in quargel (acid curd cheese) lots recalled during the multinational listeriosis outbreak 2009/2010.

It has been possible to determine the genotype diversity of Listeria monocytogenes in the actual cheese lots of acid curd cheese that caused a multinational outbreak between 2009 and 2010. Following product recall in January 2010 all lots were investigated. A total of 422 L. monocytogenes isolates were characterized by genotyping. In a first approach the PCR serogroups were defined by multiplex-PCR assays. Subsequently, the isolates were subtyped by pulsed-field gel electrophoresis (PFGE) and multi-locus sequence typing (MLST). Sequence types were assigned by submitting the DNA sequences to the Listeria MLST database at the Institute Pasteur. The serogroup PCR resulted in a homogeneous 1/2a - 3a (genetic linage II) cluster. The generated PFGE patterns divided the strains into two clusters (type 1 and 2) diverging at a homogeneity level of 74%. PFGE-type 2 was predominant, accounting for 98.3% (n = 415/422) of the isolates and was isolated during the whole period of acid curd cheese processing (01.12.2009-13.01.2010). 1.7% of all tested L. monocytogenes isolates (n = 7/422) belonged to PFGE-type 1 and were isolated from 28% of all cheese lots (n = 5/18) produced between the time span of 08.12.2009 to 13.01.2010. Furthermore, PFGE-type 1 and 2 showed the same PFGE patterns as the human outbreak strains (clone 1 and clone 2).

Listeria: an Australian perspective (2001-2010).

Despite having a low occurrence rate, Listeria monocytogenes is one of the most prominent foodborne pathogens in Australia. The organism is responsible for severe outbreaks with high case fatality and substantial economic losses due to food recalls. In this study, we analyze the incidence trends of listeriosis in Australia during 2001-2010, discuss the relevance of food recalls, and investigate the pathogen's role in foodborne outbreaks. A significant epidemiological finding was a consistently high national age-specific rate recorded for individuals aged 60 years and over. Analysis of Australian Listeria outbreak and food recall data suggests deficiencies in food safety programs of food manufacturing businesses implicated in Listeria outbreaks and revealed that ready-to-eat foods are high-risk vehicles for transmitting listeriosis. Highlighted is Australia's highly efficient Listeria management and surveillance systems bolstered by the introduction of Listeria molecular subtyping in 2010 coupled with a nationally standardized questionnaire by the "Australian foodborne disease surveillance network (OzFoodNet)." The detection of clusters and therefore outbreaks was now possible, allowing cases to be linked across multiple jurisdictions and enabling timely public health action. Considering current changes in food production and consumption patterns, continuous monitoring and improvement of surveillance systems will provide ongoing public health benefits and be crucial to future development of food safety policy for Australia.

Global harmonization of food safety regulation from the perspective of Korea and a novel fast automatic product recall system.

Efforts have been made for global harmonization of food safety regulations among countries through international organizations such as WTO and WHO/FAO. Global harmonization of food safety regulations is becoming increasingly important for Korean consumers because more than half of food and agricultural products are imported and consumed. Through recent reorganization of the Korean government, a consolidated national food safety authority-the Ministry of Food and Drug Safety (MFDS)-has been established for more efficient food safety control and better communication with consumers. The Automatic Sales Blocking System (ASBS), which blocks the sales of the recalled food products at the point of sale, has been implemented at over 40,000 retail food stores around the nation using state-of-the art information and communication technology (ICT) for faster recall of adulterated food products, and the e-Food Safety Control System has been developed for more efficient monitoring of national food safety surveillance situations. The National Food Safety Information Service was also established for monitoring and collecting food safety information and incidents worldwide, and shares relevant information with all stakeholders. The new approaches adopted by the Korean Food Safety Authority are expected to enhance public trust with regard to food safety issues and expedite the recall process of adulterated products from the market.

THE DUTY TO PERFORM A PATIENT RECALL.

In this article the so-called patient recall duty is discussed. More specifically, it has been determined if and when a physician should inform his former patients about newly discovered side effects relating to previously executed treatments. Although such an obligation may be surprising there are, in my view, sufficient arguments to justify the duty to perform a patient recall in some cases. The potential objections to the imposition of this duty do not alter my opinion. However, it is by no means the intention to impose on the physician a general post information obligation. In my opinion, two fundamental criteria should be taken into account in order to assess when the physician is obliged to carry out a patient recall, namely: the severity of the potential harm, and the foreseeability of the potential harm. This can be derived from similar existing criteria in other areas in which a recall obligation exists and from the case law concerning patient recall.

The dynamic interdependencies among the negativity and the positivity in news and user-generated content about safety in a firm's products and the firm's product recalls.

This article examines the dynamic interdependencies among the negativity and the positivity in news and user-generated content about safety in a firm's products (or the lack thereof) and the firm's product recalls. The authors use a panel vector autoregression (PVAR) to unearth theoretically novel and managerially relevant asymmetric associations. Specifically, they find that the negativity in the news negatively correlates with recalls, whereas the negativity in UGC positively correlates with recalls. Whereas the positivity in the news positively correlates with recalls, the positivity in UGC does not matter. Further, the negativity in the news and the negativity in UGC substitute for each other, whereas their positive counterparts complement each other's associations with recalls. Lastly, the negativity and positivity in the news have significant, though differently patterned, long-term associations with recalls. The findings contribute to research on the associations between earned media and managerial decisions in the product market.

Human Medicines Recall Announcements in Saudi Arabia Between 2017 and 2022: An Analysis of Saudi Food and Drug Authority (SFDA) Reports.

PURPOSE: This study aims to explore the characteristics of drug recall announcements issued over six years by the SFDA in Saudi Arabia. Additionally, to examine the patterns of voluntary drug recall requests by pharmaceutical companies (both innovator and generic) in response to product defects. METHODS: A retrospective data analysis was conducted on drug recall announcements issued by the SFDA between 2017 and December 2022. The study included recalls of registered and unregistered drugs posted on the SFDA Drugs Circulars and Withdrawal webpage. Descriptive analysis was performed on relevant variables: recall year, therapeutic class, recall type, pharmaceutical company type, recall reasons and voluntary or involuntary product defect reports. RESULTS: During the study period, a total of 371 products were recalled, with the majority being involuntary recalls (82.4%). About two-thirds of the recalls (66.0%) were related to registered products. The most common reasons for recalls were non-compliance with the manufacturer's specifications (33.2%), contamination (23.7%), and violations (20.5%). A total of 109 pharmaceutical companies were associated with the recalled products, with (85.3%) being generic pharmaceutical companies. The majority of innovator pharmaceutical companies (68.8%) requested voluntary drug recalls of defective products. Innovator pharmaceutical companies requested voluntary recalls more often than generic pharmaceutical companies. CONCLUSION: The study findings highlight the most frequent causes of drug recalls and the patterns of voluntary recall requests by pharmaceutical companies. Non-compliance with manufacturer's specifications was the most common reason for recalls. Significantly, more innovative pharmaceutical companies request voluntary recalls for product defects compared to generic pharmaceutical companies.