Endoscopic transmission of carbapenem-resistant Enterobacteriaceae: implications for U.S. Food and Drug Administration approval and postmarket surveillance of endoscopic devices.

Since the first widely reported case cluster of duodenoscope-associated transmission of carbapenem-resistant Enterobacteriaceae (CRE) in 2013 that affected 38 patients, similar outbreaks have occurred throughout the world. The U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention, professional gastroenterology societies, and endoscope manufacturers have taken multiple steps to address this issue. Unlike prior outbreaks attributed to lapses in cleaning and reprocessing, transmission and outbreaks have continued to occur despite compliance with current reprocessing guidelines. A definitive method of duodenoscope reprocessing remains elusive, and the FDA recently recommended transition to new designs with disposable components that do not require reprocessing. The first fully disposable duodenoscope received FDA clearance as a "breakthrough" device in December 2019. Although the human, microbiologic, and endoscopic design factors responsible for infectious transmissions and disinfecting techniques to avoid them have been examined, discussion has not included the critical role of FDA regulation of duodenoscopes through the 510(k) clearance pathway and the mechanisms of postmarket surveillance, including adverse event reporting. We present an overview of the FDA approval of duodenoscopes by analyzing the FDA's 510(k) premarket notification database for data supporting clearance of duodenoscope models implicated in CRE-related outbreaks as well as subsequently required postmarket studies. We address the policy implications of CRE outbreaks on postmarketing surveillance and the need for increased gastroenterologist involvement in the life cycle of duodenoscopes and other medical devices. This includes reporting thorough adverse event data to the FDA and device manufacturers, supporting active surveillance studies to ensure safety and effectiveness, and evaluating implementation of recommendations to reduce adverse events.

Sudden Cardiac Death in a Patient with Anomalous Origin of Right Coronary Artery with Concomitant Sinus of Valsalva Aneurysm.

Anomalous origin of right coronary artery (ARCA) arising from the left sinus of Valsalva (a congenital cardiac abnormality) and sinus of Valsalva aneurysm (SOVA) are rare and often have asymptomatic conditions. However, symptoms could range from chest pain, shortness of breath, palpitations, syncope to sudden cardiac death (SCD). The co-existence of these two anomalies (ARCA + SOVA) could lead to potential adverse outcomes in the absence of early intervention. The presence of these two conditions together increases the risk of SCD as reported in our case of a young male who presented to the emergency department with chest pain.

Use and abuse of fecal occult blood tests: a community hospital experience.

BACKGROUND: The Fecal Occult Blood Test (FOBT) is one of the diagnostic modalities indicated for screening patients for Colorectal Cancer (CRC). Despite being approved only for screening for CRC, numerous studies in the past have illustrated misuse of the FOBT. We examined utilization of the FOBT for patients admitted to a community teaching hospital. METHODS: The study was conducted at Saint Joseph Hospital, Chicago USA. A retrospective review of Electronic Medical Records (EMRs) of patients admitted from January 2016 to December 2017 was performed. RESULTS: We reviewed the EMRs of 729 patients who received the stool testing for occult blood (FOBT). All tests (100%) were carried out for purposes other than CRC screening. Anemia (38%) was the most common reason documented for carrying out the FOBT. Further, 88% of the tests were ordered on patients who either did not fulfill CRC screening criteria or had other contraindications for testing. Usage of contraindicated medication was the most important factor (58% of patients) that made the candidates ineligible for testing. A total 73 Colonoscopies were ordered for patients who received the test inappropriately with a resulting low yield (0.47%) of CRC diagnosis. CONCLUSION: The stool occult blood test continues to be utilized for reasons other than CRC screening. Majority of patients who underwent the test were not suitable candidates due to the presence of contraindications for testing. Unsuitable FOBT testing led to further unnecessary investigations.

Jejunojejunal intussusception secondary to metastatic uveal melanoma after 11 years of remission.

Malignant cutaneous melanoma frequently metastasises to gastrointestinal tract, small bowel being the most common site likely due to its rich vascular supply. However, most common sites for metastatic uveal melanoma are the liver (93%), lung (24%), bone (16%), skin/subcutaneous tissue (11%) and lymph nodes (10%). 1 We present a case of 46-year-old man with jejunojejunal intussusception secondary to metastatic uveal melanoma status postbrachytherapy after 11 years of remission. We aim to highlight the rare occurrence of adult intussusception secondary to uveal melanoma after a prolonged period of remission.

A bimodal approach to thymic carcinoma with pericardial sac invasion.

Thymic carcinoma is a rare tumour of the thymus, representing less than 1% of thymic malignancies. 1 It has an annual incidence of 0.15-0.32 per 1 00 000 person-years. 2 It is found incidentally in 30% of the patients as an opacity on chest X-ray or with non-specific complaints of persistent cough, chest pain, fatigue, shortness of breath, arm and facial swelling, and upper airway congestion related to tumour extension. We present the case of a 59-year-old man with a history of Graves' disease status post radiation treatment presenting with cough and left lingual opacity on chest X-ray, confirmed to be thymic carcinoma with pericardial invasion and lymph node metastasis. We aim to discuss the presentation, treatment modalities and outcome associated with this rare tumour.

Not your usual hip pain: necrotising fasciitis secondary to sigmoid perforation.

Necrotising fasciitis (NF) resulting from sigmoid perforation is rare, but none the less remains life threatening. Early surgical intervention and empiric broad-spectrum antibiotic remains the standard of care. A 65-year-old man with history of stage 4 rectal cancer presented with bilateral hip pain. An X-ray of the hip and pelvis to rule out fracture revealed abnormal gas pattern overlying the right hip. CT imaging revealed distal sigmoid perforation with air extending from the pelvis to posterior aspect of the right hip and thigh. Aggressive surgical intervention and antibiotic initiation was associated with successful outcomes in our patient. Although less common, sigmoid perforation leading to NF in posterior thigh is a reminder of a potentially lethal complication.

Non-alcoholic Wernicke encephalopathy: great masquerader.

Thiamine is an important coenzyme, which is essential for metabolism and maintaining cellular osmotic gradient. Thiamine deficiency can cause focal lactic acidosis, alteration of the blood-brain barrier and the production of free radicals through cell death by necrosis and apoptosis. Wernicke encephalopathy (WE) is a clinical diagnosis. Cytotoxic and vasogenic oedema are the most typical neuroimaging findings of WE, presenting as bilateral symmetrical hyperintense signals on T2-weighted MR images. MRI is not necessary for the diagnosis of WE, but it can be helpful in ruling out alternative diagnosis. We present the case of an 61-year-old man with the history of class II obesity presenting with diplopia, dysarthria and vertigo, confirmed to be non-alcoholic WE. We aim to highlight the occurrence of WE in patients with large bowel resection though. Delay in diagnosis, particularly in obese individuals due to lack of suspicion, can lead to grim prognosis.

Spontaneous bacterial empyema: an elusive diagnosis in a patient with cirrhosis.

Hepatic hydrothorax refers to the presence of a pleural effusion (usually >500 mL) in a patient with cirrhosis in whom other causes of pleural effusion, such as cardiopulmonary causes, pleural disease or malignancy have been excluded. It is seen in 5%-10% of patients with end-stage liver disease. A subset of these patients can develop infection of the hepatic hydrothorax, called spontaneous bacterial empyema. They may present with fever, chills and dyspnoea. We present the case of an 83-year-old man with a history of cirrhosis who developed a large right-sided pleural effusion, confirmed to be empyema by pleural fluid analysis. We aim to highlight the occurrence of spontaneous bacterial empyema. While less common that spontaneous bacterial peritonitis as a complication of cirrhosis, it is equally serious with potential for adverse outcomes.

Large cell neuroendocrine carcinoma and adenocarcinoma of gallbladder with concomitant hepatitis C infection.

Neuroendocrinetumour (NET) of the gallbladder is an extremely rare tumour and with coexisting adenocarcinoma an even rarer occurrence. Mixed NETs have the tendency to invade the lymph nodes and the hepatic tissue from their high malignant potential, leading to poor prognosis. Survival rates of the patients with mixed NET can be improved with wide excision, adjuvant chemotherapy and radiation. We present a case of 62-year-old woman with history of hepatitis C infection, a risk factor for both hepatic and extrahepatic gastrointestinal malignancies. Patient underwent exploratory laparotomy with resection of the gallbladder and partial hepatectomy. Pathology showed high-grade larger cell neuroendocrine carcinoma 5×4×3 cm along with two separate lesions found out to be adenocarcinomas. In our patient, hepatitis C infection can be an inciting factor for the development of these carcinomas. We will discuss the presentation, treatment modalities and outcomes with this kind of coexisting tumours.

Outcomes associated with prescribed medications in older adults with multimorbidity: protocol for a scoping review.

INTRODUCTION: Multimorbidity becomes increasingly prevalent with ageing. Polypharmacy is often associated with multimorbidity because patients accrue medications to treat each individual disease; however, there is uncertainty around the generalisability of disease-specific guidelines. Namely, the extrapolation of results from studies conducted in younger patients to older adults with multimorbidity. The main objective of this scoping review is to explore our current knowledge of the outcomes that older adults with multimorbidity experience from taking prescribed medications. METHODS AND ANALYSIS: A scoping review will be conducted to explore what is known about the outcomes experienced by older adults with multimorbidity who are taking guideline-recommended medications and to identify areas for future research. In addition to searching the grey literature, the following databases will be searched from 1990 onward: MEDLINE, EMBASE, PsycINFO and the Cochrane Library. Experimental, quasi-experimental and non-experimental studies consisting of patients ≥65 years old who have two or more comorbid conditions (explicitly grouped together for the purpose of analysis) and who are being prescribed a guideline-recommended prescription medication for a chronic condition will be considered for inclusion in our scoping review. We will describe patient (eg, mortality, morbidity, quality of life) and health system (eg, number of emergency department visits or hospitalisations, cost to third-party payer) outcomes associated with the prescription of medications for older adults who have two or more chronic comorbid conditions. Two reviewers will complete all screening and data abstraction independently. Data will be synthesised with descriptive statistics. ETHICS AND DISSEMINATION: Ethics approval is not required because this is a scoping review of published literature. Results will be disseminated through conference presentations and publication in a peer-reviewed journal.