Health questions and answers

Exserohilum rostratum was the predominant fungus found in NECC patients, identified by CDC laboratory testing of clinical samples from the outbreak. CDC notes that, while these molds are common in the environment, they are not spread person to person. The agency also documented that the index case had Aspergillus fumigatus, but most confirmed infections were linked to E. rostratum. This organism was detected alongside other contaminants in unopened vials and patient specimens during the multistate investigation, clarifying the etiologic agent and guiding antifungal treatment recommendations for exposed patients.

Section 503B requires outsourcing facilities to comply with current good manufacturing practice (CGMP), register with FDA, undergo risk-based FDA inspections, report adverse events, and provide FDA with periodic product lists of the drugs they compound. Drugs compounded by a registered outsourcing facility can be exempt from FDA premarket approval and adequate-directions-for-use labeling requirements, but not from CGMP. The statute defines an outsourcing facility as a single geographic location engaged in compounding sterile drugs that elects to register and meet all 503B conditions, creating a pathway for large-scale compounders to operate under consistent federal oversight.

The DSCSA requires trading partners—manufacturers, repackagers, wholesale distributors, and dispensers—to provide and capture product tracing information (transaction information, history, and statement) with each sale of most finished prescription drugs, and to meet product identifier, authorized trading partner, and verification obligations. The law specifically excludes certain products from these tracing requirements, including lawfully compounded drugs. FDA’s DSCSA FAQ explains scope, responsibilities, and exclusions, clarifying which drug movements must be documented and what data standards FDA recommends for interoperable exchange as the system matures.

In Thompson v. Western States Medical Center (2002), the Supreme Court held that FDAMA’s prohibitions on soliciting prescriptions for, and advertising, compounded drugs were unconstitutional restrictions on commercial speech under the First Amendment. The Court affirmed lower courts that had enjoined enforcement of those provisions. The opinion explained that the government had not shown the speech restrictions directly advanced its interests in a narrowly tailored way under the Central Hudson test. This ruling invalidated the advertising and solicitation limits that had been tied to compounding’s exemption from FDA’s new drug approval process.

Health Canada distinguishes compounding as a provincially regulated professional act tied to an existing patient–practitioner relationship and generally limited, patient-specific preparation; by contrast, manufacturing is federally regulated and requires authorization such as a Drug Identification Number (DIN), an Establishment Licence, and compliance with Good Manufacturing Practices. Activities like producing products for third parties, distributing beyond a patient relationship, or operating at a scale, time, and frequency outside individualized care are treated as manufacturing. The policy lays out factors for case-by-case determinations and clarifies shared federal–provincial oversight.

Yes—MADIT-II showed that prophylactic ICD implantation in patients with prior myocardial infarction and left ventricular ejection fraction ≤30% reduced all-cause mortality by 31% compared with conventional therapy (14.2% vs 19.8%; hazard ratio 0.69). The trial was stopped early for benefit, with survival curves separating at about nine months. Over extended follow-up to eight years, mortality remained lower with ICDs (49% vs 62%; hazard ratio 0.66). MADIT‑II randomized 1,232 post‑MI patients to ICD versus no ICD in a 3:2 ratio, with all-cause mortality as the primary endpoint. These findings established ICDs as life‑prolonging therapy for appropriately selected post‑MI patients with markedly reduced ejection fraction.

Despite increasing HDL and lowering LDL, torcetrapib increased deaths and cardiovascular events, leading to early termination of its phase III program in 2006. The ILLUMINATE trial was halted on December 2, 2006 for an “imbalance of mortality and cardiovascular events,” and a 60% rise in deaths was observed with torcetrapib plus atorvastatin compared with atorvastatin alone. Patients were advised to discontinue the drug. Subsequent reports noted blood‑pressure increases with torcetrapib, and development was abandoned. The episode remains a cautionary example that favorable changes in lipid surrogates do not necessarily translate into improved clinical outcomes.

The FDA accepts surrogate endpoints only when evidence shows they predict clinical benefit; validated surrogates can support traditional approval, while “reasonably likely” surrogates may be used for Accelerated Approval with required post‑marketing confirmation. The agency describes a continuum—candidate, reasonably likely, and validated surrogates—and emphasizes that extensive epidemiologic and clinical trial data are usually needed. FDA maintains a public Surrogate Endpoint Table listing endpoints used as bases for approval or considered potentially appropriate, and it invites sponsors to discuss novel surrogates through Type C meetings. This structure enables faster programs when the link to outcomes is strong while ensuring continued verification where uncertainty remains.

Flecainide is used for rhythm control in atrial fibrillation, atrial flutter, and paroxysmal supraventricular tachycardia in patients without structural heart disease, but it is contraindicated after recent myocardial infarction, in structural heart disease, and in heart failure due to proarrhythmic and negative inotropic risks. Labeling warns of increased mortality and nonfatal cardiac arrest in post‑MI patients with asymptomatic ventricular arrhythmias, and the drug is not recommended for chronic atrial fibrillation. When treating AF, a beta‑blocker or non‑dihydropyridine calcium channel blocker should be co‑administered to avoid 1:1 atrial flutter conduction. Careful selection and monitoring for QRS widening and conduction effects are emphasized.

DNA identified the mother as Janet M. Barrie, a nurse and Hollywood socialite. Investigators reported that both infants were newborn girls born to Barrie, and neither birth occurred in a hospital. The remains were discovered in 2010 in a steamer trunk, but key biographical details emerged as detectives connected the trunk’s contents and pursued DNA testing. While the children’s paternity remains unknown without a reference sample, officials said the findings reframed the case from anonymous remains to a family history issue, narrowing questions to motive, circumstances, and potential relatives. This identification was publicly confirmed by Los Angeles County coroner investigators.

She was identified as 41-year-old Sylvia June Atherton through DNA profiling and genetic genealogy. Detectives located an untested hair sample from the 1969 autopsy, sent it to a private lab to build a DNA profile, and then ran that profile through a genealogy database, which led to living relatives and a confirmed ID. Police also determined the steamer trunk belonged to Atherton, and noted her husband never filed a missing-person report after she vanished. The case, long known only by the nickname “Trunk Lady,” demonstrates how revisiting preserved evidence and applying modern DNA methods can resolve decades-old identifications.

Forensic genetic genealogy searches non–law-enforcement genealogy databases and relies on different genetic markers than CODIS’s 20 core STR loci. By contrast, CODIS is a law-enforcement DNA system used to compare STR profiles across official databases; when no match appears, agencies may turn to forensic genetic genealogy to look for potential relatives of an unknown person. The FBI explains that these approaches are distinct: familial or routine CODIS searches operate within NDIS, while forensic genetic genealogy is conducted on external, consumer-based platforms and uses other markers, enabling investigators to develop leads by triangulating family relationships.

Bones and teeth preserve DNA far better than mummified soft tissues for ancient or long-buried remains. Reporting on research that sequenced DNA from Egyptian mummies, Smithsonian Magazine notes earlier attempts often sampled muscle, skin, or organs, but the most reliable recoveries came from skeletal material—especially teeth—because those structures are less exposed to heat and humidity that degrade genetic material. This shift in sampling strategy, combined with modern high-throughput sequencing and rigorous contamination controls, has significantly increased success rates in extracting authentic ancient DNA, enabling identifications and population history insights that were previously out of reach.

The DOJ’s 2019 interim policy allows forensic genetic genealogy to generate leads in unsolved violent crimes and to help identify homicide victims’ remains, but only after conventional methods, including a CODIS search, are exhausted. The policy emphasizes balancing public safety with privacy and civil liberties. It specifies that law enforcement must outsource SNP-based analysis to a vendor laboratory and then compare the resulting profile in publicly available genetic genealogy services to look for potential familial associations. Effective November 1, 2019, the policy provides guidance on case criteria, collaboration among investigators and prosecutors, and the lead-generating (not evidentiary) role of FGG.

The FDA urged health facilities to transition away from older fixed‑endcap duodenoscopes to models with disposable components or fully disposable designs to lower infection risk. In 2019, the agency recommended beginning this shift and noted manufacturers would withdraw fixed‑endcap models. In 2022, FDA updated its communication with new information supporting the move and reiterated that innovative designs that facilitate or eliminate reprocessing can reduce contamination. The page also highlights mandated postmarket studies and standardized sampling protocols to monitor reprocessing quality, underscoring why designs that are easier to clean—or single‑use—better protect patients during ERCP procedures.

They can aerosolize bacteria from contaminated water tanks and carry them into the surgical field via device‑generated airflow. Experimental work in an operating room showed that a heater‑cooler unit’s fan disrupted ultraclean laminar airflow; smoke and particle measures demonstrated air moving from the unit toward the open chest. In a test room, air‑sedimentation plates placed up to 5 meters away grew M. chimaera when the contaminated device operated continuously. Orientation mattered: directing airflow away from the table reduced particle counts, and one center mitigated risk by positioning units away and capturing exhaust to room vents.

CDC advises ensuring labs can identify CRE and promptly alert clinicians and infection prevention staff; implementing Isolation and Contact Precautions in acute care and using Enhanced Barrier Precautions or Contact Precautions in nursing homes as appropriate; screening patients with recent hospitalization or invasive procedures abroad and placing them in pre‑emptive isolation; communicating CRE status during inter‑facility transfers; enforcing core practices such as hand hygiene, PPE, and environmental cleaning; practicing antibiotic stewardship; and coordinating with public health on surveillance and regional prevention. CDC also notes a recent rise in NDM‑CRE, emphasizing the need to include mechanism testing and regional awareness.

In June 2021, FDA issued a supplement to its 2015 safety communication, reminding facilities to follow manufacturers’ instructions for reprocessing and device maintenance and adding a new recommendation for health care providers on the use of single‑use bronchoscopes to reduce potential patient‑to‑patient transmission. The update also included information on recent adverse event reports and consolidated guidance for patients, providers, and facilities. The message underscored sterile processing quality, attention to device design and integrity, and strengthened infection control program management to mitigate bronchoscopy‑related cross‑contamination risks.

FDA reported that in Fujifilm’s ED‑580XT postmarket culturing study, 0% of samples met the threshold for low‑concern organisms indicating a reprocessing failure, and only 1.1% were positive for high‑concern organisms—better than the 4–6% high‑concern contamination observed with similar older fixed‑endcap duodenoscopes. Based on these results, the agency concluded that newer models can reduce infection risk compared with older designs. The update supports ongoing transition to devices with disposable components or fully disposable options and reinforces why design changes matter for real‑world reprocessing effectiveness.

CDC recommends three stringent options that combine chemical soaking with prolonged autoclaving for heat‑resistant instruments exposed to suspected CJD. Methods include immersing tools in 1N sodium hydroxide (NaOH) and autoclaving at 121°C for 30 minutes, or soaking in 1N NaOH or 20,000 ppm sodium hypochlorite for 1 hour followed by autoclaving at 121°C for 1 hour. A third option uses the same soak, then autoclaving for 1 hour at either 121°C (gravity) or 134°C (porous load), before routine cleaning/sterilization. CDC also notes that destroying heat‑resistant instruments is the safest approach when feasible and that all disposable items contacting potentially infected tissue should be incinerated.

CDC lists the brain, spinal cord, and eyes as high‑infectivity tissues for prions, which triggers stricter handling and decontamination measures for instruments contacting them. The guidance also distinguishes lower‑infectivity tissues—including cerebrospinal fluid, kidneys, liver, lungs, lymph nodes, spleen, and placenta—where prion levels are lower but still merit special surface and instrument precautions if exposure is suspected. CDC advises incinerating disposable items that contact potentially prion‑infected tissue and using defined chemical/autoclave protocols for reusable devices. This risk‑based tissue categorization helps perioperative teams decide when to quarantine, decontaminate, or discard instruments after procedures involving suspected CJD.

Beyond instrument reuse, documented iatrogenic CJD has occurred after cadaveric human growth hormone therapy, dura mater grafts, and corneal transplants. CDC notes that a small number of cases were historically linked to contaminated surgical or medical equipment but that such transmission has not been reported since 1976 following improved decontamination procedures. It also explains that people who received prion‑contaminated human growth hormone before 1978 may still develop iatrogenic CJD decades later, and that donor‑derived dura mater or corneal tissue can transmit disease if the donor had unrecognized CJD. These routes illustrate why tissue sourcing and device reprocessing standards became exceptionally strict.

Variant CJD differs from classic CJD by showing detectable prions in tonsils and other lymphoid tissues, whereas sporadic (classic) CJD does not. CDC’s scientific review highlights this pathologic difference along with vCJD’s younger median age at death and longer illness duration. The lymphoid distribution matters for infection control and surveillance because procedures involving tonsillar or other lymphoid tissues may pose different risks in suspected vCJD, influencing how specimens are handled and which tissues are prioritized for diagnostic testing or special precautions. This contrast underpins why guidance for tissue handling can diverge between vCJD and classic CJD contexts.

Yes—vCJD has been transmitted by blood transfusion, with three clinical cases and one asymptomatic infection reported in UK recipients of non‑leucodepleted red cell transfusions from donors later diagnosed with vCJD. UK authorities subsequently implemented public health precautions for patients who received UK‑sourced plasma products between 1980 and 2001 to minimize any onward transmission risk. Surveillance of individuals with potential exposure and risk‑reduction strategies around plasma products were strengthened in response. These findings informed broader blood‑safety policies, including donor deferral practices and heightened monitoring of recipients linked to at‑risk donors.

CDC recommends minimizing the number of central line hub accesses and blood draws, using bundled insertion and maintenance practices, considering alcohol-containing chlorhexidine for skin antisepsis when benefits outweigh risks, removing umbilical catheters and PICCs as soon as they are no longer needed, and implementing a dedicated catheter-care team. In units with ongoing CLABSIs, clinicians may also consider antimicrobial lock solutions as an adjunct to core strategies. These measures target risks introduced during hub manipulation and prolonged dwell time, and CDC frames several as conditional recommendations based on patient factors and local epidemiology.

Yes. CDC lists total parenteral nutrition as a common risk factor for invasive candidiasis, alongside central venous catheters, critical illness with prolonged ICU stay, and broad-spectrum antibiotics. The same page notes that preterm, very low birth weight infants are at higher risk, underscoring why careful line care and nutrition management matter in neonatal settings. CDC emphasizes prevention through hand hygiene, adherence to central line placement and maintenance recommendations, and antimicrobial stewardship, with neonatal candidiasis typically treated using amphotericin B deoxycholate or fluconazole based on clinical circumstances.

Hospitals prevent C. auris spread by using Contact Precautions (or Enhanced Barrier Precautions in nursing homes), rigorous hand hygiene, thorough daily and terminal environmental disinfection with EPA-registered products effective against C. auris (List P), and by cleaning and disinfecting shared equipment after each use. CDC also advises communicating a patient’s C. auris status during transfers and maintaining precautions for the entire inpatient stay because colonization can persist for many months. These steps are designed to interrupt transmission on high-touch surfaces and mobile equipment, which are frequent reservoirs during outbreaks.

A failure in the sterilization process at Meds IV, a Birmingham compounding pharmacy, appears to have contaminated total parenteral nutrition and caused Serratia marcescens bloodstream infections in 19 Alabama hospital patients, nine of whom died. Investigators found genetic matches of the bacteria on a water faucet, a container, and a mixing device used to prepare IV nutritional supplements at the pharmacy, and the outbreak was linked to TPN bags shipped to six hospitals in early 2011. The case highlighted the infection risks from contaminated compounded products entering intravenous lines.

Yes. CDC advises that when a NICU experiences ongoing CLABSIs despite core prevention strategies, clinicians may consider central line antimicrobial lock solutions as an adjunct. The guidance presents this as a conditional recommendation and emphasizes that locks supplement, not replace, standard insertion and maintenance bundles, minimizing hub access, and prompt removal of lines when not needed. The intent is to reduce intraluminal microbial burden in high-risk settings while broader bundle elements continue addressing manipulation risks and dwell-time–related infection drivers.

Chest CT is the key imaging test for a substernal goiter because it best defines size, retrosternal extent, relations to the trachea and vessels, and allows quantification of tracheal compression; MRI is an acceptable alternative when contrast is a concern. Ultrasound is useful for the cervical thyroid but cannot assess the intrathoracic portion due to bone and air limitations. Iodinated CT contrast may precipitate hyperthyroidism and also delays nuclear thyroid scans until iodine clears. StatPearls notes that CT can quantify airway narrowing and that marked tracheal compression (for example, a minimal tracheal diameter of 10 mm or less) helps guide the need for intervention.

Lung cancer and implanted medical devices are the most common current causes of superior vena cava syndrome. Cleveland Clinic explains that about seven in ten cases are malignant (most often lung cancer, but also lymphoma, breast cancer spread to mediastinal nodes, mesothelioma, or thymoma). Roughly three in ten are benign, now frequently related to intravascular devices; pacemakers, defibrillators, hemodialysis and central venous catheters can irritate the vein, trigger inflammation or scarring, and promote thrombosis. Other benign contributors include goiter, infections (such as tuberculosis or syphilis), noncancerous tumors, sarcoidosis, and post‑radiation scarring. This shift underscores how both oncology and device-related thrombosis drive modern SVCS patterns.

Clinicians commonly use the Adson maneuver and the Roos (elevated arm stress) test to screen for thoracic outlet syndrome (TOS). StatPearls describes Adson’s as extending and slightly abducting the shoulder, with neck extension and head rotation toward the examiner; diminution of the radial pulse suggests arterial compression. The Roos test abducts and externally rotates the shoulders with elbows at 90°, then repeatedly opens and closes the hands; reproduction of symptoms or fatigue supports TOS of any variant. Physical examination is the first diagnostic step; imaging such as chest or cervical spine X‑ray and, when appropriate, vascular studies can follow if bedside tests and history indicate TOS.

Surgery is recommended for symptomatic substernal goiter and for significant or fixed upper airway obstruction, with CT‑documented tracheal compression guiding urgency. StatPearls states that surgery is the treatment of choice when patients have compressive symptoms and that chest CT can quantify the degree of narrowing; a minimal tracheal diameter of 10 mm or less warrants intervention. Asymptomatic substernal goiters without marked compression may be observed with regular monitoring of symptoms, goiter size, tracheal diameter, and thyroid function, while avoiding excess iodine exposure that can trigger hyperthyroidism. This approach individualizes management around anatomy on imaging and the presence or absence of mechanical compromise.

A large or obstructively positioned goiter can narrow the airway or press on the voice box, leading to difficulty swallowing, exertional shortness of breath, cough, hoarseness, and snoring. Mayo Clinic notes that while many goiters are asymptomatic, those that obstruct the airway and larynx can cause these mechanical symptoms regardless of whether thyroid hormone levels are high, low, or normal. Management depends on cause, size, and symptom burden; small, nonobstructive goiters often need no treatment, but obstructive symptoms may prompt targeted therapy, including surgery when appropriate. Recognizing obstructive features helps distinguish cosmetic enlargement from clinically significant airway or laryngeal involvement.