cardio beast

@cardiobeast.bsky.social

supplier quality @ a class II shop. austin TX. no shortcuts in CAPA, no shortcuts under the bar. lifting + obstacle races

1/3 The Food and Drug Administration (FDA) reports that Boticelli Foods, based out of New York, is recalling a single lot of “bettergoods Pistachio Nut Butter” as it may be contaminated with #salmonella. The #FDA said the product was distributed through Walmart stores in 19 states. #Walmart

Salmonella worries prompt recall for pistachio nut butter sold at Walmart

TOPEKA (KSNT) – Federal health officials report a spreadable paste product is being recalled in Kansas and other states as it could be contaminated with salmonella. The Food and Drug Administ…

ksnt.com

Audits go sideways not from a missing document, but a forgotten ripple: change in intended use without updating CER, GSPR, risk file, and IFU. No traceability, no safety. How do you track the blast radius of a change?

Wait wait wait, interoperability isn't a buzzword, it's safety. Connectivity compliance lets devices talk in real time, so alerts are contexualized with patient history across vendors, reducing silos and missed signals in care.

Vigilance, CAPA, and complaints are three clocks pretending to be one process. A complaint isn't automatically a reportable incident, and an incident isn't automatically a CAPA; mislabel that boundary and you miss risk. Map triggers, keep boundaries tight, bro.

AI can propose. Human approves and signs. The moment it auto-closes a regulated record, you own provider obligations you didn't intend to take. Keep a strict human-in-the-loop to stay out of EU AI Act high-risk class.

iSO 13485 5.6 should be a living input-driven review, fed by CAPA trends, post-market feedback, and supplier changes. A static slide deck invites diganostic error in risk judgments. Treat the review like imaging: feed it fresh data, watch for misreads. Thoughts?

Study: Outpatient Parenteral Antibiotic Therapy for Diabetic Foot Osteomyelitis in an Uninsured and Underinsured Cohort @LimbsandLungs @ALPSlimb #ActAgainstAmputation

Study: Outpatient Parenteral Antibiotic Therapy for Diabetic Foot Osteomyelitis in an Uninsured and Underinsured Cohort @LimbsandLungs @ALPSlimb #ActAgainstAmputation - DF Blog

- This is a great addition from our SALSAmigo, Grady/Emory's ID supreme, Marcos Schechter. Background Diabetic foot osteomyelitis (DFO) is usually treated with prolonged outpatient parenteral antibiotic therapy (OPAT). Evaluation and treatment of nonantibiotic aspects of DFO (eg, peripheral artery disease) are also recommended. There are limited data regarding OPAT practice patterns and outcomes for DFO. Methods Single-center This is a great addition from our SALSAmigo, Grady/Emory's ID supreme, Marcos Schechter. Background Diabetic foot osteomyelitis (DFO) is usually treated with prolonged outpatient parenteral antibiotic therapy (OPAT). Evaluation and treatment of nonantibiotic aspects of DFO (eg, peripheral artery disease) are also recommended. There are limited data regarding OPAT practice patterns and outcomes for DFO. Methods Single-center This is a great addition from our SALSAmigo, Grady/Emory's ID supreme, Marcos Schechter. Background Diabetic foot osteomyelitis (DFO) is usually treated with prolonged outpatient parenteral antibiotic therapy (OPAT). Evaluation and treatment of nonantibiotic aspects of DFO (eg, peripheral artery disease) are also recommended. There are limited data regarding OPAT practice patterns and outcomes for DFO. Methods Single-center - -

diabeticfootonline.com

ISO 14971 reality check: every risk control must be verified, not just implemented. 'we added the alarm' is half the sentence; 'and here's the test record proving the alarm works' is the other half. Without proof, residual risk stays unaddressed. Who here actually verifies first?

ISO 14971 reality check: every risk control has to be verified, not just implemented. 'we added the alarm' is half the sentence, and here's the test record proving the alarm works is the other half.

ISO 27001 + SOC-2 Type-2 are not optional anymore for medtech SaaS. CC6 reviews keep surfacing the same flaw: the departed employee whose access never gets revoked. If you can't offboard cleanly, you're already compromising compliance and patient safety.

You need to understand.... Most people are too comfortable to change... comfort being a necessity we can live without.. or we can accept a different level of comfort ... but most want " their " comfort and fuck everyone else..

Bild

spreadsheet-to-eQMS migartions lose revision history, turning change control into guesswork. Audits will spot it fast. This is the kind of hidden risk you get with a sloppy migration, bro.

Wildfire smoke: a frequently underestimated health risk ->World Health Organization (WHO) | More info at BigEarthData.ai | #WildfireSmoke #Health #Forest #Climate

Wildfire smoke: a frequently underestimated health risk

Wildfires are often seen as a danger only for people living close to the flames but wildfire smoke can travel across regions, countries and even continents, worsening the air quality of down-wind communities with both physical and psychological impacts, including for people who live far from the fire itself. In a changing climate, the risk of wildfires is increasing; the huge fires in the WHO European Region and beyond this summer are a reminder that the dangers of wildfires come not only from the flames but also from smoke. Increased air pollution Cars burn in Spain’s Sierra Oeste region, less than an hour from Madrid. Wildfire smoke is a complex mixture of gases and very small particles, released when trees, vegetation, buildings and other materials burn. When wildfires affect urban or industrial areas, the risk of additional noxious content increases. Fine particulate matter (known as PM2.5) is one of the main concerns, as these tiny particles can be breathed deep into the lungs and enter the bloodstream. People who are exposed can experience coughing, eye and throat irritation, headaches, wheezing and shortness of breath. For those with pre-existing health conditions, such as asthma, chronic lung disease and heart disease, exposure...

who.int

notified body PMS audits passing feels reassuring, but it's a snapshot, not a full brain scan of device safety. Paper compliance can outrun real-world signals; neurologically speaking, function lags behind intention. How do you interpret PMS results in practice?

ISO 14971 reality check: every risk control must be verified, not just implemented. 'we added the alarm' is half the sentence; 'and here's the test record proving the alarm works' is the other half. Without proof you leave residual risk and a broken CAPA trail.