Medical errors now 3rd leading cause of death in U.S., study suggests - CBS News

Read the full article: Medical errors now 3rd leading cause of death in U.S., study suggests - CBS News:

"Medical errors, including wrong diagnoses, botched surgeries and medication mistakes, are the third leading cause of death in the United States, a new study suggests.

Scientists from Johns Hopkins found that more than 250,000 Americans die due to medical mishaps every year, greater than the toll from any major medical condition except heart disease or cancer."

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FDA orders manufacturers to study cleaning problems with medical scopes linked to infections - The Washington Post

Read the full article: FDA orders manufacturers to study cleaning problems with medical scopes linked to infections - The Washington Post:

"The agency ordered a trio of manufacturers to conduct real-world evaluations on how well health care workers are cleaning and disinfecting the devices and what more might be done to prevent the spread of life-threatening infections.

Known as duodenoscopes, the devices are used in hundreds of thousands of procedures each year in the United States to drain fluids from pancreatic and bile ducts blocked by cancer tumors, gallstones and other conditions. Doctors consider them a key tool in detecting and treating medical problems in a minimally invasive way."

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Healthcare Industry: The Top Target of Cyber Attacks - Pharmaceutical Compliance Monitor

Read the full article: Healthcare Industry: The Top Target of Cyber Attacks - Pharmaceutical Compliance Monitor:

". . . it might come as a surprise that most data breaches occurred within the medical/healthcare category. According to the Identity Theft Resource Center, 600+ breaches have taken place through October 2014—up nearly 26 percent from 2013. Healthcare providers and organizations account for approximately 42 percent of all breaches with 7.4 million personal records exposed this year alone.

Looking at these numbers it’s hard to argue against the vulnerability of any organization, regardless of their stature. Today, with advanced tools at hackers’ disposal, it’s truly not a matter of ‘if’ but ‘when’ a data breach will materialize."

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Stethoscopes Do As Much Dirty Work As Hands In Spreading Germs : Shots - Health News : NPR

My medical instrument (Photo credit: Wikipedia)

Stethoscopes Do As Much Dirty Work As Hands In Spreading Germs : Shots - Health News : NPR:

"But while there are guidelines that recommend that all doctors wash their hands before and after visiting each patient, there are none mandating that small medical equipment like stethoscopes should also be disinfected after every single use."

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Hackers break into networks of 3 big medical device makers - SFGate

Hackers break into networks of 3 big medical device makers - SFGate:

"Hackers have penetrated the computer networks of the country's top medical device makers, The Chronicle has learned.

The attacks struck Medtronic, the world's largest medical device maker, Boston Scientific and St. Jude Medical sometime during the first half of 2013 and might have lasted as long as several months, according to a source close to the companies.

It's not clear what exactly the hackers were after, but federal laws meant to safeguard medical information require the companies to disclose any breach involving patient information. The companies have made no such disclosures."

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2013 warning letters: NDIs, beverage vs supplement, and brand holders' obligations among important themes

2013 warning letters: NDIs, beverage vs supplement, and brand holders' obligations among important themes:

"Some themes that can be gleaned from 2013’s warning letters are part of a constant drumbeat.  Firms are cited by FDA for basic GMP violations and for making non-compliant disease claims on their products.  But other themes, while perhaps not new per se, have acquired a renewed emphasis in the last year, Prochnow said, including the following:" . . .

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Overhaul of CDRH's Office of Compliance Creates Six-Division Structure, New Advertising Office

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Follow the link below to see who's going to be in charge . . .

Overhaul of CDRH's Office of Compliance Creates Six-Division Structure, New Advertising Office - RAPS:

"The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) medical device regulation and compliance-enforcement body, has announced that it has reorganized its Office of Compliance (OC) with the stated goal of better aligning its resources to its mission."

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FDA > Decorative Contact Lenses: Is Your Vision Worth It?

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Updated August 11, 2023

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Colored and Decorative Contact Lenses: A Prescription Is A Must - FDA.gov

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Consumer Updates > Decorative Contact Lenses: Is Your Vision Worth It?:

"But before buying decorative lenses, here’s what you should know:

They are not cosmetics or over-the-counter merchandise. They are medical devices regulated by the Food and Drug Administration (FDA). Places that advertise them as cosmetics or sell them without a prescription are breaking the law."

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Mobile Medical Applications: Guidance Finalized - FDA Law Blog

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FDA Law Blog: Mobile Medical Applications: A Thoughtful Guidance Is Finalized:

"The final guidance is similar to the draft guidance – but with improved clarity. Hence, it has expanded from 29 to 43 pages. Most of the additional pages are appendices with examples and other supplementary information. This guidance is sensible and well written."

Follow this link to the Mobile Medical Applications - FDA Guidance for Industry and Food and Drug Administration Staff (PDF)

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New Joint Commission Video Offers Advice on Medical Care at Home

New Joint Commission Video Offers Advice on Medical Care at Home:

"Video characters Nurse Clare, Home Care Aide Jesse and Home Medical Equipment Specialist Boyd help Hector in his home with his IV, oxygen tank and daily living needs while his wife Reyna watches and helps. "Speak Up: At Home" emphasizes that patients and their families or friends should ask questions in order to be sure they receive the care necessary to get better."

Follow this link to the video, Speak Up: At Home

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3D-Printed Medical Devices Spark FDA Evaluation | LiveScience

3D-Printed Medical Devices Spark FDA Evaluation | LiveScience:

"The FDA currently treats 3D-printed devices the same way it treats conventionally made medical devices, an FDA spokeswoman said.

"We evaluate all devices, including any that utilize 3D printing technology, for safety and effectiveness, and appropriate benefit and risk determination, regardless of the manufacturing technologies used," spokeswoman Susan Laine told LiveScience in an email. She added, "In some cases, we may require manufacturers to provide us with additional data, based on the complexity of the device." "

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Medical Foods > FDA Draft Guidance for Industry: FAQs 2nd Ed

Medical Foods > Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition:

"The responses to these FAQs address common questions about the definition of and regulations for medical foods. This guidance is a second edition of the May 2007 guidance titled “Guidance for Industry: Frequently Asked Questions About Medical Foods.” This guidance provides responses to additional questions regarding the definition, labeling, and availability of medical foods and updates to some of the existing responses; new questions and answers and amended responses are identified by the date they were added to the guidance."

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Medical Device Industry In Critical Condition - Forbes Op-Ed

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Updated April 17, 2021

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You can still read a similar article here:

The U.S. Medical Device Industry is in Critical Condition - Orthostreams.com

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U.S. Medical Device Industry In Critical Condition - Forbes:

"The medical device industry is being ravaged by unwise public policy, including a devastating 2.3% excise tax took effect on Jan 1 as part of ObamaCare. This tax, which has already required the payment of more than $1 billion by device manufacturers, is especially pernicious because it is assessed on gross sales, not profits. To put this in perspective, imagine that you’re a manufacturer of medical devices and had a profit of $100,000 on sales of $1 million after all your costs and expenses—everything from materials and labor to research. The excise tax would be $23,000, wiping out almost a quarter of your profits."

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FDA Draft Guidance - Mobile Medical Apps - Practical Insights

A quick and insightful perspective on the much anticipated mobile medical app guidance . . .

Compliance Zen: Majority of Mobile Health Apps Class II Devices for FDA:

"FDA’s current draft guidance on mobile medical apps is woefully short of such practical specifics. And yet it’s these specifics that will get even the most forthright medical app developer in trouble with FDA-483s and Warning Letters. Warning Letters have been shown to reduce product sales by at least 8% the first year and for three years thereafter. For many of these developers, a Warning Letter might be the kiss of death and bring a painful chill to the innovation marketplace."

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FDA - Mobile Medical App Guidance - Will it be delayed?

Final days of waiting for FDA mobile medical app guidance? | mobihealthnews:

"Now, on the eve of the FDA’s publication of the final guidelines, the Bipartisan Policy Center and companies that include McKesson, Microsoft, Oracle, athenahealth, Epocrates, Siemens, UnitedHealth Group, Teladoc, the Silicon Valley Chapter of Health 2.0 and StartUp Health have asked HHS to delay the FDA’s final guidelines on mobile medical apps until the workgroup [FDASIA workgroup] finishes."

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FDA - Hurricane Safety Checklist

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Public Health Focus > Hurricane Safety Checklist:

"The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves, their families, and their pets during and after any hurricane-related rain, possible flooding and power outages.

The agency also reminds consumers that it is important to have a plan in place for emergency medication and medical supplies for both people and animals. This is especially true for those with health concerns, particularly if the power goes out.

In general, FDA encourages consumers to: . . . "

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Medical Device Tax Repeal Applauded

Medical Device Manufacturing Coalition Applauds Passage of Medical Device Tax Repeal Amendment | MedicalDevices.org:

"“Today’s overwhelming support of the amendment shows that clear majorities in the Senate and the House of Representatives recognize that the medical device tax needs to be repealed so that America’s medical technology community can spur growth and create the great jobs that come along with it,” said Mark Leahey, President and CEO of MDMA. “Every day innovators in this dynamic industry are looking at how to improve the quality of life for patients, and the medical device tax is standing in the way of progress and threatening America’s leadership position. While we have more work to do, MDMA applauds this important step towards ensuring that the United States remains the global leader in medical technology innovation.”"

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Device-Makers Critical of Medicare Competitive Bidding

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Device-makers slam Medicare competitive bidding expansion - The Hill's Healthwatch:

"The medical-device lobby is railing against a new expansion of Medicare's competitive bidding program for durable equipment, a policy projected to save billions of dollars for beneficiaries and the Part B Trust Fund by 2022.

The Advanced Medical Technology Association (AdvaMed) said that the expansion could deprive patients of their preferred medical tools and tests.

"The competitive bidding program is built in such a way that the lowest bid — which may not be the right bid — may compromise patient access to products best suited for their needs," AdvaMed President Stephen Ubl said Thursday in a statement. "

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The Only Vote That Counts: FDA 483 Round-Up

The Only Vote That Counts: FDA 483 Round-Up:

"Looking at the FDA isn’t much different. Lots of folks like to predict what the FDA will do, or try to glean trends from the often cryptic public statements FDA officials make at conferences or other gatherings.  But the FDAs real “votes” are in the 483s they issue.

Reading through a recently-released crop of the agency’s medical device letters, it looks like the FDA is maintaing an interest in CAPA and employee training."

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Related articles

• FDA's Top Supplement Issues (drughealth.blogspot.com)

ECRI Names Top 10 Health Technology Hazards for 2013

ECRI Names Top 10 Health Technology Hazards for 2013 | HITECH Answers:

"What topics made the list?  Here’s the rundown:

1. Alarm hazards
2. Medication administration errors using infusion pumps
3. Unnecessary exposures and radiation burns from diagnostic radiology procedures
4. Patient/data mismatches in EHRs and other health IT systems
5. Interoperability failures with medical devices and health IT systems
6. Air embolism hazards
7. Inattention to the needs of pediatric patients when using “adult” technologies
8. Inadequate reprocessing of endoscopic devices and surgical instruments
9. Caregiver distractions from smartphones and other mobile devices
10. Surgical fires

Of particular interest to us is that for the first time, three Health IT-related topics made the Institutes annual list."

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