FDA Safety Communications > Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication

• FDA CGMP Online Training - respected GMP online training courses provided by SkillsPlus International Inc.

Updated October 15, 2022

Previous links broke.

You might also be interested in:

Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication - FDA.gov

---  the original post follows well below  ---

Updated March 26, 2021

The link broke.

People also search for:

The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication - FDA.gov

---  original post follows below  ---

Read the entire communication: Safety Communications > Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication - FDA.gov:

"The FDA wants to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Scientists Find a Way to Block HIV from Infecting Healthy Cells | TIME

Read the full article: Scientists Find a Way to Block HIV from Infecting Healthy Cells | TIME:

"Michael Farzan, professor of infectious diseases at Scripps Research Institute, and his team used a gene therapy technique to introduce a specific HIV disruptor that acted like gum on HIV’s keys. Once stuck on the virus’s surface, the peptide complex prevents HIV from slipping into the molecular locks on healthy cells. "

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA on Tattoos and Permanent Makeup

Updated November 18, 2024

The original link broke.

---  the original post follows below  ---

FDA Webinar on Tattoos and Permanent Makeup (PDF):  'via Blog this'

The FDA hosted a webinar on tattoos and permanent makeup. Bhakti Petigara Harp, Ph.D., of the Office of Cosmetics and Colors, Division of Color Certification and Technology in FDA's Center for Food Safety and Applied Nutrition, provided an overview of the composition of tattoo and permanent makeup inks and the pigments used in them, as well as their regulatory status. Dr. Petigara Harp talked about problems that have occurred with the use of these inks, such as allergic reactions, infections, and scarring, and addressed FDA's response to these occurrences. She also discussed misrepresentation of these inks and pigments as "FDA approved." 

Background:
FDA considers the inks used in intradermal tattoos, including permanent makeup, to be cosmetics and considers the pigments used in the inks to be color additives requiring premarket approval under the Federal Food, Drug, and Cosmetic Act. However, because of other public health priorities and a previous lack of evidence of safety concerns, FDA traditionally has not exercised its regulatory authority over tattoo inks or the pigments used in them. The actual practice of tattooing is regulated by local jurisdictions. In addition, concerns raised by the scientific community regarding the pigments used in these inks have prompted FDA to investigate the safe use of tattoo inks. FDA continues to evaluate the extent and severity of adverse events associated with tattooing and is conducting research on inks. As new information is assessed, the agency will consider whether additional actions are necessary to protect public health.
Image via Wikipedia

Additional Resources:
Tattoos & Permanent Makeup: Fact Sheet - FDA.gov

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog

New Gel Reduces HIV Infection in Women

Updated July 1, 2025

The report of the results of Safety and Effectiveness of 1% Tenofovir Vaginal Microbicide Gel in South African Women: Results of the CAPRISA 004 Trial. 

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors

FDA Focus On Contact Lens Use And Safety - Medical Device

Approximately 30 million U.S. contact lens wearers use a variety of lens care products available in most pharmacies. Improper care of contact lenses can lead to a variety of eye infections. Over the past few years the FDA has been working to reduce risks of eye infections.

The FDA reinforces the latest thinking in its post, Looking Good: Safe Use and Care of Contact Lenses (May 2010).

For even more information, go to the webpage, FDA Contact Lenses.

Return Home: http://drughealth.blogspot.com/

FDA Says Yes to IV Peramivir To Treat Flu

The FDA announced today that it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. Specifically, IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically appropriate, based on one or more of the following reasons:

• the patient is not responding to either oral or inhaled antiviral therapy, or
• when drug delivery by a route other than an intravenous route -- e.g., enteral (absorbed by the intestines) or inhaled -- is not expected to be dependable or feasible;
• for adults only, when the clinician judges IV therapy is appropriate due to other circumstances.

I've been following this drug for sometime now, and I'm glad to see that it's found a niche during this flu pandemic. Additional Related Information From The FDA: EUA Letter of Authorization EUA Fact Sheet for Health Care Providers EUA Fact Sheet for Patients and Parents/Caregivers Information for Healthcare Professionals Sheet (HCP) on mandatory adverse event reporting for emergency use of peramivir under EUA 

Previous Posts: FDA Search Widget of Fraudulent H1N1 Products Got Wine Flu? Flu.gov Updated by HHS - New Resources Added 

Return Home: http://drughealth.blogspot.com/ 

Medical Devices Infected By The Conficker PC Worm

Be very afraid. Hospital and medical devices have been found to be infected by a computer worm (kind of like a virus), reports this Mercury News article, Conficker worm hits hospital devices, "A computer worm that has alarmed security experts around the world has crawled into hundreds of medical devices at dozens of hospitals in the United States and other countries, according to technologists monitoring the threat." What I find so disturbing in the article is, "the working group has seen thousands of other machines located in hospitals reach out to the Conficker mastermind by contacting another computer on the Internet for instructions." The potential danger could be leaking of your health information, or the medical devices could be recruited as robots in an attack on other computer systems. Isn't technology grand!? 

Related Posts: Read Or Download The GAO Report - The FDA And High Risk Medical Devices (pdf) 2009 - Top 10 Trends For The Medical Equipment Market 

Return Home: http://drughealth.blogspot.com/ 

New Guidelines Released for HIV Opportunistic Infections

The first complete update in five years of the U.S. guidelines for preventing and treating HIV-associated opportunistic infections has been released by the National Institutes of Health (NIH) and the Centers for Disease Control (CDC) and Prevention in cooperation with the HIV Medicine Association of the Infectious Diseases Society of America (IDSA). The new Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents apply state-of-the-art science and medicine to 29 infectious diseases of concern. More than 140 medical experts contributed their knowledge to this edition of the guidelines, released on April 10. These new guidelines can be viewed in either html or pdf formats: Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents (html) or Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents (pdf) 

Related Posts: CDC Adopts 2 New HIV Intervention Approaches HIV Pre Exposure Prophylaxis - Very Sharp Two Edged Sword HHS Updates HIV Treatment Guidelines (free pdf) 

Return Home: http://drughealth.blogspot.com/ 

FDA Advice About Pet Turtles And Salmonella Risk

• Trusted FDA GMP online training courses and programs by SkillsPlus International Inc.

Updated December 5, 2021

The original link broke.

You can still read about the same topic here:

Pet Turtles: Cute But Commonly Contaminated with Salmonella - FDA.gov

---  the original post follows below  ---

Turtles may look like cute pets, but it is estimated that they are responsible for over 70,000 cases of Salmonella infections every year in this country. Some of these infections can be serious or even fatal. In one case, a four week-old infant died of a Salmonella infection that was traced to a pet turtle in the home. In another case, two teenage girls became very ill after they swam in an unchlorinated family pool where pet turtles had been allowed to swim. Read or watch the FDA information about this, FDA report on Potentially Fatal Salmonella Infections from Pet Turtles. Personally, I had trouble viewing the video. But even with that, the text information is still valuable. 

Return Home: http://drughealth.blogspot.com/ 

HIV Pre Exposure Prophylaxis - Very Sharp Two Edged Sword

Pre-exposure prophylaxis (PrEP) against HIV infection just got a huge spotlight, in this ABC News article, ABC News Examines Pre-Exposure Prophylaxis For HIV Prevention. It seems that HIV drugs taken within days after exposure to the virus have been shown to reduce the risk of infection. Part of the debate is whether approval of such pills could lead some high-risk groups to forgo safe sex practices such as condom use.

After reading this, I'm wondering if we should all be worried about prEP usage without safe sex practices. Are you worried?

Related Posts:
Abzymes Pinpoint The HIV Achilles Heel
109 HIV Drugs And Vaccines Under Development
HHS Updates HIV Treatment Guidelines (free pdf)
HIV Hope and Breakthrough - Abzymes Attack HIV Achilles Heel (video)

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Ever Wonder How Bleach Kills Bacteria?

Not my usual kind of post, and for some reason this caught my eye. Perhaps it's because of my microbiology and healthcare training background, and throw in my obsession with cleanliness. I've always just enjoyed and taken for granted, the marvelous cleaning power of bleach. Until now, I've never stopped to consider, "How Bleach Kills Bacteria." This Medical News Today report is fun to read as it . . .

1. Explains how bleach attacks essential bacterial proteins in a way that's similar to the effect of high temperatures
2. Discusses hsp33 (heat shock protein) and "molecular chaperones"
3. Highlights the potential of this finding to give a better understanding of how our bodies might fight off bacterial infections

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Health Dangers In Flood Waters - Health Tips

With all the hurricanes and inclement weather around us, we've got some flooding going on. If you find yourself in flood waters, here are some very important health tips to follow, and health issues to consider . . .

1. Flood waters can contain fecal material from overflowing sewage systems as well as other contaminants from a variety of sources.
2. There is a risk of disease from eating or drinking anything contaminated by flood water.
3. If you have open cuts or sores that will be exposed to flood water, keep them as clean as possible by washing well with soap to control infection. If a wound develops redness, swelling or drainage, promptly seek medical attention.
4. Fish or seafood caught from these waters should be thoroughly cooked prior to eating. After handling fish and seafood, be sure to thoroughly wash your hands with soap and clean water.

Source: Public Reminded To Use Caution In Flood Waters

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

It's Summer - Do You Have Swimmer's Ear?

It's hot out, and you're swimming alot. Now your ears are bothering you. Do you have swimmer's ear? Check out the information at the Mayo Clinic online, "Swimmer's ear."

Hoping all is well with you. And if you have swimmer's ear, you'll have suspected it, checked out what you can do on your own, and have consulted a doctor as needed. Wishing you the best in the remaining days of Summer.

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Tomatoes - Yes! Jalapenos, Serranos - uhh, no. (video)

Yay! This latest CBS News Video, "FDA Lifts Tomato Warning," says it's safe to eat tomatoes, and it's still time to be cautious about Jalapeno and Serrano peppers (because of the Salmonella scare). 

 

Well, I'm ready to start eating my tomatoes in salads, on hamburgers, and with pasta. But you know what? I'm still going to be a little leery and sheepish about fresh jalapeno and serrano peppers. And definitely I'll be cautious about salsas. Here's to good summer eating! 

Prior blog posts: 

The Health, Drug, Prescription, and GMP Supersite: Food Scare - Was Tomatoes, 

Might Be Jalapeños and More#links 

The Health, Drug, Prescription, and GMP Supersite: FDA Unveils Food Protection Plan 

Return Home: http://drughealth.blogspot.com/ 

Food Scare - Was Tomatoes, Might Be Jalapeños and More

 

In the latest update to the Salmonella tomato story, the blame is starting to shift to other food items that are commonly eaten with tomatoes. It's an interesting twist as tomatoes are no longer seen as the prime suspect for Salmonella. The latest culprits now include jalapeño peppers, cilantro, Serrano peppers, and salsas. The FDA and CDC teams continue their investigation to find the source of Salmonella. For more background, read the previous post: FDA Announces Progress in Its Protection Plan. As for me, no more tomatoes, peppers, cilantro, or salsa for now. I'm hoping the investigative teams discover the root cause, and identify the food handling deviations leading to the Salmonella contamination. 

Return Home: http://drughealth.blogspot.com/

FDA Unveils Food Protection Plan

In the FDA's news release two days ago, they report progress in helping to keep Americans enjoying one of the safest food supplies in the world. The FDA lists their accomplishments to date, in the areas of prevention, intervention, and response. I imagine this update was released given the fact that many of us keep asking ourselves whether it's safe to eat tomatoes. As a personal health and safety issue, though I've not stopped eating tomatoes, I worry about when I might run into and eat a Salmonella tainted tomato and get sick.

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/