T. J. Kuhn | GxP Zone

Good Practice for the Pharmaceutical Industry from the Quality Assurance Perspective

That’s where I’d go to cry…

Posted by tjkuhn on September 14, 2017

A few months ago, I underwent surprise heart surgery to repair my mitral valve (it was leaking in a major way). I have the explanation that I give to people that ask about it down pat. I vainly make sure they know it wasn’t a heart attack, that I don’t have clogged arteries, that it was a genetic defect, that in all other ways I’m completely healthy, that it wasn’t my fault. I am not shy about it when they ask.

.

And ask they do. “How are you feeling?” “What happened?” “Do you have any restrictions?”  And comment. “We really missed you”. “It is so good to have you back”. “My husband had something very similar; feel free to call him if you have any questions”. (I never did). “You look great”. “I’m so impressed at how quickly you’re recovering”. “You do a 5k every day? That’s great!” “Wow, I didn’t expect to see you back at the boxing gym so soon”.  “You’re coaching soccer again! That’s great!” “How are you feeling?” The support and good sentiments have been overwhelming. People at work, people on facebook, neighbors, friends, family. They all let me know how much they care and I really appreciate all of it. But that’s not what I wanted to share just now.

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My wife, Susan, has been a rock during all of this. She really kept it all together: watched over me while I was in the hospital, kept the kids grounded, waited for me during during my diagnostic and repair surgeries, and took care of me when I got home. And while having surgery (and particularly cardiac surgery) is a scarey thing, I think it is much worse for the significant others than for the actual patient. This was brought home to me when during a post surgery checkup at the hospital, I noted a bank of windows along a corridor that I hadn’t noticed before and commented on them to Sue (who had driven me and accompanied me to the appointment). She looked sadly at me and told me, “Yeah, that’s where I’d go to cry”. I looked at her, a little bit startled.

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She had to see me with heart monitors, oxygen masks, eKG leads, tubes, tubes, and more tubes all coming out of me. She had to watch them prep me for procedures. She had to wait while I was in surgery. For. Six. Hours.  She had to go home and explain to preteen children what was going on without unduly scaring them. She had to keep it all together for them. She had to contemplate the prospect that she might be planning a funeral shortly. She had to spend time beating herself up with guilt over symptoms that neither of us noticed in the moment, but suddenly remembered in retrospect.  After I was home,  she had to help me into and out of the shower, get things for me,  drive me places, help me on the stairs, see me in my weakened state. She spent a lot of time blaming herself for something that wasn’t her fault.

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So she saved most of her crying for that lonely hospital corridor.

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Like me, she gets a lot of questions, but unlike me, the questions she gets usually aren’t about how she’s doing. They’re about me, about how I’m doing. “How’s Tim?” “I saw Tim’s picture on Facebook, he looks great!” “Is Tim doing ok?” “Is he back to work yet?” “We were so happy to hear about his recovery” “How’s Tim?”Don’t get me wrong, there were those who made sure she was ok. Joanne took care of the kids. Michelle took care of Sue and stayed with her during the surgery. And Tara made sure the family was fed. I can never thank them enough. The medical team at Saddleback Memorial were also great, both in their care of me and in their sensitivity to Sue. There were others who were looking out for her, but for the most part, it has been all about me.

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So, I offer up these thoughts and observations to thank my wife for going through it all for me (Love you, sweets!), to thank those who looked after her, and to highlight in a small way how much harder it can be for those who wait, for those who need a place to cry.
~TJK
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Equifax Breach

Posted by tjkuhn on September 8, 2017

Equifax says a giant cybersecurity breach compromised the personal information of as many as 143 million Americans — almost half the country.

 

http://money.cnn.com/2017/09/07/technology/business/equifax-data-breach/index.html

 

 

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Flu Vaccine Study in Maryland

Posted by tjkuhn on September 7, 2017

The NIH is looking for some volunteers.

Healthy Volunteers needed for an investigational flu vaccine study.

According to the Centers for Disease Control and Prevention (CDC), an estimated 310,000 people in the United States were hospitalized for flu-related illness during the 2015-2016 flu season.

Researchers at the National Institutes of Health (NIH) Clinical Center are testing investigational vaccines to determine if they are safe and effective at preventing influenza.

During the study you will:

Complete a health screening including medical history, physical exam and blood tests

Receive either 1 or 2 investigational flu vaccines

Have 8-10 outpatient visits that may last up to 40 weeks

Receive compensation for your participation 

You may be eligible if you:

Are healthy and between the ages of 18 and 70 (excludes those born from 1966 to 1969)

Have a BMI less than or equal to 40 (calculate your BMI at https://go.usa.gov/x5My6)

Do not have any medical conditions such as diabetes, hypertension, heart disease or psychiatric condition

Are not pregnant, breastfeeding, or planning to become pregnant

This study is being conducted at the NIH Clinical Center, America’s research hospital is located on the Metro red line (Medical Center stop) in Bethesda, Maryland.

For more information, call:
1- 866-444-1132
TTY: 1-866-411-1010
Se habla español
Online: https://go.usa.gov/xNH7U

Refer to study # NIH 17-I-0110

 

 

~TJK

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NIH: Robotic Exoskeleton Could Be Right Step Forward for Kids with Cerebral Palsy

Posted by tjkuhn on September 5, 2017

This is very cool!

#VeryCool

Robotic Exoskeleton Could Be Right Step Forward for Kids with Cerebral Palsy
09/05/2017 09:55 AM EDT
https://na01.safelinks.protection.outlook.com/…

More than 17 million people around the world are living with cerebral palsy, a movement disorder that occurs when motor areas of a child’s brain do not develop correctly or are damaged early in life. Many of those affected were born extremely prematurely and suffered brain hemorrhages shortly after birth. One of the condition’s most […]
Robotic Exoskeleton Could Be Right Step Forward for Kids with Cerebral Palsy
09/05/2017 09:55 AM EDT

More than 17 million people around the world are living with cerebral palsy, a movement disorder that occurs when motor areas of a child’s brain do not develop correctly or are damaged early in life. Many of those affected were born extremely prematurely and suffered brain hemorrhages shortly after birth. One of the condition’s most […]

More than 17 million people around the world are living with cerebral palsy, a movement disorder that occurs when motor areas of a child’s brain do not…
DIRECTORSBLOG.NIH.GOV

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NIH Reports: Brain Scans Show Early Signs of Autism Spectrum Disorder

Posted by tjkuhn on February 21, 2017

 of NIH posted this today on their blog. My wife works with ASD children and what with the challenges around diagnosis and early treatment, I found it very interesting. Medical imaging will continue to expand its role into healthcare for the foreseeable future.

~TJK

Brain Scans Show Early Signs of Autism Spectrum Disorder

Unhappy baby

For children with autism spectrum disorder (ASD), early diagnosis is critical to allow for possible interventions at a time when the brain is most amenable to change. But that’s been tough to implement for a simple reason: the symptoms of ASD, such as communication difficulties, social deficits, and repetitive behaviors, often do not show up until a child turns 2 or even 3 years old.

Now, an NIH-funded research team has news that may pave the way for earlier detection of ASD.

Full Article – https://directorsblog.nih.gov/2017/02/21/brain-scans-show-early-signs-of-autism-spectrum-disorder/

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Approved: First fully absorbable stent

Posted by tjkuhn on July 5, 2016

FDA approves first absorbable stent for coronary artery disease

07/05/2016 11:04 AM EDT

 

The U.S. Food and Drug Administration today approved the first fully absorbable stent to treat coronary artery disease. The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), which releases the drug everolimus to limit the growth of scar tissue, is gradually absorbed by the body in approximately three years.

 

Pretty cool.

~TJK

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WHO: GOOD DATA AND RECORD MANAGEMENT PRACTICES

Posted by tjkuhn on February 22, 2016

Some good stuff in this guidance….particularly the bit on True copies…..

GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES (SEPTEMBER 2015) DRAFT FOR COMMENT

True copy: A true copy is a copy of an original recording of data that has been certified to confirm it is an exact and complete copy that preserves the entire content and meaning of the original record, including in the case of electronic data, all metadata and the original record format as appropriate.

Full Guidance:  http://www.who.int/medicines/areas/quality_safety/quality_assurance/Guidance-on-good-data-management-practices_QAS15-624_16092015.pdf

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FCC votes to “unlock the cable box”

Posted by tjkuhn on February 21, 2016

I like seeing disruption in the technology sphere from the technology side rather than the regulatory side. It happened to be the Republicans on the regulatory side, but the Dems have their days too.

~TJK

http://arstechnica.com/business/2016/02/fcc-votes-to-unlock-the-cable-box-over-republican-opposition/

 

FCC votes to “unlock the cable box” over Republican opposition

Customers should be able to watch TV on any device without CableCard, FCC said.

The Federal Communications Commission today approved a Notice of Proposed Rulemaking (NPRM) that seeks to give consumers more choices in the set-top boxes they use to watch cable TV.

The vote was 3-2, with Chairman Tom Wheeler and fellow Democrats Mignon Clyburn and Jessica Rosenworcel voting in favor of the proposal, while Republicans Ajit Pai and Michael O’Rielly voted against. An NPRM is not a final vote. Instead, this will kick off a months-long public comment period leading up to a final vote that is likely to happen before the end of this year…..

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Vaccines, Real Medicine

Posted by tjkuhn on February 19, 2016

I’m so tired of #Homeopathabullshit….

~TJK

Posted in Bioethics, Data Integrity, Health Care, Healthcare, Safety, Uncategorized | Tagged: , , , , , | Leave a Comment »

Sharepoint White paper on Part 11

Posted by tjkuhn on February 19, 2016

As published by Microsoft

SharePoint 2013 Configuration Guidance for 21 CFR Part 11 Compliance

Thoughts?

~TJK

 

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