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Given the increasing frequency of infections issues related to reprocessing of duodenoscopes at FDA and the subsequent remedial post market studies they are requiring, It is becoming apparent that the methods used to clean and disinfect/sterilize reusable medical devices require some level of review in light of the emerging science about antibiotic resistant bugs. As documented in The Lancet Infectious Diseases, researchers estimate that between 38·7% and 50·9% of pathogens causing surgical site infections are resistant to standard prophylactic antibiotics in the USA. A 30% reduction in the efficacy of antibiotic prophylaxis for these procedures would result in 120 000 additional surgical site infections and infections after chemotherapy per year in the USA (ranging from 40 000 for a 10% reduction in efficacy to 280 000 for a 70% reduction in efficacy), and 6300 infection-related deaths (range: 2100 for a 10% reduction in efficacy, to 15 000 for a 70% reduction). We estimated that every year, 13 120 infections (42%) after prostate biopsy are attributable to resistance to fluoroquinolones in the USA. http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(15)00270-4/fulltext
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Karen Boyd, ASQ CQA
Equipment used on chemotherapy patients or those suspected of diseases, such as CJD, should be quarantined and destroyed! There is no known method of effective sterilization for instruments used in these cases.
I believe the primary issue with the duodenoscope manufacturers is their failure or lack of creating / implementing appropriate user instructions / IFU's for reprocessing of these devices. Marked as spam
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Mike Helmus
Resterilization should meet the same requirements of bioburden and D values equivalent to implantable devices, eg 10 -6 logs of kill. As you say, if this is not realistic, then resterilization should not be done. A couple decades ago, synthetic vascular grafts and Mechanical heart valves were resterilized if opened in the operating room and not used. This practice disappeared, I believe because documenting effective kill was not possible in a hospital setting!
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Mike Helmus
Though now on the older side, the book by Seymour Block on Sterilization, Disinfection, and Preservation is a wealth of information. https://books.google.com/books?id=3f-kPJ17_TYC&printsec=frontcover#v=onepage&q&f=false
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Nick Di Napoli
Endoscopes in general, Flexible or Rigid can be difficult to clean properly, especially if SPD is not in-serviced properly.
Also, smaller 3rd party companies that do repairs at a cheaper rate can have higher infection rates rather than sending it back to the original manufacturers due to their facilities not be properly decontaminated or operating at an FDA approval level. Also, 3rd party companies will cut corners on repairs to make more money because they don't have the resources of an OEM to repair the scopes properly. This is a huge problem and probably more infection rates come from poor sterilization process across the country. Marked as spam
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Roshni Rajput
I believe there are other factors which one has to consider after a surgery like Smoking, Having a weakened immune system, Having other medical problems or diseases etc
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Mike Helmus
You are correct. As we note in our chapter, “Medical Device Infections" pp. 957-966 https://lnkd.in/bJ6j5Hu, “The introduction of a foreign material into the body facilitates infection …easier access of external bacteria to the interior of the body; easier adherence of bacteria to the device because of local inflammatory reaction; clinically silent colonization of the device by bacteria embedded in the protective biofilm; release of free bacteria from the biofilm into tissues or blood; concurrent reduction of the body’s ability to fight infections locally and also systemically when patients receive anticancer or immuno-suppressive drugs; emergence of clinical infections, in which biofilms are resistant to known antibiotics.” The salient question here is whether “reusable” devices can be adequately resterilized whether on site or shipped off-site to meet the same sterility specifications of a one-time use device and that a quality system can be established to document and assure that level of sterility! Though contamination by CJD is considered extremely rare, other than pyrolysis and high concentrations of NaOH, a potentially contaminated device cannot be adequately decontaminated.
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Roshni Rajput
I came across an article which said catheter-related infections contribute to the increasing problem. How can one get rid of this problem?
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Mike Helmus
Roshni Rajput , this problem is longstanding (see citation below), & improvements in materials, coatings, and design can mitigate infection, the key factor is METICULOUS Adherence to Infection Control Protocols. eg M. N. Helmus, C. Raleigh, J. McGrath, J. Tolkoff, "Medical Device Design - A Systems Approach: Central Venous Catheters," Advanced Materials,: Looking Ahead to the 21st Century, Transactions, 22nd International Proceeding of Society for the Advancement of Material and Process Engineering, Nov. 1990, Boston, MA.
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Mike Helmus
Timey for this conversation: http://www.computerworld.com/article/2993386/big-data/penn-medicine-s-big-data-system-triggers-early-detection-of-life-threatening-infections.html?utm_content=bufferc117a&utm_medium=social&utm_source=linkedin.com&utm_campaign=buffer
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Karen Boyd, ASQ CQA
Great input, Mike! Thanks for your knowledge and contributions.
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Sidelight of antibiotic resistant bugs is that the "good bugs" are often the first ones killed. We live with tens of thousands of different bacteria which don't cause problems.
Is there a possibility that we could identify 'good' bacteria which we could used to crowd out the 'bad' bacteria? That would not be an antibiotic and thus antibiotic resistance would not occur. I know some researchers are looking at the good bacteria but don't know how far they have progressed. The ultimate armageddon race in antibiotics is that the worst bacteria we "train" with antibiotics win & wipe out humans because we wiped out all the bacteria who could moderate the bad guys. Marked as spam
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NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Of Note about probiotic's: The normal human stomach has very acidic conditions with the pH
sometimes as low as pH 1.5 due to hydrochloric acid and in addition there are significant amounts of proteolytic enzymes being secreted into the stomach that attack and digest protein. So for the majority of so called Probiotics including certain "Probiotic" Yogerts that are claimed to be effective and helpful to reconstitute intestinal flora well in the majority of cases that appears to just be BUNK! Many Numerous Multiple scientific research studies widely published in peer reviewed credible well recognized scientific journals have shown that the Probiotic yeasts and Lactobacilli do not survive the severe acid hydrolysis conditions alone for any appreciable time and then the proteolytic enzymes attack the bacterial protein walls and destruction results. Only a couple of products that have specially designed thick hard walled pearl like beads which will pass through the stomach and reach their intended target the intestines may be effective in helping to reconstitute intestinal microbial normal flora. Marked as spam
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NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Considerations of Normal intestinal gut Flora and Antimicrobial drug effects and therapeutic approach. One of the adverse effects of antimicrobial treatment as mentioned by numerous folks is that the antibiotic kills the pathogen if the mechanisms of resistance described in my previous post are not at play and kills the normal flora gut bacterial. The reduction or elimination of normal intestinal microbial flora may cause mal-absorption of nutrients due to the loss of the normal flora and its capability to convert food derived nutrients into molecules that can be absorbed through the intestinal wall into the bloodstream. Conversely,without antibiotics there would be a huge at least 1000X increase in morbidity and mortality due to untreated infections leaving many patients with long term disability, poor quality of life and reduced lifespan if they survived the infection.
So this is the grand dilemma the great debate that medical providers have to weigh every day when they consider prescribing antibiotics. So we have to think is it wise to not use antibiotics are the non-use consequences acceptable? When we look at this there are major factor to consider what about contagious infectious bacteria Staphlococcal and Streptococcal impetigo skin infections, Flesh eating Strep infections, highly infectious and highly fatal Bacterial Meningitis. Right now the only real time effective treatment to prevent the spread of these and other highly communicable diseases is antibiotic treatment. However, there are other equally important considerations for example: Untreated Strep throat caused by Streptococcus pyrogenes Group A is now understood and widely accepted as a causative agent of severe a form of Rheumatoid Arthritis in some patients that develops years later. What is believed to occur is the untreated Strep infection results in antibodies being made and that as we age the antibodies become less specific and begin to attack the proteins of the bone joints which is a protein quite similar to that to the Streptococcus bacteria. This results a severe auto-immune disease causing great pain suffering and crippling disabilities in many cases. The severity becomes worse over time and with advanced age. This is now termed post streptococcal reactive arthritis. It is widely believed that the if infection was treated effectively the antibody response to it would be minimal and the chance of the development of autoimmune post streptococcal reactive Rheumatoid arthritis would be greatly reduced. Marked as spam
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NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
The development of resistant microorganisms has in past extensively been attributed to a genetic transfer of drug resistance defensive changes from one species to another. For example many pathogenic bacteria developed the ability to make Beta Lactamase an enzyme that attacks the Lactam ring structures found in penicillin and and other antibiotics that include Lactam rings in their structures. It was found in numerous research studies that inoculation of non-resistant strains onto the same culture media inoculated with Beta Lactamase positive strains resulted in the non-resistant strain becoming resistant due to having adopted the same Beta Lactamase production capability. This pathogen associated Technology Transfer was deemed a drug resistant gene mutation and shown to be the result of transfer of genetic material between the species. Now increasingly we hear terms from physicians to the effect of "the patient became resistant to certain antibiotics". From a scientific viewpoint this seems to suggest that the patients have developed antibodies to the antibiotics which with repeated use is potentially true.
If you consider that the antibiotic is a foreign molecule material then repeated exposure are immunizing and acting the same way that immunizations of test animals produce antibodies of increasing strength titre and specificity. This attenuation of humoral and cellular immune responses may be a root cause of these antibiotics becoming less effective because they are being targeted by the patients immune system and even an antibody coating of the active pharmaceutical ingredient API anti-Microbial drug may render it partially or totally ineffective to physically interact with pathogenic microorganisms causing infection. Additionally, part of the immune system reaction effectively tags the antibiotic for secondary cytokine and plasma proteases and killer T-Cell and peripheral blood Monocyte macrophage attack. This attack may involve that the drug substance is phagocytized into Monocytes and removed through the Reticuloendothelial system also termed mononuclear phagocyte system (MPS). Therefore, in such scenario the drug is by one or more of these actions rendered ineffective and the MPS system reduces the drug Bioavailability. This reduction lowers the amount of free and active antimicrobial drug to below the therapeutic level known to be effective to treat the infection based upon the drugs antimicrobial susceptibility tests results or minimal inhibitory concentration (MIC) level demonstrated to be be effective. So in such case the apparent resistance of the pathogenic microorganism may not be due to the isolates changed defense abilities or may be due to a combination of these phenomenon Marked as spam
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NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Here I would provide an example case of how serious this issue is, this is a real life case involving a dear friend. My friend had a 3.5 hour serious pelvic and lower abdominal surgery. Due to the nature of and cause for the surgery the surgeons and physicians collective decided to leave an open wound in her abdomen that was 4 cm deep and approximately 8cm wide. The reasoning was that is they sutured and closed the wound it was known that a high incidence of patients that had the same surgery developed a sort of pouch over their bladders and that in turn led to recurring bladder infections. So the idea was to let the wound heal and close from within. The wound would have to be cleaned and re-packed daily and would require a month to 1.5 months to heal. As they did not want to quote "over use antibiotics" none were given or prescribed and she was sent home with this wound and a visiting nurse sent in to clean and repack the wound daily. At the same time after any major surgery the body produces a large amount of cortisol which acts like the Corticosteroid drug Prednisone and is immuno-suppressive and it will cause a pre-diabetic patient to develop severe hyperglycemia with out of control blood sugar glucose levels of over 700, for diabetic patients this is a life threatening result. This was the case here and those of us having Microbiology Bacteriology backgrounds know that bacteria love sugars and it greatly favors their growth and is an additive to almost all culture media.
Now as the ambient air in a non sterile environment contains dust particles that may carry bacteria on them, and because the visiting nurse is not performing the procedure under sterile conditions it was only a week before my friend developed a sudden high fever and raging post operative infection that became so severe that she developed a blood infection. Upon questioning the doctors of why they thought it was OK to send her home without any antibiotics in that susceptible condition they spouted the "Over-Use of antibiotics justification." So I responded so now she has a severe post-op infection and a blood septicemia and now you have her on not one but four of the strongest antibiotics known to man trying to save her life from a totally preventable infection. The open wound should have been encapsulated to keep sterile and cleaned and repacked under a portable sterile procedure tent that is placed over the abdomen and a prophylactic antibiotic would have been thoroughly justified. Do they think the 4 strongest antibiotics given IV around the clock somehow reduced the use of antibiotics? What about the patient. Well my friend luckily survived the horrible infection but the wound tissue damage was so severe that it required her to be bedridden and undergo 6 months of total disability and severely painful daily wound cleanings and repackings. In order to treat the severe pain and suffering she was required to take Percocet a highly addictive Opioid drug daily for 6 months. If a prophylactic antibiotic have been given infection would have been prevented, secondary nearly fatal septicemia blood infection would have been prevented and the wound would have healed properly and faster and so the morbidity and the pain and suffering of the patient would have been far less, and the total disability would have been far shorter. So this is the great dilemma and the approach taken in this case severely risked the patient and caused her pain and suffering, medical expenses and disability to be far in excess of what should have been. All is based upon this irrational fear of using antibiotics properly when medically indicated, antibiotics were designed to treat infections it is what they are specifically for, to prevent and treat potentially fatal infections. Marked as spam
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Roshni Rajput
Good Share! There has been a tremendous growth in diseases resulting from contaminated devices as well as invasive procedures. While the count of dialysis related infections are increasing, research analysts at Allied Market Research confirm that infection of pacemakers and catheters are also common. Contaminated devices are also responsible for causing abscesses in the injection site. Healthcare facilities including nursing homes, outpatient facilities etc. are becoming breeding grounds for nosocomial infections. So I believe hospital infection control programs worldwide should be strengthened. Can you share some measures to prevent nosocomial infections?
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Willi Glettig
Ladies and Gentlemen
Nice talk but unfortunately only talk. Everybody is more or less aware about nosocomial infections (Worldwide 6 Mio people per annum are affected and about 600 K die from nosocomial infection. In Europe four to five times more people die in hospital than through traffic accidents on the road!) We have three categories of technologies to sterilize equipment (Chemical, radiation and thermal). But they are more than 25 year old and insufficient for today’s demands in the market. That is why nosocomial infections are growing. In the past few years many hospitals have introduced training programs that motivate employees to wash hands more often. Medtech manufacturers launch disposables. Both strategies increase costs but so far were unable to stop or reduce growth of nosocomial infections. Increasing regulation will not solve the hospital infection problem. The fundamental problem is that the causers are invisible and in a way unknown quantities. (We don’t know much about the stability and toxicity of prion like molecules, hydrolysate of proteins (metabolites), peptides, mycotoxins etc.) Thus nobody is responsible or can be held responsible for the cause of nosocomial infections. Fifteen years ago I started together with one of the most knowledgeable, skilled and serious cold plasma researcher (who at that time was also dean in a leading university) to take on the fight against the nosocomial infection problem. Over more than ten years we invested more than € 10 Mio in research, one million in prototype development and substantial funds to form a company limited by shares. Finally we were seeking an additional € 2.5 Mio through sales of shares. We offered our deal to Strategic investors, VC and recently to current clients from my other business interest. All strategic investors and venture capitalist had no interest to finance the commercialization of our technology but to grab our IPR and to control our know-how and technology. In addition most VCs wasted our time and did not have equity funds to invest. Our technology is a real advancement in cold plasma technology relative the Sterrad process. (Sterrad is a peroxide process that uses plasma the neutralize peroxide and more than 25 years old). Our process eliminates at room temperature everything organic (Bacteria, virus, prions, mycotoxins, secondary metabolites, proteins, peptides) on surfaces at molecular level within seconds. Our process breaks down C-N and C-O bonds to CO, CO2 and methane. It penetrates pores and perforates endospores. We have a huge amount of research data gathered through PhD theses and together with leading research institutions. Our technology is not an academic game but something that can tangibly reduce the burden of nosocomial infection. We created a new technological basis, a new world to tackle nosocomial infection. As repeat entrepreneurs we invest our time and money to create tangible solutions for real problems but only together with serious investors that accept our terms. Our terms mean, that we commercialize the technology and that we throw it in the market – a market that complains about the problem but is not really interested in solving the nosocomial problems. We are now seeking for the rare individual investor(s) in Asia It doesn’t really matter whether or not bugs are antibiotic resistant. Fact is we have a wide range of pathogens that are invisible by the naked eye and cause hospital acquired infections. But we don’t have commercially available technology that can handle the whole spectrum of those culprits. It is a shame everybody can be affected one day by hospital acquired infection but nobody is actively supporting entrepreneurs that are determined to commercialize new technologies that have a high probability of success to reduce nosocomial infections. This is my experience from the real world Marked as spam
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Xenex robots are shown to reduce HAIs and SSIs in multiple peer reviewed published studies (56% reduction in C.Diff, 70% reduction in C. Diff, 56% reduction in MRSA, 100% reduction in SSI's). We would love to talk to you further about this in more depth of you are interested. www.Xenex.com.
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NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
A big part of this problem is ignorance of Infection Control, forgotten leaning and training and lack of and ineffective training of hospital staff.
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A recent study done by a doctor taking air samples inside of patient rooms and hallways of hospitals and culturing the bugs on dust particles revealed that the air-conditioned and filtered air in hospitals is "full of bacteria" and there appears to be little way to stop it all. The doctor found that air right outside the hospital walls was cleaner than inside the hospital.
What this suggests is that hospitals are a natural mixing & breeding ground & transmission point for microorganisms. Why? People sneeze, cough, breathe, fart, exfoliate skin with bacteria and fungi, and on and on. http://www.slideshare.net/doctorrao/air-sampling-for-microbes-in-hospitals http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1921583/ Marked as spam
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NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
From what I understand there are UV irradiation systems that can be wheeled into a patients room
after the patient had been either taken out of the room or has been discharged . These are high level UV light radiation systems that are portable units and I believe the room treatment is for 1 hour. Similar systems are used in R&D Microbiology and cell and tissue culture Biosafety cabinets. Does anyone know of how effective these are for MRSA and Clostridium difficile eradication? If effective these could greatly help in reducing transmission of infectious agents that cause Nosocomial infections. Marked as spam
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NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Infection Control here I give an example of why infection control is not being effectively taught and practiced. Recently a elderly friend was hospitalized and he had a rash on the back of his neck and upper shoulder. He was hospitalized for a different reason but based on the appearance the rash was diagnosed as Shingles. As a result the nurses posted signs on the door to the room and in the room that anyone who had not had Chicken pox or the vaccine for it should not enter the room. My friend was in that room for several days to be checked out for chest pains and was found to just have some gastritis versus a heart issue. They discharged him and so he got dressed and left with the rash still in full bloom. I was interested in this development and I asked him "did anyone say or inform you not to touch your rash not followed by a through hand washing or use of a hand disinfectant" and he replied "No". So here the patient with an infectious viral rash was in a room under precautions and with the same active infectious rash was allowed to travel through the hallways, into the elevator and through the hallways and corridors of the hospital with a condition that they had medically determined was infectious and was still infectious when he left. So any visitors or patients or staff who were in close proximity in an elevator or elsewhere were potentially exposed No viral titres or antibody assessments or cultures were performed and the rash was an open spreading rash and the patient had been taken off of the antiviral medication because it was determined to be causing an adverse reaction of gastritis. Therefore, it can be assumed that the patient was still contagious yet no instructions were given to the patient about hygiene and infection control, the patient was not put on any other antiviral medication. Yet the patient who required infection control precautions was allowed to wander through the hospital where other patients are who are ill and in many cases immuno-compromised due to their illnesses.
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Neal, I've seen some articles on UV sterilization, too, but it only works in one room at a time, with no person in the room.
What counters all forms of sterilization is people. The people in hospitals bring in both common and uncommon bacterial critters along with the patients, clinical and support staff. Then those 'critters' drop off particles of skin flakes and exhaled microdroplets all day long. Thus the whole hospital is constantly reinfected from the people in hospitals, which is not "clean" as seen by rigorous testing in clinical articles. What I personally have wondered about are the clinical trials that have shown some common forms of bacteria (specifically in the digestive tract and on the skin) are needed to keep "bad" bacteria from gaining a foothold. I recall one article talking about a non-problem C-Difficile form which inhabits the gut, which stops the aggressive form of C-Diff. Everyone knows that if you do a super cleaning of your hands with strong chemical solvents (the "old days" of manufacturing) can result in inflammation and infection in the cracks in the skin and around fingernails. We need the 'normal' skin oils and critters to keep the bad microorganisms from gaining an upper hand. One company that is using a common non-problem bacteria is illustrated by http://www.motherdirt.com/ I don't claim to know what motherdirt's bacteria is or whether it would help in hospitals, but I can't help but wonder if something like this used in hospitals might help limit the chances for skin infections. Marked as spam
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Willi Glettig
Hi Neal. Bugs always live in clusters, they sit on top of each others. UV, VUV produced in lamps is a ray that may deactivate the top layer of the clusterof bugs, those in the lower part of the cluster are unaffected.
Endospores are not affected and many bioactive protein e.g. prions are unaffected. VUV produced inside the pathogen (Bug or molecule) can be used to break selected chemical bonds. We achieve that with special frequencies in the radio wave spectrum Marked as spam
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NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Hi Bo,
Yes that is true, but we have to appreciate that in this sense. If hospital cleaning staff are going into rooms where for example a patient stayed who had C-Diff or MRSA and cleaning the room and removing all sheets blankets pillows, trash, waste ect. The cleaning staff may carry out infectious microorganisms on their uniforms & clothes, in most cases they do not change clothes before departing from such patient rooms, and the linens that they have handled may have body fluids on them which are not apparent. By having the room UV irradiated before any cleaning housekeeping processes that would at least help prevent this. Once the room is UV irradiated then the cleaning crew can go in and bundle and package up all linens and they should be in color coded bags for either disposal or a separate specialized cleaning process.* Once those are removed then the cleaning crew can use liquid and spray disinfectants on all surfaces in that room and open a window if possible to dry and air out that room. * linens cleaning disinfection processing may be achieved by using an effective disinfectant. For example the old fashioned brown liquid Lysol or something equivalent or bleach can be utilized for processing such linens they should not be placed into the regular laundry processing. Marked as spam
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NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Hi Bo,
Yes and regarding the need for normal flora bacteria and the restoration of it post antibiotic therapy. Currently, I have a posting here at Linked-In that discusses the falsehood of Probiotics in the form pills and Yogert's that claim to reconstitute the gut flora .Most of these products contain various forms of Lactobacillus which is an acid loving normal gut flora bug. The problem is the stomach hydrochloric acid (HCL) can render pH of 1.5 which the Lactobacillus cannot survive according to numerous published scientific studies and they there are the proteolytic digestive enzymes pepsin and others so unless those products are encapsulated in a very hard heavy walled capsule so that it will not dissolve inside the stomach the beneficial probiotic bacteria will not survive but with a hard walled thick capsule they can travel through the stomach and reach the intestines where intended and needed. Marked as spam
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Neal, I can appreciate that the stomach acid is a tough barrier to cross for bacteria, but it is done routinely.
It is obvious we have a lot of common bacteria that cause tremendous GI upset and worse from various forms of listeria, salmonella and others, so we know not all microorganisms are killed off in the stomach. Babies are born without a significant microbiome in their digestive tract and have to 'inherit' it from their mother and environment. Marked as spam
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NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Hi Bo,
Following up on your great comment: "I recall one article talking about a non-problem C-Difficile form which inhabits the gut, which stops the aggressive form of C-Diff." C-difficile is part of the normal flora of the gastrointestinal tract along with numerous other bacteria these various types of bacterial co-exist as normal flora and help to digest and extract nutrients from digested foods as they pass through the intestines. They collectively act to break down certain nutrients into smaller molecules by their enzymatic actions such that the digested broken down molecules are small enough to be absorbed and pass through into the blood stream surrounding and in the intestines. The normal flora of the intestines include numerous bacteria and yeasts including E. coli, Candida albicans, Enterococcus and numerous others that co-exist in the environment of the intestines. The problem that occurs is that when a patient is treated with antibiotics lot of the normal flora gut bacterial is killed but not all, it depends on which antibiotic or antibiotics have been used at what strength dose and for how long. In the case of C. diff and sometimes others they are normally in competition with each other and the number of C. diff bacterial is held in check but if all of its competitors are killed off then it becomes an opportunistic pathogen. It is still the same C. diff microorganism that was just part of the normal gut flora but now it overgrows and takes over and by the increased numbers gets a foothold in that each bacteria type excrete certain toxins that inhibit the growth of other bacteria types and it starts to cause symptoms in the patient. Of course patients who have undergone surgery or other treatments may be immuno-suppressed especially because after surgery the body normally increases the amount of cortisol production which has some beneficial effects but also is like corticosteroid drugs such as Prednisone that are immuno-suppressive at the same time. The combination of the overgrowth of C. diff in the intestines and the immuno-suppression lead to clinical illness. Elderly geriatric patients also due to their advanced age have reduced a normally decreasing immunity as their production of antibodies and immune system cells often becomes reduced and slows. This combination and or increased post surgical cortisol production and post antimicrobial treatment with loss of normal flora gut bacterial results in a triad of susceptibility factors leading to opportunistic infection. If we add that to the emergence of antibiotic resistant strains that develop in medical facilities to which patients may be exposed to the risk is compounded. Marked as spam
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NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Of note a now very recently deceased relative of mine age 85 recently suffered from this scenario. His wife passed away he was disraught and upset and failed to eat or drink and became dehydrated and dizzy. He was transported to the ER where we thought they would just give him an IV to rehydrate him. But they decided to admit him for observation due to the dizziness and he was there 4 days and then discharged and went home. over the next week he developed an increasingly severe diarrhea and because of that was re-hospitalized and by culture determined to have a C. diff intestinal infection and from that point things went from bad to worse and he ultimately died. It is my firm belief that if the ER had just given him IV fluids and sent him home rather than admitting him that he would still be alive, sadly his hospitalization was his demise.
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Neal, the irony of what follows is that in "the old day" pre-antibiotic times, it was often said by people that "you only go to the hospital to die" and now with powerful antibiotics and now immuno-suppressants that again "you don't want to stay in the hospital" or you might die. My grandfather who was a doctor, died in the mid 30s before antibiotics were available.
Obviously, out-patient & emergency clinics offer at least another option that limits one's contacts with hospitals, which are indeed moving toward only treating the most severe medical cases. Marked as spam
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NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Hi Bo,
Thanks I do like your comment about " I can appreciate that the stomach acid is a tough barrier to cross for bacteria, but it is done routinely" and that is a good point that pathogenic bacteria if ingested in large quantities seem to pass through, we can think of our stomach acid as a natural defense. Yet I do think that having probiotics formulated with an thick acid resistant hard shell encapsulation will afford that a much higher number of probiotic organisms will reach the intended target. Also I like your comment "you don't want to stay in the hospital" or you might die" it is very true. It is the reason for emergence of many urgent care and outpatient clinics which may afford a reduced risk but still have risks. Recently I went to an urgent care outpatient facility and a lot of folks were there in the waiting area, many were coughing and sneezing and although they had signs saying if you had those symptoms to put on a face mask and use hand disinfectants there were many folks who did not comply. When I got to the insurance check in person she was sitting across from me there was no glass or plexi-glass barrier and that person was showing distinct signs of illness herself. Having worked in Pediatrics over 19 years full then part time I can attest that the staff is nearly always sick the entire fall winter and into the spring and the term germ factory is in play. Flu shots and all immunizations of the staff do not provide effective protection, hand-washing, hand sanitizers and liberal use of spray disinfectants and disinfectant wipes are always in use but even with all of those precautions the staff in a Pediatrics office will have more illness than your average worker and their families often are secondary victims. The idea that such exposure build immunity just does not pan out, the bugs are mutating and resistance and immunization work for established bugs not new strains. Marked as spam
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NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Hi Willi,
I would be interested in learning more about the special frequencies in the radio wave spectrum perhaps that technology combined with pulsed Zenon light UV may be most the effective approach. Marked as spam
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NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Hi Bo,
Going back to a much earlier statement about the air quality that you made and how air just outside of hospitals has far fewer organisms I believe this is true and the newer designed hospitals that have sealed windows in patient rooms is bad, fresh air and sunlight are beneficial why seal them out. Marked as spam
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Willi Glettig
Hi Bo,
The biofilm (Glycocalix) produced by bacteria depends on species and environment. In aueous environment much of the clycocalix are crosslinked polymer od various sugars. UV penetration is not very deep. To break Glycocalixes apart requires lots of enery. Biofilms form fast and constitute a real challenge in the sterilisation industry. With peroxidants e.g (peracetic acids) and strong alkalies at elevated temp they can be metabolized. But all these procedures cant be used in medtech devices that contain sensitive optics, electronics or some polymer parts such as we have it in endoscopes. With cold plasma we have evolved a sputtering process for biofilms. Marked as spam
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Willi Glettig
Hi Neal,
anything based on light waves such as VUV is ineffective. (I think Xenon gas produces redish visible light.) Togeth penetration you need to go down to gamma rays or to fast electrons where as electron penetration is also not to efficient (about 1 mm per 100 KVe for materials with density of 1). With cold plasma we penetrate almost any organic substance e.g into bacteria with small gas molecues and there we convert the gas into plasma that has a wavelength of VUV. Magic! Process details are confidential Marked as spam
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Private answer
NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Thanks to all for our important discussion of Post Surgical and Nosocomial infections and the exchanges about the causes and potential remedies. We are discussing as well duodenoscopes and medical devices instruments that are involved and how they can be potentially improved. The conversation has been extended by other members to include discussions about Hospital acquired infections in general. It is related as any medical device or instrument may become contaminated by hospital staff. Further, we may consider that one or more of the methods put forth and described by members for disinfecting the hospital environment where patients have been with infections may also be applicable to or adapted to be a method to provide disinfection of Endoscopic and other instruments. For example: In considering Willi Glettig's comment about using special frequencies in the radio wave spectrum for disinfection can those potentially be applied perhaps along with other disinfection methods to achieve a more thorough disinfection of Endoscopes and other medical instruments? Would the special frequency radio wave technology be able to penetrate through the materials used in duodenoscopes Endoscopes?
At this forum I now see a message that quote" Your posts in this group are being moderated temporarily because members of this community marked your recent contributions as spam or not relevant." We are in a discussion about Hospital Acquired infections, Antimicrobial treatment and the emergence infections and disinfection sanitation methods, I have not endorsed or recommended any products and the exchanges with other members in this forum have been directly related to the topic of the discussion and the comments of others here. If there is some objection then I will remove myself from the membership and not spend my time to participate or contribute further to what I felt was an important subject that I have 40+ years of experience and expertise regarding. Marked as spam
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Private answer
NEAL H. WRIGHT, Pharmaceutical GMP QA Specialist
Thank you Willi for your kind reply, the technology sounds great and promising I have replied to you privately.
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