Is hand sanitizer safe during pregnancy

Alcohol Hand Rubs Pose No Risk to Pregnant HCWs |…

<p>Pregnant and breast-feeding healthcare workers appear to be well within safe exposure limits and can use alcohol-based hand rubs without risk to fetus or baby, a researcher reported recently.</p>

September 1, 2017

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Pregnant and breast-feeding healthcare workers appear to be well within safe exposure limits and can use alcohol-based hand rubs without risk to fetus or baby, a researcher reported recently in Portland, OR, at the annual meeting of the Association for Professionals in Infection Control and Epidemiology (APIC).

“The internal doses of ethanol associated with frequent use of hand sanitizers and scrubs are hundreds of times lower than the concentration that might be related to [reproductive] developmental effects,” said Andrew Maier, PhD, CIH, DABT, associate professor of environmental health at the University of Cincinnati. “That is good news. Based on this, there is no significant risk of developmental reproductive [effects] from repeated use of these types of materials. The exposure that one can get from using these products is way below the concentrations that cause these kinds of effects.”

The FDA requested information in 2015 on the safety of active ingredients in healthcare antiseptics, saying solutions and products are being used in the absence of data on long-term effects to healthcare workers. Alcohol-based healthcare antiseptics are not only ubiquitous and used frequently throughout the day in healthcare settings, they are essentially a standard of care, given their recommendation by the CDC. Though some have noted there is no established safety threshold for fetal alcohol syndrome, the FDA would have to find compelling evidence to limit the use of alcohol rubs in hospitals. An unintended consequence could be an increase in healthcare-associated infections that already kill tens of thousands of patients annually.

Studies undertaken by researchers and industry are expected to demonstrate adequate safety data to the FDA, which has recommended continuing to use the alcohol rubs while the review is in process.

The FDA requested that “maximal use” trials be conducted to ensure the safety of frequent use of alcohol-based hand rubs by healthcare workers.

“This is the new thinking from FDA and they are doing this with all drugs now,” said David Macinga, PhD, director of regulatory affairs and clinical science at GOJO Industries, Inc., in Akron, OH. “We used to see studies under typical use, and now FDA is saying we want to see safety studies done under what’s called ‘maximum’ use conditions. If you think about these alcohol hand rubs, they want to see studies done at the maximum number of uses that may be done in a single day by a single person.”

Breaking Down Data

A recently published study² used a retrospective review of the literature and analysis of two other studies that utilized hand hygiene electronic compliance monitoring (ECM) systems. The researchers found the greatest use of alcohol rubs was recorded by an ECM system in a medical ICU.

“In 95% of nursing shifts, individual nurses used alcohol-based hand rubs 141 times or less per shift, and 15 times or less per hour,” the authors reported.

Maier reviewed that study and other data involving alcohol exposures in animals and its presence in common products in a review of the issue at APIC. Maier disclosed receipt of grant funding and research support from GOJO Industries, which manufactures hand cleaners and other healthcare products.

“We’re really focusing our assessments on developmental effects — reproductive developmental toxicity,” Maier said. “The key question is making sure the exposure level is well below the concentrations where the effect might be caused. That is the margin of safety assessment.”

Evaluating data that included some 250 published studies on the reproductive effects of alcohol consumption, Maier predictably found that the majority of those involved consumption of alcoholic drinks.

“They show that binge drinking or ingestion of high levels of alcohol do cause developmental effects,” he said. “That’s no surprise to most folks in occupational health, but the question is what happens at smaller, very low levels of exposure?”

That is a much harder question to answer, but Maier pointed out at the onset that the tracking systems in place by FDA and other bodies have not identified any link between alcohol hand rubs used in healthcare and reproductive effects in workers. Maier also looked at animal toxicology studies on alcohol and reproductive effects.

“Two big findings came out of our evaluation of the animal toxicology data,” he said. “One is that it is the peak drug concentration that is really the driver for these developmental effects. It’s not the average, low-dose exposure you might have — it is high-dose peaks that are driving these types of responses.”

The blood alcohol concentration (BAC) level where developmental effects begin to occur in the animal data is 150 mg per 100 mls of blood, he said.

“Above that concentration in the blood, you start to see effects in animal toxicology studies,” Maier said. “Below that concentration, you don’t see effects. We are starting to see this boundary for the onset of effects. So, obviously, we want to make sure that the [human] exposures are maintained well below those types of concentrations.”

Scenarios Tested

A variety of different scenarios were evaluated that reflected topical application of the alcohol hand rubs under conditions representative of average use, high use, and maximal use for two different products. Maier looked at the BAC that would be predicted for the various scenarios and compared that to the threshold for safety in the animal toxicity studies.

“For example, for average use, basically the amount of exposure is 380 [times] lower than the concentration that would potentially cause adverse effects,” he said. “We have a margin of safety there of around 380-fold, which is a pretty large margin. ”

High use resulted in a BAC of 0.75, 200-fold less than the threshold for reproductive effects. Maximum use estimates of a BAC of 0.94 still fell within a wide margin of safety, 160 times less than the threshold of concern. Overall, the various scenarios of hand hygiene with alcohol rubs was 160 to 680 times lower than the threshold for developmental effects, he said.

Maier then contrasted those levels with ethanol alcohol in various fruits, noting that the average use of hand rubs over a healthcare shift resulted in an alcohol exposure equivalent to eating a ripe banana. In addition, the FDA defines drinks with no more than 0.5% of alcohol as nonalcoholic beverages, Maier said. The maximum use of alcohol rubs resulting in a BAC of 0.94 compares to one nonalcoholic beverage with a BAC of 1.20.

“The amount of ethanol blood concentration for hand sanitizers is pretty much similar to the low-dose exposures you would get from fruits,” he said. “In both cases, the margin between those BACs and the amount of concentration that might be associated with onset of developmental effects is quite large. These can be considered safe by traditional FDA standards. Ethanol sanitizers are safe for their intended use as [hand] hygiene products.”

REFERENCES

Food and Drug Administration. Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record. Fed Reg May 1, 2015: http://1.usa.gov/1SDshKy.
Boyce JM, Polgreen PM, Monsalve M, et al. Frequency of Use of Alcohol-Based Hand Rubs by Nurses: A Systematic Review. Infect Control Hosp Epidemiol 2017;38:189–195.

Pregnant and breast-feeding healthcare workers appear to be well within safe exposure limits and can use alcohol-based hand rubs without risk to fetus or baby, a researcher reported recently.

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FDA concerned with alcohol exposures to pregnant, breast feeding…

Alcohol-based hand hygiene rubs, ubiquitous in hospitals and widely praised for their efficacy and ease of use, may pose some level of risk to expectant mothers and their unborn babies, the FDA warns. As hand hygiene is performed constantly throughout a hospital workday a small level of alcohol may begin to accumulate and flow through the bloodstream. No problem for most workers, but what about those expecting?

“No known safe threshold exists for fetal alcohol exposure,” Colleen Rogers, PhD, lead microbiologist in the FDA’s Division of Nonprescription Drug Products (DNDP) said at a preliminary hearing on a recently proposed FDA rule.

The FDA is calling for a major review of the active ingredients in hospital antiseptics. As it currently stands, alcohol rubs and other healthcare antiseptics are being used in the absence of updated scientific data on the effects of prolonged exposure to healthcare workers, particularly those who are pregnant or breast-feeding. Infection preventionists have until Oct. 28, 2015 to submit comments on the controversial proposed rule by the FDA.¹

“Alcohol-based healthcare antiseptics are not only used frequently in the healthcare setting, but they are also recommended for use by authoritative bodies such as the CDC,” Rodgers said. “There are no data on the effects of systemic alcohol exposure due to healthcare antiseptic use during pregnancy, but maternal alcohol ingestion is the leading known cause of developmental and cognitive disabilities in children and a preventable cause of birth defects. Based on alcohol exposure data from non-pregnant adults, ‘moderate’ hand rub use led to a maximum systemic exposure equivalent to approximately 10% of the alcohol in a glass of wine or a bottle of beer. The implications of even this low exposure are unclear.”

The FDA would have to find compelling evidence to limit the use of alcohol rubs in hospitals, as a former CDC outbreak investigator made it perfectly clear what was at stake.

“This would lead to increased healthcare-associated infection rates and take U.S. infection control backwards at least 15 to 20 years,” warned William Jarvis, MD, an independent infection control consultant who spoke on behalf of industry at the hearing.

Healthcare settings nationwide transitioned from soap and sinks to the alcohol hand rubs after the CDC recommended the move in 2002 guidelines that cited improved compliance by healthcare workers and high efficacy against nosocomial pathogens. The notable exception is C. difficile, a spore former that may require the use of soap and water. Citing the worst-case scenario, Jarvis said removing alcohol rubs and returning to the old soap and water approach would have a devastating effect on patient safety. It would require more healthcare worker time, likely undermining compliance and providing less killing power than alcohol even when workers do comply.

“[The] rest of the world has moved forward [with alcohol rubs],” he said, “The WHO has their worldwide Hand Hygiene Campaign. All of this would occur during a time when antibiotic-resistant pathogens are on the rise and infection prevention is needed more than ever. Given that hand hygiene is thought to be the most important method to decrease healthcare-associated infections, patient safety would be significantly adversely impacted.”

The FDA proposed rule requests additional scientific data to support the safety and effectiveness of certain active ingredients used in healthcare antiseptics marketed under the over-the-counter drug monograph.

“The FDA recommends that healthcare personnel continue to use these products consistent with infection control guidelines while additional data are gathered,” the agency said in a statement. “Healthcare antiseptics are primarily used by healthcare professionals in hospitals, clinics, doctors’ offices, outpatient settings and nursing homes. They include hand washes and rubs, surgical hand scrubs and rubs (with or without water), and patient preoperative skin preparations, including pre-injection preparations. The most common active ingredients in healthcare antiseptics marketed under the over-the-counter drug monograph include alcohol and iodines. These products are different from consumer antiseptics, such as antibacterial soaps and hand sanitizer rubs, which are not part of this proposed rule.”

The FDA would require manufacturers who want to continue marketing healthcare antiseptic products to provide additional data on the active ingredients’ safety and effectiveness. This would include data to evaluate absorption, potential hormonal effects, and development of bacterial resistance. Once the proposed rule is finalized, ingredients for which adequate safety and effectiveness data have been provided would continue to be available, the FDA concluded in the proposed rule.

Given the unprecedented national emphasis the last few years on reducing HAIs and staving off a post-antibiotic era, members of the antiseptic industry have been understandably taken aback by the data demands.

“First, let’s remember we’re speaking about a healthcare setting where a significant number of infections do occur. The pathogens are becoming more and more virulent, and we have fewer effective therapies. So infection prevention is critical,” Dave Mackay of GOJO Industries told the FDA. “These products have been used safely for many decades. They are the current standard of care. Despite the decades and frequency of use, there have been no identified chronic health related issues. Yet the benefit to the patient is undisputed.”

The nation’s two leading infection control healthcare epidemiology associations cautiously endorsed the FDA action while emphasizing that hand hygiene, surgical skin preps, and other antiseptics are essential to prevent HAIs, which cause 75,000 patient deaths annually. The statement by APIC and the Society for Healthcare Epidemiology of America (SHEA) reads in part:

“APIC and SHEA strongly agree with FDA’s advice that these products continue to be used consistent with infection control guidelines while additional data is being gathered. Healthcare antiseptics are an important component of infection control strategies in hospitals, clinics, and other healthcare settings, and remain a standard of care to prevent illness and spread of infection. … Since all infection prevention and control guidelines are evidence-based, it is important to stay up-to-date on safety and effectiveness data to protect healthcare personnel and their patients.”

The FDA cited new scientific information and concerns expressed by outside scientific and medical experts on FDA advisory committees. The work practices and science have changed since the FDA began reviewing healthcare antiseptics in the 1970s. Among the changes cited by the agency are its own safety standards, the frequency of use of some of the products, hospital infection control practices, new technology that can detect low levels of antiseptics in the body, and increased knowledge about the impact of widespread antiseptic use. The research paradigm is different as well, with the FDA looking for data on the effects on healthcare workers — not the traditional focus on the safety and efficacy in patients.

“This seems obvious, but it’s an important point that is very pertinent to our discussion because it results in a different benefit/risk profile than we’re used to thinking about since the benefit of the drug occurs in a different person than the risk,” Theresa Michele, MD, director of the DNDP at the FDA, said at a Sept. 4, 2014 hearing on the proposed rule.

For example, new lines of research suggest that for at least some healthcare antiseptic active ingredients, systemic exposure (full body exposure as shown by detection of antiseptic ingredients in the blood or urine) is higher than previously thought, the FDA states. The agency is particularly concerned about the effects of repeated daily exposure to antiseptic active ingredients.

The frequency of dosing is a critical area of concern for the FDA.

“I mean, if you really think about it with the healthcare antiseptics, [healthcare workers are] probably the poster child for maximal use when it comes to frequency of dosing,” said Dennis Bashaw, PhD, director of the FDA’s office of clinical pharmacology. “You use it when you come in the room. You use it when you leave the room. You use it before you start a procedure. You do it over and over again. There’s no other topical dermatological that you’re going to use as many times per shift, per 8-hour, 10-hour, 12-hour period, as you’re going to use a topical healthcare antiseptic.”

The chemicals diffuse through the skin and accumulate as they are constantly replenished, an effect that may be compounded by healthcare workers who develop irritated and chapped or broken skin. While there is little data on the effects of alcohol on healthcare workers, there is even less on the other major antiseptic ingredient, iodine.

“One small study showed an increase in urinary iodine concentration after a single day of surgical scrub use,” Bashaw said. “Although we don’t have a lot of information about absorption as a result of healthcare antiseptic use, data on iodine absorption are available. Iodine is known to cross the placenta. It is also actively concentrated in the mammary gland and secreted in breast milk.”

REFERENCE

Food and Drug Administration. Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record. Fed Reg May 1, 2015: http://1.usa.gov/1SDshKy.

8 Things About Household Cleaning During Pregnancy.com

House Cleaning During Pregnancy: Pros and Cons

It is not possible to give up household chores completely for nine months. From the point of view of doctors, cleaning during pregnancy plays a positive role. Moderate physical activity benefits the mother and fetus: improves blood circulation, helps keep muscles in good shape, reduce swelling and not gain extra pounds.

Home hygiene helps prevent bacterial and viral diseases. Carrying heavy buckets or climbing on window sills to clean windows is still not worth it. It is better to delegate these tasks to other family members or call a professional cleaner.

A woman's body goes through many changes during pregnancy. Each trimester has its own characteristics. They should be taken into account when distributing loads during the cleaning process.

There are also a number of activities that are strictly prohibited for pregnant women:

Climbing a ladder, stool, window sill and other “high-altitude” objects;
Lift weights over 5 kg, especially in the early stages;
Use prohibited household chemicals1;
Clean up the litter box and garden because of the risk of toxoplasmosis;
Make sudden movements: tilts, turns, squats;
Exposing the body to physical stress for a long time, denying yourself rest.

Is it safe to use household chemicals

Cleaning products should be chosen carefully during pregnancy. It is better to give preference to natural cleaners: citric acid, soda, vinegar. However, household chemicals and pregnancy are also quite compatible things. The enhanced composition of store detergents allows you to get rid of germs, bacteria and mold. All household chemicals on the Russian market are subject to examination in terms of sanitary-chemical and toxicological indicators. If a drug has the potential to cause harm to a pregnant woman or unborn child, a warning label is displayed on the label.

During the first trimester, the baby's vital systems and organs are formed. To protect the fetus from the action of various toxins, the female body produces a special hormone - gonadotropin. Thanks to him, cleaning in early pregnancy can be accompanied by hypersensitivity to odors and toxicosis. To avoid "side" effects, gynecologists recommend using fragrance-free detergents.

To combat pathogenic biofilm in the bathroom and toilet, powerful antibacterial agents like Domestos are indispensable. Sodium hypochlorite in its composition effectively kills germs and mold, keeping plumbing clean. All work must be carried out with rubber gloves and a respirator, and the premises themselves must be well ventilated;
Even with the right organization of the entrance area, dirt and microbes brought on shoes from the street spread throughout the apartment. Glorix disinfectant will get rid of potentially dangerous microorganisms, dust and other contaminants. Washing floors should also be done with protective gloves;
The kitchen seems to be one of the cleanest places in the house. However, high temperature, humidity, microdrops of fat and bacteria brought on the products create all the conditions for the growth of harmful microorganisms. Work surfaces should be cleaned regularly with Cif cleaning gels or sprays, and sponges and kitchen towels should be changed every couple of weeks;
Lime scale, grease stains and other dirt can be removed with folk remedies. Apply a slurry of soda powder to the surface and after a while wash it off with a solution of vinegar;
Test on an inconspicuous area before applying detergent;
Carefully read the instructions, precautions and contraindications on the cleaning agent bottle. Follow the indicated dosage;
Never mix household chemicals. This can cause a reaction with the release of volatile chlorine - the strongest of household poisons;
If your general condition worsens after cleaning, dizziness or nausea occurs during pregnancy, immediately inform your family and, if possible, consult a doctor.
- Replace your regular mop with a modern model with a longer handle and wringer;
- Water bucket on wheels makes cleaning a lot easier;
- Avoid bending over and putting pressure on your stomach. If you need to lean forward, bend your knees and gently stretch in the desired direction;
- Vacuuming should be carried out with slow, smooth movements, after opening the windows for ventilation;
- Many pregnant women find it easier to clean the floor by hand, gently kneeling or squatting;
- If you have frequent low back pain, ask your doctor for a special abdominal support bandage.
- It is forbidden to climb ladders, chairs and other high objects to avoid the risk of falling;
- It is strictly forbidden to lean out of the windows - entrust the washing of external surfaces to household members;
- Do not raise your hands above your head - for cleaning remote areas, you can purchase a special scraper or mini window mop with a long handle;
- Instead of aerosol detergents, it is better to use a citric acid solution.
- It is better to replace ordinary washing powder with a sulfate-free detergent without fragrances - this will reduce the risk of allergic reactions;
- Wet laundry becomes heavier - it is better to entrust it to your spouse;
- Remove clothes from the washer in small batches and leave to dry at height.

Is it possible to wash floors during pregnancy

Washing floors and vacuuming during pregnancy is definitely possible. However, there is no universal instruction for this type of cleaning - doctors recommend proceeding from well-being and working in the most comfortable position for no more than half an hour, after which take a 15-minute break.

The successful course of pregnancy and childbirth is the merit of progesterone. The same hormone weakens the natural immune barrier, makes ligaments and joints more mobile. Along with the growth of the abdomen, the center of gravity shifts - this creates an additional load on the back.

Is it possible to wash windows during pregnancy

Clean windows not only please the eye, but also provide the necessary insolation. Windows should be washed as they get dirty. On the first floors, dust settles on the glass faster. The same applies to houses adjacent to highways and industrial zones.

How to wash and iron during pregnancy

Doctors advise against hand washing during pregnancy. It is detrimental to the back, besides it takes a lot of strength. If there is no choice, you should take the most comfortable position. Sit on a chair with a backrest, placing the basin with linen in front of you on a slight elevation.

Most modern materials do not need to be ironed. It is enough to dry things properly, and they can be worn. It is more convenient to align the folds and provide additional disinfection with a steam iron. For supporters of classic irons and ironing boards, doctors recommend doing all the work in a sitting position - this will help reduce the load on the legs and back, avoid swelling and varicose veins, and at the same time be less tired.

Cooking and washing dishes, as well as cleaning during pregnancy, should be done in a simplified manner. Get a comfortable chair to relieve stress on your back. Take frequent breaks and don't overwork yourself. Any household chores can wait - the main thing is your well-being and the health of the baby.

Why frequent disinfection during pregnancy is dangerous

March 30, 2022 10:35 Olga Muraya

Excessive passion for cleanliness can play a cruel joke, especially when it comes to the health of future children.
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Researchers in Japan have found a link between the frequent use of disinfectants during pregnancy and the likelihood of allergic diseases in "clean" children.

Cleanliness mums-to-be, take note: Excessive use of disinfectants during pregnancy may be associated with an increased risk of asthma and eczema in children.

Although this study is exploratory and did not reveal a causal relationship, scientists note that such conclusions are important to keep in mind for all expectant mothers, as well as their relatives, who sometimes also pay increased attention to disinfection.

The COVID-19 pandemic has also added fuel to the fire, causing a real boom in the use of disinfectants. For some people, the obsessive desire to wipe absolutely all accessible surfaces with an antiseptic has not yet passed. Which, however, is quite understandable if they themselves or their relatives had a hard time with the disease.

Still, one must remember that a person cannot live in an absolutely sterile environment. For development, as well as constant training of immunity, he needs a little stress and encounters with pathogens.

What did scientists find out earlier? Exposure to disinfectants in the workplace has been previously linked to asthma and dermatitis in workers. Some studies have also examined the impact of using disinfectants during pregnancy and the subsequent development of allergic diseases in children.

The authors of the new study used data from 78,915 mother-child couples who participated in the Japan Environment and Child Study to find out whether the use of disinfectants in the workplace in mothers is associated with an increased risk of allergic diseases in their children at the age of three years.

This study showed that children were significantly more likely to develop asthma or eczema if their mothers were exposed to disinfectants one to six times a week. Comparisons were made with children of mothers who worked in an environment where no disinfectants were used at all.

At the same time, children of mothers exposed to daily disinfectants had the highest chances of getting diagnoses - 26% higher for asthma and 29% higher% higher for eczema than in children of women who have never been exposed to disinfectants.

No significant association was found between the use of disinfectants and food allergies.

In addition to the fact that this study does not explain the reason for the results, the authors note other limitations.

Thus, information about the use of disinfectants was provided by the mothers themselves, and specific disinfectants were not named. Diagnoses of allergic diseases in children were also reported by women themselves. All this increases the likelihood that the results obtained are not entirely accurate.

However, the authors conclude, these results indicate that exposure to disinfectants during pregnancy has an impact on allergies in children regardless of whether the mother returns to work when the child is one year old, and also suggest that such an impact occurs. only during pregnancy.

The authors proposed several mechanisms that could explain the results.

Disinfectants can affect the intestinal and skin microbiota of the mother and subsequently of the baby. Also, some chemical compounds could affect the immune response in the fetus, or already born children inhaled or touched disinfectant particles on the skin of their mothers.

The mother's prejudice could also play a role. If a woman frequently uses medical disinfectants, it is likely that she is more knowledgeable about medicine and has better access to healthcare. This increases the likelihood that her child will be diagnosed with a disease early.

The work of Japanese scientists was published in Occupational & Environmental Medicine.

Earlier we wrote that the "hygiene hypothesis" of strengthening the immune system has not been tested for strength, and that pets protect children from obesity.

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