Understanding Glove Related Contact Dermatitis

[dropcap]Y[/dropcap]ou may wear disposable nitrile, latex or vinyl gloves many hours each work day.  If your hands develop dry, itchy, irritated areas or blisters, you are understandably concerned.  Wearing gloves and having healthy skin is imperative in your line of work.

Could your gloves be to blame?  In this Q&A article, we’ll help you get the bottom of the types of glove related contact dermatitis, their causes, and how you might find a resolution for your skin condition.

Q.   What is contact dermatitis?

A.   Occupationally related contact dermatitis is a skin condition that can develop from frequent and repeated use of hand hygiene products, exposure to chemicals and glove use. Contact dermatitis is classified as either irritant or allergic.

Irritant contact dermatitis is common, nonallergic, and develops as dry, itchy, irritated areas on the skin around the area of contact.  It is usually caused by an irritant, such as the chemicals commonly used in the manufacture of hand products and gloves.  It can also be caused by water, (including improper hand drying before donning gloves,) soaps, detergents, solvents, acids, alkalis and friction. Diagnosis is made by reviewing the patient’s medical history, current symptoms, and exclusion of Type IV and Type I hypersensitivity.  This is not an allergic reaction.

Allergic contact dermatitis (type IV hypersensitivity) often manifests as an itchy, red rash, sometimes with small blisters, beginning approximately 6 to 48 hours after contact.  Like irritant dermatitis, it is usually confined to the areas of contact.  It can result from exposure to accelerators and other chemicals used in the manufacture of most latex and non-latex gloves.  Diagnosis is made by reviewing the patient’s medical history, current symptoms and by performing a skin patch test.

Q.   What are chemical “accelerators?”

A.   Chemical accelerators are used in the glove manufacturing process to “accelerate” the linkage of rubber molecules in natural rubber latex or synthetic rubber latex, such as nitrile and vinyl. The chemicals transform the liquid rubber into a thin, strong and elastic glove film, and stabilizes the material.

These sulfur-based chemical accelerators (dithiocarbamates, thiurams and mercaptobenzothiazoles (MBT)) cause the majority of skin dermatitis reactions.

Q.   What are “accelerator-free” gloves?

A.   Accelerator-free gloves, like FreeStyle1100, and Scion700 are manufactured using a breakthrough cross-linking technology that does not use chemical accelerators (dithiocarbamates, thiurams and mercaptobenzothiazoles (MBT.)) The result is a thin, soft and stretchy glove that is actually stronger than traditionally manufactured nitrile glove material.

Q.   What does “Low Dermatitis Potential” mean?

A.   This is an FDA approved claim reserved for gloves that have been tested, and are 1) proven free of chemical accelerator residue, 2) will not induce skin irritation, and 3) will not cause any potential sensitization reaction.

Q.   How long should I try accelerator-free gloves?

A.   Each person is unique. Some individuals know within a few hours, while others require an extended trial of several days or even weeks to know if accelerator-free gloves will resolve their hand dermatitis. (Additional samples of FreeStyle1100 are available for individuals needing a longer period of time to evaluate the glove.)

Q.   Is there anything else in a glove that can cause allergic contact dermatitis?

A.   Yes.  Although 90% of glove allergies are caused by accelerators, the remaining individuals may be reacting to other substances sometimes used in the manufacture of gloves, such as lanolin, polyoxypropyleneglycol (a coagulant,) dyes (organic or inorganic,) quaternary ammonium compounds, and preservatives.

Q.  How important is it to resolve contact dermatitis early?

A.   Skin is an important barrier to bloodborne pathogens and disease. Broken skin due to ongoing irritation or allergy puts an individual at higher risk. A chronic skin condition is painful, and could result in an individual having to abandon their career choice.

Q.  I don’t have contact dermatitis. Should I still consider switching to an accelerator-free glove?

A.   Yes. According to NIOSH, “Because the prognosis of occupational irritant and allergic dermatitis is poor, prevention is imperative. This fact is emphasized by one study showing that 75% of patients with occupational contact dermatitis developed chronic skin disease.” (1) With thousands of potentially harmful chemicals being introduced into the workplace each year, it is important to reduce your exposure wherever possible.

References
NIOSH (The National Institute for Occupational Safety and Health,) Allergic & Irritant Dermatitis(1)
CDC (Centers for Disease Control and Prevention) Frequently Asked Questions, Contact Dermatitis and Latex Allergy

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5 Good Glove Fit Factors

There are many factors to consider when selecting a disposable glove.  After choosing the right glove type and glove material for the task, good fit ranks high on the list.  A properly fitted glove is critical to performing procedures correctly.   A glove that fits properly conforms to the hand, and does not feel too tight or too stiff.   Consider some glove physical characteristics that influence fit.

1.  Glove Length

Glove length is measured from the tip of the middle finger to the cuff.  Exam gloves are typically a minimum of 9” in length, while surgical gloves and some cleanroom gloves are 12” in length to provide more protection.

2.  Glove Width

The width of a glove is one of the most important considerations for proper glove fit.  Gloves are manufactured to specific ASTM glove standards, including palm width.  But there is a fairly wide range within each size.  A medium exam glove, for instance, can vary from 85mm to 105mm in width.   And there is room for overlap, so one manufacturer’s “medium” exam glove could be another manufacturer’s “large” glove.

3.  Finger Length and Width

Finger lengths and widths also vary between product lines from one manufacturer to another.  The finger length and width is largely determined by the formers used on the manufacturing line.  However, the glove material affects the amount of stretch, which affects finger fit.  A super stretchy, low protein latex glove works with the widest range of finger sizes, and could be a good choice for individuals with shorter fingers.  When it comes to nitrile gloves, the formulations range from “some stretch” to “very stretchy,” which affects finger fit.

4.  Glove Material

Glove thickness and stretchability also influences overall glove fit when donned.  If you are accustomed to wearing a “medium” glove in one brand, you may need to try a “small” or a “large” glove in another brand.  If you are trying a very thin glove, you may need to try a smaller size in order to get the proper fit.

5.  Finger Contour

Hand specific gloves with contoured fingers and a natural thumb position are most commonly found in surgical glove lines.  While offering the best fit, these gloves cost more than an examination glove.  Fortunately, ambidextrous nitrile exam gloves (gloves that can be worn on the left or right hand) made from newer, thinner nitrile material, allows the glove to warm and follow the contours of the hand, fingers and thumb to enhance comfort, improve tactile sensitivity, and reduce hand fatigue.

Finding a good fitting glove is essential.  A tight fitting glove can negatively affect fine motor skills, irritate the skin, and lead to hand fatigue.  On the other hand, a glove that fits too loose can cause a person to execute movements awkwardly, and potentially lead to exposure to bloodborne pathogens or hazardous chemicals.  Evaluating a glove’s ability to contour to the hand, and properly fit the width of the hand is key to finding a good fitting glove that you will enjoy wearing.

[note]Each of our HandPRO Exam Gloves offers a unique fit and stretch due to their different compounds.
Click on the glove below to request your sample pack:

AirSoft900 Nitrile Exam Gloves
Cirrus800 White Nitrile Exam Gloves
FreeStyle1100 Nitrile Exam Gloves with Low Dermatitis Potential
HandPRO 400 Latex Exam Gloves[/note]

Exam Gloves “Manufactured in Malaysia” – How Safe?

How safe are exam gloves manufactured in Malaysia?

Most of the exam gloves available here in the U.S. are manufactured and imported from other countries, such as Malaysia.  How can you be sure that you are getting a safe, reliable product?  Fortunately, manufacturers, importers and the government are working hard to ensure your safety.

FDA Regulation

Patient examination gloves are a class I medical device and subject to the controls of the FDA.  This class of disposable gloves is meant for medical purposes to protect the wearer’s hand and to prevent contamination between the patient and the wearer.   The gloves can be made from latex, vinyl or a polymer other than vinyl, such as nitrile or polyurethane.

To meet the FDA requirements for patient examination gloves, the product must meet a number of standards, including the following:

ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves
ASTM D3578 Standard Test Method for Rubber Examination Gloves

Additionally, there are specific rules for labeling.  A powder-free nitrile exam glove that meets FDA requirements will have the words “powder-free nitrile examination glove” on the box.   Disposable latex, nitrile or vinyl gloves that do not include the word “examination” on the box are for general purpose use, and are not safe to use in medical, dental or other health care settings.

Ambiguous terms such as “extra-thick” or “super-sensitive” are not allowed on the box because they could be misleading.  The term “hypoallergenic” is strongly discouraged, as it cannot be scientifically defined.  Only factual and definitive statements are allowed.

Quality System Regulation

Medical glove manufacturers are required to meet the Quality System regulation for medical devices – 21 CFR part 820.  This regulation states that “each manufacturer must establish and maintain a quality system that is appropriate for the specific medical device . . . manufactured.”

Malaysian manufacturers run state-of-the-art facilities.  There are process controls for every single stage of manufacturing, from compounding , dipping and curing, to drying, powder removal and rinsing.  With proper process and quality controls, manufacturers are able to control or eliminate defects in gloves, such as pinholes, as well as control or minimize undesirable chemical residues.

Compliance Inspections

To ensure compliance, the FDA sends auditors to manufacturers, including foreign manufacturing sites, to perform factory inspections.  They review the facility, operations, environment and records to determine the level of compliance with the Quality System regulation.

When a glove shipment arrives at a US port, the FDA may hold the shipment and collect a sample of the gloves for testing.  If the sample fails, the FDA then detains all lots of the same glove type in the shipment, effectively removing them from the supply chain.  They may also hold shipments of gloves that have been misbranded with unsubstantiated claims, or are not labeled properly.

The relationship between glove manufacturers, importers and the FDA helps ensure that the exam gloves you wear will do the job they were meant to do – prevent contamination and keep you safe.  So the next time you see “Manufactured in Malaysia” on a box of gloves or product literature, you can be confident you are getting a quality product.

Share your comments below.

Gloves, Handrubs and HAIs in the Dental Setting

staphylococcus aureus in the dental setting

Health care associated infections, or HAIs, can be acquired anywhere health care is delivered, including the dental office.  As a dental clinician or dentist, you know that proper hand hygiene and gloving is essential to your patient’s safety as well as your own.

But how prevalent are infectious agents such as bacteria, fungi and viruses in the dental setting?  And is your current hand hygiene routine enough to prevent HAIs?

Dental Staph

A recent study conducted by the Department of Public Health and Infectious Diseases at Sapienza University, in Rome, Italy, investigated staphylococci contamination on disposable gloves and clinical surfaces in the dental setting.

Environmental samples were collected from the tray and gloved dominant hand soon after dental therapy of the second or third patient at 136 general dental practitioners’ offices.  Staphylococci were detected in 41% of the trays and 57% of the gloves.  Specifically, S. aureus was found in 5% of both tray and glove samples, and MRSA was detected on 1.5% of the glove and tray samples.

The study concluded that contact surfaces and gloves in the dental setting are “frequently contaminated.”

Studies like this underscore the importance of proper hand hygiene and proper donning and doffing of exam gloves.  But even if you are using the manufacturer’s recommended amount of alcohol-based handrub, another recent study warns that it may not be enough.

Pump Up the Volume

The Bode Science Center in Hamburg, Germany evaluated the effectiveness of different volumes of alcohol-based handrubs.  They used the manufacturer recommended product volumes of 1.1 mL, 2 mL, and 2.4 mL, as well as 1 and 2 pump dispenser pushes for foams and gels.

They discovered that 70% ethanol (v/v) handrubs at the recommended volume of 1.1 mL per application “did not ensure complete coverage of both hands and do not achieve current ASTM efficacy standards.”  Whereas an application of 2 mL of 85% w/w ethanol rub reduces contamination sufficiently to fulfill the US FDA efficacy requirement.

Proper Gloving and Handrub Guidelines

To provide the safest environment possible for yourself and your patients, diligently follow proper gloving and hand hygiene guidelines to reduce HAIs.  This includes handwashing or handrubbing before donning gloves, and immediately after careful removal of gloves.  And when using an alcohol-based handrub, use enough to completely cover all surfaces of your hands.

Share Your Experience – How is your office’s hand hygiene compliance?  What have you done to improve it?  Post your comments below.

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The Latest on Latex Glove-Related Allergy

[dropcap]T[/dropcap]o reduce the risk of latex sensitization among healthcare workers, medical facilities in the U.S. and Europe have transitioned the majority of their glove usage from powdered latex gloves to powder-free nitrile and other synthetic gloves.   Additionally, a growing understanding of what led to the dramatic increase in latex allergy has resulted in changes to modern latex glove manufacturing to further reduce the risk – lowering the latex protein content, and eliminating cornstarch powder.

Have these changes lowered the risk of latex sensitization in healthcare workers?   Recent studies in Italy, China and Thailand shed some light.

A 10-year follow-up study of over 2000 healthcare workers in Trieste Hospitals in Italy was published in the May 2013 issue of International Archives of Occupational and Environmental Health.  The individuals represented 9,660 person-years of non-powdered latex glove use from 2000 to 2009.  The incidence of latex sensitization was 1 case per 1,000 person-years.  The researchers concluded that the rate of latex sensitization and latex-related symptoms was very low, “but subjects with allergic symptoms related to common allergens are at higher risk.” Non-latex gloves were suggested for these individuals.

In mainland China, powdered, natural rubber latex glove use is still widespread.  To learn the prevalence and risk factors for latex glove allergy among clinical nurses there, information was collected from over 8000 female nurses in 35 hospitals in eight provinces.  Almost 9% of the nurses surveyed had latex allergy.  The study concluded that Chinese nurses are at high risk for latex sensitization, and that “low-protein, powder-free natural rubber latex gloves, or latex-free gloves should be widely adopted in China.”

A cross-sectional study of female nurses in Thailand also demonstrated the higher risk of latex allergy associated with powdered latex gloves.  “Of 899 nurses, 18% reported health effects attributed to the use of latex products,” states the study.  It concluded that when compared to data from developed countries, the continued use of powdered latex gloves in developing countries is associated with increased prevalence of latex allergy dermal symptoms.

Clearly, regular use of powdered latex gloves with uncontrolled levels of latex proteins puts individuals at much greater risk for developing latex allergy, while modern, low-protein, powder-free latex gloves and powder-free nitrile gloves are a safer choice.

Have an opinion on powder-free latex gloves?  We’d love to hear from you.  Post your comments below.

Request Samples of HandPRO 400 Low Protein Latex Gloves

 

Green Trends in Dental, Medical and Cleanroom

Green Trends 2013

Dedicated professionals in many industries, from dental and medical to cleanroom manufacturing, have been working to establish company cultures that put the health and safety of their staff and the environment at the forefront.  This includes adopting and promoting “green” technology, products and initiatives that contribute to a healthier world and workforce.

Green Dentistry

According to the Eco-Dentistry Association, green dentistry means reducing waste and pollution, saving water, energy and money, going high-tech and supporting healthy lifestyles.

Here in the U.S. upwards of 1.7 billion sterilization pouches and 680 million patient barriers are dumped by dental offices each year.  Green practices in the dental office include replacing chemical-based and toxic cold-sterilization with steam sterilization methods using FDA-registered reusable pouches and wraps.  Switching to cloth lab coats and reusable cloth patient barriers also helps cut down on waste.

About half of all mercury entering wastewater treatment facilities comes from dental offices.  Installing an amalgam separator in the office can keep mercury out of our drinking water, irrigation and fishing waters.   By switching to digital imaging, other toxins can be eliminated, such as traditional x-ray fixing chemicals and lead foils.

If a product must be disposable because of its nature, such as gauze, gloves and depression trays, these products are increasingly available in recycled or high-count packaging, or are made from biodegradable, compostable material.

Environmentally Friendly Medical

Medical facilities are committed to improving the health of their patients, employees and communities.  Leading the way, Kaiser Permanente launched their Sustainability Scorecard in 2010, a first of its kind green purchasing model.  The Scorecard helps them evaluate the environmental and health impacts of the more than $1 billion in medical products they purchase each year, as well as the companies they purchase them from.

Another major focus in the medical industry is recycling and reprocessing devices for safe reuse.  Hospitals are the second-largest waste producers in the U.S. after the food industry.  Banner Health in Phoenix saved nearly 1.5 million over 12 months by reprocessing operating room supplies such as compression sleeves and open but unused devices.

Manufacturers and suppliers are helping reduce waste by streamlining packaging.  At University of Minnesota Medical Center, Fairview, surgical kits were reviewed.  They found that the operating room packs contained supplies that were never used (and tossed.)  One chemotherapy kit contained 44 items, but only 27 were needed.  By having their supplier change the kit components and swap disposable gowns and linens for reusable ones, they trimmed a pound of trash and$50 in supply costs per procedure.  Hundreds and thousands of procedures later, and it adds up to a whole lot of green – less waste and money saved.

Greening the Cleanroom

Professionals in cleanroom manufacturing industries are greening their workplaces as well.  As with the dental and medical industries, the focus is on waste and energy conservation, as well as products “friendlier” to workers and the environment.

One of the greatest challenges is reducing energy consumption.  The larger the facility, the more energy it uses. “Cleanrooms aren’t very efficient,” says manager Bill Bond, of QinetiQ North America, a contractor that operates cleanroom facilities for Goddard.  “Airflow is always moving, and that takes energy.”

But his team was able to create an energy efficient design that includes computer-controlled sensing systems for lights and particulate counts.  When the particle count reaches higher levels, the fans operate at higher speeds.  Other efficiencies are created by treating just 10 percent of the air to maintain required air conditions, since the other 90 percent is already-filtered air that the system is recycling.

Modern modular cleanrooms feature coved surfaces and smooth transitions, making them easier to clean.  Manufacturers have responded by redesigning wipers and mops to be reusable or use less cleaning solution or solvent.  This is better for the environment as it minimizes the amount of chemicals needed to maintain cleanliness and sterility.

When it comes to clothing and PPE, cleanrooms are working hard to reduce waste and keep their operators safe and healthy.  Rather than toss items like shoe covers and gowns after the first use, many facilities reuse these items as much their critical environment will allow for while still maintaining cleanliness.  When it does come time to dispose of protective clothing, much of it is recycled.  Products like accelerator-free cleanroom nitrile gloves are also a greener choice.  Formulated with fewer chemicals and weighing on average 20% less than older generations of gloves, they are less likely to cause dermatitis in operators and reduce waste.

As technology continues to evolve, and creative and forward thinking individuals continue to spearhead green initiatives, no doubt newer and more environmentally friendly products, processes and facility designs will emerge.

How is your office or facility going green?  Share your comments below.

Medical Gloves, Hand Hygiene Help Halt Deadly CRE

Gloves and Hand Hygiene Help Halt CRE

Hospital staffs across the country are doubling down on their efforts to stop the spread of hospital acquired infections (HAIs.)  While progress has been made in understanding and reducing the spread of MRSA, C. diff and other germs, there is a growing and far more deadly threat – carbapenem-resistant Enterobacteriaceae, or CRE.

CRE germs are resistant to antibiotics of last resort, killing one of every two patients who get bloodstream infections from them.  But it could be worse.  CRE can transfer their antibiotic resistance to other bacteria such as E. coli, making the most common cause of urinary tract infections extremely difficult to treat.  Ultimately, CRE could get out into our communities, leading to a public health crisis.

For these reasons, CDC has sounded the alarm.  In the March Vital Signs report, CDC published some alarming facts.  CRE has increased from 1% to 4% in the past decade, and one type of CRE has increased from 2% to 10%.  CRE is more common in the Northeast, but has been reported in 42 states.  About 18% of long-term care hospitals have reported at least one CRE infection during the first half of 2012.

The report also provides detailed information on what state governments, communities, health care CEOs, health care providers and patients can do to help stop the spread of CRE.

There are eight core measures for acute and long-term care facilities to implement, and at the top of the list are hand hygiene and the proper use of contact precautions.  This includes the proper use of medical gloves.

  • Hand hygiene should be performed before donning a gown and gloves.
  • Gown and gloves should be donned before entering the affected patient’s room.
  • Gown and gloves should be removed and hand hygiene performed, prior to exiting the patient’s room.

In the 2012 CRE Toolkit, the CDC states, “It is not enough to have policies that require hand hygiene; hand hygiene adherence should be monitored and adherence rates should be fed directly back to front line staff.  Immediate feedback should be provided to staff who miss opportunities for hand hygiene.”

By following CDC guidelines for CRE, several states have decreased their CRE infection rates.  Colorado is one of six states that currently require hospitals to report CRE to the Department of Public Health and Environment.  Because they are detecting and tracking the bacteria, an outbreak of CRE at the University of Colorado Hospital last August was halted.

In Florida, a year-long CRE outbreak was finally brought to an end when the facility improved its use of CDC recommendations, including the proper use of medical gloves and gowns.  This underlines the importance of proper gloving and hand hygiene, as routine as it may seem.

There is no longer any room for complacency.  This is a critical time here in the U.S.  CRE infections can be controlled if everyone involved in patient care does their part and puts forth consistent effort to follow infection control recommendations with every patient.

What do you think?  Can more be done to stop the spread of CRE?  Post your comments below.

Tips to Avoid Contact Dermatitis This Winter

Tips to Avoid Contact Dermatitis This Winter

The winter season is here.  That means colds and flu, and overly-drying, heated air in our homes and workplaces.  Add necessary frequent hand washing to this combo and you may end up with a very uncomfortable situation – contact dermatitis.

Contact dermatitis can be divided into two categories – irritant and allergic.  Irritant contact dermatitis is the most common type.  It can be as mild as a rash, or as debilitating as dry, itchy skin that can crack and bleed.  It occurs because the outer layer of your skin has been damaged.  Most often, this is due to harsh soaps and damaging chemical solvents.  Allergic contact dermatitis occurs when an allergen triggers an immune response in your skin.  It shows up as a red rash, with bumps and sometimes blisters.  It can be caused by natural rubber, the sulfur-based chemical accelerators used in the production of many non-latex gloves, as well as perfumes, cosmetics and hair dyes.

A Pricey Problem

Dermatitis is a widespread problem.  Up to 35 percent of all occupational diseases are skin diseases, with contact dermatitis making up the majority of the cases.  In 2005, The Society for Investigative Dermatology and the American Academy of Dermatology reported that contact dermatitis was associated with more than 9 million physician office visits resulting in more than $1.4 billion spent on treatment.

Because of increased exposure to chemicals, detergents and frequent hand washing, workers in health care, construction, food service and cleaning are especially vulnerable.  Individuals with a history of eczema, latex allergy, prone to sunburn, and repeated exposure to water should be especially careful in order to avoid dermatitis.

What You Can Do

To avoid occupational contact dermatitis, carefully take stock of your environment and habits:

Health Care Workers  –   After washing with soap and water, are you drying your hands gently, so that you do not cause unnecessary damage to your skin?  If you are starting to notice a rash, has your facility recently changed to a new brand of hand soap?  Your skin may be irritated by a chemical in the new product.   Because alcohol-based hand rubs do not cause dermatitis, the CDC recommends they be used whenever possible in health care settings.  These foams and gels often contain emollients and substantially reduce skin irritation and dryness.

Industrial / Cleaning / Food Service Workers – What chemicals, oils and cleaning agents do your hands come into contact with?  Are you wearing the right glove material (nitrile vs. latex) to protect your hands from that irritant?  Are you around wet cement, cement dust or paper dust?  These irritants can also cause dermatitis.  Make sure you are wearing disposable gloves to protect your hands.   If your hands do come into contact with cement or chemicals, wash your hands immediately with a fragrance-free, neutral pH hand soap with emollients, and gently dry your hands without excessive rubbing.  (Alcohol-based hand rubs are not recommended for food service workers, as its effectiveness is reduced when in the presence of food proteins.)

You will likely experience dry hands this winter.  The cold air and wind chaps your hands, and the low humidity level further removes moisture from your skin.  By paying careful attention to how you wash and dry your hands, and protect your skin from harsh detergents and chemicals, you can greatly reduce your chances of developing painful contact dermatitis.

Could your gloves be the problem?

Try FreeStyle1100 and Scion700 Nitrile Exam Gloves with “Low Dermatitis Potential”

The sulfur-based chemical accelerators – carbamates, thiurams and mercaptobenzothiazoles (MBT) – commonly found in non-latex gloves can lead to contact dermatitis.  If you suspect your gloves are causing your current skin irritation, request a sample pack of FreeStyle1100 Accelerator-Free Nitrile Exam Gloves and Scion700 Nitrile Exam Gloves with Low Dermatitis Potential.

Compounding Pharmacies – Sterile Gloves and Fingertip Sampling Required

The fungal meningitis outbreak caused by contaminated steroid medications made by New England Compounding Center in Framingham (NECC), Mass. has brought about a flurry of articles and blog posts calling for tighter regulations and direct FDA oversight of compounding pharmacies.  Some of the articles make it appear that compounding pharmacies are nothing more than renegade miniature drug companies making HRT medications and other controversial drugs.

While there appear to be some pharmacies that need to be reined in, most compounding pharmacies exist in hospitals.  These pharmacies normally prepare a medication to order, for a specific patient from a prescription.  Independent compounding pharmacies contract with hospitals and clinics to fill their compounded medication needs.  Many feel that NECC crossed the line from a traditional compounding pharmacy to a drug manufacturer with interstate commerce.

At the end of all of the debating and legal haranguing (which won’t end soon,) the primary issue is safety.  So what regulations are in place to help ensure that sterile medications from compounding pharmacies are safe?

USP 797

The U.S. Pharmacopoeia (USP) issued the first practice standards for compounding pharmacies in the U.S. back in 2004.  Chapter <797>, Pharmaceutical Compounding – Sterile Preparations, commonly referred to as USP 797, was updated in 2008, and is designed to cut down on infections transmitted to patients through “compounded sterile preparations” (CSPs).

Compliance

After eight years, how are compounding pharmacies doing on compliance?  A nationwide Compliance Study conducted in 2011 and updated in 2012 shows that although the chapter has done much to improve the quality of CSPs, there is also much room for improvement.

Here is one example, a test called Gloved Fingertip/Thumb Sampling, designed to demonstrate that the compounder can properly don PPE and sterile gloves, and prepare a medication without contamination:

“In 2011, only 30% of hospitals complied with the requirement for all compounding personnel (including supervising pharmacists) to successfully complete at least three gloved fingertip/thumb sampling procedures (success is 0 CFUs for both hands) before being allowed to compound CSPs. This requirement is designed to verify that compounding personnel can properly don sterile gloves without contaminating them . . . in 2012, compliance with this requirement has increased to 36%.” – 2012 USP <797> Compliance Survey

This is certainly a cause for concern.  Skin cells are shed from the human body at a rate of a million or more per hour and these skin particles are laden with microorganisms.  Gloved Fingertip/Thumb Sampling measures both the microorganisms and particles in the controlled compounding environment and on surfaces like gloves.  It reveals poor aseptic technique or improper disinfection of sterile gloves.

Sterile gloves are a requirement in preparing CSPs.  Non-sterile exam gloves treated with 70% IPA have not been proven adequate in preventing contamination.  Eric Kastango, MBA, RPh, FASHP, president and CEO of Clinical IQ, LLC, a health care consulting firm in Madison, N.J., and a member of the 2010-2015 USP Compounding Expert Committee, states “The decision the USP committee made in requiring sterile gloves over nonsterile gloves is that you start with a pair of gloves with zero microbial bioburden and that it’s a very inexpensive way to maintain a state of control and prevent the risk for contamination and infections. It’s critical to make sure we’re giving patients the safest, best opportunity to have the lowest risk for contamination from compounded sterile preparations.”

Enforcement

So who enforces USP 797?  While the FDA regulates the ingredients, it does not regulate practitioners.  Compounders are regulated by a patchwork of state oversight, including Joint Commission and state pharmacy boards.  In general, the FDA has deferred to states in regard to USP 797, but it can investigate allegations of contaminated drugs, as in the case of NECC.

Compounding pharmacies can be sure that they will be coming under increased scrutiny and regulation.  Compliance with USP 797, which requires sterile gloves and a host of other safety standards is imperative.   By doing so, they can ensure the highest quality compounding environment and deliver ever-safer medications to the public.

Resources:

Summary of USP 797 for Compounding Sterile Preparations

 

 

What do you think?  Are compounding pharmacies doing enough to comply with USP 797?  Share your comments below.

Proper Medical Glove Use and Hand Hygiene Reduces HAIs and Saves Lives

Proper Glove Use and Hand Hygiene Reduces HAIs and Saves Lives

[dropcap]W[/dropcap]hile medical facilities appear to have gained some ground against Hospital Acquired Infections (HAIs,) the problem is still a great and very real daily threat to human life.   Bacteria that cause HAIs, such as C. diff, MRSA, E. coli, and S. aureus result in an astounding 2 million infections a year and an estimated $6.7 billion in hospital costs.  The most sobering statistic is that these deadly infections kill 100,000 people each year – that’s more than all of the deaths from car accidents, AIDS and breast cancer in the U.S. combined.

According to the World Health Organization (WHO,) “hand hygiene is the single most important measure to protect patients, HCWs and the environment from microbial contamination.”  Unfortunately, compliance with this practice is dismally low.  According to the New England Journal of Medicine, less than 40% of Health Care Workers (HCWs) practice proper hand hygiene.

Several studies have shown that wearing medical gloves reduces hand hygiene compliance.  For instance, in one study HCWs were less likely to perform hand hygiene after removing gloves upon leaving a patients room.  In contrast, other studies have shown that glove use increased overall compliance, but these studies did not investigate glove misuse.  For these reasons the impact of wearing medical gloves on hand hygiene policies has not been determined.  One thing we know for certain, though, is that proper use of gloves combined with proper hand hygiene is critical to reducing infections.

WHO Guidelines for the appropriate and safe use of medical gloves includes the following:

Medical glove use does not obviate the need to comply with hand hygiene.  When hand hygiene is indicated, handwashing or handrubbing should be performed before donning gloves.

Careful attention should be paid to glove removal.  Gloves should be removed to perform handwashing or handrubbing to protect a body site from the flora from another body site previously touched on the same patient.  WHO states that “HCWs often fail to remove gloves between patients or between contact with various sites on a single patient, thus facilitating the spread of microorganisms.”

Perform hand hygiene after glove removal.  Hand hygiene must be performed immediately after glove removal to prevent HCW contamination and spread of microorganisms.

Clear direction about medical glove use should be provided.  HCWs should be able to clearly identify situations requiring gloves, situations that do not require gloves, and how to correctly select a glove.  This requires that medical facilities have clear glove use procedures to help HCWs reason and adjust their behavior to comply with proper hand hygiene and glove use.  This includes a clear understanding of when glove use should start and end.

Medical gloves should always be stored in their original boxes.   Tucking gloves away in pockets and carrying them about is not safe.   Gloves should remain in their original box until donned to ensure the gloves do not become contaminated.  This requires that glove boxes should always be available at point of care.

Appropriate use of medical gloves, combined with proper hand hygiene, is an evidence-based measure to protect HCWs, patients and the environment from HAIs.  HCWs that fail to remove gloves or perform proper hand hygiene between patients risk spreading deadly infections.

Fortunately, the medical community is working hard to increase compliance.  New education campaigns, surveillance programs and other tools are helping ensure more HCWs do their part to reduce the cost of HAIs  – in lives lost and the billions spent to treat them.

What do you think?  Can we do more to reduce HAIs with improved hand hygiene and glove use?

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