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.

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.

Electrostatic discharge damages the electrical characteristics of a semiconductor device.  It can also cause equipment to malfunction or fail, interfering with the normal operation of an electronic system.

An electrostatically charged surface can also attract and hold onto contaminants – bad news for the cleanroom environment.  Airborne particles can cause defects in a device’s electrical circuitry.

Controlling ESD

Failing to control ESD in a cleanroom can be expensive.  Static electricity damages electronics, leading to increased manufacturing costs and lower production yields, negatively affecting a company’s reputation and profitability.  One way that cleanrooms manage static charge is by using static dissipative materials.

Static dissipative materials fall somewhere between insulative and conductive materials.  There is electron flow through or over the material, but in a controlled fashion, by the surface resistance or volume resistance of the material.  It allows the charge to dissipate, or transfer slowly to ground without causing damage.

Cleanroom Nitrile Gloves Preferred

When selecting gloves for cleanroom applications where static discharge could harm the product, or where static could lead to contamination, nitrile gloves are the preferred choice.

Gloves made from natural rubber latex are inherently static insulative, holding on to a charge and releasing it in an uncontrolled manner, leading to damage.  The surface resistance of nitrile gloves, however, is normally on the border of insulative and static dissipative.  To be considered static dissipative, the glove should have a surface resistance of more than 1 x 10⁵ but less than 1 x 10¹¹ ohms/sq.  The surface resistance test results for a glove can usually be found on the manufacturer’s product information sheet.

Balancing ESD with Cleanliness

Interestingly, the cleaner the glove, the lower the glove’s ESD protection.  Tom Lesniewski and Kenn Yates of the TRW Space and Electronics Group conducted an evaluation of the cleanliness and ESD protective properties of cleanroom materials, including 7 different types of nitrile gloves.

They found a clear tend – as non-volative residue (NVR) increased, surface resistance decreased.  The surface contaminants on a glove make the glove more static dissipative, especially in higher humidity.

Because there is clear tradeoff between cleanliness and charge dissipation rate, cleanrooms requiring a high level of ESD protection should choose a cleanroom glove only as clean as it needs to be for the ISO level of the cleanroom.

How does a cleanroom glove’s ESD property impact your manufacturing environment?  Share your comments below.

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.

Particle Levels

Cleanroom gloves, along with other cleanroom garments, are worn to protect the product or process from particle contamination caused by the shedding of human skin.  So the gloves themselves should have low airborne and liquid-borne particle contamination.  Particulates can arise during the manufacturing process, and glove manufacturers routinely test in order to trace and reduce sources of contamination.

The lowest contamination levels are obtained through multiple rinses in deionized water, followed by drying cycles in HEPA filtered driers.  To ensure the gloves stay very clean, they are then sorted and packed in double polyethylene bags in an ISO 5 or 4 cleanroom environment.

Ion Extractables

Ionic extractables are traces of elements that can leach out of a glove and harm the product being manufactured.  They include elements such as calcium, chloride, sodium, silicon, sulfites and zinc.  The type, mobility and amount of ion extractables can seriously affect the manufacturing process.  In the semiconductor industry, ions like sodium can induce conduction and low field breakdown in devices.  In disk drive manufacturing, chlorides can cause corrosion.

Testing for inorganic ions present on a glove’s surface include using an ion chromatograph and Couple Plasma, Flame-AA or GF-AA in accordance with ASTM guidelines.  It’s important to note that in this stringent test the extractable levels are much higher than ion transfer under normal, dry glove use.

Cleanroom Gloves – Selection Criteria

Cleanroom requirements vary from one manufacturer to another, even within the same industry.  When selecting cleanroom gloves, the particle levels should match the cleanroom environment.  The extractables should be as low as possible, but taken in consideration with the glove’s overall barrier properties, such as AQL, or pinhole rate.  A glove with impressively low extractables, but with a high pinhole rate will not keep the manufacturing environment as clean as a glove with a lower AQL.

What is most important for your cleanroom application (particles, extractables, grip, ergonomics) and why?  Share your comments below.

Or perhaps not.   A search of some popular dental journals online yielded zero articles on the hazards of what the American Contact Dermatitis Society named the 2012 Allergen of the Year – Acrylates.

Acrylates – What Are They?

Though they get little mention, acrylates are everywhere.   The salts of acrylic or methacrylic acid can be polymerized to form solid plastics.  Polymerized methacrylate was first used in the 1930s, when mass production of Plexiglas began.  It is now used in windowpanes, car lights and windshields, and streetlamps.  Over time, other acrylates have been synthesized and are now found in paints, adhesives, printing inks and medical devices.  Fully polymerized acrylic plastics are inert and harmless.  However, the building blocks – acrylates and methacrylates – are strong irritants and notorious allergens.

But what does this have to do with safety in the dental office?

Acrylates in the Dental Office

These days, many methacrylates are used in dental bonding materials.  These dental materials seem to be a major cause of contact dermatitis in dental personnel.   The polymerization (curing process) of these adhesives and materials occurs with exposure to UV light and with the help of a priming photoinitiator, or when two components are mixed causing a chemical reaction.   In both cases, unreacted monomers are released.  These “free monomers” can cause irritation to skin and eyes, asthma, and allergic dermatitis.

“Dental surgeons, assistants, and technicians are also at risk of allergic sensitization from monofunctional and polyfunctional (meth)acrylates and from the epoxy acrylate prepolymers.”  - American Contact Dermatitis Society

Widely used dentin primers and dentin bonding agents and cements that contain 2-HEMA (hydroxyethyl methacrylate) have been studied.  The authors concluded that the free monomers released from HEMA can affect dental personnel as well as patients in the immediate vicinity.

There are numerous reports of acrylate associated allergy in dental personnel, including fingertip paraesthesia and occupational allergic contact dermatitis caused by a restorative dental material with polymethylmethacrylate.

Testing and Protection

Testing for allergic sensitization to acrylates is difficult.  The allergens have to be kept frozen or refrigerated, delayed positive results are common, and patch testing can cause severe allergic reaction.

Methacrylate monomers penetrate vinyl and latex gloves within minutes.  For this reason, the American Contact Dermatitis Society recommends double gloving with nitrile gloves, or polyethylene gloves under nitrile gloves.  This should afford adequate protection for tasks that do not exceed 30 to 60 minutes.

Dental products such as acrylics, resins and polymer materials represent significant advances in dentistry and are here to stay.  Your best option to minimize the risk of developing an acrylate allergy is to stay informed about the signs and symptoms of allergic reactions, keep records of dental materials being used, and put in place whatever precautions are available to limit your exposure.

Are you concerned about acrylates?  Share your comments below.

Sources:
American Contact Dermatitis Society – Acrylates – Contact Allergen of the Year
Dental Occupation Hazards – A Review

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?

A key quality measurement that glove manufacturers publish on glove boxes, bags and product literature is AQL, or Acceptable Quality Level.

Stated as a percentage, the AQL is a statistical measurement of the quality of the gloves.  An AQL of 2.5% means that statistically, only 2.5 gloves for every hundred gloves will fail a quality test.

How AQL is Determined

Let’s say a glove manufacturer produces 10,000 gloves from the same material, settings and processes.  Two hundred gloves would be pulled randomly from the line, throughout the batch, to be tested.  To meet an AQL of 2.5%, no more than 10 gloves can fail the quality tests.  If more than 10 gloves fail, the entire batch fails, and each glove must be tested individually for quality, or else the whole batch is discarded.  An AQL of 1.5% would mean that no more than 7 gloves could fail.

ASTM D5151 Test for Detection of Holes in Medical Gloves

Disposable gloves are subjected to numerous ASTM tests throughout the manufacturing process.  One test that medical and cleanroom gloves have in common is a test for pinholes.

ASTM D5151 is the Standard Test Method for Detection of Holes in Medical Gloves, often referred to as the “watertight” test or “water leak” test.   In this test, the gloves are each filled with 1000 ml of water at room temperature, secured at the cuff and hung vertically for two minutes to check for pinholes.  If water does not leak from the glove, it gets a “pass.”

The current FDA mandated maximum AQL for examination and cleanroom gloves on this test is 2.5%, down from the previous 4.0% prior to December 2008.  Some gloves, however, are manufactured and tested to meet the lower AQL of 1.5% required for surgical gloves.  This means higher quality and fewer pinholes.

Pinholes in gloves provide a path for human-borne contaminants in the clean manufacturing environment.   Just one square inch of the surface of a person’s hand can contain 10,000 microorganisms!

So how common are pinholes in cleanroom gloves?

A study published in May 2011, Integrity of Disposable Nitrile Exam Gloves Exposed to Simulated Movement,  compared cleanroom nitrile gloves to medical-grade, low-modulus and general duty nitrile gloves.  A total of thirty different glove products were tested, including six cleanroom and nine medical-grade nitrile glove products.  A modified water-leak test was used to detect a 0.15 to 0.05 mm hole in different areas of the glove, including the thumb and pinky.  What did they discover?

“The cleanroom gloves, on average, had the highest percentage of leaks, and 50% failed the water-leak test.”

Two of the cleanroom nitrile gloves tested had an out of the box failure rate of 6.25%.  The medical grade and low modulus gloves had the lowest percentage of leaks.  Even the general duty gloves performed better than the cleanroom gloves tested.   However, two of the six cleanroom gloves tested had a failure rate of zero percent.  Why such a significant difference?

The study authors indicate that it could be due to differences in nitrile material formulation.  A low-modulus nitrile glove with a higher percentage of plasticizer, which is more water resistant, was expected to perform better in the water leak test.

What was not discussed in the paper is the AQL, or Acceptable Quality Level, of the gloves tested.  The AQL for the water leak test, a test that indicates what percentage of the gloves can fail a water test for pinholes, is set by ASTM at 2.5% for cleanroom gloves.  Many manufacturers, however, use the medical grade requirement of 1.5%.  This means that less than 1.5% of the gloves from any given lot could fail due to pinholes – substantially less than 2.5%.

Clearly, there are significant differences in the quality of cleanroom gloves on the market.  To protect your cleanroom environment, select cleanroom gloves made from consistently high quality low-modulus NBR materials, and an AQL of 1.5% or less.

The Science of Nitrile

Nitrile is a shortened term for Nitrile Butadiene Rubber, or NBR.  Although it is also referred to as NBR latex, there is no natural rubber latex (or latex proteins) in the material.  Nitrile is a synthetic rubber copolymer of acrylonitrile and butadiene.  These two materials (monomers) are placed in a stainless steel vat, and using hot or cold polymerization, a chemical reaction occurs, and voila!  Nitrile is born.

The nitrile latex is filtered and blended with an antioxidant to stabilize the material.  Next, the liquid is solidified by adding coagulating agents, then finally washed and dried.  The resulting material is referred to as “crumb rubber.”  Crumb rubber can be liquefied by product manufacturers to make nitrile rubber materials, such as floor mats, footwear, adhesives and gloves.

Low-Modulus Magic

Nitrile alone, without anything added, is a fairly rigid material.  So glove manufacturers add a small percentage other chemicals to NBR in order to create a soft, or low modulus, nitrile glove.  Over the past decade, these manufacturers have continued to improve their nitrile glove material formulations.  Disposable nitrile gloves have grown softer and more elastic.  The latest innovations in nitrile glove development include accelerator-free formulations that lower the risk of Type IV contact dermatitis in wearers.

These thin and flexible gloves are what we have all come to rely on to keep ourselves, our patients, products and food items safe.  Nitrile gloves are more resistant to oils and acids than natural rubber (latex) gloves.  The material is resistant to abrasion and puncture, making it suitably durable for many tasks.  Low modulus nitrile gloves also conform well to the hand and provide excellent tactile sensitivity.

As disposable nitrile glove formulations evolve, hand protection is becoming ever safer and more comfortable.  We look forward to continuing to bring you the very best nitrile gloves made from the latest materials.

Have you noticed the improvements in disposable nitrile gloves over the years?  We’d love to hear your comments.  Share them with us below!