Do Your Medical Gloves Pass the Viral Penetration Test?

Do Your Medical Gloves Pass the Viral Penetration Test?

There are millions of types of viruses in the world. Viruses that infect human cells cause diseases ranging from the common cold and chicken pox to hepatitis C, SARS, Ebola and Zika. Healthcare workers, emergency responders and researchers are exposed to these sometimes deadly viruses.  How can they be sure that their personal protective equipment (PPE,) including their medical gloves, will help keep them safe?

No manufacturer can guarantee that their product will eliminate the risk of virus transmission. There are, however, standard tests that help ensure the wearer a high level of protection from viruses.

ASTM F1671

One of these standards is ASTM F1671, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System.

This test, usually referred to as the Viral Penetration Test, is a pass or fail test designed to show whether the material can protect a wearer from viruses that can be transmitted via blood and body fluids.

Test Procedure

ASTM F1671 Test ChamberTo conduct the test, swatches of the test material are conditioned for 24 hours at a certain temperature and humidity. The samples are then loaded into penetration test cells. Each test cell reservoir is filled with about 60 ml of Phi-X174 Bacteriophage suspension – a surrogate for viruses like HCV, HBV and HIV.

After allowing the fluid to sit for five minutes, air pressure is applied at 2 pounds per square inch gauge (psig) for one minute. After the minute is up, the pressure is released and the sample is allowed to sit for nearly an hour.

Throughout the test, the samples are monitored for fluid penetration. The specimens are then tested with a biologically based assay. Based on test results, the samples pass or fail ASTM F1671.

Virus Protection and Your Gloves

While the FDA does not require this test for medical gloves, the National Fire Protection Association does. NFPA Standard Number 1999 was developed to ensure that protective garments, gloves and facewear that are worn during a medical emergency operation will give a high level of protection from bloodborne pathogens like viruses.

Medical gloves that pass the Viral Penetration Test are considered to be highly protective against bloodborne virus transmission. Both RoyalTouch300 and FreeStyle1100 Nitrile Exam Gloves pass this test. Double gloving can provide added protection.

Resources:

http://www.astm.org/Standards/F1671.htm
https://www.nelsonlabs.com/Test/Viral-Penetration

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Medical Gloves Essential to Mitigate Ebola, SARS Outbreaks

Every day a diverse group of health care workers rely on medical gloves to guard against contracting or transmitting dangerous contagions.

In countries where gloves, face masks and other personal protective equipment (PPE) are readily available, it can be easy to take this first line of defense for granted.

Unfortunately, in many places around the world, medical gloves are frequently unavailable. This results in the sudden and sometimes explosive spread of infectious disease.

Ebola Spreads for Want of Gloves

Nowhere is this lack of basic protection more pronounced at the moment than in the West African countries of Guinea, Liberia, and Sierra Leone.

In Liberia, medical gloves are so scarce that doctors wrap their hands in plastic grocery bags to deliver babies, and nurses must routinely care for the ill with bare hands. Gloves are reserved for only the sickest of patients, and are often reused.

In Sierra Leone, where Ebola has been reported in every district, 30% of hospitals lack sterile gloves and 70% lack protective eyewear.

With conditions so ripe for the transmission of disease, the Ebola outbreak spread quickly from its epicenter in southeastern Guinea. As of September 18th there have been 5,347 suspected and confirmed cases, with 2,630 suspected case deaths, making it the largest Ebola outbreak to date and the first epidemic of the virus.

These numbers include an unprecedented number of health care workers. Because they lack gloves and other PPE, or do not use them properly, the World Health Organization (WHO) reported on August 25th that more than 240 doctors and nurses have contracted Ebola. Over 120 have died.

Understandably, health care workers are demanding gloves and other PPE before returning to work.

In the meantime, outside organizations such as WHO and Centers for Disease Control and Prevention (CDC) have stepped in to provide support and coordinate workers, supplies and training. Clinics are being reopened, but these are quickly inundated with newly sick patients.

The greatest need continues to be the availability and proper use of basic PPE – gloves, face masks and protective eyewear. Without this first line of defense, it will be difficult to mitigate the Ebola outbreak.

SARS Lessons

The 2003 SARS epidemic taught us some valuable lessons. Foremost is the importance of controlling the disease at its source. That means strict adherence to infection control practices, including proper hand hygiene and gloving.

Unfortunately, due to familiarity or lack of time, heath care workers sometimes took shortcuts. The result? Hospital workers treating SARS patients became infected.

To halt the spread, hospitals placed monitors outside patients’ rooms to ensure everyone strictly followed infection control procedures. Only then was the deadly spread of SARS stopped.

Medical gloves, so ubiquitous with health care in the U.S. and much of the world, are a crucial piece of health care equipment often missing in other countries. The availability and proper use of gloves and other PPE is critical to halting the spread of infectious diseases such as Ebola and SARS.

Even in countries where gloves are in every patient contact area, vigilance and diligence in adhering to infection control practices is critical to everyone’s safety.

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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.

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?

Disposable Glove Quality Testing

The FDA sets high standards to ensure the disposable gloves you purchase here in the U.S. perform as expected and provide an adequate barrier for their intended use.  To meet these standards, glove manufacturers have tight quality controls and manufacture gloves according to ASTM specifications and testing requirements.

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.

Accelerator-Free Nitrile Exam Gloves – A Better Alternative

As hospitals and other healthcare facilities have increasingly moved from latex exam gloves to nitrile exam gloves, skin irritation and allergy to non-latex gloves has also increased. To identify individuals with hypersensitivity to nitrile gloves, a new skin prick test has been developed by Dr. Santhosh Kumar of Virginia Commonwealth University, Richmond. “If the patient is positive,” says, Dr. Kumar, “we tell them to avoid nitrile gloves,” and he recommends vinyl gloves as an option.

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FDA Soon to Require Warning Label on Powdered Medical Gloves


UPDATE:  The “Draft Guidance for Industry and FDA Staff – Recommended Warning for Surgeon’s Gloves and Patient Examination Gloves that Use Powder,” referenced in this post, was withdrawn on April 27, 2015.


The problems associated with powdered medical gloves are well documented. The FDA first issued a Medical Glove Powder Report back in 1997, warning of adverse health events that included dyspnea, respiratory problems, allergic reactions, and granuloma formations.

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