Hand Hygiene Before Gloving – How Important?

Hand Hygiene Before Gloving - How Important?

If you work anywhere in the health care industry, you are likely aware of the importance of performing proper hand hygiene and glove use to reduce the spread of infectious organisms.

In the “Five Moments for Hand Hygiene” as outlined by the World Health Organization (WHO,) the first “moment” for performing hand hygiene is Before Patient Contact.

But is this step really necessary, especially when you are about to don a pair of gloves before touching the patient?

Recent studies on unused, non-sterile exam gloves removed from glove boxes in patient areas suggest it really is that important.

Glove Contamination in the ICU

At University Medical Center, a 412-bed tertiary care hospital in Lubbock, TX, a study compared rates and burden of non-sterile glove contamination among specialty ICUs.

A total of ninety glove pair samples were taken from occupied rooms in a 32-bed Medical ICU, a 21-bed Trauma/Surgical ICU, and a 6-bed Burn ICU.  The gloves were collected from glove boxes housed in glove box dispensers or patient carts in patient rooms where health care providers had unrestricted access to the gloves.

The results?

“We found an average contamination rate of 81.1% across all glove pairs sampled with an average bioburden of 5.83 CFU (SD = 8.04).”  These findings were consistent with previous studies, where contamination rates were 55-87% and average bioburdens ranged from 3.4-6.2 CFU per glove pair.

The study also found evidence of methicillin-resistant organism (MRO) contamination on 36.7% of glove pairs sampled.  The study noted that “because our contamination rate estimate most likely underestimates the true rate of MRO contamination due to the selective culturing process followed, actual rates of MRO contamination may be higher than those reported in this study.”

Pathogen Contamination in a Large Ward

Another study conducted in New Zealand investigated glove use on a hospital orthopaedic ward to examine whether pathogen contamination occurs prior to contact with patients.

Glove samples were removed from boxes on opening and days 3, 6 and 9 thereafter.

The results?

“Total bacterial counts ranged from 0 to 9.6 x 103 cfu/glove.  Environmental bacteria, particularly Bacillus species, were present on 31/38 (81.6%) of samples.  Half (19/38) the samples were contaminated with skin commensals; coagulase negative staphylococci were predominant.  Enterococcus faecalis , Klebsiella pneumoniae , Pseudomonas sp. or methicillin susceptible Staphylococcus aureus were recovered from 5/38 (13.2%) of samples.  Significantly more skin commensals and pathogens were recovered from samples from days 3, 6, 9 than box-opening samples.”

Clearly, both studies demonstrate that health care workers can introduce pathogenic bacteria into glove boxes, and unused, non-sterile exam gloves can become pathogen transmission vehicles in hospitals and potentially other healthcare settings.

Adhering to handwashing guidelines and performing hand hygiene before donning gloves is a critical, not to be skipped step in reducing the spread of dangerous bacteria.

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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.

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Exam Gloves’ Critical Role in Patient Safety

Healthcare professionals have long known the importance of proper glove use during patient care. For over twenty years, exam gloves have been worn to prevent transmission of bloodborne pathogens. The Occupational Safety and Health Administration mandates that gloves be worn during all patient-care activities that may involve exposure to blood or body fluids. So when we hear of a healthcare professional that has ignored such clear and common sense direction, the medical community and the public react with surprise and disgust.

Read moreExam Gloves’ Critical Role in Patient Safety

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