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Powdered surgical gloves:
Is it time for a change?
(An Online Continuing Education Activity)
An Online Continuing Education Activity
Sponsored By
Grant funds provided by
Welcome to
Powdered surgical gloves:
Is it time for a change?
(An Online Continuing Education Activity)
CONTINUING EDUCATION INSTRUCTIONS
This educational activity is being offered online and may be completed at any time.
Steps for Successful Course Completion
To earn continuing education credit, the participant must complete the following steps:
1. Read the overview and objectives to ensure consistency with your own learning
needs and objectives. At the end of the activity, you will be assessed on the
attainment of each objective.
2. Review the content of the activity, paying particular attention to those areas that
reflect the objectives.
3. Complete the Test Questions. Missed questions will offer the opportunity to reread the question and answer choices. You may also revisit relevant content.
4. For additional information on an issue or topic, consult the references.
5. To receive credit for this activity complete the evaluation and registration form.
6. A certificate of completion will be available for you to print at the conclusion.
Pfiedler Enterprises will maintain a record of your continuing education credits
and provide verification, if necessary, for 7 years. Requests for certificates must
be submitted in writing by the learner.
If you have any questions, please call: 720-748-6144.
CONTACT INFORMATION:
© 2015
All rights reserved
Pfiedler Enterprises, 2101 S. Blackhawk Street, Suite 220, Aurora, Colorado 80014
www.pfiedlerenterprises.com Phone: 720-748-6144 Fax: 720-748-6196
OVERVIEW
Preventing disease transmission and subsequent infection in surgical patients and staff
members are key outcomes across all perioperative practice settings. The problems
of surgical site infections and other health care-associated infections take on greater
significance today in the face of newly recognized pathogens and drug-resistant
microorganisms, as well as the economic incentives outlined in the Affordable Care Act,
designed to improve the safety of patient care. During an operative or invasive procedure,
both the patient and members of the surgical team are at risk for transmission of infectious
agents; therefore, surgical gloves are used on a daily basis to reduce the risk of disease
transmission for both patients and personnel. However, as the use of gloves continues to
evolve, so do concerns related to the risks associated with powdered surgical gloves; these
concerns and risks have provided the momentum for the transition to powder-free surgical
gloves as the new standard of care. Many perioperative nurses realize that continuing
the use of powder and latex is not worth the potential risks — not only for patients, but for
clinicians as well. Today, as more reimbursements are directly tied to patient outcomes
and satisfaction, the more these types of issues need to be considered. This continuing
education activity will provide a historical review of the evolution of surgical gloves used
as a protective barrier. The specific safety risks to patients and staff associated with
the use of powdered surgical gloves are outlined. Key factors, including regulatory and
professional recommendations, influencing the momentum toward the use of powder-free
surgical gloves will be reviewed. Advances in powder-free glove manufacturing and coating
technologies, followed by the clinical and economic benefits of powder-free surgical gloves,
will be discussed.
LEARNER OBJECTIVES
After completing this continuing nursing education activity, the participant should be able to:
1. Outline the historical evolution of the use of surgical gloves as protective barriers.
2. Explain the risks associated with the use of powdered surgical gloves for patients
and perioperative team members.
3. Identify factors providing the impetus toward the use of powder-free surgical gloves.
4. Discuss advances in surgical glove technology in regards to the development of
powder-free gloves.
5. Describe the clinical and economic benefits of powder-free surgical gloves.
INTENDED AUDIENCE
This continuing education activity is intended for perioperative registered nurses who want
to learn more about the risks associated with the use of powdered surgical gloves and key
considerations in the use of powder-free surgical gloves.
3
CREDIT/CREDIT INFORMATION
State Board Approval for Nurses
Pfiedler Enterprises is a provider approved by the California Board of Registered Nursing,
Provider Number CEP14944, for 2.0 contact hour(s).
Obtaining full credit for this offering depends upon completion, regardless of
circumstances, from beginning to end. Licensees must provide their license numbers for
record keeping purposes.
The certificate of course completion issued at the conclusion of this course must be
retained in the participant’s records for at least four (4) years as proof of attendance.
IACET
Pfiedler Enterprises has been accredited as an Authorized Provider by the International
Association for Continuing Education and Training (IACET).
CEU Statements
• As an IACET Authorized Provider, Pfiedler Enterprises offers CEUs for its programs
that qualify under the ANSI/IACET Standard.
• Pfiedler Enterprises is authorized by IACET to offer 0.2 CEUs for this program.
RELEASE AND EXPIRATION DATE
This continuing education activity was planned and provided in accordance with
accreditation criteria. This material was originally produced in March 2015 and can
no longer be used after March 2017 without being updated; therefore, this continuing
education activity expires March 2017.
DISCLAIMER
Accredited status as a provider refers only to continuing nursing education activities and
does not imply endorsement of any products.
SUPPORT
Grant funds for the development of this activity were provided by Cardinal Health.
AUTHORS/PLANNING COMMITTEE/REVIEWER
Elizabeth Deroian, BA, RN
Program Manager/Planning Committee
Pfiedler Enterprises
Aurora, CO
Rose Moss, RN, MSN, CNOR
Nurse Consultant/Author
Moss Enterprises
Elizabeth, CO
4
Judith I. Pfister, RN, BSN, MBA
Program Manager/Planning Committee
Pfiedler Enterprises
Aurora, CO
Julia A. Kneedler, RN, MS, EdD
Program Manager/Reviewer
Pfiedler Enterprises
Aurora, CO
DISCLOSURE OF RELATIONSHIPS WITH COMMERCIAL ENTITIES
FOR THOSE IN A POSITION TO CONTROL CONTENT FOR THIS
ACTIVITY
Pfiedler Enterprises has a policy in place for identifying and resolving conflicts of interest
for individuals who control content for an educational activity. Information listed below is
provided to the learner, so that a determination can be made if identified external interests
or influences pose a potential bias of content, recommendations or conclusions. The
intent is full disclosure of those in a position to control content, with a goal of objectivity,
balance and scientific rigor in the activity.
Disclosure includes relevant financial relationships with commercial interests related to
the subject matter that may be presented in this educational activity. “Relevant financial
relationships” are those in any amount, occurring within the past 12 months that create a
conflict of interest. A “commercial interest” is any entity producing, marketing, reselling, or
distributing health care goods or services consumed by, or used on, patients.
Activity Planning Committee/Authors/Reviewers:
Elizabeth Deroian, BA, RN
No conflict of interest
Rose Moss, RN, MSN, CNOR
No conflict of interest
Judith I. Pfister, RN, BSN, MBA
Co-owner of company that receives grant funds from commercial entities
Julia A. Kneedler, RN, MS, EdD
Co-owner of company that receives grant funds from commercial entities
5
PRIVACY AND CONFIDENTIALITY POLICY
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practices and regulations regarding continuing education. The information we collect
is never shared for commercial purposes with any other organization. Our privacy and
confidentiality policy is covered at our website, www.pfiedlerenterprises.com, and is
effective on March 27, 2008.
To directly access more information on our Privacy and Confidentiality Policy, type the
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internet-based continuing education programs.
The privacy policy of this website is strictly enforced.
CONTACT INFORMATION
If site users have any questions or suggestions regarding our privacy policy, please contact
us at:
Phone: 720-748-6144
Email:
[email protected]
Postal Address: 2101 S. Blackhawk Street, Suite 220
Aurora, Colorado 80014
Website URL:
http://www.pfiedlerenterprises.com
6
INTRODUCTION
Reducing the risk of infection for patients as well as members of the surgical team
continues to be a primary focus in today’s dynamic health care environment, as
perioperative personnel face challenges presented by newly recognized pathogens and
those that have become resistant to current treatment modalities.1 Patients are at risk
of contamination from both endogenous and exogenous microorganisms; health care
workers are at risk for contamination from various bloodborne pathogens that can be
contracted by occupational exposure to patients’ blood and body fluids. Therefore, in
the perioperative practice setting, the appropriate use of personal protective equipment
(PPE) is a key factor in preventing transmission of potentially infectious agents plays a
dual role in protecting both members of the perioperative team, as well as patients from
this risk. Gloves are one off the most frequently used items of PPE and thus are one
of the most important infection prevention products purchased to protect both staff and
patients.
The risks associated with the use of powdered surgical gloves for both patients and staff
members are well-documented. In regards to patient-related complications associated
with the use of powdered gloves, today, all health care facilities are incentivized to
reduce the risk of hospital-acquired conditions (HACs). The Affordable Care Act (ACA)
established the HAC Reduction Program to encourage hospitals to decrease HACs,
which are defined as “a group of reasonably preventable conditions that patients did
not have upon admission to a hospital, but which developed during the hospital stay.”2
A hospital’s performance under this program is calculated based upon its Total HAC
Score, which can range from 1 to 10; the higher a hospital’s Total HAC Score, the worse
it performed. Beginning in fiscal year, 2015 the law requires payments to hospitals that
rank in the quartile of hospitals with the highest Total HAC Scores to be reduced by 1
percent.
With the ongoing uncertainty in the health care industry, it remains clear that in the future,
hospitals will exist in an environment where they are rewarded more for the quality
of care they provide rather than the volume of patients that they treat.3 Therefore, as
health care facilities move from a volume-based system to a value-based system, they
must exist in two environments: one in which they still are profitable and one that views
successful outcomes as the most important measure of hospital performance.
As a result, the standard of care in glove use is changing to powder-free glove products.
The use of powder-free gloves has been a common trend to improve the safety and
health of patients and clinicians.
HISTORICAL EVOLUTION: THE USE OF SURGICAL GLOVES AS
PROTECTIVE BARRIERS
In order to appreciate the role of gloves used as protective barriers and the current trend
toward the use of powder-free gloves, it is helpful to review the evolution of the use of
surgical gloves as protective attire in the operating room (OR).
7
•
In 1758, Johann Julius Walbaum, MD becomes the first surgeon to use gloves
in the operating theater. The gloves are made from the cecum of a sheep and
cover only the fingers; they did not start a trend.4
•
1893, Dr. Joseph Bloodgood recognizes the need to prevent the spread of
infection and is the first to provide rubber gloves to his entire surgical team; by
the early 1900s, surgeons and theatre nurses were routinely wearing surgical
gloves.5
•
One year later, in 1894, William Stewart Halstead, a surgeon at Johns Hopkins
Hospital, introduced the first sterile, latex, reusable glove into the OR; Dr.
Halstead is considered to be the father of the surgical glove.6
•
In the 20th century, latex gloves were difficult to don. Lycopodium spores mixed
with talc became the lubricant of choice, until a study conducted in the late
1920s demonstrated that these spores were somewhat poisonous to humans; as
a result, many glove manufacturers changed to a talc-only lubricant.7
•
In 1947, glove technology improved; gloves became thinner, stronger, and more
flexible, but the use of talc became an issue when another study found that
the talc was causing surgical complications and preventing successful healing.
Cornstarch was introduced as the better choice for use as a glove lubricant.8
•
From 1952 until 1964, surgical gloves stay grounded, ie, they are still thin,
flexible, made from latex, covered with cornstarch for easier donning, and
reusable (after surgery, they were cleaned, sterilized, re-coated and donned
again). The first disposable glove was introduced in 1964 and quickly became
the norm, improving the odds against the spread of infections.9
•
During the 1970s, the latex in gloves began causing allergic reactions in
some users as well as patients; in addition, evidence emerges that the once
reliable cornstarch may impede healing if it contaminates the surgical wound.10
Therefore, clinicians began asking if powder is posing a risk; research begins to
find the answer.
•
During the 1980s, the acquired immune deficiency syndrome (AIDS) epidemic
confronts the nation and also changes health care. The recommendations for
universal precautions, first published in August 1987 by the Centers for Disease
Control and Prevention (CDC),11 mandated that all health care workers wear
gloves. Therefore, the use of latex gloves skyrocketed – 9 billion gloves were
sold. However, reports of allergic reactions also rose rapidly in response.12
•
As the century came to a close in the 1990s, glove research produces true glove
alternatives: first, powder-free latex and then synthetic.13
•
The 21st century began the era of avoiding latex completely as the only way to
prevent allergic reactions for patients and health care professionals.14 However,
as synthetic gloves become the future of glove use, many users cling to the past
and are reluctant to change.
8
RISKS ASSOCIATED WITH THE USE OF POWDERED SURGICAL
GLOVES
The use of powdered surgical gloves is associated with risks for both patients and
surgical staff members. The potential risks to patients and health care workers, when
powder is used as a lubricant on surgical gloves, have been well-recognized for over four
decades; moreover, the associated complications can be quite significant.
Patient-Related Risks
• Aerosolization. During donning of a powdered surgical glove,
minute particles fill the air; after donning, particles can continue
to fall away from the glove as surgery proceeds. Powdered
gloves have been identified as the largest single contributor to
latex aeroallergen levels in health care facilities; the cornstarch
powder on surgical gloves promotes the transfer of allergenic
latex proteins.15
•
Potential risk
to patients are
inflammation,
scarring,
adhesions
and wound
infection.
Inflammation, scarring, adhesions, and wound infection. Particles of glove
powder can settle on surgical suture material, instruments, drapes and
sponges.16, 17 When cornstarch is deposited in a surgical wound, it is a foreign
body; as a result, it promotes an exaggerated inflammatory response and
also interferes with the host’s defenses against infection.18 The powder
may cause delayed wound healing, as well as postoperative complications
including adhesions, joint inflammation, abdominal pain, vascular obstructions,
and starch granuloma formation.19,20 Powder contamination can also cause
misdiagnosis, resulting in inappropriate treatment or unnecessary surgery21 and
has been shown to enhance the growth of bacteria.22 Several related research
studies are summarized below.
o Yaffe, et al studied the role of cornstarch glove powder in the
formation of adhesions in patients undergoing tubal reconstructive
surgery.23 Cornstarch, contained in granulation tissue, was found in
4 of the 49 histological specimens; therefore, the authors concluded
that cornstarch powder may be an active agent in adhesion
formation.
9
o An early study conducted by Hunt, et al found starch granules in
surgical wounds, in proportion to the number of team members who
wore powdered gloves and also to the proximity of the wearer(s) to the
surgical site.24 The starch-containing phagocytes in the tissue were
surrounded by an inflammatory reaction. This inflammatory reaction
to starch, while variable, can be severe, as severe inflammation and
scarring were noted in one patient.
o Ruhl, et al reported that, in wounds contaminated with cornstarch,
the presence of cornstarch enhanced bacterial growth and also
elicited exaggerated inflammatory responses, as measured by wound
induration.25
o In a more recent animal study by Suding, et al to determine if glove
powder, combined with methicillin-susceptible Staphylococcus aureus
(MSSA) injected into the subcutaneous tissue would potentiate
abscess formation found that increases in both the concentrations of
MSSA and starch powder led to more frequent abscess formation.26
Furthermore, the presence of high concentration of starch reduced
the inoculum of bacteria needed to produce an abscess. Therefore,
the presence of starch, regardless of the concentration, increased the
likelihood of abscess formation in the presence of bacteria.
Risks to Perioperative Staff Members
The potential risks of powder to perioperative staff members are clear as well. Powder
heightens latex sensitivities and therefore, latex reactions can occur as a result of using
powdered gloves, not just latex gloves. Latex sensitivity is estimated to affect 8% to 12%
of health care workers; reactions can include irritant contact dermatitis and allergic contact
sensitivity;
eye, nasal, and sinus
symptoms;
asthma; and immediate,
potentially
life- Staff
Risks
Associated
with
Powdered
Gloves:
OR
threatening sensitivities such as anaphylaxis.27 (See Figure 1).
Figure 1 – Risks Associated with Powdered Gloves: OR Staff
Powder heightens latex sensitivities which affects 8 -12% of
health care workers
Allergic Reactions
Sensitivity Reactions
10
It should be noted that direct physical contact with a product containing latex is not
necessary to trigger an allergic reaction; both anaphylaxis and severe asthmatic reactions
have been triggered by inhaling or nose and/or eye contact with aerosolized latex proteins
from the powder in latex gloves.28 High concentrations of this allergenic powder have
been measured in ORs.29 Once inhaled, these proteins can also sensitize individuals in
addition to triggering an allergic reaction in someone who is already sensitized; research
has further demonstrated that the powder in powdered gloves contains more proteins than
powder-free gloves, which may increase the incidence of sensitization.30
A 1-year longitudinal study designed to assess the impact of powder-free latex gloves on
latex sensitization of OR personnel found that, after conversion to powder-free natural
rubber latex, there was a significant decrease in reported symptoms after exposure to
natural rubber latex (ie, 42% pre-conversion versus 29% post-conversion).31
Researchers at The Medical College of Wisconsin who studied latex allergy in health care
workers also demonstrated that the most effective strategy to prevent allergic sensitization
is to discontinue the use of powdered latex gloves.32 Prior studies identified this
association of latex allergy to powdered latex glove use, but did not completely confirm this
link in specific workers. By reducing the use of powdered gloves, the allergen in the air and
in the air ducts at two facilities was reduced; this prevented sensitization to latex in health
care workers at both of these facilities. The switch to powder-free gloves resulted in a 16fold reduction in the rate of latex sensitization among the study participants; furthermore,
among the health care workers who were sensitized to latex at the beginning of the study,
25% lost that sensitivity and are no longer considered to be latex sensitized.
Not only are powder-related potential complications major concerns, they can also
contribute to lost health care worker disability and productivity. In fact, one health system
that transitioned from powdered to powder-free gloves found a significant decrease in
workers’ compensation claims for latex-related illness.33
Costs of Removing Powder from Gloves after Donning
Based on the continued concern over adverse reactions
to cornstarch, in 1971, the U.S. FDA required glove
manufacturers to include a warning label on glove
packaging; the warning label read, “CAUTION: After
donning, remove powder by wiping gloves thoroughly
with a sterile wet sponge, sterile wet towel, or other
effective method.”34 However, studies have shown that
efforts to remove the cornstarch from surgical gloves
in a basin with sterile water or using a wet lap sponge
are unsuccessful; moreover, reports indicate that these
efforts have led to additional clumping, which results in
even fewer absorbable particles.35
If a powdered glove user reads and follows the caution statement on surgical glove
packaging, he/she should wash the powder off. Current surveys show that 9 out of 10
users are not consistently washing their gloves to remove powder after donning; even
11
more alarming is that 1 out of 2 users are unaware of the caution regarding the statement
to remove the powder, as noted on the glove packaging.36
There are costs associated with removing and also not removing glove powder:
• The most effective method to remove cornstarch from gloves is noted to
consist of a 1-minute wash with 10 mL of povidone-iodine, followed by a
30-second rinse with sterile water;37 however, this procedure cannot ensure
that all of the powder particles have been eliminated and is time-consuming,
costly, and burdensome to the staff.38
•
As noted above, the combination of latex and powder can result not only
in increased latex sensitization for clinicians, but also even life-threatening
allergic reactions to latex, potentially resulting in extended lengths of stays and
observation.39
•
The late discovery of a patient’s latex allergy can be costly for a facility. Even if
latex gloves are worn only during set-up of the OR, the last minute recognition
of a patient’s latex allergy will require teardown of the OR, as latex proteins
may be deposited on all items touched and therefore, the OR should be
considered contaminated.40 This requires all disposable items to discarded,
reusable items must be re-sterilized, and a complete new OR set-up. The
cost implications for the facility are significant, not only in terms of wasted
materials but also in terms of staff time, re-sterilization costs, and the costs of a
potentially idle OR. One facility’s costs were estimated to be41:
o Contaminated disposables:
 $300 per case.
o Re-sterilization of reusable items:
 Over 30 minutes per teardown (eg, 30 instrument trays or
less for a total hip revision, 10 minutes for sterilization of
the instrument trays, six sterilizers, two trays at a time).
o Cost of an idle OR:
 $26 per minute, $1,560 per hour excluding staff and other
costs.
o The average cost per OR tear down can cost upwards of $2k to $3k per incident.
•
If the warning label goes unnoticed or is ignored and powdered gloves are not
washed, a potential risk includes powder contaminating the surgical wound and
the development of an SSI, the average cost of which has been reported to be
about $20k per incident. 42
The increased lengths of stay and associated costs of care are particularly significant
today, since under provisions in the ACA, as outlined above, hospitals are not reimbursed
for them, but they may receive additional penalties as well for a hospital-acquired
condition.
For these reasons, powder is trending out of the OR and into history to improve the
safety and health of patients and perioperative personnel.
12
FACTORS PROVIDING THE IMPETUS TOWARD THE USE OF
POWDER-FREE GLOVES
All of the issues associated with the use of powdered gloves can be avoided up front by
eliminating powdered gloves and latex all together. This trend is as clear as the science:
America’s hospitals are switching to powder-free gloves, as the powdered latex usage
share is down 12 percentage points over last five years (see Figure 2).43
Figure 2 – Powdered Latex Glove Usage: 2008-201344
It is becoming clearer that continuing the use of powder and latex in health care facilities
is not worth the potential risks — not only for patients, but clinicians as well. As the more
reimbursements are directly tied to patient outcomes and satisfaction, clinicians will need
to focus on issues like this. Survey results indicate that 9 in 10 users would make the
switch right now, if the potential risks of powder were more well-known in their facilities.45
Recommendations to Eliminate the Use of Powdered Surgical Gloves
Many industry and professional organizations have acknowledged the risks of powdered
surgical gloves and issued recommendations.
• CDC/National Institute for Occupational Safety and Health (NIOSH). Noting
that, while latex gloves are effective in preventing transmission of many
infectious diseases to health care workers, but exposures to latex may result
in allergic reactions for some, the CDC/NIOSH recommends that:
“Appropriate barrier protection is necessary when handling infectious
materials. If you choose latex gloves, use powder-free gloves with
reduced protein content.”46
•
Occupational Safety and Health Administration (OSHA). The OSHA bloodborne
pathogens standard outlines that employers must ensure that appropriate
PPE, in the appropriate sizes, is readily accessible in the worksite or is given
to employees. For those employees who are allergic to the gloves ordinarily
provided, hypoallergenic gloves, glove liners, powderless gloves, or other
similar alternatives shall be readily available.47
13
•
Association of periOperative Registered Nurses (AORN). The current AORN
Recommended Practices for a Safe Environment of Care, also include the
use of powder-free, low protein natural rubber latex gloves or latex-free gloves
in the recommendations for developing a protocol to establish a latex-safe
environment in the perioperative setting.48
•
American College of Surgeons (ACS). The American College of Surgeons
clearly recognizes the importance of using powder-free gloves in its comment
to the U.S. FDA: “The College believes there is no reason to continue the
use of powdered gloves. Indeed, the elimination of powdered gloves will
significantly lower the risk of allergic reactions.”49
•
American Nurses Association (ANA).The ANA also advocates the use of nonlatex or powder-free latex gloves as safer alternative to reduce exposure to the
asthma risks posed by chemicals used within a health care environment.50
Powder-Free Glove Use Timeline: 1971-2014
The move toward the use of powder-free gloves has been trending since the early 1970s,
as described below and outline in Table 1.
• 1971. In 1971, the U.S. FDA issued a caution statement in regards to reducing
the amount of powder on surgeon’s gloves; either of the two following
statements needed to be included on the labeling:
“Caution: Powder should be removed from the gloves after donning
by wiping gloves thoroughly with a sterile wet sponge, sterile wet
towel, or other effective method.”
or
“Caution: After donning, remove powder by wiping gloves thoroughly
with a sterile wet sponge, sterile wet towel, or other effective method.”51
•
In the 1990s, manufacturers developed techniques to make powder-free and/or
synthetic latex gloves.52
•
1997. In 1997, the U.S. FDA published its first report on medical glove powder,
noting that at the time, it had received requests to ban the use of glove powder;
the report concluded that:53
o The primary adverse effect of glove powder seems to be its
contributing factor in the development of allergies to natural rubber
latex.
o Glove powder serves as an airborne carrier of natural latex proteins.
o Exposure to airborne natural rubber latex allergens can be most
effectively decreased by taking into consideration both the level of
natural latex proteins as well as the amount of glove powder on the
gloves.
14
•
1998. The first citizen’s petition to ban the use of powder was sent to the
U.S. FDA by Public Citizen.54 Public Citizen, founded in 1971, serves as the
people’s voice in Washington, D.C., advocating various citizen interests before
Congress.55 This letter, dated January 7, 1998, petitioned the FDA to:
“….immediately ban the use of cornstarch powder in the manufacture
of latex surgical and examination gloves because of the serious and
widespread dangers these gloves cause to medical personnel and
to patients.” 56
This letter goes on to point out that acceptable powder-free gloves are
available and that the continued use of powdered latex gloves is both harmful
and unacceptable.
•
2008. In 2008, Public Citizen sent a second petition to the U.S. FDA to ban
the use of cornstarch powder in medical and surgical gloves, again noting that
safer, powder-free gloves are available and also in use in some hospitals.57
This letter also notes that the FDA has the legal authorization to impose a
ban according to the banned devices of the Food Drug and Cosmetic Act; it
again stated that the continued use of powdered gloves is unacceptable and
dangerous and that the FDA must act to ban these products.
•
2011. Four decades since the original FDA warning, draft guidance from
the FDA published on February 7, 2011, included a stronger, more detailed
recommended warning statement to be included on the labeling for medical
gloves that use powder:
“Warning: Powdered gloves may lead to foreign body reactions and
the formation of granulomas in patients. In addition, the powder used
on gloves may contribute to the development of irritant dermatitis and
Type IV allergy, and on latex gloves may serve as a carrier for
airborne natural latex leading to sensitization of glove users.”58
o On April 25, 2011, another letter was sent from Public Citizen to the
U.S. FDA petitioning the immediate ban on using cornstarch powder
in patient exam and surgeon gloves and also a ban on the use of all
natural rubber latex patient exam and surgeon’s gloves.59
•
2013. As noted above, the AORN Recommended Practices for a Safe
Environment of Care in 2013 include the use of powder-free, low protein
natural rubber latex gloves or latex-free gloves to minimize latex exposure and
the risk of latex-associated reactions for both patients as well as perioperative
staff members.60
•
2014. The FDA expressed its intent to publish a proposed rule to ban powdered
gloves.61
15
Table 1 – Powder-Free Timeline
Year
Development
1971
 U.S. FDA issued a caution statement to reduce the amount of
powder on surgeon’s gloves.
 A caution statement to remove powder from gloves after donning
must be included on glove labeling.
1990s
 Introduction of the first powder-free and/or synthetic latex gloves.
1997
 U.S. FDA published its first report on medical glove powder, after
receiving requests to ban the use of glove powder, noting the
adverse effects of glove powder and exposure to airborne natural
rubber latex allergens.
1998
 Public Citizen sent the first petition to ban the use of cornstarch
powder in the manufacture of latex gloves to the U.S. FDA, noting
that acceptable powder-free gloves were now available.
2008
 Public Citizen sent a second letter to the U.S. FDA petitioning
ban the use of cornstarch powder in medical and surgical gloves,
noting that safer, powder-free gloves were available and in use
and that the U.S. FDA had the legal authorization to impose a ban
according to the Food Drug and Cosmetic Act.
2011
 U.S. FDA published a stronger, more detailed recommended
warning statement to be included on the labeling for powdered
gloves, including that:
- In patients, powdered gloves may lead to foreign body
reactions and the formation of granulomas.
- In staff, powdered gloves may contribute to the development
of irritant dermatitis and Type IV allergy; on latex gloves, it
may serve as a carrier leading to sensitization.
 Public Citizen sent a third letter to the U.S. FDA petitioning the
immediate ban on using cornstarch powder in gloves and on the
use of all natural rubber latex patient exam and surgeon’s gloves.
2013
 AORN Recommended Practices for a Safe Environment of Care
to include the use of powder-free, low protein natural rubber latex
gloves or latex-free gloves to minimize latex exposure and the risk
of latex-associated reactions for patients and staff.
2014
 U.S. FDA expressed its intent to publish a proposed rule to ban
powdered gloves.
ADVANCES IN POWDER-FREE SURGICAL GLOVE TECHNOLOGY
Today, with the advances in glove manufacturing and coating technologies, powder
is no longer required. Surgical glove manufacturers are able to produce powder-free
surgical gloves that eliminate the irritation and potential complications that may arise
from powdered gloves. Powder-free gloves are made from synthetic (ie, not made with
16
natural rubber latex) and natural rubber latex materials that are comfortable to wear, easy
to don and remove, and are also versatile in grip and tactile performance. Powder-free
surgical gloves go through additional steps during the manufacturing process to remove
the powder, which does add cost; however, this technology also creates more versatility
for improved glove performance. For example, powder-free gloves can be tailored for
specific surgical needs by adjusting the thickness and grip from smoother to stronger;
ie, a thin, smooth glove can be manufactured for a cardiac surgeon as well as a thicker
glove with a stronger grip for orthopedic surgeons. In contrast, powdered gloves cannot
offer as many different grip and coating options. Furthermore, health care workers with a
known sensitivity or allergy to natural rubber latex need gloves that are both powder-free
and synthetic.
Advances in powder-free glove technology also offer clinical benefits for double-gloving.
AORN recommends the practice of double gloving (ie, wearing a colored pair of gloves
beneath a standard pair of gloves) to protect scrubbed members of the surgical team
from exposure to blood, body fluids, and other potentially infectious materials62; this
system also allows personnel to detect glove perforations more frequently and reliably.63
A key factor in safe and comfortable double-gloving is proper fit. Therefore, many types
of gloves have been created to enhance the double-gloving experience, including
specialized undergloves — those worn closest to the skin — which are the first layer
of protection. In this regard, powder-free undergloves minimize irritants, which can
contribute to compromised skin health or powder-related granulomas, as previously
discussed. (See Figure 3).
Figure 3 – Double-gloving technology
17
Polymer Coatings for Powder-Free Surgical Gloves
Several coating technologies have been developed to reduce the amount of powder or to
replace powder used in the manufacturing of surgical gloves. Historically, powder has been
used to facilitate the release of gloves from formers during glove forming and also to assist
with glove donning. However, polymer coatings in combination with chemical lubricants
are often applied to the glove surface to provide optimum wet and dry donning capabilities.
A majority of the coated surgical gloves currently on the market are manufactured by
applying polymer coatings to the inner surface of the glove; this is followed by postforming
processes, such as chlorination and lubrication. The chlorination process oxidizes the outer
rubber surface to reduce the surface tackiness and also removes most of the powders
deposited on the outer glove surfaces.
Polymer coatings appropriate for use in glove manufacturing must have certain key
characteristics. In order to provide a high-quality glove on a consistent basis, it is
critical that a polymer coating is designed and engineered to meet all of the following
requirements:
• It must adhere to the underlying glove substrate and offer durability and good
donning characteristics.
• It must be resistant to chlorination and the vigorous postforming processing steps
that include rinsing, extraction, and drying.
• It should not degrade after sterilization.
Synthetic polymeric coatings used for surgical gloves are generally made from hydrogel,
acrylic, polyurethane, silicone polymers or polymer blends. The type of polymer used
depends on the intended use of the device, device material, and other processing
requirements. The following coatings, as described below and outlined in Table 2, have
been used on surgical gloves for years; each of the technologies has benefits, yet each
also has some significant drawbacks.
•
Hydrogels. Introduced to the medical device industry in the early 1960s64,
hydrogel coatings represent rather antiquated technology. Hydrogel coatings
do not dissolve in water and exhibit the ability to swell and absorb a significant
amount of water: as much as 20% of their weight.65 Hydrogel coatings are used
on medical products, such as catheters, angioplasty balloons, introducers,
contact lenses and other indwelling medical devices, to enhance surface
lubricity.66
In these applications, the absorbed water in the hydrogel coating forms a thin
water film on the contacting surface, which allows for device movement. Because
of the vast difference in elasticity between natural or synthetic rubber and the
hydrogel coating, the coating tends to crack while forming, stripping gloves
from the former, or donning. If the adhesion of the coating to the rubber is poor,
the coating flakes off from the substrate; these coating flakes could generate
particulate matter. Therefore, it is critical for the hydrogel coating to adhere well
to the underlying rubber substrate, providing integrity during donning.
18
Surface treatment processes have been developed to circumvent the potential
coating adhesion problem, including treating the rubber layer with acid
solutions or with a polymeric adhesion “tie layer” before applying the hydrogel
coating. The treatment can be effective, but it is critical that the process is
under control. In terms of physical properties, tensile strength and puncture
resistance are typically low in hydrogel coatings.
•
Polyurethanes. Polyurethane materials are used in a variety of blood-, tissueand skin-contacting medical devices due to their excellent biocompatibility and
wide range of material properties. Polyurethane materials can be very hard and
rigid (eg, those used for the adhesives for hemodialysis cartridges, or very soft
and elastic, those used for catheters and medical tubings). Polyurethanes are
hydrophilic in nature, meaning that they tend to absorb water. The degree of
water absorption is dictated by the chemical constituents used in the synthesis
of the polymers and by the structure of the polymer. As a result, polyurethanes
become softer and sometimes exhibit slight surface tackiness after exposure
to water. Polyurethane coatings used in medical gloves are generally applied
directly to the latex substrate using water-based polyurethane dispersions.
Some polyurethane coatings are not suitable for medical gloves because the
surface becomes too tacky after the gloves are chlorinated.
•
Acrylics. Acrylic coatings are based on acrylate polymers that have elastic
properties. Although the acrylate polymers can be rendered rubberlike by
copolymerization with different monomers, their tensile strength and elongation
are relatively low compared to those of natural rubber. Because of this
mismatch in mechanical properties, acrylic coatings applied to rubber gloves
typically crack and sometimes separate from the substrate. In addition, these
polymers are sensitive to certain chemicals often used in the off-line processing
of powder-free gloves.67
•
Silicones. Silicone coatings are used primarily to improve the surface lubricity
of medical devices. As surface coatings, they can be used alone or blended
with other types of polymers. Silicones are applied by either a solvent or waterbased system. Silicones that migrate to the surface of the medical device are
best for enhancing lubricity. These types of silicones are leachable and can be
transferred to any object they contact. Leachable silicones can leave an oily
feel on skin after gloves are donned. In addition, they do not provide adequate
damp and wet donning characteristics.
•
Nitrile. Nitrile generally is referred to as a synthetic polymer that is composed
of three monomers: acrylonitrile, butadiene and carboxylic acid. Acrylonitrile
monomer provides material hardness and permeation resistance to a wide
variety of chemicals and solvents, especially to hydrocarbon oils, fats and
solvents. After vulcanization, butadiene offers softness and flexibility; carboxylic
acid provides high tensile strength and tear resistance. Because of these
unique properties, nitrile gloves are used widely in laboratory environments
19
where chemicals are handled and in critical environments such as electronics
manufacturing. Due to the excellent barrier properties and superior puncture
and tear resistance, nitrile recently has become a popular choice for synthetic
medical gloves. Although nitrile has been widely used as a laminating material
for industrial gloves, until recently, it has not been used as a powder-free
coating for medical gloves. Nitrile coating, however, offers the following
benefits as compared to other polymer glove coatings such as hydrogel and
polyurethane:
o Good tensile strength and elasticity;
o Increased lubricity after chlorination; and
o Good adhesion to natural rubber and excellent chemical resistance.
The key characteristics of various types of polymer coatings are summarized in
Table 2.68,69
Table 2 – Key Characteristics of Various Polymer Coatings
Characteristic
Hydrogel
Polyurethane
Acrylic
Silicone
Nitrile
Tensile Strength
Low
Medium-High
Low
Low
High
Adhesion to
Natural Rubber
Low
Medium
Medium
Low
Medium
Elongation
Low
High
Low
Medium
High
Lubricity after
Chlorination
High
Medium
Medium
High
High
Puncture Resistance
Low
Medium-High
Medium
Low
High
Abrasion Resistance
Low
Medium
Medium
Low
Medium
Oil Resistance
Medium
High
High
Low
High
Hydration/Water
Swelling
(lower is better)
High
Medium
Low
Low
Low
Integrity after
Stretching
Low
Medium-High
Low
Low
High
CLINICAL AND ECONOMIC BENEFITS OF POWDER-FREE GLOVES
Based on the awareness of the potential complications of powdered gloves, in the U.S.
today, 4 out of 5 surgical gloves sold today are powder-free.70 While the manufacturing
process is more complex for powder-free latex gloves, the additional cost is reflected in
their price; however, in the long run, the health advantages of powder-free gloves are
clear and outweigh the cost.71
20
With new and technologically advanced coatings, such as nitrile, glove manufacturers
are able to produce powder-free surgical gloves that reduce latex sensitization,
thereby enhancing the protection of both clinicians and patients, while maintaining the
characteristics users expect from powdered gloves. Additional advantages of powder-free
surgical gloves include:
• Excellent donning and removal;
• Durability;
• Excellent tactile performance and grip;
• Strength;
• Barrier protection;
• Comfort;
• Improved options for double-gloving, eg, double-gloving systems with a colored
underglove to quickly flag barrier breaches; and
• Cost savings.
Several relevant literature articles supporting the use of powder-free gloves are
summarized below:
• Improved patient outcomes.
o As outline above, early studies conducted by Ruhl, et al72 and
Hunt, et al,73 describing the numerous postoperative complications
associated with starch powder concluded that powder-free wounds
heal without infection,74 with the advent of powder-free gloves,
cornstarch should no longer be used during wound closure. Because
powder-free gloves are available, there is no longer any reason to
use powdered gloves for surgical procedures; furthermore, hospitals
and surgeons are more responsible for starch-related adverse
outcomes to patients or staff.75
•
Reduced latex sensitization.
o One study comparing glove effectiveness concluded that
deproteinized natural rubber latex gloves (DPNRL; or low-protein
latex gloves that are chemically treated to remove the proteins
causing sensitization, which lead to allergies) provided tactile
sensitivity and barrier integrity, yet significantly reduced the risk of
sensitization to latex proteins.76
o In this regard, another study results further strengthens the case
for eliminating glove powder and also justifying the higher cost of
using powder-free gloves.77 This study, which evaluated the extent
of symptoms that could be associated with glove powder or latex
proteins, found that a relatively high percentage of the hospital
personnel were suffering from glove-related symptoms (eg, itching
on the hands, hand eczema, and upper respiratory tract disorders);
once the facility changed to a powder-free environment, there
were significant reductions in these symptoms, as well as the costs
21
of employee absence due to these associated upper respiratory
infections and skin problems. These results demonstrate that the
increased costs of transitioning to a powder-free workplace may be
offset by the decreased costs resulting from reduced sickness and
therefore absence.
o A review of 8 primary prevention intervention studies on natural
rubber latex published since 1990, demonstrated that these studies
supported the following evidence statement: substituting powdered
latex gloves with low protein, powder-free natural rubber latex
gloves or latex-free gloves greatly decreases natural rubber latex
aeroallergens, sensitization to natural rubber latex, as well as natural
rubber latex-asthma in health care workers.78
•
Cost. Often times, hospitals focus too much on the cost increase to switch from
powdered to powder-free gloves. However, this cost increase is often minimal
compared to the risk factors associated with using powdered gloves, such as
SSIs and postoperative complications that lead to longer hospital stays or even
staff members out on disability due to an allergic reaction to powdered gloves.
o As previously noted, the most effective method of removing glove
powder is a 1-minute cleansing with 10mL of povidone iodine
followed by a 30-second sterile water rinse.79 The costs associated
with glove washing procedures — determined by the adding the
cost of the basin, solution, and unit of wiping materials used and
then dividing by the number of staff members — was determined
to be $0.46 per glove, with a range of $0.26 to $1.25 per glove.80 In
addition to being costly and burdensome to the staff, this technique
is also time consuming and must be repeated every time the gloves
are changed by a member of the surgical team; moreover, also as
previously outlined, this procedure cannot ensure that all of the
powder is removed.81 Therefore, this additional step and time factor
may make the cost of using a powdered glove more expensive than
a powder-free alternative.
o Another report found that the complete elimination of powdered latex
gloves by switching to powder-free latex gloves not only reduced
overall costs, but somewhat surprisingly, also decreased glove
purchase costs.82
o One facility actually saved money by switching to powder-free gloves.
By using a new strategy for purchasing gloves and reducing the
number of types of gloves (eg, from 15 or 16 to 10) and limiting the
number of glove manufacturers, this facility was able to negotiate
better prices and realized an annual savings of $250,000.83
22
SUMMARY
Perioperative nurses are responsible for reducing the risks of disease transmission
and infection for both surgical patients and staff members. The risks associated with
the use of powdered surgical gloves are well-documented. For patients, complications
include inflammation, scarring, adhesions, delayed wound healing, wound infection, joint
inflammation, abdominal pain, vascular obstructions, and starch granuloma formation.
Powder contamination may also cause misdiagnosis, resulting in inappropriate treatment
or unnecessary surgery and increased costs of care; today, hospitals are not reimbursed
for these costs and may receive additional payment penalties as well. For health care
workers, the risks of powder-related complications, such as respiratory symptoms,
asthma, and hand dermatitis — all of which lead to latex sensitization — are major
concerns. Furthermore, all of these contribute to lost health care employee productivity
and disability.
All of these risks can be significantly decreased with the use of powder-free gloves.
Many industry and professional organizations, including the CDC/NIOSH, OSHA, AORN,
ACS, and ANA, have acknowledged the risks of powder and issued recommendations
for the use of powder-free gloves. The U.S. FDA has been petitioned several times,
requesting an immediate ban on the use of cornstarch powder in patient exam and
surgeon gloves and also on the use of all natural rubber latex patient exam and
surgeon’s gloves. The U.S. FDA issued a proposed ban on powdered natural rubber
latex and synthetic latex gloves in 2014, but a final ruling is still pending.
Today, new and technologically advanced coatings allow glove manufacturers to produce
powder-free surgical gloves with the same excellent use and wear characteristics
clinicians have come to expect from powdered gloves. Powder-free gloves can promote
positive patient outcomes and staff safety, which can save hospitals money by avoiding
the risks of powder, the potential adverse outcomes, and the costs associated with those
outcomes. As the standard of care continues to shift, it is time for a change. Health care
facilities should move away from the powder and latex glove technology and switch to
powder-free gloves; the health and safety of patients and health care workers depends
on it.
23
GLOSSARY
Aeroallergen
Any airborne substance that can cause an allergic
response.
Aerosolization
The dispersion of a liquid material or solution in
the air.
Allergic Contact Dermatitis
A delayed hypersensitivity response attributed to
chemicals used in the latex and some synthetic
manufacturing processes and absorbed through
the skin; this reaction is usually localized to the
contact area.
Allergen
An antigen that can produce a hypersensitivity
reaction in the body.
Allergy
An acquired, abnormal immune reaction to an
environmental agent that results In a symptomatic
reaction.
Antigen
A molecule that can bind to an antibody.
Bloodborne Pathogens
Pathogenic microorganisms that are present
in human blood and can cause disease in
humans. These pathogens include, but are not
limited to, hepatitis B virus (HBV) and human
immunodeficiency virus (HIV).
Chlorination
A process used in glove manufacturing that
oxidizes the outer rubber surface to reduce
the surface tackiness and remove most of the
powders deposited on the outer glove.
Double-Gloving
The practice of wearing two pairs of gloves, one
over the other.
Elongation
Stretchability.
Exposure Incident
A specific eye, mouth, other mucous membrane,
non-intact skin, or parenteral contact with blood or
other potentially infectious materials that results
from the performance of an employee’s duties.
Healthcare-Associated Infections
(HAI) An infection that is not present when a patient is
admitted to a hospital or healthcare facility.
24
Hospital-Acquired Conditions
(HACs) Conditions that are high cost, high volume, or
both; could reasonably have been prevented
through the use of evidence-based guidelines;
and result in assignment to a diagnosis-related
group (DRG) with a higher payment when they
are present as a secondary diagnosis.
Irritant Contact Dermatitis
The development of dry, itchy, irritated areas on
the skin, usually the hands. This type of reaction
is not an actual allergy to latex, but is the irritation
from wearing gloves and possibly from the soaps
and detergents that are used to wash hands
after glove use. It could also be a reaction to the
powders or lubricants used to make gloves easier
to put on.
Latex Allergy
A localized or systemic allergic response to one or
more specific proteins found in latex to which an
individual has been sensitized and has developed
antibodies; a type I hypersensitivity reaction.
Natural Rubber Latex (NRL)
This term includes all materials made from or
containing natural latex.
Nitrile
A synthetic polymer composed of three
monomers: acrylonitrile, butadiene, and carboxylic
acid; because of its excellent barrier properties
and superior puncture and tear resistance,
nitrile recently has become a popular choice for
synthetic gloves.
Occupational Exposure
Reasonably anticipated skin, eye, mucous
membrane, or parenteral contact with blood or
other potentially infectious materials that may
result from the performance of an employee’s
duties.
Personal Protective Equipment (PPE)
Specialized clothing or equipment worn by
an employee for protection against a hazard.
General work clothes (e.g., uniforms, pants, shirts
or blouses) not intended to function as protection
against a hazard, are not considered to be personal protective equipment.
25
Potentially Infectious Material
Blood; all body fluids, secretions, and excretions
(except sweat), regardless of whether they
contain visible blood; nonintact skin; mucous
membranes; and airborne, droplet, and
contact-transmitted epidemiologically important
pathogens.
Surgical Gloves
Glove intended for use in surgical procedures;
they are manufactured to a higher acceptable
quality level for holes than exam gloves.
Tactile Sensitivity
The ability to sense, discriminate, and feel
through pressure receptors located in the skin of
the hands.
Tensile Strength
The resistance of a material to breaking under
tension.
Universal Precautions
A prudent approach to infection control. According
to the concept of Universal Precautions, all
human blood and certain human body fluids are
treated as if known to be infectious for HIV, HBV,
and other bloodborne pathogens.
Vulcanization
A cross-linking process used during the
manufacturing of gloves that gives rubberlike
characteristics to polymers.
26
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