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Allergen Focus

Focus on N.A.C.D.G. Allergen: Glutaraldehyde

November 2007

In 1997 the Food and Drug Administration granted an indication for the use of the Thin-Layer Rapid Use Epicutaneous (T.R.U.E.) test (which includes panels 1.1 and 2.1) as a valuable, first-line screening tool in the diagnosis of allergic contact dermatitis (ACD). Many dermatologists utilize this standard tool in their practices and refer to contact dermatitis referral centers when the T.R.U.E test fails to identify a relevant allergen. Specifically, the T.R.U.E. test screens for 46 distinct allergens and the balsam of Peru mixture. The test is thought to adequately identify an allergen in approximately 24.5% of patients with allergic contact dermatitis.1 This being said, many relevant allergens are not detected by use of this screening tool alone and for this reason, the “Allergen Focus” column has been expanded to cover the notorious Allergens of the Year, the up-and-coming T.R.U.E. test panel 32 and North American Contact

Dermatitis Group’s (N.A.C.D.G.) Standard Allergens.


“Allergen Focus” is a column designed to concentrate on common allergens and is intended to answer some of the most frequent questions relating to their origin and most common uses.

This month, we focus on glutaraldehyde, commonly used in the medical field as a sterilizing agent, a tissue fixative, and a developing agent for radiographs. In addition, glutaraldehyde is used as a biocide in rinse-off and nonrinse-off cosmetics products such as shampoos, conditioners, and creams.
 

CONTACT DERMATIDES

The contact dermatides include, irritant contact dermatitis, contact urticaria, and allergic contact dermatitis.

Irritant contact dermatitis, the most common form, accounts for approximately 80% of environmental-occupational-based dermatoses.

Contact urticaria (wheal and flare reaction) represents an IgE and mast cell-mediated immediate-type hypersensitivity reaction that can lead to anaphylaxis. The foremost example of this would be latex protein hypersensitivity. While this is beyond the scope of this column, we acknowledge this form of hypersensitivity due to the severity of the potential reactions and direct the reader to key sources.3,4

Allergic contact dermatitis (ACD) is an important disease with high impact both in terms of patient morbidity and economics. This condition represents a T-helper cell, type 1 (Th1)-dependent, delayed-type (type IV) hypersensitivity reaction. The instigating exogenous antigens are primarily small lipophilic chemicals (haptens) with a molecular weight less than 500 Daltons.
On direct antigen exposure to the skin or mucosa, an immunologic cascade is initiated that includes cytokines, i.e., interleukin 2 and interferon gamma, T cells and Langerhan cells. This complex interaction leads to the clinical picture of ACD.
 

CLINICAL ILLUSTRATION

A 55-year-old surgical technician presented for evaluation of a chronic hand dermatitis. Of note, she regularly used Cidex.

ANTISEPSIS AND SURGERY: A LOOK BACK

The first operations were performed in antiquity using instruments made from obsidian. These procedures were thought to largely consist of amputations, circumcisions and trepanations (drilling burr holes5). Several ancient cultures including the Mesopotamians, Sumerian’s, Egyptians, Hindus and Greeks were known to have performed a variety of surgeries. The Hindus were particularly adept at surgery, performing both complex and invasive surgeries, including cataract removal and the removal of bladder stones.

One of the earliest surgical textbooks, the Sushruta Samhita, written by the ancient surgeon Sushruta, is of Hindu origin and describes 121 varieties of surgical instrumentation.6,7,8 Despite this variety of tools to perform surgeries, the lack of antiseptic techniques made surgical procedures a risky proposition. As a result, surgeons performed only the most urgent or simple procedures, such as amputations.7

Louis Pasteur (1822-1895) was the first person to suggest the sterilization of surgical instruments.7 Through the development of germ theory, Pasteur hypothesized that specific germs could cause disease.9

Based on Pasteur’s work, Joseph Lister (1827-1912) developed the concept of antiseptic surgery (also known as Listerism).9,10 During the 1860s, Lister posited and implemented the earliest principles of antiseptic surgery, selecting as the first antiseptic agent carbolic acid. His initial preparations of carbolic acid caused skin and wound irritation in both patients and medical personnel (perhaps the first case of contact dermatitis by antiseptic agents). These problems were overcome by diluting the agent. The concept of antisepsis was extended beyond surgical instrumentation to the operating theater, where aseptic technique evolved to include drapes, gowns, caps, masks, and rubber gloves.9,10

In 1886, Ernst von Bergmann (1836-1907) developed steam sterilization for surgical instruments, extending the concepts of Pasteur and Lister even further. Of interest, current surgical sterilization methods are a combination of both antiseptic (steam and chemical) and aseptic techniques pioneered by these individuals.9
 

CHEMICAL ANTISEPTIC — GLUTARALDEHYDE

Glutaraldehyde, a colorless, oily liquid with a pungent odor, was first synthesized in 1908. Soon after, chemists observed its ability to reduce sweating in hides and later its application in humans to reduce excessive sweating. In the 1960s, glutaraldehyde became a commercial leather-tanning product and was adopted by the healthcare industry as a cold disinfectant for surgical instruments and anesthesia equipment.11

Prior to commercial glutaraldehyde production, formaldehyde (a related chemical) had been a reluctantly used medical disinfectant. Formaldehyde was known to cause irritation of skin and mucous membranes, required longer time to cold sterilize equipment, and could not kill all bacterial spores. These health concerns about formaldehyde in the 1970s led to the search for effective substitutes, such as glutaraldehyde, which had far better antimicrobial and sporicidal properties than formaldehyde.12
 

USES OF GLUTARALDEHYDE

Glutaraldehyde has many different uses in various settings. This chemical has been used in the following ways:
• As an agent to sterilize surgical instruments
• As an embalming fluid
• As a fabric softener
• As a disinfectant in the hairdressing industry.13,14
(See Table 1 below for more information.)
In hospitals and healthcare settings, glutaraldehyde is commonly found in endoscopy units, operating rooms, dental offices, radiology departments and in ear, nose and throat units. It is used to sterilize equipment unsuited to other forms of sterilization, such as fiber optic endoscopes, hand-held lenses and laryngeal mirrors.

Other uses include a hardener in radiography, a fixative in laboratories, an embalming fluid, a tanning agent in the leather industry, and a preservative in some detergents and cosmetics. Glutaraldehyde was used heavily until 1967 as an additive to developer fluid used in fast automatic processing machines that developed X-ray film. Unfortunately, glutaraldehyde was been found to have considerably greater potential for skin sensitization than formaldehyde.15
 

ALLERGY TO GLUTARALDEHYDE

Reports of glutaraldehyde-induced contact dermatitis began in 1968 when two sisters working in an operating room handled instruments disinfected in glutaraldehyde. They subsequently developed contact dermatitis on the arms and hands from this chemical and the authorities at that time vowed to withdraw glutaraldehyde from their establishment as soon as an alternative method of sterilization was discovered.16

Contact dermatitis to glutaraldehyde gained notoriety as a health problem in the 1980s, when an increase in the price of silver led to a cost-saving measure by photographic companies. The decreased amount of silver used in photographic emulsions required a concomitant increase in the amount of glutaraldeyde in the emulsion.

Marjorie Gordon, an X-ray technician in New Zealand, was one of the first individuals to identify the toxic effect of glutaraldehyde. Sensitization to glutaraldehyde prevented Ms. Gordon from continuing in her career as an X-ray technician and led to her crusade to find the cause of her illness. Once glutaraldehyde was identified as the potential cause of her illness by the New Zealand Health Department, Ms. Gordon was given the task of writing some of the first guidelines about the safe use and handling of glutaraldehyde.13

By 1998, glutaraldehyde was incorporated into standard patch-testing series, and in a study by Kiec-Swierczynska of 280 healthcare workers in Poland with dermatitis, 12.4% were found to be allergic to glutaraldehyde. The sensitization rate was highest among nurses, physicians and dental assistants, with rates of 16.5%, 13.5%, and 33.3%, respectively.17 Unfortunately, the allergic dermatitis that may result can be severe and persistent.

A study by Shaffer and Belsito documented a high rate of glutaraldehyde allergy among healthcare workers who had been exposed to glutaraldehyde. Furthermore it was concluded in this study that healthcare workers were eight times more likely than non-healthcare workers to be allergic to glutaraldehyde.18

Currently, glutaraldehyde remains in use, especially in developing countries where supplies of disposable equipment and autoclaves are inadequate.19 In certain countries such as Japan, another potential workplace exposure occurs among hospital staff members performing routine disinfection, possibly because glutaraldehyde manufacturers advertise their product as an all-purpose disinfectant.20

Debate has continued as to the relationship between glutaraldehyde exposure and work-related asthma because only a small percentage of asthmatic patients have glutaraldehyde-related IgE specific antibodies.21 Other health effects caused by glutaraldehyde exposures are outlined in Table 2 above.

TESTING FOR GLUTARALDEHYDE

Since 1998, the North American Contact Dermatitis Group standard tray has included glutaraldehyde in 1% pet. It is important to note that this allergen is not included on the Thin-Layer Rapid Use Epicutaneous (TRUE) test.
 

VALUE OF THE CASE

Glutaraldehyde remains an important sensitizer in healthcare professionals. Once the patient avoided her exposure, her dermatitis cleared. The importance of safer sterilization alternatives cannot be understated. Examples are listed in Table 4. Furthermore, it is important to note that individuals can protect themselves from exposure to glutaraldehyde by following specific guidelines outlined by the Center for Disease Control, which includes the use of local exhaust ventilation, keeping glutaraldehyde baths under a fume hood where possible, using the minimum amount of glutaraldehyde to perform the required disinfecting procedure, avoiding skin contact by using gloves and aprons made of nitrile or butyl rubber, washing gloved hands after handling glutaraldehyde, wearing goggles and face shields when handling glutaraldehyde, and sealing or covering all containers holding glutaraldehyde solutions.22

 

As stated by Smith and Wang, “The 21st century also heralded a new era of super-infections such as SARS and avian influenza, where rapid disinfection was urgently required. Some of these needs were met by glutaraldehyde-related products and will continue to be. As such, it is reasonable to assume that glutaraldehyde will remain a ubiquitous disinfectant in various healthcare environments, particularly those in developing countries.”17

 

 

 

In 1997 the Food and Drug Administration granted an indication for the use of the Thin-Layer Rapid Use Epicutaneous (T.R.U.E.) test (which includes panels 1.1 and 2.1) as a valuable, first-line screening tool in the diagnosis of allergic contact dermatitis (ACD). Many dermatologists utilize this standard tool in their practices and refer to contact dermatitis referral centers when the T.R.U.E test fails to identify a relevant allergen. Specifically, the T.R.U.E. test screens for 46 distinct allergens and the balsam of Peru mixture. The test is thought to adequately identify an allergen in approximately 24.5% of patients with allergic contact dermatitis.1 This being said, many relevant allergens are not detected by use of this screening tool alone and for this reason, the “Allergen Focus” column has been expanded to cover the notorious Allergens of the Year, the up-and-coming T.R.U.E. test panel 32 and North American Contact

Dermatitis Group’s (N.A.C.D.G.) Standard Allergens.


“Allergen Focus” is a column designed to concentrate on common allergens and is intended to answer some of the most frequent questions relating to their origin and most common uses.

This month, we focus on glutaraldehyde, commonly used in the medical field as a sterilizing agent, a tissue fixative, and a developing agent for radiographs. In addition, glutaraldehyde is used as a biocide in rinse-off and nonrinse-off cosmetics products such as shampoos, conditioners, and creams.
 

CONTACT DERMATIDES

The contact dermatides include, irritant contact dermatitis, contact urticaria, and allergic contact dermatitis.

Irritant contact dermatitis, the most common form, accounts for approximately 80% of environmental-occupational-based dermatoses.

Contact urticaria (wheal and flare reaction) represents an IgE and mast cell-mediated immediate-type hypersensitivity reaction that can lead to anaphylaxis. The foremost example of this would be latex protein hypersensitivity. While this is beyond the scope of this column, we acknowledge this form of hypersensitivity due to the severity of the potential reactions and direct the reader to key sources.3,4

Allergic contact dermatitis (ACD) is an important disease with high impact both in terms of patient morbidity and economics. This condition represents a T-helper cell, type 1 (Th1)-dependent, delayed-type (type IV) hypersensitivity reaction. The instigating exogenous antigens are primarily small lipophilic chemicals (haptens) with a molecular weight less than 500 Daltons.
On direct antigen exposure to the skin or mucosa, an immunologic cascade is initiated that includes cytokines, i.e., interleukin 2 and interferon gamma, T cells and Langerhan cells. This complex interaction leads to the clinical picture of ACD.
 

CLINICAL ILLUSTRATION

A 55-year-old surgical technician presented for evaluation of a chronic hand dermatitis. Of note, she regularly used Cidex.

ANTISEPSIS AND SURGERY: A LOOK BACK

The first operations were performed in antiquity using instruments made from obsidian. These procedures were thought to largely consist of amputations, circumcisions and trepanations (drilling burr holes5). Several ancient cultures including the Mesopotamians, Sumerian’s, Egyptians, Hindus and Greeks were known to have performed a variety of surgeries. The Hindus were particularly adept at surgery, performing both complex and invasive surgeries, including cataract removal and the removal of bladder stones.

One of the earliest surgical textbooks, the Sushruta Samhita, written by the ancient surgeon Sushruta, is of Hindu origin and describes 121 varieties of surgical instrumentation.6,7,8 Despite this variety of tools to perform surgeries, the lack of antiseptic techniques made surgical procedures a risky proposition. As a result, surgeons performed only the most urgent or simple procedures, such as amputations.7

Louis Pasteur (1822-1895) was the first person to suggest the sterilization of surgical instruments.7 Through the development of germ theory, Pasteur hypothesized that specific germs could cause disease.9

Based on Pasteur’s work, Joseph Lister (1827-1912) developed the concept of antiseptic surgery (also known as Listerism).9,10 During the 1860s, Lister posited and implemented the earliest principles of antiseptic surgery, selecting as the first antiseptic agent carbolic acid. His initial preparations of carbolic acid caused skin and wound irritation in both patients and medical personnel (perhaps the first case of contact dermatitis by antiseptic agents). These problems were overcome by diluting the agent. The concept of antisepsis was extended beyond surgical instrumentation to the operating theater, where aseptic technique evolved to include drapes, gowns, caps, masks, and rubber gloves.9,10

In 1886, Ernst von Bergmann (1836-1907) developed steam sterilization for surgical instruments, extending the concepts of Pasteur and Lister even further. Of interest, current surgical sterilization methods are a combination of both antiseptic (steam and chemical) and aseptic techniques pioneered by these individuals.9
 

CHEMICAL ANTISEPTIC — GLUTARALDEHYDE

Glutaraldehyde, a colorless, oily liquid with a pungent odor, was first synthesized in 1908. Soon after, chemists observed its ability to reduce sweating in hides and later its application in humans to reduce excessive sweating. In the 1960s, glutaraldehyde became a commercial leather-tanning product and was adopted by the healthcare industry as a cold disinfectant for surgical instruments and anesthesia equipment.11

Prior to commercial glutaraldehyde production, formaldehyde (a related chemical) had been a reluctantly used medical disinfectant. Formaldehyde was known to cause irritation of skin and mucous membranes, required longer time to cold sterilize equipment, and could not kill all bacterial spores. These health concerns about formaldehyde in the 1970s led to the search for effective substitutes, such as glutaraldehyde, which had far better antimicrobial and sporicidal properties than formaldehyde.12
 

USES OF GLUTARALDEHYDE

Glutaraldehyde has many different uses in various settings. This chemical has been used in the following ways:
• As an agent to sterilize surgical instruments
• As an embalming fluid
• As a fabric softener
• As a disinfectant in the hairdressing industry.13,14
(See Table 1 below for more information.)
In hospitals and healthcare settings, glutaraldehyde is commonly found in endoscopy units, operating rooms, dental offices, radiology departments and in ear, nose and throat units. It is used to sterilize equipment unsuited to other forms of sterilization, such as fiber optic endoscopes, hand-held lenses and laryngeal mirrors.

Other uses include a hardener in radiography, a fixative in laboratories, an embalming fluid, a tanning agent in the leather industry, and a preservative in some detergents and cosmetics. Glutaraldehyde was used heavily until 1967 as an additive to developer fluid used in fast automatic processing machines that developed X-ray film. Unfortunately, glutaraldehyde was been found to have considerably greater potential for skin sensitization than formaldehyde.15
 

ALLERGY TO GLUTARALDEHYDE

Reports of glutaraldehyde-induced contact dermatitis began in 1968 when two sisters working in an operating room handled instruments disinfected in glutaraldehyde. They subsequently developed contact dermatitis on the arms and hands from this chemical and the authorities at that time vowed to withdraw glutaraldehyde from their establishment as soon as an alternative method of sterilization was discovered.16

Contact dermatitis to glutaraldehyde gained notoriety as a health problem in the 1980s, when an increase in the price of silver led to a cost-saving measure by photographic companies. The decreased amount of silver used in photographic emulsions required a concomitant increase in the amount of glutaraldeyde in the emulsion.

Marjorie Gordon, an X-ray technician in New Zealand, was one of the first individuals to identify the toxic effect of glutaraldehyde. Sensitization to glutaraldehyde prevented Ms. Gordon from continuing in her career as an X-ray technician and led to her crusade to find the cause of her illness. Once glutaraldehyde was identified as the potential cause of her illness by the New Zealand Health Department, Ms. Gordon was given the task of writing some of the first guidelines about the safe use and handling of glutaraldehyde.13

By 1998, glutaraldehyde was incorporated into standard patch-testing series, and in a study by Kiec-Swierczynska of 280 healthcare workers in Poland with dermatitis, 12.4% were found to be allergic to glutaraldehyde. The sensitization rate was highest among nurses, physicians and dental assistants, with rates of 16.5%, 13.5%, and 33.3%, respectively.17 Unfortunately, the allergic dermatitis that may result can be severe and persistent.

A study by Shaffer and Belsito documented a high rate of glutaraldehyde allergy among healthcare workers who had been exposed to glutaraldehyde. Furthermore it was concluded in this study that healthcare workers were eight times more likely than non-healthcare workers to be allergic to glutaraldehyde.18

Currently, glutaraldehyde remains in use, especially in developing countries where supplies of disposable equipment and autoclaves are inadequate.19 In certain countries such as Japan, another potential workplace exposure occurs among hospital staff members performing routine disinfection, possibly because glutaraldehyde manufacturers advertise their product as an all-purpose disinfectant.20

Debate has continued as to the relationship between glutaraldehyde exposure and work-related asthma because only a small percentage of asthmatic patients have glutaraldehyde-related IgE specific antibodies.21 Other health effects caused by glutaraldehyde exposures are outlined in Table 2 above.

TESTING FOR GLUTARALDEHYDE

Since 1998, the North American Contact Dermatitis Group standard tray has included glutaraldehyde in 1% pet. It is important to note that this allergen is not included on the Thin-Layer Rapid Use Epicutaneous (TRUE) test.
 

VALUE OF THE CASE

Glutaraldehyde remains an important sensitizer in healthcare professionals. Once the patient avoided her exposure, her dermatitis cleared. The importance of safer sterilization alternatives cannot be understated. Examples are listed in Table 4. Furthermore, it is important to note that individuals can protect themselves from exposure to glutaraldehyde by following specific guidelines outlined by the Center for Disease Control, which includes the use of local exhaust ventilation, keeping glutaraldehyde baths under a fume hood where possible, using the minimum amount of glutaraldehyde to perform the required disinfecting procedure, avoiding skin contact by using gloves and aprons made of nitrile or butyl rubber, washing gloved hands after handling glutaraldehyde, wearing goggles and face shields when handling glutaraldehyde, and sealing or covering all containers holding glutaraldehyde solutions.22

 

As stated by Smith and Wang, “The 21st century also heralded a new era of super-infections such as SARS and avian influenza, where rapid disinfection was urgently required. Some of these needs were met by glutaraldehyde-related products and will continue to be. As such, it is reasonable to assume that glutaraldehyde will remain a ubiquitous disinfectant in various healthcare environments, particularly those in developing countries.”17

 

 

 

In 1997 the Food and Drug Administration granted an indication for the use of the Thin-Layer Rapid Use Epicutaneous (T.R.U.E.) test (which includes panels 1.1 and 2.1) as a valuable, first-line screening tool in the diagnosis of allergic contact dermatitis (ACD). Many dermatologists utilize this standard tool in their practices and refer to contact dermatitis referral centers when the T.R.U.E test fails to identify a relevant allergen. Specifically, the T.R.U.E. test screens for 46 distinct allergens and the balsam of Peru mixture. The test is thought to adequately identify an allergen in approximately 24.5% of patients with allergic contact dermatitis.1 This being said, many relevant allergens are not detected by use of this screening tool alone and for this reason, the “Allergen Focus” column has been expanded to cover the notorious Allergens of the Year, the up-and-coming T.R.U.E. test panel 32 and North American Contact

Dermatitis Group’s (N.A.C.D.G.) Standard Allergens.


“Allergen Focus” is a column designed to concentrate on common allergens and is intended to answer some of the most frequent questions relating to their origin and most common uses.

This month, we focus on glutaraldehyde, commonly used in the medical field as a sterilizing agent, a tissue fixative, and a developing agent for radiographs. In addition, glutaraldehyde is used as a biocide in rinse-off and nonrinse-off cosmetics products such as shampoos, conditioners, and creams.
 

CONTACT DERMATIDES

The contact dermatides include, irritant contact dermatitis, contact urticaria, and allergic contact dermatitis.

Irritant contact dermatitis, the most common form, accounts for approximately 80% of environmental-occupational-based dermatoses.

Contact urticaria (wheal and flare reaction) represents an IgE and mast cell-mediated immediate-type hypersensitivity reaction that can lead to anaphylaxis. The foremost example of this would be latex protein hypersensitivity. While this is beyond the scope of this column, we acknowledge this form of hypersensitivity due to the severity of the potential reactions and direct the reader to key sources.3,4

Allergic contact dermatitis (ACD) is an important disease with high impact both in terms of patient morbidity and economics. This condition represents a T-helper cell, type 1 (Th1)-dependent, delayed-type (type IV) hypersensitivity reaction. The instigating exogenous antigens are primarily small lipophilic chemicals (haptens) with a molecular weight less than 500 Daltons.
On direct antigen exposure to the skin or mucosa, an immunologic cascade is initiated that includes cytokines, i.e., interleukin 2 and interferon gamma, T cells and Langerhan cells. This complex interaction leads to the clinical picture of ACD.
 

CLINICAL ILLUSTRATION

A 55-year-old surgical technician presented for evaluation of a chronic hand dermatitis. Of note, she regularly used Cidex.

ANTISEPSIS AND SURGERY: A LOOK BACK

The first operations were performed in antiquity using instruments made from obsidian. These procedures were thought to largely consist of amputations, circumcisions and trepanations (drilling burr holes5). Several ancient cultures including the Mesopotamians, Sumerian’s, Egyptians, Hindus and Greeks were known to have performed a variety of surgeries. The Hindus were particularly adept at surgery, performing both complex and invasive surgeries, including cataract removal and the removal of bladder stones.

One of the earliest surgical textbooks, the Sushruta Samhita, written by the ancient surgeon Sushruta, is of Hindu origin and describes 121 varieties of surgical instrumentation.6,7,8 Despite this variety of tools to perform surgeries, the lack of antiseptic techniques made surgical procedures a risky proposition. As a result, surgeons performed only the most urgent or simple procedures, such as amputations.7

Louis Pasteur (1822-1895) was the first person to suggest the sterilization of surgical instruments.7 Through the development of germ theory, Pasteur hypothesized that specific germs could cause disease.9

Based on Pasteur’s work, Joseph Lister (1827-1912) developed the concept of antiseptic surgery (also known as Listerism).9,10 During the 1860s, Lister posited and implemented the earliest principles of antiseptic surgery, selecting as the first antiseptic agent carbolic acid. His initial preparations of carbolic acid caused skin and wound irritation in both patients and medical personnel (perhaps the first case of contact dermatitis by antiseptic agents). These problems were overcome by diluting the agent. The concept of antisepsis was extended beyond surgical instrumentation to the operating theater, where aseptic technique evolved to include drapes, gowns, caps, masks, and rubber gloves.9,10

In 1886, Ernst von Bergmann (1836-1907) developed steam sterilization for surgical instruments, extending the concepts of Pasteur and Lister even further. Of interest, current surgical sterilization methods are a combination of both antiseptic (steam and chemical) and aseptic techniques pioneered by these individuals.9
 

CHEMICAL ANTISEPTIC — GLUTARALDEHYDE

Glutaraldehyde, a colorless, oily liquid with a pungent odor, was first synthesized in 1908. Soon after, chemists observed its ability to reduce sweating in hides and later its application in humans to reduce excessive sweating. In the 1960s, glutaraldehyde became a commercial leather-tanning product and was adopted by the healthcare industry as a cold disinfectant for surgical instruments and anesthesia equipment.11

Prior to commercial glutaraldehyde production, formaldehyde (a related chemical) had been a reluctantly used medical disinfectant. Formaldehyde was known to cause irritation of skin and mucous membranes, required longer time to cold sterilize equipment, and could not kill all bacterial spores. These health concerns about formaldehyde in the 1970s led to the search for effective substitutes, such as glutaraldehyde, which had far better antimicrobial and sporicidal properties than formaldehyde.12
 

USES OF GLUTARALDEHYDE

Glutaraldehyde has many different uses in various settings. This chemical has been used in the following ways:
• As an agent to sterilize surgical instruments
• As an embalming fluid
• As a fabric softener
• As a disinfectant in the hairdressing industry.13,14
(See Table 1 below for more information.)
In hospitals and healthcare settings, glutaraldehyde is commonly found in endoscopy units, operating rooms, dental offices, radiology departments and in ear, nose and throat units. It is used to sterilize equipment unsuited to other forms of sterilization, such as fiber optic endoscopes, hand-held lenses and laryngeal mirrors.

Other uses include a hardener in radiography, a fixative in laboratories, an embalming fluid, a tanning agent in the leather industry, and a preservative in some detergents and cosmetics. Glutaraldehyde was used heavily until 1967 as an additive to developer fluid used in fast automatic processing machines that developed X-ray film. Unfortunately, glutaraldehyde was been found to have considerably greater potential for skin sensitization than formaldehyde.15
 

ALLERGY TO GLUTARALDEHYDE

Reports of glutaraldehyde-induced contact dermatitis began in 1968 when two sisters working in an operating room handled instruments disinfected in glutaraldehyde. They subsequently developed contact dermatitis on the arms and hands from this chemical and the authorities at that time vowed to withdraw glutaraldehyde from their establishment as soon as an alternative method of sterilization was discovered.16

Contact dermatitis to glutaraldehyde gained notoriety as a health problem in the 1980s, when an increase in the price of silver led to a cost-saving measure by photographic companies. The decreased amount of silver used in photographic emulsions required a concomitant increase in the amount of glutaraldeyde in the emulsion.

Marjorie Gordon, an X-ray technician in New Zealand, was one of the first individuals to identify the toxic effect of glutaraldehyde. Sensitization to glutaraldehyde prevented Ms. Gordon from continuing in her career as an X-ray technician and led to her crusade to find the cause of her illness. Once glutaraldehyde was identified as the potential cause of her illness by the New Zealand Health Department, Ms. Gordon was given the task of writing some of the first guidelines about the safe use and handling of glutaraldehyde.13

By 1998, glutaraldehyde was incorporated into standard patch-testing series, and in a study by Kiec-Swierczynska of 280 healthcare workers in Poland with dermatitis, 12.4% were found to be allergic to glutaraldehyde. The sensitization rate was highest among nurses, physicians and dental assistants, with rates of 16.5%, 13.5%, and 33.3%, respectively.17 Unfortunately, the allergic dermatitis that may result can be severe and persistent.

A study by Shaffer and Belsito documented a high rate of glutaraldehyde allergy among healthcare workers who had been exposed to glutaraldehyde. Furthermore it was concluded in this study that healthcare workers were eight times more likely than non-healthcare workers to be allergic to glutaraldehyde.18

Currently, glutaraldehyde remains in use, especially in developing countries where supplies of disposable equipment and autoclaves are inadequate.19 In certain countries such as Japan, another potential workplace exposure occurs among hospital staff members performing routine disinfection, possibly because glutaraldehyde manufacturers advertise their product as an all-purpose disinfectant.20

Debate has continued as to the relationship between glutaraldehyde exposure and work-related asthma because only a small percentage of asthmatic patients have glutaraldehyde-related IgE specific antibodies.21 Other health effects caused by glutaraldehyde exposures are outlined in Table 2 above.

TESTING FOR GLUTARALDEHYDE

Since 1998, the North American Contact Dermatitis Group standard tray has included glutaraldehyde in 1% pet. It is important to note that this allergen is not included on the Thin-Layer Rapid Use Epicutaneous (TRUE) test.
 

VALUE OF THE CASE

Glutaraldehyde remains an important sensitizer in healthcare professionals. Once the patient avoided her exposure, her dermatitis cleared. The importance of safer sterilization alternatives cannot be understated. Examples are listed in Table 4. Furthermore, it is important to note that individuals can protect themselves from exposure to glutaraldehyde by following specific guidelines outlined by the Center for Disease Control, which includes the use of local exhaust ventilation, keeping glutaraldehyde baths under a fume hood where possible, using the minimum amount of glutaraldehyde to perform the required disinfecting procedure, avoiding skin contact by using gloves and aprons made of nitrile or butyl rubber, washing gloved hands after handling glutaraldehyde, wearing goggles and face shields when handling glutaraldehyde, and sealing or covering all containers holding glutaraldehyde solutions.22

 

As stated by Smith and Wang, “The 21st century also heralded a new era of super-infections such as SARS and avian influenza, where rapid disinfection was urgently required. Some of these needs were met by glutaraldehyde-related products and will continue to be. As such, it is reasonable to assume that glutaraldehyde will remain a ubiquitous disinfectant in various healthcare environments, particularly those in developing countries.”17