Continuation of MDDI's May 1996 article, "Selecting and Using Protective Gloves: An Overview of the Critical Issues"

May 1, 1996

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Continuation of MDDI's May 1996 article, "Selecting and Using Protective Gloves: An Overview of the Critical Issues"

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Because the medical device and in vitro diagnostics (IVD) industry produces many thousands of different products, the most efficient way to approach the potential for product contamination from gloves is to categorize the potential contaminants. It is important to remember that if powdered gloves are worn during manufacturing or packaging, products can be contaminated by aerosol particles as well as by direct contact.

Chemicals. The level and composition of the chemical residue on a glove are determined by the raw materials (type and quality), chemical formulation, and manufacturing processes of each manufacturer for each glove type.

Several of these chemicals can be detrimental to medical devices and materials. For example, chemical contamination of IVDs and laboratory products can alter results, leading to misinformation, erroneous conclusions, and costly delays. Final assembly and compounding of ingredients for such diagnostic products often occurs under HEPA filtration to prevent contamination. In view of the potential adverse effects caused by powder-borne contaminants, powdered gloves should never be allowed in or near these areas.

High-performance analytical instruments are often vulnerable to contaminants such as calcium carbonate, chloride compounds, and silicone. Interference has been reported in the curing stages of implant devices, dental polyvinyl siloxane impression materials, and orthopedic adhesives.12 It has been reported that residual sulfur on gloves resulting from its excessive use as a vulcanizing agent, or its presence as a by-product of accelerator degradation, can interfere with activating catalysts used in the manufacture of various products.13 Glove powder also has been identified as affecting the set of dental composites.

Proteins. Natural rubber latex protein contaminants can compromise product safety. Allergens from high-protein latex gloves can be transferred to medical devices during manufacturing, packaging, customer assembly, and use.2,14,15 When a protein-contaminated device comes in contact with a previously sensitized patient with Type I hypersensitivity, the effects can be devastating, with anaphylactic shock as the most extreme reaction. Local responses may include hives, heightened inflammation, delayed healing, and implant rejection.16,17 Special care should be taken to ensure that devices used in the care of patients suffering from spina bifida are not handled with high-protein gloves, as this population is uniquely vulnerable--about 40­70% are serum-positive.

Powder. Known for their abrasive properties, powder particles scratch fine lenses and ruin particle-sensitive instruments. These particles are unwelcome contaminants in the manufacturing environments of parenteral and IV drug-delivery devices. The biocompatibility of cardiac catheters, joint replacements, autotransfusion devices, and peritoneal dialyzers can also be compromised by glove powder.18­20

Pyrogens. Manufacturers whose device labels bear the claim nonpyrogenic routinely test representative samples as part of their release criteria. When products fail, manufacturers attempt to isolate and eliminate the source of contamination. During such an investigation, manufacturers should evaluate the gloves that came into contact with the failed product because gloves can carry and transfer endotoxins (lipopolysaccharides that cause pyrogenicity). Sterility is not synonymous with nonpyrogenicity, so each must be addressed separately during glove evaluations.

Manufacturers should be aware that, in addition to the gloves worn during the manufacture of their devices, the gloves used to handle the devices in the end-user setting can also affect device performance. Because improper glove selection can result in customer complaints, manufacturers should consider the benefit of specifying, in product labeling or instructional courses, the type of gloves that should be used.

Chemicals and Powder. When transferred from a glove or contaminated medical device into a wound, cytotoxic and antigenic chemicals can interfere with healing. As the list below suggests, a repertoire of responses exists with this scenario. When powder particles are coated with chemicals, they function as time-release capsules, slowly releasing contents into the wound and extending the chemical reaction into a chronic condition. The potential consequences of chemicals in a wound that may affect the real or perceived performance of a device include the following:

  • Cell lysis.

  • Augmented inflammation.

  • Complement cascade activation.

  • Stricture formation.

  • Vascular necrosis.

  • Impaired perfusion.

  • Chronic inflammatory syndromes.

  • Scar formation.

  • Granulomas.

  • Adhesions.21

  • Band formation.

  • Graft rejection.

  • Transplant rejection.

  • Dehiscence.

  • Delayed healing.

  • Weak replacement tissue.

The mere physical presence of powder in a wound can cause abrasion of soft tissues. Added to the trauma of abrasion is the grinding in of any bioincompatible substances bound to the powder. If a patient experiences complications that are sufficiently severe to require device removal, both tissue and device should be microscopically studied under polarized light--under appropriate conditions, powder particles will reflect a Maltese cross image, confirmatory for starch.

Similarly, manufacturers should consider the effect transferred chemicals from the gloves of end-users may have on the consistent performance of their diagnostic products. For example, powder contamination has been cited as the cause of false negatives from HIV diagnostic tests (through interference with the polymerase chain reaction), inaccurately low levels of cyclosporin in blood concentration assays, and contaminated tissue culture assays.22­24

Pyrogens. Blood-processing products (e.g., dialyzers), most parenterals, and devices that will come in contact with nerve tissue, spinal fluid, or the eye are tested and labeled as nonpyrogenic to minimize the adverse effects of endotoxin contamination. However, endotoxins from the gloves of health-care providers can be transferred to such devices, compromising their nonpyrogenic condition.25 Technicians in research laboratories and the biotechnology industry must also be cognizant of the potential for endotoxin transfer from gloves to instruments, growth media, and culture vessels, because even nanogram amounts can alter responses in biological systems both in vivo and in vitro. As with any toxin, the concentration, dose delivered, and system contacted or perfused will determine the extent of any biological responses. The partial list of adverse biological consequences from endotoxin contamination that follows may be useful to companies investigating product complaints or providing technical consultation. The biological effects of endotoxins include:

  • Fever.

  • Augmented inflammation.

  • Macrophage activation.

  • Release of vasoactive amines.

  • Disseminated intravascular coagulation.26

  • Complement activation.

  • Cell lysis.

  • Vascular necrosis.

  • Impaired perfusion of essential organs resulting in pathology.

  • Shock

Infections. In addition to transporting chemicals, protein allergens, and endotoxins, powder can act as a fomite, infection resistance suppressor, or abrasive. Nosocomial (hospital-acquired) infections can occur when pathogenic and opportunistic microorganisms are transferred from patient to patient. Medical devices are often assumed to be the fomites (objects of infectious agent transfer), but the possibility of contaminated powder should be investigated. Similarly, in clinical and research laboratories, glove powder can pick up pathogenic microorganisms and contaminate other areas in the work environment. This is an issue not only for assay interference and misdiagnosis, but also for employee safety--laboratory-acquired infections are a serious concern.

The mere presence of glove powder in a wound has been found to reduce resistance to infection.27 Synthetic vascular grafts, tendon materials, and braided sutures readily carry glove powder into the wound, where the local inflammatory response is augmented immediately, wasting defensive action on the coated powder particles.28 If an otherwise inconsequential number of organisms from any source later contaminates the area, an infection can take hold that, under normal conditions, would have been overcome by the immune system. And, because powder particles may not completely degrade for a number of years, such effects can become chronic, reducing local resistance to infection well after surgical closure. Therefore, when investigating the causes of postsurgical infection even months after surgery, glove powder on or in the surgical devices should be considered, if not as the primary fomite, then as a suppressor of infection resistance.

Even in cases of minimally invasive surgeries in which fewer complications are anticipated, gloves may adversely affect device performance. Powder is efficiently transferred to ridges on cannulas and into the nooks and crannies of endoscopic instruments and subsequently deposited in the peritoneum, synovial spaces, or other operative sites, potentially leading to a number of the postsurgical complications detailed earlier.29, 30

This article has addressed glove-related concerns regarding employee exposure, product contamination by gloves during manufacturing, and the effect of gloves on product use. Two final considerations are procurement and disposal.

Procurement. While the selection process should focus on the gloves' composition and performance characteristics in the workplace, supplier performance is also a consideration. For example, it is important to ensure that a vendor will continue to ship the product your company evaluated. Many distributors purchase gloves from several outside sources. Because chemical formulations and processing methods vary greatly among manufacturers, such multiple sourcing may result in product inconsistencies, requiring the purchaser to continually perform incoming inspections and costly reevaluations.

The glove supplier's delivery capability should also be reviewed. Have other companies in the industry experienced continual back-order problems with this supplier? The best gloves created are worthless if they are not available for use when they are needed.

Disposal. The environmental impact of used-glove disposal has become an increasing concern for all industries. The factors that must be considered when choosing incineration or disposal in a landfill vary with material type:

  • Combustion of natural rubber latex gloves is quite clean, although some hydrocarbons, minute quantities of unreacted nitrogen-based chemicals, and sulfur dioxide may be produced at low incineration temperatures. In a landfill, residual chemicals will leach out as the rubber biodegrades.

  • Incineration of vinyl gloves reduces the PVC to hydrochloric acid gas, minor residual chemicals, and ash. Under standard landfill conditions, vinyl is not biodegradable. However, esters of phthalic acid, which are used as plasticizers and make up about 50% of the total volume, will leach from the material if it comes in contact with nonaqueous solvents. Before choosing incineration for PVC gloves, users should ensure that local laws do not ban such a practice.

  • Nitrogen-based reaction products are released minimally during incineration of nitrile gloves; the other chemical by-products are similar to those produced by natural latex. In a landfill, residual chemicals such as accelerators will leach out, as they do in rubber gloves; the nitrile itself will resist degradation.

Gloves may affect employee health and productivity. Gloves high in chemicals, proteins, and powder can result in skin irritation and allergies, as well as occupational asthma. Conversely, the selection of gloves low in these elements can save the costs of treatment, lost working time, retraining, and possible litigation. Incorrect selection and care of gloves can result in barrier breakdown, which can also put employees at risk. Proper fit optimizes staff performance by preventing fatigue and providing adequate grip and tactile sensitivity.

Gloves used during manufacturing, assembly, and packaging may affect the quality of finished products. While knowledge of these issues assists in the investigation of the source of contaminants, it should ideally be used during glove selection to avert problems. End-users must also be informed about the potential consequences their glove selection may have on procedural outcome. This is best accomplished by label instructions or in-service courses.

Wava Truscott, PhD, is vice president of scientific affairs at Safeskin Corp. (San Diego).

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3.Heese A, von Hintzenstern J, Peters KP, et al., "Allergic and Irritant Reactions to Rubber Gloves in Medical Health Services," J Am Academic Dermatology, 25(5):831­839, 1991.

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6.Federal Register, 39(38), February 25, 1974.

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12.Kahn RL, Donovan TE, Winston WL, et al., "Interaction of Gloves and Rubber Dams with a Poly (Vinyl Siloxane) Impression Material: A Screening Test," International J Prosthodontics, 31:140, 1989.

13.Causton BE, Burke FJ, and Wilson NH, "Implications of the Presence of Dithiocarbamate in Latex Gloves," Dental Mat, 9:3, 1993.

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15.Villarroel F, and Ciarkowski AA, "A Survey on Hypersensitivity Reactions in Hemodialysis," Artificial Organs, 9:231­238, 1985.

16.Garred P, Vâge D, Mollnes TE, et al., "Latex Gloves as a Cause of Inflammation and Eczema," Lancet, 335:1469, 1990.

17.Abuck D, Phzybilla B, Enders F, et al., "Latex Allergy and Repeated Graph Rejections," Lancet, 339:1609, 1992.

18.McKee PH, and McKeow EF, "Starch Granulomata of the Endocardium," J Pathology, 12:103­107, 1978.

19.Verkuyl DAA, "Glove Powder Introduced in the Circulation by Autotransfusion and Severe Cardiac Failure," Lancet, 340:550, 1992.

20.Huertas VE, Rosenzweig J, and Weller JM, "Starch Peritonitis Following Peritoneal Dialysis," Nephron, 30:82­84, 1982.

21.Cooke SAR, and Hamilton DG, "The Significance of Starch Powder Contamination in the Aetiology of Peritoneal Adhesions," Br J Surg, 64:410­412, 1977.

22.Lampe AS, Pieterse-Bruins HJ, and Van Wissekerkejcre EJ, "Wearing Gloves as a Cause of False-Negative HIV Test," Lancet, 2:1140, 1988.

23.Hamlin CR, Black AL, and Opalek JT, "Assay Interference Caused by Powder from Pre-Powdered Latex Gloves," Clinical Chemistry, 37(8):1460, 1991.

24.Vâge DI, Garred P, Lea T, et al., "Elutable Factors from Latex-Containing Materials Activate Complement and Inhibit Cell Proliferation: An In Vitro Biocompatibility Study of Medical Devices," Complement Inflammation, 7:63­70, 1990.

25.Kure R, Grendahl H, and Paulssen J, "Pyrogens from Surgeon's Sterile Latex Gloves," Acta Pathologica Microbiologica et Immunologica Scandinavica, Sect B 90:85­88, 1982.

26.Jacobs HS, Craddock PR, Hammerschmidt DE, et al., "Complement-Induced Granulocyte Aggregation, An Unsuspecting Mechanism of Disease," New England Med, 296:769­774, 1977.

27.Jaffray DC, and Nade S, "Does Surgical Glove Powder Decrease the Inoculum of Bacteria Required to Produce an Abscess?" Royal College of Surgeons of Edinburgh, 28:4, 1983.

28.Ruhl CM, Urbancic JH, Foresman PA, et al., "A New Hazard of Cornstarch, an Absorbable Dusting Powder," J Emergency Med, 1:11­14, 1994.

29.Yaffe H, Toby R, Laufer N, et al., "Potentially Deleterious Effect of Cornstarch Powder in Tubal Reconstructive Surgery," Fertility and Sterility, 29(6):699­701, 1978.

30.Singh I, Chow WL, and Chablani LV, "Synovial Reaction to Glove Powder," Clinical Orthopaedics and Related Res, 99:285­292, 1974.

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