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By Deborah Davis, MS, MBA
Infection control is a vital concern in healthcare today, andintelligent and informed use of personal protective equipment is a criticalcomponent of your facility's infection control program. Medical gloves are partof PPE that are most frequently donned by healthcare professionals today.
When choosing a glove, the first consideration should be the barrierrequirement related to the procedure or task. Consider the level of exposurerisk prior to selecting a glove. Patient care activities that involve exposureto blood, body fluids, and other potentially infectious material and activitiesthat may stress the glove material, such as handling of instruments and sharpsand management of vascular lines, are examples of high-risk situations. Patientcare activities that require glove use for short periods of time and minimalexposure to blood or body fluids are considered low risk for exposure. Examplesof low risk situations are administering an intramuscular injection, routinesuctioning, caring for a newborn, emptying a urinal, and handling food.Individual usage patterns and length of time that the glove is worn may alsoaffect glove barrier effectiveness.
While price is certainly an important factor and comfortable fit, ease ofdonning, and grip need to be considered, barrier protection is the reason glovesare worn in the first place. So what should you look for when selecting medicalgloves? Medical gloves are regulated by the Food and Drug Administration (FDA)and must meet certain performance criteria. Many other optional tests can giveadditional information about how the gloves will perform.
Additionally, gloves labeled as "powder-free" are required by theFDA to have 2 milligrams or less of total particulate per glove, and the lowestallowed protein level claim is "less than or equal to 50 micrograms perglove."
Suppliers know what test methods were used in generating these data. TheAmerican Society for Testing and Materials (ASTM) has standardized methods totest for many of these parameters. Using these standardized methods helps assurethe technical validity of the testing and provides consistency when makingcomparisons among different products.
Understanding the tests and standards that are used to measure theperformance of medical gloves and the significance of the results will help youto choose products that provide the best barrier protection and performance forboth healthcare workers and their patients.
Deborah Davis, MS, MBA, is technical director for the Gloves BusinessUnit of Allegiance Healthcare Corporation. Her primary responsibilities includedriving clinical research initiatives, coordinating various aspects of productdevelopment between the marketing, regulatory, manufacturing, research anddevelopment organizations; and publication and presentation of technicalinformation for customers and field sales personnel. Davis is currently adoctoral student at the University of Wisconsin, Milwaukee.
Ask the supplier for the following information when selecting medicalgloves:
|CRITERIA||REQUIRED BY FDA?||NOTE|
|Process average AQL (pinhole rate)||Yes||Acceptable Quality Level refers to confidence in barrier protection, or infers the number of pinholes. All medical gloves must be statistically sampled to meet certain AQLs.|
|Tensile Strength||Yes||The number reflects how much force is required to stretch a sample of a glove until it breaks.|
|Elongation||Yes||This relates to material stretchiness; a sample with a higher elongation will stretch more before breaking.|
Tensile Stress (modulus)
|Yes (surgical gloves)||The number reflects how much force is required to stretch the sample to a specified length. A lower tensile stress implies a softer and typically more comfortable glove.|
|Thickness||Yes||FDA requires a minimum of 0.10mm for surgical gloves and 0.08mm for exam gloves.|
|Length||Yes||FDA requires a minimum length ranging from 245 to 265mm (depending on size) for surgical gloves and from 220 to 230mm (depending on size) for exam gloves.|
|Manufacturer Complies with Current Good Manufacturing Practice (CGMP) Regulations||Yes||CGMP requires a system of rigorous design control, documentation and process control.|
|Bacteriophage Penetration Resistance||No||Measures the effectiveness of materials used in protective clothing by using a surrogate microbe under conditions of continuous contact. The test method requires only three samples. Ask if the manufacturer tested a statistically significant sample size of 32. The outcome is either "pass" or "fail."|
|Puncture Resistance||No||This test measures the force required to rupture a sample of material with a steel pin. A higher number reflects greater puncture resistance.|
|Tear Resistance||No||There are standard methods to measure the force required to start a tear in a material, as well as the force necessary to continue tearing once an initial tear is made.|
|Chemical Resistance||No||Ask what chemicals were tested and what the average normalized breakthrough time was. Manufacturers must have FDA clearance to make claims for chemotherapy drug resistance. Gloves selected for chemotherapy drug exposure must be selected specifically for the types of drugs being used.|
|Residual Levels of Accelerators||No||Ask if testing has been done to detect residual levels of chemicals such as thiurams, thiasols, and carbamates as well as various antioxidants and antiozonants.|
|ISO 9001/9002 Certified||No||Certification required for marketing product internationally. Specifies a quality systems model for quality assurance in design/ development, production, installation, and servicing.|
|Details on Program for Glove Usage Analysis||No||Some manufacturers offer programs to help assure appropriate glove usage and standardization--including safety and cost savings considerations.|
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