FAQs
Q: Is it worth reprocessing such a cheap product?
A: Yes, although exam gloves are cheap when considering unit price, healthcare institutions collectively use billions of them every year. Reconditioning and reusing EcoGlove Trace gloves reduces costs by as much as 20% to 60% and provides higher quality and glove integrity checks in the interests of health care worker safety. Some examples of the savings that can be achieved:
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Savings per hospital
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100 beds
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$ 31,350
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200 beds
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$ 62,700
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300 beds
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$ 94,500
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400 beds
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$ 125,400
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500 beds
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$ 156,750
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But there are other important reasons for reprocessing – eliminating disposed waste, reducing carbon footprint, better glove use management through information previously unobtainable and local and macro-economic benefits not before realisable.
Q: How is it sure that reconditioned gloves are not contaminated?
A: EcoGlove has focused its development on the absolute security given to the HCW and patients.
The GRU process reconditions every glove individually, thus removing the possibility of cross-contamination. As a first step both glove surfaces (inside and out) are cleaned and decontaminated using ozone saturated steam.
Further decontamination then assure that the final reconditioned glove is as free from contamination as a new glove.
Q: New gloves are 'nicer' and cleaner. Is it worth the risk?
A: Tr@ce gloves both new and reprocessed, are cleaner than new conventional disposable exam gloves. They are also much safer because of individual testing for pin holes that otherwise doesn.t exist.
Conventional single-use gloves, while regulated by the FDA for stains, do not actually have to conform to any cleanliness or bioburden specification.
Except for some of the leading glove makers, that self-assess the Bioburden level risk in accordance with FDA guidelines, almost all the other single-use exam gloves present on the market do not have any microbiological contamination QA control with a real risk of cross-contamination.
In 1999, the FDA aware of the potential quality and risk issues on medical glove proposed .the reclassification of surgeon's and patient examination gloves from Class I to Class II, because general controls are insufficient to assure their safety and effectiveness. The proposed Class II glove types are:
• powdered surgeon's gloves
• powder-free surgeon's gloves
• powdered patient examination gloves
• powder-free examination gloves
(document link)
The FDA proposal could not, however, be realised specifically in relation to Class II classification for exam gloves. In December 2008, however, the AQL for exam gloves will be increased from 4 to 2.5.
EcoGlove already achieves with its reprocessed Tr@ce exam glove a Class II level quality by controlling EVERY glove to achieve an AQL of virtually zero, a level superior even to that requested for the surgical gloves.
EcoGlove is working with its suppliers to achieve the same superior quality enabling the first Class II level new glove.
Q: Does the glove shape change during reconditioning?
A: No, it remains exactly as when new – and cleaner and more comfortable than conventional single-use gloves.
Q: Can you be sure that glove are free of holes after reconditioning?
A: Barrier integrity has been a constant concern in our specifications. New technology, has been developed by EcoGlove to test from new each and every glove individually for pin holes and other defects. Those that fail the tests are automatically rejected. This unique system allows EcoGlove to achieve an AQL of virtually zero.
Q: Patient will not be comfortable being touched by used gloves
A: The reprocessed Tr@ce gloves are 100% tested and decontaminated. Their quality as barrier protection is as good as and better than most conventional single-use new gloves. The gloves delivered by the EcoGlove service provider are, by definition, always a mixture new and reconditioned gloves and there is nothing to distinguish one from the other.
Q: Are the gloves approved by the FDA?
A: The validation file for FDA and European authorities is in preparation and EcoGlove is conducting pilot projects in the USA and Europe before the market launch of its technology. The FDA has seen the glove reconditioning process and approval is anticipated for the first half of 2009. Tr@ce gloves will then become commercially available in the USA.
In Europe, Tr@ce gloves and the GRU have already received the CE mark
Q: Will bloodstains be totally cleaned off?
A: The steam cleaning eliminates bloodstains and other marks. In the rare cases where this is not successful it is detected by the GRU.s highly sophisticated visual inspection and processing system and the glove will be rejected by the GRU.
Q: Why can’t I just wash them in a conventional washing machine?
A: The reprocessing in washing machines is ineffective and unsafe. There is no certainty of decontamination of BOTH surfaces of the gloves, inside and out, no way to check for the small and potentially dangerous physical defects, and effective drying, packaging, size sorting would be prohibitively labour intensive and expensive. Furthermore, it would be impossible to control the number of reuses and introduce any practical form of traceability. All this would also need to be done under GMP and FDA approval and without traceability it would be impossible.
Q: Would the heat from drying process make gloves shrink or loss its properties?
A: Tr@ce gloves have been developed, under EcoGlove specifications, by the world-leading glove specialists, the Malaysian Rubber Board, a governmental agency, and its Rubber Research Institute. They have been developed specifically to maintain all essential physical properties, including shape, during the reconditioning process.
Q: How many times can a glove be reused?
A: Tr@ce gloves are designed for nominal reuse up to 7 times. However, given attrition from non-returned, for whatever reason, and from QA rejection in the reconditioning process the effective in-use mix at any time is one new glove and three reused. In simple terms each new glove does the work of four gloves.
Q: How do you know how many times it has already been used?
A: Each Tr@ce glove, during its manufacturing is coded with a unique glove serial number and all its characteristics such as manufacturer ID, size, lot number, and other information used for QA and QC. This code carries a ‘credit’ for each use that becomes empty when the Tr@ce glove has been reprocessed the specified number of times. Each Tr@ce glove is uniquely identified and has a corresponding electronic file where all its data and the reprocessing data are stored for comprehensive QA and QC information. During each reprocessing data is captured at each stage of reprocessing in the GRU. Each customer has access through his web portal to all of the information concerning his own glove use, budget and inventory.
Q: How do you monitor the quality of the Tr@ce gloves and the GRU?
A: The GRU is equipped on all its modules with sensors verifying accurate and within the specification functioning. If any of the modules does not function properly the GRU is automatically stopped for corrective action and all the gloves then in the GRU are automatically rejected.
Q: How do you prevent you service provider not to bringing rejected gloves back to usage?
A: When the Tr@ce gloves reach their end of life or are rejected for quality reasons the GRU automatically shreds them into small 1 sq cm pieces thereby preventing any further use. This ensures that no Tr@ce gloves are reused without complying with our strict quality criteria.
Q: What do you do with rejected gloves?
A: The shredded gloves are collected from its service providing partner by EcoGlove, which, in turn, sends them for de-vulcanization using the D-Link process that creates “Green Rubber” form where it is used to make other rubber products. The environmental loop is therefore closed with no waste disposed for landfill or incineration.
Q: Does the printed code affect the glove?
A: The selection of the ink is part of the entire specification process to meet two requirements: adherence to the surface of the glove and absence of residual contaminants. On-going product testing confirms that the performance of printed and unprinted gloves is identical in terms of particulates, ionic extractable, TNVR and physicals. The ink is also compatible with the regulations for food contact.
Q: Can my usual single-use gloves be reconditioned?
A: No, apart from Tr@ce, all exam gloves present on the market have been designed by their makers to be only single use. Tr@ce is the only one designed to be re-usable.
Q: Can EcoGlove help achieve ISO 14000 certification?
A: Yes! It reduces the number of gloves consumed more than 70%, it eliminates waste management as a concern for the user, it eliminates entirely disposed waste due to glove consumption and it reduces energy consumption for the same glove volume usage by as much as 60%.
Q: What glove properties can the reconditioning process influence?
A: None:
1. Physical properties remains indistinguishable from new gloves, This includes thickness, tensile strength, elongation, modulus and cut and puncture resistance;
2. Electrical properties remain unaffected by the reconditioning process because they are a function of the chemistry of the glove;
3. Being tested on a 100% individual base Tr@ce quality gives an AQL virtually approaching 0.