Although latex proteins have been the focus of this supplement, there are many other parameters involved in glove safety, as can be seen in Table 4
| Requirement | Notes |
|---|---|
| Barrier Properties | European standard EN-455 Part 1 Citation:en 455-1 details the test method (1 litre water test) and the limit (AQL of 1.5%) for perforations in gloves. There is also evidence to show either that HIV does not appear to leak through latex films or that the leakage is only detected with a very high challenge Citation:Carey Herman Retta Sex Transm Dis 1992 Recent press reports of viral penetration of some brands of latex surgeons gloves versus other brands have not yet appeared in a referred journal and should, for the moment, be treated with caution. |
| Strength | EN-455 Part 2 Citation:en 455-2 details the test method for force at break of medical gloves, including limits for different types of gloves. Interestingly, the limits for synthetic gloves are lower than those for latex gloves. |
| Protein levels | Draft EN-455 Part 3 Citation:pren 455-3 includes a test method for TEP but does not specify a limit. It will probably request manufacturers to monitor the amount of TEP in their gloves, and to make test results available on request. As the field matures, it is expected that limits for TEP will be agreed. |
| Other Biological risks. | EN 30993 sets out specific test methods for the biological evaluation of medical devices and includes a section which helps determine what tests should be performed for certain types of devices. In addition, draft EN-455 Part3 Citation:pren 455-3 requires that the manufacturer provides the consumer on request with a list of chemicals determined as being bioavailable in the finished product. |
| Pyrogen and Endotoxin content. | Endotoxin is the cell wall of gram-negative bacteria. Pyrogens are substances which can cause fever, such as dead bacteria, viruses, yeasts and molds. Sterilisation does not inhibit the effect of these substances, and both have been shown to cause allergic dermatitis on the surface of the hand. However, the more serious consequences occur if they find their way into blood or tissues. These include fever, inflammation, complement activation, cell lysis, vascular necrosis, macrophage activation etc. Citation:Truscott Amsterdam 1996 The draft EN-455 Part 3 Citation:pren 455-3 quotes the test method for endotoxin testing as the European Pharmacopoeia test for bacterial endotoxin. Citation:Ph Eur Test for bacterial endotoxin The standard states that if a manufacturer labels sterile gloves as "Low Endotoxin Content" then the upper process limit, as determined by the above method, should be part of the glove labelling. |
| Grip | Perhaps the grip of a glove may not be thought of as safety related, but clearly the ability of the user to carry out a task should not be hindered by a glove which is too tacky or slippery. There is no standard dealing with this aspect of medical gloves, although it is clear that glove grip has a major impact on glove selection by the medical and nursing profession. The other side of the "grip" coin is the ease of donning. Some gloves are given a special treatment on the inside of the glove during manufacture to enable easy donning of the glove without the need for powder (for example Biogel® gloves) which does not affect the "grip" on the outside of the glove. |
| Glove stiffness. | Glove stiffness is related to the elasticity of a glove. If the latex is not elastic enough, then the glove will not conform to the hand. Too stiff, and the users hand will experience fatigue over prolonged usage. There is no standard covering this aspect of medical gloves. |
| Chemical Barrier Properties and Cytotoxic permeability | Gloves are frequently used during the reconstitution of cytotoxic preparations. Different gloves have differing permeation rates when tested against various cytotoxic drugs. Citation:Fenton May Thomas 1987 carmustine exposure Citation:dinter-heidorn carstens cytotoxic gloves Citation:slevin johnston turner cytotoxic gloves An appropriate choice can only be made based on knowledge of how the substance in question permeates the glove and how long the glove is likely to be in contact with the substance. |
| Glove Powder | (See main article for discussion of the role of powder in conjunction with protein in gloves). Powder is increasingly thought to be a potential hazard in healthcare, as a vector for transport of latex proteins or for infective organisms. There is no standard covering the requirements of powder, except a BP standard for the powder itself and a requirement in the draft EN-455 Part 3 Citation:pren 455-3 that all powdered gloves carry a warning to users to remove all powder prior to undertaking operative procedures. LRC recently organised a conference (Heathrow, May 18th 1996) on the hazards of glove powder, the thrust of the conference being that evidence is mounting on the potential hazards of glove powder and that a ban should be considered. Whilst this may be an extreme point of view at present, it certainly reflects growing concern over glove powder in the health care environment. |