The 20th Century has seen major advances in medical practice leading to improved patient care and reduced risks to medical staff. One of the main advances has been in tackling cross-contamination through the introduction of infection control procedures. Universal precautions introduced aim to build on the successes already achieved. These precautions minimize the risk of cross-infection, protecting medical staff and patients from pathogens
such as hepatitis B and HIV.
A number of "good practice" measures have been implemented over the years in order to control and prevent cross-contamination, including the use of antibacterial soaps and scrubs. One of the most significant changes over the years was new legislation in the late 1980s which resulted in the increased use of latex gloves as barrier protection for the hands, the most common source of transmission of infection.
In addition, regulatory constraints have been levied on all Medical Devices with the introduction of the Medical Devices Directive (M.D.D.) 93/42 EEC O.J. L169 to Europe in 1995.
This directive became mandatory for all medical devices entering Europe from June 1998, and compliance to the applicable various Essential Requirements and Annexes enables the "manufacturer" to place the CE mark on their device/packaging.
The directive "classifies" medical devices into four main groups, Class 1, 2a, 2b and 3, by the "risks" associated with each device, using a set of rules laid down in Annex IX of the M.D.D. This classification dictates which particular route(s) you take to achieve compliance.
The use of "Harmonised" European Product Standards, Euro Norms (EN), is one way to show compliance to applicable Essential Requirements from Annex 1 of the M.D.D., and dependent on the device classification, another Annex may need to be followed to achieve full compliance to the directive.
Medical gloves fall into the Class 1 (Sterile and Non-Sterile Examination procedure gloves) and Class 2a (Sterile Surgeons' glove) categories.
The Harmonised European Product Standards that cover medical gloves are the EN 455 series of Standards:
EN 455-1 1994 (amendment May 1998)
EN 455-2 1995
EN 455-3 1999
Parts 1 and 2 refer to the physical properties of the gloves such as freedom from holes, and dimensions. Part 3, a more recent addition, refers to additional labelling requirements and to the biological evaluation of the glove. For labelling requirements, attention is drawn to the EN 1041 and EN 980 Standards where the use of symbols is encouraged rather than the repetition of important information in several languages.
The biological evaluation is required using the International ISO 10993 series of Standards, coupled with a risk analysis. This risk analysis should show that the benefits of using the product outweigh any inherent risks. These regulatory constraints and testing to various Standards are all designed to reduce risks and provide a consistent quality product to use as a barrier protection for patients and staff.
Unfortunately, as well as protecting patients and staff from the potential risks which prompted the introduction of gloves in the first place, the rise in glove use has come at a cost - a rise in latex-related allergic reactions amongst healthcare staff, as well as the general population.
Latex precautions, including a latex-safe environment, should be established in all health-care facilities. These precautions include clearly identifying the latex sensitivity in all patient records and taking appropriate measures to minimize their contact with the allergen.
Despite this, latex remains an ideal material for gloves because of its barrier effectiveness, fit, comfort, flexibility and cost. The challenge for the glove manufacturing industry is to eliminate latex sensitization without compromising the barrier protection available and much research is being done worldwide to address this issue. Additionally, a number of glove companies are researching synthetic alternatives such as neoprene and vinyl, but further research needs to be undertaken to insure their barrier effectiveness as well as possible allergenicity. This continued research into the most effective method of infection control should result in a safe gloving alternative for everyone, even those already sensitised.
