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Safety-engineered devices: technique progress


Directive 200/32/EU stems from these conclusions. However, the directive lists a series of definitions but fails to mention what is meant by 'safety-engineered devices'.
Fortunately, many international agencies set some important guidelines to define and assess correctly devices that can prevent accidental sharps injuries. (source: FDA, OSHA-US, CDC-NIOSH, GERES, NHS, ISO, ISPESL)
- The built-in safety feature should be activated automatically (passive or active activation) and, at any rate, it should be possible to activate the feature with a single-handed technique.
- The user's hands should remain behind the exposed sharp at all times.
- The activation of the safety feature should happen as early as possible; the device should be reliable and its use intuitive and easy.
- The safety feature should provide an effective, permanent and irreversible shield between the sharp and the user.
- Once activated, the sharps injury prevention feature should not be deactivated and should remain protective through disposal.
- The user should be able to easily tell whether the sharps injury prevention feature is activated, thanks to an audio or visual cue.
- The safety feature should be integral to the device, not an accessory.
- Using the safety-engineered device should not give rise to further safety issues.
- Using the device should not compromise the quality of care and the patient's safety.
These guidelines underline the importance of the user's safety but also patients' safety. They stress the need not to alter operational procedures. Nowadays the advance of technology allows us to use devices that are safer, easier to use and more ergonomic.
Therefore, awareness should be raised first and foremost among healthcare workers, both on preventing biological risk and, through information and training, on the ease of use of these new devices which respect standard procedures and at the same time increase safety for the workers themselves and their patients as well.



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