Background As needles constitute a risk for healthcare workers, many safety engineered devices (SEDs) have been marketed in Italy over the past few years. However, marketing rules do not clearly state safety mechanism standards and there are no evidence based data demonstrating effectiveness between different protective mechanisms. Therefore, selection of SEDs for hospital introduction can be challenging for the pharmacist.
Purpose To analyse the Italian SED market.
Material and methods Technical information on SEDs was collected by research on a national database using a code that identified all medical devices (with or without safety mechanisms). When not available, documentation was obtained through direct contact with the manufacturers and web consultation.
Results 134 SEDs were divided according to medical procedure and different types of safety activation mechanisms: active, including toppling shield (TS), sliding protection (SP) or by button pushing (BP), and passive (P). For venous blood sampling, 17 butterfly needles were divided into 3 different safety activation mechanisms: TS (1 SED), SP (11 SEDs) and BP (5 SEDs); 6 syringes with needles: SP (3 SEDs) and BP (3 SEDs); and 7 hypodermic needles: TS (6 SEDs) and SP (1 SED). Arterial blood sampling (5 devices): TS (3 SEDs), SP (1 SED) and recapping mechanism (1 SED). Capillary blood sampling (12 lancets): P (12 SEDs). For administration, 18 butterfly needles: TS (1 SED), SP (12 SEDs) and BP (5 SEDs); 10 syringes with needles: SP (6 SEDs) and BP (4 SEDs); 7 hypodermic needles: TS (6 SEDs) and SP (1 SED); and 4 pen needles: P (4 SEDs). Vascular catheterisation (26 devices): SP (1 SED), BP (1 SED) and P (24 SEDs). Central catheterisation (10 Huber needles): SP activated with either one (3 SEDs) or two hands (7 SEDs). Others included 6 single use scalpels (6 SP) and 6 fistula needles (2 SP and 4 BP). Overall, passive mechanisms represented 31% of devices. The mechanism was not always clear (5% erroneously reported).
Conclusion As many critical points were identified in the evaluation of SEDs, which could mislead the pharmacist in the choice of the device, a database has been built as a clear instrument to easily access all SED information.
No conflict of interest.
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