O.U. Prevention and Protection Service Director Dr. Dimitri Sossai Retractable Needle Safety Syringe Evaluation Report Safe Syringe Laila Ruzza1 , Martina Ivaldi2 1. San Martino Polyclinic Hospital, U.O. Prevention and Protection Service 2. University of Genoa, Department of Education Sciences (DISFOR), UniGe. Foreword In order to protect health care workers from the risk of accidental puncture injuries, having learned of the technological innovation regarding a syringe equipped with a passive type safety device (safety syringe with automatic needle retraction mechanism) that can be used for intramuscular, intradermal and subcutaneous drug administration, a trial was prepared to evaluate the product. The research The purpose of this research is to evaluate the use of the retractable needle safety syringe (Safe Syringe) from the company Roncadellle Operations s.r.l. by health care workers at Policlinico San Martino Hospital, delving into aspects concerning occupational risk and clinical risk. The research was organized in 4 stages: 1) 2) 3) 4) Training of health workers in the use of the Safe Syringe, at the identified Operating Units; 3-month trial phase: Data collection through an online questionnaire; Data analysis. The materials provided to the Operational Units being tested are as follows: - 3 ml syringes Syringes 5 ml Needles 21 G Needles 22 G 18 G needles (from dilution) Largo Rosanna Benzi, 10 - 16132 Genova Location: Istituto S. Caterina/3rd floor [email protected] - [email protected] tel. 010 5555370 /5376/5372 IRCCS Certified according to UNI EN ISO 9001:2015 Standard Certificate No. 41781/21/S - RINA Certified according to UNI EN ISO 45001:2018 Standard Certificate No. OHS-4459 - RINA Certificate of Accreditation and Designation as Comprehensive Cancer Centre OECI Registered Number RPM No. 0473647634

O.U. Prevention and Protection Service Director Dr. Dimitri Sossai The training was organized on January 17 - 18 - 19, 2024 at the O.U. Obstetrics and Gynecology + O.U. Cl. Obstetrics and Gynecology and on days 23 - 24 - 26 at the O.U. CL. Nephrology Dialysis and Transplantation On-the-job training was conducted by the company's Clinical Specialist at the beginning or end of the shift and lasted about 60 minutes. Objective of the questionnaire The questionnaire aims to collect the opinions of health care providers regarding the use of the retractable needle safety syringe (Safe Syringe). The...

O.U. Prevention and Protection Service Director Dr. Dimitri Sossai Syringe blister opening Needle blister opening Easy connection of the needle to the syringe body Cover-up evaluation (ease of removal) Visibility of the graduated scale and transparency of the cylinder Atraumaticity and sharpness of the needle (also consider the reaction of the pts: do they perceive pain less, more, or unchanged compared to the syringes usually used) Comfort during injection Easy activation of the safety system (automatic needle retraction) Irreversibility of the security system Integration of the security system...

O.U. Prevention and Protection Service Director Dr. Dimitri Sossai Yes, for how long." "Questionnaire" section, item "Integration of the security system into the device." Atraumaticity and needle sharpening Product Information -Article codes -Reference lots -Quantity TEST Item changed to "How do you rate the integration of the security system into the device?" Item changed to "Atraumaticity and needle sharpness: also consider the pc's reaction: does he/she perceive pain less, more or unchanged compared to the usually used syringes" Item changed to "Product information: what syringes and needles...

O.U. Prevention and Protection Service Director Dr. Dimitri Sossai Section 2: Questionnaire 7 Syringe blister opening 8 Needle blister opening

O.U. Prevention and Protection Service Director Dr. Dimitri Sossai Easy connection of the needle to the syringe body Needle cover evaluation (ease of removal) Visibility of the graduated scale and transparency of the cylinder Atraumaticity and sharpness of the needle (also consider the reaction of the pts: do they perceive pain less, more, or unchanged compared to the syringes usually used) Comfort during injection Easy activation of the safety system (automatic needle retraction) Irreversibility of the security system How do you evaluate the device's security system integration? Practicality...

O.U. Prevention and Protection Service Director Dr. Dimitri Sossai Tab.3 Frequencies bands of years of experience by department. Five participants had not received training before using the device. Results Section 1 Fifty percent of the participants had used a Safe Syringe before. Specifically, 47% of participants from the gynecology department and 55% from the nephrology department. The type of syringe previously used, its department and years of experience are given below: Syringe type Saxer Zafer Subcutaneous syringe Seleparin Needle with safety lock Safe syringe Ready syringes for heparin...

O.U. Prevention and Protection Service Director Dr. Dimitri Sossai Item 7: syringe blister opening Evaluation Good Excellent Evaluation of syringe blister opening by department Evaluation Insufficient Discreet Good Excellent

O.U. Prevention and Protection Service Director Dr. Dimitri Sossai Item 8: blister needle opening Evaluation Good Excellent Needle blister opening evaluation by department Department Discreet Good Excellent

O.U. Prevention and Protection Service Director Dr. Dimitri Sossai Item 9: Ease of connecting the needle to the syringe body. Evaluation Good Excellent Assessment of ease of needle connection to syringe body by department Department Nephrology Gynecology

O.U. Prevention and Protection Service Director Dr. Dimitri Sossai Item 10: Needle cover assessment (ease of removal) Evaluation Good Excellent Copriago rating (ease of removal) by department Evaluation

O.U. Prevention and Protection Service Director Dr. Dimitri Sossai Good Excellent Item 11: Scale visibility and cylinder transparency Evaluation Good Excellent Evaluation visibility of the graduated scale and transparency of the cylinder by department Evaluation