A Single-institutional Study to Assess the Time Efficiency and Working Satisfaction Using ANDY(Automatic Needle Destroyer)

A Single-institutional Study to Assess the Impact of ANDY(Automatic Needle Destroyer) to the Medical Staffs in Terms of Working Efficiency Assessed by Working Time and Satisfaction Assessed by Usability and Safety Using SUS Score and Survey

Evaluate the efficiency of adopting the automated needle processing system by evaluating efficiency, usability and safety when using ANDY(Automatic Needle Destroyer). Install ANDY(Automatic Needle Destroyer) in the ER, and evaluate the system by comparing the efficiency of the work, usability, actual decrease ratio of needlestick injury between using the automated needle processing system and not using it.

Study Overview

• Status: Completed
• Conditions: Needle Stick Injuries
• Intervention / Treatment: Device: Removal of needle with using ANDYs

Detailed Description

1. Background The most frequent occupational injury is exposure to blood and fluid by needlestick injury. Needlestick injuries can result in serious infections if appropriate infection control measures are not taken promptly.

   Since the use of safety devices are not popularly used, the needle and syringe are mostly taken into pieces by physical ways. There are some cases that the needle and syringe is not separated, and the entire syringe can be put directly into the waste container. There is also a problem that it takes a lot of time and efforts to remove needles from syringes. In addition, the existing safety mechanism is physical methods such as pulling out the needle, damaging or cutting the needle, or using heat to the needle, or melting it by using chemicals. It is a semi-manual since you have to wait holding the syringe during the process, and it is inconvenient to use considering a busy medical environment.

   Therefore, we developed ANDY(Automatic Needle Destroyer) that can be introduced at a convenient and reasonable cost, and try to objectively evaluate the utility of ANDY in a clinical environment.

2. Purpose The purpose of this study is to Evaluate the efficiency of adopting the automated needle processing system by evaluating efficiency, usability and safety of the system.
3. Design : RCT (randomized controlled trial)
4. Setting: EMERGENCY CENTER at the Samsung Medical Center
5. Enrollment : 129 medical staffs in the ER. 10ea ANDY and 10ea of Existing waste containers(needle box)

6. Intervention :

   6-1) 1st Week : Removal of needle with existing method

   • Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.
   • Identify the number of syringes processed by existing method.
   • Do survey after 1st week

   6-2) 2nd week: Prepare for using ANDYs

   • Provide clinicians with instruction how to use ANDY
   • Install 10 ANDYs in the ER.

   6-3) 3rd week : Removal of needle with using ANDYs

   • Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.
   • Identify the number of syringes processed by ANDY.
   • After 3rd week, do survey and interview 15 people selected by the convenient sample method. By interviewing, collect information of overall experience after using automated needle processing system, how long their hospital working experience is, and other information or systems the interviewees feel those are necessary.
7. Scoring: By the answers of the Questionnaire of Satisfaction (SUS and adjective score)
8. Study period : 3 weeks
9. Satisfaction survey: SUS and adjective score

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• medical staff of the ER
• adult ER medical staff over 19 years of age
• A subject who voluntarily agrees and signs

Exclusion Criteria:

•A subject who did not agree with this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Removal of needle with existing method; Participants will remove needles from syringes with the existing method like they are already doing. (Record the time required for the needle removal procedure by photographing during 24 hours/7 days.)
Experimental: Removal of needle with using ANDYs; Participants will remove needles from syringes with Andy. (Record the time required for the needle removal procedure by photographing during 24 hours/7 days.)	Device: Removal of needle with using ANDYs; ANDY will be provided to medical staffs to be use in removal needles from syringes during 7 days; Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.Identify the number of syringes processed by ANDY.; After 3rd week, do survey and interview 15 people selected by the convenient sample method. By interviewing, collect information of overall experience after using automated needle processing system, how long their hospital working experience is, and other information or systems the interviewees felt those are necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Efficiency: Comparing the time required to remove the needle from syringe for assessing change in time between using automated needle processing system or not	- Comparison of the required time(second) to remove the needle between using the automated needle processing system and not using it.	[1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability: Comparing the SUS score for assessing the change in usability between using automated needle processing system or not	- Comparison of the usability between using the automated needle processing system and not using it by doing survey after 1st week and 3rd week and Interview after 3rd week( Scoring by the answers of the Questionnaire of Satisfaction (SUS) and adjective score)	[1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system)
Safety: Comparing the number of accidents of the needlestick injuries between using automated needle processing system or not	- Comparison of the number of accidents of the needlestick injuries between using the automated needle processing system and not using it.	[1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system)

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: TAERIM KIM, Doctoral, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Actual): September 23, 2019
• Study Completion (Actual): September 23, 2019

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: December 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Efficiency,Usability,Safety
• Additional Relevant MeSH Terms: Wounds and Injuries; Wounds, Stab; Wounds, Penetrating; Needlestick Injuries
• Other Study ID Numbers: 2019-05-112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No