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

Needle Stick Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04039906
• Other study ID #: 2019-05-112
• Status: Completed
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: September 23, 2019

Study information

• Verified date: May 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: September 23, 2019
• Est. primary completion date: September 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Needle Stick Injuries
• Needlestick Injuries

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)