Redesign of a
Safety Syringe
Jessica Chechak
Jason Keiser
Ellsworth Weatherby
Ready To
Before Use Inject
Ready For
After Use Disposal
Design Review
Syringe Body Protective Cap
Are the dimensions in mm? Yes Are the dimensions in mm? Yes
Does the body fit into the protective shield? Yes Does the Cap have a luer thread Yes
pattern on the inside conforming to ISO
Does the syringe body have a 9mm opening Yes 594-1:1986 "Female Fittings?“
for the plunger?
Does the luer threading and cap fit onto Yes
Does the syringe body bottom opening have Yes the protective shield?
a luer thread pattern comforming with ISO
594-1:1986 "Female Fittings"? Backing Pad
Does the body have an opening to lock-in Yes Are the dimensions in mm? Yes
the push button mechanism?
Protective Shield Does the backing pad fit against the Yes
back of the protective shield?
Are the dimensions in mm? Yes
Before Use
Ready To Inject
Our Hybrid
Safety Syringe
Protective Shield
Safety Syringe
Retractable Needle
Safety Syringe
Normal Syringe
(Non-Safety)
Manufacturability
• Simple Design
• Needle is surgical grade stainless steel (standard size 23
gauge)
• Plastic components will be made from PTFE and
polypropylene
• Rapid Injection Molding will be used for production of
plastic components
Human factors
• Ease of use
• Biocompatability of components
• Non-Allergenic components
• Easily disposable – Biohazard safe
Quality Systems Considerations
Regulatory
• 29 CFR 1910.1830 - Bloodborne Pathogen
standard
• The Occupational Safety and Health
Administration (OSHA) promulgates a standard
to reduce occupational exposure to bloodborne
pathogens through a combination of:
• Engineering controls
• Work practice controls
• Enforcement Procedures
• Show evidence of adoption of devices/engineering
controls that reduce exposure
• Document plan annually and any difficulties
• Inspections: complaints & some scheduled inspections
• OSHA does not require a specific device
Quality Systems Considerations
• Regulatory (cont.)
• The Needlestick Safety and Prevention Act
• Directed OSHA to revise the bloodborne pathogen
standard:
• New definitions in engineering controls
• Sharps with engineering sharps injury protection
• Needless systems
• Annual review/update of exposure control plan
• Employers are required to select safer needle devices as
they become available
• Involve frontline workers in device selection
• maintain detailed sharps injury log
Distribution
• Hospitals, Individuals
Cost Effectiveness of Safety Devices
• Business Manager
• Research on Market Size… etc.
• Creation of final PowerPoint presentation
• Updating controlled documents
• Safety Coordinator
• Research on OSHA standards for “Safe
Sharps”
• Writing Section B of the SBIR Phase I
Application
Jason’s Achievements
• Design Coordinator:
• Modeling of design in Solidworks
• Design modifications
• Design Review
• Prototyping
• Functionality Testing
• Writing Section D of the SBIR Phase I
Application
Jessica’s Achievements
• Project Coordinator
• Scheduling Team meetings
• Creation of final PowerPoint presentation
• Writing Sections A and C of the SBIR Phase I
Application
• A: Specific Aims
• C: Relevant Experience / Preliminary Work / Design
Review
• Editing the SBIR Phase I Application
• Updating Controlled Documents
Any Questions?
Hypodermic syringes with
“Needle-Sheath” safety feature
• Active Safety
Feature
A feature that
requires the
operator to
activate the safety
mechanism, and
failure to do so
leaves the
“Needle-sheath” syringe
operator
unprotected
Hypodermic syringes with “Retractable
Technology” safety feature
• Passive Safety
Feature
A safety feature that
remains in effect before,
during and after use,
the operator does not
need to "activate" the
safety feature
• Integrated Safety
Design
The device has the
safety feature included Retractable needle
into its design and it can safety syringe
not be removed or
inactivated. This is the
preferred safety feature.