2. Current Practice
Re-Usable Sharps
Why are hospitals making this change?
How does it work?
Program Benefits
Next Steps

3. Current State of Affairs – What do the Regulators Say about Sharps?
OSHA says-
“replaced routinely..not allowed to overfill”
NIOSH says–
“an individual or group should be assigned responsibility”

4. A New Sharps Management Definition & Value Proposition
A fully integrated sharps management services should reduce the total cost, liability, and environmental impact of traditional sharps disposal programs while increasing employee safety and regulatory compliance…
Mike G

5. Safety...a different point of view
Safety through service:
Proactive container management keeps needles safely at the container bottom
Site inspection ensures proper size & mounting location for all use areas
Safety by design:
Simple design
Fully compliant with NIOSH guidelines
Puncture-resistance vs. ASTM standards
FDA 510(k)
Safety through QA systems:
Cleaning and disinfection process monitored to assure compliance to parameters
100% production inspection followed by an independent quality inspection
Mike G.

6. Current Practice – The Effect on Staff
With disposable sharps containers the nursing staff:
Worries about getting a needle stick from over filled or “auto-locked” containers.
Feels like they are taking time away from their most important task - patient care.
Unwelcome additional responsibility

7. Financial Benefits Cost reduction through better utilization
Flat fee structure means no longer balancing cost of containers versus safety requirements
Assists with budgetary projections
Eliminate purchase, handling, storage, inventory, monitoring, transporting, labeling and packaging of sharps containers
Reduce exposure control concerns
25% of RMW is sharps
GPO relationship
Brian B.

8. Current Practice – The Effect on the Environment
In the US, by using disposable sharps containers, hospitals currently discard:
30,000 tons of plastic
5,000 tons of cardboard
This is enough to fill 19.5 miles of semi trucks lined up nose to tail.
All is either incinerated or treated and placed in landfills

9. Treatment Facility – Program Quality Overview
FDA Registration
All containers are cleared for commercial distribution via the 510K pre-market notification process.
Quality System Regulation Compliance
GMPs from 21 CFR Part 820 are followed to create Standard Operating Procedures.
Process Validations
Protocols developed by an independent medical device testing lab using the latest AAMI guidelines.
PLC, Installation, Operational and Performance Qualifications are conducted.
Mike G.