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

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What is driving this change????

Presentation transcript:

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

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”

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

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.

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

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.

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

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.