US Requirements for Sharps Containers
Reviewed: Jan 14th 2013 (TG)
1. FDA Regulations
Yes/
No
All sharps containers
510(k) available
Compliant with CFR 21 Part 820 Quality System Regulation and
Good Manufacturing Practices.
Labeled with clear directions for safe use
OSHA compliant (Closable, Puncture resistant. Label/colorcoded, Leak resistant when upright)
Puncture Resistant (base, sides, closure, top)
Reusable Sharps Containers
510(k) performance tests included:
o Repeated filling and emptying container of sharps, equal to
stated lifespan-uses, using normal processing
o DOT Vibration test
Passes Impact Resistance, Puncture Test, Leak Test after
above lifespan-use simulation
2. DOT Regulations
All sharps containers
DOT UN Specification Packaging Tests (Containers <20gall Exempt):
o
Drop test (1.2m/4ft, -18C/0F)
o
Stacking Strength Test (3m high, 24hrs, 40C/104F)
o
Stacking Stability Test (3 containers high, 1 hr, ambient temp.)
o
Vibration test.
Marked appropriately if represented as meeting UN Standard
Leakproof in all orientations (DOT requirement June 2006)
Secure closure preventing leaks or punctures
Puncture resistant
Visible Biohazard symbol or Infectious Substance Label, in
contrasting color with background
Labelled with proper UN Shipping Name & Number
Reusable Sharps Containers
Container capacity between 2-40 galls (7.57-151.42 L) in vol.
Permanently marked for reuse
Approved & certified by U.S. FDA as a medical device for reuse
Disinfected prior to reuse, effective for infectious substance
previously contained.
Yes/
No
3. OSHA Regulations
Yes/
No
All sharps containers
Decision process enables non-managerial employees to identify,
evaluate and select sharps containment system
Containers shall be:
o Closable
o Puncture resistant
o Leakproof on sides and bottom
o Labeled/color-coded to BBP standard.
During use, containers shall be:
o Easily accessible to personnel and located as close as is
feasible to the immediate area where sharps are used or
can be reasonably anticipated to be found (e.g., laundries);
o Closed immediately prior to removal or replacement
o Replaced routinely and not allowed to overfill
o Maintained upright throughout use
Needle unwinders on containers are general prohibited.
During container movement:
o Containers shall be closed immediately prior to removal or
replacement to prevent spillage or protrusion of contents
during handling, storage, transport, or shipping
o Containers shall show no sign of leakage of fluids during
handling, storage, transport, or shipping
o If container cannot be sealed to prevent leakage it must be
placed in a leakproof secondary container constructed to contain
all contents during handling, storage, transport or shipping.
Reusable Sharps Containers
During Processing, reusable containers shall:
o
Be cleaned and decontaminated such that they are
rendered safe for reuse
o
Not be opened, emptied, or cleaned manually or in any
other manner which would expose employees to the risk of
percutaneous injury
o
Examined and maintained or replaced on a regular schedule
to ensure their physical, mechanical or replacementdependent controls are functioning as intended.
4. ASTM Standard F2132-01 (2008)e1
All areas of differing thickness/material on sharps container
(including base, sides, closure, top) meet Penetration Test
Yes/
No
5. NIOSH Guideline
Functionality
Stable on horizontal surfaces and when used in manufacturer’s
holders
Puncture resistant
Leak resistant on sides and bottom
Impact resistant
Durable labels, warnings, brackets and locking mechanisms
Autoclavable, if necessary
Available in various sizes and capacities to accommodate
volume of sharps generated
Restricted access to sharps in container
Closure mechanism does not allow needlestick injury during
engagement or transport
Closure mechanism provides secure seal
Design minimizes needle-tip flipback
Promotes clinical performance, e.g. does not compromise sterile
field or increase injury or infection control hazards
Resists easy reopening after sealing
Inlet defeats waste removal when open
Inlet defeats spillage while in use in intended upright position
If re-openable, has tight closure that facilitates ease of opening
with grip safety and comfort
Mounting brackets are rugged, easy to service & decontaminate
Accessibility
Available in various opening sizes and shapes
Entanglement-free opening
Opening and fill status visible to user
Design does not impede ease of use
Handles:
o Are located above fill-line
o Facilitate safe vertical transport
o Are located away from opening
o Are located away from potentially soiled surfaces
Can be fixed within arm's reach of sharps generation
Can be fixed below horizontal vision level i.e. allows user to see
into inlet opening
Secure against tampering in high patient or visitor traffic areas
Agree
1
Disagree
2
3
4
5
NIOSH (contin.)
Visibility
Color or warning label implies danger
Warning color/label readily visible to users
Overfill and current fill status readily visible to user
Complies with OSHA requirements
Inlet opening visible to user
Security, mounting, aesthetic, and safety features do not distort
visibility of opening/access or fill status indicator
Accommodation
No sharps edges or materials
Safety features do not impede free access to opening
Promotes patient and user satisfaction
Simple and easy to operate
Any emissions from final disposal comply with emission pollution
regulations
Easily assembled (if required)
If unassembled, components are easy to store prior to assembly
Promotes one-handed disposal of sharps
Special designs available for environments with specific needs
e.g. laboratories, ER, pediatrics, emergency medical services,
correctional facilities
Mounting system durable, secure, safe and cleanable
Optional lockable mounting available
Mounting system allows height adjustment
Design promotes task confidence
System is cost effective
Additional NIOSH Requirements for Sharps Containers
Remain functional during entire usage until final disposal
Inlet prevents spillages during closure, sealing & transport in facility
Durability and puncture resistance unaffected by minor changes in
temperature during storage and use.
Materials resistant to chemical or liquid permeation or degredation,
tearing, abrasion and laceration
Closure mechanism, once activated, is resistant to manual opening
Available in size able to accommodate largest sharps
Has mechanism to restrict hand-entry during use, including
children’s hands.
Handles are sturdy
Designed for simple, easy and safe disposal of sharps
Available with mountings on wheels.
Agree
1
Disagree
2
3
4
5
Agree
Additional NIOSH Requirements (contin.)
Container placement complies with regulatory, site-specific, or
accreditation requirements
Containers can be placed so as to be:
o Accessible within room where sharp was generated
o Unobstructed by furniture, equipment etc.
o Easily visible and recognizable
o Sufficiently illuminated
Containers can be placed so as not to be:
o In room corners
o Backs of doors
o Under or inside cabinets, or attached to inside of cabinet door
o Under sinks
o Above where patients or visitors sit or lie
o Near light or thermostat switches, or mail boxes
o Subject to traffic or equipment impact
Design should minimize cross infection hazards
Easy, safe placement and removal from mounting systems
Mountings designed specifically for system
Worker training provided before system introduced
Multilingual educational materials, where appropriate
Sufficient quantities of containers available for projected volumes.
User instructions include:
All sharps containers
Assembly (where appropriate)
Safety considerations
Optimal storage conditions
Warranty information
Bilingual or multilingual material, where needed
Disposal procedures and considerations
Information for periodic in-service re-training, if required.
Reusable sharps containers:
Maintenance criteria
Decontamination recommendations
Container retirement considerations
Score: NIOSH Requirements (possible Best = 85)
1
Disagree
2
3
4
5
6. Clinical Requirements
All Sharps containers
Peer-reviewed published studies confirm system’s ability to
reduce sharps injuries
Written evaluative research confirms high approval rating by
clinical users
Certified to meet Emergency Care Research Institute Tests for
Sharps Containers
Certified high Needle Penetration Force ≥4.5 lbf / 20N.
Leakproof when dropped on lid (i.e. tested while containing 5%
fluid)
Colour-coded containers for Pharmaceutical sharps waste.
Stable when used or stored (i.e. pass 150 Topple Test)
Preassembled
Intuitive and simple to use
Foot-operated models available
Large opening with passive safety features in patient-room
containers allows safe sharps disposal while passively restricting
hand entry.
Needle unwinder absent
Container promotes wall-space efficiency
Passive safety features prevent overfilling and protrusion injuries
Bracketry enables ergonomic container placement at all
workstations, including walls, benches, carts, gurneys
Temporary closure device enables safe closure and movement.
Tamper-proof when closed for disposal
Designed to facilitate vertical stacking in Utility rooms
Ergonomic handle
Safe, ergonomic & spatially-economic on-site storage systems.
Multi-media education systems for users.
Electronic summary of container locations by room & clinical
unit.
Reusable Containers
Peer-reviewed published studies confirm system’s ability to
reduce greenhouse gas emissions of sharps waste stream
System allows container exchange either by healthcare facility
or external contractor
Clear cost benefit analysis comparing current and reusable
system
Testimonials confirm QA and service performance
Container traceability, including client history & number of uses
Continuous monitoring of container wash parameters
Automated processing of all container sizes.
Laboratory confirmation that washing process achieves effective
reduction of vegetative pathogens
Yes/
No
Reusable Containers (contin.)
Closure mechanism is integrally attached to container
Internal transportation systems facilitating ease of transfer of full
and clean containers between clinical unit and dock/Store
External transportation systems facilitating ease of transfer of full
and clean containers between user and processing facility
After processing, the containers:
o Are subjected to a multi-point QA check
o Meet their original performance elements
o Are aesthetically clean, i.e. free of soil and organic matter,
prominent marks, scuffs or abrasions, etc.
Processor:
o Has written comprehensive Risk Assessment to:
 Assess risks
 Decide what precautions are needed
 Prevent or adequately control sharps injury and
infection/illness exposure
o Has Standard Operating Procedures for operating, cleaning
and servicing machine, including PPE for staff & visitors
o Maintains sharps injury Log
o Ensures injury control measures are used and maintained
o Ensures employees are informed, trained and supervised in
BBP Exposure Precautions.
o Has written plans and procedures to deal with accidents,
incidents and emergencies
Score: Clinical Requirements (maximum = 42 Yes)
Yes/
No