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Sharpx®
Frequently Asked
Questions
Regulatory Questions
Why do we need to comply with the OSHA Bloodborne Pathogen
Standard?
Because it is the law. The high incidence rate of accidental
needlesticks has forced legislators to enact these laws. Failure
to comply can lead to citations, fines, withholding of Medicare
payments and, in some states, criminal charges. Occupational
exposures caused by non-compliance could also lead to lawsuits
based on employer negligence.
If I’m in a ____________, do I need to comply?
- Dr’s Office
- Nursing Home
- Surgery Center
- Traveling Nurse
- Home Health,
- Other
Yes. These regulations affect any facility or organization
that employs individuals that may be reasonably anticipated
to experience an occupational exposure to blood or other potentially
infectious materials.
American Medical News further explains: "Physicians who
are unincorporated sole proprietors or partners in a bona fide
partnership are employers and may be cited if they employ at
least one employee, such as a technician or secretary."
(see "OSHA Focuses on Reducing Needlesticks" article).
What will OSHA do if we do not comply?
OSHA violations may result in citations, fines or lawsuits.
OSHA has notified 13,000 employers that they will be conducting
detailed and comprehensive site inspections. This year, nursing
homes have been regrouped which will result in higher scrutiny
of these facilities. (see "OSHA Identifies 13,000"
article). In addition to using employer-reported incident data,
OSHA relies on reports from current and former employees to
target their inspections. Even an erroneous report from a former,
disgruntled employee could result in an inspection.
Most importantly, by not complying, facilities open themselves
to potential lawsuit. Several accidental needlesticks have led
to multi-million dollar lawsuits. (see "Fatal Error"
and "Patients Need HIV Tests" articles).
Does a Needle Destruction Unit comply with OSHA’s Standard?
OSHA advocates the reduction of accidental needlestick risk
and gives no preference to any particular device or method that
helps achieve this goal. To quote OSHA’s compliance directive,
"OSHA does not advocate the use of one particular device
over another."
Is a one-hand operated safety syringe the only acceptable
method of compliance?
OSHA advocates the reduction of accidental needlestick risk
and gives no preference to any particular device or method that
helps achieve this goal. To quote OSHA’s compliance directive,
"OSHA does not advocate the use of one particular device
over another."
Sharpx Product Questions
Why does the needle get oxidized to a nub and not to the
hub?
For two very good reasons:
- Burning the needles hub increases the likelihood of exposure
to the remaining syringe contents by increasing the aperture
at end of the syringe.
- Burning the glues and plastics in the hub may emit nauseas
or even hazardous gases.
Does the needle and syringe still need to go into a sharps
container after the needle has been disintegrated?
Destroying the needle reduces the risk of accidental needlestick.
OSHA mandates, however, that all potentially sharp items, including
conventional needles, safety needles, and even destroyed needle
hubs, be disposed in sharps containers.
Can the customer just put the swarf in the red bag and re-use
the cup liner?
In FDA pre-clinical product tests incinerating needles with
contaminated control bacteria, no bacterial residue was found
in the incinerated debris. We cannot predict, however, if other
infectious pathogens may survive needle incineration (e.g.,
viruses, prions, etc.). Therefore, our FDA labeling, OSHA regulations
and prudent material handling processes, mandate that the remaining
needle "swarf" and the cup liner be disposed
of in a sharps container.
How long does it take to charge the unit?
Between 45 and 90 minutes.
How long does the battery hold its charge?
The Sharpxâ Needle
Destruction Unit (NDU) destroys needles by passing a high current
through the needle to produce sufficient heat to melt the metallic
portion of the needle. Needle length and gauge will have a significant
effect on the amount of current required to completely destroy
the needle. Our literature states a range of 25 – 100 needles
that can be properly destroyed before the battery must be recharged.
This statement is meant to imply that 25 of the largest gauge
to 100 of the smallest gauge needles can be destroyed between
battery charges. To further clarify, the Sharpxâ
will destroy approximately forty (40) 21 gauge 1 ½"
needles (needle most commonly used for blood collection or IM
injections) and approximately eighty five (85) 25 gauge 5/8"
needles (needle most commonly used for sub-Q injections).
To maximize operational time between charges, the Sharpx NDU
should not be used for needle destruction while on the charger
cradle. Also, the unit should be used (off the cradle) until
an audible and visible "charge required" is indicated
or the workday is complete, whichever comes first.
If account has more than one unit, it is suggested to rotate
usage. This will extend not only the life of the battery, but
also the life of the electrodes.
When the Sharpx NDU is first received, it should be charged
approximately 24 hours before it’s first use.
What do all of these charge lights mean?
To explain the indicator lights’ function simply, the
Sharpxâ NDU can
destroy a needle anytime the green "Ready" light on
the unit is flashing. When the unit needs to be charged, the
red "Charge" light on the unit will begin flashing
and the unit will emit an audible beep. When the unit is on
the base and is fully charged, the green "Status"
light on the base will flash quickly. Any other time the unit
is on the base and the green "Status" light is not
flashing quickly, the unit is either charging or self-diagnosing.
The green "Power" light on the base indicates that
the unit is plugged into an outlet.
Repeating what was explained previously, the Sharpxâ
NDU does not need to be fully charged to destroy a needle.
Charge Indicator Description Chart:
Light Name Color Location
Ready Green On the unit
Charge Red On the unit
Status Green On the base
Power Green On the base
Destroying the needle with the SharpX® is
an "extra step".
Ensuring the safety of health care workers requires an extra
step. All safe needle systems and safety needles involve an
extra step; be it engaging a sheath, extending a blunted cannula,
activating a retractable needle, or incinerating a conventional
needle. Without an extra step, the health care worker is handling
a dangerous, lethal device.
What do I do if there is a problem with the SharpX®?
Contact our technical service department at (888) 393-9595.
Ordering Questions
Do I have to buy the disposables for the trial period?
Yes.
How do I prove that SharpX® is the lowest
cost method of compliance?
By reviewing the "Sharpx Savings Analysis" chart
with the customer (see attached chart) or by calculating their
savings using the Sharpxâ
savings calculator (see attached calculator).

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©2000 Biomedical Disposal, Inc.
3690 Holcomb Bridge Road, Norcross, GA 30092
tel: 770-300-9595 toll free: 888-393-9595
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