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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:

      1. Burning the needles hub increases the likelihood of exposure to the remaining syringe contents by increasing the aperture at end of the syringe.
      2. 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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