Exposure Control Plan
«Healthcare Facility»
Nuclear Medicine Department
Exposure Control Plan Addendum
Overview and Purpose
The goal of this Exposure Control Plan is to meet the requirements of the OSHA Bloodborne Pathogens
Standard 29 CFR (1910.1030) as amended by the Needlestick Safety and Prevention Act (H.R. 5178, Public Law
106-430). In the Needlestick Safety and Prevention Act, Congress authorized OSHA to revise its Bloodborne
Pathogens Standard to require the use of safety-engineered sharp devices. OSHA’s revised standard took effect
on April 18, 2001.
Accordingly, this plan focuses on safer work practices, personal protective equipment and engineering and
administrative controls for «Healthcare Facility»’s Nuclear Medicine Department. The Nuclear Medicine
Department has the unique responsibility of implementing policies and procedures to assure workplace and
patient safety related to biohazards as well as radiation safety when disposing of contaminated sharps. In nuclear
medicine the radiation and biohazard exposure of workers must be managed and controlled simultaneously to
meet OSHA, NRC and agreement state requirements. The aforementioned requires an addendum to the facilities’
general exposure control plan to address the added responsibility and oversight necessary to safely and
effectively manage compliance with the revised OSHA Bloodborne Pathogens Standard.
Scope and Applicability
This policy and procedure will be followed by all employees and physicians working within «Healthcare Facility»’s
Nuclear Medicine Department. Failure to follow these procedures may result in disciplinary action.
Description of Appropriate and Effective
Engineering Controls for Nuclear Medicine
Specifically, Occupational Exposure to Bloodborne Pathogens; Needlestick and Other Sharps Injuries; Final Rule,
Federal Register #66:5317-5325, 29 CFR Part 1910, Section III, “Summary and Explanation,” states:
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For purposes of this standard, an “appropriate” safer medical device includes only devices whose use,
based on reasonable judgment in individual cases, will not jeopardize patient or employee safety or be
medically contraindicated. Although new devices are being continually introduced, OSHA recognizes that a
safer device may not be available for every situation. If a safer device is not available in the marketplace
the employer is not required to develop any such device. Furthermore, the revised requirements are limited
to the safer medical devices that are considered to be “effective.” For purposes of the standard, an
“effective” safer medical device is a device that, based on reasonable judgment, will make an exposure
incident involving a contaminated sharp less likely to occur in the application in which it is used.
Requirements Overview
Administering a nuclear medicine dose is a specialized procedure that requires:
•
Radiopharmaceutical doses delivered to or stored in the nuclear medicine department must be contained
within a shielding unit (lead or tungsten “pig”) to reduce the radiation exposure to the healthcare worker
and the patients in the department.
•
Workers with the propensity to receive occupational radiation exposure are required to practice the
concept of ALARA (As Low As Reasonably Achievable) to minimize their radiation exposure.
•
Prior to patient injection, the syringe must be placed in a protective radiation shielding device, a hand held
syringe shield, to reduce radiation exposure to the technologist performing the injection.
•
Consideration must be given to the removal of a syringe from a syringe shield without contaminating the
surrounding area with radioactive material and protecting the healthcare workers from the potential of a
needle stick with a sharps device that has been exposed to bodily fluids.
•
Safe and compliant disposal of a contaminated syringe into a 510k registered sharps container that meets
the requirements of 29 CFR 1910.1030 (d)(4)(iii)(A).
Needle Safety Device Evaluation Criteria
The «Healthcare Facility» Nuclear Medicine Department has adopted the following criteria to evaluate new needle
safety devices for nuclear medicine. These criteria were designed and set forth by the Council on Radionuclides
and Radiopharmaceuticals (CORAR). CORAR provided the criteria to OSHA in the form of a Request for
Interpretation. In OSHA’s response to CORAR, OSHA agreed that, “one hazard should not be exchanged for
another…” and that at this time no apparent safer needle device was available in the marketplace to meet the
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needs of Nuclear Medicine1. In their response OSHA instructed CORAR to include their evaluation criteria in their
exposure control plan and to evaluate other engineering controls and work practice controls to reduce the chance
of exposure to biohazardous material. OSHA specifically stated that this did not preclude or exempt Nuclear
Medicine from compliance with the Bloodborne Pathogens and Needlestick Safety legislation. If no controls were
available and if occupational exposure still remained, personal protective equipment must be utilized to remain
compliant.
According to CORAR any needle safety device must meet five (5) criteria before it can be safely used with
radiopharmaceuticals:
1.
The syringe must fit snuggly into a radiation protective syringe shield to facilitate patient injection.
-
A loose fit between the syringe and the syringe shield will cause the needle to wobble increasing
the probability of a missed vein and repeat injections.
-
Additional injections increase the potential of a needle stick with a sharps device that has been
contaminated.
2.
Healthcare practitioners must be able to operate the syringe without displacing the radiation syringe
shield (ALARA).
3.
The syringe must not “leak” or expel radioactive material in an unintended fashion before, during, or
following operation. Some of the safety mechanisms have the potential to leak or expel radioactive
residual from the syringe upon activation.
-
Increases the probability of a radioactive materials contamination and/or spill event which
compromises both patient and employee safety.
4.
The needle must be removable. In certain instances, the radiopharmaceutical will be injected into a
catheter using a canula rather than a direct patient stick.
5.
The filled syringe must fit snuggly and safely into the lead or tungsten shipping container to reduce the
propensity of the contents of the syringe being inadvertently expelled into the container during transport
The committee evaluated additional criteria developed by the Training for Development of Innovative Control
Technology Project (TDICT):
1
U.S. Department of Labor, Occupational Safety and Health Administration, Standard Interpretations, 2001 - 08/17/2001 - Evaluation of safer
medical devices and the use of therapeutic radiopharmaceuticals, (Richard E. Fairfax, Director, Directorate of Compliance Programs)
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1.
The safety feature must be activated using a one-handed technique.
2.
The safety feature does not obstruct vision of the tip of the sharp.
3.
The device provides a better alternative to traditional recapping
3.
There is a clear an unmistakable change that occurs when the safety feature is activated.
Upon evaluating the needle safety devices on the market (see Attachment A) the Committee has determined that
none of the safety devices meet the above stated criteria in their entirety. The Committee will continue to evaluate
and implement new technologies as they become available in the marketplace.
Methods of Compliance
While the Committee did not find an appropriate safer needle, its review found several safety devices and
engineering controls that are appropriate and effective for addressing the joint exposure hazards prevalent in the
nuclear medicine department.
1.
SECURE® Syringe Shield - A clamshell designed radiation syringe shield that enables the nuclear
medicine technologist to dispose of the contaminated syringe without re-capping. This also prevents the
contamination of the syringe shield with radioactive material.
2.
NeRD® - A one-handed needle-recapping device with a suction cup base. The base is very important
because it eliminates the need to steady the device with one hand while inserting the spent syringe with
the other hand. The nuclear medicine technologist places the NeRD® on a smooth surface. When
preparing for an injection, the needle cap is removed, and placed into the device with the open end up.
After injection, using one hand, the needle is reinserted into the cap that is contained within the NeRD®.
The syringe may then be removed from the radioactive syringe shield without risk of contamination with
radioactive material.
3.
SECURE® Safety Insert System – The Nuclear Pharmacy Services business of Cardinal Health has
offered their patented SECURE® Safety Insert System, which provides a clean, protective insert
enclosing the unit dose syringe before and after injection. Post administration, the insert holding the used
syringe is capped using a red color lid labeled as biohazard. Once the used syringe is returned to the
Cardinal Health nuclear pharmacy, the insert containing the spent syringe is discarded, and a new insert
is reloaded inside the pig before reuse. The insert is a FDA 510k registered sharps container (FDA
registration no. K945825). The insert device also meets the Bloodborne Pathogens Standard 29 CFR
(1910.1030) for a compliant sharps container for biohazardous material.
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Approved Unit Dose Handling Procedure
Based on the Committee’s findings, we adopt the following unit dose handling procedure:
1.
At «Healthcare Facility», nuclear medicine unit doses arrive from our centralized radiopharmacy vendor
(Cardinal Health) with the SECURE® safety insert bottom already in a radiation attenuation container,
i.e., a radiopharmaceutical “pig.” Our technologists check the outer label to assure proper drug and
patient. The technologist removes the unit dose syringe from the radiopharmaceutical pig, behind an Lblock radiation shield, and places the unit dose syringe inside the dose calibrator to assure the proper
activity (dependent on the facility RAM license).
2.
The technologist places the unit dose in a syringe shield and administers the unit dose. Following the
injection, the technologist places the spent syringe into the insert already inside the pig (this does not
require any needle recapping).
3.
After the syringe has been placed inside the SECURE® safety insert, the technologist turns the insert a
sharps container by capping and locking on the red, biohazard labeled insert top, which encloses and
seals the container, thus isolating the biohazardous and radioactive spent syringe.
4.
The pig’s cap is screwed back on, and the entire assembly is then packaged and labeled according to
OSHA and DOT regulations and returned for disposal to the radiopharmacy vendor.
5.
If any steps require physical recapping of the needle, the NeRD® device that allows for one-handed
recapping of needles, is also available for technologists’ use.
Adhering to this handling procedure ensures compliance with applicable laws and regulations relating to
bloodborne pathogens exposure and is in accordance with the OSHA Bloodborne Pathogens Standard. Our
Committee is convinced that using the SECURE® Safety Insert is an effective device to reducing needle sticks in
our Nuclear Medicine Department. We have also adopted the SECURE® Safety Insert System as our point-ofuse sharps container for spent and potentially contaminated syringes.
The committee has reviewed the nuclear medicine needle stick trends for last ____ year period ending on
_________ and found _____ needlesticks. Based upon these findings, the committee considers our method of
protecting nuclear medicine healthcare workers from needlestick injuries effective for reducing exposure to both
biohazardous and radioactive materials.
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Cardinal Health strongly recommends that you contact your regional OSHA office to address any concerns about
the implementation of policies and/or procedures related to the Needlestick Safety and Prevention Act, and to
seek independent legal advice with respect to the legal issues that may arise as a result of adopting this policy.
This policy is supplied by Cardinal Health 414, Inc. solely for the use of its customers. Any other use, including
copying, reproduction or distribution of this policy is expressly prohibited.
2012 Cardinal Health. All Rights Reserved
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Attachment A
Device Review Listing That Were Unacceptable*. Indicate “none”, if no safer devices were commercially
available.
Device # 1 __________________________________________________________________
Device # 2 __________________________________________________________________
Device # 3 __________________________________________________________________
* The following criteria were used in evaluating safety devices for the administration of
nuclear medicine doses:

The safety device fits correctly in the appropriate sizes syringe shield.

The safety device does not spray radioactivity when activated.

The safety device does not leak materials post activation.

Using the safety device for nuclear medicine does not increase the technologist hand or finger
exposure to radiation.
Members of Evaluation Committee (comprised of the nuclear medicine users listed below)
Date of Review ___________
Name & Title
1. _____________________________________________________________
2. _____________________________________________________________
3. _____________________________________________________________
4. _____________________________________________________________
5. _____________________________________________________________
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