CMS: Revised Guidelines on
Single-Use Intravenous Medication Vials
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The following is the text of an E-mail sent to the Wisconsin
Division of Quality Assurance from the CMS Region V Office in Chicago, August 2002 - see also CMS
Letter S&C 02-43 (exit DHS; PDF), 9/12/02:
The Centers for Disease Control and Prevention (CDC) issued a July 5,
2002, letter to Dr. Sean Tunis, Medical Director of CMS, revising its
recommendations on the multiple use of single-use intravenous medication
vials used in ESRD facilities.
The Survey Procedures and Interpretive Guidelines for ESRD facilities
state that facilities should institute the current recommendations of the
CDC relative to infection control and prevention.
The current (April 27,
2001) guidelines from the CDC say "intravenous medication vials
labeled for single use, including erythropoietin, should not be punctured
more than once."
We have been aware that for several months the CDC
has been reconsidering its position on the repeated use of single-use
Therefore, we had asked Regions and States to hold these
intravenous-medication-vial citations in abeyance because we expected a
revised guideline from the CDC.
We have just received the revised CDC
recommendation. The revised recommendation changes the CDC practice
guidelines for ESRD facilities. Therefore, we are also changing the
guidance to Regions and States regarding this issue.
Effective immediately, ESRD facilities will be expected to follow the
revised CDC recommendations for injectable medications administered by
The CDC has stated that failure to comply with the
following recommendations poses a significant health and safety risk to
Therefore, we expect that either facilities will continue the
practice of single use of single-use vials or facilities will follow the
1. All doses must be drawn-up by a licensed professional whose scope of
practice includes administration of parenteral medications and knowledge
of aseptic technique.
2. All doses from a given vial should be drawn-up and administered
within a 4-hour period.
3. Only one vial of a given concentration of the medication should be
opened and used by the administering professional at any given time. A
second vial of the same medication must not be opened until the previous
vial is discarded.
4. Any opened vials or filled syringes (with epoetin alpha, iron, or
vitamin D) must be discarded if not used within 4 hours of first puncture
of the vial.
Vials must be labeled to document the time of first entry and
maintained at a temperature of 2-8 degrees Celsius (or 36-46 degrees
Fahrenheit) during non-use.
5. Residual amounts of these medications (either in the vial or
syringes) must never be pooled with medication from another vial or
If a patient requires more medication that is in a single, drawn
syringe, then medication from a separate vial should be drawn into a
separate syringe for administration.
6. Each facility must have in place a process monitoring (quality
assurance) program which ensures compliance with these policies and
These policies must include: a) recording data on infections
in treated dialysis patients; and b) unannounced practice audits involving
quality assurance staff observing performance of re-use techniques.
ESRD facilities will now need to be monitored based upon these revised
CDC guidelines. The CDC has stated that these procedures must be followed
strictly to ensure patient health and safety. Not following these
guidelines is a serious threat to patient health and safety.
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Last Updated: July 29, 2011