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NEURAXIAL SAFETY UPDATE
(ISO 80369-6 AND CALIFORNIA LAW)
ANTONIA ROTH – PRODUCT MANAGER, PAIN CONTROL MARKETING
October, 2016
AGENDA
Background
ISO 80369-6 and California Law
Timing
Products Affected
Questions
Why Are We Here?
Wayne Jowett, 18, died after a toxic cancer drug
was wrongly injected into his spine at
Nottingham's Queen's Medical Centre in 2001.
The drug he was given to complete his
treatment, Vincristine, is safe if injected into a
vein, but highly toxic if given "intrathecally" into the spine.
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Mayra Cabrera, 30, suffered a heart attack when
Bupivacaine, a potent epidural anesthetic, was
mistakenly attached to her intravenous drip in
2004.
She died after giving birth to her son Zac at
Great Western hospital, where she had worked
as a nurse.
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Medication Errors During Regional Anesthesia
Authors
Study design
Results
Patel et al. 2015
Systematic review
Obstetric Neuraxial Drug
Administration Errors
The review found 29 cases of drug administration
errors. There were 14 ampoule errors, 8 syringe
swaps, 3 line confusions and 4 infusion errors.
Beckers et al.
2012
Systematic review
Inadvertent epidural
injection of drugs for
intravenous use
The authors found that syringe swap and
ampoule error and epidural catheter–IV line
confusion were common causes of error.
Hew et al. 2003
Systematic review
Inadvertent epidural
injection of drugs for
intravenous use
"Syringe swap", "ampoule error", and
epidural/intravenous line confusion were the main
sources of error in 36/37 cases (97%).
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Medication Errors During Regional Anesthesia
 It is difficult to define the relevant literature, as there is no consensus about the
definition of medication errors.
 A cluster review found that 30 claims alleged administration of the wrong drug; 24
claims that a drug was administered in the wrong dose; 5 claims that a drug was
administered in the wrong order; and 2 claims that administration occurred by the
wrong route.
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Consequences of Medication Errors
 According to the seminal report ‘To err is human’ by the US-based Institute of Medicine
in 2000, adverse events occur in 2.9–3.7% of hospital admissions, with 6.6-13.6% of
adverse events leading to death. On the basis of these numbers, the report estimated
44000–98000 deaths per year due to medical errors in US hospitals, with 50% of these
adverse events considered to be preventable. [Wacker et al. 2014]
 A self-reporting survey (Canadian Society of Anesthesiologists) on 687
anesthesiologists reports found four deaths. [Orser et al. 2001]
 A systematic literature research found a total of 29 cases of errors in obstetric
neuraxial
drug administration, with 4 deaths. [Patel et al. 2015]

Systematic review on administration of Intrathecal chemotherapy:
 Case reports, clinical studies, and review articles pertaining to Intrathecal
medication errors were included in the review. There have been numerous cases
of antineoplastic agents intended for administration by the parenteral route being
inadvertently given intrathecally. Vincristine has been implicated 31 times (25
deaths), as well as vindesine, asparaginase, bortezomib, daunorubicin, and
dactinomycin. This has led to profound toxicity and, commonly, death. [Gilbar
2014]
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Consequences of Medication Errors
 Accidental Intrathecal vincristine administration resulting in progressive ascending
radiculomyeloencephalopathy has been repeatedly reported. [Pongudom et al. 2011,
Qweider et al. 2007, Dettmeyer et al. 2001]
 Epidural analgesia can cause severe cardio- and neurotoxicity when inadvertently
administered via the intravenous route. Koczmara et al. described a case of
Bupivacaine given intravenously, resulting in death. [Koczmara et al. 2007]
 Other authors have described accidental Intrathecal administration of a large dose of
tranexamic acid, also resulting in death. [Yeh et al. 2003]
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Possible Reasons for Wrong Route
Administration & Misconnections
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Low
Lighting
Multiple
Devices
Multiple
Lines
Time
Pressure
Compatible
Connectors
Disconnections
Lack of
Tactile
Feedback
Unintended
Use of
Tubes
Moving
Patient
Setting
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http://www.stayconnected.org/resources.html
The Challenge
Connectivity within the same
therapy...
but not with other routes
IV/
Hypodermic
Enteral
Respiratory
Limb Cuff
Neuraxial
Urinary
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StayConnected
Who’s Involved?
Various Manufacturers, Group Purchasing Organizations,
Societies, Foundations, Associations and Institutes
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Who’s Involved?
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Who’s Involved?
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ISO 80369 Series
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Status of ISO 80369-6 (NRFit)

Standard for small-bore connectors for liquids and gases in healthcare applications
Part 6: Connectors for neuraxial applications … PUBLISHED March 15, 2016.
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Scope of ISO 80369-6 (NRFit)

Specifies requirements for small-bore connectors intended to be used for connections
in neuraxial applications. Neuraxial applications involve the use of medical devices
intended to administer medications to neuraxial sites, wound infiltration delivery, and
other regional anesthesia procedures or to monitor or remove cerebro-spinal fluid for
therapeutic or diagnostic purposes.

Sites for neuraxial application include…
 the spine
 intrathecal or subarachnoid space
 ventricles of the brain and the epi-, extra, or peri-dural space
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Scope of ISO 80369-6 (NRFit)

Neuraxial application anesthetics can be administered regionally affecting a large part
of the body, such as a limb, and include plexus blocks, such as brachial plexus blocks
or single nerve blocks. Also included are continuous infusion of wounds with local
anesthetic agents.

For the purposes of this standard, local anesthesia injected hypodermically is not
considered a neuraxial application.

Intended administration includes intrathecal chemotherapy, local anesthetics,
radiological contrast agents, antibiotics, analgesics.
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Timing for Implementation

It is the recommendation of the committees
that the content of this publication be
adopted for implementation nationally not
earlier than 3 years from the date of
publication for equipment newly designed
and not earlier than 5 years from the date of
publication for equipment already in
production.

IMPORTANT NOTE FOR CALIFORNIA
CUSTOMERS: Starting 2017, California law
prohibits health facilities from using an
epidural connection that would fit into a
connection port other than the type for which
it was intended. This means California
health facilities should no longer use
epidural products with Luer connectors
as of Jan. 1, 2017.
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California Legislation
Assembly Bill No. 444
CHAPTER 198
An act to amend Section 1279.7 of the Health and Safety Code, relating to health
facilities.
[Approved by Governor August 13, 2015. Filed with Secretary of State August 13, 2015.]
legislative counsel’s digest
AB 444, Gipson. Health facilities: epidural and enteral feeding connectors.
Existing law, as of January 1, 2016, prohibits a health facility, as defined, from using an
epidural connector or an enteral feeding connector, that would fit into a connector other
than the type it was intended for, unless an emergency or urgent situation exists and the
prohibition would impair the ability to provide health care. Existing law also requires a
health facility to develop a patient safety plan and, until January 1, 2016, requires that
plan to include measures to prevent adverse events associated with misconnecting
enteral feeding and epidural lines. Violation of these provisions is a misdemeanor.
This bill would make the provisions relating to an epidural connector operative as of
January 1, 2017, and would make the provisions relating to an enteral feeding connector
operative as of July 1, 2016. The bill would make conforming changes.
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California Legislation
Assembly Bill No. 444
CHAPTER 198
The people of the State of California do enact as follows:
SECTION 1. Section 1279.7 of the Health and Safety Code is amended to read:
1279.7. (a) A health facility, as defined in subdivision (a), (b), (c), or (f) of Section 1250,
shall implement a facility-wide hand hygiene program.
(b) Commencing January 1, 2017, a health facility, as defined in subdivision (a), (b), (c),
or (f) of Section 1250, is prohibited from using an epidural connector that would fit into a
connector other than the type it was intended for, unless an emergency or urgent
situation exists and the prohibition would impair the ability to provide health care.
(c) Commencing January 1, 2016, a health facility, as defined in subdivision (a), (b), (c),
or (f) of Section 1250, is prohibited from using an intravenous connector that would fit
into a connector other than the type it was intended for, unless an emergency or urgent
situation exists and the prohibition would impair the ability to provide health care.
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California Legislation
Assembly Bill No. 444
CHAPTER 198
The people of the State of California do enact as follows:
(d) Commencing July 1, 2016, a health facility, as defined in subdivision (a), (b), (c), or (f)
of Section 1250, is prohibited from using an enteral feeding connector that would fit into
a connector other than the type it was intended for, unless an emergency or urgent
situation exists and the prohibition would impair the ability to provide health care.
(e) The Advanced Medical Technology Association shall, on January 1 of each year until
the standards are developed, provide the Legislature with a report on the progress of the
International Organization for Standardization in developing new design standards for
connectors for intravenous, epidural, or enteral applications.
(f) A health facility that is required to develop a patient safety plan pursuant to Section
1279.6 shall include in the patient safety plan measures to prevent adverse events
associated with misconnecting intravenous, enteral feeding, and epidural lines. This
subdivision shall become inoperative as to epidural connectors upon the operative date
of subdivision (b), and as to intravenous connectors upon the operative date of
subdivision (c). and as to enteral feeding connectors upon the operative date of
subdivision (d).
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ISO 80369-6 (NRFit)
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Examples
Examples of devices affected in ISO 80369-6 include:
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Spinal needles
Epidural needles
Catheter connectors
Loss of resistance syringes
Epidural / spinal syringes
Epidural pump tubing / extension tubing
Filters, Filter Straws, Filter Needles
Stopcocks used with Manometers
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B. Braun Affected Devices
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Epidural Filter
Longer collar
Longer, thinner
Luer
Shorter collar
Shorter, thicker
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Spinal Procedural Slip Syringe
Collar
Indicates “NRFit slip”
No Collar
No indication of “NRFit slip”
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Glass LOR Lock Syringe
Elongated Collar
Indicates “NRFit”
Luer
No “NRFit” indication
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20 mL Dosing Syringe
Indicates “NRFit Lock”
Yellow plunger
Clear plunger
No “NRFit Lock” indication
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Epidural Needle
Translucent stylet hub
NRFit
Luer
Opague stylet hub
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Spinal Needle
Prism to help identify CSF
Translucent stylet hub
UV bond for better introducer fit
Epoxy bond
Opague stylet hub
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No Prism
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Spinal Needle w/ introducer
Luer needle w/ current
luer introducer
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NRFit needle w/ new
luer introducer
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B. Braun Products with NRFit - Launching Q4 2016
CATEGORY
QUANTITY
17G CONT EPIDURAL TRAYS
5
18G CONT EPIDURAL TRAYS
4
SD EPIDURAL TRAYS
2
EPIDURAL NEEDLE SINGLES
(includes two longer lengths)
5
PEDIATRIC EPIDURAL SETS
1
EPIDURAL CATHETER SINGLES
2
CATHETER CONNECTOR SINGLES
2
PLASTIC LOR SYRINGE SINGLES
2
EPIDURAL FILTER
1
SPINOCAN TRAY
PENCAN TRAYS
Luer
1
2
SPINOCAN NEEDLE SINGLES
(includes two longer lengths)
6
PENCAN NEEDLE SINGLES
(includes one longer length)
3
ESPOCAN TRAYS
2
ESPOCAN SETS
2
SYRINGE AND FILTER NEEDLE SETS
2
SYRINGE SINGLES
2
FILTER STRAWS/NEEDLE SINGLES
3
Total Products with NRFit
47
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Information Sources

BBraunNRFit.com

StayConnected.org

CHPSO.com
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Questions?
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