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SAFE INJECTION PRACTICES AND

POINT OF CARE DEVICES


Debbie Hurst RN, BSN
Program Manager, Infection
Prevention & Control
Rogue Valley Medical Center

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Objectives

• Discuss outbreaks related to unsafe


injection and infusion practices
• Discuss outbreaks related to unsafe use of
diabetes blood sugar monitoring devices
• Identify safe injection practices
and safe handling and
disinfection of point of
care devices

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Outbreaks Linked to Unsafe
Injection Practices
• In the last 10 years, 33 infectious disease
outbreaks, such as Hepatitis C, have been
reported; thousands of patients have been
notified that they may have been harmed
• Referral of providers to licensing boards for
disciplinary action
• Legal actions such as malpractice suits
filed by patients
• Nearly half of the outbreaks were
related to anesthesia/sedation
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Viral Hepatitis Outbreaks in Outpatient
Settings Due to Unsafe Injection Practices
State Setting Year Type
2001 to 2010
NY Private MD office 2001 HCV
n=16
NY Private MD office 2001 HBV
NE Oncology clinic 2002 HCV
OK Pain remediation clinic 2002 HBV+HCV
NY Endoscopy clinic 2002 HCV
CA Pain remediation clinic (ASC) 2003 HCV
MD Nuclear imaging 2004 HCV
FL Chelation therapy 2005 HBV
CA Alternative medicine clinic 2005 HCV
NY Endoscopy/surgery clinics 2006 HBV+HCV
NY Anesthesiologist / pain clinic 2007 HCV

NV Endoscopy clinic (ASC) 2008 HCV


NC Cardiology clinic 2008 HCV
NJ Oncology clinic 2009 HBV
FL Alternative medicine clinic 2009 HCV
CA Pain remediation clinic 2010 HCV+HBV

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Nevada Hepatitis C Outbreak
• January 2008: cluster of three acute Hepatitis C virus
(HCV) cases identified in Las Vegas
• All three patients underwent procedures at the same
endoscopy clinic during the incubation period
• Clinic performed upper and lower endoscopies
• 50-60 procedures/day
• 2 procedure rooms
• Reviews of surveillance records, laboratory records and a
physician report identified three additional clinic-
associated cases; health department later identified over
77 additional HCV cases likely acquired at the clinic
(MMWR: May 16, 2008; 57:19)

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Review of Anesthesia Delivery
• Started induction with syringe filled with lidocaine (1 cc)
and propofol (9 ccs)
• Clean needle and syringe used to inject directly through
intravenous catheter
• If patient need more anesthesia, some providers:
• Removed needle from syringe and replaced with a new one
• Used old syringe w/ new needle to draw more propofol
• Medication remaining in the single dose propofol vial was
used to sedate the next patient

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Review of Anesthesia Delivery

• Propofol is a single-dose
medication
• Preservative free
• Approved for use on a single
patient for a single procedure
• Facility purchased 20-50 cc vials
but only used approximately 10-15 cc
per patient

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Unsafe Injection Practices That
Likely Lead to HCV Transmission

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Bacterial Outbreaks due to Unsafe
Injection Practices
Pain clinic: seven cases of Serratia marcescens
• Spinal injections; all patients hospitalized

Primary care clinic: five cases of S. aureus


• Joint injections; all patients hospitalized

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Safe Injection Practice Research

Report found that of 5,446 provider


respondents:
• 6% sometimes or always use single-dose/
single-use vials for more than one patient
• 1% sometimes or always reuse a syringe but
change the needle for a second patient
• 15.1% reuse a syringe to enter a multi-dose vial
• 6.5% save multi-dose vial for use on another
patient (Pugliese G., et al AJIC Dec. 2010)

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Incorrect Practices That Have Resulted
in Transmission of Pathogens
• Direct (i.e., “overt”) syringe reuse
• Using the same syringe from patient to patient
(with/without the same needle)
• Indirect syringe reuse
• Accessing shared multi-dose medication vials or bags
with a used syringe that will be used on subsequent
patients (with/without the same needle)
• Reuse of single dose vials
• Diversion

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Provider-to-Patient Transmission of HCV
Associated with Diversion of Fentanyl
Colorado, 2009
• HCV-infected surgery technician stole fentanyl
syringes that had been pre-drawn and left
unattended in the ORs
• Contaminated syringes were refilled with saline
and swapped with unused syringes
• 24 patients infected; nearly 600 notified
• Diversion has emerged as the leading cause of
provider to patient HCV transmission

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Injection Practice Myths

• If there's no blood, there's no risk


• Mistaken belief that the following can
prevent infection transmission risks:
• Changing the needle
• Injecting through intervening lengths of
intravenous tubing
• Presence of a check valve
• Always maintaining pressure on the plunger to
prevent backflow of body fluids
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Single-use / Single-dose

Recommended whenever possible


(unless unavailable)
Single-use: a vial where a single dose can be
removed and then the vial and its remaining
contents are discarded
Single-dose: a vial containing a single unit of
a parenteral drug product
(FDA, C-DRG-00907)

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Single-use Medication Reuse

• Using single-dose medications for more


than one patient
• Purchase vials containing quantities in
excess of those needed for a single patient
• Mistaken belief they can be used
in a multi-dose fashion
• Commonly abused medications
• Contrast agents, propofol, botox

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Multi-dose Vials

What types of vials are considered to be “multi-


dose”?
• A multi-dose vial is a bottle of liquid medication
(injectable) that contains more than one dose of
medication and is approved by the Food and Drug
Administration (FDA) for use on multiple persons
Multi-dose vials contain a preservative but the
preservative does not necessarily protect from
contamination

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Inappropriate Handling of
Multi-dose Medications

Inappropriate handling includes keeping


medication in the immediate patient
treatment area, as the medication is then in
the presence of contaminated supplies or
patient equipment

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Appropriate Handling of
Multi-dose Medications
Multi-dose medication should be:
• Dedicated to single patient, whenever possible
• Entered only with sterile needle and sterile syringe
• Rubber septum should be disinfected with alcohol prior to
each entry
• Dated upon initial entry and discarded within 28 days of
opening or according to manufacturer’s instructions
• Discarded if sterility is compromised
Multi-dose medications should not be:
• Kept in the immediate patient treatment area

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Expiration Date Versus
Beyond-use Date
Manufacturer’s expiration date: the date after
which an unopened multi-dose vial should not be
used

Beyond-use date: The date after which an opened


multi-dose vial should not be used
The beyond-use date should never exceed the
manufacturer’s original expiration date

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Spiking/Priming IV Bags
“In Advance”
United States Pharmacopeial Convention (USP):
1 hour time limit from preparation (spiking bag)
until beginning administration if not prepared in
an ISO 5 environment
• Precludes microbial growth in the event of
contamination
• Organisms replication can occur within 1-4 hours

Longer timeframes if primed by pharmacy in ISO 5


environment

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Medication Labeling

• Draw up medication just prior to the procedure;


do not draw up for multiple patients
• Pre-drawn medications must be labeled with time
of the draw, initials of the person drawing up the
medication, name of the medication, strength of
the medication and the expiration date if the
manufacturer has not printed it on the vial
• Medication syringes should not be carried in
personal clothing or pockets

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Re-education is KEY
• Individuals want to do the right thing, which might include
not wasting medications that are expensive or in short
supply
• Individual training may be inadequate or incorrect
• There may be a lack of understanding of how bloodborne
pathogens are transmitted
• Culture at the work place may not support individuals
speaking up when they see non-compliance
• Cost and supply can be barriers to changing to single-dose
medication distribution systems

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CDC Injection Safety Campaign

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Oregon Survey Findings

• Outdated medications and expired supplies


• Multi-dose vials were not always dated or
dated correctly
• Pre-drawn medications were not dated and
labeled correctly according to standards
• Multi-dose vials not always disinfected
between patients

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Important

Medication vials labeled for single-use


cannot:
• Be used during a second case
• Be returned to a medication cabinet
• Have remaining medication withdrawn and
pooled with the partial contents of other
vials

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Tip: A Special Note on Code Carts

Follow your own policy!


Expired medications and supplies have been
found on code carts MONTHS after their
expiration dates despite ongoing, regular code
cart log checks and signatures

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Toolkit Contents

• Use, Handling, and Storage of Medication, Eye


Drops, and Solutions Policy (5.01)
• Web links to:
• CDC’s Unsafe Injections webpage - includes resources
for training all HCWs, including CMEs for MDs
• One and Only Campaign - includes downloadable
posters and information brochures for patients,
medical staff, and employees

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Infections Associated with Unsafe
Diabetes Care Practices

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Hepatitis B Virus Outbreaks

• The CDC reports that there have been 15


HBV outbreaks in the last 10 years
associated with unsafe blood glucose
monitoring
• Health fair in New Mexico (2010) reused
fingerstick lancets potentially exposing
2,000+ individuals

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Device-associated HBV Transmission
Among Persons with Diabetes

Challenge: increased point of care


testing and use of over-the-counter
personal care devices

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Lancet and Insulin Syringes

Sharing of multi-lancet fingerstick devices


reported as a cause of HBV infection
outbreak in a nursing home
(Gotz, et al. Eurosurveillance 2008;13:1-4)

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Multi-dose Insulin Pens

Sharing of multi-dose insulin pens reported


• www.newsinferno.com/archives/3066
• www.lcsun-news.com/ci 11670031

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Fingerstick Devices

Recommendations
• Fingerstick devices should never be used
for more than one person
• Autodisabling single-use fingerstick devices
should be used for assisted monitoring of
blood glucose

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Blood Glucose Meters

• Whenever possible, blood glucose meters should


be assigned to an individual and not shared
• If meters must be shared, the device should be
cleaned and disinfected after every use (per
manufacturer’s instructions) to prevent carry-
over of blood and infectious agents
• If the manufacturer does not specify
how the device should be cleaned and
disinfected, then it should not be shared

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Insulin Pens and Vials

• Insulin pens are intended for use by a single


person
• Insulin pens should be labeled with the individual
persons name
• Multi-dose insulin vials should be dedicated to a
single person whenever possible
• Injection equipment (e.g., insulin pens, needles,
syringes) should never be used for more than one
person

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Gloves

• Wear gloves during blood glucose


monitoring and during any other procedure
that involves potential exposure to blood
or body fluids
• Change gloves between patient contacts
and practice hand hygiene

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Storage

• Unused supplies and medications should be


maintained in clean areas separate from
used supplies and equipment (e.g., glucose
meters)
• Do not carry supplies and medications in
pockets

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Additional Focus

• Point of care devices (e.g., glucometer): make


certain it is designed for multiple patient use and
cleaned after every use with an EPA-registered
disinfectant
• Be certain disinfectant does not interfere with
blood sugar readings
• If performing point of care testing (e.g.,
glucometers), you need CLIA certificate; have it
available

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Toolkit Contents

• Point of Care Device Safe Handling and


Disinfection Policy and Procedure (5.02)
• Web links to:
• CDC’s Infection Prevention during Blood Glucose
Monitoring and Insulin Administration – includes
references, educational materials, and additional
information linking to FDA communications on diabetic
blood glucose monitoring and insulin administration
devices

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Conclusions

• Injection safety is a basic expectation in


patient safety
• Safe practices should not be sacrificed in
effort to save time or money
• If you have to justify or qualify your
injection practices, you might be doing
something wrong

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