Back to Basics: Ensuring Safe
Injection Practices
Joseph Perz, DrPH
Prevention Team Leader
Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention
Gina Pugliese, RN MS
Vice President
Safety Institute, Premier healthcare alliance
No disclosures or conflicts of interest
The findings and conclusions in this presentation are those of
the presenters and do not necessarily represent the official
position of the Centers for Disease Control and Prevention
3
Outbreaks of HBV-HCV still
happening in 2010
4
Injection Safety
• Measures taken to perform injections in a safe
manner for patients and providers
• Part of Standard Precautions
– Infection prevention practices that apply to all
patients, regardless of suspected or confirmed
infection status, in any healthcare setting
• Healthcare should not provide any opportunity
for transmission of bloodborne viruses
– Patient protections in the context of IV injections
should be on par with transfusion safety and
healthcare worker safety (OSHA BBP Standard)
5
HBV- HCV Infections
Background
Features of HBV, HCV and HIV
relevant to healthcare transmission
Characteristic
HBV
HCV
# with chronic
infection (U.S.)
1.25
million
3.8
million
Titer (per ml)*
108-9
106
>week
days
30%
~3%
* Blood, acute infection
Environmental
stability
Infectivity (needlestick)
Beltrami et al, Clin Microbio Reviews, 2000. MMWR 2001;50(No. RR-11).
Bond et al. Lancet 1981; 8219:550-1. Shikata et al.. J Infect Dis 1977;136:571–76.
7
7
Reported acute cases per 100,000
Era of decreasing acute HBV/HCV incidence
7
6
•HIV prevention
•Hepatitis B vaccine
•Screening of blood donors
•Healthcare worker safety
Decline in healthcare
transmission
5
4
HBV
Est. new
cases
3
2
HCV
43,000
1
0
1992
17,000
1997
2002
CDC. Surveillance for Acute Viral Hepatitis – United States, 2007. MMWR 2009;58 (No. SS-3).
2007
8
However, increase in viral hepatitis outbreaks
associated with healthcare procedures
•
Considered uncommon, isolated events in US
–
Not identified via acute HBV/HCV surveillance data
•
Increase in the number, size of outbreak investigations,
number of persons affected
•
Increase in attention
–
Public, media, public health officials, healthcare
providers/professional organizations
9
TRANSMISSION OF BLOODBORNE PATHOGENS VIA
UNSAFE INJECTION PRACTICES
SOURCE
Infectious person,
e.g. chronic, acute
CONTAMINATED
INJECTABLE
EQUIPMENT OR
PARENTERAL
MEDICATION
CASE
Susceptible,
non-immune person
10
Person-to-person transmission of blood borne
viruses during blood glucose monitoring
Newly infected persons now become source of
infection for others, the cycle continues
2. Contaminated
equipment/supplies
1. Infected
Indirect contact
transmission1
3. Susceptible
11
1. HICPAC: Preventing transmission of infectious agents in healthcare settings, 2007
www.cdc.gov/hicpac/2007IP/2007isolationPrecautions.html
11
The Infection Control Ideal:
“Each Patient an Island…”
SOURCE
Infectious person,
e.g. chronic, acute
CASE
Susceptible,
non-immune person
12
Standard Precautions
• Assume that anyone might be infected with a
bloodborne pathogen
• Basic infection control principles that apply every
where and every time healthcare is delivered
• Safe Injection Practices
– Never administer medications from the same
syringe to more than one patient
– Do not enter a vial with a used syringe or needle
– Minimize the use of shared medications
– Maintain aseptic technique at all times
13
Outbreaks due to Unsafe Injection
Practices – Summary of US Experience
over the Past Decade
• Steady increase in requests for assistance in investigating
infections and outbreaks potentially stemming from unsafe
injection practices
• Over 51 outbreaks of hepatitis B or C have occurred in
healthcare settings
– Approximately one-fourth investigated in the last 24 mos
– Majority attributable to unsafe injection practices or
related breakdowns in safe care
• Approximately 20 outbreaks involving bacterial pathogens
(e.g., drug resistant gram negative and invasive staph
infections), typically resulting in bloodstream infections
– Prolonged hospitalization and intravenous antibiotics
14
Healthcare-associated HBV/HCV outbreaks by
year reported – US July 1998 to June 2009
10
9
8
7
No. of
outbreaks 6
•51 outbreaks (42 non-hospital)
-17 long-term care
-16 outpatient med/surg clinics
-9 hemodialysis
-9 hospital
•>75,000 persons potentially exposed
•620 persons newly infected
5
4
3
2
1
0
09
20
08
20
07
20
06
20
05
20
04
20
03
20
02
20
01
20
00
20
99
19
98
19
15
Features of transmission of
HBV-HCV Outbreaks
July 1998 to June 2009
• In non hospital settings (42 of 51, 82%)
• Patient-to-patient transmission due to poor
infection control practices by staff
(47/51, 92%)
– During administration of injections
– Cross contamination during hemodialysis,
blood glucose monitoring
• Preventable with standard precautions and
aseptic technique
16
Indirect transmission of HBV during
blood glucose monitoring
Stable in environment
for at least 7 days1
Transmission via
contaminated
surfaces/equipment
High viral titer: virus
present in absence
of visible blood2
1: Bond et al. Lancet 1981; 8219:550-1.
2: Shikata et al. J Infect Dis 1977;136:571–76.
19
19
What happens when Safe Injection
Practices (SIP) are not followed?
• Improper use of syringes, needles, and medication vials
has resulted in:
– Infection of patients with bloodborne viruses, including
hepatitis C virus, and other infections
– Notification of thousands of patients of possible
exposure to bloodborne pathogens and
recommendation for HCV, HBV, and HIV testing
– Referral of providers to licensing boards for disciplinary
action
– Legal actions such as malpractice suits filed by patients
20
What factors are contributing to
an increase in outbreaks in the
ambulatory care setting (ACS)?
Trends in Ambulatory Care Visits,
United States, 1996-2006
1 http://www.cdc.gov/nchs/data/nhsr/nhsr008.pdf
22
Growth in Outpatient Care
• Shift in healthcare delivery from acute care settings to
ambulatory care, long term care and free standing
specialty care sites
• Dialysis Centers
– 2008: 4,950 (72% increase since 1996)
• Ambulatory Surgical Centers
– 2009: 5175 (240% increase since 1996)
• Approximately 1.2 billion outpatient visits / year
– Quick turnover of patients
– Lack of systematic surveillance to detect infections
– Regulatory requirements varied widely settings and
little oversight
23
Viral Hepatitis Outbreaks (n=15) in Outpatient Settings
due to Unsafe Injection Practices, 2001-2009
MM
State
Setting
Year
Type
NY
Private MD office
2001
HCV
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
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
2008
HCV
NC
Cardiology clinic
2008
HCV
NJ
Oncology clinic
2009
HBV
FL
Alternative medicine clinic
2009
HCV
24
Examples of Bacterial Outbreaks due to
Unsafe Injection Practices, 2008-2009
• FL – pain clinic – 7 cases – Mycobacterium abscessus
– Epidural injections; all patients required lamenectomy
• FL – pain clinic – 24 cases – invasive S. aureus
– Epidural + other lumbar injections; 10 required lamenectomy
• NYC – pain clinic – 9 cases – Klebsiella pneumoniae
– Sacroiliac joint injections; 4 patients hospitalized
• WV – pain clinic – 8 cases – invasive S. aureus
– Epidural injections; 7 patients hospitalized (range 5-23 days)
 Common elements: reuse of single dose contrast dye and
other unsafe injection practices / infection control deficiencies
• GA – primary care clinic – 5 cases – S. aureus (MSSA)
– Joint injections; all patients hospitalized ≥1 week
25
Patient Notifications for Bloodborne
Pathogen Testing Due to Unsafe Injection
Practices, Outpatient Settings, 2007–2009
• New York City – Endoscopy clinic – Hepatitis C virus
transmission  4,500 patients notified
• Long Island, NY – Pain Management Clinic – Hepatitis C
virus transmission  10,400 patients notified
• Michigan – Dermatologist – Fraud investigation  13,000
patients notified
• Las Vegas, NV – Endoscopy clinic – Hepatitis C virus
transmission  >50,000 patients notified
• North Carolina – Cardiology clinic – Hepatitis C virus
transmission  1,200 patients notified
• New Jersey – Oncology clinic – Hepatitis B virus
transmission  6,000 patients notified
26
27
What are some of the incorrect
practices that have resulted in
transmission of pathogens?
• Direct (i.e., “overt”) syringe reuse
– Using the same syringe from patient to
patient
• Indirect syringe reuse
– Accessing shared medication vials or IV
bags with a used syringe
• Reuse of single dose vials
• Sharing of blood contaminated glucose
monitoring equipment
28
Example of outbreak attributed
to Direct Syringe Reuse
• 2002: Oklahoma pain clinic
– Example of “multidose syringe” technique
• Loaded a syringe with enough medication to treat
multiple patients
• Reused this “prefilled’ syringe to inject into
heparin lock attached directly to an IV
– 71 cases of HCV and 31 cases of HBV
Comstock et al. ICHE 2004;25:576-583
29
Provider-to-Patient Transmission of
Hepatitis C Virus Associated with
Diversion of Fentanyl, Colorado 2009
• HCV-infected surgery technician stole
fentanyl syringes that had been predrawn
and left unattended in ORs
• Contaminated syringes were refilled with
saline and swapped with unused syringes
• 24 patients infected; nearly 6000 notified
• Tech sentenced to 30 years
30
Narcotics Theft a.k.a. “Diversion”
• Diversion has emerged as the leading cause of
provider to patient HCV transmission
• Prevention needs extend beyond traditional
“infection control”
– Limit opportunities for access or deception
• Good example of need for safety- engineered
solutions and system approach
31
Indirect Syringe Reuse
Nevada endoscopy center HCV
outbreak investigation, 2008
• Syringes were reused to withdraw multiple doses for
individual patients
• Remaining volume in single dose propofol vials was
used for subsequent patients
• The vial became the vehicle for HCV spread
32
Example of outbreak attributed to
reuse of single dose vials
• 1991-1993, 7 hospitals experienced outbreaks
traced to mishandling of propofol
• Six different bacterial pathogens
• Wide variety of lapses in aseptic technique
• “...the larger vials look like multidose vials, and our
investigations revealed that the vials are sometimes
being used for an extended period of time, for more
than one patient or procedure, and to refill syringes
meant to be used only once.”
NEJM 1995 333:147-154
34
35
• Pain Clinic – 7 cases – Serratia marcescens
– Spinal injections; all patients hospitalized
• Breaches in aseptic handling of injections
– Reuse of syringes to access/combine multiple
medications likely resulted in extrinsic
contamination of reused single-dose vials of
contrast solution
Clin J Pain 2008;24:374–380
36
Single dose
Single dose bottle
Photo: Don Weiss, NYCDOMH
37
ARCH INTERN MED/VOL 170 (NO. 8), APR 26, 2010
• Overall, 74% of drug administrations had at least 1
procedural failure; 25% had clinical errors
• Interruptions occurred in 53% of administrations
• Error rate and severity increased with the
number of interruptions
• Aseptic technique compliance was 83%
38
Examples of outbreaks attributed to
sharing blood contaminated glucose
monitoring equipment
Practices associated with HBV transmission during
assisted blood glucose monitoring: re-use of blood
contaminated devices, poor infection control
Sharing of
fingerstick devices
Blood contamination
of glucose testing
meters
Failure to change or use gloves, perform
hand hygiene between procedures
Patel et al. ICHE 2009;30:209-14
Thompson et al. JAGS 2010; 58:914–918, 2010.
40
40
An emerging problem: the new
generation of devices
Sharing of multi-lancet fingerstick
devices reported as cause of HBV
infection outbreak in Nursing Home1
Multi-lancet
fingerstick device
Sharing of multidose insulin
pens reported2,3
Multidose Insulin Pens
41
1: Gotz et al. Eurosurveillance 2008;13:1-4
2: www.newsinferno.com/archives/3066 3. www.lcsun-news.com/ci_11670031
41
What are we doing to ensure
safe injection practices?
42
A comprehensive
approach is needed
• Surveillance and investigation capacity
– Recognize and contain transmission
– Inform prevention
• Professional oversight, licensing, and public
awareness
• Healthcare provider education and training
• Improvements in medical devices and
medication packaging
• Patient empowerment
43
Oversight and Enforcement
• Increasing efforts to strengthen regulatory
and accreditation standards across
healthcare settings
– Particular focus on infection control
• Collaboration with the Centers for Medicare
and Medicaid Services
– Expanded incorporation of infection control
requirements into conditions for coverage and
inspection procedures
44
Infection control survey tool for
ambulatory surgical centers
http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter
09_37.pdf
45
• Labeling and
sizing that are
appropriate for
the clinical setting
and application
• Injection versus
infusion / IV drip
46
Challenges
• Cost containment and the drive for efficiency
• Trend toward patient care settings where
infection control programs are lacking
• Ingrained behaviors – “unthinking force of habit”
• “Culture of complacency” vs. “safety culture”
47
THEN
48
NOW
49
Unsafe injection practices are not
intentional but result from lack of
knowledge, misperceptions, and
mistaken beliefs
Misperceptions
• I changed the needle so I can reuse the
syringe
• The vial says single does but it has
enough medication for more than one
patient, so I can use it
51
How have providers justified
syringe reuse?
• Mistaken belief that the following practices
prevent contamination and infection
transmission
– Changing ONLY the needle between patients (not the
syringe)
– Injecting through intervening lengths of IV tubing
– Maintaining constant pressure on the plunger to
prevent backflow
– Lack of visible contamination or blood
52
Examples of some “BIG
IFs”
• IF I’m going to be throwing away this vial
after this case, I can reuse this syringe to
draw more meds
• IF we always use a new needle and syringe
to draw meds, it’s OK to reuse vials
• IF I’m very careful, I can safely predraw
multiple syringes from this saline bag or vial
• IF I keep things straight, I can predraw
meds for the next case during this case
53
How are we doing?
Premier Safety Institute
National Survey
of Injection Practices
CDC
Safe Injection Practices Survey
Premier Safety Institute
Electronic survey:
Link to on-line survey sent in email and included in
newsletters directed at clinicians in acute and nonacute healthcare settings, May-June 2010
Collaborating organizations:
– APIC, AAAA, AACN, AAAHC, ASHP, INS, Innovatix,
PRHI, SHEA, SGNA
Number of respondents: 7,164 (as of June 3)
Survey information and results at
www.premierinc.com/injectionpractices
CDC
55
Resources – Guidelines
for Education and Training
CDC
57
58
Injection Safety Recommendations
• Use aseptic technique during the preparation and
administration of injected medications
• Do not use medication drawn into a single syringe for
multiple patients, even if the needle is changed
• Consider a syringe or needle contaminated after it has
been used to enter or connect to a patients’ intravenous
infusion bag or administration set
• Do not enter a vial with a used syringe or needle
Adapted from: CDC. Guideline for isolation precautions: preventing
transmission of infectious agents in healthcare settings 2007.
http://www.cdc.gov/ncidod/dhqp/gl_isolation.html
59
Minimizing the use of shared
medications affords an extra layer
of protection to reduce patient risk
• Use single-dose medication vials whenever possible
• Single-dose vials should not be used for more than one
patient
• Assign multi-dose vials to single patient whenever possible
• Do not use bags or bottles of intravenous solution as a
common source of supply for more than one patient
Adapted from: CDC. Guideline for isolation precautions:
preventing transmission of infectious agents in healthcare
settings 2007. http://www.cdc.gov/ncidod/dhqp/gl_isolation.html
60
CDC Materials
www.cdc.gov/ncidod/dhqp/injectionsafety.html
61
62
63
64
65
SPIRIT Audit Tool for Injection Practices
U of Michigan Hospitals and Health Centers
Safe Injection Practices Review IT Survey (SPIRIT)
Adapted from: APIC Position Paper: Safe Injection, Infusion and Medication Vial Practices
www.apic.org
66
Acknowledgements
•
•
•
•
•
Melissa Schaefer, CDC, Division of Healthcare Quality Promotion
Nicola Thompson, CDC, Division of Healthcare Quality Promotion
Judene Bartley, Premier Safety Institute
Cathie Gosnell, Premier Safety Institute
Lisa Sturm, U of Michigan Hospitals and Health Centers
67
Thank you
Jperz@cdc.gov
gina_pugliese@premierinc.com
69