Back to Basics: Ensuring Safe Injection Practices

Joseph Perz, DrPHPrevention Team Leader

Division of Healthcare Quality PromotionCenters for Disease Control and Prevention

Gina Pugliese, RN MSVice President

Safety Institute, Premier healthcare alliance

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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

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Outbreaks of HBV-HCV still happening in 2010

May 13, 2010

May 28,2010

March 20, 2010

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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)

HBV- HCV InfectionsBackground

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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)** Blood, acute infection

108-9 106

Environmental stability

>week days

Infectivity (needlestick) 30% ~3%

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.

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Era of decreasing acute HBV/HCV incidence

CDC. Surveillance for Acute Viral Hepatitis – United States, 2007. MMWR 2009;58 (No. SS-3).

•HIV prevention•Hepatitis B vaccine•Screening of blood donors •Healthcare worker safety

Decline in healthcare transmission

HCV

HBV

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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

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TRANSMISSION OF BLOODBORNE PATHOGENS VIA UNSAFE INJECTION PRACTICES

SOURCEInfectious person,e.g. chronic, acute

CASESusceptible,

non-immune person

CONTAMINATED INJECTABLE

EQUIPMENT OR PARENTERAL MEDICATION

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Person-to-person transmission of blood borne viruses during blood glucose monitoring

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1. Infected 3. Susceptible

2. Contaminated equipment/supplies

Indirect contact transmission1

1. HICPAC: Preventing transmission of infectious agents in healthcare settings, 2007 www.cdc.gov/hicpac/2007IP/2007isolationPrecautions.html

Newly infected persons now become source of infection for others, the cycle continues

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The Infection Control Ideal:“Each Patient an Island…”

SOURCEInfectious person,e.g. chronic, acute

CASESusceptible,

non-immune person

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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

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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

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Healthcare-associated HBV/HCV outbreaks by year reported – US July 1998 to June 2009

0

1

2

3

4

5

6

7

8

9

10•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

No. of outbreaks

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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

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Indirect transmission of HBV during blood glucose monitoring

Transmission viacontaminated

surfaces/equipment

Stable in environmentfor at least 7 days1

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.

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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

What factors are contributing to an increase in outbreaks in the

ambulatory care setting (ACS)?

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Trends in Ambulatory Care Visits, United States, 1996-2006

1 http://www.cdc.gov/nchs/data/nhsr/nhsr008.pdf

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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

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Viral Hepatitis Outbreaks (n=15) in Outpatient Settings due to Unsafe Injection Practices, 2001-

2009State 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

Nearly half of these outbreaks were caused by unsafe

injection practices related to anesthesia/sedation

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• 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)

• GA – primary care clinic – 5 cases – S. aureus (MSSA)– Joint injections; all patients hospitalized ≥1 week

Examples of Bacterial Outbreaks due to Unsafe Injection Practices, 2008-2009

Common elements: reuse of single dose contrast dye and other unsafe injection practices / infection control deficiencies

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• 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

Patient Notifications for Bloodborne Pathogen Testing Due to Unsafe Injection Practices, Outpatient Settings, 2007–2009

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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

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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

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• 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

Provider-to-Patient Transmission of Hepatitis C Virus Associated with

Diversion of Fentanyl, Colorado 2009

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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

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Indirect Syringe ReuseNevada 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

Example of outbreak attributed to reuse of single dose vials

34NEJM 1995 333:147-154

• 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.”

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• 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

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Photo: Don Weiss, NYCDOMH

Single dose

Single dose bottle

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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%

Examples of outbreaks attributed to sharing blood contaminated glucose

monitoring equipment

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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;30:209-14Thompson et al. JAGS 2010; 58:914–918, 2010.

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An emerging problem: the new generation of devices

1: Gotz et al. Eurosurveillance 2008;13:1-42: www.newsinferno.com/archives/3066 3. www.lcsun-news.com/ci_11670031

Sharing of multi-lancet fingerstick devices reported as cause of HBV infection outbreak in Nursing Home1

Multidose Insulin Pens

Sharing of multidose insulin pens reported2,3

Multi-lancet fingerstick device

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What are we doing to ensure safe injection practices?

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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

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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

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Infection control survey tool for ambulatory surgical centers

http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter09_37.pdf

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• Labeling and sizing that are appropriate for the clinical setting and application

• Injection versus infusion / IV drip

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• 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”

Challenges

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THEN

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NOW

Unsafe injection practices are not intentional but result from lack of knowledge, misperceptions, and

mistaken beliefs

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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

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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

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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

How are we doing?

Premier Safety InstituteNational Survey

of Injection Practices

CDC

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Safe Injection Practices SurveyPremier Safety Institute

Electronic survey: Link to on-line survey sent in email and included in

newsletters directed at clinicians in acute and non-acute 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

Resources – Guidelines for Education and Training

CDC

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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

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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

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CDC Materialswww.cdc.gov/ncidod/dhqp/injectionsafety.html

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SPIRIT Audit Tool for Injection PracticesU 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

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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

Thank youJperz@cdc.gov

gina_pugliese@premierinc.com

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