AOHP ONLINE EDUCATION PROGRAM

2013WEB005 - INJECTION SAFETY

FOR PATIENTS AND HEALTHCARE FOR PATIENTS AND HEALTHCARE

WORKERS

NICOLE NOMIDES, MT(ASCP), MS, CIC

UNIVERSITY OF MICHIGAN

INFECTION CONTROL & EPIDEMIOLOGY

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OVERVIEW OF PRESENTATION

• Incidents and outbreaks of infections during routine healthcare

procedures involving intravenous injections

• Survey identified unsafe injection practices among a small

percentage of US clinicians

• Prevention strategies include oversight and enforcement of safe

practices AND education and empowerment of both patients practices AND education and empowerment of both patients

and healthcare providers

• US national initiative to educate providers and public: Safe

Injection Practices Coalition (SIPC) and its One and Only

Campaign

WHAT IS INJECTION SAFETY?

Injections include:

• Intradermal, subcutaneous and intramuscular needle injections

• Intravenous (IV) infusions and injections

• Dental injections

• Phlebotomy and lancet (surgical) procedures

According to World Health Organization, a safe injection is one that:According to World Health Organization, a safe injection is one that:

• Does not harm the recipient

• Does not expose the provider to any avoidable risk

• Does not result in any waste that is dangerous for other people

Part of Standard Precautions

Infection prevention practices that apply to all patients, regardless

of suspected or confirmed infection status, in any healthcare setting

WORLD HEALTH ORGANIZATION AND SAFE INJECTION

GLOBAL NETWORK ISSUE TOOLKIT FOR SAFE

INJECTION PRACTICES, 2010

Includes prevention of

harm to both

Patients Patients

AND

Healthcare Workers

OUTBREAKS IN THE US

Medical assistant administered flu vaccine from the same syringe to more than1 patient

ERA OF DECREASING ACUTE

HBV/HCV INCIDENCE

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

Decline in healthcare transmission

HBV

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

Est. new cases

43,000

17,000

HCV

SEEING INCREASE IN VIRAL HEPATITIS

OUTBREAKS ASSOCIATED WITH

HEALTHCARE PROCEDURES

Once considered uncommon in US

• Not identified via acute HBV/HCV surveillance data

Over past decade, increase in the number, size of

outbreak investigations, number of persons affectedoutbreak investigations, number of persons affected

Increase in attention

• Public, media, public health officials, healthcare providers/professional organizations

OUTBREAKS DUE TO UNSAFE INJECTION PRACTICES

Steady increase in detected outbreaks from unsafe injection practices,

Over 20 outbreaks involving bacterial pathogens, typically resulting in bloodstream infections and requiring prolonged hospitalization and IV antibiotics

Over 80 outbreaks of hepatitis B or C have occurred in healthcare settings

• Majority in non-hospital settings: long-term care, outpatient, hemodialysis, MD office, pain clinic, endoscopy clinic• Majority from unsafe injection practices or breakdown in infection control - aseptic practices• Requiring notification of thousands of patients

HEALTHCARE-ASSOCIATED HBV/HCV OUTBREAKS

BY YEAR REPORTED – US 1998 TO 2012

4

6

8

10

12

Nu

mb

er

of

Ou

tbre

aks

72 total outbreaks (61 non-hospital):• 28 long-term care• 21 outpatient clinics• 12 hemodialysis facilities• 11 hospitals

0

2Nu

mb

er

of

Ou

tbre

aks

http://www.cdc.gov/hepatitis/outbreaks/healthcarehepoutbreaktable.htm

Hepatitis Outbreaks in Outpatient Clinic Settings due to Unsafe Injection Practices

1998-2008

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 Alternative medicine clinic 2005 HBV

CA Alternative medicine clinic 2005 HCV

NY Endoscopy/surgery clinics 2006 HCV

NY Pain remediation clinic 2007 HCV

NV Endoscopy clinic 2008 HCV

NC Cardiology clinic 2008 HCV

Thompson, Annals Int Med, 2009

US SURGICAL PROCEDURES MOVING FROM

INPATIENT TO OUTPATIENT SETTING

30

35

40

45Outpatient

Pro

ced

ure

s (

mil

lio

ns)

0

5

10

15

20

25

30

Inpatient

Pro

ced

ure

s (

mil

lio

ns)

UNSAFE INJECTION PRACTICES

ASSOCIATED WITH A VARIETY OF

PROCEDURES IN U.S.

• Anesthesia for outpatient surgical, diagnostic and pain management procedures

• Administration of other IV medications including chemotherapy, cosmetic procedures and alternative medicine (e.g., chelation therapy, alternative medicine (e.g., chelation therapy, vitamins/steroids)

• Flushing IV lines or catheters

• Vaccination

• Administration of contrast media

OUTBREAKS DO NOT TELL THE FULL

STORY

Identified outbreaks

Asymptomatic

infection

Difficulty

identifying

single

healthcare

exposure

Under-

reporting of

cases

Under-

recognition of

healthcare as

risk

Sporadic

transmission

exposure

Barriers to

investigation

(e.g., resource

constraints)

DIRECT SYRINGE REUSE

OKLAHOMA HOSPITAL-BASED PAIN

CLINIC, 2002

102 cases (71 with HCV and 31 with HBV)

• Filled syringes of midazolam, fentanyl, and propofol with enough medication to treat up to 25 patientsmedication to treat up to 25 patients

• Reused these syringes to inject into heparin lock attached directly to an IV

• Contract anesthesia staff (1day/wk)

• $25 million settlement

Comstock et al. ICHE 2004;25:576-583; CDC MMWR 2003 (52):38

“Did, did you just double dip that

chip?” Timmy asks incredulously, “That’s like putting your whole

mouth right in the dip!”

Slide courtesy of Dr. Joseph Perz, CDC

“INDIRECT” SYRINGE REUSE OR

DOUBLE DIPPING

Accessing vials with a used syringe and reuse of the

vial or container for additional patients

• Single dose medications commonly involved•Single dose medications commonly involved

•Accounts for the majority of viral hepatitis outbreaks due to unsafe injections

INDIRECT TRANSMISSION OF HBV

Transmission via

contaminated

Stable in environment

for at least 7 days1

contaminated

surfaces/equipment

High viral titer: virus

present in absence

of visible blood2

1: Bond et al. Lancet 1981; 8219:550-12: Shikata et al. J Infect Dis 1977;136:571–76

INDIRECT SYRINGE REUSE

NEBRASKA – ONCOLOGY CLINIC, 2002

99 cases of HCV

Nurse drew blood from IV catheter, then

reused same syringe to obtain saline from

IV bag and perform a flush IV bag and perform a flush

• New syringe was used for each patient

• Solution from 500cc bag used for multiple patients

• No active infection control program

Macedo de Oliveira et al., Annals of Internal Medicine, 2005, 142:898-902

INDIRECT SYRINGE REUSE AND VIAL

CONTAMINATION

LAS VEGAS NEVADA ENDOSCOPY CLINIC

115 cases of HCV

Clinics performed 50-60 procedures/day

• Anesthesia induction with syringe of lidocaine (1cc) and propofol (9ccs)-Clean lidocaine (1cc) and propofol (9ccs)-Clean needle/ syringe to inject into IV catheter

• If patient needed more anesthesia, some providers changed needle but used same syringe to draw more propofol

• Contaminated propofol vial used to sedate next patient

MMWR; May 16, 2008; 57:19

NEVADA OUTBREAK – EPILOGUE

License revoked and clinic was closed

Unsafe practices had been commonly used by some staff at the

clinic for at least 4 years

• Health department notified 63,000 persons to recommend HBV, HCV, HIV screeningHCV, HIV screening

Prompted assessments of infection control practices at all licensed

ambulatory surgical centers

INSULIN PEN REUSE INCIDENTS

Incidents in which insulin pens were reused for multiple

patients, reportedly after changing needles

NY hospital, 2008

TX hospital, 2009

cdc.gov/injectionsafety

Jan 2012www.cdc.gov/injectionsafety

HBV TRANSMISSION ASSOCIATED WITH

GLUCOSE MONITORING DEVICES

• Higher risk of transmission of hepatitis associated with “on-meter” test strip (patient’s finger touches test strip on the machine)

• Survey found 30% of glucometers • Survey found 30% of glucometers had blood contamination

• Most facilities do not clean after each use as recommended

• Failure to clean and disinfect unit between patients may also lead to glove contamination

SYRINGE REUSE AND LAX INFECTION

CONTROL

CALIFORNIA PAIN CLINIC, 2010

2 confirmed cases HBV and HCV; (19 potential cases)

2,300 patients notified

Re-entry of multidose vials with contaminated syringe

to get additional doses for same patient and then to get additional doses for same patient and then

returned vial to the cart for reuse.

• Reuse of single dose vials of contrast (Omnipaque) for multiple patients

Lax infection control

• No masks during neuraxial procedures

LA County California Health Department Report, June 2011

HEPATITIS B OUTBREAK NEW YORK CITY,

38 CASES HBV FROM LAX INFECTION CONTROL PRACTICES

• Most injections given by medical technicians

• All multi-dose vials used

• Contaminated syringes left on same table where meds prepared

• Likely contamination of tops of vials during syringe disassembly

Infect Control Hosp Epidemiol 2005; 26: 745-60

CONTAMINATED MEDICATION

PREPARATION AREA

NEW YORK DOCTOR’S OFFICE

• 38 cases of HBV

• Most injections given by medical technicians

• All multi-dose vials used

• Contaminated syringes left on same table where medications prepared

• Likely contamination of tops of vials during syringe disassembly

Samardurai T. Infect Control Hosp Epidemiol 2005; 26: 745-60

Storage of multi-dose vials and

preparation of injections in same

area that used needles and syringes

were dismantled and discarded

FACT: injection preparation on surfaces where contaminated

substances are handled can lead to the spread of infections

Ref: Samandari et al. ICHE 2005; 26: 745-750

Photo: Don Weiss / NYCDOHMH

AND….

NOT JUST VIRAL BLOODBORNE

PATHOGENS!

REUSE OF SINGLE DOSE VIALS OF CONTRAST AGENTS

BACTERIAL INFECTIONS- OUTBREAKS

’05 MA: 7 cases S marcescens

‘08 FL: 7 cases – Mycobacterium abscessus *

‘08 FL: 24 cases – invasive S. aureus *

‘08 NYC: 9 cases – K pneumoniae & Enterobacter

‘09 WV: 8 cases – invasive S. aureus

‘09 CA: 7 cases – invasive S. aureus

*Patients required laminectomy

UNSAFE INJECTION PRACTICES ARE COSTLY TO

PATIENTS,

PROVIDERS, AND HEALTH DEPARTMENTS

Unsafe injection practices have resulted in:

• Transmission of life-threatening infections, including hepatitis C virus, to patients

• Notification of thousands of patients of possible exposure to bloodborne pathogens and recommendation that they undergo testing

• Referral of providers to licensing boards for disciplinary action • Referral of providers to licensing boards for disciplinary action

• Malpractice suits filed by patients

WHAT CAN WE DO

ABOUT IT?

SURVEY OF INJECTION PRACTICES

AMONG CLINICIANS IN US HEALTHCARE

SETTINGS, 2011

5,500 respondents

Practice setting:

• Hospital setting 66%• Non-hospital setting 34%

Department or area:

• General pt care 25%• Surgery-anesthesia 18%• Critical care 16%• Endoscopy 6%• Emergency care 7%• Oncology 3%• Pain management 2%• Radiology/Radiation 2%

Pugliese G, Gosnell C, Bartley JM, Robinson S. Am J Infect Control Dec 2010

SURVEY OF INJECTION PRACTICES AMONG

CLINICIANS IN US HEALTHCARE SETTINGS,

2011Professional Training:

Registered Nurses 4,570

Licenses practical nurses 145

Anesthesiology assistants 120

Physicians 120Physicians 120

Anesthetists (CRNA) 49

Patient care technicians 35

Pharmacists 23

Laboratory technologists 13

Respiratory therapy 10

OR technician 10

Dentists 9

SURVEY OF INJECTION PRACTICES AMONG

CLINICIANS IN US HEALTHCARE SETTINGS, 2011

Results:

• 1% “sometimes or always” reuse a

syringe for a second patient

• 1% “sometimes or always” re-enter a

multidose vial with a contaminated

syringe and safe vial for reusesyringe and safe vial for reuse

• 6% use single-dose vial for more than

one patient

• 8% use a bag/bottle of intravenous

solution as a source for medication

diluent/flush for multiple patients

Pugliese G, Gosnell C, Bartley JM, Robinson S. Am J Infect Control Dec 2010

MISTAKEN BELIEFS ABOUT PRACTICES

TO PREVENT CONTAMINATION AND

INFECTION TRANSMISSION

• Changing the needle

between patients (not the

syringe)

• Injecting through IV tubing• Injecting through IV tubing

• Maintaining pressure on the

plunger to prevent backflow

• Lack of visible blood

• Large single-dose vials are

ok for more than one

patient

VIAL SIZE AND LABELING ADDS

CONFUSION

xxxx

Single doseSingle dose bottle

Photo: Don Weiss, NYCDOMH

WHAT LIES IN DRAWERS?

Pre-drawn up syringes –

preparing for next case (Pharmacy costs and supply issues lead to this)

CREATIVITYCREATIVITYCREATIVITYCREATIVITY

“HOW DO YOU KNOW ?”

Pre-dated M > 24 hrs. ?

Empty syringes M Used ?

• Cost containment and the drive for

efficiency

• Increase care in outpatient care settings

where infection control programs

lacking and less oversight

CHALLENGES

• Old ingrained behaviors – “force of

habit” not based on current knowledge

• Lack of safety culture and

empowerment to “speak up”

• Myths about sterile technique and

contamination risks

DRUG SHORTAGES PROMPT PHYSICIANS TO PUSH

FOR RE-USE OF SINGLE-DOSE VIALS

OVERSIGHT, ENFORCEMENT,

EDUCATION

US government and its agencies and accreditation organizations are strengthening regulations, standards, guidelines and inspections across all healthcare settings

• Particular focus on infection control including injection safety in ambulatory , outpatient and oncology careambulatory , outpatient and oncology care

• Worksheets and checklists to assess practices

LAPSES IN INFECTION CONTROL

COMMON IN SURVEY OF AMBULATORY

SURGICAL CENTERS

67% (46 of 68 ASCs) had at least one lapse in infection control

17% had 3 or more lapses

Most common lapses -Most common lapses -

• Using single-dose medication vials for more than 1 patient

• Improper reprocessing of equipment

• Mishandling of blood glucose monitoring equipment

Schaeffer MK, Infection control assessment of ambulatory surgical centers JAMA.

2010;303(22):2273-70

INFECTION CONTROL WORKSHEET

COMPONENTS

FOR AMBULATORY SURGICAL CENTERS

� Elements from CDC/HICPAC Guidelines

� Emphasis on Standard Precautions

� Injection safety and medication handling

� Hand hygiene and glove use

� Instrument reprocessing

� High-level disinfection (e.g., endoscope reprocessing)

� Sterilization

� Environmental cleaning

� Point-of-care devices (e.g., blood glucose meters)

www.premierinc.com/injectionpractices

INFECTION CONTROL WORKSHEET FOR LICENSED FACILITIES

(DOWNLOAD AT PREMIERINC.COM/INJECTIONPRACTICES)

http://www.cms.gov/manuals/downloads/som107_exhibit_351.pdf

SURVEY TOOL ADAPTED FROM APIC SAFE

INJECTIONS PRACTICES POSITION PAPER

SAFE INJECTION PRACTICES

EVIDENCE-BASED GUIDELINES

EDUCATIONAL RESOURCES AND EDUCATIONAL RESOURCES AND

TOOLS

www.cdc.gov/injectionsafety

Frequently asked

Questions:

• Medication preparation• Single-dose-single-use vials• Multi-dose vials

www.cdc.gov/injectionsafety

www.cdc.gov/HAI/settings/outpatient/outpatient-settings.html

CDC RELEASED GUIDE AND CHECKLIST

FOR OUTPATIENT SETTINGS, JULY 2011

CDC’S NEW PROGRAM, PREVENTING

INFECTIONS IN CANCER PATIENTS, NOV 2011WWW.CDC.GOV/CANCER/PREVENTINFECTIONS/

Includes:

Basic Infection Control Plan

Interactive website for patients, caregivers, healthcare providers

SAFE INJECTION PRACTICES

COALITION (SIPC)

SIPC• Established in 2008• Established in 2008• Led by CDC• Partnership of healthcare organizations

• Launched “One and Only Campaign”

www.oneandonlycampaign.org

Injection Safety is Every Provider’s responsibility

Safe Injection Practices Coalitionwww.oneandonlycampaign.org

The One & Only Campaign – a public health education and

awareness campaign – aimed at both healthcare providers and

patients to advance and promote safe injection practices

Safe Injection Practices Coalitionwww.oneandonlycampaign.org

The One & Only Campaign

•Tools

•Posters, brochures

•Educational materials

•Videos and Smart phone app

for training

•Research findings

SIPC PROVIDER TRAINING VIDEO

Three settings where

medications are prepared

and administered: an

operating room, an

oncology clinic, and a pain

management clinicmanagement clinic

Outlines and corrects

myths and misperceptions

that healthcare providers

may have about safe

injection practices www.premierinc.com/safetystore

DOWNLOAD BROCHURES, POCKET GUIDES,

POSTERS, SLIDES AT

www.cdc.gov/injectionsafety

CDC MEDSCAPE COMMENTARY

Discusses myths and misperceptions

about safe injection practices:

• Removing needle makes syringe safe

to reuse (Not true)

• IV tubing or valves guarantee

against contamination (Not true)against contamination (Not true)

• Lack of visible blood = lack of

contamination (Not true)

• Large single dose vials can be used

for >1 patient (Not true)

www.medscape.com/viewarticle/735593

PREMIER AND SIPC MEETING, 2011

Providers, manufacturers,

inventors, unions, professional

organizations, government met to

raise awareness and continue

dialogue on safer and innovative dialogue on safer and innovative

approaches and designsM

Download proceedings at:

www.premierinc.com/injectionpractices

Adherence to Safe Injection Practices and Basic Infection Control Needs to Extend Across the Entire Healthcare Continuum

Tranquil GardensNursing Home

HomeCare

Acute CareFacility

Outpatient/AmbulatoryFacility

Long Term CareFacility

WHAT’S NEXT???WHAT’S NEXT???

HEPATITIS C OUTBREAK, COLORADO HOSPITAL 2009

“INJECTION SAFETY MEETS NARCOTICS SECURITY…”

2009 Colorado Hospital

• 24 patients with HCV infection

• HCV-infected surgery technician stole unattended fentanyl syringes, stole unattended fentanyl syringes, injected self, and refilled contaminated syringe with saline

• 6,000 patients were notified

• Technician convicted and serving 30 year prison term

DIVERTER CASES RESULTING IN HCV

TRANSMISSION

In Colorado, a surgical tech accessed narcotic vials in the OR from the Anesthesia carts; infected 37 patients with her HCV

K.Parker; serving 30 yr. prison term

In Florida an IR tech infected 5 patients with their HCV

IR tech responsible for at least 35 cases of HCV in 9 states; exposed 1000’s of patients

CURBING DRUG DIVERSION

•TIGHT INSTITUTIONAL POLICIES AROUND

DRUG-FREE WORKPLACE

•DRUG TESTING ?

•PATIENT SAFETY FOLLOW UP WHEN DIVERTOR

IDENTIFIED ?

•LICENSING AND CERTIFICATION •LICENSING AND CERTIFICATION

•FLAGGING OFFENDERS

•STATE AND FEDERAL LEGISLATION?

http://www.naddi.org

SOMEDAY IS NOT A DAY OF THE WEEK

• Bloodborne pathogens- HAI surveillance ?

• Routine safe injection practice surveys of clinical areas

• Routine reporting by providers and • Routine reporting by providers and non-punitive response

• Audits and provider-level timely feedback

• Routine disclosure and testing of potentially exposed patients

• Testing IV diverters for BBP

ACKNOWLEDGEMENTS

Joseph Perz , CDC, Division of Healthcare Quality Promotion

Melissa Schaefer, CDC, Division of Healthcare Quality Promotion

Nicola Thompson, CDC, Division of Healthcare Quality Promotion

Alice Guh, CDC, Division of Healthcare Quality Promotion

Karen Weiss, FDAKaren Weiss, FDA

Gina Pugliesi, Premier Safety Institute

Cathie Gosnell, Premier Safety Institute

Scott Robinson, Premier Research Services

Lisa Sturm, University of Michigan Hospitals and Health Centers

THANK YOU!