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 March 20, 2010 May 28,2010 May 13, 2010

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 Infections Background

Features of HBV, HCV and HIV relevant to healthcare transmission Draft 4/21/2017 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. 7

Era of decreasing acute HBV/HCV incidence HIV prevention Hepatitis B vaccine Screening of blood donors Healthcare worker safety Decline in healthcare transmission HBV Est. new cases 43,000 17,000 HCV CDC. Surveillance for Acute Viral Hepatitis – United States, 2007. MMWR 2009;58 (No. SS-3).

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

TRANSMISSION OF BLOODBORNE PATHOGENS VIA UNSAFE INJECTION PRACTICES CONTAMINATED INJECTABLE EQUIPMENT OR PARENTERAL MEDICATION SOURCE Infectious person, e.g. chronic, acute CASE Susceptible, non-immune person POP QUIZ – are the infected persons usually yellow? People with hepatitis can be but not usually. Most people with hepatitis and HIV for that matter look exaclty like the rest of us and many don’t even know they are infected

2. Contaminated equipment/supplies Indirect contact transmission1 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 Indirect contact transmission1 1. Infected 3. Susceptible 11 1. HICPAC: Preventing transmission of infectious agents in healthcare settings, 2007 www.cdc.gov/hicpac/2007IP/2007isolationPrecautions.html

The Infection Control Ideal: “Each Patient an Island…” SOURCE Infectious person, e.g. chronic, acute CASE Susceptible, non-immune person POP QUIZ – are the infected persons usually yellow? People with hepatitis can be but not usually. Most people with hepatitis and HIV for that matter look exaclty like the rest of us and many don’t even know they are infected

Standard Precautions Safe Injection Practices 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 If you would do something diferently if you knew person was infected with hepatitis or HIV, you aren’t doing it right… 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

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

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

52% of outbreaks in past 5 years Outbreaks (n=23) of HBV infection associated with blood glucose monitoring practices in US healthcare settings,1990-2009 Hospital Nursing Home Assisted Living Facility 52% of outbreaks in past 5 years Number of outbreaks identified Thompson, Perz. JDST, 2009; and unpublished data 17

52% of outbreaks in past 5 years 23 of the outbreaks of HBV infection were associated with blood glucose monitoring practices Hospital Nursing Home Assisted Living Facility 52% of outbreaks in past 5 years Number of outbreaks identified Thompson, Perz. JDST, 2009; and unpublished data 18

Indirect transmission of HBV during blood glucose monitoring Draft 4/21/2017 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

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

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

Viral Hepatitis Outbreaks (n=15) in Outpatient Settings due to Unsafe Injection Practices, 2001-2009 State Setting Year Type NY Private MD office 2001 HCV HBV NE Oncology clinic 2002 OK Pain remediation clinic HBV+HCV Endoscopy clinic CA 2003 MD Nuclear imaging 2004 FL Chelation therapy 2005 Alternative medicine clinic Endoscopy/surgery clinics 2006 Anesthesiologist/pain clinic 2007 NV 2008 NC Cardiology clinic NJ 2009 Nearly half of these outbreaks were caused by unsafe injection practices related to anesthesia/sedation MM

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) GA – primary care clinic – 5 cases – S. aureus (MSSA) Joint injections; all patients hospitalized ≥1 week  Common elements: reuse of single dose contrast dye and other unsafe injection practices / infection control deficiencies

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

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

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

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

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

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

Example of outbreak attributed to reuse of single dose vials

Six different bacterial pathogens 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

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 2005, 7 cases Clin J Pain 2008;24:374–380

Photo: Don Weiss, NYCDOMH Single dose Single dose bottle Photo: Don Weiss, NYCDOMH

Interruptions occurred in 53% of administrations 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

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

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 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?

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

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

Infection control survey tool for ambulatory surgical centers http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter09_37.pdf

Labeling and sizing that are appropriate for the clinical setting and application Injection versus infusion / IV drip

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

NOW Tehter and netting 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

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

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 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 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

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

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

CDC Materials www.cdc.gov/ncidod/dhqp/injectionsafety.html

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

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 you Jperz@cdc.gov gina_pugliese@premierinc.com