2. 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

3. 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

4. Outbreaks of HBV-HCV still happening in 2010
March 20, 2010
May 28,2010
May 13, 2010

5. 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)

6. HBV- HCV Infections Background

7. 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, MMWR 2001;50(No. RR-11).
Bond et al. Lancet 1981; 8219: Shikata et al.. J Infect Dis 1977;136:571–76. 7

8. 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, MMWR 2009;58 (No. SS-3).

9. 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

10. 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

11. 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,

12. 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

13. 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

14. 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

15. 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

16. 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

17. 52% of outbreaks in past 5 years
Outbreaks (n=23) of HBV infection associated with blood glucose monitoring practices in US healthcare settings,
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

18. 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

19. 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

20. 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

21. What factors are contributing to an increase in outbreaks in the ambulatory care setting (ACS)?

22. Trends in Ambulatory Care Visits, United States, 1996-20061

23. 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

24. 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

25. 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

26. 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

28. 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

29. 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:

30. 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

31. 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

32. 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

33. Example of outbreak attributed to reuse of single dose vials

34. Six different bacterial pathogens
, 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 :

36. 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

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

38. 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%

39. Examples of outbreaks attributed to sharing blood contaminated glucose monitoring equipment

40. 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

41. 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: 41

42. What are we doing to ensure safe injection practices?

43. 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

44. 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

45. Infection control survey tool for ambulatory surgical centers

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

47. 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

48. THEN

49. NOW
Tehter and netting 49

50. Unsafe injection practices are not intentional but result from lack of knowledge, misperceptions, and mistaken beliefs

51. 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

52. 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

53. 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

54. How are we doing? Premier Safety Institute National Survey of Injection Practices
CDC

55. Safe Injection Practices Survey Premier Safety Institute
Electronic survey:
Link to on-line survey sent in 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
CDC

56. Resources – Guidelines for Education and Training
CDC

59. 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

60. 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

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

66. 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

67. 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

68. Thank you Jperz@cdc.gov gina_pugliese@premierinc.com