1. Safe Injection Practices and Point of Care Devices
Debbie Hurst RN, BSN
Program Manager, Infection Prevention & Control
Rogue Valley Medical Center

2. Objectives
Discuss outbreaks related to unsafe injection and infusion practices
Discuss outbreaks related to unsafe use of diabetes blood sugar monitoring devices
Identify safe injection practices and safe handling and disinfection of point of care devices

3. Outbreaks Linked to Unsafe Injection Practices
In the last 10 years, 33 infectious disease outbreaks, such as Hepatitis C, have been reported; thousands of patients have been notified that they may have been harmed
Referral of providers to licensing boards for disciplinary action
Legal actions such as malpractice suits filed by patients
Nearly half of the outbreaks were related to anesthesia/sedation

4. Viral Hepatitis Outbreaks in Outpatient Settings Due to Unsafe Injection Practices
State
Setting
Year
Type NY
Private MD office
2001
HCV
HBV NE
Oncology clinic
2002 OK
Pain remediation clinic
HBV+HCV
Endoscopy clinic CA
Pain remediation clinic (ASC)
2003 MD
Nuclear imaging
2004 FL
Chelation therapy
2005
Alternative medicine clinic
Endoscopy/surgery clinics
2006
Anesthesiologist / pain clinic
2007 NV
Endoscopy clinic (ASC)
2008 NC
Cardiology clinic NJ
2009
2010
HCV+HBV
2001 to 2010
n=16

5. Nevada Hepatitis C Outbreak
January 2008: cluster of three acute Hepatitis C virus (HCV) cases identified in Las Vegas
All three patients underwent procedures at the same endoscopy clinic during the incubation period
Clinic performed upper and lower endoscopies
50-60 procedures/day
2 procedure rooms
Reviews of surveillance records, laboratory records and a physician report identified three additional clinic-associated cases; health department later identified over 77 additional HCV cases likely acquired at the clinic
(MMWR: May 16, 2008; 57:19)

6. Review of Anesthesia Delivery
Started induction with syringe filled with lidocaine (1 cc) and propofol (9 ccs)
Clean needle and syringe used to inject directly through intravenous catheter
If patient need more anesthesia, some providers:
Removed needle from syringe and replaced with a new one
Used old syringe w/ new needle to draw more propofol
Medication remaining in the single dose propofol vial was used to sedate the next patient

7. Review of Anesthesia Delivery
Propofol is a single-dose medication
Preservative free
Approved for use on a single patient for a single procedure
Facility purchased cc vials but only used approximately cc per patient

8. Unsafe Injection Practices That Likely Lead to HCV Transmission

9. Bacterial Outbreaks due to Unsafe Injection Practices
Pain clinic: seven cases of Serratia marcescens
Spinal injections; all patients hospitalized
Primary care clinic: five cases of S. aureus
Joint injections; all patients hospitalized

10. Safe Injection Practice Research
Report found that of 5,446 provider respondents:
6% sometimes or always use single-dose/ single-use vials for more than one patient
1% sometimes or always reuse a syringe but change the needle for a second patient
15.1% reuse a syringe to enter a multi-dose vial
6.5% save multi-dose vial for use on another patient (Pugliese G., et al AJIC Dec. 2010)

11. Incorrect Practices That Have Resulted in Transmission of Pathogens
Direct (i.e., “overt”) syringe reuse
Using the same syringe from patient to patient (with/without the same needle)
Indirect syringe reuse
Accessing shared multi-dose medication vials or bags with a used syringe that will be used on subsequent patients (with/without the same needle)
Reuse of single dose vials
Diversion

12. Provider-to-Patient Transmission of HCV Associated with Diversion of Fentanyl
Colorado, 2009
HCV-infected surgery technician stole fentanyl syringes that had been pre-drawn and left unattended in the ORs
Contaminated syringes were refilled with saline and swapped with unused syringes
24 patients infected; nearly 600 notified
Diversion has emerged as the leading cause of provider to patient HCV transmission

13. Injection Practice Myths
If there's no blood, there's no risk
Mistaken belief that the following can prevent infection transmission risks:
Changing the needle
Injecting through intervening lengths of intravenous tubing
Presence of a check valve
Always maintaining pressure on the plunger to prevent backflow of body fluids 
This is a technology that's over a century old, but there's a perception that the needle becomes contaminated when used on a patient, but there's the lack of awareness that the needle and syringe are one unit. Removing a needle does not make the syringe safe for use, and in fact, that's a very, very dangerous practice.“
"That's always false. We need to consider everything, from the needle and syringe or the medication bag all the way to the patient as a single, interconnected unit, and take great caution to avoid any temptation to reuse syringes in that context."
People forget that germs are not visible to the naked eye. We've unfortunately have encountered situations where healthcare workers thought they somehow had a sterile field because they were injecting through a short length of IV tubing and only saw clear fluid. That's another dangerous myth."

14. Single-use / Single-dose
Recommended whenever possible
(unless unavailable)
Single-use: a vial where a single dose can be removed and then the vial and its remaining contents are discarded
Single-dose: a vial containing a single unit of a parenteral drug product
(FDA, C-DRG-00907)

15. Single-use Medication Reuse
Using single-dose medications for more than one patient
Purchase vials containing quantities in excess of those needed for a single patient
Mistaken belief they can be used in a multi-dose fashion
Commonly abused medications
Contrast agents, propofol, botox

16. Multi-dose Vials
What types of vials are considered to be “multi-dose”?
A multi-dose vial is a bottle of liquid medication (injectable) that contains more than one dose of medication and is approved by the Food and Drug Administration (FDA) for use on multiple persons
Multi-dose vials contain a preservative but the preservative does not necessarily protect from contamination

17. Inappropriate Handling of Multi-dose Medications
Inappropriate handling includes keeping medication in the immediate patient treatment area, as the medication is then in the presence of contaminated supplies or patient equipment

18. Appropriate Handling of Multi-dose Medications
Multi-dose medication should be:
Dedicated to single patient, whenever possible
Entered only with sterile needle and sterile syringe
Rubber septum should be disinfected with alcohol prior to each entry
Dated upon initial entry and discarded within 28 days of opening or according to manufacturer’s instructions
Discarded if sterility is compromised
Multi-dose medications should not be:
Kept in the immediate patient treatment area

19. Expiration Date Versus Beyond-use Date
Manufacturer’s expiration date: the date after which an unopened multi-dose vial should not be used Beyond-use date: The date after which an opened multi-dose vial should not be used The beyond-use date should never exceed the manufacturer’s original expiration date

20. Spiking/Priming IV Bags “In Advance”
United States Pharmacopeial Convention (USP):
1 hour time limit from preparation (spiking bag) until beginning administration if not prepared in an ISO 5 environment
Precludes microbial growth in the event of contamination
Organisms replication can occur within 1-4 hours
Longer timeframes if primed by pharmacy in ISO 5 environment

21. Medication Labeling
Draw up medication just prior to the procedure; do not draw up for multiple patients
Pre-drawn medications must be labeled with time of the draw, initials of the person drawing up the medication, name of the medication, strength of the medication and the expiration date if the manufacturer has not printed it on the vial
Medication syringes should not be carried in personal clothing or pockets

22. Re-education is KEY
Individuals want to do the right thing, which might include not wasting medications that are expensive or in short supply
Individual training may be inadequate or incorrect
There may be a lack of understanding of how bloodborne pathogens are transmitted
Culture at the work place may not support individuals speaking up when they see non-compliance
Cost and supply can be barriers to changing to single-dose medication distribution systems

23. CDC Injection Safety Campaign

24. Oregon Survey Findings
Outdated medications and expired supplies
Multi-dose vials were not always dated or dated correctly
Pre-drawn medications were not dated and labeled correctly according to standards
Multi-dose vials not always disinfected between patients
outdated medications, including emergency drugs, and expired supplies including dressings, IV solutions, disinfectants, and skin antiseptics were available for use;
multi-dose vials were not always dated or dated correctly;
pre-drawn medications were not dated and labeled correctly according to standards;
multi-dose vials were not always wiped down with alcohol or an antiseptic in-between patients;

25. Important Medication vials labeled for single-use cannot:
Be used during a second case
Be returned to a medication cabinet
Have remaining medication withdrawn and pooled with the partial contents of other vials
The reason for that is CMS is attempting to get people to have repeated practices that will leave no room for error should there be an incident where there is a possibility for error," she says. "It's like your seatbelt. We had to get to a point where you would be fined if you didn't have your seatbelt on. So now every time you get in the car, you automatically put on your seatbelt. [CMS is] trying to install good practices where every single time you enter a vial, you don't even think about if it's same patient, different patient, same medication or different medication; every time you enter a vial, whether it is a single-use or multi-dose, it is a new needle and a new syringe."

26. Tip: A Special Note on Code Carts
Follow your own policy! 
Expired medications and supplies have been found on code carts MONTHS after their expiration dates despite ongoing, regular code cart log checks and signatures

27. Toolkit Contents
Use, Handling, and Storage of Medication, Eye Drops, and Solutions Policy (5.01)
Web links to:
CDC’s Unsafe Injections webpage - includes resources for training all HCWs, including CMEs for MDs
One and Only Campaign - includes downloadable posters and information brochures for patients, medical staff, and employees

28. Infections Associated with Unsafe Diabetes Care Practices

29. Hepatitis B Virus Outbreaks
The CDC reports that there have been 15 HBV outbreaks in the last 10 years associated with unsafe blood glucose monitoring
Health fair in New Mexico (2010) reused fingerstick lancets potentially exposing 2,000+ individuals

30. Device-associated HBV Transmission Among Persons with Diabetes
Challenge: increased point of care testing and use of over-the-counter personal care devices

31. Lancet and Insulin Syringes
Sharing of multi-lancet fingerstick devices reported as a cause of HBV infection outbreak in a nursing home
(Gotz, et al. Eurosurveillance 2008;13:1-4)

32. Multi-dose Insulin Pens
Sharing of multi-dose insulin pens reported

33. Fingerstick Devices Recommendations
Fingerstick devices should never be used for more than one person
Autodisabling single-use fingerstick devices should be used for assisted monitoring of blood glucose

34. Blood Glucose Meters
Whenever possible, blood glucose meters should be assigned to an individual and not shared
If meters must be shared, the device should be cleaned and disinfected after every use (per manufacturer’s instructions) to prevent carry-over of blood and infectious agents
If the manufacturer does not specify how the device should be cleaned and disinfected, then it should not be shared

35. Insulin Pens and Vials
Insulin pens are intended for use by a single person
Insulin pens should be labeled with the individual persons name
Multi-dose insulin vials should be dedicated to a single person whenever possible
Injection equipment (e.g., insulin pens, needles, syringes) should never be used for more than one person

36. Gloves
Wear gloves during blood glucose monitoring and during any other procedure that involves potential exposure to blood or body fluids
Change gloves between patient contacts and practice hand hygiene

37. Storage
Unused supplies and medications should be maintained in clean areas separate from used supplies and equipment (e.g., glucose meters)
Do not carry supplies and medications in pockets

38. Additional Focus
Point of care devices (e.g., glucometer): make certain it is designed for multiple patient use and cleaned after every use with an EPA-registered disinfectant
Be certain disinfectant does not interfere with blood sugar readings
If performing point of care testing (e.g., glucometers), you need CLIA certificate; have it available

39. Toolkit Contents
Point of Care Device Safe Handling and Disinfection Policy and Procedure (5.02)
Web links to:
CDC’s Infection Prevention during Blood Glucose Monitoring and Insulin Administration – includes references, educational materials, and additional information linking to FDA communications on diabetic blood glucose monitoring and insulin administration devices

40. Conclusions Injection safety is a basic expectation in patient safety
Safe practices should not be sacrificed in effort to save time or money
If you have to justify or qualify your injection practices, you might be doing something wrong