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

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

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

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

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)

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

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 20-50 cc vials but only used approximately 10-15 cc per patient

Unsafe Injection Practices That Likely Lead to HCV Transmission

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

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)

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

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

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."

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)

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

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

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

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

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

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

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

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

CDC Injection Safety Campaign

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;

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."

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

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

Infections Associated with Unsafe Diabetes Care Practices

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

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

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)

Multi-dose Insulin Pens Sharing of multi-dose insulin pens reported www.newsinferno.com/archives/3066 www.lcsun-news.com/ci 11670031

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

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

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

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

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

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

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

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