CDC facts, myths on vials, needle safety

The Centers for Disease Control and Prevention is trying to overcome some stubborn myths and misperceptions about single-dose vials including the following, which the agency refuted with the current facts.

Myth: Improper use of single-dose/single-use vials puts patients at risk of infection with only bloodborne pathogens such as hepatitis C virus.

Fact: Infection risk is not just limited to bloodborne pathogens. Outbreaks from improper use of single-dose/single-use vials have resulted in life-threatening bacterial infections including bloodstream infections, meningitis, and epidural abscesses. Many of these infections have occurred following injection procedures performed in pain remediation clinics.

Myth: Guidance regarding safe handling of single-dose/single-use vials is new and has only been in place since 2010.

Fact: CDC injection safety guidelines are not new. They have been part of Standard Precautions since 2007 (http://www.cdc.gov/injectionsafety/IP07_standardPrecaution.html).

Myth: According to CDC, there is never a circumstance when contents from a single-dose/single-use vial may be used for more than one patient.

Fact: CDC recommends that providers limit the sharing of medications whenever possible. Qualified health care personnel may repackage medication from a previously unopened single-dose/single-use vial into multiple single-use vehicles (e.g., syringes).

This should only be performed under ISO Class 5 conditions in accordance with standards in the United States Pharmacopeia General Chapter 797, Pharmaceutical Compounding – Sterile Preparations, as well as the manufacturer's recommendations

pertaining to safe storage of that medication outside of its original container.

Myth: There is no evidence that single-dose/single-use vials used for multiple patients are responsible for infections if "proper infection control measures" are applied.

Fact: Dedicating a single-dose/single-use vial to one patient is, in and of itself, a critical element of proper infection control. CDC continues to see outbreaks in health care settings where providers thought they were preparing and administering injections safely. In the last five years alone, CDC is aware of at least 26 outbreaks due to unsafe injection practices. These outbreaks resulted in more than 95,000 patients being referred for testing after potential exposure to infectious diseases. Nineteen of these outbreaks involved use of single-dose/single-use medications for more than one patient. These and other suboptimal practices are common, as reported by numerous studies about infection control compliance rates. Moreover, infection surveillance is lacking in most outpatient settings; thus it is likely that outbreaks are occurring at a higher frequency, but going undetected.

Myth: CDC's recommendations regarding single-dose single-use vials are flexible. In 2002 the agency issued a communication to the Centers for Medicare & Medicaid Services (CMS) regarding how to safely use contents from single-dose/single-use vials for more than one patient in a dialysis setting. If they allowed use of single-dose/single-use vials for more than one patient in dialysis clinics, why can't it be applied to other patients?

Fact:The current injection safety guidance is part of CDC's 2007 Guideline Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. This guidance supersedes all other formal and informal guidance on this topic and was developed to reflect accumulating evidence, including bloodborne pathogen risk, gathered from outbreaks caused by unsafe injection practices. In 2002, an informal communication from CDC to the CMS suggested that certain medications packaged in a single-dose/single-use vial could be used for more than one patient in dialysis settings, assuming that certain criteria were followed. In 2008, CDC issued a formal clarification specifically to dialysis providers stating that the 2007 guidance superseded the 2002 CDC communication to CMS (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5732a3.htm).

Myth: Considerable health care savings could be achieved if less stringent policies were in place.

Fact: Any potential savings from stretching the contents of single- dose/single-use vials by health care providers can be quickly offset by the costs associated with viral hepatitis, bloodstream infections, meningitis, epidural abscesses and other infectious complications. These costs are primarily borne by patients and their families. In addition, clinicians could face legal costs and potentially lose their medical licenses if basic safe practices are not followed and patients are harmed.