Wednesday, April 13, 2011

VA patients, adults, now children at risk for contracting HCV/HBV/HIV in a medical setting

Happy middle of the week folks,

Today on the blog is an unsettling story about a clinic in Fort Collins which administered doses of a vaccine to children from the same syringe, although a sterile needle was used.
You can view the complete story here.

A medical assistant at the office took the pre-measured children's influenza vaccine and only gave half to each child, assuming it was the adult dosage. Children between 6 months and 35 months are only supposed to receive half of the recommended dosage for adults.

Since children are supposed to receive two doses of the pediatric influenza vaccine within a month of each other, the assistant removed the needle from each half-full syringe, assuming it was an adult dose, and replaced it with a sterile needle, but not a new syringe.

Med Peds said the medical assistant then placed the used syringes in a box marked "second doses," which also contained unused, fully filled pediatric vaccines.

When our children are put at risk for contracting bloodborne pathogens such as HIV and hepatitis in route of a visit to their pediatricians office or any healthcare setting, to me, it screams that this country is in dire need of a solution. These children were simply undergoing routine vaccines, the horrified parents are now facing uncertainty, fear and shock . If the children are safe, and there is no transmission of disease, the parents will rejoice.  However, this tragic event will haunt them as their child visits a new clinic, a trip to the ER or with each medical encounter they face in the future. The incident is alarming on all levels, in the U.S. this has been an ongoing problematic nightmare.  I can only mutter inexcusable.

People Making A Difference

One program is making a difference, the (SIPC) - The Safe Injection Practices coalition was founded in June 2008 and initiated this campaign ; "The One and Only Campaign" 

The SIPC is comprised of patient advocacy organizations, foundations, provider associations, industry partners and the Centers for Disease Control and Prevention (CDC). The SIPC focuses its efforts on advancing and promoting safe injection practices by informing and educating healthcare professionals and the public, especially in outpatient settings. Issues of particular concern include the reuse of syringes and misuse of single-use and multi-dose vials.

From Medscape; 

Dr. Joseph Perz

It is hard to believe, but in the last 10 years, across the United States, reuse of syringes and misuse of medication vials has resulted in the need to alert more than 100,000 patients to seek testing for bloodborne pathogens such as hepatitis B, hepatitis C, and HIV.

Every year millions of injections are administered in the United States. Every injection should be safe from infection risk. However, recent experience in the United States includes dozens of outbreaks in which infections were spread as a result of breakdowns in safe injection practices. Although all of us work to ensure that we are keeping patients safe, there are some dangerous myths on injection safety that may be putting your patients at risk.

Myth #1. Contamination of injection devices is limited to the needle and removing the needle makes the syringe safe for reuse. False! The truth is that once used, both the needle and the syringe are contaminated and must be discarded. A new sterile needle and a new sterile syringe should always be used for each patient and to access medications.

Myth #2. Intravenous (IV) tubing or valves can prevent backflow and contamination of injection devices. This is also false! The truth is that everything from the syringe or medication bag to the patient's IV catheter is a single interconnected unit. Distance from the patient, gravity, or even positive infusion pressure do not ensure that small amounts of blood won't contaminate the syringe and needle. The temptation to economize by reusing this equipment simply isn't worth the risk.

Myth #3. If you don't see blood in the IV tubing or injection equipment, there is no risk of cross‐contamination. Another false assumption. The truth is that pathogens, including hepatitis C and B viruses, and HIV, can be present in sufficient quantities to produce infection without any visible blood.

Myth #4. Single-dose vials that appear to contain multiple doses may be used for more than 1 patient. False again! The truth is that single-dose vials are intended for use in a single patient for a single procedure and should not be used for more than 1 patient, regardless of the vial size. To ensure that you are not inadvertently mistaking a larger single-dose vial for a true multidose vial you should check the medication label or package insert.

The following practices can help ensure the safety of your patients:

Needles and syringes are single-use devices. They should not be used for more than 1 patient or reused to draw up additional medication. Once used, the syringe and needle are both contaminated and must be discarded;

Do not administer medications from a single‐dose vial or an IV bag to multiple patients, and never combine leftover contents for later use;

In general, limit the use of multidose vials and dedicate them to a single patient, whenever possible; and

Finally, please take a moment to pause, with your staff and colleagues, to review injection procedures to ensure that safe practices are understood and followed by all.

The Outbreaks

The Endoscopy Center In Southern Nevada

Reusing Syringes and Vials

This outbreak of HCV infection was likely related to contamination of open propofol vials through refilling of syringes that had become contaminated with the source patients' blood.

In 2007  we saw an outbreak of HCV at the Endoscopy Center in Southern Nevada, which occurred when staff members reused syringes and vials in administering propofol, a drug that is manufactured by Teva. The company eventually was sued and slapped with a judgment of $500 million, the jury found them negligent when product packaging contributed the one patent’s Hepatitis infection.

Again the problem of  multi-dose vials, reported last month by Fox news;

Teva Parenteral Medicines distributed the anesthetic propofol in vials that were larger than necessary, inviting multiple uses.

At the time 40,000 patients were put at risk, and advised to get tested for blood-born diseases such as hepatitis B, hepatitis C and HIV. Dr. Desai, was named as the responsible party along with two nurse anesthetists. The doctor owned the facility where the hepatitis C outbreak took place.

As of April 9th 2011 there are 250 of Dr. Desai's former patients who are infected with hepatitis, these patients have since all filed lawsuits against the doctor.  You can read the update here.

Other recent cases of possible HCV infections transmitted via a clinical setting have caused the public to question their own safety in regard to the transmission of all bloodborne pathogens while undergoing future medical procedures.

Another route of transmission comes to us from a few drug addicts infected with HCV who worked as healthcare providers at various clinics. These individuals  were stealing the drug Fentanyl and replacing the syringes with saline to be reused on unknowing patients, thus transmitting the HCV virus.

In a few of these clinical settings innocent patients were infected with HCV via contaminated syringes, with the drug Fentanyl named at three different clinics; Mayo, Rose Medical Center and Riverside Regional. Apparently in all three cases the guilty parties stole syringes and injected themselves with the painkiller fentanyl replacing the syringes with saline to be reused on patients. We can only surmise how often this has played out across the country in other hospitals or clinics. All three guilty parties were infected with HCV, although not all admitted to knowing it. Employees working in the health care profession with drug addiction often steal drugs from their employees. However, when the employee is infected with a disease which is transmitted to unknowing patients via their contaminated syringes it becomes more then a case of stolen drugs, it may become murder;

View the article here

The recent VA outbreak is another example of extreme negligence, if our government can not follow proper sterilization procedures how can patients feel safe in any clinical setting ?

 Due to improper handling and cleaning of dental instruments at VA medical centers recently put patients at risk for the transmission of Hepatitis and other bloodborne pathogens .

The protocol put in place to ensure public safety has been ignored or its evidently flawed.
The past and current lack of "adherence to sterilization practices" or "inadequate practices" at VA dental centers continues to rise. This blog has put together a summary of the VA facilities involved. We begin with the 2009 to 2010 notification letters sent to 1,812 veterans who may have been exposed to hepatitis B, hepatitis C and HIV; when a breach in protocol instrument processing took place at the John Cochran Veterans Medical Center in St. Louis, MO. The Associated Press reported in March 2011 that most of the 1,812 veterans potentially exposed have been tested with no infections connected to the dental clinic.

View the article here.   April update here

In the December 2010 newsletter from ISMP  in an article entitled;  Perilous infection control practices with needles, syringes, and vials suggest stepped-up monitoring is needed, came these staggering numbers.
In 2010  according to the CDC, in the past 10 years there have been more than 50 outbreaks of blood-borne transmission of HBV,HCV, and HIV that required notification of more than 125,000 potentially exposed patients and identification of more than 600 who became infected.There have been  50 outbreaks of hepatitis B or C which have occurred in healthcare settings

Unfortunately I suppose we must add to those outbreaks, fifty has evolved into a few more.
In March of this year Southern Nevada health officials are notifying 101 patients of a Las Vegas urologist they may be at risk of blood-borne disease because of the reuse of medical implements during office biopsy procedures.

The Bottom  Line

While the healthcare community continues to learn from these medical mishaps, sadly this fact remains, they have not learned to prevent a recurrence.

Related Links;

US Outbreak Investigations Highlight the Need for Safe Injection Practices and Basic
Infection Control

Wisconsin State Survey Agency 2010 Educational Conference November 17, 2010
Back to Basics: Ensuring Safe Injection Practices

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