Tampered IV bags raise questions over safety of medical products

DALLAS (CBSDFW.COM) - The Texas Medical Board suspended a Richardson anesthesiologist's license after it was determined he could pose "a continuing threat to public welfare."

Raynaldo Rivera Ortiz Jr. has been under federal investigation in connection with tainted IV bags that may have caused the death of a colleague and caused complications in patients during routine surgeries. 

The I-Team sent several questions to our regulatory agencies and pharmaceutical associations to get answers about the safety and integrity of IV bags and the medicines which go in them prior to the bags moving into patients' rooms.

THE FDA SAYS IV BAGS ARE NOT "TAMPER-PROOF"

If you have a headache, you might reach for an over-the-counter pain killer.

Before you take it, you'll likely open a box, pull off a plastic seal wrap, remove a child-proof cap, punch out a foil seal, and probably remove a cotton ball before getting to the pills.

If any of these safety features were removed or tampered with, you could visually tell.

However, if you're lying in the hospital, in your most vulnerable state, knocked out on a table, the I-Team has learned the equivalent of all these precautions does not exists for the doctors giving patients medicine through an IV.

The case involving Dr. Raynado Ortiz may have patients asking:

HOW CAN SOMEONE TAMPER WITH AN IV BAG BEFORE IT GETS TO A PATIENT'S ROOM?

The Federal Drug Administration would not go on camera, but in a statement, it told the I-Team that IV bags do not normally contain a tamper proof feature.

In a letter to the I-Team, a spokesperson said:

"Empty IV bags are devices intended for the transfer and admixture of medications and are used to administer solutions intravenously via a spike port. These devices do not normally contain a tamper proof feature. The agency has cleared accessories to these devices that are intended to provide a tamper evident seal for IV bags. IV bags are only used in prescription use settings (i.e. hospitals, certain other inpatient and outpatient facilities."

The FDA also stated individual bags do not normally contain a tamper evidence feature:

"The bags do not normally contain a tamper evidence feature. Available accessories provide visual evidence that medication has been added to the bag (e.g., a seal or cap that is placed onto a medication port)," a spokesperson stated in an email to the I-Team.

Tamper proof means the bags, or product, cannot be compromised.

Tamper evident means, if the bags, or products, have been compromised, someone could tell.

The National Association of Boards of Pharmacy also told the I-Team individual IV bags are not considered tamper proof or tamper evident.

In an email exchange with the I-Team, a spokesperson stated:

"No, individual IV bags are not considered "tamper proof." These individual IV bags are shipped in a sealed, cardboard case from the manufacturer. A hospital or medical facility may receive a sealed case from their distributor. There is a procedure that is typically followed by the hospital or medical facility to match the case to what was ordered and a brief inspection of the case for signs that it has been opened, a spokesperson stated in an email to the I-Team.

For example: A case of 1 Liter (1000 mL) bags of normal saline (0.9% sodium chloride) may have 12 individual IV bags per case. The manufacturer typically has placed a protective, plastic overwrap over each individual IV bag within the case. When the sealed case is opened up by the hospital or medical facility, they may remove the individual IV bag but will leave on the protective, plastic overwrap. This protective, plastic overwrap is what should remain in place until it is ready for use."

The I-Team asked:

CAN YOU TELL IF A BAG, EITHER FILLED WITH SALINE OR UNFILLED, HAS BEEN POTENTIALLY COMPROMISED PRIOR TO USAGE?

The NABP spokesperson said:

"This would be very difficult and the scenarios where this could potentially be detected would widely vary depending on the circumstances."

IV BAG TAMPERING COULD GO "UNDETECTED"

The NABP and the American Society of Anesthesiologists both said a bag typically has a thin, protective plastic film surrounding it.

ASA President-elect Dr. Michael Champeau said that wrapper should remain in place until use; however, he says, "It would be possible to tamper with that and have it be largely undetected. ….It would be possible to create a very small hole there."

In the investigation involving Baylor, Scott and White Surgicare, investigators state the bags "…showed small puncture holes in the clear plastic packaging bags that encase the IV bags."

The bags usually arrive to medical facilities pre-filled with saline. Additional meds are added through a port.

WHAT SAFETY FEATURES ENSURE THE INTEGRITY OF MEDICINES PUT INSIDE IV BAGS?  

"It's a unique system," explained Dr. Marv Shepherd, a lecturer and consultant for the University of Texas College of Pharmacy.

Dr. Shepherd said medicines are sealed and digitally tracked and traced as they travel to pharmacies; however, once they get there, they arrive in "larger bottles" where tampering would be hard to detect.

"It will have a plastic seal on the top, but, once that's broken, a lot of people will have access to it then, but hopefully, they are professionals, and they won't tamper with it," explained Shepherd.

Dr. Shepherd says a medical professional tampering with medicines or IV bags is "very rare!" He only recalls one other tampering case involving a "professional."

He does point to a very public case as the answer to the next question:

WHY DO OVER-THE-COUNTER MEDICINES HAVE SAFETY FEATURES?

In 1982, seven people died after taking Tylenol bought on store shelves - that were laced with cyanide. The culprit was never caught but good did come.

This is why over-the-counter bottles typically are in sealed boxes, have triple plastic wraps and foil punch-out coverings under the child-proof lid.

WILL THIS HIGHLY PUBLICIZED NORTH TEXAS IV BAG CASE RESULT IN ANY REGULATORY CHANGES?

"I think it's highly probable the FDA will require tamper resistant packaging seals on IV bags," said Dr. Shepherd, "Very probable!"

Dr. Shepherd told the I-Team that regulations will likely happen as a direct result of the North Texas surgicare case. 

FDA-APPROVED "ACCESSORIES" WOULD PROVIDE TAMPER-PROOF AND TAMPER-EVIDENT FEATURES

The FDA regulates IV bags as Class II Medical Devices. This means they are subject to adverse event reporting and label requirements.

An FDA spokesperson told the I-Team:

"IV containers are regulated as Class II devices under the Code of Federal Regulations. They are subject to FDA premarket review under section 510(k) of the Federal Food, Drug, and Cosmetic Act and to general controls under the statute and regulations, such as labeling requirements and reporting of adverse events. To learn more about device classification, please see our website."

In responding to the I-Team's questions, the spokesperson stated that the FDA has cleared accessories for IV bags with tamper proof and tamper evident features.

"FDA regulation requires that manufactures follow current good manufacturing practice (GMPs) for methods used in, and the facilities and controls used for, the manufacturing, packing, storage, and installation of medical devices. These requirements are in place, in part, to help ensure the integrity of the products released from the facility, and that the devices have proper instructions for shipping, storage, and handling. "

For now, these IV bag safety accessories are not mandated.