CDC, CMS targeting vile practices with vials

MRSA infections 'completely preventable'

By Gary Evans, Executive Editor

Michael Bell, MDIn what is getting to be a familiar, tragic refrain, the improper use of single-dose vials recently resulted in patients at pain clinics in Arizona and Delaware acquiring serious bacterial infections that were "completely preventable," the Centers for Disease Control and Prevention reports.

While such outbreaks are often linked to transmission of bloodborne infections, in this case bacterial infections with susceptible and resistant strains of Staphylococcus aureus occurred at the two clinics. Overall, 10 patients at the two pain clinics were hospitalized due to severe infections with MRSA or MSSA that required treatment for conditions such as mediastinitis, bacterial meningitis and sepsis.1

In both of the outbreaks, providers were splitting single-dose vials (SDV) designed for one patient into doses for multiple patients. The clinics reported having difficulty obtaining the right vial size, either because of a drug shortage or because the smaller vial size isn't manufactured. Such scenarios do not excuse unsafe practices, says Michael Bell, MD, associate director for infection control in the CDC's Division of Healthcare Quality Promotion.

"We are continuing to see the same problems," he says. "It is generally in the same groups of products, related both to [drug] shortages but also more importantly just to the lack of a convenient vial size. I think that there is this one-size-fits-all approach in some cases, and at the bedside that doesn't translate to safe practices very easily — especially when you are talking about contrast material for x-ray procedures that are made in substantially larger volumes."

In the Arizona clinic, the CDC reported that each morning, clinic staff members typically prepared contrast medium in the patient procedure room, before the arrival of patients. Two new syringes were used to withdraw 5 mL each from a 10 mL SDV of contrast medium (300 mgl/mL) and a 10 mL SDV of saline solution. The contents from each syringe then were transferred to the alternate vial, resulting in two 10 mL vials of diluted contrast solution, one for use in the morning and one reserved for the afternoon. Among patients receiving contrast solution on the day of the outbreak, six received injections from the morning vial and four from the afternoon vial. Three of the patients who received diluted contrast from the afternoon vial developed MRSA infections.

MRSA not ruled out in one death

The three Arizona patients were eventually hospitalized, with stays ranging from nine to 41 days and additional long-term acute care required for one patient. "The fourth recipient of diluted contrast from the afternoon vial was found deceased at home, 6 days after treatment at the clinic," the CDC reported. "The cause of death was reported as multiple-drug overdose; however, invasive MRSA infection could not be ruled out."

In the Delaware clinic, reuse of SDVs of the anesthetic bupivacaine for multiple patients was the only breach of safe practice identified during the investigation and represented a recent change. Previously, the orthopedic practice had used 10 mL SDVs of bupivacaine for single-patient use. When a national drug shortage disrupted the supply of 10 mL SDVs, office staff members began using 30 mL SDVs of bupivacaine for multiple patients, the CDC reported. The joint injection procedures done in the clinic typically required 1–8 mL of anesthetic, with each injection prepared immediately in advance of the procedure in a separate, clean, medication preparation room. Only one 30 mL vial of bupivacaine was opened at any given time; each vial was accessed over a course of several hours for multiple patients until all contents were withdrawn. Occasionally, an opened 30 mL vial was stored in a medical cabinet for use the next day, the CDC investigators found.

Noting that the infections in both clinics were "completely preventable," Bell says the outbreaks underscore a lack of awareness that such practices put patients at risk. Because injections were prepared with new needles and syringes — and in a separate "clean" prep room in Delaware — the clinicians thought the practices were safe.

On the contrary, the preservative-free medications are not safe for multi-patient use, he emphasized. However, providers do have options, Bell noted. High-quality pharmacies that adhere to standards in United States Pharmacopeia General Chapter 797 can be used to safely split doses from SDVs to increase availability, prevent waste, and minimize risk to patients. In addition, some providers are using appropriate alternate medications in times of shortage, he says.

"We have had pharmacies that have been able to split doses safely for a very long time — nothing new there," Bell says. "But that does add to the complexity of care. It is much easier to carry a big vial in your coat pocket and just take some out when you want it. Unfortunately that leads to the risk of contamination and cross infection."

The CDC and other federal agencies have had discussions with drug manufacturers about producing vial sizes that do not lend themselves to inappropriate use.

"That is something we are continuing to explore, but it is not an easy solution it turns out," Bell says. "When you are asking a manufacturer to produce a new vial size, in order to do that they need to go through a great deal of stability testing and what-not for due diligence that can take upwards of a couple of years. It's certainly a financial investm ent for the manufacturer, so it is not going to be an easy sell necessarily to say that everyone must now start making a wide range of [vial] volumes ."

In addition, smaller volume vials may cost more than the same solution in larger quantity vials. "It certainly wouldn't be the first time we saw that pattern where a large volume for one purpose is much less expensive than a tiny volume for another purpose," he said. Likewise, having compounding pharmacies safely split doses – instead of trying to do it in-house – is naturally going to add to a clinic's overhead.

"It's not free," Bell says. "It certainly adds to the costs, but at a certain point it's just doing things properly so the additional cost becomes kind of a false argument. We need to do the right thing. How we go about doing that is still under discussion in the sense that we are not saying that pharmacy aseptic handling is the only option. There are also prefilled syringes being produced by compounding pharmacies and that is another option for some of these things."

It goes without saying, that the potential "costs" in human suffering and ensuing liability should certainly give clinics pause before undertaking such practices. Moreover, new regulatory oversight on this issue is also on the horizon.

CMS survey includes injection safety

Infection preventionists should be aware that the Centers for Medicare & Medicaid Services (CMS) is targeting vials and needle injection practices as part of a hospital infection control survey program slated to begin next year. The draft version of the CMS survey includes many provisions looking for signs of reuse of needles, syringes and single-dose vials on multiple patients. (See box, below.) This is something of a sensitive issue for the CMS, so they may inspect these measures with particular vigilance. The impetus for the CMS inspections, first in ambulatory care and now in hospitals, was a 2008 hepatitis C virus outbreak at a Las Vegas endoscopy clinic. That outbreak has resulted in at least nine HCV infections and more than 100 suspect cases of people who may have been infected during medical care. As we reported at the time, CMS inspectors had actually been to the Las Vegas clinic while the outbreak was ongoing, but apparently were insufficiently trained in infection control to identify improper practices with syringes and single-dose vials. They are getting up to speed now, and we asked Bell whether CMS oversight could finally make a difference on this longstanding problem.

CMS inspectors will look for safe injection practices

A draft infection control survey by the Centers for Medicare & Medicaid Services (CMS) includes the following provisions on safe injection practices:

  • Syringes are used for only one patient (this includes manufactured prefilled syringes and insulin pens).
  • Injections are prepared using aseptic technique in an area that has been cleaned and free of visible blood, body fluids, or contaminated equipment.
  • Needles are used for only one patient.
  • The rubber septum on a medication vial is disinfected with alcohol prior to piercing.
  • Medication vials are entered with a new needle. Note - Reuse of syringes and/or needles to enter a medication vial contaminates the contents of the vial making the vial unsafe for use on additional patients. If a surveyor sees needles or syringes being reused to enter a vial to obtain additional medication for the same patient, no citation should be made if the vial is discarded immediately.
  • Medication vials are entered with a new syringe. Note - Reuse of syringes and/or needles to enter a medication vial contaminates the contents of the vial making the vial unsafe for use on additional patients. If a surveyor sees needles or syringes being reused to enter a vial to obtain additional medication for the same patient, no citation should be made if the vial is discarded immediately.
  • Single dose (single-use) medication vials are used for only one patient.
  • Bags of IV solution are used for only one patient (and not as a source of flush solution for multiple patients).
  • Medication administration tubing and connectors are used for only one patient.
  • Multi-dose vials are dated when they are first opened and discarded within 28 days unless the manufacturer specifies a different *(shorter or longer) date for that opened vial. Note: This is different from the expiration date for the vial. The multi-dose vial can be dated with either the date opened or the discard date as per hospital policies and procedures, so long as it is clear what the date represents and the same policy is used consistently throughout the hospital.
  • If multi-dose vials are used for more than one patient, they do not enter the immediate patient treatment area (e.g., operating room, patient room, anesthesia carts). Note: If multi-dose vials are found in the patient care area they must be dedicated for single patient use and discarded after use.

Ruth Carrico PHD, RN, CIC"I think it already has," he says. "The interesting thing is that none of these recommendations are new. This is a basic standard of care that has been around a long time. We've republished reminders for health care personnel on a couple of occasions in the past couple of years and we didn't really hear any pushback until CMS decided to start incorporating it in their surveys. All of a sudden several parts of the medical community took notice and were not entirely happy. I think they took notice because it is now part of CMS requirements."

Though injection safety was really the issue that prompted CMS action, the resulting hospital survey includes many areas that generally encourage a culture of safety. These provisions range from non-punitive policies allowing workers to voice concerns about patient safety to stringent provisions on reprocessing equipment.

It is both timely and "forward thinking" for the CMS to emphasize such measures, because sometimes "questioning the status quo is a good thing," says Ruth Carrico, PhD, RN, CIC, an associate professor at the School of Public Health and Information Sciences at the University of Louisville, KY. Given current economic conditions, health care workers are inundated with messages to avoid wasteful practices and conserve resources. "Sometimes when we are talking to all staff, we tell them our survival depends upon us making good use of our available resources," she says. "We encourage them to think before they throw things away and not be wasteful. So this [CMS survey] is a way of making sure that the message that we are giving about cost control is being translated appropriately by the frontline staff. With the inclusion of this, I think CMS is recognizing that this can be a problem — the same sort of problem we have seen with our single-dose vials and with some of the drug shortages. Staff are trying to make the best decision that they can, but sometimes it is not the safest decision. They are building some of this in as a patient safety safeguard."

Reference

  1. CDC. Invasive Staphylococcus aureus Infections Associated with Pain Injections and Reuse of Single-Dose Vials — Arizona and Delaware, 2012. MMWR 2012; 61;501-504