Safety by Design: Capturing Ideas and Innovations to Make Injections Safer - May 2010

On May 24, 2010, the Centers for Disease Control and Prevention (CDC), the CDC Foundation, the Food and Drug Administration (FDA), insurance companies and industry partners (see Appendix for list of all participants) participated in a one-day meeting at CDC’s headquarters in Atlanta, Georgia to explore product design solutions that, if implemented, would reduce the risk of blood-borne pathogen exposure to patients receiving injections of medications and other parenteral fluids. The following is a summary of the discussions and identified next steps from the meeting.

The Situation

Since 1999, at least 125,000 patients around the United States have been notified of potential exposure to hepatitis B virus (HBV), hepatitis C virus (HCV) and HIV due to lapses in safe injection and basic infection control practices. Some of the inappropriate use and handling of needles, syringes, and medications identified in CDC and health department-led outbreak investigations include:

• The same syringe is used for more than one patient;
• A used syringe is used to access a medication vial/container, and then the contaminated vial/container is used for another patient;
• “Single dose” or “single use” medication containers are used for >1 patient outside a pharmacy setting
• A healthcare worker contaminates a syringe or container as a result of trying to divert or steal medication due to an addiction.

In addition to leading to significant patient harms, it is also important to note that following outbreaks in Colorado[1] and Las Vegas[2] clinicians and healthcare facilities were subject to criminal sentencing and significant civil penalties.

Oversight to prevent these harmful practices in many healthcare facilities, such as ambulatory care clinics, is limited because these facilities aren’t licensed through State Survey Agencies nor are they subjected to the Centers for Medicare and Medicaid Services (CMS) survey and certification process because they do not receive reimbursement for services from CMS. Additionally, for some front-line care providers, cost reduction is a strong motivator that might lead to unsafe injection practices (e.g., saving partially-used vials of single-use medications to be used on more than one patient). Addressing these issues is a focus of the broader goal to eliminate unsafe injection practices. This meeting focused on a third factor, ensuring that products are designed in a way as to engineer safe practices into delivery of injectable medications, as product design or issues might unknowingly encourage unsafe injection practices (e.g., medication vial label instructions not visible and/or do not clearly indicate single-use).

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What Can We Do About It?

The Safe Injection Practices Coalition (SIPC), a partnership of healthcare-related organizations, led by the CDC, was formed to promote safe injection practices in all U.S. healthcare settings. The SIPC is fostering change through a multifaceted approach that includes 1) education and awareness, 2) encouragement of safety incentives across government, and 3) engineering safety into processes and products. To address awareness, the Coalition developed the “One and Only Campaign” to reinforce the importance of using “one needle, one syringe, only one time.” The message is aimed at healthcare providers as well as patients.

The meeting held on May 24, 2010, focused on safe product design. Experts representing all facets of healthcare – from nurses to product engineers – discussed the question: “Can we make the systems failsafe to eliminate human error?”

Highlights of the discussion are below.

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Equipment Changes

• Categorically, needles and syringes should only be used for one application, in one patient, and never reused for multiple patients. Distinguishing “used” from “unused” is not easy, especially when providers are multitasking. Perhaps visual indicators could be added so that, for example, a red stripe appears when the syringe plunger is pushed. In addition, there are existing technologies that result in the plunger “freezing” after it is pushed.
• When it comes to medication and fluids, vial sizes and quantities often complicate the issue of reuse.
  • Vials labeled as “multiple-dose” infer that they can be used for multiple patients – but this is only true if they’re kept out of the immediate patient treatment area and always handled aseptically. Single-dose vials are also misinterpreted in some settings; for example, anecdotal evidence shows that in some oncology clinics, “single-dose” or “single-use” is thought to mean “single-day” rather than “single-patient.”
  • Labeling and sizing should be appropriate for clinical setting and application. One participant noted that a 50 ml vial of magnesium sulfate was labeled “for IM (intramuscular) use or for IV use after dilution.” Yet upon polling his colleagues, none could think of why a patient would be given a single 50 ml dose of this substance intramuscularly. “There’s obviously some confusion that’s engendered with this kind of packaging.”
• What if labeling was designed so one could discern at-a-glance whether the vial was for single patient use only or a true multiple dose vial?
• What if there were right-sized vials for specific clinical applications? What can be done to increase availability and uptake of pre-filled syringes? “Maybe we need a group of syringes for infusion, and a group for immunization, and a group of lure locks for this, and special vials for that.”
• Other possibilities include auto-disable syringes and vials, tamper-evident packaging, and “female-to-male” marrying of devices as is done with other types of delivery systems (e.g., anesthesia).
• As an example of how an existing technology can be made safer for more vulnerable applications, consider the evolution of traditional syringes for catheter flushing. Traditional syringes are not optimally designed for catheter flushing because they promote blood reflux back up into the catheter. Several companies have introduced pre-filled syringes that eliminate syringe-induced reflux.
• Potential solutions need to be analyzed carefully from a human factors, end-user perspective. For example, one participant pointed out that pre-filled saline flush syringes are being used for other purposes than intended, such as for reconstituting and drawing up other medications, “and that’s a risk because you can’t change the label, and there’s no adequate measurement.”

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Processes

In addition to redesigning devices, there also needs to be behavioral change.

• Some providers are “working around” current systems to save money or increase efficiency. Others believe it is safe to do so, as described by one participant: “A common workaround I’ve heard is, ‘I have a large quantity in the syringe, and yes, I am going patient to patient, but there is a filter between the patient and the line, and since the efficacy of that filter is reportedly greater than 99%, I don’t need to swap it out.’”
• Some providers get into the bad habit of using their own visual cues instead of proper labels, e.g., “I put the heparin in one color syringe and the saline in a different color syringe and therefore I don’t need a label.” Yet CMS conditions for coverage, Joint Commission standards and other safe medication practice guidelines are very clear on the issue of labeling.
• A major problem is that the end user is far removed from the purchasing decision. Often, the people in the field demonstrating and servicing products are not allowed into the facilities where they can discuss products, processes, and opportunities for improving safety with clinicians. Furthermore, industry representatives might not have personnel covering the smaller facilities or more rural areas. Anything that decreases access for manufacturers to have one-on-one engagement in the clinical setting will hinder innovation. “Finding products that have existed in the hospital market for five, six, seven years is not necessarily straightforward for some of these sort of very, very far removed clinics.”
  • There is confusion as to required practices versus recommendations. As one participant pointed out, “There are so many ‘shoulds’ in the guidelines, not ‘shalls.’” Things need to be stated in terms of “must do,” not “should do,” because a clear mandate will drive the purchase and use of the safer products. Participants also emphasized the need to look at specific practices within different settings to better characterize what constitutes “good practice.”
  • It was noted that CDC HICPAC guidelines clearly state that a saline bag is not an appropriate source of supply for multiple patients, and there’s similar guidance from other professional groups, including pharmacists. And yet, significant gaps remain in terms of actual practice in the field.
  • Another participant noted that, “CMS does not enforce best practices; they enforce the regulations. If there is a gap between best practices and regulation, the best practices don’t get enforced.”
• Many times, physicians are dictating practices beyond their knowledge of the standards – and there may be reluctance on the part of nurses and other staff to correct the physician.

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Clarifying Cost Misperceptions

• As noted, cost is a driving factor in the tendency to reuse syringes or make a quantity of medication go further. There are misperceptions that need to be clarified. Examples include:
  • Larger sizes aren’t always cheaper.
  • It might seem more economical to purchase a saline bag at 87 cents instead of a pre-filled saline flush at 36 cents. However, no one is factoring in the complete life cycle of costs – the labor and material costs of pre-drawing and labeling multiple syringes; the risk of infection and degradation of life; lawsuits; lost wages; fines; negative publicity; etc.
• Disparities in CMS reimbursement may affect purchasing decisions in different facilities; non-acute facilities often get reimbursed at a much lower rate than hospitals.

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Industry Engagement

Concerns over patient-to-patient infection from unsafe injection are percolating throughout the industry. Examples that were discussed included:

• A survey by the Premier Safety Institute shows that the majority of providers are hearing about injection practices from their professional association[3]. The role of these organizations is important because they define standard practices for their particular area of specialty.
• ECRI Institute has been asked to work with some malpractice insurers to develop assessment guidelines for their insurance companies to use with their insured facilities/providers. There is increasing interest by insurers to assess provider practices to ensure adherence to guidelines and standards.

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Continuing the Conversation

The following next steps for the Safe Injection Practices Coalition and other attendees were outlined by attendees:

1. Determine which providers perform injections and other invasive procedures in office or outpatient clinics (e.g., gastroenterologists, surgeons, nurses, medical assistants, and dental professionals) to guide partnership development with relevant professional associations to provide education on safe injection practices.
2. Explore the use of incentives through provider insurance companies; i.e., making safe practices a condition of certain levels of coverage.
3. Identify new public/private partnerships that can be used to continue to raise awareness of the issue.
4. Advocate for better surveillance of healthcare-associated infections, at the state, national and institutional levels, so that the impact of prevention efforts – or failures to adhere to safe practices – can be documented and shared.
5. Ensure that parenteral medications are available in a form that is ready to deliver, minimizes opportunity for contamination and disease transmission, and is cost-neutral to end users.
6. Articulate and broadly communicate current expectations for injection safety best practices for common processes of care.
7. Evaluate cost-benefits of using current technologies that enhance injection safety best practices vs. older technologies, and make data publicly available to those who make purchasing decisions in the health care setting.
8. Improve understanding of barriers to safe practice in order to inform product design changes and implementation of developed technologies. Communicate findings to industry groups and FDA.

The CDC and the SIPC promote safe injection practices in all U.S. healthcare settings though education and awareness, encouragement of safety incentives, and engineering safety into care processes.

This meeting focused on the engineering safety aspect of the injections safety issue. Further discussion is needed to identify which solutions can be achieved through strong collaborations most easily.

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References

1. “Hospital tech who spread hep C via drug thefts gets 30 years.” Denver Post, February 25, 2010. Accessed April 25, 2011.
2. “Jury finds drugmakers liable in first hepatitis Ctrial.” Las Vegas Sun, May 5, 2010. Accessed April 25, 2011.
3. Pugliese G, Gosnell C, Bartley JM, Robinson S. Injection practices among clinicians in United States health care settings. Am J Infect Control. 2010 Dec;38(10):789-98.

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Appendix: List of organizations in attendance

American Association of Nurse Anesthetists (AANA)
American Society of Health-System Pharmacists
Association for Professionals in Infection Control and Epidemiology, Inc. (APIC)
Battelle
B&D Consulting
Becton Dickenson and Company (BD)
Centers for Disease Control and Prevention
CDC Foundation
Chartis
Covidien
ECRI Institute
Food and Drug Administration (FDA)
Georgia Institute of Technology
HONOReform Foundation
Hospira
Infusion Nurses Society
Lexington Insurance
National Patient Safety Foundation
Nevada State Health Department
Nevada State Medical Association
New York State Department of Health
PATH
Safety Institute, Premier Healthcare Alliance
University of Michigan

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