Large Volume Infusion Pumps: MedSun Small Sample Survey Summary
MedSun: Newsletter #54, November 2010

Survey Topic: Large Volume Infusion Pumps
Year Conducted: 2009

Large volume infusion pumps are an integral part of patient care. They provide safer administration of fluids and medication than in the past. The variety of pumps available is expanding all the time. With the numerous recalls of large volume infusion pumps recently, the FDA wanted to learn more about how future recalls might affect hospitals and their quality of care. To meet this need, a special study or survey was conducted with nine healthcare professionals from nine MedSun facilities. The information that follows is a summary of the interviews.

The Hospira Plum, Baxter Colleague, Sigma Spectrum, and the Alaris were cited as the primary brands of infusion pumps used by respondents. They also use large volume infusion pumps in high acuity areas, including the ICU, ER, NICU, and OR. The average number of pumps used per patient in these areas varied greatly depending on the hospital, the type of pump, and patient needs.

In the case of pump failures, all respondents had extra pumps on critical care units. The number of additional back up pumps varied based on patient census. Other options in case of pump failure included borrowing pumps from other units or hospitals, and rentals. When asked about the estimated time it took to replace a pump the response was immediately when pumps were available on the unit, and 5-45 minutes if obtained from central supply. Once a replacement pump is found, all said it would take 5 to 10 minutes to re-initiate infusion therapy.

All respondents conduct product trials before changing out their pumps. Under normal circumstances, this process takes anywhere from 3-18 months. Training time for clinical staff on new pumps varied from 2 weeks to 3-4 months.

Overall, respondents described a permanent recall and product support discontinuation of their primary brand of infusion pumps as a complicated scenario. None have a plan in place that would address this while continuing to provide care for patients. Most stated they could use intravenous (IV) flow regulators or count drips until they could replace infusion pumps, but they all considered these methods to have major safety and training issues. However, most felt they could meet the challenge, especially with help from the vendors. They said the replacement process of infusion pumps would be easier and executed more quickly if they had vendor information and products readily available.

Respondents also said that if multi-channel pumps were no longer available it would create a different set of challenges to care for patients needing multiple therapies. Those challenges include an increase in plugged-in devices, space requirements, and an increase in the number of devices sent to the biomedical department and central supply. It was suggested that FDA could assist manufacturer actions by providing comparisons of pumps and encouraging or requiring vendors to respond to hospitals in a timely fashion.

Small scale surveys are one of many tools the Agency uses to evaluate the public health impact of the potential problems associated with the use of medical devices. Because these surveys utilize a small sample size that is not statistically derived, the results provide only qualitative and not quantitative results. Additionally, FDA continues to receive adverse event reports from its Medical Device Reporting program, and will continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff are made aware of the survey results as needed. If FDA believes a possible public health problem may be emerging from the results of a survey, it will combine those results with data gained from the other sources and may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.

FDA will work with the manufacturers and health care professional organizations to make important information known about medical devices to the clinical community.

Small Sample Survey Questions

1. How many large volume infusion pumps does your hospital have in use? (own or rent)

2. How many do you have available for back up? (own or rent)

3. What types and brands are they? And, are your pumps multi-channel, single channel or both?
a. For example, there are several types of infusion pumps on the market now with various module or channels such as,
i. Baxter has (Colleague, Flo-gard, etc.),
ii. Cardinal Health Alaris has (Medley, Signature Edition, Signature Gold, Gemini, etc.),
iii. Hospira has (Omniflow, Plum, Symbiq, etc.)

4. In your hospital, what areas do you consider to be high acuity areas? Are pumps used all the time in these areas? (e.g., ICU, ER, OR, oncology, other specialty areas, etc.)
a. In the type of clinical setting(s) you mention, what is the average number of patients that are being cared for at one time?
b. Of these patients, what is the average number of pumps used on a high acuity patient?

5. When a pump fails:
a. What procedures are in place for critical care areas and general units to replace pumps that fail?
b. On average, how long does it take you to find a replacement pump?
c. On average, how long does it take you to initiate or re-initiate infusion therapy with a patient?

6. Can you please describe for us what you use when a patient needs multiple infusions and...
a. You don’t have the pumps you need.
b. What do you do if you have the pumps you need but the space required to set up multiple pumps at the bedside is not available? Do you ever find you have to move other beds to have access to outlets and additional space?

7. What other types of pumps does your hospital have and how many of each?
a. Elastomeric?
b. Peristaltic?
c. Syringe?

8. What is the process your facility uses to determine when to change out (purchase new/different pumps) the infusion pumps from your hospital? For example, do you have a (new products) committee, or use a specific purchasing process or decision tree, etc?) If you have a committee, what staff are on the committee?
a. Do you conduct product trials before changing out the pumps?
b. How long does that process usually take? Given normal circumstances how long would it take to replace your infusion pump supply?

9. If your primary brand of infusion pumps was permanently recalled with product support discontinued and instructions given to remove the devices from use:
a. How would you address this scenario while continuing to provide care to your patients? (Include additional training, other expenses, etc.)
b. What would make your replacement process easier and faster to execute?
c. How could FDA and the manufacturer facilitate the actions you take in your hospital?

10. If your multi-channel pumps were no longer available, what actions would you take to meet the requirements for patients needing multiple therapies?
a. If you replaced your multi-channel channel pumps with single channel pumps, (for example 3 single channel pumps in place of one triple channel pump), could you accommodate the:
*Increased space requirement for storage (i.e. extra I.V. poles, outlets in storage locations)?
*Increased number of devices that need to be plugged in except during transport?
*Increased space requirements and number of outlets needed for the pumps in the OR, ER, etc.
*Increased number of devices that your central supply and biomed departments would need to process?

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