Thinking of Buying...Ambulatory Pain Pumps

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Choose for durability, portability and ease of use.


Perineural local anesthesia infusion pumps — also known as "pain pumps" — offer benefits to both ambulatory surgical facilities and to patients undergoing certain ambulatory procedures. Not only do they speed the patients through recovery with less need for post-op interventions, providing case and cost efficiency, but also they comfortably manage a patient's post-op pain even after he has returned home. Each model of pain pump tends to be comparable in its operation and ease of use, but there are a few factors you'll want to keep in mind when you and your surgical team are choosing which one you'll use. Here's a review of the details.

Beware tubing pulling loose
The end of the catheter, the point at which it is joined to the external unit, is the most fragile part of the system and the most likely to break. This proved to be the biggest inconvenience my facility encountered in using the pumps. During our product trialing process, several surgeons and staff members quickly found this to be a problem on certain models of pumps. Sometimes the catheter broke off even before the patient left the ASC.

If the catheter becomes separated from the pump, there is no way to repair it. You can't re-attach the tubing to the device: You'll have to implant an entirely new pump. And if the patient has already been discharged when the tubing is disconnected, installing a new pump would require impractical, unsafe and cost-prohibitive surgical intervention. They'll just have to remove the catheter early and forsake whatever pain relief the continuous infusion would have offered.

As a result, look for durability in the pumps you select for your post-op pain management interventions. These are, after all, medical devices you'll send home with your patients to operate without clinical supervision. You'll want them to be sturdy. Be sure to play with one of the devices to simulate normal activity, testing out the catheter-tube-to-pump-device connection yourself. Ask the manufacturer's representative how well they stand up to everyday use, how delicately they must be handled and whether they've received many complaints about breakage. Also ask if they've made any improvements to the product in terms of its construction. In our pump product trials, once we'd switched to a model with a sturdier connection, our clinicians reported that they didn't see another incident of the tubing pulling loose.

Carrying the load
An ambulatory pain pump is designed to be lightweight and portable. But a patient is carrying it around on his person, 24/7, for 3 or 4 days after surgery, and the device can end up being a weighty hassle to deal with. So you may want to base your purchasing decision not only on a pump's functionality, but also on how adaptable it is to patient mobility. We are, after all, in the business of ambulatory surgery.

Given the issue of potential catheter breakage, however, and the possibility that kinked tubing could obstruct the anesthetic infusion process, resulting in a failure of the pump to provide optimal pain relief, it's best if patients prevent the pump from dangling freely. To that end, you might consider a pain pump that offers some form of assistance in carrying it, such as a pouch or sleeve that the device fits into and that hooks to the patient's belt, waistband or shoulder sling. Such a feature offers added value in securing the device and decreasing the likelihood of accidental breakage, resulting in greater patient satisfaction.

Clinical involvement
In post-op pain management, as in any clinical intervention, patient safety should be your No. 1 priority. Since infection prevention is always a concern whenever a medical device is inserted into a patient's body, ask the manufacturer about the catheter's antibacterial abilities and obtain its quality initiatives ensuring that microbes will not enter the patient through the catheter. Also, given the rising numbers of patients with latex allergies or sensitivities, find out if the pump's components are latex-free.

The surgeon or anesthesia provider inserts the pump's catheter into the patient's surgical area while the nursing staff prepares the pump for use. But it is the entire surgical team's responsibility to teach patients and caregivers how to use the devices and manage any complications. Make sure that the pump you choose is easy for both your staff and your patients to operate.

From your staff's perspective, that means making sure they're well-educated on whichever pump you select for your facility, and that a pump's preparations don't present any undue difficulties. In order for the pump to work effectively, staff not only have to be able to fill the pump's reservoir accurately, but also secure the catheter to the patient (following manufacturers' directions) to prevent slack tubing and the risk of kinking, and possibly program the device's rate of medication delivery. A vendor that offers training and periodic in-services on the proper operation of its pumps is a valuable added service to a purchase.

Keep in mind that all pain pumps are generally similar in how they're inserted and how they function. A catheter, much smaller in size than those used for intravenous injections, is placed in a patient's shoulder, abdomen or other surgical area, exiting not through the incision but through a separate site. An extended-length catheter, perhaps 2 feet of tubing, attaches to the device that contains and dispenses the anesthetic.

FDA Focusing on Infusion Pump Safety

The FDA announced last month that it will increase its premarket oversight of infusion pumps in response to the more than 56,000 reports of adverse events associated with the devices that the administration says have resulted in serious injuries, 500 deaths and 87 product recalls in recent years.

According to the FDA, problems have occurred across multiple manufacturers and pump types and include ineffective designs that cause built-in safety alarms to fail, unclear on-screen prompts that lead to dosing errors and components that break under routine use as well as battery failures and device fires.

As part of its safety initiative, the FDA is requesting public comment on its draft guidance document calling for pump manufacturers to submit detailed design and engineering information for products under premarket review. Under the terms of the draft guidance, manufacturers would be required to conduct trials of their devices in settings where they will be used most often in order to demonstrate safe use prior to securing FDA approval. The FDA might also inspect device makers' manufacturing plants before clearing their products for sale.

The FDA says pump makers can submit devices for early review by government experts so potential software problems are detected in the initial phases of the design process. The FDA also intends to host a public workshop on May 25 and 26 to discuss safety issues and design changes that might reduce pump malfunctions.

— Daniel Cook

Patient education
Pain pumps don't demand much from their patient users. But this limited interaction with the devices doesn't mean that a short course of post-op, or even pre-op, patient instruction won't be necessary.

Some pumps offer patients the ability to administer themselves extra doses of anesthetic to deal with breakthrough pain. If you choose a model with this option, the self-administration should be a simple function for patients to accomplish. Similarly, if the pain pump you're considering is a programmable model with an adjustable rate of anesthetic delivery, you should make sure its method of input is lockable to prevent patients from accidentally or intentionally changing the rate.

Once all of the anesthetic contained in the pump has been dispensed, patients should remove the catheter as soon as possible to prevent any further risk of site infection and to spare themselves the burden of carrying an empty pump around for the remaining days until their follow-up visits with their physicians. They, or their caregivers, will be removing the catheters themselves at home, so easy removal is an important aspect to consider. Many ambulatory pain pumps are disposable, with the external unit and catheter tubing discarded upon removal, but if you choose a reusable model, be sure that your patients know to return the devices.

For both the self-administration and removal functions, how can you know if a pump is easy for a patient to operate and handle? You can usually gauge the simplicity of a device through a reading of its instructions. Is it something you can easily understand and feel comfortable with? (Some pump manufacturers even include a toll-free customer service telephone number for patients to call in the event they need assistance.) Or are the instructions lengthy and more difficult to understand? When instructions get complicated, there's usually a reason.

Cost of relief
The cost, and cost-efficiency, of equipment and supply purchases are always an issue in surgical care. Some insurers may cover the cost of pain pumps after some procedures, but other insurers, and other situations, may require patients to pay for them. But while cost is often a question in terms of pain pumps, we've found that their efficiency is rarely in doubt.

When patients have to pay for a pain pump out of their own pocket, we offer it to them at its cost to the facility as a line item in their practice charges. We let them know the advantages it's likely to bring to their recovery. They're often willing to pay for the added relief. If I were a patient, I know I'd appreciate that option.

At our facility, we use pain pumps predominantly for our abdominoplasty patients, and have seen great success with them among that population. From a cosmetic surgery point of view, tummy tuck patients are at the greatest risk of suffering deep vein thrombosis, so the sooner a patient can comfortably ambulate, the better the patient safety.

Your patient satisfaction scores will benefit as well. One of the most daunting pre-surgical fears patients have is how much pain they'll be in after surgery, but knowing that they'll have a pain pump afterward aids in reducing pre-op anxiety. Post-op pain, whatever the level, is one of the biggest complaints patients end up reporting. Pain pumps are a great reassurance to them.

Advanced Infusion
Alpha Infusion Pump and Catheter System
(770) 979-3379
www.advancedinfusion.com
Price range: $195 to $250
FYI: These latex-free pumps with kink-resistant catheters can provide the safe delivery and simultaneous controlled flow of topical anesthetics to multiple surgical sites, even at different rates, for localized pain relief. The controlled flow is a function of the unique patented design of the elastomeric pressure chambers and a steady-flow internal pressure regulator.

B. Braun Medical
Accufuser Plus
(800) 227-2862
www.bbraunusa.com
Price range: not disclosed
FYI: The Accufuser Plus infusion pump combines simplicity and safety for effective post-op pain control. The disposable pump fills easily with minimal force, requires minimal patient training and is lightweight with no heavy batteries. Its preset parameters and tamper-proof operation in a latex-free system also make it safe for ambulatory patient use.

I-Flow Corporation, a Kimberly-Clark Health Care Company
On-Q Pain Relief System
(800) 448-3569
www.myon-q.com
Price range: $275 to $650
FYI: The On-Q Pain Relief System provides automatic, continuous infusion of local anesthetic to a patient's surgical site area or peripheral nerves following surgery, reducing the need for narcotics and decreasing breakthrough pain. It requires little to no management, is completely portable and can be carried in a pouch or attached to clothing.

LMA North America
LMA PainCare System
(800) 788-7999
www.lmapaincare.com
Price range: not disclosed
FYI: LMA North America's comprehensive system of disposable pumps that serve wound sites or nerve blocks offer physicians a choice between quantifiable, mechanical pumps (with bolus-only or continuous flow with bolus options) or electronic, programmable and reusable pumps (with an hourly bolus). Durable, trimmable catheters are designed to fit multiple surgical situations.

Medical Flow Systems
SmartInfuser PainPump
(832) 239-9924
www.smartinfuserusa.com
Price range: $200 to $400
FYI: Distributed in the United States by SmartInfuser USA, this Israeli-made wound-bathing pump features an advanced, patented regulating system that offers a flow rate stability of +/-5% and lets physicians set and modify the device's key performance settings — reservoir volume, flow rate and bolus availability and amount — throughout the course of treatment.

Smiths Medical ASD
CADD-Solis Ambulatory Infusion System
(800) 258-5361
www.cadd-solis.com
Price range: $3,500 to $4,500
FYI: Designed for nurses, anesthesia providers, pharmacists and others involved in pain management, the CADD-Solis System and Medication Safety Software provide intuitive programming in a state-of-the-art system that meets industry standards for error-reduction features. The system promotes patient safety and patient care as well as scalable connectivity, letting it grow with evolving clinical and technology needs.

Summit Medical Products
AmbIT PCA and PreSet Electronic Infusion Pumps
(877) 352-1888
www.ambitpump.com
Price range: not disclosed
FYI: Reusable AmbIT pumps provide more than pain relief: They provide pain control, says the company. Each lets clinicians set the basal flow rate, bolus volume and bolus lockout. The volumetric accuracy of all pumps is +/-6%. The PreSet Pump has 4 preprogrammed delivery settings in addition to its patient-controlled anesthesia mode.

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