What should my first action be?

The FDA recommends that hospitals have a back-up plan in case the Baxter Colleague pump fails. Facilities are encouraged to notify all clinicians about this recall and provide information and/or training regarding the issue in how to handle high-risk infusions when the infusion pump fails.

Hospira is providing assistance in developing a back-up plan. The Hospira Option ^[1] provides assistance to healthcare facilities in safety goal assessment, plan development and implementation.

How many Colleague pumps are on the market?

The FDA believes there may be as many as 200,000 Baxter Colleague pumps currently in use. This includes approximately 50,000 triple-channel pumps and 150,000 single-channel pumps.

How much will my refund be?

Your refund is based on a formula agreed upon between Baxter and the FDA. The minimum value of your reimbursement is $1,500 for a single-channel pump and $3,000 for a triple-channel pump, or the purchase price if it was less than that amount. The maximum value is based on a formula where 90% of the purchase price is depreciated on a 10-year schedule through 29 June 2006. Contact Baxter for complete details and confirmation of your reimbursement amount.

Will there be enough replacement pumps on the market?

With so many pumps to be replaced and with only a few manufacturers, some hospitals may be concerned about infusion pump availability. Hospira is making a significant investment to increase production to provide more of our most reliable general infusion devices than ever before. Early planning may be appropriate if you have supply concerns.

Will Baxter provide me with triple-channel pumps?

If you choose replacement pumps as your option, Baxter is not required by the FDA to provide you with three single-channel devices for your triple-channel Colleague. Baxter has the option to mix device replacements with cash reimbursements and offer you fewer channels of infusion capability than the pumps being replaced.

When must my return of Colleague pumps be completed?

The FDA has ordered that all Colleague pumps be returned to Baxter by 14 July 2012, but there are steps you must take before then. To qualify for the reimbursement, pump owners or users of Baxter Colleague pumps must complete a Certificate of Medical Necessity (“CN”) form and return it to Baxter no later than November 14, 2010.

When will I receive my reimbursement from Baxter?

The FDA requires Baxter to issue your refund within 10 days of receiving your returned pumps.

Should I just wait for Baxter to guide my replacement process?

While you certainly need to communicate with Baxter regarding the recall, reimbursement and replacement action, it would also be prudent to begin planning your replacement strategy immediately. Hospira has created The Hospira Option ^[1] to facilitate your decision-making process, including like-for-like pump specification, financial constraints, roadmap for safety software and implementation plans.

What about my consumables contract?

The FDA has ordered that Baxter may not enforce shortfall or minimum purchase penalties if your new pumps cannot use Baxter consumables. The FDA specifically mentions pricing tier changes are allowed.

If you’re affected by this recall, call Hospira to develop a plan to move your facility to Hospira infusion pumps. The Hospira Option ^[1] provides assistance to healthcare facilities in safety goal assessment, plan development and implementation.

What other information is available?

Baxter released a transition guide to provide some guidance to Colleague owners on September 14, 2010. The guide includes some recommendations on your decision process and considerations through implementation. The guide is available through www.baxter.com ^[2].

The FDA has also made their orders available to the public through www.fda.gov ^[3].

For more information about alternate pumps, you may also contact Hospira ^[1].

What should I plan for in the transition?

Whether you choose Baxter or another brand of pumps, there will be implications for pharmacy and clinical workflow including training and deployment of the equipment. It may also include changeover of your IV sets and solutions, and if safety software is included you will need to update your drug library. A smooth changeover will require significant planning and may include IT software or wireless network integration as well.

Hospira offers a dedicated team of pharmacy consultants, IT consultants and clinical nurse trainers to assist in the transition. Our team can share full details. Just sign up for The Hospira Option ^[1] to receive more information.

I heard something about a recall on Sigma. Will this impact my Colleague reimbursement?

Sigma has announced a voluntary recall of 17,000 devices that will require the units to be removed from service and shipped for repair or replacement. Details are available at www.sigmapumps.com ^[4]. Hospitals expecting Colleague replacements should contact Baxter regarding availability of replacement units to determine any impact on shipment or availability. Hospitals electing to use the Colleague reimbursement option should not be impacted.