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Invitation to Manufacturers of Infusion Pumps

(See Related Information)

FDA is inviting manufacturers of infusion pumps to contribute pump instructions for use and product information to a publicly accessible FDA home health care device website.

In June 2001 the FDA created the Center for Devices and Radiological Health (CDRH) Home Health Care Committee (HHCC) to review CDRH’s involvement in addressing problems that arise when devices are used in the home environment. After meeting with various stakeholders, the HHCC agreed with the stakeholders’ recommendation that promoting the safe use of infusion pumps presented a significant health challenge for which the Committee could focus the CDRH’s educational outreach efforts. As a result, the FDA is asking that all manufacturers of infusions pumps submit instructions for use and basic pump information to CDRH for every pump marketed during or after 1984. Once collected, the infusion pump information and instructions will become part of CDRH’s publicly accessible home health care device website. This website will increase the likelihood that users—home health nurses, patients, and patients’ families—will have continuous access to pump information and instructions for use to help ensure the safe and effective use of infusion pumps in the home.

How do stakeholders benefit from this project?

All stakeholders involved with infusion pumps may benefit from the results of this project. The infusion pump manufacturing industry benefits because the website is an additional way of providing consumers with important information about the pumps it manufactures, thus decreasing the likelihood that pumps will be incorrectly used and contribute to patient injury. Home health care providers benefit by having continuous access to the instructions for the vast variety of infusion pumps on the market, which will assist them in navigating the complex controls of an infusion pump. Home care personnel may be able to provide higher quality, more efficient health care to their patients as a result of this project. Patients benefit as the recipients of safer, more effective use of infusion pumps and may have a diminished risk of injury from incorrect infusion pump usage. The increased communication between stakeholders may have a significant impact on the safe use of infusion pumps as we collectively reduce the risk of incorrect pump use in the home.

How does the FDA benefit from this project?

FDA will benefit by introducing an additional way to accomplish our mission of protecting the health of the American public by providing an opportunity to directly help providers and patients safely and effectively use infusion devices. Through this website, FDA expects to increase the level of contact and communication among the manufacturing industry, home health care providers, and patients.

How do I submit pump information?

Submitting pump information is a four-step process:

  1. Right click on the following link Infusion-Pump-Form.xls and select “save target as…” to download the MS Excel file containing the required fields.
  2. Fill out all requested information in the spreadsheet for all applicable infusion pumps and save the file.
  3. Attach the completed Excel file and an electronic file of every pump’s current instructions for use to a blank e-mail message1.
  4. Submit the materials by sending the e-mail to homehealth@cdrh.fda.gov. HHCC staff will notify you by e-mail once your submission is successfully received.

1 If you are submitting instructions for patient controlled analgesia (PCA) pumps, please send instructions for use that do not include lockout instructions. To protect the safety of PCA users, the HHCC infusion pump website will refer home health providers to manufacturers for lockout instructions.

Who should I contact for more information?

You can contact the HHCC members responsible for this project by sending an e-mail to homehealth@cdrh.fda.gov. If you would prefer to speak with the Committee by telephone, you can call Mary Brady, HHCC Chair, at (301) 594-2102. For more information about the HHCC, please visit the Committee’s website at http://www.fda.gov/cdrh/cdrhhhc.

The information collection on this page has been approved by the Office of Management and Budget (OMB) under OMB Control No. 0910-0387. This approval expires on March 31, 2005. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Updated August 11, 2004

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