RETURN RECEIPT REQUESTED
April 23, 2010
Dear Infusion Pump Manufacturer:
FDA’s records have identified you as the “Official Correspondent” to the Medical Device Manufacturer stated above. Please ensure that the following message is relayed to the Most Responsible Individual at the Medical Device Manufacturer.
The Food and Drug Administration (FDA) is notifying you of our intent to improve the current premarket and postmarket regulatory processes associated with infusion pumps. These actions are being taken in light of serious adverse events noted in Medical Device Reports and an increasing number of recalls involving several different types of infusion pumps. The FDA believes that this effort will help mitigate current risks and reduce future risks associated with infusion pumps.
FDA has seen an increase in the number and severity of infusion pump recalls. Analyses of MDRs have revealed device problems that appear to be a result of faulty design. Between January 1, 2005 and December 31, 2009, FDA received over 56,000 MDRs associated with the use of infusion pumps. Of these reports, approximately 1% were reported as deaths, 34% were reported as serious injuries, and 62% were reported as malfunctions.
The most frequently reported external infusion pump device problems are: software error messages, human factors (which include but are not limited to use error), broken components, battery failure, alarm failure, over infusion and under infusion. In some reports, the manufacturer was unable to determine or identify the problem and reported the problem as “unknown”. Subsequent root cause analyses revealed that many of these design problems were foreseeable and, therefore, preventable.
We have evaluated and analyzed a broad spectrum of external infusion pumps across manufacturers and concluded there are numerous, systemic problems with device design, manufacturing, and adverse event reporting. We believe these types of problems are preventable. To address these device problems, manufacturers may need to conduct additional risk assessments of new products or changes to products currently being marketed.
Given the concerns involving software errors, we offer, on a voluntary basis, a static analysis of your software for a new or changed infusion pump. The analysis can help manufacturers identify potential defects earlier in the product development cycle and support validation of the software. This analysis can be performed in conjunction with or in advance of a premarket submission for that device. We believe this action can facilitate the development of safer infusion pumps while reducing costs to manufacturers. For further information, please contact Mr. Richard Chapman, Division of Electrical and Software Engineering, Office of Science and Engineering Laboratories at (301) 796-2585 or Richard.Chapman@fda.hhs.gov.
We strongly recommend external infusion pump manufacturers meet with the Agency early in the device development process to discuss submissions regarding new infusion pumps or changes to existing devices. For further information, please contact Mr. Anthony Watson, Director, Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Office of Device Evaluation at 301-796-6296 or Anthony.Watson@fda.hhs.gov.
FDA believes these actions, early communication between the FDA and infusion pump manufacturers, and additional actions being announced by the agency today will result in safer and more effective infusion pumps. We look forward to working with you on this important public health issue.
Jeffrey E. Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration