Product Watch 395

FDA Issues Guidance to Infusion Pump Manufacturers

The US Food & Drug Administration (FDA) has issued new guidance and letters to infusion pump manufacturers as part of an initiative to institute stricter pre-market requirements. The FDA has asked manufacturers to conduct additional risk assessments to support clearance of new or modified pumps and proposed new guidelines to manufacturers advising them to run more in-depth clinical trials. The federal watchdog agency organised a General Hospital and Personal Use Devices Panel to review the risks posed by the pumps after 18 recalls over a five-year period. Manufacturers can also voluntarily submit the device’s software code for analysis prior to the FDA’s review of an application, the letter said. Additional pre-market requirements for infusion pumps are to be established, in part through issuance of a new draft guidance to infusion pump manufacturers suggesting they provide additional design and engineering information to the agency during premarket review of the devices. There have been almost 17,000 adverse events, of which 310 deaths and 12,000 injuries occurred possibly as a result of problems caused by pump failures, the FDA’s report said. A public meeting is scheduled for 25-26 May to discuss the device’s safety issues and issues related to improvement in cooperation with international regulatory bodies.

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