Health Informatics News |
- FDA Launches Initiative to Reduce Infusion Pump Risks
- McNutt Speaks on Incentive Funding at AHA
- Senate passes defanged pill bill
| FDA Launches Initiative to Reduce Infusion Pump Risks Posted: 27 Apr 2010 07:17 AM PDT The Washington-based U.S. Food and Drug Administration announced a new initiative to address safety problems associated with external infusion pumps. As part of its initiative, the FDA is moving to establish additional premarket requirements for infusion pumps through issuance of a new draft guidance to infusion pump manufacturers. The FDA is also announcing a May public workshop on infusion pump design, and launching a new Web page devoted to infusion pump safety. Failures of infusion pumps have been observed across multiple manufacturers and pump types, says the agency, adding that many of the reported problems appear to be related to deficiencies in device design and engineering. As part of its initiative, the FDA published draft guidance today recommending that infusion pump manufacturers begin to provide additional design and engineering information to the agency during premarket review of the devices. Additionally, the FDA issued a letter to infusion pump manufacturers, informing them that they may need to conduct additional risk assessments to support clearance of new or modified pumps. The FDA’s public workshop will be held May 25-26, 2010. To help reduce infusion pump risks, the FDA asks clinicians to consider the following general strategies. • Plan ahead and be ready to respond in the event of a pump failure. • Label infusion pump channels and tubing to prevent errors. • Check infusion pump settings and monitor patients for signs of over- or under-infusion. • Use available resources to prevent and respond to pump problems. • Report adverse events promptly to the FDA. |
| McNutt Speaks on Incentive Funding at AHA Posted: 27 Apr 2010 07:13 AM PDT Pamela McNutt, a leader among efforts by the Ann Arbor, Mich.-based College of Healthcare Information Management Executives (CHIME) to respond to federal policies and regulations, participated on a panel discussing potentials and pitfalls of federal stimulus investment in hospital information technology. The panel, part of the agenda at the American Hospital Association’ s Annual Membership Meeting in Washington, D.C., sought to raise the awareness of hospital executives in federal funding approaches as they craft HIT strategies. McNutt is senior vice president and CIO of Methodist Health System in Dallas . Participating with McNutt on the panel was David Blumenthal, national coordinator for the Office of Health Information Technology , and Raymond Grady, a trustee of the Cincinnati Health Alliance . According to CHIME, the AHA and CHIME have advocated nearly identical views on these issues, such as supporting a building block approach to meaningful use, changing proposed quality reporting requirements, and raising concerns over the basic time compression for spelling out the certification process, including how it impacts providers’ efforts to adopt health information technology. McNutt is chair of CHIME’s Policy Steering Committee and former chair of CHIME’s Advocacy Leadership Team. As PSC chair, she’s leading a team of CHIME members in developing a response to the CMS- and ONC-proposed rules, the last of which is the rule governing a permanent certification program. |
| Senate passes defanged pill bill Posted: 4/27/2010 © Palm Beach Post Convicted felons or bad doctors could no longer own pain clinics under a measure approved by the Senate on Monday, but the bill doesn't address how many pills the clinics can dispense. In Tampa, a pain clinic doctor accused of causing a man's death through careless prescribing gave up his medical license. |
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