PubMed Health⌕ Search
Home/Archive/PubMed

PubMed · 3273919

Hypo/hyperthermia machines.

View original source ↗Export metadata ↓

Abstract

We evaluated three hypo/hyperthermia machines from three manufacturers. [Because each manufacturer's blankets can be used with other brands of hypo/hyperthermia machines, we evaluated them separately; see our report in this issue.] Two units are rated Acceptable, and one is rated Acceptable-Not Recommended. Purchasing considerations include safety features, status and warning indicators, ease of use, and ease of servicing.

Explore related subjects

Disposable EquipmentEquipment DesignEquipment SafetyEvaluation Studies as TopicHumansHyperthermia, InducedHypothermia, InducedIntraoperative CareMaintenanceManuals as TopicTechnology Assessment, BiomedicalJournal Article

Keep this discovery

Explore connections, maps & timelines

BibTeXRIS

1988. Hypo/hyperthermia machines.. https://pubmed.ncbi.nlm.nih.gov/3273919/

Cite the original work for its findings. Save a collection to share your selection of sources.

KEEP EXPLORING

Related citations

PubMed2006

Medical devices; reprocessed single-use devices; requirement for submission of validation data. Direct final rule.

The Food and Drug Administration (FDA or we) is amending certain classification regulations for reprocessed single-use devices (SUDs) whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This action codifies actions taken in previous Federal Register notices in accordance with MDUFMA.

Disposable Equipment↗