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Enthermics Medical Systems is now ISO Certified December 29th, 2009 was a red letter day for Enthermics Medical Systems. That was the day we received official notification that we are an ISO 13485:2003 certified company. Back to Top It’s Been a Year of Change: In July 2009, ECRI published a hazard report update changing the recommended safe temperature setting for blanket warmers. The Association of perioperative Registered Nurses (AORN) amended their Recommended Practices for a Safe Environment of Care (2010) to reflect ECRI’s updated guidelines. While the Joint Commission currently does not have any required range settings for the temperature of blanket warming cabinets, their environment of care standards (EC 6.10 and 6.20) require that institutions provide written plans concerning the effective, safe, and reliable operation of medical equipment. To that end, Lorna R. House, RN, MS, CNOR wrote a paper regarding warmed blankets that we’d like to share with you.  Back to Top Blankets Warmed to 200°F Do No Harm Lorna R. House, RN, MS, CNOR Overview A warmed blanket is no longer considered just a comfort item for the surgical patient; it is also an important modality in maintaining a surgical patient in a normothermic state. Incidence of inadvertent hypothermia is estimated to occur in 50%-90% of all surgical cases. Besides patient discomfort, consequences of even mild hypothermia can produce a host of adverse physiological and psychological responses. Evidence-based practices show that maintaining normothermia in a surgical patient from the time of admission into the preoperative holding area, through surgery, to discharge from the post anesthesia care unit (PACU) results in faster recovery and discharge, lower infection rates, reduced hospital costs, better thermal comfort, and increased patient satisfaction. Read full article here (PDF) New Faces Matthew Rotterman joined Enthermics as our Eastern Regional Sales Manager, and is based in Ohio.
Tom Kloha started C.C. & E. Inc. in 1995. At the time the company represented a single line of medical products and concentrated its efforts toward medical facilities primarily in the State of Michigan. As the years passed and new lines were acquired, the business expanded to sell to medical facilities nationwide, and even the occasional international client.
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By definition, ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices.
Matthew’s background includes serving as a Community Educator for Alternate Solutions where he marketed value-added conceptual healthcare services for post-hospital rehabilitation facilities. He has also served as Territory Manager for Astrazeneca, the manufacturer of such products as Nexium, Seroquel and Symbicort. In addition, Matthew has a background in selling capital equipment and consumables with such notable companies as NCR and AT&T.
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