Masimo SET Receives FDA Clearance
Masimo Corporation, Irvine, Calif, has received FDA 510(k) clearance for its Masimo SET pulse oximetry system and sensors, including accuracy specifications during conditions of motion and low perfusion. This is significant because these are the conditions that have traditionally caused pulse oximeters to fail. Masimo SET is the only pulse oximetry system to receive clearance from the FDA for accuracy claims under these conditions.
Masimo SET represents an advancement in pulse oximetry since the invention of pulse oximetry over 25 years ago. The Masimo SET pulse oximetry system is able to account for interference caused by patient motion and offers the sensitivity to read small signals. Masimo SET utilizes proprietary algorithms and sensor technologies to separate the arterial signal from noise in real time. The result has been a virtual elimination of false alarms and vastly improved performance during low perfusion, which has been proven in 17 published clinical studies.
Masimo does not sell directly to end-users but rather licenses its technology to all patient-monitoring companies. By utilizing this strategy, hospitals will be able to continue to purchase monitors from their preferred vendors who can integrate the Masimo technology into their monitors. Masimo prices its technology and sensors to its licensees such that they can be offered to end-users at prices that are competitive with those of products currently offered. (877) 4-Masimo; www.masimo.com.
Respironics Comments on Revised NPPV Guidelines
Respironics Inc, Pittsburgh, recently commented on announcements made by the Medicare program regarding revised coverage and reimbursement policies for noninvasive positive pressure ventilation (NPPV). The revised guidelines first appeared on the Durable Medical Equipment Regional Carriers (DMERCs) Web site in May 1999.
According to Dennis S. Meteny, president and CEO of Respironics, the DMERCs incorporated many points that were recommended by physicians at the NPPV Consensus Conference held in February 1998 and subsequent communications with the Medicare program. However, in an attempt to correct certain provisions in its original guidelines, which were issued in July 1998, the DMERCs eliminated other important conclusions detailed in the conference report. Respironics states that the current draft proposal is still overly restrictive for patients and is administratively burdensome for clinicians and health care providers.
The DMERCs also stated that the Health Care Financing Administration (HCFA) will consider whether NPPV ventilators should be changed from the current frequent and substantial service category to a capped rental category for reimbursement purposes. However, Respironics believes that the contemplated change in reimbursement status can be done only through an act of Congress. The company will continue its discussions with HCFA and members of Congress to prevent the misclassification of these ventilators into the capped rental category. (412) 731-2100; www.respironics.com.
Heart Attack Survivor Returns to 12K Racing with Sunrise Medical’s Oxygen Conserving Device
Heart attack survivor Ray Cottle no longer needs to worry about having enough oxygen to enjoy his most challenging competition—an annual 12K cross-country walking event—since he began using the DeVilbiss Versatile PulseDose oxygen conserving device from Sunrise Medical, Longmont, Colo.
Cottle, who underwent double by-pass surgery 4 years ago for a heart condition known as pulmonary fibrosis, ran out of oxygen at the end of last year’s race. This year, however, he had nearly one-third of the oxygen left in his cylinder at the end of the day.
“Last year for this event I used the same cylinder with another manufacturer’s conserving device at its maximum setting and I ran out of oxygen,” Cottle says. “This year with the DeVilbiss Versatile PulseDose, I received adequate oxygen throughout the race.”
The DeVilbiss Versatile PulseDose was introduced in November 1998 and is a conserving device that can triple the use time of a standard oxygen cylinder. Its patented PulseDose technology delivers the needed amount of oxygen at the beginning of every breath. (800) 333-4000; www.sunrisemedical.com.
IL Announces Fiscal 1998 Results and New Agreement
Instrumentation Laboratory SpA (IL), Lexington, Mass, and Milan, Italy, has released its results for the fiscal year that ended November 30, 1998. IL also announced a new Strategic Alliance and Cross Distribution Agreement with Beckman Coulter Inc, Fullerton, Calif.
For the year ending November 30, 1998, net revenues decreased Lit. 20.5 billion, or 4.7%, to Lit. 415.4 billion from Lit. 435.9 billion in fiscal 1997. The decrease is mainly attributed to lower sales in Italy due to competitive product offerings, the company’s efforts to rebuild its sales force, and lower sales of hemostasis products by Beckman Coulter.
IL’s majority shareholder, CH-Werfen, entered into the new Strategic Alliance and Cross Distribution Agreement with Beckman Coulter. The new agreement, which replaces an agreement entered in 1992, has an initial term of 10 years. The parties may extend the contract for up to 10 additional years. Beckman Coulter will continue distributing IL’s hemostasis products (including IL’s recently acquired Hemoliance product line) in North America. IL will continue to distribute Beckman Coulter’s hematology, flow cytometry, and particle characterization products in Italy and Austria. (781) 861-0710; www.ilww.com.
Pulmicort Turbuhaler Improves Asthma Symptom Control
AstraZeneca LP, Wayne, Pa, has announced that a once-daily treatment regimen with its inhaled corticosteroid, Pulmicort Turbuhaler® (budesonide inhalation powder), in adult patients who have stable, mild to moderate asthma showed significant improvement in asthma control. The results were published in the July issue of the Journal of Allergy and Clinical Immunology.
The 18-week trial involved 309 adults who received either Pulmicort Turbuhaler (400 mg or 200 mg) once daily or placebo for 6 weeks. In the next 12 weeks, the 400-mg dose was reduced to 200 mg. In the patient groups treated with Pulmicort Turbuhaler, the study revealed a significant decrease in bronchodilator use, increased lung function, and improved asthma symptom control. Researchers concluded that Pulmicort Turbuhaler, in doses as low as 200 mg once daily, may be an appropriate introductory or maintenance dose in patients with stable, mild to moderate asthma.
Prior to this approval, the recommended dosing regimen for the entire class of inhaled corticosteroids had been two to four times a day. (800) 942-0424; www.astrazeneca-us.com.
Oridion Announces Capnography Agreement
Oridion Medical Inc, Danville, Calif, has recently signed an OEM agreement to supply its patented Microstream™ capnography to Medtronic Physio-Control, Redmond, Wash, a manufacturer of defibrillators and other emergency medical products. The new agreement marks the first time Oridion has engaged a partner in both a private label and OEM relationship.
Under the new agreement, Medtronic Physio-Control will integrate Oridion’s Microstream-enabled MediCO2™ capnography module into its new LIFEPAK®12 defibrillator/monitor series. Earlier this year, the two companies launched a private label arrangement for Medtronic Physio-Control to market handheld Microstream capnographs using their trade names LifeCap® and LifeCap Plus (with pulse oximetry).
Oridion Medical designs and produces technically advanced noninvasive carbon dioxide monitoring equipment employing its patented Microstream co2 measuring technology. (888) ORIDION; www.oridion.com.
Passy-Muir Receives ISO 9001/EN 46001 Certification Upgrade
Passy-Muir, Inc, Irvine, Calif, manufacturer of the patented Passy-Muir Tracheostomy & Ventilator Speaking Valves, has announced that it has received a quality system certification upgrade to ISO 9001/EN 46001 for its products. The Tracheostomy & Ventilator Speaking Valves are the only closed position “no leak” speaking valves and are distributed in more than 35 countries worldwide. (800) 634-5397; www.passy-muir.com.
MSA Develops Respiratory Cartridge Change-out Schedules
After months of extensive studies, Mine Safety Appliances (MSA), Pittsburgh, has developed a mathematical model for determining cartridge change-out schedules.
In April 1998 the Occupational Health and Safety Administration (OSHA) implemented a revision to its respiratory protection standard—29 CFR 1910.134—the first in more than 25 years. The most significant change for both employers and workers is the need to utilize air-purifying cartridges and canisters that have an end-of-service-life indicator (ESLI) or are changed according to a schedule developed from objective data. To help respiratory users comply more cost-effectively with the ESLI change-out schedule requirement, MSA began conducting the most comprehensive chemical cartridge breakthrough study to date.
The study, which began in May 1998, comprised a series of tests and data analysis aimed at developing a more comprehensive approach to MSA cartridge change-out schedules. MSA conducted approximately 350 different tests; experiments ran on five different test systems, 7 days a week, 24 hours a day. The study took more than 3,000 hours and cost approximately $250,000.
As a result, MSA developed a scientific approach with an accuracy level of ±25%, and is as accurate as the Woods Equation (a predictive mathematical model for estimating the service life of organic vapor cartridges) and can produce change-out schedules with longer cartridge service life values. Customers can obtain MSA’s scientific model by accessing MSA’s Cartridge Life Expectancy Calculator, an automated Web-based application, on its Web site at www.MSAnet.com/safetyproducts/cartlife. (800) 851-4500; www.msanet.com.
Monaghan Peak Flow Meter Available Over-The-Counter
Monaghan Medical Corp, Plattsburgh, NY, announces that its TruZone™ Peak Flow Meter (PFM) is now available over-the-counter.
The company recently received FDA 510k clearance to market the TruZone PFM without prescription labeling—a first for Monaghan. TruZone PFM is one-size-fits-all and is recommended to patients of all ages with respiratory disease. Its clear, ergonomic body shape uses a logarithmic scale, making calculations unnecessary for zone management. For asthma monitoring, patients are advised to use TruZone PFM and the enclosed Color Zone® Tape in conjunction with a treatment plan under the direction of a physician or other licensed practitioner.
TruZone PFM has an unconditional 1-year guarantee. It also meets the National Asthma Education and Prevention Program guidelines and the American Thoracic Society Standardization of Spirometry. For more information and a demonstration, call (800) 833-9653; www.trudellmed.com.
In the June/July issue of RT, the telephone number for SensorMedics Critical Care was incorrectly printed. The correct number is (800) 520-4368.