Dive Brief The Food and Drug Administration called for further testing by Philips to evaluate the risks of soundproofing foam used in its recalled sleep apnea machines and ventilators. “We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Thursday statement that included more details on the recall and the agency’s actions. Philips has claimed use of the devices is “not expected to result in appreciable harm to health in patients,” but agreed with the FDA’s recommendations to run additional testing. Dive Insight Philips’ recall of sleep apnea devices and ventilators has continued since June 2021, when the company began an effort to repair or replace millions of devices that used polyester-based polyurethane (PE-PUR) foam for soundproofing. ...
Dive Brief The Food and Drug Administration is expanding a program for accelerating device development to cover neurological and physical medicine technologies. Initially, the voluntary total product life cycle advisory program (TAP) pilot was limited to cardiovascular devices. This week, the FDA Office of Neurological and Physical Medicine Devices also began accepting enrollment requests. Expanding the program to cover cardiovascular, neurological and physical medicine devices is part of a scaling up of the pilot, which enrolled 12 products in its first year. The FDA could enroll up to 45 additional devices over the coming year. Dive Insight The FDA and industry agreed to the TAP pilot in MDUFA V. While the industry initially opposed the advisory program, the FDA secured a chance to show it can “spur more rapid development and more rapid and widespread patient access” by facilitating early engagement and coordination with external stakeholders. A year ago, the ...
Dive Brief Hamilton Medical’s recall of ventilators for a software problem was designated Class I by the U.S. Food and Drug Administration, the agency wrote in a Monday notice. Hamilton contacted customers in June after learning that its C1, C2, C3 and T1 ventilators switch to “ambient state” if used in neonates for more than 91 days without a restart. In ambient state, the device sounds an alarm and no active ventilation is provided to patients. In light of the fault, which has caused 80 complaints but no injuries or deaths, Hamilton is asking users of its ventilators to regularly restart their devices. Dive Insight Hamilton sells mechanical ventilators for use in adults, children and infants. The problem that caused the Class I recall happens when the devices “are used for long-term ventilation in neonatal group.” If the ventilation time exceeds 91 days, the devices enter ambient state, causing them ...
Dive Brief Penumbra is expected to retain and take market share in the peripheral vascular market over the next 6 to 18 months, according to a survey of physicians by J.P. Morgan analysts. The firm surveyed 25 vascular surgeons, who forecast that Penumbra will take share as the broader peripheral market is expected to grow. “New products should drive share capture across both arterial and venous,” J.P. Morgan analyst Robbie Marcus wrote in a Thursday research note, although the majority of doctors surveyed expect to continue using devices from multiple manufacturers even when targeting the same vessels. Dive Insight Alameda, Calif.-based Penumbra recently launched two new thrombectomy devices: Lightning Bolt 7, which is designed to remove clots from the arteries, and Lightning Flash, which is designed for the veins and pulmonary arteries. The surgeons’ reception to both devices was “broadly positive,” Marcus wrote, with the majority saying they expected Lightning ...
April 12, 2023 By Jim Hammerand Leave a Comment FacebookTwitterLinkedIn New ethylene oxide rules from the EPA would reduce EtO emissions from commercial sterilizers by 80%, the agency said. The EPA this week proposed new regulations for companies that sterilize medical devices with EtO, following up on last week’s proposal for new EtO rules on chemical plants that make or store the sterilant. EtO is the most common method of medical device sterilization, used for around half of the 40 billion devices sterilized each year in the U.S. For some devices, there’s no alternative to EtO because gamma ray and electron beam sterilization can only be used on certain materials. FAQ: What is electron beam sterilization? But health risks for sterilization plant workers and neighbors have the EPA, FDA, Centers for Disease Control and Prevention (CDC) and Occupational Safety and Health Administration (OSHA) working together to reduce those risks without reducing sterilization capacity. “OSHA’s mission is to ...
By Brenda Goodman, CNN Updated 2:49 PM EDT, Tue April 11, 2023 The US Environmental Protection Agency on Tuesday proposed a set of new restrictions on facilities that use the cancer-causing chemical ethylene oxide, a colorless, odorless gas that is used to sterilize medical devices and spices. The agency said the new rules, which have not been finalized, would help to reduce ethylene oxide gas that these facilities release by 80%, bringing emissions below a Clean Air Act standard for elevated cancer risk. Communities exposed to ethylene oxide gas have been pushing the EPA to put tighter controls on plants that use ethylene oxide gas. In 2018, an EPA report found that dozens of communities across the nation faced elevated cancer risks because of trace of amounts of ethylene oxide released into air as part of the sterilization process. The EPA issued the report on the new risks without issuing a news release, as ...
A lot of emphases is placed on medical devices and equipment necessary for ensuring the well-being of patients, and rightly so. There are however medical products that are often overlooked, but essential to every medical institution. These are the tool that keeps your medical facility sterile and safe, the cleanroom wipes and disposable mop covers.
Ddu (drugdu.com) is an ideal platform to find all your healthcare-related products or devices. You will find the most trusted medical equipment suppliers or manufacturers linked to Ddu on its B2B online platform. One of the essential commodities to set-up a hospital or nursing care center is a hospital bed. Hospital beds have evolved from simple resting mattresses to electrically powered multifunctional beds that provide comfort to the patient and convenience to the caretaker as well. Ddu brings to its consumer’s hospital bed suppliers/ manufacturers that are proficient in manufacturing simple examination beds to automatic multifunctional ICU beds. One of the hospital bed suppliers on Ddu is: Surgitech India: This company, as its name suggests is a manufacturing company from India which supplies hospital furniture, delivery bed, blood donor chair, Led X-ray, etc. On Ddu, it supplies its ISO certified examination bed which has 3 sections. Its height can be ...
The competition among medical diagnostic equipment suppliers/manufacturers is really tight as they have to come up with the latest technology, high accuracy diagnostic machines. New researches in the field of medicine ask for new diagnostic equipment every now and then. Ddu (Drugdu.com) the leading global medical devices online B2B platform has collaborated with the best medical diagnostic equipment suppliers/manufacturers in the industry for providing the best equipment to consumers. Ddu features the following companies on its platform: Medicom MTD Ltd. is a manufacturing company based in Russia which builds the Electroencephalograph-recorder “Encephalon-EEGR-19/26″. It gives a high technical performance and includes a unique feature of a changeable configuration of portable electroencephalograph-recorder ” Encephalon-EEGR-19/26″ which means that it can be applied to various fields of neurophysiology. It is CE certified and has a warranty of 2 years. Getein Biotech, Inc. is a manufacturer from China which is a professional biotechnology firm that ...
Medical ultrasound devices are used as an imaging technique to visualize internal soft organs in the body. It is extensively used for ante-natal care in pregnant women and to diagnose cardiac abnormalities.
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