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medical devices 92 articles

FDA speeds up medical device recall notification in 2017

The Food and Drug Administration (FDA) vowed that it will deliver warnings regarding recalled medical devices to the public in a more timely manner in 2017. The FDA defines a medical device recall as a correction or removal action to address a problem with a device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. When the FDA learns of a company’s recall or removal action regarding a medical device, the agency reviews the strategy the company poses ... Read More

FDA releases final rule on symbols for medical devices

The Food and Drug Administration (FDA) is allowing symbols to be placed on the labels of medical devices without accompanying text, and giving manufacturers more control over what symbols are used, in a final rule released this week. The rule is now published in the Federal Register. In 2013, the FDA had proposed all symbols be developed by a specialized group, such as the American National Standards Institute or the International Organization for Standardization. But the agency said in its final rule that manufacturers could better discern whether a symbol “Is likely to be read and understood by the ordinary individual ... Read More

OSHA investigates Medical Manufacturing Plant After Workers Suffer Amputation Injuries

After two workers had their index fingers partially amputated in separate workplace accidents last October, federal investigators found numerous machines that lacked required safety guards inside the Becton, Dickinson and Company (BD) plant in Holdrege, Neb. The Occupational Safety and Health Administration (OSHA) cited the global medical technology company on April 11 for one repeat and 12 serious safety violations that the agency said contributed to the finger amputations, which occurred on Oct. 14 and Oct. 22, 2015. Multiple other hazards not related to those injuries were also found, resulting in proposed fines of $122,700. BD is a global medical technology company operating in ... Read More

Republicans propose massive changes to FDA oversight of drugs, medical devices

House Republicans want to dramatically overhaul the Food and Drug Administration’s (FDA) regulation of prescription drugs and medical devices, tripling patent protection for brand-name drugs, stripping detailed safety information from promotional materials, cutting some of the red tape in clinical trials, and expediting approval of medical devices. The 400-page draft bill, known as the 21st Century Cures Initiative, comes after nine months of meetings from both parties on the House Energy and Commerce Committee. The guidance is designed to modernize FDA oversight of drugs and medical devices, and regulations. While both parties offered input, most of the priorities come from ... Read More

BBB warns of scams promising payouts for medical device settlements

The Jacksonville, Fla., Better Business Bureau (BBB) is warning consumers of a scam involving legal settlements on medical devices, and to be wary of callers promising big payouts but only after the consumer agrees to lay out cash. The Jacksonville BBB says it received a report from a woman who got a phone call claiming that the woman was entitled to $25,000 as part of a class action lawsuit settlement involving a medical procedure in which she was implanted with a bladder sling, also known as transvaginal mesh. The woman was told to put $150 on a Green Dot card – ... Read More

North Carolina senate supports measure to shield drug makers from personal injury claims

The North Carolina Senate has approved an amendment to a bill that would give pharmaceutical companies protection against litigation regarding adverse effects from their drugs if they have previously warned of specific side effects and followed all Food and Drug Administration (FDA) rules. If the legislation becomes law, North Carolina consumers would likely have a more difficult time suing drug companies for injuries caused by their products. Supporters say the measure will put drug companies on equal footing with consumers. Opponents disagree, saying the move could hurt people who hare harmed by side effects that emerge after a drug is ... Read More

5 health products that are dangerous to women

Medical devices, prescription drugs, and even consumer products offer unique benefits to women. But sometimes they can cause unexpected harm. Here are some products that women should use with caution: 1. Talcum powder – It might sound far-fetched, but women who apply baby powder or body powder regularly to their genitals are a third more likely to develop ovarian cancer than women who do not use the product. Talcum powder, derived from talc, contains various elements, including asbestos, which is a known carcinogen. Researchers say the powder when applied to the genitals can travel up the vagina through the uterus ... Read More

3 medical devices that can harm you

Medical devices are vitally important to the industry. They vary in complexity and application, from tongue depressors and disposable gloves to implants and prostheses. Because they are used to diagnose, prevent or treat disease or other conditions, these items are regulated by the Food and Drug Administration (FDA) to ensure their safety and efficacy. However, this does not guarantee the devices don’t have hidden design flaws that can cause serious health risks. Here are three commonly used medical devices that were designed to help people, but ultimately caused more harm that good: 1. Transvaginal mesh – Also known as vaginal ... Read More

Studies reveal not all FDA-approved drugs and medical devices receive adequate testing

According to articles in the Journal of the American Medical Association (JAMA), there can be major discrepancies in the amount of testing medical devices and drugs go through before being approved or given to patients. For example, the Food and Drug Administration (FDA) process used to approve certain heart devices using the assumption that if earlier versions of the product are safe and effective, newer products are, too, according to a recent study. Aaron Kesselheim, an assistant professor at Harvard Medicine School and author of one of the studies, notes that these devices go through rigorous testing to begin with, ... Read More

DePuy settles ASR metal hip complaint before trial start

Johnson & Johnson has settled a personal-injury lawsuit that accused its DuPuy Orthopaedics unit of manufacturing defective metal-on-metal hip replacement devices. The lawsuit had been selected as a bellwether case among several other cases DePuy faces over its ASR hip implants, and was destined for an October 15 trial in San Francisco Superior Court. In March, a Los Angeles jury ordered DePuy to pay Loren “Bill” Kransky, a retired prison guard, $8.3 million in damages for injuries he allegedly received from an all-metal ASR hip device made by DePuy. Mr. Krannsky’s case was chosen as the first of more than ... Read More