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Every year, more than 7 million patients receive home health medical care under the direction of their medical providers. Many such cases require the use of medical devices in the home to treat or maintain a wide variety of conditions. The devices are put to use by the patient directly, or with the help of a caregiver or family member. While, to a certain extent, home health providers may be able to offer a degree of training in the proper utilization of a home-use medical device, federal regulators have expressed concern over the lack of a standardized labeling format for the devices.

Home-use medical devices include a wide range of equipment, including more simple things like canes and crutches, to more complicated items such as infusion pumps, glucose monitors, and continuous positive airway pressure (CPAP) machines. According to the U.S. Food and Drug Administration (FDA), there have increasing reports of adverse events related to medical devices used in the home, many of them related to the unavailability of the manufacturers instructions.

Over the course of time, and many devices are used in the home for years, the original packaging and documentation can easily be lost or separated from the equipment. This can create problems for a family member or new caregiver who may be unfamiliar with the proper use of the medical device. For a “lay user” without formal training, the device label and package insert may be his or her only possible resource to facilitate the device's proper use.

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Tagged in: Fda Medical device

Defective medical devices are not limited to those implanted in a patient's body. Patients who must use canes, wheelchairs, or other devices to get around are susceptible to a whole array of device warnings and risks that other Americans are not. According to The Baltimore Sun, it is imperative to maintain wheelchairs and walkers as you would a car, as a lack of proper maintenance can result in unsafe conditions such as broken or bent parts. If the device is broken, it can result in the requirement of extra energy to get around, more pain, or—worst-case scenario—a devastating accident that can result in hospitalization.

The onus of maintaining these devices is not, however, solely the responsibility of the patient. Sometimes these devices, and machinery used in conjunction with them, are not properly built or vetted before it is put on the market. One such incident occurred earlier this year, when a California-based manufacturer was ordered to pay a $1.75 million civil penalty for continuing to sell faulty wheelchair lifts. The lifts were recalled by the National Highway Traffic Safety Administration (NHTSA), according to an agency report, as they had been labeled as potential fire hazards. Even after the recall was announced, the manufacturer, Rincon Corporation, continued selling the lifts to the public.

More than 4,000 Rincon lifts had been sold to manufacturers of buses and vans to help meet the transportation needs of wheelchair-bound patients. The recall was first announced in September 2012 because the lifts contained a defective cable determined to increase the risk of starting a fire. When the NHTSA followed up with the van and bus companies in 2013 to make sure that Rincon had informed them of the recall, the administration found that though Rincon had stopped producing the defective lifts it had not stopped selling them. Rincon later reported that it had sold 356 defective lifts after the recall had been issued.

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The benefits and risks of mammography screening have long been debated in the scientific community. According to the National Cancer Institute, while screening may be effective in reducing the number of deaths from breast cancer through early detection of a cancerous tumor, it can, at the same time, cause harm to the woman who is participating. The most common limitations of breast cancer screening can include false-positives, overdiagnosis, false-negatives, discomfort, radiation risk, and anxiety.

Yet a new medical device approved in February by the U.S. Food and Drug Administration, may alleviate some of the risks posed by mammograms, according to the University of Rochester Medical Center (URMC). The device, which passed the FDA's most stringent premarket approval process, was developed by a URMC startup company, Koning.

The Koning Breast CT system is intended to diagnose cancer in women who have signs or symptoms of the disease, and those who have abnormal findings after a standard mammogram. As of right now, it is not intended to replace annual screenings, yet the use of the new device may help to alleviate the risks of overdiagnosis or false-positives. Because it is also the first breast imaging device that allows for a readable picture without compression of the breast tissue, the Koning Breast CT system is also a more comfortable procedure for patients undergoing treatment.

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Sometimes a medical device meant to provide relief for patients suffering and expedite healing causes more pain than relief. One of these devices is known as a pain pump, most commonly used in patients recovering from shoulder surgery after a serious shoulder injury. According to the New York Times, these devices became popular in the late 1990s because they allowed patients to leave the hospital earlier while they received narcotic painkillers for recovery through the pump. While the pain pumps had received clearance from the U.S. Food and Drug Administration, the FDA had never cleared the devices for use in joints.

It was not long until several young patients returned to their surgeons suffering from chondrolysis, a rare ailment in which the cartilage dies, precipitating the painful condition of a bone grinding on an adjacent bone. One orthopedic surgeon told the Times that he had lost many hours of sleep trying to figure out what was causing the chondrolysis before several medical studies identified pain pumps as a likely culprit.

Throughout 2010 and 2011, hundreds of lawsuits were filed against the manufacturer of one widely implemented pain pump, I-Flow Corporation. The company was ordered to pay millions of dollars in settlements to patients who had experienced negative side effects, many who had to have shoulder joints entirely replaced. The FDA issued a warning discouraging the use of pain pumps in joints, and required manufacturers of anesthetics to change labels, encouraging doctors not to use such anesthetics through pain pumps.

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Though the manufacturer has come under fire for defective devices in the past, this year the da Vinci Sp Intuitive single port robot system used in surgical procedures is expected to hit the consumer market, according to MedGadget.com. The system is designed to allow for single-incision surgeries, and is a competitor to manufacturing giant Titan. The system was first introduced as a prototype more than five years ago, but only received approval from the U.S. Food and Drug Administration (FDA) last year.

The first da Vinci Intuitive surgical robot was introduced more than a decade ago. When the company first went public, 15 years ago, it posted $10 million in annual sales, though the robot had only been used on 600 patients worldwide. The machine was thought by the medical professional community to be a great symbol of technological surgical advance, and, according to ModernHealthcare.com, “one of the most coveted status symbols of 21st-century medicine.” Yet the $2.3 million machine caused serious side effects and even injury in several patients, due to a disregard for patient safety on the part of the manufacturer and aggressive marketing tactics that often preceded patient testing.

As of 2013, according to ModernHealthcare.com, da Vinci was facing 25 product liability lawsuits. Many of the lawsuits allege that the manufacturer failed to properly train surgeons on how to use the innovative machine, and instead pushed through patents and marketing efforts before hospitals were equipped enough to handle the new technology.

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