Articles Posted in Medical Devices

Usually when one thinks of medical malpractice, he or she thinks of an error by a doctor or nurse that leads to a serious medical complication. Sometimes, however, the problem is not with the medical staff. Instead it is with the medical device. One such medical device has been making news ever since the FDA warned the public about it last year. This device is used for a treatment called laparoscopic power morcellation and the problem with it is that it appears to be causing cancer to spread throughout the body. Called a ¨power morcellator,” this device has been made by companies like Johnson & Johnson. The FDA warned doctors about the dangers of the device last year, but the FBI is investigating whether Johnson & Johnson knew about the problem long before that warning.

FDA Warned Doctors About the Device Last Year

Over a year ago, in April 2014, the Food and Drug Administration (FDA) issued a warning about laparoscopic power morcellation. The procedure involves using a power tool to chop up the tissue of fibroids or, in the case of a hysterectomy, to chop up the uterus itself. Tissue fragments are then removed from the body using tiny incisions. The problem is that roughly one out of every 350 women undergoing fibroid removal or a hysterectomy has a type of cancer called uterine sarcoma.
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Again and again in the news we have heard that Ebola is only transmittable through contact with the bodily fluids of an infected person, and that if proper safety protocols are handled it is an extremely difficult illness to transmit from person to person. And experts all seem to agree that this is true. But when the makers of equipment designed to protect medical professionals from disease exposure fails, the story changes. Just like medical device failures, these failures could be deadly.

Lawsuit Alleges Kleenex-Maker Falsely Claimed its Surgical Gowns Protect Against Ebola
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Failing to sterilize surgical instruments is one type of medical malpractice. This sort of health care provider error can result in serious infections, and sometimes, even death. The severe consequences of a failure to sterilize hospital equipment have lead to hospitals putting strict measures into place to insure that only proper equipment is used on patients. However, despite there being universal agreement on the importance of sterilization of instruments, two different news agencies are reporting this month on two different hospitals in two different cities that used unsterilized equipment on patients.

Hospital Used Unsterilized Surgical Equipment

NBC News Channel 11 KARE reports that Abbott Northwestern hospital in Minneapolis, Minnesota used unsterilized equipment in surgeries earlier this month. A hospital employee who spoke to KARE said, “This is … incredibly unacceptable and dangerous.” Fourteen unsterilized instrument sets were released into service. Four of them were actually used on patients. Those four patients have all been contacted by the hospital and have been offered testing for infections. So far no information has been released to the public about how this happened or how the problem was eventually discovered.
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Whether a patient is simply finding out whether or not she’s pregnant, or is undergoing serious life-or-death surgery, lab tests are a large part of the hospital experience. If something goes wrong with those lab tests the result can be a delayed diagnosis which in the worst cases, can result in a wrongful death. While one might assume that the Food and Drug Administration (FDA) already regulated these tests, that is not the case for all tests. However, that is about to change.

New Process

The New York Times reports that the FDA announced on Thursday that it will start regulating medical laboratory testing. This move has been opposed by both some laboratories and some pathologists who claim that regulation is unnecessary and will hurt innovation when it comes to creating tests for rare diseases. The FDA has attempted to address these concerns by saying it will phase in the regulations of the tests over nine years. It will also focus primarily on regulating tests that pose a high level of risk to patients if the test result is incorrect.
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Patients are in many ways at the mercy of their doctors. Doctors have training and skills the average person lacks, and are licensed professionals. Those doctors rely on the manufacturers of their tools and equipment. If the equipment malfunctions, the doctor can’t do her job, and the patient suffers. Unfortunately, sometimes the manufacturers of the doctors’ tools commit serious errors, and the tools don’t work. This has recently happened with an important tool used by doctors on patients requiring blood thinners. The U.S. Food and Drug Administration has issued a recall for certain Alere clotting time test strips. According to the recall notice, there have been nine reports of the strips malfunctioning. Six of those malfunctions resulted in injury, and three others resulted in death.

These strips are used by medical professionals to determine how long it takes a patient’s blood to clot. This information is very important to doctors making the decision as when a blood thinner, like warfarin, is being administered to a patient. If the test results are inaccurate, then the doctor will order an incorrect dosage of warfarin. This can lead to excessive bleeding and wind up being fatal.
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Surgery can be a terrifying experience. Whenever a patient goes to a hospital he or she has to rely on medical professionals to do what is best for him or her. But in the case of surgery, the patient is usually not even away or aware during the procedure. So there is no way of knowing what is going on. The patient has to trust completely in the doctors, nurses, and other medical support staff. But the patient also has to trust completely in the people who design and manufacture the tools the medical professionals use. Unfortunately, sometimes the tools fail, leaving the patient suffering from personal injury.

The Food and Drug Administration (FDA) announced that Datascope Corp/MAQUET issued a worldwide recall of intra-aortic balloon pumps. Specifically, the pumps being recalled are the 98/98 XT, the CS100, the CS100i, and the CS300. They are being recalled due to potential mechanical failure of the power supply fan assembly. Approximately 12,360 affected units have been sold globally. This is another case of what is called “medical device error.”

According to the FDA, intra-aortic balloon pumps are electromechanical systems used to inflate and deflate an intra-aortic balloon to provide temporary support to the left ventricle of the heart. The devices rely on the principle of “counterpulsation.” Counterpulsation is defined by MedicineNet as:

A technique that synchronizes the external pumping of blood with the heart’s cycle to assist the circulation and decreasing the work of the heart. Counterpulsation pumps when the heart is resting to increase blood flow and oxygen to the heart. Counterpulsation stops pumping when the heart is working to decrease the heart’s workload and lessen oxygen demand.
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Reuters reports that the FDA proposed a new plan to speed up medical device approvals. The program is called the Expedited Premarket Approval Application Program, and it is in theory designed for patients who have exhausted all other available treatment options. It is not a new pathway to market, but instead a “change in approach.”

The reason the FDA gives for the program to respond to criticisms that the already existing process for device approval is too slow, and that it delays patients’ access to potentially life-saving products. Delays in treatment are certainly a legitimate concern, and properly tested medical devices that are safe and can save lives absolutely should be used in medical treatment. The goal here is a noble one. But there are also serious risks involved that will have to be addressed as the program is rolled out.

Medical Device Reporting

Take only as directed. It’s a warning that’s easy to follow. But what happens when physicians transfer a patient’s care to another provider without knowing what medications that patient has already been prescribed? Serious injury and even death can occur when transitions in care leads to uninformed medication orders. To combat these complications, the medical community has been implementing Medical Reconciliation, a process to compare a patient’s medications across caregivers and pharmacies in order to identify duplications, interactions between medications, and whether patients should continue taking current medications.

Medical Reconciliation should be implemented whenever there is a transition in care where new medications are ordered or existing orders are rewritten. A care transition may include changes in setting, service, practitioner, or level of care. For example, a patient’s daily medication may be suspended during a hospital stay, and the need to restart the medication upon discharge may be overlooked. Or a dosage has been mis-transcribed and when a new physician assumed care, the patient was overdosed and seriously injured. Medical Reconciliation attempts to prevent discrepancies like this.

The process of Medical Reconciliation includes

When medical patients go into the hospital to receive care they rely on the expertise and professionalism of all those working on their behalf–doctors, nurses, aides, and others. Not only that, but patients also rely on the products those professionals use. From the high-tech medical beds to immensely complex surgical robots, medical care today is dependent on the sophistication of many different medical devices.

Unfortunately, at times these products are designed dangerously or there are manufacturing mistakes that put patients at risk.

FDA Catheter Recall

Doctors, hospitals, and medical providers in general all owe a duty to their patients which must meet a minimum standard of care. A standard of care is the reasonable degree of prudence exercised by a medical provider in tending to a patient. In the medical world, such standards may be measured against treatment and care standards across the medical industry in a particular state or jurisdiction. There may also be published guides to care and treatment that doctor or hospitals commit to abide by.

This standard of care also includes a medical provider’s duty to inform patients of particular risks with a medication or a certain procedure, for example. A failure to disclose the risk could result in malpractice liability if the patient were to get hurt and claims he or she would not have opted for a particular course of treatment if they were aware of the risks. In general, plaintiffs must demonstrate that a standard of care was breached as an element to their overall malpractice claim.

A Case Study

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