JustCare

Tag: Medical device

  • US and European patients at risk without medical device registry

    US and European patients at risk without medical device registry

    The BBC reports on findings of the Royal College of Surgeons that the rules for approving medical devices in the United Kingdom leave a lot to be desired, much as they do in the US. Notwithstanding widespread reports of patients at risk, the European Union, like the US, succumbed to pressure from industry and won’t support a medical device registry. Before agreeing to having a medical device implanted in your body, make sure you understand everything you can about it.

    To protect patients from dangerous devices being implanted in them, the Royal College of Surgeons has been advocating for a compulsory registry of all devices so that they can be tracked for efficacy and safety over the long-term. That would help physicians understand whether a particular device causes harm and help patients avoid harm.

    We need such a registry in the US as well. But, industry, so far, is winning this fight. The argument is that a registry would somehow jeopardize discoveries of new devices that could save lives. Without the registry, however, no one can understand how serious the problem with a device is, and many patients can be harmed. A registry is a fairly simple after-market regulatory solution as compared to having a government body that checks all devices before they go to market–which would be the safest solution.

    In the United Kingdom, investigations by 58 media organizations reveal that patients are getting unsafe implants, just as they are in the US. These unsafe implants include pacemakers, artificial hips, and contraceptives. A BBC Panorama investigation in collaboration with the International Consortium of Investigative Journalists shows that the European Union has approved implantable devices that have not worked in clinical trials or that have only been shown to work on pigs and corpses.

    The United Kingdom’s government agency spokesman defended the process in place today. He argued that it has been around for 25 years and “improved and transformed countless lives.” He fears that a registry could undermine innovation.

    But, it is hard to justify innovation that leads to a pacemaker failing with parts falling off inside patients, which is what happened to patients in the UK who received the Nanostim pacemaker. Only after the government learned about 90 patients seriously harmed and one dying from the Nanostim was it recalled. The Nanostim had been approved to go to market after only one 90-day trial on 33 patients.

    For sure, some medical devices are life-saving. But, others cause serious injury. Investigators uncovered back implants that cracked inside patients, which had not worked in tests on baboons. In addition, they found that some birth control implants cause damage and bleeding, some defibrillators misfire, and some mesh implants used to help with incontinence lead to abdominal pain.

    Here’s more from Just Care:

  • Amazon plans to reform the marketplace for medical supplies

    Amazon plans to reform the marketplace for medical supplies

    Amazon appears to be using its enormous power and reach to become a serious player in the multi-billion dollar health care marketplace. According to Bloomberg News, Amazon plans to reform the marketplace for medical supplies, building relations with big hospital chains and other provider groups, squeezing out distributors, and increasing its sales of bandages, latex gloves and other health care products. The move may be a first step towards a deeper dive into the bigger and costlier medical device and prescription drug business. How Amazon will transform the health care marketplace over time is anyone’s guess.

    Amazon already sells a small array of medical supplies. It now intends to expand that business significantly and sell a host of medical supplies directly to doctors, outpatient clinics, and, over time, to large hospital systems. It is building new technology to enhance the buying process for health care providers and allow comparison shopping. Traditionally, health care providers have entered into contracts with distributors for bulk purchases of medical supplies.

    According to the Wall Street Journal, Amazon is making security and safety a priority. Amazon has to persuade hospitals and clinics that purchasing medical supplies through its new channels makes sense financially as well as practically. If it can, it may be able to take over market share from the biggest distributors today, cutting them out of the process and bringing down health care costs.

    And, if successful, Amazon may increase its revenues substantially. Northwell Health in New York, one of hundreds of large hospital systems in the US, spends $3 billion a year on supplies, contract services and pharmaceuticals. Between 20 percent and 30 percent of that cost is for administration, marketing and shipping.

    At its best, Amazon would make it cheaper, safer and easier for both health care providers and patients to order health supplies. Time will tell.

    Amazon’s foray into health care already is putting competitive pressure on health insurers and pharmacies. Just recently, Amazon partnered with Berkshire Hathaway and JP Morgan Chase to improve quality and reduce health care costs for their employees. It also appears to be gearing up to sell prescription drugs; it has received approval for a wholesale pharmacy license in 12 states.

    Here’s more from Just Care:

  • Which advocacy groups can you trust?

    Which advocacy groups can you trust?

    You might think you can trust advocacy groups with names like “Alliance for Patient Access” to represent your interests. But, it would be a mistake to do so. Many of them are industry fronts and many others of them depend enough on health care and pharmaceutical companies for their funding that they are not prepared to challenge these companies on behalf of consumers or patients.

    Health New Review explains how people can determine whether a group that sounds like a patient or consumer group truly represents consumer interests, and why it is important to uncover the truth. The two key questions they advise asking are who is in control of the organization and who supports the organization financially. If you don’t ask these questions–and many journalists, let alone consumers, do not–you would not know that, for example, the Alliance for Patient Access is a pharmaceutical industry group.

    As it turns out, more than half of patient advocacy groups report that they take money from pharmaceutical companies, medical device companies and/or biotech companies. And four in ten say they have a corporate executive on their board of directors. Often that means they are silent on the high cost of prescription drugs or on legislative solutions that would rein in drug prices and make health care more affordable for Americans.

    A recent research paper in the New England Journal of Medicine found that virtually all disease organizations are beholden to the health care and/or pharmaceutical industries, including the American Heart Association, the Americans Diabetes Association, the American Cancer Society. They get significant industry money for research, and they are often governed by industry executives. In return, they are silent on the cost of treatment and do not represent patient interests.

    So, before you trust advice from any organization that claims to be representing your interests, find out where its funding comes from and who’s in charge. You can learn about Just Care here.

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  • FDA approved medical devices may not be safe

    FDA approved medical devices may not be safe

    Health News Review explains why FDA-approved medical devices may not be safe or effective in a tool-kit for reporters; its message is important for everyone to understand. In short, as with drugs, the FDA approves a medical device if the manufacturer can show a benefit of the device over a placebo. The manufacturer does not have to show that it is better than other devices on the market or free from harmful side effects.

    Medical devices are non-drug products that are used to diagnose or treat a medical condition, from bandages to MRI machines. It appears that the FDA has approved tens of thousands of them without a lot of focus on patient safety. Even when the device is implanted in a person’s body, the level of safety evidence required for FDA approval is low.

    What’s even scarier is that after these products go to market, there is no systematic review of their safety. So, reports of serious harm to patients may go unnoticed and unaddressed. The FDA oversight can be weak, and the FDA may not issue a recall or even a warning about patient safety. You can read here about a heater-cooler devices (HCDs) used during heart surgery that can cause life-threatening infections and here about how using morcellators to remove fibroids can cause cancer to spread.

    StatNews has also reported on the patient safety problems with medical devices. It refers to a  January 2016 Senate  Democratic staff report on how ineffective oversight of medical device safety led to a major superbug outbreak that killed at least 20 people and harmed 35o others. In that case, the medical device was an Olympus duodenoscope that is widely used. And, though Olympus was aware of the design flaw that caused the superbug outbreak, it did not alert U.S. hospitals or the FDA. U.S. hospitals are required to report patient safety issues to the FDA, but many hospitals who experienced superbug outbreaks failed to let the FDA know. The FDA’s oversight is “passive,” depending upon alerts from doctors, hospitals and device manufacturers.

    To make matters worse, when patients are harmed, they generally have little recourse. The Supreme Court has ruled that FDA premarket approval for riskier devices generally protects the manufacturers. And, Public Citizen says that the 21st Century Cures Act, which is about speeding drugs and devices to market, may weaken FDA oversight even more.  The law protects manufacturers from FDA regulatory burdens.

    Here’s more from Just Care:

  • Can your pacemaker be hacked?

    Can your pacemaker be hacked?

    An article on Wired.com describes the scary security issues that come with high-tech medical devices. These health technology devices can be super “smart,” allowing remote control adjustment to better serve your medical needs. But, if they are not secure, patient safety is compromised, and it’s possible that someone could take control of your body. Can your pacemaker be hacked?

    In brief, pacemakers, insulin pumps, defibrillators and a wide range of electronic medical equipment are all subject to hacking. You should not assume that the manufacturers of this health technology have put in place the security to prevent hacking. And, when electronic medical equipment is hackable, someone at a computer on the other side of the world could wreak havoc on patient safety, for example deactivating pacemakers or releasing insulin overdoses.

    What’s even scarier is that if hackers can control a single medical device, there’s the potential for them to control the monitors that work in tandem with the device and, in turn, the pool of information and networks associated with that device and all related devices at a hospital. Medical records could be stolen. Entire systems controlling medical devices could be held hostage.

    Today, hospitals often use a dozen or more “smart” devices to monitor and treat patients, potentially compromising patient safety and imposing grave risk on everyone they are treating. MRI machines and CT scanners can be easy targets for hackers as well, and hospitals may not even be paying attention.

    While we haven’t heard much about medical device hacking, in the last three years “the health care sector has been hacked even more than the financial sector,” according to the chief technology officer at Zingbox.  “And more and more hacking incidents are targeting medical devices.” This is real and serious.

    MedJack, a current hack, steals medical data and uses it for identity theft and prescription medication theft.  In the last year, Rainbow Children’s Clinic in Texas and Hollywood Presbyterian Medical Center were hacked. These attacks can and do disable computers, email, and other hospital systems.

    Since 2013, the FDA has been assessing cybersecurity on medical devices before approving them. But, it’s just a start. For now, we are all at some risk. And, it’s not at all clear how we protect ourselves, short of staying healthy and out of the hospital.

    Here’s more from Just Care:

  • Cures Act threatens drug safety and efficacy

    Cures Act threatens drug safety and efficacy

    After an intense lobbying campaign heavily funded by the pharmaceutical industry and featuring sick children and pleading parents, a bill called the 21st Century Cures Act (“Cures Act”) easily passed through both houses of Congress this month, and the President is expected to sign it into law. Everyone wants cancer and other dire diseases cured, but will this 996-page bill, largely fashioned by politicians and their corporate allies really work towards those ends? Many consumer advocacy groups, such as the National Center for Health Research and Public Citizen, as well as some doctors in universities who don’t take funding from drug companies, believe that the legislation will do more harm than good.

    The bait that hooked the vote of many of those in Congress is the increased funding for cancer and other research at the National Institutes of Health, although Congress still may not appropriate this funding each year. Members of Congress also liked the idea that the bill would streamline the FDA approval process for prescription drugs and medical devices. But, our FDA approves these products faster than its counterparts in other part of the world and approves almost 90% of products put forward. And, it does so already increasingly and worryingly under lower standards than in the past. Many drugs are approved that turn out not to work at all. These drug often stay on the market nonetheless.

    As a result, we all pay higher drug and health costs.

    The 21st Century Cures Act would actually set some standards at the FDA back to the 20th century, as less reliable evidence would be accepted, such as anecdotes or patient experience, and observational studies, notoriously less trustworthy than randomized, controlled clinical trials.

    While more than 200 patient groups supported the Cures Act, most of these groups receive a substantial portion of their support from the pharmaceutical companies that stand to benefit most from the bill.

    As StatNews reported, most of the 1,300 (!) lobbyists pushing for the Cures Act worked for the pharmaceutical industry. Not surprisingly, the primary congressional sponsors of the bill, Representatives Fred Upton (R-Mich), and Diana DeGette (D-Colo) received some of the largest donations from pharmaceutical companies among members of Congress.

    Although the increase in funding for the National Institutes of Health hardly needed to be linked to the provisions of the bill likely to harm public health, there are other provisions that may be beneficial. Some funding will be allocated to help states fight the opioid drug epidemic, ironically created in large part by marketing campaigns by the drug industry. A rider to the bill also boosts funding for mental health care.

    Here’s more from Just Care:

  • A medical device may make heart surgery even riskier

    A medical device may make heart surgery even riskier

    Every year, more than half a million Americans have heart bypass surgery to get blood flowing to the heart. As we all know, heart surgery can be risky. What most of us don’t know is that a new infection associated with a medical device used in heart surgery may make heart surgery even riskier. While the Centers for Disease Control (CDC) is alerting hospitals to this risk and asking them to alert patients, neither the FDA nor the CDC has required hospitals to warn heart bypass patients about the risk nor does either have the authority to do so.

    Consumer Reports writes about a patient who died after experiencing chest pain and fever post heart bypass surgery. He had been discharged from the hospital and then rehospitalized. The doctors found that his wound had opened and was oozing pus. He had non-tuberculosis mycobacteria (NTM), a rare microbial infection that can be deadly in the chest cavity or prosthetic heart valve but is otherwise generally harmless. While the infection can be treated in healthy patients, the patient was not healthy enough to tolerate the drug cocktail treatment and the hospital could do nothing to save him.

    As it turns out, several other patients who have had heart surgery have also developed NTM infections, sometimes many months after surgery. In the past six years, at least 45 patients have been infected during surgery and at least nine have died. We do not know how many more cases have gone undiagnosed or unreported.

    It appears that heater-cooler devices (HCDs), which regulate patients’ body temperatures during surgery are likely to be responsible. Hospitals use these HCDs in about 250,000 heart bypass surgeries each year. Many think that the HCDs spray the NTM bacteria into patients’ bodies during surgery through their exhaust fans. In most instances where infections were reported, the hospitals used a particular HCD, the Sorin Stockert 3T Heating-Cooling System, manufactured by the European company LivaNova.

    The FDA and CDC have sent notices to hospitals warning them about the HCD risks for heart surgery patients, asking them to clean the HCDs in a particular way and recommending they turn the HCD exhaust fans away from the operating tables. But, believe it or not, it is up to individual state health departments to require hospitals to notify patients about the risks.

    Some hospitals have addressed the possible problem by moving the HCDs outside the operating room in a way that allows them to regulate patients’ body temperature but keeps their exhaust vents away. But, many hospitals have not, and many hospitals do not have the ability to adopt this solution.

    If you or someone you love is getting heart bypass surgery, Consumer Reports recommends you ask whether the hospital is using an HCD, whether it has been tested for NTM and other bacteria and whether any of their heart bypass patients have gotten NTM or other infections.

    Here’s more from Just Care:

     

  • More data needed to drive down health care costs, improve patient safety

    More data needed to drive down health care costs, improve patient safety

    A new Health Affairs blog post speaks to the need for Medicare to collect and report data on the hundreds of thousands of hip and knee replacements it pays for each year. Medicare should report this data, as should every commercial health insurer. Indeed, we should have access to a wide range of health care data from both commercial insurers, like UnitedHealth, Blue Cross and Aetna, and Medicare. More data is needed to drive down costs and improve patient safety.

    Medicare should be able to identify and address defect and safety problems with medical devices and products. It should also have a way to steer people to high-quality devices and products. But right now it can’t. Commercial insurers should collect and report these problems as well, and should be holding companies that sell defective products accountable on behalf of their policyholders. But, it’s not clear they can. How often do they do so?

    When it comes to traditional Medicare, to a significant extent, Congress is to blame. It compels Medicare to cover every FDA-approved product and device that’s medically reasonable and necessary. Commercial insurers should have nothing stopping them from identifying and steering their members to quality products and devices. But, who knows whether they do or even what data they collect? While they are called for stricter rules for FDA approval and tracking of medical devices, they do not share their data, to the extent they have it, to help improve overall patient safety. Their business interests appear to outweigh the public benefit.

    The Health Affairs post suggests Medicare can remedy the problem of not knowing which medical devices are defective or unsafe by collecting data on which devices are implanted on its claim form. It should. Why leave this responsibility exclusively to Medicare though? The Brookings Institute reports more than 3,000 potential deaths each year from defective medical devices and more than 50,000 serious adverse events.

    Why not have a public registry that records all devices implanted, and which are found to be unsafe or defective, so that we can track and report how well they perform and notify everyone with an implanted device easily if it fails or is found to be unsafe?

    The authors claim that registries are costly to implement and maintain. In this digital world, and with electronic medical records, one would think that the cost of setting up registries pales in comparison to the benefits, including easy notice of product failures to all patients, not simply Medicare patients, and better information to all insurers about the products they are paying for. Doctors should have this information available as well. The medical device industry makes a practice of giving them money and gifts as a way to market their products, and we need a strong check on that.

    There is no perfect health insurance in the United States. All insurers impose large out-of-pocket costs. And, many make it hard to access care and impossible to be assured continuity of care. We should keep in mind that, while it could do better, only traditional Medicare ensures both relatively easy access to care and continuity of care and makes much of its data public.

    One of the most compelling arguments for expanding Medicare, as Hillary Clinton proposes, is that it offers our only wide lens into what’s working and not working in our health care system and the power to drive system-wide change and improve quality of care for everyone. Commercial insurers should either step up to do their part for the public health or step away and support giving everyone the choice of Medicare.

    Here’s more from Just Care:

  • Medical device to remove fibroids causes cancer to spread

    Medical device to remove fibroids causes cancer to spread

    About half of all women have uterine fibroids. Some need them removed. A story in Boston Magazine explains how a medical device to quickly remove fibroids causes hidden cancer to spread, harming patients unnecessarily. Would you think to ask your doctor about the potential risks of using this or any other surgical device? It’s clear we should. (Here’s a set of questions you should always ask your doctor before surgery.)

    Instead of taking out a fibroid mass in one piece, doctors may use a power morcellator when they perform laparoscopic surgery. It is an easy and inexpensive tool. It minces and suctions up the fibroid. But, in the process, it can also chop up a cancer that may be growing hidden in the uterine wall and scatter it throughout the abdomen. That’s what happened to Amy Reed, at Brigham and Women’s Hospital in Massachusetts.

    As a result, after her operation, Reed’s doctor let her know she had an aggressive cancer, and her doctor told her she needed another operation to remove her ovaries.  Amy ended up needing four more operations to remove new tumors that were seeded in her abdominal cavity, along with chemotherapy.

    Amy’s husband has made sure that everyone knows the danger of power morcellation, to prevent its use for the removal of fibroids. He has managed to get some health insurers to stop paying for procedures that remove fibroids using morcellators. And, he has enlisted two members of Congress to review the current FDA process for reviewing new medical devices, as well as requirements for manufacturers to report adverse events. The FDA did not require pre-market testing of morcellators in women with fibroids.

    Johnson and Johnson no longer sells its morcellator. The FDA has now issued an opinion discouraging the use of morcellators to remove fibroids and put a black-box warning on their use for fibroid removal.

    The FDA recently stated that the odds are abut one in 350 that someone needing surgery to remove a fibroid will have a cancer as well. If a fibroid is removed in one piece, there is a 50 percent survival rate for people with cancer. With morcellation, the survival rate drops to 20 percent or less.

    Here’s more from Just Care: