JustCare

Tag: Registry

  • Health care: Where’s the data?

    Health care: Where’s the data?

    If we’ve learned anything during this novel coronavirus pandemic, it’s that the data matters. We need data to know what’s working and not working in our health care system, and how to fix problems. Not making data a priority is tantamount to ignoring issues of equity and access to care. And, yet, a national electronic health care data system does not yet seem to be either a Congressional or Biden administration priority.

    Rachana Pradhan and Fred Schulte report for Kaiser Health News that the government is not even collecting important data about the people receiving COVID vaccinations. As a result, we don’t know who has received and who is receiving the vaccine. We don’t know whether people less in need are getting the vaccine ahead of health care workers or the extent to which minority populations are being discriminated against.

    President Biden recognizes that data matters. Yet, the federal government is literally spending trillions of dollars on health care, including on the vaccine, and it has little data to show for it, except in traditional Medicare. If the goal is to promote racial and social equity, to address issues of discrimination in health care, to ensure that critical treatments are available throughout the country, where they are needed, data must be a top priority.

    Right now, the available data reveal that Black Americans are not getting vaccinated at the same rate as whites. But, the data is limited. And, it’s hard to know where vaccinations are needed to reach herd immunity.

    Each state has a vaccine registry, but the sophistication of the registry varies by state. It’s inexcusable that vaccination data collection is not standardized and, in this technological era, states are not collecting and reporting to HHS all the needed data. It’s beyond inexcusable that registries do not even exist for drugs or medical equipment; when equipment is defective or drugs are causing harmful side effects, the data is generally not available.

    Real-time data does not exist for health care services, including vaccinations. There is no national public health system in charge of data. Moreover, each of the 64  immunization registries that collects vaccination data is siloed, unable to connect with one another.

    The CDC wants the name, address, sex, birthday, race, ethnicity and vaccine site for every person vaccinated. It does not ask for occupation, so few states collect that information. And race and ethnicity information is often missing. In many states, half the time, race and ethnicity information is not collected.

    Electronic health records companies that provide software to hospitals and other facilities said they are scrambling to modify software to accommodate data reporting requirements that vary by state.

    There are plans in place to invest in better data collection at the national level, when it comes to vaccines. But, really, data collection only for vaccines? For our individual and collective health, we need a single national system collecting real-time time that flows directly to the appropriate federal government agency.

    We can learn a lot about strengths and deficiencies in our health care system through a national electronic database. We could develop plans to address deficiencies. You have to wonder why Congress and the Biden administration are not making it data collection and reporting a priority.

    Here’s more from Just Care:

  • 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: