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RNs Urge Tougher Federal Oversight on Unproven Medical Technology on which Hospitals Spend Billions

National Nurses United Press Release, 7/8/14

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National Nurses United is calling on the U.S. Food and Drug Administration to enact meaningful oversight and public protections on the use of unproven medical technology that is rapidly spreading through the nation’s healthcare system.
 
NNU, the largest U.S. organization of nurses, made its appeal in formal comments submitted Monday to the FDA which has just concluded a comment period on its proposed “Risk-Based Regulatory Framework and Strategy for Health Information Technology Report.”
 
The assessment comes at a time when hospitals have spent tens of billions of dollars on electronic health records (EHRs) and computerized clinical decision support systems which are also promoted by more than $23 billion the Centers for Medicare and Medicaid Services have paid to hospitals and other providers in incentives since 2011 to implement them.
 
CMS has handed out the cash gifts, NNU notes, despite an admission in March by a CMS official that there is no evidence that “a broader adoption of electronic health records can save lives” and a federal report that there are no safeguards to prevent widespread abuse of fraud in billing practices.
 
Given the “startling” admission by CMS about lack of evidence on safety, “NNU thinks that CMS should halt the EHR incentive program unless and until we have unbiased, robust research showing that EHRs can and do, in fact, improve patient health and save lives,” said NNU Executive Director RoseAnn DeMoro in a letter to the FDA Monday.

NNU members, DeMoro noted, “witness first-hand the serious problems and unanticipated risks that patients are subjected to as electronic health records and computerized decision support systems are rolled out in our hospitals with too little training, testing or safeguards and even less thought to the potentially catastrophic consequences for patients of system errors and outright failures.”
 
DeMoro also blasted the FDA report as a “remarkable abdication of federal regulatory responsibility” for emphasizing a “non-punitive” reporting environment that, she charged, seeks to protect the profits of the healthcare industry rather than public safety.
 
Such a conclusion was predictable, says NNU, given the composition of the 31-member “workgroup” that produced the report, nearly half of whom were either health IT or other technology vendors. The group also included a number of other healthcare industry representatives, just one consumer and no patients.
 
DeMoro called on the FDA to take the following steps on health IT systems:
 

  • Extensive government research and testing.
  • Regulating health IT systems as medical devices at the highest level of oversight, such as is applied before replacement heart valves are approved.
  • Protection for RNs and other health professionals to assure they have the freedom to override the diagnosis, prognosis, or treatment recommendations of the devices.
  • Pre-testing of the devices, before they are used by a provider, and post-implementation and mandatory reporting of adverse events and near misses.
  • Improved transparency, including the use of open source computer codes accessible and available on a public website.

 
In May, NNU launched a national public advocacy campaign with radio ads, video, and a social media push to highlight some of the problems RNs experience at the bedside that put patients at risk of harm. At the center of that campaign was an alert for the public about the proliferation of unproven medical technology and the untested implications for patients.
 
It included a spoof video https://www.youtube.com/watch?v=YthF86QDOXY about a dubious bedside computer and a radio ad https://soundcloud.com/national-nurses-united/radio-ad-algorithms  that describes “algorithms that tell us what disease you should have based on what other patients have had.”
 
In a recent commentary, NNU Co-President Deborah Burger, RN noted that “NNU has long held that technology should be skill enhancing, not skill displacing, that doctors and RNs should not be mere adjuncts to machines that supplant their professional expertise, experience, education, and judgment.
 
“To a growing extent, the directives of the machines are not recommendations but mandates, tied to economic incentives, under the threat of discipline for the caregiver who does not follow the computer order and toe the line exactly. To qualify for the federal incentive payments, hospitals and doctors must show ‘meaningful use.’ They can choose not to follow what the computer suggests and still get the money, but more and more they face organizational pressure to adhere to guidelines.
 
“Federal incentives and reimbursements are there because of massive lobbying by the health information technology industry, supported by other healthcare giants, and woe betide those who stand in the way.
 
“Ultimately, the proliferation of health IT and the restrictions it places on caregivers is another reminder of how misguided the priorities of our broken healthcare system have become. It’s the reason NNU and America’s nurses will never stop our broader campaign, for a transformation from a health care industry based on profit and greed to one based on a comprehensive, humane, single standard of excellence in care system for everyone based on individual patient need,” Burger wrote.

 

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