Your Comments Needed Today

—FDA Debating Regulations on Health Information Technology-DEADLINE—July 7

 
The US Food and Drug Administration, (FDA), is now taking public comments on how (and if) it should regulate Health Information Technology (HIT) and Clinical Decision Support (CDS) systems.
 
The FDA has already suggested that it thinks that regulation of these systems is NOT necessary! They need to hear your voice to protect our patients.
 
As direct-care registered nurses we are acutely aware of the rapid spread in the use of unproven electronic health records and other forms of medical technology and the untested implications for patients.    
 
You know first-hand the problems that arise when technology is rolled out that may be skill displacing, not skill enhancing, and when RNs are hampered by a system design in making autonomous judgments in response to the protocols directed by the computer programs. And how the systems take RNs away from the patients to interact instead with patients – as one RN said this week, “the computer is now my 5th patient.”

Hospitals are spending tens of billions on buying health IT systems and it is vital to ensure we have protections for public safety that also safeguards the patient advocacy role of RNs.
 
It is critically important that you take a few minutes to send comments using your personal experiences and observations as a bedside RN to make the points below as applicable.
 
You may draft your own comments, or use one of the forms by inserting a short description of your own experience with the dangers of these tools that attempt to fit real live, individual patients into preprogrammed care plans.

Submitting Comments

Click here to submit comments to the FDA
 
Short sample version:
 
HIT (Health Information Technology) IS DANGEROUS: I have been a registered nurse for ___ years. As an RN I have witnessed firsthand the dangers of health information technology. [Examples__________].

Finally, the regulations should explicitly state that RNs and other licensed caregivers have the right to use their professional judgment to override health information technology in the interest of individualized patient care and safety.

Instructions for posting comments

___Comments due: Jul 07, 2014 11:59 PM ET___
 
It’s probably best to work on your comments before going to the website and then paste them into the comment box after you are finished.

Click here to submit comments to the FDA

Step 1: Your information

• Enter comments
• Option to upload files
• Enter First and Last name
• Option to check boxes
  
  • I want to provide my contact information
  • I am submitting on behalf of a third party (Do not check)
• Enter category: Health Professional – A0007 (or as applicable)

Step 2: Your preview

• You will see your comments and can either edit or submit comment.

Step 3: Your receipt

Here’s an NNU commentary on the problems with healthcare technology
 
See our national public advocacy campaign on the issue

If you listen to the lobbyists for medical device manufacturers and many of their best friends forever in the healthcare industry and Washington, health IT is the answer to our biggest healthcare troubles, from medical errors to the high costs of care.

America’s registered nurses, who interact with the machines and have to implement their regimen, all too often have a very different daily experience.

We’ve launched a national campaign intended to emphasize the point that all that glitters is not gold.

Our campaign describes a number of changes occurring in healthcare delivery at the bedside that RNs believe are putting patients at risk.  These include the premature discharge of patients to other settings, including the home, where the burden for care falls entirely on family members.

A central theme of our message is about the rapid spread of unproven medical technology and the untested implications for patients. That concern is captured, with a humorous vent, in this video and this radio ad.

Obviously, with the tens of billions the hospitals are spending on buying health IT systems, and the more than $23 billion the Centers for Medicare and Medicaid Services has paid in incentives to hospitals and other providers since 2011 to implement them, the machines are not likely going away soon.

National Nurses United 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.

While problems with the electronic health records have garnered some limited notice, much less has been said about the bedside computers.

Bedside computers today are increasingly used to provide a diagnosis of the patient’s condition, determine a prognosis of whether to continue or withdraw care, and, if care is permitted, to set out treatment protocols.

Typically, those directives are based on a misapplication of the concept of population-based health, which assesses the patient and determines the protocols and treatment options based on a similar set of conditions or patients.

But you can’t treat everyone like an identical Model T Ford. Human beings are not steel girders, they are organisms that adapt and react uniquely.

When you are just following a computer protocol, it can leave out multiple other variables that can affect the source of the patient’s illness and what is needed for their treatment and recovery based on that individual, not some other patient or group of patients. Each patient can respond differently, and does.

That’s where the skill and judgment comes in, something lacking in HAL 9000 or the FRANK of our video. What is needed for the patient is still best determined by the personal interaction of the doctor and the RN with the individual patient.

And 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.” This includes using what is sometimes labeled clinical decision support, the computers. 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.

Not surprisingly, what is mostly behind those decisions is money. Federal incentives and reimbursements are in place because of massive lobbying by the health information technology industry, supported by other healthcare giants, and woe betide those who stand in the way.

The technology generates profits for healthcare corporations who standardize treatment protocols based on a model of care that is derived from earlier experiences on the factory floor.  The results were not always great in the industrial sector as the recent GM scandal might illustrate, and in healthcare the life and death consequences are even more pronounced.

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 care system for everyone based on individual patient need.