September 2019 Patient Network Digest
Visit our website to see what we've added!

Last month we featured John James and his recently published research article, "Informed consent, shared-decision making and a reasonable patient’s wishes based on a cross-sectional, national survey in the USA using a hypothetical scenario."  This month we want to show how this research can be applied in practical ways for advocacy and patient care.
First, this study provides a practical pathway forward for advocates wishing to make changes in informed consent policy.  John James states, "There are two basic forms of informed consent as reflected in state laws. About half the states have defined informed consent as what a ‘reasonable patient’ would want to know and the other half have defined it as what physicians think should be revealed to the patient."  Advocates would do well to understand which of these definitions is used in their own state, and work toward a patient-centered definition that is more clearly defined by what reasonable patients have said they want to know.  
Secondly, perhaps the most critical part of medical care takes place as part of decision-making between the provider and patient.  Therefore, it is necessary to know what questions should be asked by a patient in order to have the best chances at making a truly informed decision. Using Table 2 of the study, we created a list of questions that patients can use in their own process of shared decision-making. 

To download the questions patients need answered, please go to Questions Patients Should Ask

Read more about John James in our Spotlight on John.  John's study published in the BMJ can be found here:

Amanda Dykeman, advocate and USA Patient Network board member, recently attended the Stanford University MedX conference where she found this quote inspiring.

Take Action on two important petitions to support two important bills.

Take action in letting your representatives know that you want them to support the MDSA and Guardian Act legislation. 

Adverse event reporting is critical to maintaining safety and effectiveness in our medical treatments, yet we know there is a severe problem with under-reporting. As a user facility, hospitals are required to report adverse events, but the Office of Inspector General noted that they do so at a a mere 14%. when hospitals report, it is usually to the manufacturer for reasons related to warranty issues. Their concern is primarily supply chain. Dr. Rita Redberg, Editor JAMA, Internal Medicine was quoted as saying that only 3-4% of adverse events are reported by physicians. The Guardians Act would make reporting mandatory for doctors.

Adverse event reporting touches every area of our medical care. No one is exempt from this harm. The only way we can begin to assure safety, reduce costs, and rid the market of dangerous devices, is if the negative outcomes are reported. 

Please write a letter or make a phone call to your Congressperson today. A list of talking points you may use to discuss the legislation.

Links to sign both Petitions and tell your representative you want them to support these bills are given below.

The Medical Device Safety Act 2019 H.R. 2669

The bill would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting all Class III devices. Including, but not limited to Essure, nerve stimulators, hip implants, defibrillators, pacemakers, infusion pumps, surgical mesh, cochlear implants, and breast implants. This bill is identical to The Medical Device Safety Act of 2009 that Senator Ted Kennedy introduced after the 2008 Riegel vs. Medtronic ruling, which had 23 cosponsors. Kennedy immediately recognized that the Supreme Court's interpretation of the Medical Device Amendment was inappropriate. However, when Kennedy passed away, the bill never went to vote.

Read more about H.R. 2669 and sign the Petition here.

The Medical Device Guardians Act of 2019 H.R. 2915

We are asking for your support of The Medical Device Guardians Act H.R. 2915. This bill will REQUIRE physicians to file an adverse event report with the FDA when they see a patient that has or had an adverse event from a medical device.

Currently, this is NOT a requirement!  Requiring this action will help to ensure that the FDA quickly flags devices that are causing injury or death.

Read more about H.R. 2915 and sign the Petition here.

We are in the process of adding a list of resources for people who want information, support, or to connect to an advocacy group for a variety of issues.  
If you know of a group that you want to make sure we include, please send us an email with the group's name and website information.  


John became an advocate after losing his 19-year-old son due to a medical error in the summer of 2002. Unfortunately, John soon discovered that the medical error that claimed the life of his son was all too common. He knew he had to do something and decided to take matters into his own hands. Since then, John has been educating patients and fighting for their rights through Patient Safety America. In honor of his son, he published a book, A Sea of Broken Hearts.

After my son's death, I realized how often medical errors occur but are usually overlooked. Something must be done to protect patients from our failing health care system. In September 2013, I published an article entitled "A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care" in the Journal of Patient Safety, which redefined what constitutes a medical error. The article garnered a lot of attention and reset the monitor for medical errors.

Two colleagues and I just published a study involving surveys of 3 populations: nursing students, health profession educators, and the American public. All groups consistently wanted to know more than is typically revealed during informed consent.

This is particularly important to members of the USA Patient Network with their focus on drug and device safety. Responders to our survey consistently wanted to know risks and benefits of any device to be placed in them and whether any prescribed drugs are off-label or have a black box warning. They also wanted ongoing access to their medical records while hospitalized and to know their out-of-pocket costs of procedures. There are several other important things ‘reasonable patients’ want to know. Please have a look at the study (especially Table 2) to glean your rights as a ‘reasonable patient.’ If your state does not have the ‘reasonable patient’ standard for informed consent, then propose a change in that law. The time is now for patients to seize control of their medical care.

Dr James founded Patient Safety America as a no-budget organization dedicated to educating people about problems in the US health care industry.  He paid out of his own funds to make the study published in the BMJ open access for all to read.

DENTAL CARE for TMJ problems and other dental implants and devices.

In June of this year, the U.S. Food and Drug Administration released more than 20 years of reports detailing adverse events involving medical devices, ending a program that allowed some manufacturers to keep safety issues from the public. Those reports previously were exempted under the FDA's Alternative Summary Reporting program.

Of those reports, 2.1 million of the 5.8 million summary reports of adverse events dealt with dental devices. There is poor regulations of best practices, and very little science behind what happens in many dental procedures. Those who suffer with TMJ are some of the most abused by a system that looks out only for the providers. Temporomandibular joint (TMJ) syndrome is a pain in the jaw joint that can be caused by a variety of medical problems. The TMJ connects the lower jaw (mandible) to the skull (temporal bone) in front of the ear. ... The TMJ is comprised of muscles, blood vessels, nerves, and bones.

HELP by completing this survey from the FDA The TMJ Association - FDA Patient & Caregiver Connection Survey
A product to help track recall information for devices implanted in the body.

TrackMy Solutions
is a safety application rooted in providing transparency and timely notifications of any FDA recalls directly to the healthcare consumers and associated care teams.  This, free for the patient, application allows for direct engagement with up to date recall information ensuring no one falls through the cracks of healthcare and suffers through avoidable adverse events!  This innovative platform enables direct education of the healthcare consumers so they can stay informed on important factors in their health. TrackMy’s mission is to involve the everyday healthcare consumer in important decisions with their healthcare care team and give them the tools to protect our most important commodity, our health!

Visit their website at Track My Solutions and read their most recent newsletter.
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