[Reblog] Illnesses, injuries linked to medical devices a ripe area for investigation #ahcj15

From the 14 May 2015 post by the Association of Health Care Journalists

Most medical devices marketed in the United States do not need formal approval from the U.S. Food and Drug Administration.

Members of a panel at Health Journalism 2015 on medical device coverage provided a variety of advice for reporters covering and of the implants, instruments and diagnostic tools common to the modern medical machine.

Moderator of the session was Chad Terhune, aLos Angeles Times reporter who recently found himself chasing an outbreak of carbapenem-resistant enterobacteriaceae (CRE) linked to dirty duodenoscopes. Contributing to the discussion were panelists USA Today investigative reporterPeter Eisler and Scott Lucas, associate director of accident and forensic investigation at the ECRI Institute.

A recent CRE outbreak at Ronald Reagan UCLA Medical Center illustrates the broader issues of medical device approval and oversight. The Olympus scopes used at the Los Angeles hospital, and at other facilities around the nation where the superbug infected patients, did not require any formal study or approval from the FDA before hitting the market because they were considered “substantially equivalent” to a previous models. Equivalency, Eisler explained, allows thousands of devices to move from labs to patients with little more than a short 510K statement that the manufacturer files with the FDA.

Only 10 percent of devices, such as those which “sustain or support life, are implanted, or present potential unreasonable risk of illness or injury” fall into the FDA’s “premarket approval’” category requiring a greater level of regulatory scrutiny, including safety and effectiveness studies, before sale.

Things are not much better once devices hit the market.

…

It is important to understand that medical devices seldom stand alone, he said. They are usually part of much broader systems used to deliver care safely to patients. When a patient dies after a ventilator fails, for example, it may be that alarms, communications networks or staffing protocols designed to quickly detect and report the failure did not work.

Thus, if reporters want to understand what went wrong in a specific incident, they should ask about more than the device itself. “The system approach to an investigation is key to finding the answer,” Lucas said.

Also be aware that hospitals are supposed to have detailed plans that tell employees what to do when there is a problem with a device. Sequestering machines that malfunction, and downloading data from them before it is purged, are examples of best-practice steps that reporters can ask about.

Handling the pitch

So what should a reporter do when he or she receives a glowing pitch from a local hospital about the latest device?

Terhune suggests starting with Medicare’s open payments database to see if the doctors involved have a financial interest in the device that’s being pitched. While a financial interest is not necessarily a deal breaker for coverage, it is something reporters should know about going in and make sure they can adequately address in their coverage.

Next, look at whatever FDA approval process was required for the device

..,

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[News article] Could a wireless pacemaker let hackers take control of your heart?

From the 9 February 2015 Science article

Medical devices don’t get regular security updates, like smart phones and computers, because changes to their software could require recertification by regulators like the U.S. Food and Drug Administration (FDA). And FDA has focused on reliability, user safety, and ease of use—not on protecting against malicious attacks. In a Safety Communication in 2013, the agency said that it “is not aware of any patient injuries or deaths associated with these incidents nor do we have any indication that any specific devices or systems in clinical use have been purposely targeted at this time.” FDA does say that it “expects medical device manufacturers to take appropriate steps” to protect devices. Manufacturers are starting to wake up to the issue and are employing security experts to tighten up their systems. But unless such steps become compulsory, it may take a fatal attack on a prominent person for the security gap to be closed.

For more on privacy and to take a quiz on your own privacy IQ, see “The end of privacy” special section in this week’s issue of  Science.

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[News] New regulations proposed for off-label uses of drugs, devices — ScienceDaily

New regulations proposed for off-label uses of drugs, devices — ScienceDaily.

Excerpts

Date:January 22, 2015

Source:University of California, Los Angeles (UCLA), Health Sciences

Summary:Researchers have proposed a system for off-label drug prescriptions combining reporting, testing and enforcement regulations, and allowing interim periods of off-label use. This would give patients more treatment options while providing regulators with evidence of the drugs’ safety and efficacy.

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Medicine drugs (Photo credit: Wikipedia)

Off-label use of drugs and medical devices — using approved remedies in unapproved ways — has long been a part of medicine. The practice provides public health benefits but also presents some risks.

For the most part, the U.S. Food and Drug Administration allows physicians to prescribe drugs and devices off-label in the same way they are prescribed for their approved uses. The FDA couldn’t require approval for each off-label use because the burden for approval would be so high that few off-label uses would be approved, which would deprive patients of effective treatments for which the drugs weren’t originally intended.

As a result, health care providers have had to make their own decisions about using drugs off-label, often in the face of uncertain evidence.

To address that issue, researchers from the David Geffen School of Medicine at UCLA have proposed a system combining reporting, testing and enforcement regulations, and allowing interim periods of off-label drug prescription. Their recommendations, published in the Duke Law Journal, would give patients more treatment options while providing regulators with evidence of the drugs’ safety and efficacy.

….

The authors’ proposal comprises three elements:

• Improved reporting of off-label use through disclosure of diagnostic codes in reports to the FDA, in detailing data that pharmaceutical companies obtain on physicians’ prescribing habits, and in reports to the FDA and Medicare/Medicaid reimbursement requests. This information, which would omit details that could identify individual patients, could then be shared with academics and pharmaceutical companies for use in research. • Expansion of post-market testing requirements for off-label use of drugs and medical devices. • A tiered labeling system for drugs consisting of “red box” warnings that prohibit certain off-label uses; informed consent from patients receiving prescriptions for off-label use of some drugs that currently carry “black box” warnings, which identify drugs that pose a significant risk of serious or life-threatening adverse effects; and the creation of a new “grey box” warning that blocks Medicare Part D and Medicaid reimbursements by the Centers for Medicare and Medicaid Services.

“The improved reporting, testing and enforcement regulation would work together to produce a more layered range of regulatory responses,” the authors write. “The FDA, armed with better information about the extent of off-label use and adverse effects, would be in a better position to require post-market testing and to discourage off-label use with new types of warnings if manufacturers fail to provide sufficient, timely evidence of safety and efficacy in that particular extrapolation.”

The report can be found at: http://scholarship.law.duke.edu/cgi/viewcontent.cgi?article=3785&context=dlj

 

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[Reblog] JAMA papers raise questions about FDA drug and device approval

JAMA papers raise questions about FDA drug and device approval.

JAN24 2014

Posted by Gary Schwitzer in FDA

An important series of papers was published in the Journal of the American Medical Association this week.

“Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012,” by Dr. Joseph Ross and colleagues, concluded that the quality of clinical trial evidence used by the FDA as the basis of approving new drugs varies widely.  A couple of interesting data points:

• in the seven-year period of analysis, 37% of drugs were approved on the basis of a single pivotal trial.
• trials using surrogate end points as their primary outcome formed the exclusive basis of approval for 45% of drugs approved. (See our primer, “Surrogate markers may not tell the whole story.”)

In an opinion piece,  “Opening the FDA Black Box,” Drs. Steven Goodman and Rita Redberg said the study:

“…raises a host of questions needing further exploration. Despite the FDA requirement for evidence from a minimum of 2 randomized clinical trials supporting an effect on health outcomes, 37% of product approvals were based on only 1 trial, 53% of cancer trials were nonrandomized, and an active comparator was used in only 27% of non–infectious disease trials. Surrogate end points were used in almost all approvals via the accelerated approval process and in 44% of nonaccelerated approvals. Trials were comparatively short, with most lasting less than 6 months, even those assessing chronic treatments for chronic diseases. Cancer drugs, perhaps predictably, were more often approved via the accelerated process and with weaker designs.”

Another paper looked at the reasons that FDA marketing approval for new drugs was delayed or denied.

And a fourth paper looked at FDA regulation of medical devices, “a process that has received relatively little attention,” according to Goodman and Redberg, who continued:

In USA Today, Liz Szabo wrote a good summary of the JAMA papers under the headline, “Not all FDA-approved drugs get same level of testing: Evidence behind FDA-approved drugs and devices often has major limitations.”

Read the entire article here

Related Resources

• ClinicalTrials.gov

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human             participants conducted around the world.
When available, study results information is included in the study record under the Study Results tab. See How to Find Results of Studies for more information on finding results entered in the results database.

Results (after 2008, only those required by US federal requirements) include
–Participant data (how many started the trial, dropped out, etc)
—  Information about participants (age, gender, blood pressure readings, etc)

[Speaking of gender…]

Good to know, most drugs can affect women and men differently

    —   Outcome (results of taking the drug plus any placebo), with statistics

    –Adverse effects , serious and other (this was not required before 2008)

• Evaluating Health Information (from my personal Google site)

  • Research Articles Summarized for Us All

  • How to Read a Research Paper

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Turning toys into cheap, effective medical gear

At a TB hospital in Leon, Nicaragua, Jose Gomez-Marquez tests patient samples. Instead of using a pipette, he uses a drinking straw.

(Credit: Jose Gomez-Marquez)

Read more: http://news.cnet.com/8301-17938_105-20093280-1/turning-toys-into-cheap-effective-medical-gear/#ixzz1VV3oFhUh

 

From the 17 August 2011 cnet news article

Jose Gomez-Marquez is like the MacGyver of medical devices, hacking toys and turning them into gadgets that can be used to diagnose conditions such as diabetes and dengue fever. By taking everyday items like Legos and bike pumps and turning them into replacements for expensive medical devices, he’s attempting to save lives on the cheap.

“Most of the devices that get donated to developing countries fail because they were not designed to be used in these environments,” Gomez-Marquez said during a visit to CNET this week to show some of his creations. “We need to make the Land Rover version of medical devices for these countries. Right now we are sending the Ferrari versions and they fail.”….

 

Gomez-Marquez is program director for MIT’s Innovations in International Health initiative, which aims to teach medical professionals in the developing world how to hack ordinary objects to make their own medical devices. With a degree in mechanical engineering and a love of design, Gomez-Marquez wants to level the playing field in health care.

“One of the ways to empower better designs is by empowering users who are everyday users of the devices,” he said. “So we made these kits to do that.”…

Read the article