Darren Beck
Survivor of a clinical trial catastrophic failure, patient advocate, speaker, writer

 

I'm passionate about innovation. I've had the opportunity to test drive two experimental medical devices. Both very different devices; an artificial spinal disc and an inferior vena cava filter. Both failed. Both failures were life threatening. Both failures caused a lifetime of injury and pain. Both experiences were unnecessary had the manufacturers, FDA, and Congress prioritized patient welfare.

 

In one instance, it was a miracle to survive when the unexpected and unimaginable happened during a clinical trial for an artificial spinal disc. Post-trauma, with life altering injuries, I learned to walk again (twice), had to find new ways of living and new paths to peace, joy and health in what had become an unfamiliar world.

 

I share here just a small portion of my unexpected journey to highlight the importance (or necessity) of being proactive, self-reliant and responsible for our own health & wellness. It’s a story for inspiration, to never give up hope, know that miracles happen everyday, always have faith, choose love over fear, and keep moving forward.

 

Namaste,
You are more beautiful and powerful than you can imagine
Darren

My purpose is to empower others, create a healthier and happier world, inspire and be inspired

 

 

July 17, 2006 The artificial disc migrated out the front of my spine, crushing my vena cava, major blood vessels and nerves at the base of my spine. The surgical scars down my abdomen are mirrored down my lower back

 

Being a young athlete I fit the perfect patient protocol, they said. The artificial spinal disc was invented by an Olympic gymnast in Germany, they were excited to tell me during recruitment. With decades of history in Europe, now they'd do a clinical trial to bring this first-of-its-kind device to the U.S.

 

I'd recently finished the two year clinical trial for the Charite artificial disc. One day some extra pains sent me into my surgeons office for imaging. His face went white while we looked at the X-ray on the light box. He had tears in his eyes. He didn't know what to do. He sincerely wanted this artificial disc to work out for me. The device had slipped out the front of my spine. "Honestly, this is really not good."

 

The surgeon explained although he'd been trained to implant the experimental device, he didn't have the skills now that it slipped out. He said he "could count on one hand the number of surgeons in the world who could help.” He urged I call the clinical trial coordinator and decision makers at Johnson & Johnson for help immediately. This was not something that could wait. This was urgent. We both lost our breath and words. On my way out he quietly slipped me a note with four names. "You really don't have much time. Start by calling the clinical trial coordinator then work your way up as high as you have to go. But, I think you might need these." In fact, I was facing what was later described to me as imminent death.

 

I could feel the panic setting in. I had to act. Fast! I placed countless calls to Johnson & Johnson over the coming hours. Starting in their clinical trials and research departments, no one knew what to do. I kept getting forwarded to different people higher and higher up the corporate ladder. No one, at any level or within any department, could help. My calls reached the executive C-suites, Bill Christianson's office, Vice President Medical Devices & Diagnostics. I spoke to sympathetic ears and left many messages for anyone who could help. When I finally got a return call it was from Johnson & Johnson "business affairs". I was told because the clinical trial was over, for liability and legal reasons they couldn't help. I was in shock. I had to change direction. How would I find a surgeon who’d agree to an emergency operation on this failed experimental device?

 

My implant surgeon was working with this disc from the very beginning, before Johnson & Johnson bought the disc from Germany's Link Spine Group. He worked with J & J as a study site here in the U.S. throughout the clinical trial. He knew there was no system in place to help me with this crisis as I experienced what they called a "catastrophic failure". Remembering the clandestine note he slipped me, it had four names written on it. I looked up contacts. It turns out these were four of the top spine researcher surgeons in the world. I blindly emailed X-rays to France, Germany and the Netherlands. I got one immediate reply within an hour.

 

I was at work managing Crunch gym when the call came. An alarmed and brilliant Dr. Van Ooij at the University Hospital Maastricht received my images on his phone during some down time on the golf course. Van Ooij’s office called immediately. "You're still standing?" his assistant asked. "You really shouldn't be. Can you lie down? You're in great danger. Stop whatever you're doing. Try to limit your movements. Can you get to the airport tonight?" I should take the next flight to the Netherlands. They'd clear his schedule and the operating room for my arrival in a few hours.

 

Van Ooij had seen this before and knew there were only a handful of surgeons who'd attempted revision surgeries on these failed Charite devices. Time being of the essence, Van Ooij suggested there was a surgeon in the U.S. with experience operating on a case like mine. Van Ooij suggested I take an emergency flight to the offices of Dr. Paul McAfee in Maryland.

 

When I first arrived in Maryland, the team immediately performed an emergency angiogram/venogram to survey the extent of the damage . Aside from the lumbar plexus and nerve damage I’d sustain at the base of my spine, a main concern was my inferior vena cava, the single life-sustaining vein that returns all the blood from your lower body back to your heart. They knew this is where my injuries would become most life-threatening.

 

I was cold and laying awake on a steel table. My brilliant vascular surgeon Samir Saiedy inserted a catheter in my left groin. He immediately met a blockage. I didn't realize there was a problem until he started to jab this catheter into my groin with no success.

 

With my arms down at my sides, I began splashing my hands. I was laying in a large pool, "is this what I think it is?" Suddenly I understood the steel table. "That's normal," he assured me. "There'll be more. Don't worry, we'll get you cleaned up when we're done."

 

"Since I can't get in from the left, I'm going to do what they call an 'up and over'" he says. "I'm going to go in from the right side, go up and over, to see if I can get through." The catheter went in my right groin. Up and over. Then, jab jab jab. No luck getting through.

 

Saiedy's demeanor began to change. He asks his team "I don't understand. His vena cava is completely blocked." He knew I shouldn't be conscious, and wouldn't be for long. As a longshot, he asks "did any of his records or radiology show a double vena cava?" "No sir, no records show a duplicate vena cava" the nurse answered. Saidey was obviously concerned. "Let's get him cleaned up. We'll discuss this with the team and come up with a plan."

 

After reviewing the results and imaging, McAfee and his team remarked they really couldn't explain why I was still alive. They’d attempt a surgery they really didn’t want to do because my chances of surviving the surgery itself were so low (the percentage chance of survival they quoted was insanely low), but it was my only chance.

 

They'd use the same anterior approach surgery used to insert the device and attempt to completely remove the device. They'd bracket my spine at the front, then flip me over and do a posterior fusion securing my spine with brackets and screws from the back as well.

 

Awake when they rolled me into the OR, the theater was absolutely packed, filled with surgeons, assistants, techs, nurses and student on-lookers.

 

Working beside orthopedic surgeon Paul McAfee, Dr Saidy saved my life. Aside from the huge clots blocking my left illiac and renal veins, he explained the unique difficulties of the vascular part of this surgery. Saidy recounted laboring for hours with my crushed vena cava, meticulously peeling away the vein walls that had become fused to the metal portions of the device. Saidy fought through massive bloodloss while I received blood transfusions, stopping my heart numerous times throughout the many hours before he decided not to push his luck further. Afterwards he joked I would likely become a case study in his book and a highlight of his career.

 

I awoke in the ICU, watching my chest rise and fall as a ventilator pumped air into my lungs. It was so alien to feel a machine force my breaths; to not be in control of my own breathing, my own life. A machine was keeping me alive, profound and humbling.

 

Pulling out the breathing tube and trying to take that first breath on my own is a most vivid memory. The nurse warned what was about to happen would be painful, unpleasant and difficult. "We don't know if you can breath on your own. There's really only one way to find out. Please take that first breath so I don't have to use these" the nurse implored as she placed scalpels for an emergency tracheotomy on the tray next to my head "just in case." The pain of pulling out the tube, the fear and anxiety of those next few moments was intense. "Come on Darren! Breath"!

 

Miracles Do Happen

A couple days earlier, the surgeons explained I was facing "imminent death." And, I “should get my affairs in order.” Which of course I did my best to do. It mostly came down to surreal, profound phone calls to say goodbye to friends and loved ones, just in case.

 

With a crushed vena cava, why was I alive? The surgeons noted I’d had countless scans over the years with no indication of a duplicate vena cava, an uncommon congenital abnormality occuring in less than 2% of the population)

 

Fifteen years later, in 2022, I flew to Philadelphia to a specialized vascular surgeon to correct remnant damage to my vena cava that was still threatening my life. Looking at my CT scan on a 52” monitor, he pointed out both my primary and duplicate vena cavas. His opinion, this was likely a congenital condition that definitely saved my life.

 

Being witness to this miracle; one of the many reasons I am thankful, sincerely grateful this unexpected journey happened to me, not to someone less fortunate.

 

 

Johnson & Johnson's Monkey Business

This was a high-profile clinical trial for many reasons. During the two year trial, I began to hear whispers in the industry. Johnson & Johnson's U.S. market entry strategy for the SB Charite artificial spinal disc was pushing boundaries. Digging through medical journals, trade articles, published research studies, FDA filings, transcripts and public records, it reads like Johnson & Johnson may have manipulated the clinical trial design and empirical data, with catastrophic results for patients. While all my surgeons, nurses, clinical trail coordinators throughout my experience were all kind, talented and amazing, it became apparent my patient welfare was not the priority at corporate nor with the entire trial design, endpoints, data collection and statistical analysis. There is so much more to tell than I have space for here.

 

Corporate Greed vs The Hypocratic Oath

In pursuit of growth, Johnson & Johnson movied into in orthopedic devices by acquiring DePuy Orthopedics, a leader in artificial joints: knees and hips. In Johnson & Johnson's 2000/2001 annual reports, they note while the sale of artificial hips and knees had plateaued, J & J would grow the division creating a whole new category of artificial joints for the spine, a new billion dollar revenue stream for years to come. An artificial spinal joint would be revolutionary. There was big pharma competition to be first to market.

 

When I first arrived at McAfee's office in Maryland, his team lit up my X-ray and he remarked “Oh, you must have gotten one of the uncoated discs. The coated discs don’t migrate out.” Startled, I asked what he was talking about. He went on to tell me they noticed the discs migrating out of patients in Europe. The problem had been solved by using a coating on the discs. Dr. McAfee even went on to tell me that before the U.S. clinical trial began, before they ever inserted the first disc into a U.S. patient, he was requesting J & J use the newer-designed coated discs they were using outside the U.S. “Ultimately, the decision was made to start the U.S. trial with the uncoated discs.” When I pushed “but why if you had fixed the problem?” McAfee could only rationalize “since we only just recently started coating all the European discs, most of the European data was from uncoated discs, so by starting the US trial with uncoated discs the data set would more comparable statistically to the European data set." Whether the decision was made for statistics or rush to market, my personal patient welfare was not the priority.

 

I set out to uncover why Johnson & Johnson knowingly put my life at such risk with a problem they already fixed in Europe. What about the doctors' Hypocratic Oath to do no harm? It was only because of my faith and trust in this oath that I enrolled in a clinical trial.

 

During my consent I wasn't informed of the high failure rates and migrations they were having in Europe, especially before they started coating the discs. I wasn't aware that Dr. Van Ooij in the Netherlands was doing revision surgeries on failed Charite discs and publishing studies about the dangers and high failure rates the Charite was having in Europe. Astonishingly, the very concerned Van Ooij flew to Washington to testify at the FDA Review Panel for the final approval of the Charite disc of Johnson & Johnson's data manipulation and the catastrophic failures they were experiencing with this device in Europe. "These patients represent the most disabled group of patients that I have personally seen in 24 years of spine practice" Dr. Van Ooij said in a letter to the editors of the North American Spine Society's online publication. As with my case, one mode of life threatening catastrophic failure in Europe was migration. In rebuttal to Van Ooij, Johnson & Johnson’s Dr. McAfee wrote a letter to the editor of the Journal of Spinal Disorders & Techniques in February 2005. "The authors (Van Oiij) fail to mention anywhere in the paper that these devices were implanted prior to the addition of an electrochemically treated porous titanium and calcium phosphate coating (“bone cement”) to the Charite endplates in 1998." A remarkable statement given in 2001 Johnson & Johnson implanted an UNCOATED disc in me during the US clinical trial.

 

McAfee boasts “there's never been a reported case of migration from a coated disc. For years throughout the clinical trial, J & J, the European distributor, and the manufacturer were publishing reports telling the industry and the world the Charite device design specifications include this necessary coating to prevent them from migrating. Yet, while using the updated coated design in Europe to prevent the device from migrating out of the spine, Johnson & Johnson put their older design uncoated Charite device in me during the US clinical trial.

 

The Secret Baboon Trials

As with artificial knees and hips, it's industry-standard whenever there's a metal-to-bone interface,the device must be secured with a bone cement or porous titanium coating. But rather than use the "bone cement" coated artificial spinal discs to protect patients lives like they were in Europe, Johnson & Johnson put the old uncoated discs in the first U.S. patients while simultaneously testing the discs with “bone cement” on baboons. SB Charite Disc Replacement: Biologic Ingrowth Using a Non-Human Primate Model, Dr. Paul McAfee, et al (2003), The Artificial Disc

 

At the end of the baboon studies they changed the device specifications in the U.S. to include the "bone cement" coating (FDA Premarket Approval Supplement S002 Feb. 2005, Change Design/Components/Specifications/Material ENDPLATES COATED WITH VACUUM PLASMA-SPRAYED PURE TITANIUM AND CALCIUM PHOSPHATE).

 

Although J & J knew clinical data showed these devices need a bone cement coating, U.S. clinical trial patients wouldn't be getting the latest generation, safest, coated artificial disc they were using in Europe. If Johnson & Johnson was actually concerned with patient welfare, why didn't they wait until the end of the baboon trial and only implant U.S. patients with the safer coated disc they were using in Europe at the time? Why? Unbridled greed and because the FDA said they could. This is strategy used by Johnson & Johnson to get their Charite artifical spinal disc approved after a brief, opaque and dangerous 2 year clinical trial in U.S. patients.

 

Medical Device Approval and Regulation

Complex devices are approved too quickly by American authorities and oversight is lacking. When it comes to medical devices in the US, there are concerns that Food and Drug Administration processes may not be sufficient to meet the assurances of safety and efficacy as intended. It takes only 2 to 5 years to bring a new medical device to market, unlike the average of 12 years for a new drug to be brought to market through the FDA process studying safety and efficacy.

 

The FDA is now loosening its rules even further in order to get new products onto the market with substantially less testing than before, a move seen as part of a broader effort to bolster the U.S. as a competitor to Europe, which offers manufacturers an even faster path to approval of new products. There's been a decades long "drift" by the FDA, whose budget is largely financed by the pharmaceutical industry, and at the behest of our state representatives in Congress, away from patient protections, towards competitive advantage and financial gain.

 

The FDA notes that laws passed by Congress require the agency to emphasize the “least burdensome approach” to reviewing new devices. And the agency itself helped fashion those laws working with industry lobbyists and lawmakers. “Basically, it was ‘We need to find ways to get products on the market quicker, faster and we need to figure out how to reduce the premarket data requirements,’” said Christy Foreman, an industry consultant who spent 22 years at the FDA, including four years leading its device review office.

 

Testifying in front of a Congress Subcommittee on the subject, the philosophy of “acceptable uncertainty” is sometimes the price of making devices quickly available, according to the FDA. At the same time, it acknowledges its main system for tracking problems is riddled with “incomplete, inaccurate, untimely, unverified or biased data.” “So instead, you have devices of unknown benefit on the market that still harm patients,” said Dr. Rita Redberg, a prominent medical researcher and cardiologist at the University of California San Francisco. “I do feel that the FDA sees their role as making industry happy and not as much protecting the public health.”

 

When the Data Doesn't Support the Claims

Manipulating the trial design and data, gaining FDA approval in the U.S. after a short two year clinical trial, Johnson & Johnson had to remove the Charite artificial spinal disc after just 3 years on the market. Insurance companies wouldn’t reimburse because the data didn't support Johnson & Johnson’s claims about patient safety and effectiveness. It was, "at best, insufficient." When FDA says Yes, but Insurers Say No, NY Times, Gainesville Sun

 

Michael Mahoney, chairman of J & J’s DePuy orthopedics group said the fundamental design of the devices is right but could do with some “tweaks.” Mahoney said DePuy was “tweaking” the design of Charite but maintained the problem is not the product.

 

The issue, he said, is in the company’s inability to get full reimbursement amid a lack of clinical data. “The great lesson for us for the future is to balance clinical data with reimbursement. That was our shortfall” Mahoney said in an interview at the American Academy of Orthopaedic Surgeons in San Francisco.

 

Mahoney’s statement highlights Johnson & Johnson's unwillingness to accept their Charite artifical disc is not as safe and effective as the standard of care lumbar fusion. It also highlights their propensity to manipulate clinical trial design and empirical data to prioritize revenue at the expense of patient needs, welfare and centricity.

 

(Undetered and unable to sell the Charite to the U.S. market, J&J tweaked and renamed the device the InMotion Charite disc, introducing it to Europe in 2017)

 

Our Patient Experience & Patient Data

Just weeks after getting my Charite artificial disc, Johnson & Johnson asked me (and other patients from the clinical trial) to attend steak dinners and stand in front of a restaurant filled with surgeons. Still in extreme pain, in a back brace, using a walker, learning to walk again, we were shown off at the front of the room as success stories with the one and only data point of their concern, "preserved range of motion". The totality of the data however, most of which was not collected from me as a clinical trial patient, did not support claims that their Charite artifical disc is as safe and effective as the standard of care lumbar fusion.

 

Johnson & Johnson wasn’t interested in what the clinical trial patients were actually experiencing post-surgery. We were actually in the midst of injury, pain, and trauma. Like so many of the others, among other things, I have classic symptoms of Complex Regional Pain Syndrome (CRPS) from damage to the nerves at the base of my spine.

 

While dealing with my own injuries, I began getting phone calls and emails from other Charite patients and their families. I heard stories of deaths, suicides and life-altering injury. Marriages, families and lives fell apart. I became consoler and counselor to badly injured bodies, minds and spirits. I became a patient advocate.

 

 

The Data: Our Patient Advocate

Ironically, the payers/insurers and Centers for Medicare and Medicaid Services (CMS) have become our last line of defense to protect patients from stakeholder greed

When the FDA originally approved Johnson & Johnson's Charite disc, Medicare and private health insurance companies didn't believe the artifical spinal disc was more safe and effective than a spinal fusion. In a detailed review they found Johnson & Johnson's clinical trial data was "insufficient". Without Medicare/insurance reimbursement, Johnson & Johnson was forced to remove the device from the U.S. market. When FDA says Yes, but Insurers Say No, NY Times, Gainesville Sun

 

With the Charite no longer in the U.S. market, by 2024 the FDA had approved 2 more artificial disc devices, the ProDisc and the activL. In 2019/2021 Medicare, in their non-coverage determination, extensively detailed the data in an Analysis of Evidence, Rationale for Determination for denying coverage of Lumbar Artificial Disc Replacement with any of the FDA approved devices in the U.S. Because again, only Medicare and private insurers are protecting patients and the American public from these devices and insufficient clinical data.

 

Insufficient Clinical Data

Johnson & Johnson claimed their Charite artificial spinal disc was more safe and effective than the standard-of-care lumbar fusion. However, during the clinical trial, they were obsessively concerned with only one data point, preserved range of motion. My actual patient experience during, and after, the trial was not reflected in the data they collected and reported. From my own personal experience, the Charite was not as safe and effective as a lumber fusion.

 

In denying coverage for these artificial spinal discs, Medicare agreed. CMS points out the clinical trial data points and the Oswestry Disability Index (ODI) don't reflect patients' lived experience.

"While the premise of the artificial disc is that it offers an advantage to fusion from its ability to preserve range of motion, radiographically measured range of motion is not an outcome that addresses a patient’s symptoms or ability to engage in life activities. Notably, the FDA approval studies of artificial discs were all based on composite outcome measures each of which included a radiographic outcome, which did not itself necessarily translate to clinically meaningful improvement in the patient’s life. Presently, the ODI is 1 of the most important and commonly used clinical outcomes in studies of the human spine. In 2 of the 3 devices studied (Charite and ProDisc-L), the sponsor-proposed and the FDA requested definitions of ODI success differed."

 

Regulators: FDA and Congress

The entire American public have become trial patients and test subjects to promote innovation and product manufacturing in an internationally competitive medical device industry

 

FDA's Least Burdensome Approach

In the 1970's, Senate Committee on Labor and Public Welfare chair Senator Kennedy championed the Medical Device Amendments, a bill that gave the Food and Drug Administration long-overdue authority to regulate medical devices. In support of that bill, Senator Kennedy said at the time:

 

‘‘Today the medical device industry plays a prominent role at the very heart of American medicine. Many devices today are actually used to sustain life. We will grow more and more dependent upon medical devices in the future. We stand to benefit a great deal from them, but we must be sure that they are safe and effective in order to avoid needless injury and death.’’

 

However, the FDA's "least burdensome" approach has become the law
As part of the Food and Drug Administration Modernization Act of 1997 and the 2016 21st Century Cures Act Congress enacted laws mandating the FDA use the "least burdensome" approach in approving and regulating medical devices. A policy that puts stakeholder greed above patient welfare.

 

In a 2019 Med Device Online article, The FDA Redefines 'Least Burdensome' as Critics Fear Chilling Effect on Reviewers, critics called it the latest step by FDA to speed device approvals at the expense of robust patient protection. FDA commissioner Scott Gottlieb said the definition "will help reduce outdated burdens that can add to development costs or forestall beneficial innovations."

 

The most recent document implementing this policy is the
FDA's 2019 Final Guidance: The Least Burdensome Provisions: Concept and Principles

"The Secretary shall consider, in consultation with the applicant, the least burdensome appropriate means of evaluating device effectiveness and safety that would have a reasonable likelihood of resulting in approval"

 

Congressional Hearings Illuminate Stakeholder Greed

Furthermore, Congress created a legal liability shield (pre-emption) for the device industry. Pre-emption states that if the FDA approves a device, it's assumed to be safe & effective so patients are barred from suing for liability or negligence.

 

Soon after Johnson & Johnson's Charite artificial disc clinical trial, in 2008 and 2009 Congress held hearings on pre-emption to highlight how this policy injures patients and public health, specifically mentioning the Johnson & Johnson's Charite artificial disc.

 

2009 Congressional Hearing Transcript

"PROTECTING PATIENTS FROM DEFECTIVE MEDICAL DEVICES"

 

Senator Harkins opening statement is everything I experienced first hand that led to my injuries. Reading the full transcripts highlights the many elements of device approval and post-market approval we can improve to create a system that prioritizes patient welfare

 

Opening Statement of Senator Harkin

"We are here because last year in a U.S. Supreme Court case, the Court held that the Medical Device Amendments, a statute whose explicit purpose was, ‘‘to provide for the safety and effectiveness of medical devices,’’ —the Court said that this law preempts State tort claims when a medical device causes harm. This means complete immunity from lawsuits for corporations that endanger consumers with unsafe devices. The upshot is that a negligent corporation could not be held accountable and victims could not receive fair compensation, and thus, consumers are at risk. Unfortunately, this has had catastrophic consequences for ordinary Americans."

 

"Consider Judd Orcutt, of Oregon. During his National Guard service, where he earned the Army Commendation Medal, he sustained a spinal cord injury. In an effort to reduce pain, he had his herniated disk replaced with an artificial Charite disk—I hope I pronounced that right—manufactured by (Johnson & Johnson) DePuy Spine. Instead of experiencing relief from the artificial disk, Judd, like hundreds of others, experienced extreme pain and bouts of paralysis. However, because of the Court’s ruling in Riegel, Judd has no recourse to seek remedies for his injuries."

 

"While the FDA approval of medical devices is important, it cannot be the sole protection for consumers. I say that because FDA approval, as we’ll hear today, is simply inadequate to replace the longstanding safety incentives and consumer protections provided by longstanding State tort law."

 

"No matter how diligently and effectively the FDA does its job, it simply cannot guarantee that no defective, dangerous, and deadly medical device will reach consumers...The fact is, the FDA conducts the approval process with minimal resources and simply does not have adequate funds to genuinely ensure that devices are safe or to properly and effectively reevaluate approvals as new information becomes available. Moreover, the FDA relies on manufacturers to provide information about their products. Once on the market, the FDA relies on manufacturers to track devices and monitor for problems. However, without the threat of any liability, there is little incentive for manufacturers to report problems to the FDA or to the public. This puts thousands of consumers at risk of harm. Indeed, thousands have already been harmed in instances where manufacturers knew of problems with the device but withheld that information from the patients."

 

LINK TO FULL TEXT

 

2008 Congressional Hearing Transcript

"SHOULD FDA DRUG AND MEDICAL DEVICE REGULATION BAR STATE LIABILITY CLAIMS?"

 

LINK TO FULL TEXT

 

 

U.S. Legislation

Ensuring Patient Access to Critical Breakthrough Products Act 2023

Pending, introduced in House 03/22/2023
This bill provides for Medicare coverage of medical devices that are approved under the Food and Drug Administration (FDA) Breakthrough Devices Program. The bill allows designated medical breakthrough devices to be temporarily covered under Medicare during a four-year transitional period. The Centers for Medicare & Medicaid Services (CMS) must assign payment codes for such devices within three months of FDA approval. The CMS must also establish a process to allow for continued coverage after the transitional period has expired, taking into account any additional evidence or data the CMS deems necessary. The CMS must also provide for temporary and, where appropriate, permanent Medicare coverage of breakthrough devices for which there is no existing benefit category (i.e., classification).

 

THIS BILL IS A BAD IDEA. Unfortunately, payers have become our only patient advocates in a system designed to speed medical devices to market. Medicare/CMS/Insurers are our last line of defense, actually scrutinizing the clinical data and protecting patients. I agree with the Medicare Rights Center in their letter to the Chairman "This legislation would allow FDA-designated medical breakthrough devices to be temporarily covered under Medicare during a four-year transitional period. In so doing, H.R. 1691 would override Medicare’s ability to determine what services are “reasonable and necessary” for beneficiaries. This is an important patient safety and consumer protection in general, and in particular with respect to breakthrough technologies. These devices, by their nature, lack complete evidence of efficacy, safety, or clinical benefit for use among the Medicare population. We support adhering to the existing reasonable and necessary safeguard. The bill’s sharp departure from this standard would undermine CMS’s ability to advance evidence-based coverage policies and put beneficiaries at significant risk. We also echo stakeholder requests for better data regarding breakthrough devices as well as more extensive and inclusive clinical trials, clear evidence-based approval and monitoring standards, and robust oversight."

 

Medical Device Recall Improvement Act

Pending, introduced 2023 to improve the medical device recall process in order to protect patients. The Medical Device Recall Improvement Act would require the Food and Drug Administration (FDA) to establish an electronic format for medical device recall notifications to streamline communication between device manufacturers, FDA, hospitals, and health care professionals. It also would require manufacturers to include in recall notices information about how the recall could affect patients with medical devices and instruct hospitals and health care professionals to provide that information to patients. The legislation was inspired by Illinois constituents who had shared their personal stories about medical harms and other concerns related to recalled devices.

 

Medical Devices; Quality System Regulation Amendments

Department of Health and Human Services, FDA
Quality Management System Regulation (QMSR) Final Rule
Effective February 2, 2026
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation, incorporating the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO). We are harmonizing to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e. other countries). We are doing so by incorporating by reference an international standard specific for device quality management systems. Through this rulemaking we also establish additional requirements and make conforming edits to clarify the device CGMP requirements for such products. This action will continue our efforts to align our regulatory framework with that used by regulatory authorities in other jurisdictions to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.

 

Europe

Meanwhile Europe has passed the EU MDR. The European Union Medical Device Regulation Regulation (EU) 2017/745

 

By 2024, any existing medical device products certified under the MDD need to be recertified under the MDR, if they wish to continue to be sold within the European Economic Area (EEA). The EU MDR medical device regulations are a set of regulations that govern the production and distribution of medical devices in the European Union. These regulations aim to ensure that medical devices have no negative impact on human health.

 

The European Medical Device Regulation (EU MDR) is a regulatory framework that aims to improve patient safety and the quality of medical devices in the European market. The EU MDR has several benefits for patients, including

Higher safety standards. The EU MDR enforces stricter regulations on medical devices to ensure a higher level of patient safety
Greater transparency. The EU MDR promotes greater transparency and traceability of medical devices throughout their lifecycles, which can help identify and address any potential safety issues
Enhanced quality and reliability. The EU MDR enhances the overall quality and reliability of medical devices available

 

 

Contact

 

Looking forward to our conversations darren@clinicaltrialpatient.org