RDN thinking - Registered Dietitian Updated: 2023

On average, around 4,500 drugs and medical devices are pulled from shelves across the United States each year.¹ This alarming statistic underscores the importance of controlling and mitigating risk in healthcare-related products. latest updates to regulatory guidances and standards are encouraging life sciences companies to step up their risk management efforts by infusing risk-based thinking into their entire quality ecosystem. For example:

• ISO 13485:2016 – The current version of ISO 13485 has a significant focus on integrating active risk assessment and mitigation in quality processes, which includes documenting requirements and maintaining risk management records throughout the product’s life cycle.²
• ISO 14971:2019 – The 2019 updates to ISO 14971 regarding risk management with medical devices include risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. It applies to risk with intended use, reasonably foreseeable misuse, identifiable characteristics related to safety, and identification of hazards and hazardous situations throughout the product’s life cycle.³
• European Union Medical Device Regulation (MDR)/In-vitro Diagnostics Regulation (IVDR) – The updated regulations for medical devices are slated to go into effect in May 2021, while the regulations for in vitro devices are slated to go into effect in May 2022. Compliance requirements include establishing and documenting a risk management plan for each device. The requirements for postmarket risk management will be more granular and stringent. Once the product is on the market, manufacturers will be accountable for continuing to gather and examine data throughout the device’s life cycle.⁴
• Medical Device Safety Action Plan – The FDA’s Center for Devices and Radiological Health (CDRH) is pursuing initiatives to protect patients and promote public health while continuing to drive innovation to address unmet medical needs. A key component of the agency’s efforts is its Total Product Life Cycle (TPLC) approach to device safety.⁵

Healthcare providers need to have the necessary medical devices available to perform procedures. Unless a device is fully compliant with the regulations, it cannot be used where it is needed. With more robust global regulatory requirements being enforced, companies will need to revisit their core quality system processes—particularly risk management.

Overall, employing risk-based thinking throughout the organization is important, but how do companies put risk policies and procedures into practice? Most often, risk management is viewed as a requirement to meet regulatory compliance. The guidances and standards leave the “how” up to the companies. Some of the most common methods for assessing risk include a risk matrix, a risk register, and a failure mode and effects analysis (FMEA). But what is really needed is a practicable and effective risk management system within the organization.

Risk management needs to be a continuous, iterative process. It involves employing a systematic, data-driven approach to monitoring trends and identifying and mitigating risks before they result in costly delays, rework, or product recalls. Individual events such as out of specifications (OOS) and other deviations are easy to silo and overlook as part of a larger risk. For instance, there could be a new risk that may have been missed or an unforeseen hazard that now needs to be monitored. That said, risk management is not a quality-only responsibility—it needs to be integrated into all areas of the company.

Much of the impetus for making risk management an all-hands endeavor is attributed to advancing technology and more-sophisticated medical devices. Software-based medical devices are a prime example. More disparate entities (internal and external) are involved in the design and development of the components of these devices. All too often, defects or functionality discrepancies go undiscovered until later in the production process or postmarket. Risk management needs to start earlier and be performed in greater detail and at every stage of the product’s life cycle. Staff involved in product design, development, manufacturing, supply chain, etc. must participate in risk control and mitigation.

Setting up an effective risk management system involves effectively aligning people, processes, and technology. This all starts with building a risk management plan that includes clearly defined, documented policies, such as a policy for risk acceptability. Best practices include establishing organization-wide collaboration, clarifying priorities, and empowering people in all areas to make decisions, including stopping production if necessary. This way all employees understand the purpose of the procedures as well as the overall goals of the risk management system.

To successfully implement this type of all-inclusive system means all stakeholders need the ability to access and share data in real time in order to more effectively track and trend risk data. The need for this level of interaction, speed, and efficiency renders paper-based or spreadsheet data collection and analysis impracticable.

With platform-based technology, every business unit can have an appreciable impact on the company’s overall risk management efforts. Integrating business unit-specific systems across the organization dissolves siloes, harmonizes disparate operations, and fosters real-time, company-wide communication. This augments the company’s capacity for gathering quality data and making more confident decisions based on predictive insights.

Using technology to proactively monitor and control risk reduces regulatory interaction, which makes sense on a compliance and business level. In return, the organization experiences shorter product development cycles and faster regulatory clearance, reducing the overall cost of compliance. Regulators have greater assurance of the company’s ability to identify and mitigate risks and develop safe and effective products. Essentially, the organization's risk management system becomes a catalyst for business success. 

1. "FDA Recalls,” Drugwatch, https://www.drugwatch.com/fda/recalls/.
2. “Reducing the Risks of Medical Devices: International Guidance Just Updated,” Clare Naden, Dec. 18, 2019, https://www.iso.org/news/ref2465.html.
3. “ISO 14971:20198 Medical Devices – Application of Risk Management to Medical Devices,” https://www.iso.org/standard/72704.html.
4. “The European Union Medical Device Regulation of 2017,” https://eumdr.com/.
5. “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health,” Center for Devices and Radiological Health, Jan. 5, 2021, https://www.fda.gov/about-fda/cdrh-reports/medical-device-safety-action-plan-protecting-patients-promoting-public-health

In February 2022, Mario Andres Espinosa Hernandez was nearing graduation from the UAB Heersink School of Medicine and was looking forward to Match Day in March, when he would learn where he has matched into residency. However, there was one more challenge for him to overcome—one that arrived unexpectedly and with higher stakes than any he had previously encountered.

It was an ordinary Tuesday when Espinosa Hernandez headed to the gym to work out. There, something happened that changed two lives in dramatic ways. “I was doing my workout, and out of the corner of my eye I saw my friend crouched over a girl who was lying on the floor, and he was motioning for me to come over,” Espinosa Hernandez says. “It looked like she was having a seizure.”

Leaning into his medical school training, Espinosa Hernandez says he thought about the ABCs (airway, breathing, circulation), felt for a pulse (which he says was “very thready”), and began performing the jaw thrust maneuver to open her airway. A nurse who also happened to be at the gym hurried over to help. A few minutes later, Espinosa Hernandez saw that the woman’s face, lips, and fingers were turning blue, and he checked her pulse again and found none. He asked the nurse to begin CPR and asked another person to get one of the gym’s automated external defibrillators (AEDs). When they removed the woman’s shirt to place the AED pads, he noticed a long scar running down her chest. “I saw that and thought, ‘Oh no, this might be cardiac. It could be very serious.’” Indeed, once applied the AED diagnosed that the young woman’s heart was in a fatal arrhythmia.

It was a moment that could have triggered what Espinosa Hernandez says medical students call “imposter syndrome”—the feeling that, regardless of all the training, you’re not truly prepared to handle a life-or-death situation. Instead, he says the opposite sensation kicked in. “I didn’t have time to be scared or nervous. My brain was like, ‘You’ve done the simulations. You’ve had the training. You know what needs to be done, and she may die without it.’”

Mario Andres Espinosa Hernandez

Espinosa Hernandez says he shocked her three times with the AED before the emergency medical system (EMS) team arrived. EMS shocked her again, finally bringing the woman back to a regular heart rate before rushing her to the ambulance.

Only then did the enormity of what had just happened hit Espinosa Hernandez. “When I knew she was at least temporarily stabilized, all of the emotions flooded in,” he says. “I was shaking, and it seemed like the entire gym walked up to me, asking me questions and calling me a hero. It was insane.”

Knowing his quick reactions had helped save a young woman’s life would have boosted the confidence of any medical student, but it held particular significance for Espinosa Hernandez. Growing up, he helped care for his mother, who suffers from multiple sclerosis. The two watched a lot of medical shows together, and he says he was hooked. “My mom would call me her little doctor,” Espinosa Hernandez, whose family is from Puerto Rico, says. “I knew medicine was what I needed to do. I wanted to help people.”

Not surprisingly, Espinosa Hernandez’s first call after helping save the young woman’s life was to his mother. “We were both on the verge of tears, because she’s my motivation for everything,” he says. “She told me she always knew I had it in me and said she was really proud of me. It made me feel, ‘I need to do this.’” He says he felt in those moments like he genuinely belongs in medicine.

That hasn’t always been the case. Espinosa Hernandez admits he occasionally struggled with doubt and insecurity while in medical school. “I sometimes had feelings of, ‘I’m different than a lot of the other medical students, I’m from Puerto Rico, I come from a low-income household.’ I thought maybe I didn’t really belong,” he says. “But I will always love UAB, because UAB was the medical school that gave me a chance. And then this happened, and it definitely gave me a boost of confidence.”

For several weeks, Espinosa Hernandez did not know the fate of the woman he had helped keep alive, until one day a staff member at the gym told him that her father was trying to track him down. “I called him, and it was very emotional,” he says. “He filled me in on a lot of details. She has a congenital heart disease called Tetralogy of Fallot, and she had had open-heart surgery when she was 15 or 16 months old. She was actually scheduled to have another heart procedure done before the incident at the gym happened.”

Espinosa Hernandez learned that the woman spent several days in the ICU before being transferred to the hospital where her heart surgeon practices. Her father told him she had had the scheduled heart procedure and was home recovering well.

Today, Espinosa Hernandez has started residency training at the University of Florida in Gainesville. His specialty is an appropriate one: emergency medicine. “Maybe this is cheesy, but when I was a kid taking care of my mom, I really wanted to be a hero. One of the reasons I wanted to go into emergency medicine is I wanted to know what to do in case of an emergency, and this scenario has showed me that I achieved my dream.” – Rosalind Fournier

The intent to keep one’s New Year resolution only lasts two to four months before goal-setters supply up or forget about it, according to Forbes Health survey findings. Just under one in 10 (8%) say their resolutions have lasted a month, 21.9% report two months, 22.2% report three months and 13.1% say their resolutions have lasted four months in the past.

“We often fail in achieving and keeping New Year’s resolutions because they focus on a specific outcome (e.g., a precise body weight),” says Dr. Romanoff. When individuals focus on a particular outcome, it can be challenging to persevere in your efforts if results are not immediately apparent, she explains. “Goals take time, and many folks become discouraged and eventually relent before attaining the goal.”

Experts agree that setting resolutions that align with one’s personal values (instead of a specific outcome) can serve as a great source of motivation. Additionally, setting short-term goals to stay motivated along the way toward bigger-picture resolutions can be helpful. To help individuals stick to their goals, our experts offer the following advice.

Link Your Goals to Your Values

“Values are never actually achieved, rather they operate as a compass, constantly informing and guiding our behaviors,” says Dr. Romanoff. Instead of focusing on a specific number on the scale, she suggests using your specific motivation to lose weight—whether it be improved health or self-esteem—as a value to incentivize your goal. This can help ground your resolutions in purpose and contextualize them in a meaningful way, Dr. Romanoff says.

Create Short-Term and Long-Term Goals

One of the biggest factors that lead people to abandon their resolutions is setting goals that are unrealistic, according to Dr. Romanoff. “Divide your goals between those that can be accomplished either in the long or short term,” she suggests, adding that, “creating an action plan that links the long-term goal with the near-term achievable and realistic goals will ensure success.”

Jeff Temple, Ph.D., professor, psychologist and associate dean of research at UTHealth’s School of Behavioral Health Sciences and Forbes Health Advisory Board member suggests setting goals that are specific and measurable. “You’re more likely to succeed if your goal is: ‘I want to lose one pound per month for six months’ as opposed to: ‘I want to lose weight,’” he says. It may also be helpful to enlist an encouraging, non-critical friend to keep you accountable, he says.

Dr. Ho recommends starting with small changes to help build confidence. “Things that you can shift in your habits a little at a time, beginning with something you can accomplish within a few minutes to 15 minutes a day,” she says. Some small changes Dr. Ho suggests are taking a walk around the block during your lunch break, tracking how much water you drink, doing a five to 10 minute yoga or stretch routine upon waking up and engaging in a hobby you enjoy for 10 to 15 minutes like knitting, playing music or drawing.

Make a Plan to Overcome Obstacles

Dr. Ho suggests assessing potential barriers and making a plan to navigate those barriers before they happen. “This involves visualizing the barriers that might get in the way of your goals, and then making ‘if/then’ plans for each barrier,” she says. For example, if you’re tempted to skip a morning workout, put on your running shoes and drive to the gym anyway, “because once you get to the gym, you’re much more likely to get out of the car and go in, at least for a few minutes,” notes Dr. Ho.

Be Flexible—and Reward Yourself

Dr. Romanoff encourages individuals to have an easy grasp on their resolutions, and let go of any rigid thinking around them, as accommodating change and being adaptive can help resolutions stick.

Another key to sticking with your New Year’s resolutions? Rewarding yourself for steps taken toward achieving your goals. “This will shape and reinforce improvement and sustain motivation,” says Dr. Romanoff.

To do this, Dr. Romanoff recommends setting measurable benchmarks toward your goal. “For example, if you walk 5,000 steps daily in the next month, buy yourself special headphones to use on your walks. If you exercise four days per week for the next three weeks, buy yourself a new workout set you’ve been eyeing.”

Dr. Romanoff also suggests giving yourself a reward that extends beyond purchasing something, but rather focuses on how you spend your time or involves a valued activity. As a reward for making progress toward your resolution, Dr. Romanoff recommends giving yourself a spa night, eating your favorite dessert or giving yourself permission to have a lazy morning in bed.

(Note: Product details and pricing are accurate as of the publication date and are subject to change.)

Back in the day, the office staff answering the phone was my means of protecting my time. They would take messages and deflect calls. Today, with the advent of portals, those protections have been lost, only to be replaced by the castle-guarding moat of email. I am not sure exactly how I feel about texting or email, although I must admit I am doing it more and more as a patient. But perhaps because I was “in the trade,” most of my digital communication has been relatively direct and free of charge. But charging for physician email response are becoming a thing.

The New York Times covered the problem earlier this year. Cleveland Clinic, along with the VA, among other health systems, is charging a “co-payment” for the service imposed on patients as we are all herded into patient portals for communication. Of course, there is a code for this digital service. CMS approved Medicare billing codes in 2019, and private insurers have followed suit to varying degrees.

There are some reasons why charging for those last-minute questions makes sense. First, in a world increasingly dominated by providers paid on the clock for their work (as relative value units), responding to email takes time. There is no doubt that email to physicians has dramatically increased during the pandemic, rising by 150% or more. Numbers are hard to come by, but physicians, on average, spend about an hour a day on their email, and at least a percentage of that is done outside the office – digital communications often blurs the work-life balance. Another study found that physicians spend a little over 2 minutes responding to an email question. One might note at this point that CMS requires a minimum of 5 minutes responding to initiate a bill for this digital service – but who is punching a time clock?

Responding to patients’ questions, whether in person or virtually, is a form of medical consultation. At a minimum, the physician must be cognizant of the patient’s history, hopefully understanding their current health concerns and be able to access pertinent laboratory or imaging information in order to provide professional advice. Of course, when a physician gives advice, there attaches to use a legal phrase, liability. To adequately defend against such concerns, text messages must be added to the clinical record, an additional time cost.

Charging for email correspondence has resulted in a win-win for some bean counters. A study at UCSF before and after adopting a charge for email demonstrated that email messaging and back-and-forth texting decreased after fees were introduced, but virtual visits increased – those small email fees drove more patients into more remunerative e-visits. What is unclear is whether these charges, which reduce the demand for access, resulted in poorer care. One would hope that synchronous face-to-face communication, even over video, would be better than the asynchronous back-and-forth of texting. Looming large over that discussion are the disparities of care already baked into the system by those patients without the proper digital tools, insurance, or inadequate coverage for this form of care.

I freely admit I am no longer practicing, so my sense of how well the physician-patient relationship is maintained in these circumstances is unclear. To the extent that I prefer a face-to-face conversation over a telephone call, I am a curmudgeon. I use email extensively, but I am put off by texting. There is, of course, an entire generation raised on texting and email that may be far more comfortable, but I defer. On the other hand, as a physician, I have experienced the power of “laying on of hands” and soft conversation, so while I defer judging, I can’t help but feel this digital back-and-forth will ultimately fail in the moments you need a physician the most.

A new study from The Ohio State University Wexner Medical Center and College of Medicine, University of Utah and University of Exeter (UK) substantiates previous groundbreaking research that rumination (overthinking) can be reduced through an intervention called rumination-focused cognitive behavioral therapy (RF-CBT). In addition, the use of functional MRI (fMRI) technology allowed researchers to observe correlated shifts in the brain connectivity associated with overthinking.

Study findings are published online in the journal Biological Psychiatry Global Open Science.

"We know adolescent development is pivotal. Their brains are maturing, and habits are forming. Interventions like RF-CBT can be game-changers, steering them towards a mentally healthy adulthood. We were particularly excited that the treatment seemed developmentally appropriate and was acceptable and accessible via telehealth during the early pandemic," said corresponding author Scott Langenecker, Ph.D., vice chair of research in the Department of Psychiatry and Behavioral Health at Ohio State, who started this project while at the University of Utah.

RF-CBT is a promising approach pioneered by Ed Watkins, Ph.D., professor of experimental and applied Clinical Psychology at the University of Exeter. It has been shown to be effective among adults with recurrent depression.

"We wanted to see if we could adapt it for a younger population to prevent the ongoing burden of depressive relapse," said Rachel Jacobs, Ph.D., adjunct assistant professor of psychiatry and behavioral sciences at Northwestern University who conducted the pilot study in 2016.

"As a clinician, I continued to observe that standard CBT tools such as cognitive restructuring didn't supply young people the tools to break out of the painful mental loops that contribute to experiencing depression again. If we could find a way to do that, maybe we could help young people stay well as they transition to adulthood, which has become even more important since we've observed the mental health impact of COVID-19," Jacobs said.

In the trial, 76 teenagers, ages 14–17, with a history of depression were randomly assigned to 10–14 sessions of RF-CBT, while controls were allowed and encouraged to receive any standard treatment. Teens reported ruminating significantly less if they received RF-CBT. Even more intriguing, fMRI illustrated shifts in brain connectivity, marking a change at the neural level.

Specifically, there was a reduction in the connection between the left posterior cingulate cortex and two other regions; the right inferior frontal gyrus and right inferior temporal gyrus. These zones, involved in self-referential thinking and emotional stimuli processing, respectively, suggest RF-CBT can enhance the brain's ability to shift out of the rumination habit. Notably, this work is a pre-registered replication; it demonstrates the same brain and clinical effects in the Utah sample in 2023 that was first reported in the Chicago sample in 2016.

"For the first time, this paper shows that the version of rumination-focused CBT we have developed at the University of Exeter leads to changes in connectivity in brain regions in adolescents with a history of depression relative to treatment as usual," Watkins said.

"This is exciting, as it suggests the CBT either helps patients to gain more effortless control over rumination or makes it less habitual. We urgently need new ways to reduce rumination in this group in order to Improve the mental health of our young people."

Next, the researchers will focus on demonstrating the efficacy of RF-CBT in a larger sample with an active treatment control, including continued work at Ohio State, Nationwide Children's Hospital, University of Exeter, University of Utah and the Utah Center for Evidence Based Treatment.

Future directions include bolstering access to teens in clinical settings and enhancing the ways we can learn about how this treatment helps youth with similar conditions.

"Our paper suggests a science-backed method to break the rumination cycle and reinforces the idea that it's never too late or too early to foster healthier mental habits. Our research team thanks the youths and families who participated in this study for their commitment and dedication to reducing the burden of depression through science and treatment, particularly during the challenges of a global pandemic," Langenecker said.

Shrinkage of one of the brain's key memory centers appears to herald thinking declines, a new study finds.

The region in question is the hippocampus, a two-sided structure located roughly above each ear and embedded deep within the brain's temporal lobe. It's long been known to play a crucial role in the storage and transference of short- and long-term memory.

The new research was published Wednesday in the journal Neurology. It focused on brain scan data collected from 128 people averaging 72 years of age.

A team led by Dr. Bernard Hanseeuw, of Harvard Medical School in Boston, used the scans to track changes in brain levels of amyloid plaques or tau tangles. Both are linked to the onset of Alzheimer's disease.

The team also used the scans, which were taken annually, to chart any changes in the size of an individual's hippocampus over the course of seven years.

People who showed the most significant shrinkage in their hippocampus were also most likely to display thinking declines over the study period, Hanseeuw's group reported.

This seemed to occur independently of changes in levels of either amyloid or tau, they noted. They estimated that hippocampus shrinkage might account for 10% of thinking declines.

"These results suggest that neurodegenerative diseases other than Alzheimer's are contributing to this decline, and measuring the hippocampus volume may help us evaluate these causes that are currently difficult to measure," Hanseeuw said in a news release from the American Academy of Neurology.

"This could help us better predict who would respond to these new drugs as well as people's trajectories of cognitive decline," he reasoned.

More information:

Find out more about the brain and the hippocampus at Johns Hopkins Medicine.

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