#evaluation of medical devices

[iziel-healthcare]

What is Post Market Surveillance?

Overview

Post Market Surveillance (PMS) refers to the monitoring and evaluation of medical devices after they have been placed on the market.

It involves collecting and analysing data to ensure the continued safety and effectiveness of the devices.

Importance of PMS

PMS is crucial in identifying any issues or risks that may arise post-sale of medical devices.

This helps manufacturers take appropriate actions to address any safety concerns promptly.

It also allows regulatory authorities to make informed decisions regarding the use of the devices.

Objectives of PMS

The primary goal of PMS is to monitor the performance of medical devices in real-world settings.

This includes detecting any adverse events or malfunctions that were not identified during pre-market testing.

It also involves assessing the long-term safety and efficacy of the devices.

Components of PMS

PMS typically includes the following components:

Post-market clinical follow-up studies.

These studies involve monitoring patients who have been implanted with a medical device.

Complaint handling and reporting.

Manufacturers must establish procedures for handling and reporting complaints related to their devices.

Periodic safety update reports.

Manufacturers are required to submit reports on the safety and performance of their devices at regular intervals.

Conclusion

In conclusion, Post Market Surveillance is a critical aspect of ensuring the safety and effectiveness of medical devices.

By monitoring devices post-sale, manufacturers can identify and address any issues that may arise, ultimately protecting patient safety.

[swapnamakro]

What are the most important steps for a successful EU IVDR clinical evaluation?

When it comes to a successful EU IVDR clinical evaluation, there are several crucial steps to follow:

Define Clear Objectives: Start by outlining the specific goals of your clinical evaluation, aligning them with the requirements of the EU IVDR.

Comprehensive Data Collection: Gather all relevant clinical data, including pre-existing data and new studies, ensuring that they meet the necessary standards.

Thorough Data Analysis: Analyze the collected data rigorously to demonstrate the safety, performance, and benefits of the device.

Continuous Documentation: Maintain detailed and up-to-date documentation throughout the evaluation process.

Expert Review and Validation: Have your evaluation reviewed by qualified experts to validate your findings and ensure compliance.

By following these steps, you can achieve a robust and compliant clinical evaluation under the EU IVDR.

For more info:

https://www.makrocare.com/blog/eu-ivdr-performance-evaluation-in-8-steps/

[i3c-global]

How Regulatory Consulting Smooths Your Medical Device Journey

The medical device industry is a world of innovation, constantly pushing boundaries to improve patient care. But with this progress comes a complex web of regulations.  Ensuring your medical device meets these requirements is crucial for market approval and successful launch. This is where regulatory consulting comes in, acting as your guide through the labyrinth of regulations.

What is Regulatory Consulting?

Regulatory consulting firms specialize in helping medical device companies navigate the ever-changing regulatory landscape.  They possess a deep understanding of national and international regulations, including those from agencies like the FDA (Food and Drug Administration) in the US and the IMDR (EU Regulation on Medical Devices) in Europe.

Benefits of Partnering with a Regulatory Consulting Company

Reduced Risk of Delays: Regulatory consultants can identify potential roadblocks early on, preventing delays and keeping your project on track.

Streamlined Submissions: They ensure your regulatory submissions are complete, accurate, and meet all agency requirements, minimizing the chance of rejection.

Expert Guidance: They provide in-depth knowledge and experience to help you navigate complex regulations and make strategic decisions.

Increased Efficiency: Consultants can help optimize your regulatory processes, saving you time and resources.

Global Expertise: For international market aspirations, they offer guidance on navigating the diverse regulatory requirements of different countries.

How Can a Regulatory Consultant Help with Medical Devices?

Regulatory Strategy Development: Creating a comprehensive plan to navigate the regulatory approval process.

Clinical Trial Design and Support: Ensuring your clinical trials meet regulatory requirements and provide robust data for approval.

Regulatory Documentation Preparation: Assisting in the creation and submission of all necessary regulatory documents.

Quality Management System (QMS) Development and Implementation: Guiding you in establishing and maintaining a compliant QMS.

Regulatory Post-Market Support: Helping you manage post-market surveillance and reporting requirements.

Finding the Right Regulatory Consulting Company

Choosing the right regulatory consulting company is crucial. Here are some key factors to consider:

Experience: Look for a company with a proven track record in the medical device industry.

Expertise: Ensure they have deep knowledge of the specific regulations applicable to your device.

Global Reach: Consider your target markets and choose a company with expertise in those regions if needed.

Communication Style: A good fit is a company that communicates clearly, understands your needs, and keeps you informed throughout the process.

Conclusion

Regulatory consulting can be an invaluable asset for any medical device company. By partnering with an experienced and qualified firm, you can navigate the regulatory maze with confidence, maximizing your chances of success and bringing your innovative device to market faster.

[feminist-space]

"FACTUAL ALLEGATIONS

9. Plaintiff Alexander Morris is an African American man and is the lead singer of the famous Motown group the "Four Tops." At the time of the incident the Four Tops were on a national music tour with the Temptations and had recently performed at the Grammy Awards.

10. On or about April 7, 2023; Plaintiff was transported to the Ascension Macomb Oakland Hospital emergency room via ambulance, and he presented to the emergency room with difficulty breathing and chest pain, he was on oxygen, and he had a significant known history of cardiac disease including the placement of stints and defibrillator. During his hospitalization, Plaintiff was ultimately diagnosed with a heart infraction that may require a heart transplant, pneumonia, and he suffered three seizures during his stay.

11. When he presented to the emergency room Plaintiff informed a nurse and a security guard that he was a member of the famous Motown group the "Four Tops," and that he had current security concerns due to stalkers and fans.

12. Shortly after check-in a nurse Holly Jackson, a White male security guard Greg Ciesielski, and a White male emergency room doctor Brandon Harris Fishman, DO racially profiled him and/or profiled him based upon a perceived disability and placed an order for a psychological evaluation for Plaintiff because they did not believe he was a singer or member of the "Four Tops." Doctor Brandon Harris Fishman, DO, the emergency room doctor who was on staff met with Plaintiff and interviewed him, Plaintiff informed him of his medical history, and informed him that he was having difficulty breathing and chest pain. Defendants and Brandon Harris Fishman, DO wrongfully assumed he was mentally ill when he revealed his identity as a celebrity figure. Defendants and/or Brandon Harris Fishman, DO made the decision to remove him from oxygen and pursue a psychiatric evaluation instead despite his clear symptoms of cardiac distress and significant medical history.

13. Plaintiff had a valid identification on his person and could easily have been identified as a singer in the Four Tops group.

14. Brandon Harris Fishman, DO ordered a psychological evaluation for Plaintiff instead of ordering the emergency medical treatment he needed. Plaintiff was denied the emergency medical care he needed due to his heart condition and pneumonia, and instead a security guard was instructed to ensure he was placed into a restraining jacket and/or a four-point restraint mechanism, removed his belongings, and Plaintiff was told he was going to have a "psych eval" or psychological evaluation. Plaintiff was referred to Virjaya Gopal Kotha, MD for the psychological evaluation.

15. Plaintiff asked if he could prove his identity by showing his identification card, and the White male security guard ordered him to "sit his Black ass down." None of the nursing staff intervened to stop the racial discrimination and mistreatment of Plaintiff. Upon information and belief none of the nursing staff reported the mistreatment or use of the racial slur to a supervisor. Moreover, none of the nursing staff thought to simply ask for Plaintif's identification.

16. Plaintiff told medical staff he was having difficulty breathing and asked for the oxygen back but was ignored. Plaintiff asked to have the restraint device removed and asked for his personal belongings back so he could leave and seek treatment at another hospital, and he was told he was not free to leave; thus, he was falsely imprisoned and deprived of his personal property. During this time his medical condition continuously declined and he was denied the medical treatment he desperately needed.

17. Several security guards were called to surround the nursing station to ensure Plaintiff could not leave. During this entire incident Plaintiff was not being treated for his medical emergency, namely a severe heart condition and pneumonia. Defendant Hospital and Defendant Jackson blatantly refused to provide Plaintiff with medical treatment due to his race and/or perceived mental disability. Instead, Plaintiff received a deliberate misdiagnosis and received a lower standard of medical care based on his race that amounted to racial discrimination and delayed his actual diagnosis.

18. Finally, Plaintiff's wife came to the nursing station to collect his belongings and she saw what was transpiring and Plaintiff informed his wife that the doctors thought he was delusional. Plaintiff's wife informed one of the security officers that he was actually a member of the Four Tops, but he took no action on Plaintiff's behalf, and he was left in the restraints and denied medical treatment. A nurse came to Plaintiff's side, and Plaintiff asked to show the nurse the video of him performing at the Grammys. The nurse realized Plaintiff was a member of the Four Tops, and the nurse went and got the emergency room doctor to inform him. The emergency room doctor returned and said he was cancelling the psychological evaluation.

19. The restraint jacket was finally removed, and he was placed back on oxygen. Plaintiff was restrained for approximately an hour and a half or 90 minutes. As aforementioned, during his hospitalization, Plaintiff was ultimately diagnosed with a heart infraction that may require a heart transplant, pneumonia, and he suffered three seizures during his stay.

20. Plaintiff was offered a $25.00 gift card to Meijers as an apology for the dehumanization and discrimination he faced at the hands of the hospital. He refused to accept the gift card.

21. Subsequent to the incident, a security guard that worked at the hospital contacted Plaintiff and informed him that Greg Ciesielski the security guard that restrained Plaintiff and made the racist comment, made racist comments and jokes to him and other coworkers about African Americans, and that he frequently used excessive force with patients.

22. The security guard who called Plaintiff also reported that he witnessed employees tampering with the internal incident report made on the incident involving Plaintiff, and he believed the use of racial slur was removed from the internal incident report, and he stated that employees were instructed not to discuss the incident. The security guard also stated that Greg Ciesielski was not disciplined or suspended because of the incident.

23. As a result of the above actions and inactions of Defendants as described above and below, Plaintiff suffered injuries and damages. Defendants are sued jointly and severally."

[methodsense]

Increased Cybersecurity For Your Medical Device

MethodSense Inc exploit vulnerabilities in medical devices in a multi layered approach with cybersecurity experts and ensure the patient safety. Reach us by calling at 919-313-3960 or visit our website.

[patientguarduk]

Significance Of Medical Device Clinical Evaluation 

The medical device clinical evaluation is a mandatory step for giving your product recognition by the regulatory authority. Different countries have different medical device registration standards. For instance, European standards differ from American standards. If you want entrance to the market of a particular country, evaluation certification through concerned authorities is necessary.

[reasonsforhope]

"In a highly-anticipated world-first, the Texas Heart Institute has successfully implanted an artificial titanium heart that uses the same technology as bullet trains to pump blood mechanically throughout the body.

Called the Total Artificial Heart (TAH), the feat is seen as a major step in keeping people alive for longer and longer periods while they wait for heart transplants.

Texas Heart partnered with the medical tech company BiVACOR to create the TAH. It’s a titanium-constructed biventricular rotary blood pump with a single moving part that utilizes a magnetically levitated rotor that pumps the blood and replaces both ventricles of a failing heart.

The benefit of using magnetic levitation is that none of the moving parts ever scrape or slide against each other, reducing friction, and dramatically increasing the longevity of the device. But what’s really cool is the TAH can pump blood at a rate of 12 liters per minute, enough to allow an adult male to engage in exercise.

The first-in-human clinical study, overseen closely by the FDA, aims to evaluate the safety and performance of the BiVACOR TAH as a bridge-to-transplant solution for patients with severe bi or univentricular heart failure. Following this first implantation completed at Baylor St. Luke’s Medical Center in the Texas Medical Center, four additional patients are to be enrolled in the study.

“The Texas Heart Institute is enthused about the groundbreaking first implantation of BiVACOR’s TAH. With heart failure remaining a leading cause of mortality globally, the BiVACOR TAH offers a beacon of hope for countless patients awaiting a heart transplant,” said Dr. Joseph Rogers, President and Chief Executive Officer of The Texas Heart Institute and National Principal Investigator on the research.

“We are proud to be at the forefront of this medical breakthrough, working alongside the dedicated teams at BiVACOR, Baylor College of Medicine, and Baylor St. Luke’s Medical Center to transform the future of heart failure therapy for this vulnerable population.”

Heart failure is a global epidemic affecting at least 26 million people worldwide, 6.2 million adults in the US, and is increasing in prevalence. Heart transplantations are reserved for those with severe heart failure and are limited to fewer than 6,000 procedures per year globally. Consequently, the US National Institutes of Health estimated that up to 100,000 patients could immediately benefit from mechanical alternatives.

The successful implantation of BiVACOR’s TAH highlights the potential of innovative technologies to address critical challenges in cardiac care, such as long transplantation waitlists.

“This achievement would not have been possible without the courage of our first patient and their family, the dedication of our team, and our expert collaborators at The Texas Heart Institute,” said Daniel Timms, founder and CTO of BiVACOR."

-Article via Good News Network, August 1, 2024. Video via 7News Australia, July 26, 2024.

[thatsrightice]

HOW TO BECOME A FIGHTER PILOT

So as you may or may not know, I am writing a fanfic. Unfortunately for me, I can never do things half way, and because aviation is my passion I must do hours of research on a particular subject that I probably won't even use or reference in said fanfic. Here is a guide for how our favorite characters (probably) became fighter pilots. If there are inaccuracies let me know, I want to know :)

United States Naval Academy

The USNA is an undergraduate college that is a combination of academics and military development programs. Students who want to go into Flight School could qualify with one of a variety of different majors, but there are particular majors that obviously may provide a bit of an advantage to aspiring pilots. The USNA currently offers a variety of different majors and minors, though there are fewer than you might expect from a typical university, and overall the degrees are more tailored towards the Navy. They encourage participation in athletics in the form of a Varsity or club/intramural sport(1). 

NOTE: Maverick likely attended a regular college and was a part of the Naval ROTC program at that school. He would have gotten his degree in a field relevant to aviation, likely Mechanical Engineering given his mechanical aptitude seen in Top Gun Maverick, and then attended the 13-week program called Officer Candidate School. To be honest, Maverick’s path within the Navy is a mess and impossible to follow but in the most straightforward scenario, he would go to flight school following Officer Candidate School.

Flight School 

Flight School is an approximately 2-year-long program that is required for Naval Aviators to earn their wings. Primarily located at the “Cradle of Naval Aviation” aka Pensacola, FL, flight school consists of many different phases that will divide students into different specializations. 

1. Naval Introductory Flight Evaluation (NIFE)

Divided into four phases, NIFE is a program that evaluates students’ aeronautical aptitude as well as screens them to ensure they’re capable of becoming aviators. Students may earn a “pink sheet” for any score below 80% or a failure of a task, requiring them to stand before a panel of instructors to explain why they failed and how they plan to improve. Too many pink sheets result in removal from the program(2).

1a. Water Survival Training Following medical clearance, students are taught and tested on their ability to swim while wearing flight gear as well as formerly instructed on various survival techniques and CPR(2).

1b. Academics  A 3-week phase where students take classes and exams in five subjects. It is condensed to test a student’s ability to retain information, learn new information in a high-stress environment, and challenge their self-discipline in regard to time management and other areas(2).

1c. Introductory Flight Screening (IFS) Students are entered into a 2-week-long modified civilian flight training program where one week is dedicated to ground school courses before they must conduct a series of flights in a Cessna using Navy flight procedures during the second week. Students had to memorize and prioritize information to complete the flights, specifically in regard to conducting pre-flight briefings and emergency procedures. Overall, they’ll conduct seven flights in which they are required to complete a set of standardized maneuvers(2). 

1d. Aviation Physiology A week-long training course that consists of emergency-specific training evolutions such as the hypoxia chamber, emergency first aid, and the “helo dunker.” The “helo dunker” (from what I understand) is a particular training device that consists of strapping a pilot into a cockpit-like or helicopter contraption within a pool and submerging the entire structure under the water, simulating an environment in which their aircraft has landed in the water and they need to escape from the seat(3). An image of this can be seen below(2).

The Top Gun cast had to undergo a similar training course in order to be allowed to fly in military airplanes for filming. A video of some of their training can be viewed below.

2b. Aviation Pre-Flight Indoctrination

A 6-week long program that marks the beginning of the aviation pipeline. Located in Pensacola, FL, students attend classes covering the basics of aerodynamics, weather in relation to aviation, air navigation, flight rules and regulations, and aircraft engines and systems (3). 

Prior to API, those interested in becoming Radar Intercept Officers (RIO) will have expressed their interest and requested a designation as a Naval Flight Officer (NFO). 

2c. Primary Flight Training

A 6-month-long program that teaches the students the basics of flying. There are two locations for Primary, one at Training Air Wing 5 at Naval Air Station Whiting Field in Pensacola, FL, or Training Air Wing 4 at Naval Air Station Corpus Christi in Corpus Christi, TX. Both Naval Air Stations (NAS) are taught the same curriculum and fly the same aircraft, the T-6 Texan II. The students learn about the instruments, flight basics, radio instrument navigation, formation flying, and aerobatics, and also conduct several solo flights. At the end of Primary, students choose which pipeline they would like. This is conducted depending on the needs of the Navy and how many spots are available(3). 

Obviously, Iceman, Slider, Goose, Cougar, and everyone else got Jets, though they may not have gone through flight school at the same time. 

2d. Intermediate Flight Training

Intermediate Flight Training is a 27-week program. Split into five platforms; Jet, E2/C2, Helicopter, Maritime, and E-6 TACAMO. The jet platform flight training focuses more on navigation, air traffic control, individual skills, and cooperative skills of flying jets. The intermediate flight training program for jets is located at Meridian, MS (Training Air Wing One) at either VT-7 or VT-9, and Kingsville, TX (Training Air Wing Two) at either VT-21 or VT-22, both of which teach the same curriculum. Students in the jet platform will complete 58 graded flights in the T-45C Goshawk jet trainer aircraft(3). 

2e. Advanced Flight Training

Similar to Intermediate Flight Training, the program is split into five platforms but lasts 23 weeks. The students will probably have stayed with the same training squadron throughout the intermediate and advanced flight training. This stage includes learning skills specific to the chosen platform. The Advanced Flight Training program for jets is what’s called the Strike Syllabus. The Strike Syllabus includes an additional 67 graded flights in the T-45 covering air combat maneuvers, low-level navigation, tactical formation flying, and aircraft carrier qualifications. Students will then graduate from Advanced Flight Training with the Wings of Gold(3). 

3. Squadron Selection 

The final selection process assigns naval aviators to a particular squadron based on the needs of the service. Naval Aviators are assigned to a fleet replacement squadron or other similar training assignments for further training on their specific aircraft type. Here, RIOs and pilots must become qualified by gaining the required flight hours and meeting the proficiency standards necessary.

NOTE: It’s kind of hard to figure out when exactly the RIO training occurs. I know it takes place over the course of all the primary through advanced training occurs as well but I’m not sure if they have to attend seperate courses for it. 

TOPGUN

From there, pilots and RIOs may have been moved to their first official squadron for deployment. They would have been in their first squadron for approximately one and a half years, deploying with them. Their squadron would come back from a deployment and during the stand-down time before their next deployment, their commanding officer would select them to go to TOPGUN.

Sources

(1) https://www.usna.edu/homepage.php

(2) https://www.navy.mil/Press-Office/News-Stories/Article/2944668/nife-lays-foundation-for-naval-aviation-training/

(3) https://www.cnatra.navy.mil/tw4/flight-school.asp

[swapnamakro]

What are the essential steps for submitting a Clinical Evaluation Report (CER) for medical devices?

Submitting a Clinical Evaluation Report (CER) is a critical process for medical device organizations, ensuring that their devices meet safety and performance requirements under the European Medical Device Regulation (MDR). A well-prepared CER not only demonstrates compliance but also supports the ongoing marketability of the device.

Here are the essential steps medical device companies should follow when preparing and submitting a CER:

Define the Scope: Clearly outline the device's intended use, clinical benefits, and target population.

Collect Clinical Data: Gather all relevant clinical data, including both pre-market and post-market data, to support the device’s safety and effectiveness.

Conduct a Literature Review: Review existing literature to identify potential risks, benefits, and clinical performance data for similar devices.

Analyze Data and Compile Findings: Analyze the collected data to identify any gaps, risks, or additional clinical evidence needed. Document these findings thoroughly.

Prepare the CER Document: Ensure the report is comprehensive, covering all necessary regulatory aspects, and follows the latest guidelines.

Submit and Maintain the CER: Submit the CER to the relevant authorities and continuously update it based on post-market surveillance and new clinical data.

For a deeper understanding of how to navigate the CER submission process, refer to this detailed guide: A Guide for Medical Device Organizations in Clinical Evaluation Report (CER) Submission. This resource offers practical insights to help you streamline your CER submissions and ensure regulatory compliance.

[lesinquietes]

Reworked the prologue of Thief to include more detail and a richer Dabi perspective. Trying to gently return from my Thief hiatus. This has definitely helped 😊

Thief: Prologue [Reworked]

Summary: As an inmate in a high-security institution for villains, your false sense of security amuses Dabi. He thought shrinks were supposed to be cunning. No one would let their guard down around someone like him — unless your carelessness is a subtle sign that you want him, too.

Pairing: Yandere!Dabi x Psychologist!Reader.

Warning: 18+ (kids and teens don't interact), angst, delusional thinking, implied noncon, kidnapping, misogyny, violence.

—

When you touch his leg, he fantasizes about you stroking his hard cock through his sweatpants. When you look him directly in his dark, callous eyes, he thinks about how sweet your lips would look, wrapped tightly around his length, and how prominent the bulge in your throat would be from how thick you make him. And when you grab his wrist to inject the medication he once so vehemently denied, he thinks about snatching you by the hair and slamming you down on the gurney, instead. He wants you to understand how much it hurts when you do this to him.

He supposes he can’t fault you for doing your job, though. When there’s a task to be done, the responsibility falls on those with the ability to complete it. You’re capable. You push yourself to the limit. You set your emotions aside to do what you know best. You’re a lot like him in those ways. But he can’t ignore the stark difference between you two, either. You’re far less jaded. Your career as a psychologist in this psychiatric unit has required you to shoulder the burdens of others. How do you do it? It’s as though you’ve adapted to the stress. It’s that superior nature of yours that equally pisses him off and drives him wild for you.

He quells his temper by telling himself that sooner or later, this dynamic won’t matter. You won’t be his doctor anymore. He won’t be a mandated patient. His scheme to escape from this daunting institution will come to fruition in the next few weeks, and then? Well, then, you’ll finally be his.

No more seeing other clients.

No more talking to your colleagues, friends, or family.

No more lingering glances from that bastard with the blue tie, who loves to hover over you when you’re so busy at work.

All you’ll have — when he takes you away from this terrible place — is him.

“Dabi?” 

Your voice penetrates through his vindictive thoughts like cupid’s sharpest arrow. He perks up, bringing his lazy, half-lidded gaze to yours. He casts you a lopsided smile.

“What’re we doin’, dollface? More shots?”

You’re sitting in front of him, clipboard in hand, staring intently across the table. He’s restrained; otherwise he would have his chin resting against his fist, inspecting your beauty for the umpteenth time. You’re wearing that blouse he likes today. He appreciates the effort you put into your hair, as well. It’s clear that you’re baiting him into complimenting you.

“Fuck, you look good.” He hums. “Who do you dress up for in this dump, anyways?”

The exasperation on your visage is evident. Maybe he misread you.

“(F/n) is fine.” You correct him with a casual wave of your hand. “No more shots today, just a questionnaire or two.”

But you don’t have to be such a bitch.

“Don’t feel like answering a bunch of stiff questions.”

And if you’re going to act like a brat, so will he.

“Okay.” You concede. “That’s fair.”

You reach down and pull something out of your bag. It’s a series of pictures. Dabi isn’t a stranger to this evaluation. You put a cap with electrodes onto his head and ask him about his reaction to each photo. In another room, a device records his brain activity. He fucking hates it. He feels powerless.

“Wanna do some emotion work?”

The control you have over him in this dynamic is enraging. He doesn’t do well taking orders from others. It’s part of the reason he nearly snapped at Shigaraki when they met. To lose authority is to be weak; to lose authority is reminiscent of a sordid childhood with his selfish father. If it wasn’t for the initial impression you left, he would have given up on attempting to speak with you long ago. 

The hospital sent you into his cell because you were their last resort. He wouldn’t talk to any of the other staff. He attacked doctor after doctor, orderly after orderly, until he was tossed into a cushioned quarantine room. He recalls how they practically shoved you through the door.

You stumbled into his chamber, wearing a vest that framed your figure and a long skirt that shone you in a matronly light. The moisture left his mouth for a moment; then, he jeered at you to get the fuck out. He didn’t know why you left him starstruck, and he tried not to care — until you asked if it was okay to sit down with him. 

He scoffed. He wondered who the hell you thought you were, sauntering into his domain and demanding him to cooperate. It was only when you told him you weren’t trying to force him to do anything that he ceased his verbal tirade to let you speak. He tested you, of course. He claimed he wouldn’t say a damn thing to a whore like you. He thought you’d cry. You didn’t. Rather, you did something completely unexpected; you inquired why he thought they let a whore into his room and not a registered psychologist.

It was the first time he laughed in months.

In the present, he gazes at you across the table. You haven’t changed since then. It wasn’t a mere ploy to get him to cooperate. You continue to respect his boundaries. You don’t press him when he tells you to back off. You don’t bullshit him about the consequences of his actions, but you do it in a manner that’s exponentially humane. He truly believes you’re one of a kind.

“Questionnaires are less of a pain in the ass,” he replies at last. “Let’s do those, doc.”

He doesn’t want to have electrodes on his skull while he’s admiring you. It’s too invasive. What if the technicians are in the back, reading his thoughts, transcribing all the filthy things he wants to do to you?

“I imagine so.” You comment, grabbing a stack of papers from your bag. “In that case, I’ve got some quality of life and aggression stuff for you.”

“Quality of life scale?” He grunts. “I’ll save you the trouble. It’s been shitty.”

You offer him a half-smile.

“We’ll start with the aggression scale, then?”

He could stand to explore his anger, as you so diligently put it one session. You want to see him improve. He doesn’t mind indulging in some work while he’s here, particularly if it gives you an opportunity to get to know him better. He just won’t say enough to give himself away; you can’t know his actual identity, yet.

“Whatever.”

You accept this as a cue to commence. You scoop one of the papers from your pile and place it on the table. He cranes his neck to read it. You snatch it into your grasp before he can.

“Okay. Zero means not at all, whereas five means to a great extent. Got it?”

He nods.

“In the last week, how angry have you felt?”

He thinks about it. He spent the week before this one in solitary confinement. He sat with his thoughts enough to feel like a lunatic. Meals never came on time, and his bed was little better than a stone slab. After getting out, they gave him privileges in the common area for his good behaviour with you. It was meant to encourage his rehabilitation. In fact, he was told that you urged the guards to be more lenient with him.

He’s heard you talk to other patients at the facility. You’re not nearly as kind. You don’t go out of your way to do things for them. Your tone barely takes on the precise smoothness that it does with him. It’s obvious that you have feelings for him.

Before you, Dabi never believed in the concept of a soulmate. He simply slept with who he pleased and kept to himself whenever they got attached. Relationships aren’t his deal. And then you came along, with your perfect hair and calm face, and your lab coat and notepad, and your dorky glasses and irresistible smile.

“Two.”

So, it hasn’t been bad since he was released back into the general pool of prisoners. He notices his rage is at a record low. He wasn’t sure that was feasible after the accident.

“How helpless have you felt?”

He understands the correlation between anger and helplessness. The two intermingle in a turbulent dance of self-depravity. He couldn’t decide which of them to act on when he was in the heat of his recovery, in the days, weeks, months, and years following his coma. Being locked in this ward, with few virtues and little humility, has done nothing for the restlessness in his soul.

“Five.”

You tilt your head to the side.

“Can we explore that feeling?”

He snorts.

“I’d rather not.”

You don’t compel him to extrapolate. You simply move on. You realize there’s no point in grilling him. If he isn’t ready to tell you, he won’t tell you. You resolve to return to the inventory at a later date. As far as you know, he won’t be going anywhere. You have all the time in the world to uncover what’s ailing his mind.

“How much have you wanted to hurt yourself?”

“Zero.”

Another uncomfortable question. He doesn’t want to revive chilling memories of the day he took his life. The pain was immeasurable. In his final minutes of consciousness, he prayed for it to stop. He had no idea that three years would pass wherein he remained in a state of limbo.

“And we don’t want to talk about what zero means, right?”

Inwardly, he applauds you for trying.

“Nah.”

“Got it.” You surrender. “Can I keep going?”

He shrugs. You pause to give him a breather.

“In the last week, how much have you noticed aggressive behaviour coming up?”

Surely you must be aware of his one day stint in solitary a couple days ago. Do you really not claim to know why he beat this shit out of his cellmate? The poor guy didn’t do a damn thing but existed in his proximity; the true culprit was the man who put his arm around your waist. Dabi saw him through the small window of his shared room. He still can’t explain the blind fury that coursed through him.

It took three guards to get him off the man. In the end, they had to sedate him. His mate is going to live, but he doesn’t get to have anyone else in his room anymore. That’s fine by him; he prefers silence over yapping.

“Three.”

You hum, putting the papers down on the table. He knows that adorable expression; you’re worried about him. Is a three that bad?

“Tell me what a three means to you.”

He shakes his head and attempts to lean back in his chair. His eyelids droop, drinking in the way your blouse drops above your breasts.

“I’d rather not, gorgeous.”

“(F/n).” You sigh. “And if you’re sure you don’t want to talk about it, I won’t push you.”

He deliberates indulging in your request. It’s about time he told you how he feels, isn’t it? For you, that is. Enough with the questionnaires. Enough with the pretending. He wants to make his intention to have you known, so that you can begin to envision what a life with him would look like.

"Okay, last question, and it's open-ended," you murmur, moving on without the knowledge of the horror he’s planning to unveil. "In as much detail as possible, can you describe a time within the last week where you've had the impulse to harm someone?"

You don’t know how deliciously this question is, as it sinks into the sludge of his vindictive, rotten mind. He could describe hurting his cellmate — that’s probably what you’re anticipating him to do — but he’s not going to. He’s going to illustrate how he would kill one of your coworkers. Perhaps then you’ll realize the chokehold you have over him, and why you ignite a sinister greed in his decomposing depths.

“You know that bastard with the blue tie?”

Confusion washes across your face. You contemplate. He uses more descriptors to aid in your reflection, including his hair and eye colour. Slowly, you register who he’s referring to.

"...do you mean Dr. Seagrave?"

His grin is unable to be contained. Seagrave. What a fitting surname for a man who will be dead in a matter of weeks.

“Yeah, guess that’s him.”

You process his admittance. He perceives a flash of some emotion in your pretty orbs, though he can’t identify it.

“You’ve thought about hurting Dr. Seagrave this week?”

“Every damn day.” He professes. “Whenever I see him touch you, it makes me want to press my palm against his face and turn him to ash.”

You seem disturbed by his show of love and possessiveness. Unfortunately, that doesn’t deter him. You need to hear this.

“Whenever his hand brushes over your back, I want to burn his legs to charred stumps, and then use his head as target practice.” 

You visibly grimace. The images are too much for you. That’s a shame.

“The worst is when he smiles at you. Heh. That’s when I want to grab him by his hair, press my boot against his back, and pull until something breaks.”

He doesn’t seek to give Seagrave a death devoid of agony. Maybe that’s his father’s genetics talking. When someone takes what’s yours, it’s imperative that they pay the price.

“And if he’s ever within reach of me again.” A darkness flashes over his pale, marred face, while cerulean eyes twinkle with sheer cruelty. “I swear I’ll fucking do it.”

“Okay!” You clap your hands, uncharacteristically interrupting him. “I think I get your point.”

Dabi snickers.

“I’m not sure you do, doll.”

You could never hope to grasp his compulsions. You don’t feel for him with the same degree of intensity as he feels for you. You will, though; he’ll make sure of it.

Hastily, you check your watch. There’s a jagged line of sweat on your forehead, highlighting your anxiety. This isn’t like you. Has he finally made you fear him?

“Let’s explore this more next time.” You say. “I think that’s enough for today.”

So skittish. So cute.

You pack up your documents and get up from your seat. Hoisting your bag over your shoulder, you walk stiffly towards the door. He’s never seen you act this way.

“You don’t gotta run, doc.” He snickers, a hint of unease in his tone. “You’re not on my shit list.”

You halt as you punch in your code to release the lock. Regarding him over your shoulder, you manage a small smile.

“That’s good to know.”

You bid him goodnight and leave the cell.

Your heels clack against the ground as you wander down the long corridor of rooms. Some of them are occupied. Many are empty. When you’re halfway down the block, you lose your composure.

The panic hits you like a tsunami. It brings you to your knees. Sobbing into your palms, you muffle your cries so that no one can hear you break down. A nausea bubbling in your gut threatens to boil over.

Your boss assigned you to Dabi’s case as a last resort. He didn’t show signs of obsession until recently. Your humanistic approach, combined with your implied validation of his existence, might have primed you to be the target of his affection. You must have awakened something inside him with your acceptance. He wasn’t shown this sort of care as a child; men like him find it difficult to establish platonic relationships with women because they unconsciously seek to syphon that empathy until it’s dry. 

You’ll have to remove yourself from his case to remedy this. You don’t want anyone to be harmed; particularly not your fiancé. Although Doctor Seagrave doesn’t deal with Dabi, you have a nagging sensation in your heart imploring you to confide in him about what occurred mere moments ago. The purpose is not merely to vent to your lover, but also, to warn him of the arsonist’s wrath.

You wipe your eyes and straighten yourself out. You focus on the air flowing into, and departing from, your lungs. It’s almost six o’clock in the evening. If you run, you’ll catch your boss. After that, you’ll head to your fiancé’s office. 

You try to soothe your flaring nerves. Everything will be okay. Everything will sort itself out. After all, this is what protocols are for.

You walk towards the East wing of the large building, serenaded by the rough, hoarse voice of a patient, somewhere on the ward. His raspy notes echo off each lonely wall.

“Like a thief in the night... I’m coming for your heart, I’m coming for your heart. This time it’s anything goes. I guess I’m just a selfish ghost.”

[cal-writes]

As always I’m loving the “unpacking” of all of the Zoro happening over here at all times. After much thought on this whole Zoro thinks himself weak- must get stronger no matter the cost agenda. Do you think he’s anti-pain meds? Viewing it as weak? Especially after events like thriller bark where he’d be like … I withstood that, I don’t need the fucking pills for a migraine brought on by my mysterious eye injury and prolonged use of one eye for my routine feats of impossibility.

Meanwhile flash to the domestic as shit scenarios where Law is just like… take the fucking Motrin so you can get back on your bullshit.

Btw loved the car accident bit. That’s the brand of domestic shit I needed 🫶

ohhh interesting question. mhh i think it depends on the situation because we all know that zoro is definitely in favor of self medicating. he does drink a lot (and even if canon treats it like a fun character quirk) that is just what it is. i dont think he would be necessarily against pain medication in general if he felt he needed it to function. see him in wano with the magic healing serum, in the broadest sense that was also a "pain medication" even if it made everything worse after

i do think afterwards he would deny himself that. if it was outside of a dangerous situation where he needed to function he wouldnt take pain medication. he does have a self harm streak a mile wide and i think thats just an extention of that. like why else would he train while already injured and deny himself rest. i think with pain meds it would go the same way. IF left to his own devices. i dont think he would refuse it if it came come chopper or someone else. like he does let the others take care of him

i just think that he doesnt often give them opportunity to do so and they often dont see that he needs to

zoro would have a very complicated relationship to pain.

so i think if he thinks he has to "learn" from the pain he has he would refuse any relief from that bc then where is the lesson right

(actually a thing i also go into in laws twelve sequel like i dont think zoro has known a lot of affection or physical touch that has been gentle period so his perception and evaluation of pain is going to be skewed as hell)

in terms of your examples for the migraine i could see him taking some as long as he doesnt associate it with his lost eye (given the lost eye is something he views as a failure - we dont know what happened to it after all) also never considered hed get headaches from that but you right. i can also see him have chronic pain after thriller bark so his normal level of pain is already debilitating for most people

or in general could be why he drinks as a subconcious way of numbing the pain while not even considering medication

[methodsense]

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