#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.

[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

[ms-scarletwings]

On Defective Irkens

“It is theorized that Tak may also be an Irken defect because-“

“Say guys do you think Skoodge is defective? He did a thing he wasn’t told to do once do you suppose-“

“Service Drone Bob's contempt for the Tallest is extremely abnormal, even for most defective Irkens…”

“Hints of the comms officer being a defective are seen when-“

Ohhh mauling the fan wiki writers grr biting biting thrashing and then turning around to the rest of you before I’m done, you bet, for I have sat and listened for over 12 years of leaps and speculations of this sort and now I’m now one of the ones who gets to have what the cool kids these days call a hot take on the matter.

By the end of this I’M going to bring up and expose who I actually think may be the only other defective Irken(s) in the show besides Zim, whom I’m aghast I haven’t seen anyone suggest before.

But before anything else, I want to front one preassumption center and loud.

It took me a long time to guess at why very few people can ever seem to get on the same page of what it actually means to call an Irken defective. Implicitly, the bulk of what we are given is that something can be wrong with a member of this species, and Zim is our prime and singular clear example of that. So there’s a ton of trying to find patterns between Zim’s behavior and that of other Irken characters. Weirdly (to me), a lot of people have, in their efforts, chalked the status up to a sense of rebelliousness or insubordination- a defectiveness in the manner of D&D illithids, stomping out disloyal break-aways from the collective hive mind with punitive wrath. Don’t get me wrong, it’s a cool concept, and it’s definitely closer to my opinion at least than the comparisons to real life mental disorders or disabilities. Not knocking the comfort or the enthusiasm, obviously.

From my view of the canon, I hope it’s at least apparent to other fans that “defective” isn’t some empirical measurement or status to Irkens. Look at the way they determine the defects from normal society. IRL, if I have a faulty device on my hands, there’s some way out there to tell me in a clear cut fashion if there’s a problem and what exactly it is. If it’s code, it can be scanned and debugged. If it’s mechanical, something can be seen, fixed physically. Most organic health problems are only different in the complexity of the matter, but the entire purpose of medical research is to come close as we can to bridging that gap. In Irk’s people, that line is rapidly becoming one long smear of wet chalk. I’m going on like this because if defective paks were akin to hardware actually being damaged, as Purple had put it, it doesn’t make as much sense that they are neither “fixed” nor given real, concrete diagnostics. The only way we know of that the aliens are tested in a since on this merit is by existence evaluations. And existence evaluations are anything but empirical, impartial events. They’re worlds more political and cultural than clinical.

Digest the terms we keep seeing all around the concept: Innocent, justice, trial/evaluation, Judgementia, these are terms of judicial courts and moral weight and sentencing. In effective practice,

Irk labels defects by what one does, not by what one is.

Yet, defection is presented as if that’s not the case, and there are reasons for that. Reasons that reinforce the current power structures and promote what its leadership has decided is healthy for the broader society. When Zim was merely re-encoded from invader status to food service work, it was a more secluded evaluation, presumably done on Irk. His only seen witnesses then were the Tallests and the single control brain dishing the judgement. His existence evaluation, on the other hand, rings more similarly to the IRL historical practice of literal “show trials”. Show trials were something that existed way less for the actual crimes of the accused and so much more for their audience, which, show trials are always for an audience. Three main points about them off the Wikipedia cuff:

• Typically, the defendant of such has already been determined to be guilty (oftentimes of completely fabricated transgressions), and the trial serves mostly to make a massive public spectacle and warning of the accused.

• They tend to focus on retributive punishment over correction. The disproportional brutality and lack of mercy is often the point.

• Their goals are propagandistic in nature, and there’s many notable examples to be found in the history of Nazi Germany, the USSR, and in witch trials across the world (because it was never just Salem).

A formality? Well, that much they couldn’t have more brazenly admitted to. Retribution? There’s hardly a more absolute punitive sentence I could craft up over obliteration PLUS Damnatio Memoariae. And as for the degree of spectacle, I will let you make your own observation here.

Believe it or not, the part where my comparisons along this line end with Existence Evaluations is that their standard for taking place isn’t actually this cartoonishly oppressive one that some fans try to make it out to be. In “The Trial”, Zim was not having his data read for some binary is/is not determination… he was having his experiences and actions interpreted by how much damage he has done against the Armada. He said it himself, that hotseat is reserved for criminals. Likely outright traitors and maniacs. Those who have given cause to alert the brains to a genuine existential threat to their civilization and who have repeatedly failed every opportunity given to redeem themselves.

Defective doesn’t just mean “different” to Irk. We’ve hardly seen an exploration of what the median Irken example even is, because the more we see of any one of these characters, the more they show us their eccentric uniqueness and will. Yes, Irkens are authoritarian; yes they’re over-militarized; yes, they’re a supremacist breed aligned under one ruling military… but listen, they are not literally The Borg, or illithids.

The biggest victims of this government itself are those races it colonizes. Average civilians on the other hand, they get to largely enjoy all the vices and pains and indulgences of hyper-space-capitalism. The height-ocracy may limit their opportunities, but even the lowest drones among them are supposedly hired into their positions in return for wages. Irkens are pretty selfish, but in a rugged individualism sense. It’s a dystopia of atomization instead of collectivization. If everyone had agreed that “defective” had anything to do with arrogance, free will, or an ability to feel one’s sense of self worth, no one would ever be pointing to Skoodge as a possible example. That guy’s the poster boy for what it means to be a “tool” in the derogatory sense. I’m not forgetting that he technically never even left his job. He was fired and more or less forced into hiding, and he’s still not even that perturbed over the whole thing.

Moreover, it also takes some extreme acts of harm to justify such a trial. Real harm- not rebellious attitude or even disrespect to authority. The control brains and the tallests alone get to define that threshold, and neither Tak’s/Zim’s insubordination nor Bob’s audacity concerned them enough for a ticket to Judgementia. In fact, they really don’t seem that bothered at all by deserters and those that abandon their encoded function. Tak is likely to be merely the responsibility of her janitorial squadron, the same way that enforcing Zim’s banishment was the responsibility of his Frylord. Because Irk actually does have standards of justice and layers of bureaucracy to work within when it comes to dealing with true malice. Small fry problems are for the lower rungs of the ladder to handle, until they become a higher priority by necessity. Incompetency alone isn’t a crime, either. The go-to punishment for failure in one function is demotion to a lower position. These are the only Irkens formally not allowed to change jobs, making what they do a kind of communal service or forced labor sentencing. Remember how Tak’s motivation for leaving Dirt wasn’t solely dissatisfaction with the grunt labor? Remember how she kept justifying her actions by the logic of fairness and setting things right? Not to mention how she fully made the Tallest aware of what she was up to and how her plan was well crafted enough to probably work out exactly like she wanted. Tak is utterly as loyal to the empire and competent as any invader. She was genuinely just dealt a shitty hand, and her response to it is at least understandable.

She even went to great lengths to identify and specifically target Zim and to use a planet that otherwise had less than no value to the armada’s operations. She is a great foil to Zim, but I can’t see how she’s any bit defective, only full of rage that she was screwed over by the actions of a real disgrace to their species. Genuinely destructive cases like Zim are an incredible rarity. Such a rarity that I can only guess it took this long for him to go to Judgementia because his degree of dysfunction outright baffles the system. It also would appear that it’s an event of such significance that it can only be set into motion by the command of the ruling Tallest. By murdering a couple of them, and then being a clown show for a couple more, he inadvertently bought himself some time.

And the crazy thing to remember here is that Zim doesn’t even understand that his actions are an existential threat to the Empire- that he IS a whole supervillain to his planet. This is how effective Irken programming and the education plugs are. They’re supposed to do 99% of the work of setting up the population, even the lowest drones, for not turning out like traitors to their kin in the first place. ALL of them grew up on a steady diet of the same drip-fed propaganda and essentialist ideology as their most militant soldiers. So I can see the logic behind the conclusion that the only explanation for criminals in their society must be outright brain damage or corrupted data… and I’m not gonna lie I do openly headcanon that the latter case is exactly what happened to bad egg Zim.

The limits of only having the one example in him notwithstanding, I’m anything but against theorizing about who else could be “worthy” in the Irken sense to also stand before those brains, playing sweaty advocate for the worth of their continued existence and all. I just don’t see it in Bob, or the Comms officer, or any other invader. Tak, there may be some hypothetical ramp to that end, in her future, but as things are right now, I only see a candidate that has become comfortable right in the control brains’ biggest blind spot of all. See, eggs don’t always have to crack in order to go bad. Sometimes, maybe they just spoil. Sometimes, I believe just the right conditions and time can turn them downright rotten.

Dramatic musical flourish, please.

I forget whoever said the quote “Power doesn’t corrupt, It just exposes who people really are”, but I’m a huge fan of the fact that they did. In my opinion, it’s less about power itself and more about a complete lack of accountability that allows the weakest and most toxic seeds to really fester in a seat of authority. Indeed, we all know that there is something pathetic, and vapid, and cruel floating around The Massive’s bridge. I am saying I’d call Red defective, but I couldn’t be certain enough with myself to say that Purple’s largely the one carrying a lot of fault. His greatest sin is his negligence and enabling his companion. whoever we can say shoulders more of the blame, they have been running this horror show as a joint unit, so they will both bear the guilt. Without a doubt, these two are terrible- popular maybe, but terrible leaders. Like, more responsible for the near ruin of their home world and species than I can even pin on Zim at this point. By almost every measure once you hold them up to Miyuki’s and Spork’s barely few moments of would-be screen time, they’re the worst Tallests for the Empire we’ve ever known. It’s too bad that they have no one over them we know of to flag them for an existence evaluation, because I am assured that the real orchestrators of the Armada would be disgusted to look over their track records since they took power.

I mean, what can I remember just off the top of my head?

- Full awareness of Zim’s blackout-causing history before the beginning of Operation Impending Doom I and not keeping a close eye on him, removing him from his position, or keeping him away from the homeworld’s WoMDs

- Overseeing the shipment of faulty equipment to Invader Tenn (even if the packages had not been switched, the Megadoomer still had a potentially fatal flaw), and then presumably NOT giving her urgent guidance/assistance to avoid being captured by native hostiles

- Showing an egregious amount of immaturity and frivolity when making logistical decisions, such as the flight path of the Armada or how conquered planets are utilized

- Repeated abuses of their standing, trying to extra-judicially get rid of subjects over the pettiest reasons (if they had the formal authority to just vaporize Skoodge, Bob, OR Zim on the spot, they wouldn’t need to come up with convoluted and indirect methods that they only hope kill said targets)

- Upon Zim returning to them from his banishment: not sending him back to Foodcourtia and not refusing to humor his wishes to larp as an invader

- Oh yeah, also granting Zim at least some invader tech and allowing him to leave Conventia in what I assume is a ship he could have only stolen

- Still not dealing with Zim with extreme prejudice in a timely fashion after the events of Backseat Drivers from Beyond the stars, or investigating enough to find out and deal with prisoner 777

- HAVING WAITED THROUGH ALL OF THE ABOVE BEFORE SENDING FOR ZIM’S EXISTENCE EVALUATION

- Spending the bulk of their reign so far dicking around in space and gorging themselves. Seriously, Red showed us one act of proactive competence… and it was in order to fix a mess that they allowed Zim to get them into. Not to mention, the Resisty got away from that scrap after thoroughly humiliating their flagship.

Red, and by extension, Purple, are the almighty, Tallest threats to the entire Irken project of galactic conquest, as much as Zim would have loved all the credit in the universe. By what they’ve done, and who they are. He might be damaged, but them? There’s some defective moral character if I’ve ever seen.

[methodsense]

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