The Real Concern Behind The FDA's RF Microneedling Warning

Why the Space Shuttle disasters have everything to do with medical aesthetics and why "we got away with it" is the most dangerous thought in your practice

The Pattern That Kills

On January 28, 1986, the Space Shuttle Challenger exploded 73 seconds after liftoff, killing all seven astronauts aboard. The technical cause was simple: rubber O-rings in the solid rocket boosters failed to seal properly in the 36 degree temperature. But engineers had known about the O ring problem since 1977. Nine years before the disaster. They had documented it blow-by. They had seen the erosion first-hand. They had tested the O-rings and found they lost resilience below 53 degrees.

The night before launch, with temperatures predicted to drop into the twenties, Thiokol engineers argued against proceeding. They presented their data. They explained the risks. And then management told them to "take off your engineering hat and put on your management hat." The launch recommendation was reversed. Schedule trumped safety.

Seventeen years later, on February 1, 2003, the Space Shuttle Columbia disintegrated during reentry, killing another seven astronauts. The cause was foam from the external tank striking and damaging the thermal protection system during launch. Engineers had documented foam strikes since the program began. They had photographed them. They had analyzed them. And each time nothing catastrophic happened, the deviance became a little more normal. Until it wasn't.

NASA had 22 years of foam strikes that didn't kill anyone. Until one did.

The Columbia Accident Investigation Board concluded that NASA had "failed to learn many lessons from the Challenger disaster" and that "the causes of the institutional failure responsible for Challenger have not been fixed." The same organizational pathology what sociologist Diane Vaughan termed the "normalization of deviance" had claimed two orbiters and fourteen lives.

Vaughan defined it precisely: "The gradual process through which unacceptable practice or standards become acceptable. As the deviant behavior is repeated without catastrophic results, it becomes the social norm for the organization."

Or, in the language that pervades far too many medical spas: "Nothing happened this time." 

October 15, 2025: The FDA Issues a Warning

On October 15, 2025, the U.S. Food and Drug Administration issued a safety communication about radiofrequency (RF) microneedling devices. The warning was direct:

"The FDA is aware of reports of serious complications (adverse events) including burns, scarring, fat loss, disfigurement, and nerve damage, and the need for surgical repair or medical intervention to treat injuries."

The FDA made a classification with immediate legal implications:

"RF microneedling is a medical procedure, not a cosmetic treatment."

Think about what this means. RF microneedling is offered in thousands of medical spas across the country, often performed by aestheticians or minimally trained personnel. The federal government just reclassified it as a medical procedure requiring medical oversight. The devices themselves are Class II medical devices, cleared through the FDA's 510(k) process.

And yet, how many practices offer this treatment with:

• Providers who got an eight hour training from the device manufacturer?

• Medical directors who have never watched the procedure being performed?

• No written protocols for device settings, patient selection, or complication management?

• No physician available immediately if something goes wrong?

The complications the FDA documented aren't minor. Burns requiring surgical debridement. Scarring requiring laser revision. Subcutaneous fat loss (lipoatrophy) in the periorbital and malar regions creating permanent facial contour deformities. Nerve damage causing numbness or dysesthesia.

Dermatology Times noted that providers should watch out for "device misuse, operator inexperience, or aggressive treatment parameters" especially in sensitive areas like the periorbital, perioral, and mandibular regions.

The American Academy of Dermatology said it clearly: performing these procedures safely requires understanding the structure and function of the skin.

And here's the critical question: If your RF microneedling provider doesn't have that training, and your medical director isn’t supervising, what exactly makes you think you're operating safely? Additionally, do you know if your medical director has that level of knowledge? If not, how can they effectively supervise?

The Illusion of Invulnerability

NASA's organizational failures after both shuttle disasters were studied exhaustively. The patterns identified have become case studies in business schools, engineering programs, and safety management courses worldwide. These patterns needs to be required reading for every medical spa owner:

Production Pressure Over Safety

• NASA: Schedule pressures and a "can-do" attitude that minimized consideration of failure

• Med Spas: Revenue targets, and appointment bookings that discourage turning away patients or declining to perform procedures.

Past Success as Evidence of Future Safety

• NASA: "We flew 22 missions with foam strikes and nothing happened, so foam strikes must be safe"

• Med Spas: "We've done RF microneedling hundreds of times and never had a problem, so our approach must be fine"

Erosion of the Safety Oversight Function

• NASA: Safety personnel had inadequate authority; concerns were filtered out before reaching decision-makers

• Med Spas: Medical directors who are absent, uninvolved, or who never actually observe procedures being performed.

Normalization of Technical Deviation

• NASA: O-ring erosion and foam strikes were initially concerning, then became routine, then were actively discounted

• Med Spas: Operating outside prescriptive authority agreements, using devices without proper training, delegating to unqualified personnel all becoming "just how we do things". Shortage of qualified providers is not an excuse, nor is not having the time or resources to properly train.

Communication Barriers

• NASA: Engineers' concerns were discounted by management; hierarchy prevented critical information from reaching decision-makers

• Med Spas: Front-line providers hesitant to raise concerns; medical directors not present to observe actual practice

The "We Got Away With It" Fallacy

• NASA: Each successful launch after an O-ring problem reinforced the belief that the next one would also be fine

• Med Spas: Each treatment that doesn't result in immediate complication reinforces the belief that qualified personnel, protocols and oversight don't matter

The most chilling finding from the Columbia investigation: "NASA's response to the Rogers Commission did not meet the Commission's intent." Even after losing Challenger, even after the investigations and reforms and promises, the same cultural pathology persisted and claimed Columbia.

Why? Because changing organizational culture requires more than new policies. It requires a fundamental shift in how leadership and an organization thinks about risk. 

The FDA's Warning: Energy-Based Devices Are Medical Procedures

RF microneedling is not unique. It's part of a broader category of energy-based devices that medical spas commonly offer:

• RF microneedling: Creates thermal injury to induce collagen remodeling

• Laser treatments: Intense pulsed light targeting pigment, vasculature, or tissue

• Ultrasound devices: High-intensity focused ultrasound creating thermal coagulation points

• Cryolipolysis: Controlled cooling to destroy fat cells

• Radiofrequency skin tightening: Heat-based tissue remodeling

All of these devices:

• Are Class II medical devices requiring FDA clearance

• Deliver energy into and through human tissue

• Create intentional, controlled tissue injury

• Have potential for serious complications if improperly used

• Require understanding of tissue depth, anatomical structures, and device parameters

• Should be performed only by properly trained personnel under physician oversight

And yet, many in the medical spa industry have normalized offering these treatments with minimal physician involvement, limited provider training, and inadequate protocols. Why? Because most of the time, nothing happens. The treatment goes fine. The patient is happy. Revenue is generated. And the deviation becomes the norm.

Until it doesn't go fine.

Connecting the Dots: Peptides, Medical Directors, and Energy Devices

This is the third article in a series examining safety and compliance in medical aesthetics. The pattern is unmistakable:

Our First Article: Peptides and Hormone Replacement Therapy

We examined how compounds like BPC-157, thymosin beta-4, and tesamorelin which have legitimate therapeutic potential are being administered in medical spas by staff who often don't understand pharmacokinetics, contraindications, drug interactions, or proper monitoring protocols. The justification? "We've been doing peptides for years and nothing has happened."

The reality: The FDA has issued multiple warnings about compounded peptides. Several compounds have been specifically prohibited. Adverse events are being reported. And regulatory scrutiny is intensifying.

Our Second Article: Medical Director Oversight

We examined the death of Jenifer Cleveland at a Texas med spa, where IV therapy was administered by an unlicensed individual under the supervision of a medical director who was present onsite only three times the last being the day of the fatal incident. We documented how the Texas Medical Board found "ordering of prescription medication to be administered by an unlicensed and unqualified delegate without adequate supervision, oversight or protocols presents a continuing threat to public safety."

The pattern: A medical director relationship that existed on paper but not in practice. No protocols. No supervision. No real oversight. Not qualified to provide medical direction. And the normalization of this arrangement until tragedy struck.

This Article: Energy-Based Devices

Now the FDA is warning about RF microneedling complications serious enough to require surgical intervention. And the underlying pattern is identical: treatments that appear cosmetic but are fundamentally medical, being performed by minimally trained personnel, under inadequate physician oversight, with the justification that "nothing has happened so far."

The common thread? Medical procedures being treated as cosmetic services because we've normalized the deviance. The mindset that "it's less invasive than surgery" blinds us to the reality that it's still a medical procedure with real risks requiring real medical oversight.

What Normalization of Deviance Looks Like in Your Practice

Be honest. Do any of these sound familiar?

"Our aestheticians have done hundreds of RF microneedling treatments and never had a problem."

Translation: Past success has created a false sense of invulnerability. Each treatment without complication reinforces the belief that protocols and training don't matter right up until the moment something goes catastrophically wrong.

"Our medical director signed off on the protocols two years ago, so we're covered."

Translation: A document was created once and filed away. But does your medical director actually review how the procedures are being performed? Has anyone updated the protocols as device technology has evolved? Are they being followed consistently?

"The device manufacturer trained our staff they're certified."

Translation: An eight-hour course from a company trying to sell devices does not constitute medical training. It does not replace understanding of facial anatomy, nerve pathways, tissue layers, and complication management.

"We can't have our medical director onsite every time we do RF microneedling we'd never make money."

Translation: Production pressure is trumping safety. If your business model only works when you minimize physician involvement, your business model is built on normalized deviance and not built to withstand the test of time. This does not mean that a medical director has to be in the room every time a procedure occurs. What it means is the medical director needs to be actively involved. See our previous article on this topic for more clarity about our position.

"Everyone in the industry operates this way."

Translation: The entire sector has normalized the same deviance. This is not reassuring. NASA's entire shuttle program normalized foam strikes. The fact that it was widespread did not make it safe.

"Our medical director is available by phone if something goes wrong."

Translation: When RF energy creates a thermal burn through the dermis, a phone call is not an adequate emergency response. "Immediately available for emergency consultation" is not the same as "reachable by cell phone."

"Nothing bad has happened yet."

Translation: This is the exact phrase that preceded both shuttle disasters. It is the foundational belief of normalized deviance. The absence of disaster is not evidence of safety it's evidence that you haven't yet experienced the consequences of operating outside safe parameters.

The Data You Can't Ignore

Let's look at what we know about complications in the medical spa industry:

From the 2023 Dermatologic Surgery Study (published in Allure's "Med Spa Nation"):

• Overall complication rates: 16.4% at med spas vs. 11% at physicians' offices

• Skin-tightening procedures: 77% complication rate at med spas vs. 0% at physicians' offices

• Fat reduction procedures: 80% complication rate at med spas vs. 36% at physicians' offices

From the same Chicago-area study:

• 80% of med spas had no physician onsite

• Only 65% of med spas informed patients that no physician was present

• Less than half of advertised medical directors were trained in dermatology or plastic surgery

From the American Society of Dermatologic Surgery's statement:

"Rent-a-license" medical directors are being solicited to act "in name only in exchange for a fee," with medical directors from unrelated specialties (radiologists, gynecologists, anesthesiologists) overseeing aesthetic procedures they have no training to supervise.

From the RF microneedling safety communication:

The FDA is now specifically documenting burns, scarring, fat loss, disfigurement, and nerve damage serious enough to require surgical intervention or additional medical treatment.

This is not hypothetical risk. These are documented complications happening right now in practices that, until the moment of incident, would have told you "nothing has happened."

Why "Less Invasive" Doesn't Mean "Less Medical"

One of the most dangerous misconceptions in medical aesthetics is that because procedures don't involve scalpels and operating rooms, they're somehow not real medical procedures.

Consider what actually happens during common med spa treatments:

RF Microneedling:

• Penetrates needles 0.5-4mm into the skin

• Delivers radiofrequency energy creating localized thermal injury up to 60-70°C

• Directly affects dermis, potentially reaching subcutaneous fat and nerve structures

• Parameters vary by device: needle length, energy output, pulse duration, treatment density

• Treatment in periorbital area near infraorbital nerve; perioral area near mental nerve

IV Therapy:

• Penetrates peripheral vein with catheter

• Delivers medications, vitamins, or compounds directly into bloodstream

• Bypasses first-pass metabolism no hepatic filtering before systemic circulation

• Potential for immediate severe reactions: anaphylaxis, cardiac events, electrolyte imbalances

• Requires understanding of pharmacokinetics, drug interactions, contraindications

Injectable Peptides:

• Delivers bioactive compounds with systemic effects

• May affect hormone signaling, growth factors, immune function, tissue healing

• Requires understanding of dosing, contraindications, monitoring parameters

• Potential interactions with medications and underlying health conditions

• Long-term safety data often limited or nonexistent

Laser Treatments:

• Delivers concentrated light energy absorbed by tissue chromophores

• Creates controlled thermal destruction of targeted structures

• Potential for burns, scarring, pigmentary changes, eye injuries

• Requires understanding of laser physics, skin types, anatomical landmarks

• Parameters must be adjusted for individual patients wrong settings cause injury

All of these are medical procedures. They all involve penetrating or significantly altering human tissue. They all have the potential for serious complications. And they all require medical knowledge, medical judgment, and medical oversight.

The fact that they're performed in spa-like settings with aesthetic rather than therapeutic goals does not change their medical nature. It just makes it easier to normalize operating outside proper medical standards.

The Filler Complication No One Wants to Talk About

While we're discussing procedures that "seem safe because nothing has happened," let's address dermal filler injections particularly the rare but catastrophic complication of vascular occlusion.

Dermal fillers, especially hyaluronic acid fillers, are among the most common aesthetic procedures performed globally. More than 5.5 million filler injections were administered in 2014, generating over $11 billion in annual revenue. The procedures are quick, often performed in spa-like settings, and the vast majority of patients experience good outcomes. Which is precisely why vascular occlusions are so normalized away.

What Actually Happens

A vascular occlusion occurs when filler is accidentally injected into an artery or compresses an artery from the surrounding tissue. When this happens, blood flow to the affected tissue stops. The mechanism, according to recent research published in Scientific Reports, involves retrograde embolization: the injected material flows backward from the injection site into facial arteries and, in some cases, all the way to the internal carotid artery and cerebral circulation.

The consequences is immediate and devastating:

Skin Necrosis: Loss of blood supply causes tissue death. The nasal ala (side of the nose) is particularly vulnerable a patient documented in World Journal of Plastic Surgery experienced nasal alar necrosis requiring reconstructive surgery with an auricular composite graft after hyaluronic acid injection into the nasolabial folds.

Blindness: Retrograde flow into the ophthalmic artery or its branches can cause central retinal artery occlusion. A 2024 study of 12 patients in China found that 41.7% (5 patients) ended with final visual acuity of "no light perception" meaning permanent, complete blindness in the affected eye. This wasn't from some exotic, risky procedure. This was from nasolabial fold injections, glabellar injections, cheek augmentation routine aesthetic treatments.

Stroke: The same retrograde mechanism can deliver filler emboli to the cerebral circulation. In the same Chinese study, 5 of 12 patients (41.7%) developed acute cerebral infarction strokes along with their vision loss. Two patients who received injections on only one side of the face suffered bilateral cerebral infarction, as emboli traveled through the Circle of Willis to reach both cerebral hemispheres. According to meta-analysis data, cerebral infarction occurs in 12.9-24% of patients with serious filler-related complications.

Even more concerning: many patients with cerebral infarction on MRI showed no neurologic symptoms initially. They came in for vision loss, and imaging incidentally revealed they'd also had strokes. The actual incidence of cerebral ischemia from filler injections is believed to be higher than reported because brain MRI is not routinely performed on patients without obvious neurologic symptoms.

The Time Factor

Here's what makes this even more sobering: outcomes are highly time-dependent. In the Chinese study, the mean time from symptom onset to hospitalization was 19.4 hours, with a range of 0.5 to 72 hours. Most patients arrived too late for optimal intervention. The visual prognosis was poor despite treatment five patients experienced permanent blindness, and only two showed significant improvement.

The High Dose Pulsed Hyaluronidase (HDPH) protocol, published in Aesthetic Surgery Journal, has prevented skin necrosis in virtually all cases when implemented within 48 hours of the ischemic event. But it requires:

• Immediate recognition of the problem

• Occlusion Kit: Hyaluronidase and related items immediately available onsite (not "we can get some")

• Knowledge of proper dosing (high doses, repeated hourly until resolution)

• Understanding of the entire area of compromised tissue (not just where filler was injected)

• Clinical skill to assess capillary refill, skin color, and tissue viability

Vision loss is even more time critical. Treatment within the first 4 hours offers the best chance of recovery, yet in the Chinese study, nine of twelve patients exceeded this threshold.

Just Because It Hasn't Happened...

And here's where normalization of deviance enters the picture.

How many filler injections does an injector perform before experiencing a vascular occlusion? Hundreds? Thousands? Each successful injection reinforces the belief that "I know what I'm doing" and "this is safe." The risk of vascular occlusion is low but it's never zero, even for highly skilled, experienced injectors with excellent anatomic knowledge.

Which leads to predictable patterns of normalized deviance:

"We don't really need that much hyaluronidase on hand."

Many practices stock one or two vials. Experts recommend having at least 6-24 vials immediately available. The HDPH protocol may require multiple high-dose administrations over several hours. If you don't have adequate supply onsite, by the time you obtain more, the tissue damage might be irreversible.

"I've done thousands of these and never had a problem."

That's not evidence of safety it's evidence of probability working in your favor so far. NASA flew 87 successful missions between Challenger and Columbia. Past success did not prevent the next catastrophe.

"I know what to look for, I'd recognize it immediately."

Really? Have you actually practiced identifying early signs of vascular compromise? Can your staff recognize acute pain, blanching, loss of capillary refill? Do they know that delayed onset can occur hours after the patient leaves? Do you have a 24/7 emergency number for patients to report symptoms?

"I aspirate before injecting, so I'm safe."

Research shows that aspiration is unreliable for confirming vascular placement. Different filler products, needle sizes, and injection techniques affect aspiration accuracy. A negative aspirate does not guarantee safety. This is a false sense of security that enables continued risk-taking.

"We have a protocol written down somewhere."

Is it rehearsed? Can your staff find the hyaluronidase in under 60 seconds? Do they know the dosing? Have you practiced the emergency sequence as a team? Or is the "protocol" a document that was written once, filed away, and never actually used?

As Dr. Greco stated in the Allure article, “It ultimately may happen to every injector if you inject enough people. I mean, I would be wrong to be sitting here and telling you that I've never had a vascular occlusion [blockage of a blood vessel],”

The Questions You Need to Answer

Time for radical honesty about filler injections in your practice:

Can you describe the signs of impending vascular occlusion?

Pain, blanching, mottling, delayed capillary refill (>3 seconds), loss of pulse, skin discoloration. If you hesitated answering this, that's a problem.

Do you have at least 6 vials of hyaluronidase immediately available?

Not "we can order it." Not "it's in the doctor's car." Immediately available in your practice during all injection hours.

Have you rehearsed the emergency protocol with your entire team?

Not "read about it" but actually practiced: who gets the hyaluronidase, who calls the medical director, who documents, who stays with the patient, what the injection sequence is, when to transfer to emergency care.

Do you know which high risk facial areas have limited collateral circulation?

The glabella and nasal ala are "danger zones" with single arterial branches. Do you modify your technique in these areas? Do you use smaller volumes? Do you understand the vascular anatomy well enough to know why these areas are high risk?

When was the last time you saw a complication?

If your answer is "never," one of two things is true: either you're extraordinarily lucky, or you're not recognizing minor complications when they occur. Both scenarios should concern you the first because luck runs out, the second because it suggests you might not recognize a major complication when it presents.

What's your plan for vision loss?

Do you have contact information for an ophthalmologist or retina specialist who can see the patient emergently? Have you discussed this scenario with them in advance? Vision loss is an ophthalmologic emergency requiring immediate specialized care beyond your capability to provide.

Do your patients know the signs of delayed vascular occlusion?

Your informed consent should specifically address this. Patients need to know that symptoms can develop hours after leaving your office, and they need your 24/7 emergency contact information. Do they have it?

The Integration

Notice the pattern across everything we've discussed in this article:

• RF Microneedling: "We've done hundreds without problems" → Until FDA documents serious complications requiring surgical repair

• Peptides: "Everyone's doing peptides, they're natural" → Until adverse events and regulatory warnings accumulate 

• Medical Director Oversight: "Our medical director signed off years ago" → Until someone dies and the board investigates

• Injectable Fillers: "I've done thousands of injections without issues" → Until retrograde embolization causes blindness and stroke

The normalization of deviance doesn't require ignorance or incompetence. It requires only that we treat repeated success as evidence that our current practices are safe, rather than understanding that we're operating within a margin of acceptable risk that can narrow without warning.

Just because vascular occlusion hasn't happened in your practice doesn't mean it won't. Just because your last thousand filler injections went well doesn't mean injection 1,001 is safe. Just because you haven't seen skin necrosis doesn't mean your emergency preparedness is adequate.

The question is: when it does happen and probability suggests it eventually will will you be prepared? Or will you discover in that moment that you've been operating on normalized deviance?

The Cost of Getting This Wrong

Let's be clear about the consequences when the normalization of deviance catches up with you:

For Patients

• Permanent scarring and disfigurement

• Nerve damage and chronic pain

• Fat loss creating facial contour deformities

• Infection and prolonged healing

• Need for corrective surgery

• Psychological trauma

• Medical bills for complication treatment

• Loss of trust in aesthetic medicine

For Providers

• Civil liability for malpractice

• Potential criminal charges for practicing medicine without a license or beyond scope of practice

• Loss of professional licensure

• Reputational damage

• Emotional burden of having harmed a patient

• Reputational damage

For Medical Directors

• Board complaints and investigations

• License suspension or restrictions (see: Dr. Gallagher in the Jenifer Cleveland case allowed to practice anesthesiology but permanently restricted from supervising or delegating in all other circumstances)

• Civil liability as supervising physician

• Professional reprimand

• Fines and penalties

• Permanent record of disciplinary action

• Reputational damage

For Practice Owners

• Civil liability exceeding insurance coverage

• Business closure or bankruptcy

• Criminal exposure for unlicensed practice of medicine

• Loss of ability to operate (no reputable medical director will work with you after a serious incident)

• Destroyed reputation negative publicity is devastating in aesthetic medicine

• Regulatory investigations and ongoing monitoring

• Reputational damage

For the Industry

• Increased regulation and restrictions

• Loss of public trust

• Pushback from legitimate medical professionals who see patient harm

• Legislative action (see: Texas HB 3749 "Jenifer's Law")

• Higher insurance costs for everyone

• Barrier to entry for quality operators as capital requirements increase

• Reputational damage

The shuttle disasters cost NASA billions of dollars, years of program delays, and incalculable reputational damage. More importantly, they cost fourteen lives.

Your incident probably won't make national news. But it will cost someone their face. Their confidence. Their trust. And it will potentially cost you everything you've built.

What Proper Oversight Actually Looks Like

If you're thinking "this is making me anxious about my operations," good. That's the appropriate response. NASA's postshuttle culture change emphasized "maintaining a sense of vulnerability" staying "chronically uneasy" rather than complacent.

Here's what bringing RF microneedling (and other energy-based devices) into compliance actually requires:

1. Medical Director Active Involvement

Not Compliant:

• Signed protocols once, three years ago

• Available "by phone" if something goes wrong

• Has never observed your providers performing the procedure

• From an unrelated specialty (radiology, internal medicine, emergency medicine)

Compliant:

• Involved in the selection and hiring of medical providers

• On-site regularly to observe procedures and assess techniques

• Certified, experienced, knowledgeable, and skilled in aesthetic procedures

• Personally familiar with the devices you use

• Able to perform and competently supervise the procedures themselves

• Immediately available meaning physically present or at minimum able to arrive within minutes

• Reviews cases regularly, discusses complications, participates in quality improvement

2. Provider Training and Credentialing

Not Compliant:

• Eight-hour manufacturer training certificate

• "Learn as you go" under another provider

• No formal assessment of competency

• No continuing education requirements

Compliant:

• Comprehensive training on device physics, tissue interactions, and parameters

• Formal training in facial anatomy relevant to treatment areas

• Observed performance of procedures with documented competency assessment

• Regular continuing education on devices and techniques

• Documented understanding of complications and their management

• For aestheticians: clear understanding of scope of practice limitations and when to escalate to medical professionals

3. Written Protocols That Are Actually Followed

Not Compliant:

• Generic template downloaded from the internet

• One protocol for "all RF microneedling" regardless of device or patient

• Protocols filed away and never referenced

• No record of who trained on them or when

Compliant:

• Device-specific protocols accounting for different technical parameters

• Patient selection criteria clearly defined (contraindications, skin types, anatomical considerations)

• Treatment parameters specified by anatomical region (periorbital requires different settings than cheeks)

• Documentation requirements for each treatment

• Complication recognition and management protocols

• Escalation procedures when issues arise

• Regular review and updating (at least annually)

• Documentation that each provider has been trained on current protocols

4. Patient Selection and Informed Consent

Not Compliant:

• "Anyone who wants RF microneedling can get it"

• Consent form lists only minor, transient side effects

• Consent doesn't mention FDA warnings or serious complications

• No medical history evaluation by qualified professional

Compliant:

• Medical history reviewed by physician or qualified advanced practice provider

• Contraindications screened: bleeding disorders, active infections, keloid tendency, recent filler placement, anticoagulation therapy, connective tissue disorders

• Realistic expectations set RF microneedling is not a facelift

• Informed consent specifically discusses burns, scarring, fat loss, nerve damage per FDA warning

• Patient informed that this is a medical procedure, not a cosmetic treatment

• Patient informed of medical director's qualifications and involvement

5. Emergency Preparedness

Not Compliant:

"We'll call 911 if something goes wrong"

No emergency equipment onsite

No one trained in emergency response

No clear emergency protocols

Compliant:

• Emergency equipment immediately available (oxygen, epinephrine, AED at minimum)

• At least one person onsite trained in BLS (Basic Life Support) at all times

• Clear emergency protocols posted and rehearsed

• Direct line to medical director for urgent consultation

• Documented emergency drills at least annually

• Transfer arrangements with nearby emergency facilities if needed

Critical for Injectable Fillers:

• Minimum 6 vials of hyaluronidase immediately available (experts recommend 12-24 vials)

• Written vascular occlusion protocol that is actually rehearsed, not just filed

• All staff can identify signs of vascular compromise (pain, blanching, delayed capillary refill)

• Established relationship with ophthalmologist/retina specialist for vision emergencies

• Patients provided with 24/7 emergency contact number

• Provider demonstrates competency in High Dose Pulsed Hyaluronidase protocol

• Emergency supplies checked monthly for expiration

6. Complication Tracking and Quality Improvement

Not Compliant:

• "We don't really track that"

• Complications attributed to patient factors ("difficult skin," "poor healing")

• No systematic review process

• Problems not discussed or analyzed

Compliant:

• Every adverse event documented, regardless of severity

• Regular case review meetings with medical director

• Analysis of near-misses and complications to identify patterns

• Protocols adjusted based on experience

• Providers receive feedback and additional training as needed

• Serious complications reported to FDA via MedWatch

• Culture that encourages reporting rather than hiding problems

7. Device Maintenance and Calibration

Not Compliant:

• Devices serviced only when they break

• Settings adjusted based on "what feels right"

• No maintenance logs

• Using devices beyond their recommended service life

Compliant:

• Regular maintenance per manufacturer specifications

• Calibration verification documented

• Settings parameters logged for each treatment

• Equipment replaced or serviced when indicated

• Multiple energy settings validated and documented

The Uncomfortable Questions You Need to Ask

Time for radical honesty. These questions should make you uncomfortable:

Question 1: If a state medical board investigator walked into your practice tomorrow unannounced, would you be confident in what they'd find?

Not "could you produce the right documents eventually" but would your actual day to day operations demonstrate proper oversight?

Question 2: If a patient experiences a serious complication from RF microneedling at your practice, can you prove you met the standard of care?

You'll need to demonstrate:

• Qualified provider with documented training

• Physician oversight of the actual procedure (not just theoretical availability)

• Protocols that were followed

• Appropriate patient selection and informed consent

• Emergency response capability

Can you actually prove all of that?

Question 3: If the FDA's warning leads to increased scrutiny of energy-based devices, is your practice operating in a way that would survive an audit?

The FDA doesn't issue safety communications casually. This warning likely signals the beginning of increased regulatory attention to RF microneedling and potentially other energy devices. Are you prepared?

Question 4: Is your current approach based on "everyone does it this way" rather than "this is the right way"?

Remember: NASA normalized foam strikes across the entire shuttle program. Industry-wide normalization of deviance doesn't make it safe it just means when something goes wrong, it affects a lot of people simultaneously.

Question 5: If your defense is "nothing has happened yet," are you willing to bet your practice, your reputation, and someone's face on that streak continuing?

Because that's exactly what you're doing.

Moving From Deviance to Diligence

If this article has made you uncomfortable, you have two choices:

Choice 1: Rationalize

"Our situation is different."

"We're really careful."

"We can't afford to change our business model."

"The FDA is overreacting."

"Everyone else operates the same way we do."

This is the path NASA took between Challenger and Columbia. It led to another seven dead astronauts.

Choice 2: Act

Acknowledge that good intentions and past success do not guarantee future safety. Recognize that you may have normalized practices that put patients at risk. And commit to closing the gap between how you operate and how you should operate.

Here's what that looks like practically:

Immediate Actions (This Week):

1. Conduct an honest operational audit

• Review all energy-based devices you offer

• Assess actual medical director involvement (not what the agreement says, what actually happens)

• Evaluate provider training and credentials

• Examine your protocols and consent forms

2. Update RF microneedling consent forms

• Specifically include FDA's documented complications: burns, scarring, fat loss, disfigurement, nerve damage

• Note that this is a medical procedure, not a cosmetic treatment

• Document provider qualifications and training

• Ensure patients understand risks

3. Schedule medical director involvement

• Have your medical director directly observe RF microneedling being performed by each provider

• Document competency assessment

• Establish regular onsite presence schedule

Short-Term Actions (This Month):

1. Review and update all protocols

• Make device-specific for each RF microneedling device you use

• Include anatomical considerations and parameter guidelines

• Add emergency response protocols

• Document training of all providers on updated protocols

2. Provider training assessment

• Evaluate whether current provider training is adequate

• Identify gaps (anatomy, device physics, complication management)

• Arrange for additional training where needed

• Consider whether some procedures needs to be restricted to higher-credentialed providers

3. Emergency preparedness

• Ensure BLS-trained personnel always onsite

• Verify emergency equipment is available and current

• Conduct emergency drill

• Establish clear escalation procedures

Ongoing Actions:

1. Monthly medical director meetings

   - Case review

   - Complication discussion

   - Protocol refinement

   - Quality improvement

2. Complication tracking

   - Document every adverse event

   - Report serious complications to FDA

   - Analyze patterns

   - Adjust protocols and training accordingly

3. Culture change

   - Replace "nothing happened this time" with "are we doing this right?"

   - Encourage staff to raise concerns without fear of retaliation

   - Celebrate near-miss reporting these are opportunities to prevent disasters

   - Recognize that safety and compliance are not obstacles to success but foundations of sustainable practice

Why This Matters Now

Three converging forces make this the moment to act:

1. Regulatory Scrutiny Is Intensifying

• FDA safety communication on RF microneedling (October 2025)

• Texas HB 3749 specifically regulating IV therapy (effective September 2025)

• Texas Medical Board's explicit focus on inadequate medical spa physician involvement

• Increasing state medical board enforcement actions

• Multiple ongoing investigations of practices with serious complications

2. Public Awareness Is Growing

• Allure's "Med Spa Nation" investigation brought industry practices into public view

• Social media amplifies complication stories

• Patients are becoming more educated about the difference between med spas with proper oversight and those without

• Negative publicity can destroy a practice's reputation permanently

3. The Legal Standard Is Evolving

• FDA's classification of RF microneedling as a medical procedure creates new liability exposure

• State boards are holding medical directors accountable for inadequate oversight

• Civil liability for complications when proper protocols weren't followed

• Insurance companies denying claims when procedures fell outside authorized practice parameters

The window for voluntary compliance is open now. Once a major incident occurs, once regulatory crackdowns begin, once insurance coverage becomes contingent on demonstrable compliance, the cost and difficulty of reform increase exponentially.

NASA learned this lesson twice at the cost of fourteen lives. The medical aesthetics industry doesn't have to learn it the same way.

The Integration: Peptides, Oversight, and Energy Devices

These three articles form a comprehensive picture of what's required for responsible medical aesthetics practice:

Article 1 (Peptides): The compounds you use are powerful, medically active, and require real medical knowledge to use safely. "Natural" doesn't mean safe. "Compounded" doesn't mean unregulated. You're administering medications that affect human physiology act like it.

Article 2 (Medical Director Oversight): The physician relationship that enables your business is not a piece of paper. It's active, engaged supervision by a qualified medical professional who understands your operations and takes responsibility for them. When that relationship is fake, people die.

Article 3 (Energy Devices): The procedures you perform may seem less invasive than surgery, but they are fundamentally medical. They penetrate tissue, deliver energy, create controlled injury, and have potential for serious complications. Treating them as cosmetic services because "nothing has happened yet" is the textbook definition of normalized deviance.

The throughline is clear: medical aesthetics is medical practice. The industry's growth was built on blurring that distinction, but the consequences of continuing to operate that way are mounting.

You have a choice: continue normalizing deviance until tragedy forces change, or choose diligence now.

The Bottom Line

The Space Shuttle program was an incredible achievement of human engineering and capability. And yet, twice, organizational culture failures led to catastrophic disasters that were entirely preventable. The people at NASA were not bad people. They were not incompetent. They were smart, dedicated professionals operating in a culture that had normalized risk-taking.

The medical aesthetics industry is not fundamentally different. Smart, well-intentioned people operate in a culture where inadequate oversight, minimal training, and absent physicians have become normal. "Nothing happened this time" becomes the rationale for continuing practices that violate the basic principles of medical safety.

The FDA's warning about RF microneedling is a gift it's a chance to examine your operations and bring them into compliance before a patient is permanently injured. It's an opportunity to build a practice based on genuine medical oversight rather than normalized deviance.

NASA eventually got it right, but only after two catastrophic failures. The medical aesthetics industry has a chance to learn from someone else's disasters rather than creating its own.

The question is: will you take it?

Disclaimer: This article is intended for educational and awareness purposes only. It does not constitute legal or medical advice. Med spa owners should consult with qualified healthcare attorneys and medical advisors in their respective states for specific guidance. All citations and facts presented herein are drawn from publicly available sources, including FDA safety communications, scholarly research on organizational behavior, and documented safety incidents.

Action Items for Med Spa Owners

For RF Microneedling Specifically:

[ ] Review FDA safety communication in detail

[ ] Update consent forms to include specific FDA-warned complications

[ ] Have medical director observe all providers performing RF microneedling

[ ] Review and update device-specific protocols

[ ] Verify provider training is adequate and documented

[ ] Ensure immediate availability of qualified medical professional during procedures

[ ] Establish complication tracking and reporting system

For Injectable Fillers Vascular Occlusion Preparedness:

[ ] Stock minimum 6 vials of hyaluronidase (many experts recommend 12-24 vials)

[ ] Verify hyaluronidase is not expired and is immediately accessible during all injection hours

[ ] Create written vascular occlusion emergency protocol

[ ] Rehearse emergency protocol with entire team (not just read it actually practice)

[ ] Ensure all injectors can identify signs of vascular compromise (pain, blanching, delayed capillary refill >3 seconds)

[ ] Establish relationship with ophthalmologist/retina specialist for vision loss emergencies

[ ] Provide patients with 24/7 emergency contact number

[ ] Update consent forms to specifically address vascular occlusion, blindness, stroke risk

[ ] Document provider training in facial vascular anatomy and high risk zones (glabella, nasal ala)

[ ] Verify providers understand aspiration is unreliable for safety confirmation

[ ] Practice recognizing early vs. delayed onset vascular occlusion presentations

For All Energy-Based Devices:

[ ] Audit all energy-based devices: RF, laser, ultrasound, cryolipolysis, IPL

[ ] Classify each as medical procedure requiring medical oversight

[ ] Evaluate provider credentials and training for each device

[ ] Review protocols for each device and treatment type

[ ] Assess medical director involvement and competency for each device category

[ ] Update consent forms to reflect medical nature of procedures

[ ] Verify emergency preparedness for device-specific complications

For Overall Practice Safety Culture:

[ ] Read about normalization of deviance (recommended: Diane Vaughan's work)

[ ] Conduct anonymous staff survey about concerns and near-misses

[ ] Establish regular medical director involvement (not just availability)

[ ] Create culture where raising safety concerns is encouraged, not punished

[ ] Implement regular case review and quality improvement meetings

[ ] Document everything training, protocols, medical director involvement, competency assessments

[ ] Consider: if a regulator walked in tomorrow, would you be confident or anxious?

For Integration with Previous Compliance Efforts:

[ ] Review peptide protocols and oversight (see first article)

[ ] Evaluate medical director relationship authenticity (see second article)

[ ] Recognize pattern: medical procedures require medical oversight

[ ] Stop treating medical aesthetics as "cosmetic services that happen to be regulated"

[ ] Start treating medical aesthetics as "medical practice that focuses on aesthetic outcomes"

Resources

FDA RF Microneedling Safety Communication:

https://www.fda.gov/medical-devices/safety-communications/potential-risks-certain-uses-radiofrequency-rf-microneedling-fda-safety-communication

FDA MedWatch Adverse Event Reporting:

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

American Academy of Dermatology Finding a Board-Certified Dermatologist:

https://www.aad.org

American Society for Dermatologic Surgery:

https://www.asds.net

Texas Medical Board (for Texas providers):

https://www.tmb.state.tx.us

NASA Resources on Normalization of Deviance:

https://sma.nasa.gov (search: normalization of deviance)

Diane Vaughan, "The Challenger Launch Decision":

University of Chicago Press (definitive work on normalization of deviance)

Disclaimer: *This article does not constitute medical or legal advice. Consult with qualified healthcare attorneys and medical advisors in your state for guidance specific to your practice. All statements herein are based on publicly available information and are intended for educational purposes only.*

About the Author

Randy Stepp is the owner of B.A.R. Aesthetic Advisors, providing strategic consulting, competitive intelligence, and market analysis for medical aesthetics practices and private equity firms evaluating acquisition opportunities. With extensive C-suite experience scaling medical aesthetics businesses, Randy works with both individual practices and institutional investors to build sustainable, compliant, and clinically excellent operations. His background includes serving as President/CEO/COO of VIO Med Spa/VIO Franchise Group, where he led the development of a proof-of-concept medical spa to become a national franchise brand.

Randy specializes in helping practices navigate the gap between rapid industry growth and evolving regulatory requirements. His consulting focuses on operational excellence, market positioning, and risk management in the medical aesthetics sector.

For inquiries about strategic consulting, market analysis, or operational assessments, contact hime at randystepp@baraesthetics.com