FDA rules: needle sterilization

Hair Removal Methods Professional Electrolysis
#1

I had a friend ask me if she could use her pre-sterile needles IF they are out of date?

I have read the FDA rules on needle sterilization and they are very specific. Needles are classified as medical instruments and must be sterilized in an FDA approved facility that is regularly inspected (by the FDA). Also, an expiration date must be stamped on each needle.

Needle sterilization requirements have nothing to do with State laws … this is federal. Any and all State statutes discussing sterile needle sales are “trumped” by mandatory FDA standards.

So, I wonder if it’s legal for us to use needles that are “out of date?” My guess is that it would be okay … as far as actual sterilization concerns. If the needle had been stored properly and never used, I would assume it’s okay. But what does “okay” mean?

However, that’s NOT my question!

My question is the legality of using out of date needles. I suppose were a patient to get an infection, and could show that a needle was “out of date,” this could be actionable? Again, an almost non-existent possibility.

But this is the question my friend posed to me: can she use out of date needles? And, by what authority?

I don’t know the answer.

#2

While this might be a great place to argue “What is the applicability of the code”, and suggest people read The Most Dangerous Superstition by Larken Rose, I will limit that type of conversation to my friends who suffer my ideas with a drink of camomile tea.

What I will offer to this conversation is that most needle/probe manufacturers offer a free exchange program that allows you to trade expired date product for new product. Since the only “problem” with the probes is the date stamp and possibly the seal on the packaging all they would really need to do is repackage, resterilize and resell the like new product. All anyone loses here is repackaging and shipping costs.

This is one thing the electrolysis conventions were always good for; if you brought any expired date probes with you, one could exchange them on the spot for new date product on the vendor’s floor. Now there is a feature and benefit of going to the AEA’s yearly shindig that doesn’t get advertised. :slight_smile:

#3

Thanks for the information … I had no idea this could be done. Frankly, I probably seldom actually look for the expiration date on my needles (I suppose I should?). But then, folks will always find something to worry about?

I will pass this information on to “Betsy” … she’s actually pretty new to the field and I think she’s going to be a “star.” She’s doing wonderful work and I’m doing all I can to get her new business going “full steam ahead.” It’s great to see young people finally entering the field!

#4

Well, you might want to include in your information the fact that most state’s that have anything in writing about what they expect of electrolysis providers reads that they want the probes to be heat sterilized prior to working on the client. As the practitioner can not vouch for the actual sterilization of the company the probes were purchased from (and many manufacturers only use gamma rays not heat to sterilize the probes in the packages) what seems to be expected by those who wrote the regulations is that we heat sterilize all probes in our office, even pre-packages ones, prior to use, so that we can in fact testify to the fact that they were, indeed heat sterilized. I seem to recall a statement by one person involved with the regulations that went something like, “We tell them to do 12 things, knowing they might only do 6, when 3 would have been good enough.”

Almost no one loads prepackaged probes into their heat sterilizer along with their probes and runs them through a cycle prior to working on a client, but that would be the thing that a person bent on compliance with any and all regulations from all directions would tend to do.

Of course, the goal of the sum total of regulations is to provide an avenue to say that we all are criminals breaking laws every day of our waking lives, and ignorance is no excuse.

Oh, my, I just let an opinion slip.

#5

Yes, some State laws are stupid and confusing!

And, to that point, California very recently tossed out all rules involving in-office needle sterilization, and now mandates the use of ONLY pre-sterile (commercially sold) disposable needles. There is no mention whatsoever of “how to sterilize needles” in the office at all … because the practice is now illegal. California says: "use pre-packaged FDA approved (commercially sold) sterile needles and dispose of them after one use.”

Now, it’s simple … at least here in California. “As Cailfornia ‘goes’ so goes the nation.”

#6

I will let you know when the wheat grass & sushi bars start popping up on the street corners of New York. :confused:

#7

My father Jim Paisner, President of Synoptic Products, has been involved in the field of electrology for over 25 years. As is typical of nearly all family businesses, we children were all involved with the business from an early age. I recall fondly filling sample envelopes to be sent to electrologists at the dining table when I was 13 years old.

I am now 37 and an adjuct chemistry professor at Portland Community College. I am also getting reaquainted with my father’s business and felt a need to get involved in the conversation here at Hairtell.

With regard to the role of FDA in electrology, it is important to keep in mind that the FDA regulates electrolysis equipment – things like epilators, needleholders, and needles (which must be pre-sterilized under the supervision of the FDA) – while state and local agencies regulate the practice of electrolysis itself, including requirements of whether electrologists must use pre-sterilized, disposable needles while doing treatments. See the FDA’s website for more information: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048995.htm

Ballet has always offered a 100% guarantee for their needles. Feel free to contact your distributor to swap out expired needles for current ones at no charge. Call Synoptic Products if you have any question: US or Canada: 800-535-7707, Rest of the world: 978-287-0728

#8

Welcome to Hairtell, Dave and thanks for that contact information. Like Mr.Bono, I didn’t know this was an option until James posted the above. Perfect harmony!

#9

(Funny about the sushi bars … made me laugh).

Dave, can you please amplify this point you made:

" … which must be pre-sterilized under the supervision of the FDA."

Would it be appropriate for a needle-maker to do “in house” sterilization and follow FDA rules, or does the facility actually have to be directly supervised by the FDA … and, what does that mean?"

#10

Thanks Dee for the kind welcome :slight_smile:

FDA is responsible for writing regulations as well as enforcing them.

From the FDA website:

“manufacturers are expected to control their devices from design stage through post-market surveillance. Manufacturing processes, such as sterilization, are required to be implemented under appropriate controls.”

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm244265.htm

If appropriate controls are not in place, upon inspection FDA will require changes be made, and if changes are not made, has the authority to stop manufacture of the medical device.

#11

My warmest welcome, Dave Paisner! It is a delight to see that Electrology will be perpetuated in the hands of the younger generations. Good genes, good future!

#12

Thanks Josefa!!

What find of regulations do you need to follow practicing electrology in Spain? Is it the same as here in the US?

#13

Hi Dave, thanks for your interest.

Depending on the regulatory ordinance for each community or province, some sections are different, but essentially, they all agree on issues such as the use of containers for waste collection, installation of sink in each cabin, the walls and floors should be easy to clean, the use of appropriate measures for disinfection and sterilization, etc…

As for the needles, in some provinces, clearly specified the epilation needles will be personalized use, while others refer to a single use.

Regarding the regulation in individual packaging, and expiration date, I guess that regulation in Spain is the same as in the USA. I know a Spanish brand that packaged in packs of two units in the 90s, and now are individual units.