What Does "Medical-Grade" Really Mean?

By Janet Lieberman-Lu

If we’re putting something inside us, we want to be sure it’s the best possible quality, right? But how to figure out if a material is safe isn't entirely straightforward, and there's a lot of misinformation. Why is material safety important, what makes a material safe, and what do words like "medical-grade" really mean?

Your body has mucous membranes just about everywhere your insides meet the outside: mouths, noses, vaginas, anuses, etc.  They protect you by preventing dirt and pathogens from entering your body. However, mucous membranes are also more permeable than the rest of your skin — they can absorb fluids and chemicals. For a material to be safe for repeated use on these tissues, it needs to be non-porous and inert.

Porosity

A sponge is porous. It holds water, and that’s cool. But if that water has gross things in it, and you let the sponge sit for a while, you end up with a funky-smelling sponge.  Even if you practice impeccable sponge hygiene, it’s impossible to get everything out of every little microscopic nook and cranny.

A porous sex toy gives germs a chance to settle down and start a family.  Even if you clean them well, they always have a chance to regroup and come back stronger.

Elastomer is a big blanket term for anything rubbery. They usually have microscopic air pockets in them — that’s how they squish when you press on them. Their suitability for sex toys depends on if they’re closed cell (made up of a ton of closed bubbles so they can’t absorb anything) or open cell (made up of a latticework, so air and liquids can pass through). Open cell materials are porous, closed cell materials are non-porous. Most synthetic elastomers can be made either way, so the material doesn't tell you the porosity, though we always use non-porous silicones.

Inertness

 The second thing we want from sex toy materials is for them to be (relatively) chemically and biologically inert. Inert means non-reactive. With the exception of the noble gasses, nothing is completely inert, so it's all relative. Poisons and toxins are bad because they react with your biology in undesirable ways. But even less dangerous chemicals can create irritation that increases your risk for infection. Non-reactive materials are at a chemical state where they are neutral toward your tissues. "Medical grade" is a standard of inertness, but even medical grade materials are going to react to some things.

Silica (silicon + oxygen) is often a starting place for inertness. It’s the main ingredient in glass, which is used widely from chemistry labs to cookware because of its inertness and impermeability.  It’s also the main ingredient in silicone rubber.

There aren't a lot of elastomers found in nature. You usually have to do things to materials to get rubbery properties out of them, which means chemical reactions. So, regardless of base material, they're a higher risk for inertness than hard plastics.

Many silicone rubbers are very safe. However, manufacturers produce different properties in materials by mixing in additives. If something with a silicon base is mixed with something reactive, it can end up reactive, whereas something with a generally reactive and maligned base, like a PVC, can be made inert. So the material itself doesn’t tell you if something is inert — only testing can tell you that.

Glossary of Materials

Here’s a helpful glossary of both the relevant and irrelevant terms we’ve seen used to describe sex toy materials, to help us understand the landscape a little better:

Plasticizers: Additives that make a solid material malleable, without bonding chemically to the material. For example, water is a plasticizer when added to clay — it makes it malleable, and then the clay becomes hard again when the water evaporates.

Phthalates: A category of plasticizer commonly used to turn hard plastics into elastomers. Since they do not chemically bond to the plastic they modify, they often leach out pretty easily. Chemical leaching is bad; the fact that some phthalates are probably carcinogens or harmful to reproduction makes it worse. While we're pretty sure some phthalates are bad, no one's 100% sure which ones are dangerous, so the regulations around them change pretty often.

Silicone: Silicone rubber is an elastomer largely comprised of silica. Because silica is inert, many silicone rubbers are, too. Silicone is often used in medical devices, kitchen products, and children’s toys. It’s expensive, so it is mostly only used when you need those properties, which means that most silicones are also manufactured to be non-porous (these requirements often go together).

However, not all silicones are necessarily medical-grade or non-porous — they have to be made that way on purpose. Plus, many types of silicone have had additives like plasticizers or colorants that might pose risks. Others could end up being porous. So, the word “silicone” doesn’t necessarily mean “safe.”

Latex: What natural rubbers are made of. Like most things that come from nature, natural latex rubber is not inert, and some people are allergic to it.

“Jelly” or “jelly rubber”: You probably recognize this type rubber from very cheap toys and novelty gifts. It’s wiggly like jello, and sometime transparent. Jelly rubber is the mystery meat of the elastomer world. These products are traditionally made from materials that aren’t chemically stable, safe, or non-porous. Unless you're using a condom over it, avoid it!

PVC: Polyvinyl chloride, a very versatile and controversial polymer. PVC is used to make pipes, pleather, and ⅓ of plastic-based medical devices.  Flexible PVC is used in sex toys, which means that plasticizers are added. Until recently, most of those plasticizers were phthalates, until phthalates were flagged as a potential risk. Modern flexible PVC doesn’t necessarily contain phthalates, and some of it can be medical-grade. Like silicone above, “PVC” doesn’t necessarily means “bad” or “good” — it’s a case-by-case situation.

Glass: As glass is inert and non-porous, it’s generally safe. That’s glass’s whole deal! Just make sure it’s sturdy, and unlikely to break.

Stainless steel: The “stainless” in the name refers to its inertness, though it comes in different grades. As long as it doesn’t rust, you’re probably good to go.

Who and What Can I Trust?

The unfortunate truth is that material safety in sex toys involves the honor system. Customers need to trust sex toy companies, and those sex toy companies need to trust their factories and material suppliers.

Because this is an unregulated industry, no one is requiring companies to pay attention to the safety of the materials in their products, or routinely checking their claims. "Body safe" has no meaning beyond the company's assertion that the material is safe.

There are two industries that are regulated by the FDA that use similar materials: the medical device industry and the food production industry. There's a lot of regulations and approvals involved in in making medical devices or food production equipment, and one part is that the end products undergo a series of tests that are specific to the applications they'll be used for. In order to help ensure the end products will pass those tests, manufacturers will make sure to source only materials, dyes, and additives that have already independently passed the tests. That give the best chance that, when combined, the end result will also pass.

When a device says "FDA-approved silicone", usually they mean that it is food grade (and they're hoping you'll just assume they meant medical grade). Food grade, again, means that it's been tested for suitability for use in food production, like to make conveyor belts or machinery that will contact the food. While those will be tests for inertness, they're not tests for contact with the human body.

When we say we use "medical grade" silicone, that means that the silicone (and anything that's going in or on it) has been tested and found suitable for use in medical devices. There are six grades; we only use grades IV, V, or VI. Since we *aren't* interested in buying that bridge in Brooklyn, we require third-party test reports for all materials to verify that the tests were performed. We pay a premium for a name brand - we only source silicones from major vendors for the medical device industry. That said, the product isn't classified as a medical device, so it's the raw materials and not the final product that's medical grade.

Use Your (Common) Senses

There are some red flags for material safety that are pretty easy to observe:

• “Weeping” or “bleeding”: Your sex toy spontaneously develops a weird slick film? Those are the plasticizers falling out. It's not inert.
• Changes in color or material properties: Assuming we’re not talking about a slight dinginess from handling, those are two clear indicators of chemical reactions (Though bear in mind, if you leave anything out in the sun for long enough, it will start to change).
• New smells: Coming from the factory, there are lots of reasons why there might be a slight smell to a product (some of which are even good signs, like they sterilized it right before they put it in the box). Anything like that should go away pretty quickly.  However, if your product didn’t smell at first, and now it does, that is bad. It’s likely either leaching chemicals or hosting something funky.
• It doesn’t look like it’s getting clean: It isn’t. Non-porous only means that nothing is growing on the inside. If it isn't getting clean, something can still grow on the surface. Trust your eyes!
• It doesn’t stay clean: The grippy, sticky, or tacky nature of some sex toy materials means that they pick up dirt and lint and things. If it’s holding on to things you can see, it’s holding on to things you can’t see.

 

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Janet Lieberman-Lu is an MIT-educated engineer and Dame's co-founder.