Pediatric Medical Devices

Pediatric medical devices treat or diagnose diseases and conditions from birth through age 21. The Federal Food,
Drug, and Cosmetic Act (FD&C Act) defines pediatric patients as persons aged 21 or younger at the time of their
diagnosis or treatment. Pediatric subpopulations are further categorized as follows:

Neonates - from birth through the first 28 days of life

Infants - 29 days to less than 2 years
Children - 2 years to less than 12 years
Adolescents - aged 12 through 21 (up to but not including the 22nd birthday)
Some products are designed specifically for children, while others are borrowed from adult applications or produced
for more general use. Designing pediatric medical devices can be challenging: children are often smaller and more
active than adults, body structures and functions change throughout childhood, and children may be long-term device
users -- bringing new concerns about device longevity and long-term exposure to implanted materials.

FDA is committed to supporting the development and availability of safe and effective pediatric medical devices.
Current initiatives include:

Increasing the number of medical devices with labeling for pediatric patients by incorporating known information about
device effects in other populations to support pediatric indications.
Recruiting pediatric experts for FDA advisory panels whenever there is a reasonable likelihood that the device under
discussion will be used for children.
Protecting children who participate in clinical trials.
Collaborating with the Institute of Medicine on the effectiveness of post-market surveillance of pediatric medical
devices.
Collecting data on the unmet needs for pediatric medical devices and the barriers to the development of new pediatric
devices.

3D Printing of Medical Devices

3D printing is a type of additive manufacturing. There are several types of additive manufacturing, but the terms 3D
printing and additive manufacturing are often used interchangeably. Here we will refer to both as 3D printing for
simplicity.

3D printing is a process that creates a three-dimensional object by building successive layers of raw material. Each
new layer is attached to the previous one until the object is complete. Objects are produced from a digital 3D file, such
as a computer-aided design (CAD) drawing or a Magnetic Resonance Image (MRI).

The flexibility of 3D printing allows designers to make changes easily without the need to set up additional equipment
or tools. It also enables manufacturers to create devices matched to a patient’s anatomy (patient-specific devices) or
devices with very complex internal structures. These capabilities have sparked huge interest in 3D printing of medical
devices and other products, including food, household items, and automotive parts.

Medical devices produced by 3D printing include orthopedic and cranial implants, surgical instruments, dental
restorations such as crowns, and external prosthetics.

Due to its versatility, 3D printing has medical applications in:

Medical devices regulated by FDA’s Center for Devices and Radiological Health (CDRH),
Biologics regulated by FDA’s Center for Biologics Evaluation and Research, and
Drugs regulated by FDA’s Center for Drug Evaluation and Research
Baby Products with SIDS Prevention Claims

When is a Baby Product Regulated by the FDA as a medical device?

A baby product is considered a medical device if claims to cure, treat, prevent, or reduce a disease or condition are
made in the product’s labeling, packaging, or advertising (ref. section 201(h) of the Federal Food Drug & Cosmetic
(FD&C) Act). Baby products that do not meet the definition of “device” under section 201(h) of the FD&C Act may be
regulated by another federal agency, for example the Consumer Product Safety Commission.

SIDS Prevention Claims

Some retail baby products are being marketed with claims that the products prevent Sudden Infant Death Syndrome
(SIDS). The National Institute of Child Health and Human Development defines SIDS as "the sudden, unexplained
death of a baby younger than 1 year of age that doesn’t have a known cause even after a complete investigation
including performance of a complete autopsy, examination of the death scene, and review of the clinical history."

To date, the FDA has not cleared or approved a baby product to prevent or reduce the risk of SIDS.
The Agency is not aware of any scientific studies showing that a medical device prevents or reduces the risk of SIDS.
In fact, baby products with such claims can actually pose a suffocation risk to infants. As a result, the agency cautions
parents and caregivers not to purchase or use baby products with claims to prevent or reduce the chance of SIDS.

Examples of common over-the-counter baby products with unproven claims to prevent or reduce the risk of SIDS
include:

baby monitors,
mattresses,
crib tents,
pillows,
crib bedding, including bumpers and blankets, and
infant sleep positioners.
Current research shows that the best way to reduce the chance of SIDS is to create a safe sleep environment for a
baby: alone, in their own sleeping space with no other people in the crib or bassinet; on their backs on a firm sleep
surface; and in a crib or bassinet free of pillows, blankets, bumpers, sleep positioners, and other objects.
Cardiovascular Devices

Automated External Defibrillators (AEDs)

An automated external defibrillator (AED) is a device that automatically analyzes the heart rhythm in victims of cardiac
arrest, and delivers an electrical shock to the heart to restore its normal rhythm. AEDs are important tools in providing
a rapid response to victims of cardiac arrest.

An AED system consists of an AED device, battery, pad electrode, and if applicable, an adapter.

AEDs are found in airports, community centers, schools, government buildings, and other public locations. These
devices are intended for use by the general public.

AEDs can save lives – but the devices have been associated with manufacturing problems and many devices have
been recalled.

The FDA issued a Final Order: Effective Date of Requirement for Premarket Approval for Automated External
Defibrillator Systems; Republication on February 3, 2015, which represents a tailored approach to help manufacturers
assure the quality and reliability of AEDs. AEDs can be highly effective in saving the lives of people suffering cardiac
arrest when used in the first few minutes following collapse from cardiac arrest. To help to assure the quality and
reliability of AEDs, the FDA is requiring manufacturers to obtain premarket approval for all future and currently-
marketed AEDs and necessary AED accessories (e.g., pad electrodes, batteries, adapters and hardware keys for
pediatric use).

The PMA process allows the FDA to review quality systems and manufacturing information; conduct pre-approval
inspections; review changes in manufacturing facilities where devices are made; and review design and
manufacturing changes that affect safety and effectiveness to ensure that the changes are adequately evaluated and
tested prior to implementation. We believe these actions will help address the problems that have been of concern for
AEDs.

Given the importance of these devices in emergency situations, AEDs currently on the market will remain available
while manufacturers work to meet the new PMA requirements. See Press Release: FDA takes steps to improve
reliability of automated external defibrillators for more information.
Cosmetic Devices Dermal Fillers (Soft Tissue Fillers)

Dermal fillers, also known as injectable implants, soft tissue fillers, or wrinkle fillers are medical device implants
approved by the Food and Drug Administration (FDA) for use in helping to create a smoother and/or fuller appearance
in the face, including nasolabial folds, cheeks and lips and for increasing the volume of the back of the hand.

Approved Uses
Risks
Information for Health Care Providers
Information for Patients
Approved Uses
The FDA has approved dermal fillers made from absorbable or temporary material for the correction of moderate to
severe facial wrinkles and skin folds, such as nasolabial folds, which are the wrinkles on the sides of your mouth that
extend towards the nose often referred to as "smile lines" or "marionette lines."

The FDA approved a dermal filler made from non-absorbable (permanent) material ONLY for the correction of
nasolabial folds and cheek acne scars in patients over the age of 21 years.

The FDA has approved some dermal fillers for the restoration and/or correction of the signs of facial fat loss
(lipoatrophy) in people with human immunodeficiency virus (HIV).

The FDA has approved several absorbable dermal fillers for uses such as lip and cheek augmentation in patients over
the age of 21, and the correction of contour deficiencies, such as wrinkles and acne scars.

The FDA has also approved one filler for hand augmentation, which increases the volume of the back of the hands.

Patients may need more than one injection to get the desirable smoothing/filling effect. Successful results will depend
on the health of the skin, the skill of the doctor, and amount and type of filler used. The time that the effect lasts
depends on the filler material used and the area where it is injected.

Unapproved Uses
The FDA has NOT approved dermal fillers to:

increase breast size (breast augmentation)

increase size of the buttocks
increase fullness of the feet
implant into bone, tendon, ligament, or muscle
The FDA has not approved injectable silicone for large-scale body contouring or enhancement. Such use can lead to
ongoing pain, infections, and serious injuries, such as scarring and permanent disfigurement, embolism (blockage of a
blood vessel), stroke, and death.

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Risks
As in any medical procedure, there are risks involved with the use of dermal fillers. That is why it is important for you
to understand their limits and possible risks.
Any dermal filler can cause short- or long-term side effects, permanent side effects, or a combination. However, most
side effects associated with dermal fillers occur shortly after injection and most go away in less than two weeks.
Swelling and pain after hand treatment may last a month or more. In some cases, side effects may appear weeks,
months or years after injection.

Patients should be tested for allergies before using fillers made with certain materials, especially animal materials
(e.g., cow or rooster comb).

The following risks accompany FDA-approved uses of Dermal Fillers. The risks associated with unapproved uses of
dermal fillers, or with the use of unapproved products are not known.

Common side effects include:

Bruising
Redness
Swelling
Pain
Tenderness
Itching, rash
Difficulty in performing activities (only observed when injected into the back of the hand)
Less common side effects include:

Raised bumps in or under the skin (nodules or granulomas) that may need to be surgically removed
Infection
Open or draining wounds
A sore at the injection site
Allergic reaction
Necrosis (tissue death)

The following rare side effects have also been reported to the FDA:

Severe allergic reaction (anaphylactic shock) that requires immediate emergency medical assistance
Migration/ movement of filler material from the site of injection
Leakage or rupture of the filler material at the injection site or through the skin (which may result from tissue reaction
or infection)
The formation of permanent hard nodules in the face or hand
Vision abnormalities, including blindness
Stroke
Injury to the blood supply,
Damage to the skin or the lips

If you choose to have permanent fillers removed or reduced through surgery, you may experience the same adverse
events typically associated with surgery. You should be aware that it may be difficult to remove the filler material.

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Information for Health Care Providers

Only use FDA-approved dermal fillers. The FDA urges health care providers to carefully inspect all dermal filler
packages for authenticity. The FDA is aware of counterfeit products being marketed and used in the U.S.
Do not inject dermal fillers if you do not have the appropriate training or experience.
Make sure that you are familiar with the anatomy at and around the site of injection, and do not inject dermal fillers into
blood vessels in the face.
Before injection, thoroughly inform the patient of all risks of the procedure and the specific product you intend to use.
Note that the approved indications for use of dermal fillers vary depending on the product. The FDA may not have
reviewed use of dermal fillers in some locations in the body.
Inject dermal fillers slowly and applying the least amount of pressure necessary.
Know the signs and symptoms associated with injection into blood vessels, and have an updated plan detailing how
the patient will be treated should this occur. This may include on-site treatment and/or immediately referring the
patient to another health care provider for treatment.
Immediately stop the injection if a patient exhibits any signs or symptoms associated with injection into a blood vessel,
such as changes in vision, signs of a stroke, white appearance (or blanching) of the skin, or unusual pain during or
shortly after the procedure.
Tell patients that they should seek immediate medical attention after the procedure if they experience signs and
symptoms associated with injection into a blood vessel.
Educate facility staff and employees on how to quickly assist patients calling with signs and symptoms of filler
complications on how to receive appropriate medical care.
Report to the FDA and the manufacturer if you become aware of any adverse event associated with the use of dermal
fillers, including unintentional injection of dermal filler into a blood vessel.
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Information for Patients

Before deciding to have a procedure using dermal fillers, the FDA recommends that:

You seek a licensed health care provider with experience in the fields of dermatology or plastic surgery.
Select a doctor who is trained to perform the dermal filler injection procedure. Having filler injected should be
considered a medical procedure, not a cosmetic treatment. Ask your health care provider about their training and
experience injecting dermal fillers in the face.
Do not inject yourself with dermal fillers.
Do not purchase dermal filler products online, because they could be counterfeit products, or products not approved
for use in the U.S.
Talk with your health care provider about appropriate treatment injection sites and the risks associated with the
procedure.
Be aware that FDA reviewed and approved different products for use in certain areas of the face. The FDA may not
have reviewed the use of certain dermal fillers for all locations in the body.
Read and discuss the patient labeling for the specific filler you are receiving. Your doctor can provide this information,
or you can find it on the FDA's website.
Seek immediate medical attention if you experience unusual pain, vision changes, a white appearance of skin near
the injection site, or any signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face,
arms, or legs, difficulty walking, visual changes, face drooping, severe headache, dizziness, or confusion) during or
shortly after the procedure.
Additionally, you should be aware that:

FDA approval is based on controlled, clinical study of these products when used in the face or hand.
The safe use of these products with Botox or other dermal (skin) therapies has not been evaluated in a controlled,
clinical study.
The safety of these products used repeatedly over a long period of time has not been evaluated in a controlled, clinical
study.
The safety of these products is unknown when used during pregnancy, while breast feeding or in patients under 18
years of age.
The safety of these products is unknown in patients who are prone to excessive scarring (keloids) and/or thick
scarring (hypertrophic scars).

Ask your health care provider for the patient labeling to help determine whether the dermal filler you are considering is
appropriate for you. Carefully review the patient labeling with your health care provider if you have any of the following
conditions or symptoms:

All Dermal Fillers

Your skin is inflamed or infected. If you have an active inflammatory condition, (cysts, pimples, rashes, or hives) or
infection, dermal filler injection should be delayed until this inflammatory condition has been managed.
You have a bleeding disorder.
You have severe allergies or have a history of anaphylaxis (acute allergic reaction).
Dermal Fillers Containing Certain Materials

You are allergic to collagen or eggs when considering dermal fillers that contain collagen or egg-derived products.
You are allergic to animal products when considering dermal fillers that contain materials from animals.
You are allergic to lidocaine when considering dermal fillers that contain lidocaine.
You are allergic to bacteria when considering dermal fillers that contain hyaluronic acid material derived from bacteria
fermentation.
You have joint, tendon, or vascular disease affecting the hand when considering hand augmentation.
Check Before You Inject

The FDA has created a checklist for consumers with helpful information when considering an injectable dermal filler.

Dental Devices
Background

Denture adhesives are pastes, powders or adhesive pads that may be placed in/on dentures to help them stay in
place. Sometimes denture adhesives contain zinc to enhance adhesion.

In most cases, properly fitted and maintained dentures should not require the use of denture adhesives. Over time,
shrinkage in the bone structure in the mouth causes dentures to gradually become loose. When this occurs, the
dentures should be relined or new dentures made that fit the mouth properly. Denture adhesives fill gaps caused by
shrinking bone and give temporary relief from loosening dentures.

Zinc and Potential Risk

Zinc is a mineral that is an essential ingredient for good health. It is found in protein-rich foods such as shellfish, beef,
chicken and nuts, as well as in some dietary supplements.

However, an excess of zinc in the body can lead to health problems such as nerve damage, especially in the hands
and feet. This damage appears slowly, over an extended period of time.

Overuse of zinc-containing denture adhesives, especially when combined with dietary supplements that contain zinc
and other sources of zinc, can contribute to an excess of zinc in your body.
Reports of Problems

The FDA is aware of case reports in the medical literature linking negative reactions such as nerve damage,
numbness or tingling sensations from denture adhesives that contain zinc to chronic overuse of the products. The
subjects of these case reports used at least two tubes of zinc-containing denture adhesive each week. Some product
instructions indicate that one tube should last seven to eight weeks.

The FDA has also received reports of adverse events linked to use of denture adhesives. However, the FDA’s
adverse event reporting system is not designed to establish injury rates and individual reports vary in the amount and
reliability of data included.

Neither published data nor FDA adverse event surveillance data are adequate to associate injuries with specific
device types or brands.

The FDA has not found conclusive evidence that these problems result from using zinc-containing denture adhesive
as instructed in the product labeling.

To help address the potential risk that overuse of zinc-containing denture adhesives may pose, the FDA asked
makers of zinc-containing denture adhesives to consider:

 Including directions that will prevent overuse if zinc is an ingredient. (Some companies include graphics of the
amount of adhesive to use or the amount of time that a tube should last under correct usage.)
 Modifying the labeling to specify that the product contains zinc as an ingredient, if appropriate and consider
replacing zinc with an ingredient that presents less health risks in situations of overuse.

Manufacturers, importers and distributors of denture adhesives are required by the FDA to register their facilities, list
their products and report adverse events. In addition, they are required to adhere to other general regulatory controls
such as good manufacturing practice and adequate directions for use or a clear definition of an unsafe dosage or
methods or duration of application.

Advice for Denture Wearers

Denture wearers may have difficulty determining the proper amount of denture adhesive to use if the instructions are
not clear. If a denture wearer is uncertain about how much to use, he or she should contact a dental health
professional to help determine the correct amount.

Denture wearers should know that a large amount of denture adhesive will not necessarily address problems with ill-
fitting dentures, and prolonged use of ill-fitting dentures may lead to an increase in bone loss.

The FDA recommends that consumers of denture adhesive products:

 Follow the instructions provided with the denture adhesive. If the product does not come with instructions or the
instructions are unclear, consult with a dental professional.
 Do not use more adhesive than recommended.
 Understand that some denture adhesives contain zinc, and that although they are safe to use in moderation as
directed, if overused, they could contribute to harmful effects if over-used.
 Know that manufacturers may not always list their product ingredients.
 Know that there are zinc-free denture adhesives products.
 Stop using the denture adhesive and consult your physician if you experience symptoms such as numbness or
tingling sensations in the extremities.
 Start with a small amount of adhesive - if the adhesive oozes off the denture into your mouth, you are likely using
too much adhesive.
 Know that a 2.4-ounce tube of denture adhesive used by a consumer with upper and lower dentures should last
seven to eight weeks.
 Track how much denture adhesive you use by marking on a calendar when you started a new tube, and when the
tube is empty.
 Consider speaking to your dentist to see that your dentures fit properly. Dentures can become ill-fitting as a
person's gums change over time.
Reporting Problems to the FDA

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical
products. If you suspect problems associated with the use of denture adhesives, we encourage you to file a voluntary
report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Multiple-Use Dental Dispenser Devices

Definition

Multiple-use dental dispensers, sometimes called dental “syringes” are devices used to deliver various dental products
including impression materials, adhesives, dental composites , and endodontic (root canal) materials to a treatment
site in the mouth. Multiple-use dental dispensers do not include disposable syringes or dental needles (hypodermic
syringes) for injection of anesthetics and other medications.

Importance of Infection Control

Manufacturers typically supply multiple-use dental dispensers as pre-filled syringes with disposable tips. The tips are
intended to be discarded after each patient use, but the dispensers containing the remaining dental material often are
reused.

Contamination or infection control issues arise for patients when the body or housing of multiple-use dental dispensers
comes in contact with a previous patient’s cheek or lips, or when the dispenser is handled by a dental practitioner
whose gloves have become contaminated with previous patient’s blood or saliva.

According to the Centers for Disease Control and Prevention (CDC), devices that come in contact with mucous
membranes of the mouth are classified as “semicritical” depending on the potential risk for infection associated with
their intended use. CDC recommends that once a device in this category (such as a dental dispenser) becomes
contaminated, it should be heat sterilized or subjected to immersion in a high-level chemical disinfectant.

However, multiple-use dental dispensers cannot be reprocessed using heat sterilization (e.g., steam autoclave) or
immersion in high-level disinfectants because this may damage the dispenser or material contained in the dispensers.
Also, the FDA does not believe that these devices, once contaminated, can be adequately disinfected by wiping with a
chemical disinfecting solution. Therefore, the FDA recommends disposal of contaminated multiple-use dental
dispensers in order to avoid the risk of cross-contamination to patients.

Tips for Dental Practitioners

The following information should help dental practitioners reduce the risk of cross-contamination between patients
when using multiple-use dental dispensers.

DO:

 Apply disposable barrier sleeves/wraps over multiple-use dental dispensers before use with each patient.
 Use new, uncontaminated gloves when handling multiple-use dental dispensers.
 Utilize dental assistants to dispense material for the dentist
 Avoid contact of the reusable parts (e.g., the body of the multiple-use dental dispenser) with the patient’s
mouth.

DO NOT:

 Reuse the multiple-use dental dispenser if it becomes contaminated.

 Reprocess a contaminated multiple-use dental dispenser by using chemical wipes or disinfectants.
 Immerse multiple-use dental dispensers in a high level chemical disinfectant. This may damage the
dispenser and the material contained in the device.
 Sterilize multiple-use dental dispensers. This may damage the material contained in the device.

Dental Amalgam
Dental amalgam is a dental filling material which is used to fill cavities caused by tooth decay. Its primary component
is elemental mercury.
Tooth decay results in a loss of tooth structure. Dental amalgam is one type of dental filling material used to repair
tooth structure that has been destroyed by decay and to restore the biting surfaces of a decayed tooth. Other
materials, commonly referred to as composites, are also used for dental fillings.

This website contains information about dental amalgam and other types of dental filling materials. It provides general
information and is not meant to replace a discussion with your dentist.

General Hospital Devices and Supplies

Medical devices health professionals use to support patient care or for their own health and safety are covered in this
category.

Liquid Chemical Sterilization

Although the terms are similar, "liquid chemical sterilization" is different from thermal and gas/vapor/plasma low
temperature "sterilization." As explained on this webpage, FDA believes that sterilization with liquid chemical sterilants
does not convey the same sterility assurance as sterilization using thermal or gas/vapor/plasma low temperature
sterilization methods.

Traditional Sterilization

"Sterilization," as defined in FDA's Liquid Chemical Sterilants/High Level Disinfectants guidance document, is a
validated process used to render a product free of all forms of viable microorganisms. In many cases, thermal
methods, such as steam, are used to achieve sterilization. Thermal sterilization methods have been studied and
characterized extensively. In addition, the survival kinetics for gas/vapor/plasma low temperature sterilization methods
have also been well characterized.

Liquid Chemical Sterilization

Liquid chemical sterilization involves a two-part process:

1. Devices are treated with a liquid chemical germicide (LCG).
2. The processed devices are rinsed with water to remove the chemical residues.

There are several limitations with liquid chemical sterilization. Although the rinse water is treated to minimize any
bioburden, it is not sterile. Because the rinse water is not sterile, devices rinsed with this water cannot be assured to
be sterile. Furthermore, devices cannot be wrapped or adequately contained during processing in a liquid chemical
sterilant. This means that there is no way to maintain sterility once devices have been processed.

Recommendations

For the reasons stated above, FDA recommends that the use of liquid chemical sterilants be limited to reprocessing
only critical devices that are heat-sensitive and incompatible with sterilization methods such as steam and
gas/vapor/plasma low temperature processes.

Biological and Chemical Indicators for Liquid Chemical Sterilization

Biological Indicators are not appropriate or required for monitoring liquid chemical sterilization process. They are
generally used for monitoring traditional sterilization processes where a SAL 10-6 is achieved. FDA has not cleared
any biological indicators for monitoring liquid chemical sterilization process.

Chemical indicators are appropriate and are required for monitoring the minimum required concentration of most liquid
chemical sterilants. FDA has cleared many Chemical Indicators for monitoring the concentration of liquid chemical
sterilant. Refer to the manufacturer's instructions for a compatible Chemical Indicator that is cleared by the FDA for
use with the liquid chemical sterilant.

Patient Lifts
Patient lifts are designed to lift and transfer patients from one place to another (e.g., from bed to bath, chair to
stretcher). These should not be confused with stairway chair lifts or elevators. Patient lifts may be operated using a
power source or manually. The powered models generally require the use of a rechargeable battery and the manual
models are operated using hydraulics. While the design of patient lifts will vary based on the manufacturer, basic
components may include a mast (the vertical bar that fits into the base), a boom (a bar that extends over the patient),
a spreader bar (which hangs from the boom), a sling (attached to the spreader bar, designed to hold the patient), and
a number of clips or latches (which secure the sling).
These medical devices provide many benefits, including reduced risk of injury to patients and caregivers when
properly used. However, improper use of patient lifts can pose significant public health risks. Patient falls from these
devices have resulted in severe patient injuries including head traumas, fractures, and deaths.

The FDA has compiled a list a best practices that, when followed, can help mitigate the risks associated with patient
lifts. Users of patient lifts should:

 Receive training and understand how to operate the lift.

 Match the sling to the specific lift and the weight of the patient. A sling must be approved for use by the patient lift
manufacturer. No sling is suitable for use with all patient lifts.
 Inspect the sling fabric and straps to make sure they are not frayed or stressed at the seams or otherwise
damaged. If there are signs of wear, do not use it.
 Keep all clips, latches, and hanger bars securely fastened during operation.
 Keep the base (legs) of the patient lift in the maximum open position and situate the lift to provide stability.
 Position the patient’s arms inside the sling straps.
 Make sure that the patient is not restless or agitated.
 Lock the wheels on any device that will receive the patient such as a wheelchair, stretcher, bed, or chair.
 Make sure that the weight limitations for the lift and sling are not exceeded.
 Follow the instructions for washing and maintaining the sling.
 Create and follow a maintenance safety inspection checklist to detect worn or damaged parts that need immediate
replacement.

In addition to following these best practices, users of patient lifts must read all instructions provided by the
manufacturer in order to safely operate the device.

Safe patient handling laws mandating the use of patient lifts to transfer patients have been passed in several states.
Due to the passage of these laws, and the clinical community’s goal of reducing patient and caregiver injury during
patient transfers, it is expected that the use of patient lifts will increase. The best practices listed above are designed
to help reduce the risks while enhancing the benefits of these medical devices.

Surgical Stapler Information

About Surgical Staplers

Surgical staplers and clip appliers are complex mechanical medical devices that have been on the market for years
and are mature in their technology. These devices are used in gastrointestinal, gynecologic, thoracic, and many other
surgeries to remove part of an organ (resection), to cut through organs and tissues (transection) and to create
connections between structures (anastomoses). The benefit of using these devices allows for more complex
procedures and shorter surgical procedure time.

Adverse Events and Product Problems Associated with Surgical Staplers

Each year over the past 5 years there have been 8,000 to 9,000 adverse event reports related to surgical staplers.
Ninety-percent were malfunctions, 9% injuries and less than 1% deaths. The most frequently reported device
problems were: staples did not form, staplers misfired or failed to fire, and separated suture lines. The most frequently
reported patient problems were anastomosis failure, prolonged surgery, bleeding, and infection.
Infusion Pumps
An infusion pump is a medical device that delivers fluids, such as nutrients and medications, into a patient’s body in
controlled amounts. Infusion pumps are in widespread use in clinical settings such as hospitals, nursing homes, and in
the home.

In general, an infusion pump is operated by a trained user, who programs the rate and duration of fluid delivery
through a built-in software interface. Infusion pumps offer significant advantages over manual administration of fluids,
including the ability to deliver fluids in very small volumes, and the ability to deliver fluids at precisely programmed
rates or automated intervals. They can deliver nutrients or medications, such as insulin or other hormones,
antibiotics, chemotherapy drugs, and pain relievers.

There are many types of infusion pumps, including large volume, patient-controlled analgesia (PCA), elastomeric,
syringe, enteral, and insulin pumps,. Some are designed mainly for stationary use at a patient’s bedside. Others,
called ambulatory infusion pumps, are designed to be portable or wearable.
Because infusion pumps are frequently used to administer critical fluids, including high-risk medications, pump failures
can have significant implications for patient safety. Many infusion pumps are equipped with safety features, such as
alarms or other operator alerts that are intended to activate in the event of a problem. For example, some pumps are
designed to alert users when air or another blockage is detected in the tubing that delivers fluid to the patient. Some
newer infusion pumps, often called smart pumps, are designed to alert the user when there is a risk of an adverse
drug interaction, or when the user sets the pump’s parameters outside of specified safety limits.

Over the past several years, significant safety issues related to infusion pumps have come to FDA’s attention. These
issues can compromise the safe use of external infusion pumps and lead to over- or under-infusion, missed
treatments, or delayed therapy.

From 2005 through 2009, FDA received approximately 56,000 reports of adverse events associated with the use of
infusion pumps, including numerous injuries and deaths. During this time period, manufacturers conducted 87 infusion
pump recalls to address identified safety concerns. Seventy of these recalls were designated as Class II, a category
that applies when the use of the recalled device may cause temporary or medically reversible adverse health
consequences, or when the probability of serious adverse health consequences is remote. Fourteen recalls were
Class I – situations in which there is a reasonable probability that use of the recalled device will cause serious adverse
health consequences or death. These adverse event reports and device recalls have not been isolated to a specific
manufacturer, type of infusion pump, or use environment; rather, they have occurred across the board.

Although some adverse events may be the result of user error, many of the reported events are related to deficiencies
in device design and engineering, which can either create problems themselves or contribute to user error. The most
common types of reported problems have been associated with software defects, user interface issues, and
mechanical or electrical failures and are explained on the Examples of Reported Infusion Pump Problems page.

In 2010 the FDA announced three steps it would take to improve infusion pump safety. These steps were to (1)
increase user awareness, (2) proactively facilitate device improvements, and (3) publish new guidance for industry.
For more information on FDA’s progress in completing these steps see the Infusion Pump Improvement
Initiative page.

On this website, you can learn more about infusion pump problems, actions FDA is taking to improve pump safety,
strategies to reduce pump-related risks, and how to report problems to FDA.

Personal Protective Equipment for Infection Control

Personal protective equipment (PPE) refers to protective clothing, helmets, gloves, face shields, goggles, facemasks
and/or respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.

PPE is commonly used in health care settings such as hospitals, doctor's offices or clinical labs. When used properly,
PPE acts as a barrier between infectious materials such as viral and bacterial contaminants and your skin, mouth,
nose, or eyes (mucous membranes). The barrier has the potential to block transmission of contaminants from blood,
body fluids, or respiratory secretions. PPE may also protect patients who are at high risk for contracting infections
through a surgical procedure or who have a medical condition (for example immunodeficiency) from being exposed to
substances or potentially infectious material brought in by visitors and healthcare workers. When used properly and
with other infection control practices such as hand-washing, using alcohol-based hand sanitizers, and covering
coughs and sneezes, it minimizes the spread of infection from one person to another. Effective use of PPE includes
properly removing and disposing of contaminated PPE to prevent exposing both the wearer and other people to
infection.

When an infection outbreak affects a broad population in the U.S., the Centers for Disease Control and Prevention
(CDC), is responsible for making specific recommendations for infection control measures in different circumstances
and settings. For example, the CDC has provided the following recommendations:

 What You Should Know about the Flu

 What You Should Know about Ebola

The FDA's role in regulating personal protective equipment

All personal protective equipment (PPE) that is intended for use as a medical device must follow FDA's regulations
and meet specific performance standards for protection. This includes surgical masks, N95 respirators, medical
gloves, and gowns. The performance standards and FDA's requirements vary depending on the specific type of PPE.
When these standards and regulations are followed, they provide reasonable assurance that the device is safe and
effective.

Some PPE are reviewed by FDA before they are allowed to be sold in the United States. In this review, known
as Premarket Notification or 510(k) clearance, the manufacturers have to show they meet specific criteria for
performance, labeling, and intended use to demonstrate substantial equivalence. One way substantial equivalence
may be demonstrated, in part, is by conforming to consensus standards for barrier performance and resistance to
tears and snags. Voluntary consensus standards may also be used to demonstrate sterility (when applicable),
biocompatibility, fluid resistance, and flammability. Manufacturers must validate the methods used to test conformance
to standards and support each product with appropriate performance test data.

On November 30, 2017, a proposed order (FDA-2017-N-4919) was published in the Federal Register to announce
FDA's intent to exempt N95s from premarket notification requirements and execute a Memorandum of Understanding
(MOU) between FDA and the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational
Safety and Health (NIOSH), regarding regulatory oversight of N95s.

For additional information on FDA's role in regulating specific PPE, please go to:

 Masks and N95 Respirators

 Medical Gloves
 Medical Gowns

Hospital Beds
Between January 1, 1985 and January 1, 2013, FDA received 901 incidents of patients caught, trapped, entangled, or
strangled in hospital beds. The reports included 531 deaths, 151 nonfatal injuries, and 220 cases where staff needed
to intervene to prevent injuries. Most patients were frail, elderly or confused.

The efforts of the FDA and the Hospital Bed Safety Workgroup have culminated in FDA's release of Hospital Bed
System Dimensional and Assessment Guidance to Reduce Entrapment. This guidance provides recommendations for
manufacturers of new hospital beds and for facilities with existing beds (including hospitals, nursing homes, and
private residences).

Healthcare facilities developing comprehensive bed safety programs should consider:

 following the Clinical Guidance for the Assessment and Implementation of Bed Rails to assess an individual
patient's needs when using a side rail; and
 consulting with the hospital bed manufacturer and their facilities’ risk managers.

The HBSW has developed a Bed Safety Entrapment Kit containing information and tools that can be used to assess
the risk of entrapment in hospital beds. Additional information about the kit is also provided in the FDA Guidance.

Medical Device Connectors

Background

Patients in health care settings receive food, medication and other therapies through a variety devices, or delivery
systems, such as syringes, catheters, and tubing sets that connect to each other. Connectors are the parts of devices
that attach tubing, catheters and syringes to other medical devices.

Medical devices are often packaged together in tubing sets or co-packaged with another device (e.g. feeding set and
enteral feeding tube). These sets comprise all the parts needed to use the tubing for its intended purpose, including
the connectors that attach tubes to the other parts of the set or to other devices.

In a typical hospital setting, several different types of medical devices, each with their own connections, may be in use
at the same time on a single patient. In specialized settings, such as intensive care units (ICUs), cardiac care units, or
emergency departments, patients may require dozens of different devices at once.

Devices that need to connect to each other are also used in the home setting, and other environments beyond
professional health care facilities. Patients may have to use these devices for the duration of an illness, recuperation,
long-term care, or throughout their lives.

Medical Device Misconnections

Medical device misconnections may occur when one type of medical device is mistakenly attached to another type of
medical device that performs a different function. Because these connectors are easy to use and may be compatible
with different medical devices, users can mistakenly connect unrelated systems to one another. This may cause
medication or other substances to be delivered through the wrong tubing into the incorrect area of the body. These
errors are sometimes called tubing misconnections, wrong route errors, catheter misconnections, or Luer
misconnections and can result in patient injury or death. For examples of potential misconnections, see the Examples
of Medical Device Misconnections page, which includes case studies of errors and how to correct or prevent them.

Device misconnections can occur for many reasons, including:

 The similar design of many connectors and widespread use of connectors with similar sizes and shapes.
 Human error, arising from conditions such as multiple connections on one patient, poor lighting, lack of training,
time pressure, fatigue or high-stress environments.

Reducing Risks Associated with Medical Device Misconnections

Manufacturers and health care facilities have tried many methods to prevent device misconnections, including color-
coding, labels, tags, and training. However, these methods alone have not effectively solved the misconnection
problem because they are not consistently applied, nor do these methods physically prevent the misconnections.

Soon, the way devices connect to each other may be changing, greatly reducing the risk for misconnections. New
design standards are being developed for tubing connectors for high-risk medical applications (e.g., enteral,
respiratory, neuraxial), so that unrelated devices cannot connect with each other. For additional information, see
the Reducing Risks through Standards Development for Medical Device Connectors page.

The FDA’s Role

The FDA is working with standards organizations, federal partners, professional societies, advocacy groups, patients
and other stakeholders to reduce the chance of medical device misconnections. The FDA continues to address this
issue through:
 Participating in international consensus standards development;
 Developing draft and final guidance;
 Evaluating medical device adverse event reports about medical device misconnections;
 Communicating with patients and other stakeholders to understand the impact of new connector designs.

Implants and Prosthetics

Medical implants are devices or tissues that are placed inside or on the surface of the body. Many implants are
prosthetics, intended to replace missing body parts. Other implants deliver medication, monitor body functions, or
provide support to organs and tissues.

Some implants are made from skin, bone or other body tissues. Others are made from metal, plastic, ceramic or other
materials.

Implants can be placed permanently or they can be removed once they are no longer needed. For example, stents or
hip implants are intended to be permanent. But chemotherapy ports or screws to repair broken bones can be
removed when they no longer needed.

The risks of medical implants include surgical risks during placement or removal, infection, and implant failure. Some
people also have reactions to the materials used in implants.

All surgical procedures have risks. These include bruising at the surgical site, pain, swelling and redness. When your
implant is inserted or removed, you should expect these types of complications.

Infections are common. Most come from skin contamination at the time of surgery. If you get an infection, you may
need to have a drain inserted near the implant, take medication, or even have the implant removed.

Over time, your implant could move, break, or stop working properly. If this happens, you may require additional
surgery to repair or replace the implant.

If you learn that you need a medical implant, you should ask your doctor the following questions before agreeing to the
procedure:

 Will my implant be permanent or removable? If the device is permanent, find out how long it should last. If the
device is removable, find out how long it will be implanted in you and what factors will determine when it can come
out.
 What material will the implant be made from? Make sure you are not allergic to any of the components in the
implant.
 How many of these procedures have you done? The more experience a doctor has with inserting implants, the
better the outcome may be.
 What are the complication rates from the procedure? Make sure you understand the risks of the surgery, infection,
and device failure.
 What are the benefits of the procedure? Make sure you understand how the device will benefit you and if it will
affect your quality of life.

Breast Implants

Breast implants are medical devices that are implanted under the breast tissue or under the chest muscle to increase
breast size (augmentation) or to rebuild breast tissue after mastectomy or other damage to the breast
(reconstruction). They are also used in revision surgeries, which correct or improve the result of an original surgery.

There are two types of breast implants approved for sale in the United States: saline-filled and silicone gel-filled. Both
types have a silicone outer shell. They vary in size, shell thickness, shell surface texture, and shape (contour).

The information provided on this website is designed to support, not replace, the relationship that exists between a
patient and a physician. We have provided this information to:

 Help women make informed decisions about whether or not to get breast implants.
 Explain the risks of breast implants and describe the surgical procedures used to implant them.
 Provide information on saline-filled and silicone gel-filled breast implants, including data supporting a reasonable
assurance of safety and effectiveness, approval letters, labeling and information on post-approval studies.
 Provide information on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in women with breast
implants.
 Outline the regulatory history of breast implants in the United States.
 Encourage reporting of adverse events associated with breast implants through our Medwatch Reporting System.

Cerebral Spinal Fluid (CSF) Shunt Systems

Placement of cerebral spinal fluid (CSF) shunt systems to treat hydrocephalus is a common medical procedure and a
life-saving treatment for many patients. These shunt systems drain excess fluid from the brain to another part of the
body where the fluid is absorbed as part of the circulatory process. CSF shunts contain three main components: an in-
flow tube (catheter), a valve that regulates the flow of fluid, and an outflow catheter that carries the fluid to the
abdomen or the heart where the fluid can be absorbed.

Types of CSF Shunt Valves

There are two types of CSF shunt valves: fixed and adjustable. Fixed shunt valves allow CSF fluid to drain when CSF
pressure exceeds a certain “fixed” threshold. Adjustable shunt valves allow for changes to the amount of fluid that
flows through the valve. There are two types of adjustable CSF shunt valves: magnetic externally adjustable and non-
magnetic externally adjustable.

Magnetic Externally Adjustable Shunt Valves

Magnetic externally adjustable shunts have mechanical parts that can be moved non-invasively from outside the body.
To adjust these valves, a clinician places a magnetic tool on the skin near the valve and manually rotates it. The
magnetic field of the programming tool passes through the skin to adjust the position of the valve. This process,
setting a valve to drain more or less fluid from the brain, is sometimes called “programming,” although the process
involves no electronics. Once implanted, no additional surgical procedures are required to change the setting of a
magnetic externally adjustable shunt valve.

Non-Magnetic Externally Adjustable Valves

These types of shunts DO NOT use an external magnetic field for valve adjustments. Some valves have self-adjusting
flow-regulating mechanisms, while others can only be adjusted using minimally invasive surgical procedures.
Cochlear Implants
Welcome to the Food and Drug Administration (FDA) website on cochlear implants. Cochlear implants are electronic
hearing devices. Doctors implant cochlear implants into people with severe to profound hearing loss to produce useful
hearing sensations.

The purpose of this website is to describe cochlear implants, link to FDA-approved implants, tell the benefits and
risks of cochlear implants, and provide news about cochlear implant recalls and safety issues. You can find
information here too on what educators of implant users need to know, what happens before, during and after
surgery, and where to report problems.

The FDA regulates manufacturers of cochlear implants. For manufacturers to sell cochlear implants in the United
States, they must first show the FDA that their implants are safe and effective. As a matter of policy, FDA does not
rate or recommend brands of cochlear implants or medical facilities that implant them.

Essure Permanent Birth Control

Essure is a a permanently implanted birth control device for women (female sterilization). Implantation of Essure does
not require a surgical incision. In the procedure, a health care provider inserts flexible coils through the vagina and
cervix and into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus. Over a period of
about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from
reaching the eggs, thus preventing conception. Essure is considered a permanent form of birth control and therefore is
not intended to be removed.

Over the past several years, the FDA has been examining the growing number of adverse event reports associated
with the use of Essure. Reported adverse events include persistent pain, perforation of the uterus and/or fallopian
tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity
reactions. Some women have had surgical procedures to remove the device. In addition, Essure failure, and, in some
cases, incomplete patient follow-up, have resulted in unintended pregnancies.

The FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory
Committee on September 24, 2015, to hear expert scientific and clinical opinions as well as patients’ experiences
regarding the benefits and risks of Essure. In addition, a public docket soliciting comments on the device remained
open from July 22, 2015 until October 24, 2015. FDA received more than 2,800 comments in this docket and reviewed
each comment and considered all views and perspectives expressed.

Hernia Surgical Mesh Implants

In this website, the FDA describes hernias, the different treatment options to repair hernias and recommendations for
patients that are considering surgery for their hernias. The FDA wants to help patients make informed decisions about
their health care and to facilitate a discussion between patients and their surgeons.

What is a Hernia?

A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding
muscle or connective tissue. Hernias often occur at the abdominal wall. Sometimes a hernia can be visible as an
external bulge particularly when straining or bearing down.

Types of Hernias

The most common types of hernias are:

 Inguinal: occurs in the inner groin
 Femoral: occurs in the upper thigh/outer groin
 Incisional: occurs through an incision or scar in the abdomen
 Ventral: occurs in the general abdominal/ventral wall
 Umbilical: occurs at the belly button
 Hiatal: occurs inside the abdomen, along the upper stomach/diaphragm

Causes of Hernias

Most hernias are caused by a combination of pressure and an opening or weakness of muscle or connective tissue.
The pressure pushes an organ or tissue through the opening or weak spot. Sometimes the muscle weakness is
present at birth but more often it occurs later in life. Anything that causes an increase in abdominal pressure can
cause a hernia, including obesity, lifting heavy objects, diarrhea or constipation, or persistent coughing or sneezing.
Poor nutrition, smoking, and overexertion can weaken muscles and contribute to the likelihood of a hernia.
Treatment Options for Hernias

Hernia repairs are common—more than one million hernia repairs are performed each year in the U.S. Approximately
800,000 are to repair inguinal hernias and the rest are for other types of hernias. 1
 Non-Surgical
o Watchful Waiting - Your surgeon will watch the hernia and make sure that it is not getting larger or causing
problems. Although surgery is the only treatment that can repair hernias, many surgical procedures are elective
for adult inguinal hernias. Watchful waiting is an option for people who do not have complications or symptoms
with their hernias, and if recommended by their surgeon.
 Surgical
o Laparoscopic - The surgeon makes several small incisions in the abdomen that allow surgical tools into the
openings to repair the hernia. Laparoscopic surgery can be performed with or without surgical mesh.
o Open Repair - The surgeon makes an incision near the hernia and the weak muscle area is repaired. Open
repair can be done with or without surgical mesh. Open repair that uses sutures without mesh is referred to as
primary closure. Primary closure is used to repair inguinal hernias in infants, small hernias, strangulated or
infected hernias.

Hernias have a high rate of recurrence, and surgeons often use surgical mesh to strengthen the hernia repair and
reduce the rate of recurrence. Since the 1980s, there has been an increase in mesh-based hernia repairs—by 2000,
non-mesh repairs represented less than 10% of groin hernia repair techniques.

The use of surgical mesh may also improve patient outcomes through decreased operative time and minimized
recovery time. However, recovery time depends on the type of hernia, the surgical approach, and the patient’s
condition both before and after surgery.

Information found in medical literature has consistently demonstrated a reduced hernia recurrence rate when surgical
mesh is used to repair the hernia compared to hernia repair without surgical mesh. For example, inguinal hernia
recurrence is higher with open repair using sutures (primary closure) than with mesh repair2.

Despite reduced rates of recurrence, there are situations where the use of surgical mesh for hernia repair may not be
recommended. Patients should talk to their surgeons about their specific circumstances and their best options and
alternatives for hernia repair.

Surgical Mesh

Surgical mesh is a medical device that is used to provide additional support to weakened or damaged tissue. The
majority of surgical mesh devices currently available for use are constructed from synthetic materials or animal tissue.

Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic
materials used can be absorbable, non-absorbable or a combination of absorbable and non-absorbable materials.

Animal-derived mesh are made of animal tissue, such as intestine or skin, that has been processed and disinfected to
be suitable for use as an implanted device. These animal-derived mesh are absorbable. The majority of tissue used to
produce these mesh implants are from a pig (porcine) or cow (bovine) source.

Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide
permanent reinforcement to the repaired hernia. Absorbable mesh will degrade and lose strength over time. It is not
intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue growth is intended
to provide strength to the repair.

Hernia Repair Surgery Complications

Based on FDA’s analysis of medical device adverse event reports and of peer-reviewed, scientific literature, the most
common adverse events for all surgical repair of hernias—with or without mesh—are pain, infection, hernia
recurrence, scar-like tissue that sticks tissues together (adhesion), blockage of the large or small intestine
(obstruction), bleeding, abnormal connection between organs, vessels, or intestines (fistula), fluid build-up at the
surgical site (seroma), and a hole in neighboring tissues or organs (perforation).

The most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion,
and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are
mesh migration and mesh shrinkage (contraction).

Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been
associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion,
obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis
of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and
obstruction complications.

Please refer to the recall notices here for more information if you have recalled mesh. For more information on the
recalled products, please visit the FDA Medical Device Recall website. Please visit the Medical & Radiation Emitting
Device Database to search a specific type of surgical mesh.

If you are unsure about the specific mesh manufacturer and brand used in your surgery and have questions about
your hernia repair, contact your surgeon or the facility where your surgery was performed to obtain the information
from your medical record.

Metal-on-Metal Hip Implants

Hip joint deterioration can lead to pain, stiffness or difficulty walking. When these symptoms do not respond to
conservative treatment, such as physical therapy, patients may be advised to undergo total hip replacement or hip
resurfacing. As part of this treatment, they may receive a “metal-on-metal” hip implant in which the “ball and socket” of
the device are both made from metal. This webpage provides information on: hip implants, how metal-on-metal
implants differ from other hip implants and recommendations for patients and health care providers about the benefits
and risks of these products. The information provided on this webpage is not meant to replace a discussion with your
health care provider.

During the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting, the FDA reviewed available
data and discussed the safety risks and effectiveness of metal-on-metal hip implants with patients, physicians,
researchers, international regulatory agencies, professional societies, and manufacturers. Issues discussed included:

 Failure rates and modes;

 Metal ion testing;
 Imaging methods;
 Local and systemic complications;
 Patient risk factors; and
 Considerations for follow-up after surgery.

The FDA considered the input provided by the Panel members and is now providing updated safety information to
patients and health care providers. The FDA will continue to gather and review available data on currently marketed
metal-on-metal hip implants and will provide updates as necessary to patients and health care providers.

Phakic Intraocular Lenses

Phakic intraocular lenses are new devices used to correct nearsightedness. These thin lenses are implanted
permanently into the eye to help reduce the need for glasses or contact lenses.

This web site is meant to help you learn more about phakic lenses. It only provides general information and is not
meant to replace a discussion with your doctor, because every patient is unique and every doctor practices medicine
slightly differently.

Urogynecologic Surgical Mesh Implants

Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged
tissue. The majority of surgical mesh devices currently available for use are made from man-made (synthetic)
materials or animal tissue.

Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic
materials used can be either absorbable, non-absorbable, or a combination of absorbable and non-absorbable
materials.

Animal-derived mesh are made of animal tissue, such as intestine or skin, that have been processed and disinfected
to be suitable for use as an implanted device. These animal-derived mesh are absorbable. The majority of tissue used
to produce these mesh implants are from a pig (porcine) or cow (bovine).

Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide
permanent reinforcement in strength to the urogynecologic repair. Absorbable mesh will degrade and lose strength
over time. It is not intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue
growth is intended to provide strength to the repair.
Surgical mesh can be used for urogynecologic procedures, including repair of pelvic organ prolapse (POP) and stress
urinary incontinence (SUI). It is permanently implanted to reinforce the weakened vaginal wall for POP repair or
support the urethra or bladder neck for the repair of SUI. There are three main surgical procedures performed to treat
pelvic floor disorders with surgical mesh:

 Transvaginal mesh to treat POP

 Transabdominal mesh to treat POP
 Mesh sling to treat SUI

Each of these procedures has unique risks and benefits and it is important not to confuse the procedures and the risks
and benefits.

In this website, the FDA describes POP and SUI, the different surgical and non-surgical treatment options,
recommendations for health care providers that treat women with POP and/or SUI, recommendations for patients who
are considering surgery for these conditions and steps to report problems to the FDA. This information is to help
patients make informed decisions about their health care and to facilitate a discussion between patients and their
health care providers about treatment options. The information provided on this website is not meant to replace a
discussion with your health care provider.

In Vitro Diagnostics
In vitro diagnostics are tests done on samples such as blood or tissue that have been taken from the human body. In
vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person’s overall health to help
cure, treat, or prevent diseases.

In vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific
treatments or therapies. These in vitro diagnostics can include next generation sequencing tests, which scan a
person’s DNA to detect genomic variations.

Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at
home.

Companion Diagnostics
A companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for
the safe and effective use of a corresponding drug or biological product. The test helps a health care professional
determine whether a particular therapeutic product’s benefits to patients will outweigh any potential serious side
effects or risks.

Companion diagnostics can:

 identify patients who are most likely to benefit from a particular therapeutic product;
 identify patients likely to be at increased risk for serious side effects as a result of treatment with a particular
therapeutic product; or
 monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to
achieve improved safety or effectiveness.

If the diagnostic test is inaccurate, then the treatment decision based on that test may not be optimal.

On July 31, 2014 the FDA issued "Guidance for Industry: In Vitro Companion Diagnostic Devices," to help companies
identify the need for companion diagnostics at an earlier stage in the drug development process and to plan for co-
development of the drug and companion diagnostic test. The ultimate goal of the guidance is to stimulate early
collaborations that will result in faster access to promising new treatments for patients living with serious and life-
threatening diseases.

On July 15, 2016, FDA released the draft guidance, "Principles for Codevelopment of an In Vitro Companion
Diagnostic Device with a Therapeutic Product." This guidance document is intended to be a practical guide to assist
therapeutic product sponsors and IVD sponsors in developing a therapeutic product and an accompanying IVD
companion diagnostic. A 90-day public comment period will last until October 13, 2016. Electronic comments should
be submitted through www.regulations.gov. Written comments may be submitted to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify
comments with Docket No. FDA-2016-D-1703.

Nucleic Acid Based Tests

This is a list of nucleic acid-based tests that have been cleared or approved by the Center for Devices and
Radiological Health. These tests analyze variations in the sequence, structure, or expression of deoxyribonucleic acid
(DNA) and ribonucleic acid (RNA) in order to diagnose disease or medical conditions, infection with an identifiable
pathogen, or determine genetic carrier status.

This list includes nucleic acid-based companion diagnostic tests. A full list of FDA cleared or approved companion
diagnostic devices is maintained on a separate page at In Vitro Companion Diagnostic Devices.

Precision Medicine
Most medical treatments are designed for the "average patient" as a one-size-fits-all-approach, which may be
successful for some patients but not for others. Precision medicine, sometimes known as "personalized medicine" is
an innovative approach to tailoring disease prevention and treatment that takes into account differences in people's
genes, environments, and lifestyles. The goal of precision medicine is to target the right treatments to the right
patients at the right time.

Advances in precision medicine have already led to powerful new discoveries and FDA-approved treatments that are
tailored to specific characteristics of individuals, such as a person's genetic makeup, or the genetic profile of an
individual's tumor. Patients with a variety of cancers routinely undergo molecular testing as part of patient care,
enabling physicians to select treatments that improve chances of survival and reduce exposure to adverse effects.

Next Generation Sequencing (NGS) Tests

Precision care will only be as good as the tests that guide diagnosis and treatment. Next Generation Sequencing
(NGS) tests are capable of rapidly identifying or 'sequencing' large sections of a person's genome and are important
advances in the clinical applications of precision medicine.
Patients, physicians and researchers can use these tests to find genetic variants that help them diagnose, treat, and
understand more about human disease.

The FDA's Role in Advancing Precision Medicine

The FDA is working to ensure the accuracy of NGS tests, so that patients and clinicians can receive accurate and
clinically meaningful test results.

The vast amount of information generated through NGS poses novel regulatory issues for the FDA. While current
regulatory approaches are appropriate for conventional diagnostics that detect a single disease or condition (such as
blood glucose or cholesterol levels), these new sequencing techniques contain the equivalent of millions of tests in
one. Because of this, the FDA has worked with stakeholders in industry, laboratories, academia, and patient and
professional societies to develop a flexible regulatory approach to accommodate this rapidly evolving technology that
leverages consensus standards, crowd-sourced data, and state-of-the-art open-source computing technology to
support NGS test development. This approach will enable innovation in testing and research, and will speed access to
accurate, reliable genetic tests.

Streamlining FDA's Regulatory Oversight of NGS Tests

In April 2018, the FDA issued two final guidances that recommend approaches to streamline the submission and
review of data supporting the clinical and analytical validity of NGS-based tests. These recommendations are intended
to provide an efficient and flexible regulatory oversight approach: as technology advances, standards can rapidly
evolve and be used to set appropriate metrics for fast growing fields such as NGS. Similarly, as clinical evidence
improves, new assertions could be supported. This adaptive approach would ultimately foster innovation among test
developers and improve patients' access to these new technologies.

Clinical Databases Guidance

The final guidance "Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and
Genomic-Based In Vitro Diagnostics" allows developers to use data from FDA-recognized public databases of genetic
variants to help support a test's clinical validity and outlines how database administrators can seek recognition for their
databases if they meet certain quality recommendations. This approach incentivizes data sharing and provides a more
efficient path to market.

More information about database recognition is available on the FDA’s Recognition of Public Human Genetic Variants
Databases webpage.

Analytical Validation Guidance

The final guidance "Considerations for Design, Development, and Analytical Validation of Next Generation
Sequencing (NGS) – Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline
Diseases" offers recommendations for designing, developing and validating NGS tests. The guidance also
encourages community engagement in developing NGS-related standards by standards developing organizations
(SDOs) since standards can more rapidly evolve with changes in technology and knowledge and can therefore be
used to set appropriate metrics such as specific performance thresholds for fast growing fields such as NGS.

FDA's Bioinformatics Platform

The FDA created precisionFDA, a cloud-based community research and development portal that engages users
across the world to share data and tools to test, pilot, and validate existing and new bioinformatics approaches to NGS
processing. Individuals and organizations in the genomics community can find more information and sign up to
participate at http://precision.fda.gov.

Neurological Devices
Neurological devices can help diagnose, prevent, and treat a variety of neurological disorders and conditions such as
Alzheimer’s disease, Parkinson’s disease, major depression, epilepsy, spinal cord injury, and traumatic brain injury.
Neurological devices can be used to help restore hearing and sight and provide increased function for those with limb
loss or congenital limb differences. Examples of neurological devices include neurodiagnostics, neurointerventional,
and neurostimulation devices.

The FDA’s Center for Devices and Radiological Health works with manufacturers and developers to support
innovation and bring patients in the US access to safe and effective medical devices first in the world.

It also conducts regulatory research regulatory research to support the development of medical devices and monitors
the safety of devices on the market. The FDA is working to enhance the transparency and predictability of the
regulatory process for developers and innovators of neurological medical devices.

This webpage is intended to assist neurological device developers, sponsors and innovators with navigating the
regulatory process. It provides insight into the premarket review process and the scientific, clinical and regulatory
considerations to bringing new neurological devices to market.

For additional information, including a complete overview of the FDA’s regulatory process, visit:

 Device Advice: Comprehensive Regulatory Assistance

 CDRHLearn

Obesity Treatment Devices

Overview

Obesity is a major public health concern in the United States and has been linked to many health problems such as
heart disease, stroke, diabetes, high blood pressure, sleep disorders, and breathing problems. Obesity (an excessive
amount of body fat) is defined by body mass index (BMI), which is calculated from a person's weight and height. A
BMI of 30 kg/m² or more is considered obese.

Obesity Treatment Devices

Treatments for obesity range from healthy eating and exercise, to prescription medicine and surgery. FDA-regulated
medical devices also help treat obesity. Currently, there are four types of FDA-approved devices on the market
designed to treat obesity:
 Gastric Band - bands are placed around the top portion of the stomach leaving only a small portion available for
food.
o Lap-Band Adjustable Gastric Banding System [ARCHIVED]
 Electrical Stimulation Systems - electrical stimulator is placed in the abdomen to block nerve activity between the
brain and stomach.
o Maestro Rechargeable System
 Gastric Balloon Systems - inflatable balloons are placed in the stomach to take up space.
o ReShape Integrated Dual Balloon System (Reshape Dual Balloon)
o ORBERA Intragastric Balloon System
o Obalon Balloon System
 Gastric Emptying Systems - a tube is inserted between the stomach and outside of abdomen to drain food after
eating.
o AspireAssist
Factors to Consider Before Beginning Obesity Treatment

Prior to prescribing medicine or recommending surgery, doctors will probably want their patients to demonstrate
healthy lifestyles that include better nutrition and increased physical activity. Even after medical or surgical treatments,
patients will need to maintain a healthy lifestyle for the rest of their lives. And some patients, despite treatments and
lifestyle changes, may not be able to lose weight or maintain weight loss.

Patients should be evaluated and treated for eating disorders before considering obesity treatment. An undiagnosed
and untreated eating disorder can have serious health consequences for patients, and in fact, some devices are
contraindicated for patients that have a history of eating disorders. Medical professionals may also find it appropriate
to closely monitor patients that have received obesity devices during treatment for evidence of an eating disorder.

Common eating disorders include binge-eating disorder and bulimia nervosa. According to the National Eating
Disorders Association, some 30 million people in the U.S. suffer from a clinically significant eating disorder at some
time in their life.

Surgery Devices
Laparoscopic Power Morcellators
Laparoscopic power morcellators are Class II medical devices used during laparoscopic (minimally invasive) surgeries
to cut tissue into smaller pieces so the tissue can be removed through a small incision site (typically 2 cm long or
less).

These devices are commonly used in gallbladder, kidney, liver, and spleen removal surgery. They are also used in
hysterectomy (surgical procedure to remove a women’s uterus) and myomectomy (surgical procedure to
remove uterine fibroids which are noncancerous growths in the lining of a women’s uterus).

Laparoscopic surgeries are associated with shorter post-operative recovery time and a reduced risk of infection
compared to hysterectomy or myomectomy done through an abdominal incision.

What Women and their Health Care Providers Need to Know about Using Laparoscopic Power Morcellators to
Treat Uterine Fibroids

Uterine sarcoma (a type of cancer) is more common in women undergoing surgery for uterine fibroids(noncancerous
growths in the lining of a women’s uterus) than previously thought, and it can be hard to distinguish between a uterine
sarcoma and a uterine fibroid prior to surgery with available tests. When laparoscopic power morcellators are used for
myomectomy or hysterectomy in women with presumed uterine fibroids that are actually uterine sarcomas, the
surgical procedure poses a risk of spreading cancerous tissue beyond the uterus, worsening their chances of long-
term survival without cancer.

The FDA currently estimates that a hidden uterine sarcoma may be present in approximately 1 in 225 to 1 in 580
women undergoing surgery for uterine fibroids based on recent publications. The FDA also estimates that a
leiomyosarcoma (a specific type of uterine sarcoma) may be present in approximately 1 in 495 to 1 in 1100 women
undergoing surgery for uterine fibroids based on recent studies. Prior to 2014, the clinical community estimated
uterine sarcomas to be present much less frequently, in as few as 1 in 10,000 women undergoing surgery for uterine
fibroids.

Several studies show that using a laparoscopic power morcellator during gynecologic surgery in women with hidden
uterine sarcomas is associated with lowering their chances of long-term survival without cancer. While these studies
have limitations, women who have had fibroid surgery with a laparoscopic power morcellator later found to have a
hidden uterine sarcoma, have lower disease-free survival (less time without any sign or symptom of cancer after
surgery), when compared to women who were treated with manual morcellation or without morcellation.

Uterine sarcomas and uterine fibroids have similar signs and symptoms. There are no imaging tests proven
completely accurate or reliable laboratory markers to distinguish between uterine sarcomas and uterine fibroids. Pre-
procedure or pre-operative tests, including endometrial biopsies (tissue sampling), cannot reliably predict the
presence of a hidden uterine sarcoma.

The FDA recommends health care providers share this information with patients, and warns against using
laparoscopic power morcellators in gynecologic surgeries to treat patients with suspected or confirmed cancer, and in
the majority of women undergoing myomectomy or hysterectomy for uterine fibroids.

Health care providers and informed patients can work together to choose the best treatment approach based
on known risk factors for uterine sarcoma (e.g., age, exposure to pelvic radiation therapy, prior use of the drug
Tamoxifin, and race). For some patients, the benefits of minimally invasive surgery with a laparoscopic power
morcellator may outweigh the risks. These patients may include some younger women who wish to maintain their
fertility.
Considerations for Manufacturers of Laparoscopic Power Morcellators

The FDA recommends that manufacturers of laparoscopic power morcellators with a general indication or a specific
gynecologic indication include more information in their device’s labeling to inform health care providers and patients
about the risk of cancer spread when these devices are used to treat uterine fibroids.

Manufacturers have added the information below to the labeling on their devices:

 Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated
is known or suspected to contain malignancy;
 Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in
patients who are peri- or post-menopausal, or candidates for en bloc tissue removal, for example, through the
vagina or via a mini-laparotomy incision; and,
 A specific boxed warning that states that uterine tissue may contain unsuspected cancer. The use of laparoscopic
power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This
information should be shared with patients when considering surgery with the use of these devices.

Using Real-World Data to Compare Treatments for Uterine Fibroids on Patient Outcomes

The FDA is collaborating with Duke Clinical Research Institute, patients and patient advocacy groups, health care
providers, professional associations, and other federal agencies on the COMPARE-UF registry to gather real-world
data from women having any treatment for uterine fibroids. Real-world data are data relating to patient health status
and/or the delivery of health care routinely collected from a variety of sources.

The registry will collect information about clinical outcomes, quality of life, need for additional procedures, and issues
related to pregnancy for women aged 18-54 through three years post-fibroid treatment.

The FDA believes that this information will be used to help future patients, clinicians, and others make the most
informed decisions about the best type of treatment for each patient's situation.

To learn more about this registry, or learn how to participate, see the “Participate” section of the COMPARE-UF
registry website .

Making Surgeries with Laparoscopic Power Morcellators Safer through Containment Systems

In 2016, the FDA allowed the first tissue containment system on the market for use with certain laparoscopic power
morcellators to isolate uterine tissue not suspected to contain cancer. This containment system is a first step in FDA-
regulated device innovations to help mitigate potential risks of tissue spread.

The containment system has not been proven to reduce the risk of spreading cancer during these procedures, and is
intended to be used only in a limited patient population, including women without uterine fibroids undergoing
hysterectomy and some pre-menopausal women with fibroids who want to maintain their fertility.

Reporting Problems Related to Laparoscopic Power Morcellators to the FDA

The FDA calls for patients, health care providers, and manufacturers to continue to report events associated with
laparoscopic morcellators to the Agency; such information is critical in helping us learn as much as possible about the
adverse events associated with these devices.

If you suspect a problem resulting from the use of a laparoscopic power morcellator, we encourage you to file a
voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirementsshould
follow the reporting procedures established by their facilities.

Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

LASIK

LASIK is a surgical procedure intended to reduce a person's dependency on glasses or contact lenses. The goal of
this Web site is to provide objective information to the public about LASIK surgery. See other sections of this site to
learn about what you should know before surgery, what will happen during the surgery, and what you should
expect after surgery. There is a glossary of terms and a checklistof issues for you to consider, practices to follow, and
questions to ask your doctor before undergoing LASIK surgery. This web site also provides information on FDA’s
role in LASIK surgery, FDA’s current LASIK activities, and FDA-approved lasers for LASIK.
LASIK stands for Laser-Assisted In Situ Keratomileusis and is a procedure that permanently changes the shape of the
cornea, the clear covering of the front of the eye, using an excimer laser. A mechanical microkeratome (a blade
device) or a laser keratome (a laser device) is used to cut a flap in the cornea. A hinge is left at one end of this flap.
The flap is folded back revealing the stroma, the middle section of the cornea. Pulses from a computer-controlled laser
vaporize a portion of the stroma and the flap is replaced. There are other techniques and many new terms related to
LASIK that you may hear about.

Below is a video that summarizes some risks of LASIK surgery and other important information. The video includes
images of common visual problems that a LASIK patient may see. Please be sure to visit the other sections of this
web site to get more information.

Radiation-Emitting Products and Procedures

List of Regulated Products & Procedures

 Cabinet X-Ray Systems (Closed X-Ray Systems)

 Information on Cell Phones

 Compact Fluorescent Lamps (CFLs) – Fact Sheet/FAQ

 What is Computed Tomography?

 Dental Cone-beam Computed Tomography

 Fluoroscopy

 Laser Light Shows

 Laser Products and Instruments

 Mammography

 Medical Lasers

 Ultraviolet Phototherapy Equipment - Medical Ultraviolet Lamps and Products

 Medical X-ray Imaging

 Mercury Vapor Lamps (Mercury Vapor Light Bulbs)

 Microwave Ovens

 MRI (Magnetic Resonance Imaging)

 Radiofrequency and Microwave Products Other than Microwave Ovens

 Radiography

 Security Systems

 Sunlamps and Sunlamp Products (Tanning Beds/Booths)

 Televisions and Video Display Monitors

 Ultrasound Imaging

 Ultrasound Products Other than Diagnostic or Therapy

 Ultrasonic Therapy Product or Ultrasonic Diathermy

 X-Ray & Particulate Products other than Medical Diagnostic or Cabinet

Medical Imaging
Medical imaging refers to several different technologies that are used to view the human body in order to diagnose,
monitor, or treat medical conditions. Each type of technology gives different information about the area of the body
being studied or treated, related to possible disease, injury, or the effectiveness of medical treatment.
 Additional Information
 Ultrasound Imaging

 MRI (Magnetic Resonance Imaging)

 Pediatric X-ray Imaging

 Medical X-ray Imaging

Additional Information on Medical X-Rays
 Radiography

 Computed Tomography (CT)

 Dental Cone-beam Computed Tomography

 Fluoroscopy

 Mammography

Surgical and Therapeutic Products

 Medical Lasers
 Medical Ultraviolet Lamps and Products
 Radiofrequency and Microwave Products Other than Microwave Ovens (including Microwave Diathermy and
Microwave Blood Warmers)
 Ultrasound Therapy
 Ultrasound Products Other than Diagnostic or Therapy
Home, Business, and Entertainment Products
 Cabinet X-Ray Products
 Cell Phones
 Compact Fluorescent Lamps
 Laser Light Shows
 Laser Products and Instruments (including Pointers, Light Shows and Displays, CD Players, CD-ROMs, DVDs,
and Printers)
 Mercury Vapor Lamps
 Microwave Ovens
 Radiofrequency and Microwave Products Other than Microwave Ovens (including Microwave Diathermy and
Microwave Blood Warmers)
 Sunlamps and Sunlamp Products (Tanning Beds/Booths)
 Televisions and Video Display Monitors
 Ultrasound
o Ultrasound Products Other than Diagnostic or Therapy
o Ultrasonic Therapy Product or Ultrasonic Diathermy
o Ultrasound Imaging
 X-Ray & Particulate Products other than Medical Diagnostic or Cabinet

Security Systems
Security Systems that Emit Radiation
Security systems are products used to prevent harm, crime, or loss. Many security systems emit radiation to
accomplish their primary purpose. For example some security systems emit ultrasound to detect intrusion into a
secure area and others emit x-rays to produce an image used for non-intrusive inspection of containers to detect
concealed threats or contraband.

The manufacturers of electronic products that emit radiation used for security are subject to FDA regulation. The
applicable regulations depend on the type of radiation emitted and the intended recipient of that radiation.
 Non-Intrusive Inspection
 Cabinet X-Ray Systems (Closed X-Ray Systems)

 X-Ray & Particulate Products other than Medical Diagnostic or Cabinet

 Products for Security Screening of People

Intrusion Detection
 Laser Products and Instruments

 Ultrasound Products Other than Diagnostic or Therapy

 Radiofrequency and Microwave Products Other than Microwave Ovens

Tanning
This site is intended to provide a source of general information on skin tanning, ultraviolet (UV) exposure, UV emitting
products, and skin protection.

While this site provides general information on UV safety, it is not intended to provide medical advice. If you have
questions about your health, the best source of information is your doctor.

The FDA wants consumers to know that UV radiation in tanning devices poses serious health risks. A recent report by
the International Agency for Research on Cancer (IARC), part of the World Health Organization, concludes that
tanning devices are more dangerous than previously thought. Exposure to UV radiation, whether from the sun or
indoor tanning beds, can cause:

 Skin cancer
 Skin burns
 Premature skin aging
 Eye damage (both short- and long-term)

Given these risks, the FDA in 2014 required that labeling be included on sunlamp products stating that the products
should not be used by anyone younger than 18, and will require specific warnings be included in certain promotional
materials for sunlamp products and UV lamps. The new labeling requirements were part of the final order classifying
sunlamp products into class II, subject to premarket review.

Because people under age 18 are particularly at risk, the FDA is now proposing to restrict the sunlamp products to
people age 18 years old and older, and require that they sign a risk acknowledgement certification before use, and
then every 6 months, that states that they have been informed of the risks to health that may result from use of
sunlamp products.