In order to understand medical devices, it is important to understand what a medical device is and how the FDA classifies medical devices.

What is a Medical Device?

A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is:

• recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them
• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

How are Medical Devices Classified?

The FDA regulates a wide range of medical devices, including, pacemakers, cardiovascular stents, respiratory ventilators, breast implants, diagnostic tests (pregnancy tests, blood glucose tests, etc.) and relatively simple devices such as tongue depressors, patient scales, and elastic bandages.

Medical devices are classified based on the risks associated with the use of the device. Devices are classified as Class I, Class II, or Class III, with Class I being the lowest risk and Class III the highest risk.

• Class I – These are devices that present minimal potential for harm to the user. Examples include enema kits and elastic bandages. 35% of medical device types are Class I and and 93% of these are exempt from pre-market review.
• Class II –These are devices that generally present a moderate risk of harm to the user. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 53% of device types are Class II, most of which require FDA review through premarket notification (510(k)).
• Class III – These are devices that sustain or support life, are implanted, or present potential high risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 9% of device types are Class III and require FDA review through premarket approval (PMA) or humanitarian device exemption (HDE).
• Unclassified/Not classified – These are device types that FDA has not yet classified. 3% of device types are unclassified/not classified..

Some devices may be considered “exempt”. If a device is considered “exempt”, the manufacturer would not be required to submit a premarket notification submission [510 (k) submission] and obtain FDA clearance before marketing the device in the U.S. Examples of exempt devices include Class I devices and some Class II devices such as manual stethoscopes, mercury thermometers, AC-powered adjustable hospital beds, powered heating pads, and bedpans. However, the manufacturer is required to register their establishment and list their devices with the FDA.

How are Medical Devices Regulated in the United States?

There are various processes that FDA use to review information about medical devices before they are allowed to be marketed in the United States:

• Premarket Notification [510(k)] – submission required to demonstrate that the device is substantially equivalent to a device already placed into one of the three device classifications before it is marketed.
• Premarket Approval (PMA) – application required to demonstrate that the device is safe and effective when used. It is the most stringent type of device marketing application and is required for Class III devices.
• Humanitarian Device Exemption (HDE) – a marketing application for a Humanitarian Use Device (HUD). An HUD is a medical device that is intended to benefit patients in the treatment or diagnosis of a disease or condition that affects, or is manifested in not more than 8,000 individuals in the United States per year.

What is the difference between Cleared and Approved?

In order for medical devices to be legally marketed (sold) in the United States, they are required to be cleared or approved by the FDA unless it is 510(k) exempt.

Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to (similar) another legally marketed device. A premarket notification submission is referred to as a 510(k) and must be submitted to FDA to review and provide clearance.

Approved medical devices: Approved medical devices are those devices that the FDA has approved a premarket approval (PMA) application or a Humanitarian Device Exemption (HDE) application. This review and approval process is for Class III medical devices (the ones with the highest risk) and involves a more rigorous review than the 510(k) review process.

A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They range from small and simple, like a blood glucose meter, to large and complicated, like a ventilator. You might use one at home or at work, or you may need one in a hospital.

To use medical devices safely

• Know how your device works. Keep instructions close by
• Understand and properly respond to device alarms
• Have a back-up plan and supplies in the event of an emergency
• Keep emergency numbers available and update them as needed
• Educate your family and caregivers about your device

Patients and consumers are using medical devices more often at home—not just in health care facilities. Many medical devices are now portable, and this feature enables patients to live active lives outside of the confines of the hospital room or treatment center.

"(Home use) devices once were designed only to keep you alive. Now they're designed to keep you as independent as possible," according to Mary Brady, MSN, RN, a senior policy analyst at FDA's Center for Devices and Radiological Health (CDRH).

However, the Food and Drug Administration (FDA) has long been concerned that consumers may sometimes be literally left to their own devices—depending upon medical devices they might not know how to operate and for which they might not understand the safety risks.

There have been serious, and even fatal, problems reported to FDA associated with medical devices used at home. For example, a woman with kidney failure got cat hair in her dialysis tubing, resulting in peritonitis, a life-threatening abdominal infection. And a child died when his mother didn't hear an alarm on his ventilator signaling that the tubing had become disconnected.

FDA is working on ways to help consumers safely operate and maintain home use devices, which include blood glucose monitors, infusion pumps (a device that delivers fluids, including nutrients and medications, into a patient's body) and respirators. These efforts include issuing a draft guidance document for manufacturers on the design and testing of devices intended for home use, and the development of clearer instructions for use.

Understanding the Instructions

Using a medical device at home is not as simple as it might sound. Brady explains that the device might not come with the written instructions that inform a home user how to operate it safely and how to know if it's not working properly. Even if the device comes with instructions, the language used in the instructions might be too technical.

"If you can't understand the directions," said Brady, "it's hard to be independent."

While more medical devices are being specifically designed for home use, some devices used at home weren't originally designed for use by the average person. "Devices are often designed for the health care professional to use in a clinical setting such as a medical office or a hospital," says Brady.

Also, home use devices designed to be used in medical facilities—not homes—might be adversely affected by things found in a home environment, such as pet hair, well water or temperature variations.

Other challenges include the user's and the caregiver's physical and emotional health. People taking medications that affect their alertness or memory might have trouble using or taking care of their devices. Similarly, the emotional impact of caring for a loved one might influence the caregiver's ability to use complex, high-maintenance devices.

Usability is a critical factor in the design of medical devices. It refers to the extent to which people can use their medical device safely and effectively to accomplish specific tasks. The ECRI Institute (formerly the Emergency Care Research Institute), an organization that evaluates medical products and processes, has found that poor usability is among the top 10 health technology hazards of 2012.

Examples include users having difficulty with the start/stop button on an infusion pump or the inability to hear different types of alarms in other rooms in a house.

Working on Providing Resources

In April 2010, the FDA launched the Medical Devices Home Use Initiative. The agency has been working since then to develop information and resources for manufacturers, health care professionals, patients (home care recipients), consumers and caregivers. These efforts include:

• Issuing a draft guidance document for manufacturers that describes factors to consider when designing, testing, and developing home use devices, focusing on the realities of how people use their devices at home. FDA is asking device makers to consider factors such as the user's likely physical condition, emotional issues like anxiety, necessary training, and the home environment that might have children and pets. This document also addresses the development of user-friendly instructions, including how to handle the device in an emergency.
• Designing Visual Learning Guides, using mostly pictures. The first two guides will be produced over the next two years, and will focus on containers for the disposal of sharps, (needles, syringes, and lancets) and patient lifts (used to move disabled or injured people).
• Exploring the feasibility of making device labeling available on the Internet.

The agency has also created a list of recommended practices regarding the use of patient lifts. These devices are increasingly used in the home to transfer patients from one place to another, such as from bed to bath. These recommendations are designed to reduce risks associated with the use of these devices, such as falls.

Tips for Consumers

• Know how your device works; keep instructions close by.
• Understand and properly respond to device alarms.
• Have a back-up plan and supplies in the event of an emergency.
• Keep emergency numbers available and update them as needed.
• Educate your family and caregivers about your device.
• Frequently ask your doctor and home health care team to review your condition and recommend any changes related to your equipment.
• Report serious events to the device supplier and to FDA's MedWatch.

For more advice to consumers, see Home Healthcare Medical Devices: A Checklist and Additional Resources on Home Use Devices.

December 12, 2012

Pacemakers, insulin pumps and other medical devices are becoming more advanced. Most contain software and connect to the internet, hospital networks, your mobile phone, or other devices to share information. So, it is important to make sure medical devices are cyber secure.

New technologies are being applied to all different types of devices—those that are implantable or wearable, or used at home or in health care settings. The advances can offer care that is safer, timelier and more convenient. For example, patients with an implanted heart device can be monitored remotely and possibly spared a visit to the doctor’s office. People with diabetes have new options for managing their blood-sugar levels because some glucose meters and insulin pumps can essentially talk to each other. And hospitals aiming to improve care and efficiency are using more pieces of equipment that are networked together to share data.

Anytime a medical device has software and relies on a wireless or wired connection, vigilance is required. The software behind these products, like all technologies, can become vulnerable to cyber threats, especially if the device is older and was not built with cybersecurity in mind.

FDA’s Role in Keeping Medical Devices Cyber Secure

The U.S. Food and Administration (FDA) regulates medical devices and works aggressively to reduce cybersecurity risks in what is a rapidly changing environment. It is a responsibility the Agency shares with device makers, hospitals, health care providers, patients, security researchers, and other government agencies, including the U.S. Department of Homeland Security and U.S. Department of Commerce.

The FDA provides guidance to help manufacturers design and maintain products that are cyber secure. And on behalf of patients, the FDA urges manufacturers to monitor and assess cybersecurity vulnerability risks, and to be proactive about disclosing vulnerabilities and solutions to address them.

If a weakness in software that could pose a risk is identified, the FDA may issue what is called a “safety communication.” These messages contain information about the vulnerability and recommended actions patients, providers and manufacturers can take. Nine cyber safety communications have been issued since 2013. The FDA wants to make these messages as helpful as possible without causing unnecessary worry or burden on patients.

Patients Can be Active Participants in Keeping Their Devices Safe

Medical devices are intended to improve health and help people live longer, healthier lives. Patients should feel assured about the safety and security of their medical devices, knowing the FDA is being proactive and working with manufacturers throughout the entire lifecycle of a product. Patients and caregivers can also play a critical role. Consider the following tips:

• Technology evolves over time, so software will need to be updated. Recognize the value of applying those updates and talk with your health care provider if you have any questions about them.
• Register your device with the manufacturer. It is an extra step, but it may help the manufacturer reach you more quickly to send you important information.
• Be observant and vigilant. If you think your device is not functioning as it should, do not ignore it. Discuss it with your health care provider. Notify the device manufacturer and report it to the FDA's MedWatch.
• Involve your family or caregivers. Educate them about your device or enlist their help if you are not tech savvy.
• If there is a serious event, seek medical attention.

Using a technology that "takes a look" at people's insides and promises early warnings of cancer, cardiac disease, and other abnormalities, clinics and medical imaging facilities nationwide are touting a new service for health-conscious people: "Whole-body CT screening." This typically involves scanning the body from the chin to below the hips with a form of X-ray imaging that produces cross-sectional images.

The technology used is called "X-ray computed tomography" (CT), sometimes referred to as "computerized axial tomography" (CAT). A number of different types of X-ray CT systems are being promoted for various types of screening. For example, "multi-slice" CT (MSCT) and "electron beam" CT (EBCT) - also called "electron beam tomography" (EBT) - are X-ray CT systems that produce images rapidly and are often promoted for screening the buildup of calcium in arteries of the heart.

CT, MSCT and EBCT all use X-rays to produce images representing "slices" of the body - like the slices of a loaf of bread. Each image slice corresponds to a wafer-thin section which can be viewed to reveal body structures in great detail.

CT is recognized as an invaluable medical tool for the diagnosis of disease, trauma, or abnormality in patients with signs or symptoms of disease. It's also used for planning, guiding, and monitoring therapy. What's new is that CT is being marketed as a preventive or proactive health care measure to healthy individuals who have no symptoms of disease.

No Proven Benefits for Healthy People

Taking preventive action, finding unsuspected disease, uncovering problems while they are treatable, these all sound great, almost too good to be true! In fact, at this time the Food and Drug Administration (FDA) knows of no scientific evidence demonstrating that whole-body scanning of individuals without symptoms provides more benefit than harm to people being screened. The FDA is responsible for assuring the safety and effectiveness of such medical devices, and it prohibits manufacturers of CT systems to promote their use for whole-body screening of asymptomatic people. The FDA, however, does not regulate practitioners and they may choose to use a device for any use they deem appropriate.

Compared to most other diagnostic X-ray procedures, CT scans result in relatively high radiation exposure. The risks associated with such exposure are greatly outweighed by the benefits of diagnostic and therapeutic CT. However, for whole-body CT screening of asymptomatic people, the benefits are questionable:

• Can it effectively differentiate between healthy people and those who have a hidden disease?
• Do suspicious findings lead to additional invasive testing or treatments that produce additional risk with little benefit?
• Does a "normal" finding guarantee good health?

Many people don't realize that getting a whole body CT screening exam won't necessarily give them the "peace of mind" they are hoping for, or the information that would allow them to prevent a health problem. An abnormal finding, for example, may not be a serious one, and a normal finding may be inaccurate. CT scans, like other medical procedures, will miss some conditions, and "false" leads can prompt further, unnecessary testing.

Points to consider if you are thinking of having a whole-body screening:

• Whole-body CT screening has not been demonstrated to meet generally accepted criteria for an effective screening procedure.
• Medical professional societies have not endorsed whole-body CT scanning for individuals without symptoms.
• CT screening of high-risk individuals for specific diseases such as lung cancer or colon cancer is currently being studied.
• The radiation from a CT scan may be associated with a very small increase in the possibility of developing cancer later in a person's life.

FDA's Recommendation:

Before having a CT screening procedure, carefully investigate and consider the potential risks and benefits and discuss them with your physician.

Sharps is a medical term for devices with sharp points or edges that can puncture or cut skin. They may be used at home, at work, and while traveling to manage the medical conditions of people or their pets, including allergies, arthritis, cancer, diabetes, hepatitis, HIV/AIDS, infertility, migraines, multiple sclerosis, osteoporosis, blood clotting disorders, and psoriasis.

Examples of sharps include:

• Needles – hollow needles used to inject drugs (medication) under the skin
• Syringes – devices used to inject medication into or withdraw fluid from the body
• Lancets, also called “fingerstick” devices – instruments with a short, two-edged blade used to get drops of blood for testing. Lancets are commonly used in the treatment of diabetes.
• Auto Injectors, including epinephrine and insulin pens – syringes pre-filled with fluid medication designed to be self-injected into the body
• Infusion sets – tubing systems with a needle used to deliver drugs to the body.
• Connection needles/sets – needles that connect to a tube used to transfer fluids in and out of the body. This is generally used for patients on home hemodialysis.

How to Dispose of Sharps

Used sharps should be immediately placed in a sharps disposal container. FDA-cleared sharps containers are generally available through pharmacies, medical supply companies, health care providers and online. These containers are made of puncture-resistant plastic with leak-resistant sides and bottom. They also have a tight fitting, puncture-resistant lid.

If an FDA-cleared container is not available a heavy-duty plastic household container, such as a laundry detergent container can be used as an alternative.

Importance of Safe Sharps Disposal

Used needles and other sharps are dangerous to people and pets if not disposed of safely because they can injure people and spread infections that cause serious health conditions. The most common infections are:

• Hepatitis B (HBV),
• Hepatitis C (HCV), and
• Human Immunodeficiency Virus (HIV).

Safe sharps disposal is important whether you are at home, at work, at school, traveling, or in other public places such as hotels, parks, and restaurants.

Never place loose needles and other sharps (those that are not placed in a sharps disposal container) in the household or public trash cans or recycling bins, and never flush them down the toilet. This puts trash and sewage workers, janitors, housekeepers, household members, and children at risk of being harmed.

Pet owners who use needles to give medicine to their pets should follow the same sharps disposal guidelines used for humans.

What to Do If You Are Accidently Stuck By a Used Needle or Other Sharp

If you are accidently stuck by another person’s used needle or other sharp:

1. Wash the exposed area right away with water and soap or use a skin disinfectant (antiseptic) such as rubbing alcohol or hand sanitizer.
2. Seek immediate medical attention by calling your physician or local hospital.

Follow these same instructions if you get blood or other bodily fluids in your eyes, nose, mouth, or on your skin.

"Hospital beds are found in nearly all patient care settings or environments," says Joan Ferlo Todd, RN, a senior nurse-consultant at the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). "They are used not only in hospitals, but also in outpatient care centers, long-term care facilities, and in private homes."

CDRH reports that about 2.5 million hospital beds are in use in the United States. The center regulates these beds as medical devices.

"Many of today’s hospital bed models are quite complex. Patients and health care professionals should understand how to use them properly, and manufacturers must provide adequate instructions for use," says Todd, who works in CDRH’s Office of Surveillance and Biometrics.

Beware of Entrapment

"Patient entrapment is uncommon," says Todd, "but when it occurs, it’s often fatal."

Between January 1, 1985 and January 1, 2013, FDA received reports of 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 intervened to prevent an injury. Most of the affected patients were frail, elderly, or confused.

"Not all patients are at risk for entrapment, and not all hospital beds pose an entrapment risk," says Todd. "But health care facilities, as well as patient caregivers, are urged to take a careful look at hospital beds. They need to determine if there are large openings that present an entrapment risk, and to take steps to minimize this risk."

Any type of rail or grab bar attached to a bed, as well as the fit of the bed mattress, should be assessed for entrapment risks, she adds. "It is important to view the hospital bed as a system," she says. "Not all mattresses or bed rails are suitable with any given bed frame."

Guidance

FDA regulates hospital beds through post-market activities such as analyzing reports of product problems and adverse events, says Todd. “Although the agency does not regulate the design of the beds, it offers safety guidance to industry.”

FDA is a member of the Hospital Bed Safety Workgroup (HBSW), a partnership among the medical bed industry, national health care organizations, patient advocacy groups, and federal agencies.

In 2006, FDA with collaboration from HBSW issued "Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment," recommendations for manufacturers of new hospital beds and for facilities with existing beds, including hospitals, nursing homes, and private homes.

"The guidance may also be used by health care facilities," says Jay A. Rachlin, director of CDRH’s Division of Health Communication in the Office of Communication, Education, and Radiation Programs. "It offers useful information for health care facility staff."

Rachlin says the guidance, along with other educational products from FDA and the HBSW, have improved patient safety. "Manufacturers have redesigned their bed frames and their side rails to reduce the risk of entrapment."

Entrapment Zones

The guidance characterizes the head, neck, and chest as key body parts at risk of entrapment. It also identifies these seven potential "zones of entrapment" in hospital beds:

1. within the rail
2. under the rail, between the rail supports or next to a single rail support
3. between the rail and the mattress
4. between the rail, at the ends of the rail
5. between split bed rails
6. between the end of the rail and the side edge of the head or foot board
7. between the head or foot board and the mattress end

Rachlin says that proper fitting rails can be useful. However, health care professionals and patients need to assess whether rails are necessary in each instance. "In addition to entrapment, there are other potential hazards associated with bed rail use, including serious injuries from falls when patients climb over rails, and having patients feel isolated or unnecessarily restricted," he says.

Fire Prevention

Fire is a rare safety risk associated with motorized hospital beds. “Fires are due mostly to a lack of maintenance,” says Todd. “There are electrical shorts due to frayed or strained wires, motors overheat, or dust or other materials from the hospital fall into the motor casing.”

She suggests these steps to cut the risk of fire incidents:

• Inspect the bed’s power cord for damage.
• Don’t connect the bed’s power cord to an extension cord or to a multiple-outlet strip.
• Inspect the floor beneath the bed for buildup of dust and lint, which could clog the motor.
• Inspect the bed control panel covering for signs of damage where liquids could leak in.
• Check equipment for signs of overheating or physical damage.
• Keep linens and clothes away from power sources.

Home Use

Todd says there have been very few reports of safety incidents with hospital beds used in private residences. "This may represent underreporting by consumers," she says. "The reporting system for these incidents is set up for health care facilities, but consumers and home patients can still report medical device incidents to FDA through its MedWatch program."

She adds that hospital beds used at patients’ homes are usually prescribed devices. "They’re not required to be prescribed, but the beds are usually very expensive to rent or buy, and most patients get them for home through health plans."

It is important to ask that the bed meet the guidelines in the FDA guidance to reduce the risk of entrapment. Some hospital beds used at home may require patient or caregiver training, Todd says. "It depends on the complexity of the bed."

Safety Tips

CDRH offers the following safety tips for home use of hospital beds:

• Check the motors, especially for dust and debris.
• Ensure that each component—the bed frame, mattress, rails, and any added accessories—properly fits together. Make sure the mattress is the correct size for the bed frame so unsafe gaps are not present. If you see an opening let a health care professional know or call the manufacturer.
• When in doubt, consult the bed frame manufacturer to determine if a component or accessory is compatible with your bed frame.
• Use rails cautiously. Patients should not try to climb around or over the rails to get out of bed.

What is a Hospital Bed?

Todd says that there is no standard definition for hospital beds, a fact that consumers shopping for such a bed need to be aware of.

"A bed becomes a hospital bed when it meets the requirements for being a medical device," she says.

CDRH defines a medical device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease."

"There are beds sold in retail stores that don’t meet the definition of medical devices under the law, but which may have some of the characteristics of a hospital bed," says Todd. "These beds may have features such as height-adjustment mechanisms or adjustable positions for the back and knee, or be fitted with snap-on rails. But they’re not regulated by FDA."

She says that such beds fall under the jurisdiction of the U.S. Consumer Product Safety Commission. "If these beds are used with any type of rail, consumers should adhere to the same safety recommendations in place for hospital beds."