Device & Procedure-Associated Conditions

Modern healthcare employs many types of invasive devices to help patients recover. Such devices bypass patients' natural defenses against invading micro-organisms. Therefore, use of these devices has been linked to infections of the lung, bloodstream, and urinary tract. Similarly, surgical treatment may place a patient at risk of acquiring infection at the surgical site. Guidelines for preventing infections associated with devices and procedures are available.

Patient Safety

Instrument reprocessing errors and other infection control breaches in health care settings can present unique challenges for health care professionals and public health officials.

* Developing a broader approach to management of infection control breaches in health care settings
Experiences with health departments and health care facilities suggest that questions surrounding instrument reprocessing errors and other infection control breaches are becoming increasingly common. We describe an approach to management of these incidents that focuses on risk of bloodborne pathogen transmission and the role of public health and other stakeholders to inform patient notification and testing decisions. (Am J Infect Control 2008;36:685-90.)

Bloodborne Pathogens in Healthcare Settings

Healthcare personnel are at risk for occupational exposure to bloodborne pathogens, including hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Exposures occur through needlesticks or cuts from other sharp instruments contaminated with an infected patient's blood or through contact of the eye, nose, mouth, or skin with a patient's blood.

Healthcare-Associated Infections (HAIs)

Healthcare-associated infections are infections that patients acquire during the course of receiving treatment for other conditions within a healthcare setting. Healthcare-associated infections are one of the top ten leading causes of death in the United States. As the nation’s health protection agency, CDC is committed to helping all Americans receive the best and safest care when they are treated at a hospital or other healthcare facility.

Guidelines for Protecting Patients (by date)

isted here are the primary, CDC published, guidelines and recommendations for the prevention of Healthcare-Associated Infections. Guidelines for more specific topics and diseases may be found elsewhere on the CDC site by that specific topic or disease.

Guidelines for Protecting Patients (by date)

* Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
PDF (1.80 MB / 158 pages
* Guideline for Isolation Precautions 2007
* Management of Multidrug-Resistant Organism 2006 PDF (233 KB, 74 page)
* Preventing Healthcare-Associated Pneumonia, 2003
* Environmental Infection Control in Healthcare Facilities, 2003
* Hand Hygiene in Healthcare Settings, 2002
* Prevention of Intravascular Device-Related Infections, 2002
* Prevention of Surgical Site Infections, 1999
* Prevention of Catheter Associated Urinary Tract Infections, 1981

Industry (Biologics)

The Center for Biologics Evaluation and Research (CBER) has established a Manufacturers Assistance and Technical Training Branch to provide assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures. Manufacturers assistance is available in numerous areas including: clinical investigator information, adverse event reporting procedures, electronic submissions guidance and requirements, and information on how to submit an Investigational New Drug Application (IND) to administer an investigational product to humans.

Postmarketing, Compliance and Enforcemen

* Biologics Post-Market Activities
* Biologic Product Security
* Biologic Product Shortages
* Compliance Programs (CBER)
* Impact of Severe Weather Conditions on Biological Products
* Importing & Exporting (Biologics)
* Lot Distribution Database (LDD)
* Product Surveillance (CBER)
* Recalls (Biologics)
* Report a Problem to the Center for Biologics Evaluation & Research
* Safety & Availability (Biologics)
* Untitled Letters (CBER)

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Recalls & Alerts

* Recalls (Biologics)
* Biologic Product Shortages
* Report a Problem to the Center for Biologics Evaluation & Research

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Approvals & Clearances

* Biologics Products & Establishments

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More Information

* For Industry

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Contact Us

* (800) 835-4709
* (301) 827-1800
* matt@fda.hhs.gov
*

Manufacturers Assistance and Technical Training Branch (CBER)

Division of Manufacturers Assistance and Training

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-41

Rockville, MD 20852-1448

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Blood & Blood Products

The Center for Biologics Evaluation and Research (CBER) regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes standards for the products themselves. CBER also regulates related products such as cell separation devices, blood collection containers and HIV screening tests that are used to prepare blood products or to ensure the safety of the blood supply. CBER develops and enforces quality standards, inspects blood establishments and monitors reports of errors, accidents and adverse clinical events.

CBER works closely with other parts of the Public Health Service (PHS) to identify and respond to potential threats to blood safety, to develop safety and technical standards, to monitor blood supplies and to help industry promote an adequate supply of blood and blood products.

Over a period of years, FDA has progressively strengthened the overlapping safeguards that protect patients from unsuitable blood and blood products:

* Blood donors are now asked specific and very direct questions about risk factors that could indicate possible infection with a transmissible disease. This "up-front" screening eliminates approximately 90 percent of unsuitable donors.
* FDA requires blood centers to maintain lists of unsuitable donors to prevent the use of collections from them.
* Blood donations are tested for seven different infectious agents.

In addition to strengthening these safeguards, FDA has significantly increased its oversight of the blood industry:

* FDA inspects all blood facilities at least every two years, and "problem" facilities are inspected more often.
* Blood establishments are now held to quality standards comparable to those expected of pharmaceutical manufacturers.

While a blood supply with zero risk of transmitting infectious disease may not be possible, the blood supply is safer than it has ever been. As biological products, blood and blood products are likely always to carry an inherent risk of infectious agents. Therefore, zero risk may be unattainable. The role of FDA is to drive that risk to the lowest level reasonably achievable without unduly decrea

Biographical Sketch, John Kilbourne, M.D.

Title: Medical Officer
Office:
National Library of Medicine
National Institutes of Health
Bldg. 38A, Room B2E17
8600 Rockville Pike
Bethesda MD 20894 USA
Telephone:
(301) 594-2897 (voice)
(301) 402-2002 (fax)
Electronic mail:
kilbourj@mail.nih.gov


John received his M.D. degree from the University of Illinois College of Medicine. After completing his Family Medicine residency and practicing near Chicago, he joined the SNOMED division of the College of American Pathologists as a clinical editor. His role there expanded to include implementation training, and in 2005 he joined the NLM.

Biographical Sketch, Dan-Sung C. Cho

Title:
Technical Information Specialist
Office:
National Library of Medicine
National Institutes of Health
Bldg. 38A, Room B2E17
8600 Rockville Pike
Bethesda MD 20894 USA
Telephone:
(301) 301-594-2086 (voice)
(301) 402-2002 (fax)
Electronic mail:
mailto:chodan@mail.nlm.nih.gov


Dan Cho joined the Medical Subject Headings Section in July 2008. He earned his undergraduate degree in Biology from Texas A&M University and has a Ph.D. degree in Genetics from North Carolina State University.

He received postdoctoral training at the Wistar Institute where his main research interest included RNA editing enzyme and RNAi mechanisms. Prior to arriving at the Medical Subject Headings Section, he was involved in molecular etiology of Schizophrenia and Bipolar disorders and held the position of a Research Scientist at the University of Pennsylvania, School of Medicine. He also examined US patent applications on DNA technology at the US PTO.

Biographical Sketch, Stuart J. Nelson, M.D.

Title:
Head, Medical Subject Headings Section
Office:
National Library of Medicine
National Institutes of Health
Bldg. 38A, Room B2E17
8600 Rockville Pike
Bethesda MD 20894 USA
Telephone:
(301) 496-1495 (voice)
(301) 402-2002 (fax)
Electronic mail:
nelson@nlm.nih.gov


Stuart J. Nelson, MD, was born and raised in California. His undergraduate education was at the University of California at Berkeley. He took a Bachelor's degree in Mathematics in 1970, and moved to Brooklyn, New York, to attend medical school at the State University of New York.

After obtaining the MD degree, he interned at Philadelphia General Hospital on the University of Pennsylvania's medical service, and completed a residency in Internal Medicine at Metropolitan Hospital Center in New York City. He was certified by the American Board of Internal Medicine in 1978. From 1978 to 1991, he served on the faculty of the State University of New York at Stony Brook. In 1991 he moved to the Medical College of Georgia.

His research interests are in the area of computer applications to medicine, and he collaborated for several years with Dr. Marsden S. Blois, one of the founders of the field of Medical Informatics. He is a Fellow of the American College of Physicians and a Fellow of the American College of Medical Informatics.

In 1996 he came to the National Library of Medicine as the Head of the Medical Subject Headings Section. He has published extensively in the field of medical informatics, especially in the area of computerized vocabularies.

Keeping Your Health Care Professional Informed

It's important to keep your health care professional updated about your progress on PRISTIQ and informed about any changes to your health and other medications you may be taking, including prescription and over-the-counter medications.
Before taking PRISTIQ, talk to your health care professional about:
All your medical conditions, especially if you have or have had high blood pressure, heart problems, high cholesterol or high triglycerides, a history of stroke, glaucoma, kidney problems, liver problems, seizures or convulsions, mania or bipolar disorder, or low sodium levels in your blood.
– Your health care professional should check your blood pressure regularly while you are taking PRISTIQ.
Taking PRISTIQ if you are nursing, pregnant, or plan to become pregnant, as it is not known if PRISTIQ will harm your unborn baby.
All prescription and over-the-counter medications you are taking or plan to take, including:
– Medicines to treat migraines or mood disorders, to avoid a potentially life-threatening condition.
– Aspirin, NSAID pain relievers, or blood thinners because they may increase the risk of bleeding.
Keep a list of all medications you have taken or plan to take to show your health care professional.
Do not start new medications without first checking with your health care professional.
Stopping an antidepressant medicine, especially suddenly, can cause side effects called discontinuation symptoms. Your health care professional may want to decrease your dose slowly to help avoid these side effects. Therefore, do not stop taking or change the dose of PRISTIQ without first talking to your health care professional, even if you feel better. Only your health care professional can tell you how long you should use PRISTIQ.

Keeping Your Health Care Professional Informed

It's important to keep your health care professional updated about your progress on PRISTIQ and informed about any changes to your health and other medications you may be taking, including prescription and over-the-counter medications.
Before taking PRISTIQ, talk to your health care professional about:
All your medical conditions, especially if you have or have had high blood pressure, heart problems, high cholesterol or high triglycerides, a history of stroke, glaucoma, kidney problems, liver problems, seizures or convulsions, mania or bipolar disorder, or low sodium levels in your blood.
– Your health care professional should check your blood pressure regularly while you are taking PRISTIQ.
Taking PRISTIQ if you are nursing, pregnant, or plan to become pregnant, as it is not known if PRISTIQ will harm your unborn baby.
All prescription and over-the-counter medications you are taking or plan to take, including:
– Medicines to treat migraines or mood disorders, to avoid a potentially life-threatening condition.
– Aspirin, NSAID pain relievers, or blood thinners because they may increase the risk of bleeding.
Keep a list of all medications you have taken or plan to take to show your health care professional.
Do not start new medications without first checking with your health care professional.
Stopping an antidepressant medicine, especially suddenly, can cause side effects called discontinuation symptoms. Your health care professional may want to decrease your dose slowly to help avoid these side effects. Therefore, do not stop taking or change the dose of PRISTIQ without first talking to your health care professional, even if you feel better. Only your health care professional can tell you how long you should use PRISTIQ.

Overview & Facts

Start here. Learn the basic facts about being HIV positive. Find out who's at risk of getting the AIDS virus -- and how to prevent AIDS.
What Is HIV?
HIV/AIDS Facts
Start here if you're just beginning to learn about HIV and AIDS.
Related Web Site: HIV Positive
If you just learned you have HIV, this is for you.
Related Web Site: AIDS Myths
Myths and misconceptions about HIV and AIDS abound. This web site can help.
AIDS in America
Lots of things about HIV and AIDS have changed. Some things haven't. Read about AIDS in the 21st century.
HIV in Children
Written for doctors, this is a highly technical overview of pediatric AIDS.
Related Web Site: How to Talk with Children about AIDS
Kids need age-appropriate HIV/AIDS information. Here's how it's done.
Related Web Site: Teen AIDS
Many, many teens get AIDS. Learn more here.
AIDS and Women
They're calling it "the feminization of AIDS." Find out why.
Related Web Site: AIDS in Africa
About two thirds of people living with HIV are in Africa. This site will tell you all about it.
Related Web Site: The History of AIDS
The history of AIDS: This site has an illustrated timeline.
Related Web Site: AIDS History
Hear NIH researchers tell about the early days of the AIDS epidemic
Causes
HIV Causes AIDS
HIV causes AIDS. Find out how.
Does HIV Cause AIDS?
A few people don't believe HIV causes AIDS. They are dangerously wrong. Here is why.
Are You at Risk?
HIV: What Raises Your Risk
Learn about the risk factors for getting HIV.
Men on the Down Low
AIDS prevention messages may miss men who have sex with men -- but who aren't gay.
Related Web Site: AIDS Risk
Here's where to find out if you're at risk of HIV infection.
The Elderly and AIDS
Anyone who's sexually active -- at any age -- can get HIV. Read this if you're an active senior.
Prevention
Postexposure Prophylaxis
It's not a morning-after pill. But after a risky exposure, HIV drugs can prevent infection.
AIDS Prevention
Did you know AIDS is easily prevented? Here's how.
Related Web Site: Safe Sex
Learn about it. Practice it. This site can help.
HIV Status
There's somebody you have to tell about your HIV status: Your sex partner. Find out why men rarely regret doing this.
Related Web Site: HIV Disclosure
When you're HIV positive, here's whom to tell -- and how.
Related Web Site: Vaccinations and HIV
There isn't a vaccine against HIV or AIDS. Click here to find out why -- and to find out what's being done.
Related Web Site: HIV Microbicide
The world needs an AIDS vaccine. But a vaginal microbicide -- something that kills or blocks HIV from entering a woman's body -- would be a huge advance. Learn more from this helpful web site.

Overview & Facts

Start here. Learn the basic facts about being HIV positive. Find out who's at risk of getting the AIDS virus -- and how to prevent AIDS.
What Is HIV?
HIV/AIDS Facts
Start here if you're just beginning to learn about HIV and AIDS.
Related Web Site: HIV Positive
If you just learned you have HIV, this is for you.
Related Web Site: AIDS Myths
Myths and misconceptions about HIV and AIDS abound. This web site can help.
AIDS in America
Lots of things about HIV and AIDS have changed. Some things haven't. Read about AIDS in the 21st century.
HIV in Children
Written for doctors, this is a highly technical overview of pediatric AIDS.
Related Web Site: How to Talk with Children about AIDS
Kids need age-appropriate HIV/AIDS information. Here's how it's done.
Related Web Site: Teen AIDS
Many, many teens get AIDS. Learn more here.
AIDS and Women
They're calling it "the feminization of AIDS." Find out why.
Related Web Site: AIDS in Africa
About two thirds of people living with HIV are in Africa. This site will tell you all about it.
Related Web Site: The History of AIDS
The history of AIDS: This site has an illustrated timeline.
Related Web Site: AIDS History
Hear NIH researchers tell about the early days of the AIDS epidemic
Causes
HIV Causes AIDS
HIV causes AIDS. Find out how.
Does HIV Cause AIDS?
A few people don't believe HIV causes AIDS. They are dangerously wrong. Here is why.
Are You at Risk?
HIV: What Raises Your Risk
Learn about the risk factors for getting HIV.
Men on the Down Low
AIDS prevention messages may miss men who have sex with men -- but who aren't gay.
Related Web Site: AIDS Risk
Here's where to find out if you're at risk of HIV infection.
The Elderly and AIDS
Anyone who's sexually active -- at any age -- can get HIV. Read this if you're an active senior.
Prevention
Postexposure Prophylaxis
It's not a morning-after pill. But after a risky exposure, HIV drugs can prevent infection.
AIDS Prevention
Did you know AIDS is easily prevented? Here's how.
Related Web Site: Safe Sex
Learn about it. Practice it. This site can help.
HIV Status
There's somebody you have to tell about your HIV status: Your sex partner. Find out why men rarely regret doing this.
Related Web Site: HIV Disclosure
When you're HIV positive, here's whom to tell -- and how.
Related Web Site: Vaccinations and HIV
There isn't a vaccine against HIV or AIDS. Click here to find out why -- and to find out what's being done.
Related Web Site: HIV Microbicide
The world needs an AIDS vaccine. But a vaginal microbicide -- something that kills or blocks HIV from entering a woman's body -- would be a huge advance. Learn more from this helpful web site.

Symptoms & Types

Here's where you can find out more about the signs and symptoms of HIV infection -- and the types of opportunistic infections and cancers linked to AIDS.
Symptoms
HIV Symptoms
A very brief list of the symptoms of HIV infection.
Warning Signs
Warning Signs
These links provide warnings for people living with AIDS.
Types
HIV-2
Most people with HIV are infected with HIV type 1. But there's another type. Here's the scoop.
Stages of HIV Infection
There's a progression of illness from HIV infection to AIDS. Here's a brief description.
Complications
No Shame
Everyone who is ill struggles with shame. Here's how to deal with it.
AIDS Complications
Learn more here.
Related Web Site: AIDS-related Cancers
This article includes information on KS, different lymphomas, cervical cancer, anal cancer.
Related Web Site: AIDS Dementia
AIDS dementia complex is a feared complication of AIDS. This web site offers a very complete description.
Related Web Site: Wasting Syndrome
In Africa, they call HIV "slim disease." Find out why here.
Related Web Site: PML
PML is a viral infection of the brain. Learn how more about it here.
Related Web Site: Peripheral Neuropathy
That tingling in your feet or hands may be a nerve problem. HIV infection can cause it. So can some AIDS drugs. Learn more here.

HIV/AIDS: Treatment

Related Web Site: HIV Treatment
There are many anti-HIV drugs. Learn more about them from this helpful web site.
Related Web Site: HIV Treatment

Related Web Site: HIV/AIDS Drug Directory
Here's where you can learn as much as you want to know about any HIV/AIDS drug.
Tool: HIV/AIDS Drug Directory

Related Web Site: HIV Drug Side Effects
Yes, these are very powerful drugs that can have very powerful side effects. Here's what you need to know.
HIV Drug Side Effects

Related Web Site: Complementary treatments for HIV
It's important to know the facts about alternative approaches to AIDS treatment. This web site has a very helpful fact sheet.
Related Web Site: Complementary Treatments for HIV

Blood Type Test

Blood type tests are done before a person gets a blood transfusion and to check a pregnant woman's blood type. Human blood is typed by certain markers (called antigens) on the surface of red blood cells. Blood type may also be done to see if two people are likely to be blood relatives.
The most important antigens are blood group antigens (ABO) and the Rh antigen. Therefore, the two most common blood type tests are the ABO and Rh tests.
ABO test
The ABO test shows that people have one of four blood types: A, B, AB, or O. If your red blood cells have:
The A antigen, you have type A blood. The liquid portion of your blood (plasma) has antibodies that fight against type B blood. In the United States, about 40% of the white population, 27% of African Americans, 28% of Asians, and 16% of Native Americans are type A.
The B antigen, you have type B blood. Your plasma has antibodies that fight against type A blood. In the United States, about 11% of the white population, 20% of African Americans, 27% of Asians, and 4% of Native Americans are type B.
Neither the A nor B antigen, you have type O blood. Your plasma has antibodies that fight against both type A and type B blood. In the United States, about 45% of the white population, 49% of African Americans, 40% of Asians, and 79% of Native Americans are type O.
Both the A and B antigens, you have type AB blood. Your plasma does not have antibodies against type A or type B blood. In the United States, about 4% of the white population, 4% of African Americans, 5% of Asians, and less than 1% of Native Americans are type AB.
Blood received in a transfusion must have the same antigens as yours (compatible blood). If you get a transfusion that has different antigens (incompatible blood), the antibodies in your plasma will destroy the donor blood cells. This is called a transfusion reaction, and it occurs immediately when incompatible blood is transfused. A transfusion reaction can be mild or cause a serious illness and even death.
Type O-negative blood does not have any antigens. It is called the "universal donor" type because it is compatible with any blood type. Type AB-positive blood is called the "universal recipient" type because a person who has it can receive blood of any type. Although "universal donor" and "universal recipient" types may be used to classify blood in an emergency, blood type tests are always done to prevent transfusion reactions.
Minor antigens (other than A, B, and Rh) that occur on red blood cells can sometimes also cause problems and so are also checked for a match before giving a blood transfusion.

Who Should NOT Take Cymbalta?

You have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI)
You have uncontrolled narrow-angle glaucoma (an eye disease)
You are taking Mellaril® (thioridazine)
Before starting Cymbalta, tell your healthcare provider:
About all of your medical conditions, including kidney problems, glaucoma, or diabetes
About your alcohol use
If you are taking nonprescription or prescription medicines, including those for migraine, to address a possible life-threatening condition
If you are taking NSAID pain relievers, aspirin, or blood thinners. Use with Cymbalta may increase bleeding risk
If you are pregnant, plan to become pregnant during therapy, or are breastfeeding an infant
While taking Cymbalta, tell your healthcare provider:
If you have itching, right upper belly pain, dark urine, yellow skin/eyes, or unexplained flu-like symptoms, which may be signs of liver problems. Severe liver problems, sometimes fatal, have been reported
If you have high fever, confusion, and stiff muscles to address a possible life-threatening condition
Before stopping Cymbalta or changing your dose
If you experience dizziness or fainting upon standing, especially when first starting Cymbalta or when increasing the dose. Your healthcare provider may periodically check your blood pressure while you are taking Cymbalta
If you have any questions, talk to your healthcare provider before taking Cymbalta.
Cymbalta is not approved for use in patients under age 18. Remember, only your doctor can decide if Cymbalta is right for you.

No. 1: Know Why You Want to Quit

No. 1: Know Why You Want to Quit
So you want to quit smoking, but do you know why? “Because it's bad for you” isn't good enough. To get motivated, you need a powerful, personal reason to quit. Maybe you want to protect your family from secondhand smoke. Maybe the thought of lung cancer frightens you. Or maybe you'd like to look and feel younger. Choose a reason that is strong enough to outweigh the urge to light up.

What is rheumatoid arthritis?

Rheumatoid arthritis (RA) is an autoimmune disease that causes chronic inflammation of the joints. Rheumatoid arthritis can also cause inflammation of the tissue around the joints, as well as in other organs in the body. Autoimmune diseases are illnesses that occur when the body tissues are mistakenly attacked by its own immune system. Because it can affect multiple organs of the body, rheumatoid arthritis is referred to as a systemic illness and is sometimes called rheumatoid disease. While rheumatoid arthritis is a chronic illness, meaning it can last for years, patients may experience long periods without symptoms. Typically, however, rheumatoid arthritis is a progressive illness that has the potential to cause joint destruction and functional disability.

The Warning Signs of Skin Cancer

Like many cancers, skin cancers—including melanoma, basal cell carcinoma, and squamous cell carcinoma—start as precancerous lesions. These precancerous lesions are changes in skin that are not cancer but could become cancer over time. An estimated 40% to 50% of fair-skinned people who live to be 65 will develop at least one skin cancer. Learn to spot the early warning signs. Skin cancer can be cured if it's found and treated early.

What is ringworm?

Ringworm is a common skin disorder otherwise known as tinea. While there are multiple forms of ringworm, the most common affect the skin on the body (tinea corporis), the scalp (tinea capitis), the feet (tinea pedis, or 'athlete's foot'), or the groin (tinea cruris, or 'jock itch').

Do you have skin problems?

Is your skin itching, breaking out, covered in a rash, or playing host to strange spots? Skin inflammation, changes in texture or color, and spots may be the result of infection, a chronic skin condition, or contact with an allergen or irritant. You can learn to recognize common adult skin problems. Yet, while many are minor, they may signal something more serious, so always consult a doctor for proper diagnosis.

ntroduction to pregnancy symptoms

Most women equate a missed menstrual period with the possibility of being pregnant, but other symptoms and signs are experienced by most women in the early stages of pregnancy. It's important to remember that not all women will experience all of these symptoms or have the symptoms to the same degree. Even the same woman can have different types of symptoms in a subsequent pregnancy than she had in previous pregnancies. The following are the most common pregnancy symptoms in the first trimester.

Depression: What Is It?

It's natural to feel down sometimes, but if that low mood lingers day after day, it could signal depression. Major depression is an episode of sadness or apathy that lasts at least two consecutive weeks and is severe enough to interrupt daily activities. Depression is not a sign of weakness or a negative personality. It is a major public health problem and a treatable medical condition.
Shown here is a PET scan revealing "hot spots" of increased activity in a non-depressed brain.