Dialysis Club of the Philippines

Complication: Sleeping and Bleeding Problems

2009-05-24T11:35:00.003+08:00

CKD patients respond poorly to sleep medications. Sleeping problems are really common among people with kidney failure. Although, more researches are needed in order to better understand the theoretical underpinning of sleeping irregularities among these patients. This may further worsen if the patient sleeps during dialysis. However, sleeping problems may improve with a more intensive dialysis as in nocturnal dialysis.

Bleeding problems are also very common among people with chronic kidney disease. This is because of the complex blood factor changes that happens in the patients' body. Symptoms include easy bruising, prolonged clotting time, gastrointestinal bleeding, blood in stools and nose bleeding.

Complication: Neuropathy

2009-05-24T11:26:00.003+08:00

In the long run, some patients, especially those with diabetes may result in a condition known as peripheral neuropathy or nerve damage. The classic symptom is the "pins and needles" feeling. Other symptoms include restlessness in the legs. This condition may make it hard for patients to walk. However, the real cause is really unknown. There may just be contributing factors for the occurence of this specific disorder such as sodium imbalance, high calcium levels, secondary hyperparathyroidism, and also retention of other toxins which are not not efficiently removed through dialysis.

Complication: Amyloidosis

2009-05-24T10:47:00.004+08:00

There is a protein called the beta2- microglobulin that is normally found on the surfaces of cells an in the body fluids. The excess of this protien is usually excreted by the healthy kidneys. If you have kidney failure, the excess of this specific protien is accumalated in the body and is converted to amyloid resulting in the condition known as the "Amyloidosis". By definition, amyloidosis is a condition where a waxy protien is deposited in the soft tissues, bones and joints. Deposits of amyloid can cause a lot of disturbing complications such as carpal tunnel syndrome (painful compression of a nerve in the wrist), bone cysts, joint pain, and fractures. Amyloid is found in 20% of patients who have been undergoing hemodialysis for 10 years. And the longer years of dialysis, the more increasing number of patients who will have the disorder. Again, the very simple but effective prevention is to have a a more freqent dialysis in order to remove excess beta2 microglobulin.

Pericarditis: Complication of CKD

2009-05-19T18:27:00.002+08:00

If you are not dialyzing as often as you should have been, you may develop pericarditis or the inflammation of the membrane or sac around the heart. Of course, poor dialysis may be one of the causes, other causes would be infection, surgery or any other acute illnesses. It usually manifests with a constant pain in the center of the chest. Other symptoms are hypotension or low blood pressure and fever. You may also have irregular heartbeat. There is also the presence of a pericardial friction (heart sound) that is heard using a stethoscope. Treatment of pericarditis includes having yourself dialyzed as often as you could and adherance to medications and diet as prescribed by your doctor.

IF YOU ARE EXPERIENCING HEAVINESS ON THE CHEST OR ANY PAIN ON THE CHEST, REPORT IT IMMEDIATELY!!!

Secondary Hyperparathyroidism: Complication of CKD

2009-05-12T17:39:00.002+08:00

The overproduction of parathyroid hormone in the parathyroid glands in the neck is also known as Hyperparathyroidism. An active form of Vitamin D is produced by the healthy kidneys. This hormone is called "calcitriol". Its main responsibility is to help absorb calcium from the food that we eat. When you have chronic kidney disease or when your kidneys fail, you produce less calcitriol therefore, less calcium can be absorb by the body. At the same time phosphorus can also build up which we also get from the food that we eat. It builds up because the kidneys are already unable to excrete them. Less calcium in the body triggers the parathyroid gland to release parathyroid hormone (PTH). The main responsibility of PTH is to make sure that the levels of your calcium and phosphorus are within normal. Remember that because of the failure of your kidneys, you have less calcitriol hence low calcitriol level and because of this less calcium is absorbed therefore you have low calcium level and finally since you are unable to excrete phosphorus, you will then have a high phosphorus level. In the long run, the overactivity of the parathyroid gland in a long span of time will cause it to become big that it can not be shut down. This is what you call the cycle of the Secondary Hyperparathyroidism. The condition can also lead to bone problems since you're very deficient with calcium. Renal osteodystrophy is one bone problem which you can have. This may also lead to stroke and other heart problems since experts say that secondary hyperparathyroidism is related to calcium deposits in the heart and blood vessels .
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Core Curriculum for Dialysis Technician

Anemia: Complication of CKD

2009-04-30T16:01:00.007+08:00

Healthy kidneys make a hormone called "erythropoeitin" or EPO. EPO triggers the bone marrow to produce red blood cells. It follows when the kidneys fail, there is less EPO being produced and so there would be less RBC therefore anemia would occur. RBCs carry hemoglobin (Hgb), a protien which carries oxygen all throughout the body. You can see from here that if you're anemic, your tissues don' t get enough oxygen. Anemia in CKD patients is usually associated with LVH or left ventricular hypertrophy (the walls of the left ventricles of the heart become abnormally thick), which is one of the leading causes of death in people with chronic kidney disease. In fact, LVH has been increasing in patients whose renal function is lower and can be found in as many as 30- 40 % of patients with chronic kidney disease (Berns, 2009).

Your question now may be how does anemia actually causes LVH? It has been said early on that your hemoglobin is reduced when you have anemia. Due to the inadequate oxygenation of your tissues which in medical terms is called "tissue hypoxia", the heart tries to compensate by increasing its output. The chronic cardiac compensation leads to hypetrophy of the ventricles. From there, anemia causes a series of cardiovascular alterations that would result in the compensatory increase in cardiac output. Aside from this, on a short term effect, this would also result in an increase in heart rate. This alterations however, if uncontrolled and may persist over a long period of time could result to CVD or cerebrovascular disease. It may also worsen certain cardiac conditions such as congestive heart failure, angina pectoris, or even myocardial infarction.
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Berns, Jeffrey S. Anemia and left ventricular hypertrophy in chronic kidney disease.Updated 12/11/08. Last reviewed 01/ 2009
[online]Anemia and cardiovascular disease. pp 20- 21.
Core Curriculum of the Hemodialysis Technician: A Hemodialysis Review. pp 48- 49

Urine Tests

2009-04-30T14:10:00.011+08:00

There are many different types of urine tests. The routine urinalysis usually looks into the following tests:

COLOR. Medicines, diseases, diet affect urine color. How much dark or light the color of your urine tells you how much water is in it. Your urine color should be clear amber yellow in color. Some medicines such as vitamins may turn your urine color into bright yellow. However, some things such as blackberry or even blood may turn your urine into red- brown in color.

CLARITY. Urine should be clear. Blood, bacteria, mucus, crystals will make your urine cloudy.

ODOR. Urine usually has a "nutty" odor and is not usually very strong. For certain conditions such urine with bacteria (e.g. ecoli), the urine usually has a very bad odor. For diabetic patients, there urine usually has a sweet odor.

SPECIFIC GRAVITY. This shows the ability of the kidneys to balance the amount of water in the urine. More specifically, this checks the substances present in the urine. A high specific gravity tells you that your urine is concentrated which means that there are more solid materials present in the urine. On the other hand, a low specific gravity means that your urine is diluted as in the case of drinking many glasses of water.

pH. The pH level of your urine tells if it is acidic or alkaline (basic). Oftentimes the pH level of your kidney may be affected by certain treatments.

PROTIEN. Protien should not be present in the urine. People with kidney disease may expect protien in their urine.

GLUCOSE. There is usually an insignificant amount of glucose in the urine, or in most cases non at all. If there are large amount of glucose in the urine, the kidneys are damaged. Glucose is also found in the urine as in the case of diabetes because of spillage of sugar in the urine due to excessive blood sugar level.

NITRITES. Nitrites in the urine show that UTI is present because the bacteria that causes UTI is the one that converts nitrates to nitrites.

LEUKOCYTES (WBC). The presence of WBC in the urine may mean the presence of UTI

KETONES. Ketones are produced from fat breakdown for energy. This is usually passed in the urine but when large amount of ketones are found in the urine, this is usually associated with a very serious disorder called diabetic ketoacidosis.

RBC. Blood cells are not usually found in the urine. Presence of it may mean trauma to the kidneys, ureter, bladder, and urethra.

Laboratory Tests for Kidney Function

2009-04-30T10:32:00.008+08:00

People who have chronic kidney disease may not exhibit symptoms until there kidney function has dropped to a significantly low level. Why do you need to undergo laboratory tests? First of all, it will help you determine if your disease have developed suddenly or abruptly as in the case of an acute renal failure. Another is to determine the cause of your kidney damage, the best type of treatment you can possibly have, and how well the treatment goes or the prognosis of the disease. Consequently, after you have been diagnosed to have a chronic kidney disease whether from varying types of renal etiologies, you are required to undergo certain blood and urine tests to determine the function of your kidneys.

TESTS FOR KIDNEY FUNCTION
If you have CKD, the level of your kidney function significantly drops thus disabling your kidney to excrete harmful chemicals or toxins inside the body. This follows that there are certain substances that may build up which can cause harmful effects to the body. Some of these substances include urea, creatinine, BUN and certain electrolytes.

Now one thing that you have to consider is to undergo a Fasting Blood Glucose Test usually termed as FBS (Fasting Blood Sugar). This test measures your blood sugar level. High amounts of blood sugar significantly destroys the blood vessels in the kidneys and thus maintaining your blood sugar to a normal level is very important. Glucose is a kind of sugar in the blood which comes from carbohydrate foods. It is the main source of energy for the body. A hormone called insulin helps the body cells use the glucose. When the amount of glucose in the blood rises, insulin is activated and released from the pancreas. Insulin makes sure that your glucose is within normal limits (60-90 or 70-99, above 100 is already considered abnormally high). That's why you can expect a slightly elevated glucose level after you have eaten something however, if your blood sugar level is signifiantly high for over long periods of time, this will then damage not only your kidneys but also your eyes, nerves and blood vessel.

So if you're going to undergo an FBS make sure that you have not eaten anything 8 hours prior to the procedure. A preparation time of less than or more than 8 hours will yield inaccurate results. So 8 hours is all that it takes and will be very very important.

Another blood test may be required to know the levels of your electrolytes particularly sodium (Na) and pottasium (K). These electrolytes are normally filtered out by the kidneys hence abnormal levels may mean that the kidneys are not functioning well already. These two elements play a major role in maintaining balance in fluid and electrolyte. They are inversely proportional with each other meaning when sodium level goes up, it is expected that your pottasium level is low and vice versa. Pottasium is needed for muscle contraction while sodium affects your circulation. Low or high levels of any of these elements or both is potentially dangerous. Abnormal potassium levels may cause symptoms such as muscle cramps or weakness, nausea, diarrhea, frequent urination, dehydration, low blood pressure, confusion, irritability, paralysis, and changes in heart rhythm. On the other hand, too much sodium raises your blood pressure. This follows that having too much salt in your diet may increase your risk of having heart problems and may worsen kidney damage. Furthermore, other electrolytes such as calcium, magnesium, chloride, and phosporus may also be taken together with sodium and pottasium.

iPTH or intact parathyroid hormone may also be considered if you have chronic kidney disease. A blood test is also necessary in order to know the level of iPTH in the blood. This test is used to find out the occurence of hyperparathyroidism or excessive activity of the parathyroid gland and is also used to find out abnormal calcium levels. PTH is secreted by the parathyroid gland. The amount of parathyroid hormone in the body is influenced by the level of Calcium. If the blood calcium level is too low the parathyroid gland release more PTH. Due to the overactivity of the parathyroid gland, it will go so large that it cannot be shut off. This will then lead to a disease called the "Secondary Hyperparathyroidism".

Toothloss May Lead to CKD

2009-04-30T09:46:00.005+08:00

A new research published in the Journal of Periodontology embarked on periodontal disease which may have a significant link on the occurence of Chronic Kidney Disease. The study suggests that edentulous or toothless adults may be more likely to have chronic kidney disease than dentate adults. This is a study conducted at the Case Western University which found that "Edentulism is significantly associated with CKD, indicating that oral care may play a role in reducing the prevalence of chronic kidney disease in the US Population".

The study utilized 4,053 adults, 40 years of age and older. After careful considerations and adjustments made to recognized risk factors of CKD (race, age, ethnicity, smoking status), the results revealed that participants who have lost their teeth in the long run where more likely to have CKD than those participants who have maintaned their dentition.

According to Monica Fisher, the author of the research, the study's basic rationale is to observe the long term effects of periodontal disease on the presence of CKD. It might be a little bit vague at this point why being toothless is associated with a higher prevalence of CKD. This is because of the destructive nature of chronic inflammation which plays a great role on both CKD and periodontal disease. Inflammation has also been proved by previous researches to be the major link between these two diseases. Since chronic periodontal disease may lead to tootloss in the long run, edentulous people may have been exposed to chronic oral inflammation.

As a conclusion, it is quite reassuring to think that just by taking care of your oral cavity and thus maintaining your dentition, the incidence and progression of CKD may be lessened.

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Article written from a research by Monica Fisher, Ph.D,DDS,MPH

American Academy of Periodontology

What is Hemodialysis?

2009-04-12T18:08:00.000+08:00

Hemodialysis is a procedure which allows the patient's blood to flow with pressure through a machine and enters an artificial kidney called the "dialyzer" to remove wastes and excess water from the body and let the clean blood flow back to the patient. The wastes and excess water of the body are removed so that the blood pressure will be kept in normal levels and important chemicals within balance.

Undergoing hemodialysis means that the patient has to follow a strict schedule. The treatment is usually 3x a week. For other patients this may be more frequent. Each treatment lasts for 4 hours or more depending on the physician. A lot of patients go to a dialysis center for the treatment but this can also be done at home. If the patient prefers to have his treatment at a dialysis center, a dialysis nurse, a hemodialysis technician, a dietician,a social worker, and of course a nephrologist will take care of your hemodialysis management. Some patients who prefer to have the treatment done at home may be required for a home training. However, the schedule really depends on the availability of the patient because most of them still go to work. So they will either have a M-W-F schedule or a T-Th-Sat schedule.

The longer the time, the more frequent the dialysis, the better patient outcome.

Remember: not only every patient is different, every treatment session is also different.

Kidney Disease Prevalence: Philippine Setting

2009-04-01T20:06:00.000+08:00

TIME TO BE AWARE!!!

Do you know that End Stage Renal Disease is already the 7th leading cause of death among Filipinos? It is said that a Filipino is having the disease hourly or 120 Filipinos per million population per year. This shows that about 10, 000 Filipinos need to replace their kidney function. Unfortunately though only 73% or about 7, 267 patients recieved treatment. An estimate of about a quarter of the whole population probably just died without recieving any treatment.

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Source:

Danguilan, Romina. The burden of kidney disease in the philippines. ABS- CBN News

National Transplant and Kidney Institute

Be a Certified Nephrology Nurse

2009-04-01T19:09:00.000+08:00

BONENT is an international organization for certification of nephrology professionals. It regulates training, certification, and credentialing of all nephrology practitioners. Aside from any requirements by any state lisencing authorities, an RN who wish to be certified as a nephrology nurse in the US must have a 1 year experience in nephrology and must be currently practising in an ESRD facility. All experience must be verified by your immediate supervisor and the other from a professional (e.g. a mentor in the field of nephrology). You can choose whether you might want to be certified as a hemodialysis nurse (CHN), a peritoneal dialysis nurse (CPDN) or a technician (CHT). You need not worry because the examination is given on other parts of the world. Aside from the US, exams are given in Singapore, Australia, New Zealand, Turkey and to other growing list of countries.

READ THE CANDIDATE'S HANDBOOK

Glomerular Filtration Rate

2009-04-01T18:15:00.000+08:00

Glomerular filtration rate is the best test to measure kidney function. It also determines the stage of kidney disease. It is being computed using these parameters: your blood creatinine test, age, race, gender and kidney function.

Creatinine is a by-product of creatine phosphate in the muscles. It is chiefly filtered out of the blood by the kidneys. The typical range for creatinine is 0.5- 1.0 mg/dl or about 45- 90 mmol/ L for women and 0.7- 1.2 mg/dl or about 60- 110 mmol/L (wikipedia, 2009). The creatinine blood test is usually done together with a BUN (blood urea nitrogen) test to assess kidney function. When there is an increased creatinine levels in the blood, the result may suggest diseases or conditions that affect kidney function.

I WA NT TO CALCULATE MY GFR

A GFR of more than 90 indicates that you are at an increased risk of kidney disease. At this point you have to take care of your blood pressure. You also have to consider diabetes, family history, older age, and ethnic group. STAGE 1 also indicates a GFR of more than 90 and there is already a presence of protein in the urine. At this time kidney damage may be possible. STAGE 2 indicates a mild decrease in GFR (60- 89), there is already a damage to the kidneys. STAGE 3 is moderate decrease in GFR, as in 30- 59. STAGE 4 has severe decrease in GFR, about 15- 29, and STAGE 5 indicates KIDNEY FAILURE with a GFR of less than 15. During this dialysis or transplant is needed. You need to understand that a person might be asymptomatic (no symptoms) until the diagnosis of a STAGE 5 kidney disease. That's why it is paramount to be very observant in terms of how you feel with your body. The prognosis of this disease depends on how early it is diagnosed.
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Source: wikipedia, 2009 and The National Kidney Foundation

Filipino Nurse in the US

2009-03-31T13:19:00.000+08:00

To all the Filipino Nurses in the Philippines...BE INSPIRED!

How Do Hemodialysis and Peritoneal Dialysis Work?

2009-03-27T19:14:00.000+08:00

How to Cannulate

2009-03-27T17:36:00.000+08:00

Please be informed that practises in dialysis especially in cannulation may vary from clinic to clinic. However, this video shows the basic cannulation technique.

Fluid Balance

2009-03-27T15:54:00.000+08:00

Fluid balance is associated with homeostatis indicating that the amount of fluid lost from the body is equal to the amount of fluid taken. The state of normal body fluid volume is called "euvolemia". A constant supply of fluid is needed in order to replenish what has been lost through normal physiological activities such as sweating, respiration and urination.

There is approximately 1200 mls/day of fluid ingested in the normal resting state. There is 1000 mls/day from ingested foods and 300 mls/ day of fluid from metabolism totaling 2,500 mls/ day (wikipedia, 2009)

The body needs to maintain a constant internal environment through the body's homeostatic control mechanisms. This means that there has to be an equal amount of fluid loss and gain. The major hormones that play an important role in this balance is what we call the anti-diuretic hormone (ADH) also known as vasopressin and aldosterone. If the body is deficient in water, there will be an increased secretion of ADH, causing fluid to be retained by the kidneys hence urine output is reduced. On the other hand, aldosterone's main function is to increase the reabsorption of sodium and water and the release of potassium in the kidneys. The result is that the fluid volume of the body inceases. If uncontrolled, this can increase the body's blood pressure through the renin-angiotensin system.

In patients with chronic kidney disease, the kidneys are unable to secrete excess sodium. Sodium is the primary electrolyte in retaining water inside the body. When the body is unable to excrete it, there will be an accumulation of sodium in the long run resulting to extracellular fluid volume overload or hypervolemia. This situation increases the risk of complications such as pulmonary edema or congestive heart failure.

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References:

Legg, Veronic, Complications of kidney function. AJN: American Journal of Nursing.Vol. 105, No 6, pp 40- 49. 2005

Wikipedia [online]. www. wikipedia.com

Function of the Nephron

2009-03-27T15:39:00.000+08:00

How Urine is Formed

2009-03-27T15:34:00.001+08:00

Anatomy of the Kidney

2009-03-27T15:27:00.000+08:00

Assessment of the ArterioVenous Fistula (AVF) for Maturity

2009-03-25T17:25:00.000+08:00

Before a fistula can be used for hemodialysis it needs to be matured enough for treatment. A fistula maturation is the process by which a a fistula becomes suitable for cannulation. Factors such us adequate flow, wall thickness, and diameter are taken into consideration.

THE RULE OF 6 (Ball, Lynda et. al.)
A fistula is mature when it is already a minimum of 6 mm in diameter with discernible margins when a torniquet is in place, be less than 6 mm deep, have a blood flow greater than 600 ml/ min, and be evaluated for non maturation 4- 6 weeks after surgical creation if it does not meet the above criteria.

During the maturation process, it is most necessary to feel, look, and listen and feel the AVF at every dialysis treatment. You can begin assessing the AVF by placing a torniquet gently placed just below the axilla area. Instruct patient to start exercising their access provided it is cleared by the surgeon. It is very important for you to document patient education and including the condition and maturation ofthe fistula.

According to Robinn, ML., et. al., experienced dialysis nurses have an 80 % success rate for identifying a mature fistula.

Furthermore, a mature fistula has a vessel diameter of 4-6 mm, the wall should be firm to the touch, there should be no prominent collateral veins, there is a strong thrill at the arterial anastomosis, and the presence of bruit.

Cardio- Renal Nurse Training Program for 2009

2009-03-24T18:47:00.000+08:00

The Philippine Heart Center together with the H.E.A.R.T. Foundation, Inc. is to going to hold a 5-week Cardio- Renal Nurse Training Program at 4A Hospital Building, Philippine Heart Center, East Ave. Quezon City Philippines. The tentative schedule for the training will be on the ff. dates:
January 12- February 13
February 23- March 27
April 6- May 8
May 18- June 19
July 6- August 7
August 24- September 25
October 5- November 6
November 9- December 11

REQUIREMENTS:
- PRC License
- RENAP Membership
- 2 pcs. 1x1 picture
- complete resume
- a fee of 20, 000 php (inclusive of BLS, ECG, ACLS trainings, 2 scrub suits and 1 lab gowns)

The training is on a first come first serve basis. Dates may change without prior notice. For more information, please call Ms. Raquel Tejada at 925- 2401 local 2474

Effects on the Skin

2009-03-24T17:12:00.000+08:00

People should always be aware of manifestations that their kidneys might already be deteriorating. According to Dr. Jay B. Wish, there is no level of kidney function or glomerular filtration rate (GFR) at which all patients with CKD can be expected to develop symptoms of kidney failure. Patients who have co- morbidities or additional complications usually have these symptoms at a higher GFR than those patients who are free from co-morbidities.

EFFECTS ON THE SKIN
Patients who have CKD have marked differences in skin appearance. A yellowish hue coupled with a dark hyperpigmentation to sun exposed areas have been seen in these patients. There can also be extensive bruising because of platelet problems and other problems associated with hemostatic abnormalities. The skin appears dry and scaly because of chronic dehydration. Some patients may also experience plaques of chalky-like subtance on the larger joints because of the accumulation of calcium. Some patients may also notice have of their finger nail beds becoming white because of chronic edema of the nails which is called "half and half nails'. Uremic frost can also be seen because of the accumulation of phosporus on the patient's skin. This is already a rare condition since treatments in dialysis have marked improvement. Genealized itching is also a problem. It is believed that 60- 80% experiences this specific symptom.

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References:
*Wish, Jay B. Signs your kidneys may be failing. Kidney Beginnings: The Magazine, Vol 4 No 3. 2005

*Taylor, Thomas. AAKPRenalLife. Vol. 16, No. 5, March 2001

What is CKD?

2009-03-24T16:09:00.000+08:00

Chronic kidney disease is a progressive loss of renal function over a period or months or years. The person diagnosed with CKD usually manifests a variety of many different symptoms that's why the symptoms of worsening kidney function are usually non specific and the feeling of the person is generally unwell and would generally feel a reduced appetite. Oftentimes, the disease is diagnosed from screening people known to be at risk of kidney probems such as those who are chronic hypertensives, those people with diabetes, and those with a relative with CKD. It is also brought about by conditions such as chronic glomerulonephritis, diabetic nephropathy, and other polycystic kidney diseases.

IVT Training Schedule for May 2009

2009-03-20T20:23:00.000+08:00

May 23- 25: Bicol Regional Training ang Teaching Hospital

IVT Training Schedules for April, 2009

2009-03-20T20:17:00.000+08:00

APRIL 1- 3: Bicol Medical Center
APRIL 18- 20: Unciano Medical Center
APRIL 22- 24: Mount Carmel Dioscesan Medical Center
APRIL 21- 23: Lung Center of the Philippines

IVT Training Schedules for March 2009

2009-03-20T19:59:00.000+08:00

FOR MARCH 25- 27, the following hospitals will provide IVT:
Mary Mediatrix Medical Center and Bulacan Provincial Hospital

FOR MARCH 31- APRIL 2:
Lung Center of the Philippines

*schedules can change without prior notice, please coordinate with ANSAP or directly to the medical institution involved

What is AAMI?

2009-03-20T18:12:00.000+08:00

The AAMI has been the major body for standardization of medical instrumentation for many years now. It is a non- profit organization created in 1967. The Association for the Advancement of Medical Instrumentation, is an association of nearly 6000 members from all over the globe with a common aim of increasing the understanding and use of medical instrumentation. AAMI is the principal source of the current information on these medical instrumentations and technology. It provides leadership and programs that continue to improve the knowledge of the different professions, healthcare institutions and industry to efficiently and safely use medical instrumentation and technology. The association helps its members stay current when it comes to technology developments and advancements, add worth to existing healthcare organizations, enhance professional skills and improve patient outcomes. Since AAMI has been the essential source of information on medical equipments since 1967, it continues to fulfill its mission through the organization of conferences, through research and publication of technical documents, books, softwares, and periodicals.

On March 18- 19, 2009, AAMI in association with FDA will hold an International Conference on Medical Device Standards and Regulations at the Hyatt Regency Reston in Reston, Virginia. The conference will present up-to-date standards and regulatory initiatives which affect manufacturers of medical devices both in the US and overseas.

SCHEDULE OF THE CONFERENCE

WEDNESDAY, MARCH 18, 2009
8:00am- 8:45am Registration Open and Continental Breakfast
8:45am- 9:00am Welcome Remarks :David Osborn, Philips Healthcare
9:00am- 10:00am A Discussion of Recently Implemented FDA 510k Submissions Processes and an Update on Revisions to Form 3654 – Speakers will provide an update on the recently implemented 510k submission procedures required by the FDA and walk through common challenges and how to overcome them as well as give an overview of the status of revisions to Form 3654.

Carol Herman, U.S. Food and Drug Administration
David Osborn, Philips Healthcare
Barbara Zimmerman, U.S. Food and Drug Administration 10:00am- 11:00am FDA Recommendations on 510(k) Submissions for Medical Devices That Include Antimicrobial Agents - This presentation will cover information that the FDA recommends a sponsor to provide in the 510(k) submission, pertaining to the antimicrobial agent description and characterization, indications for use, safety and effectiveness testing. It will also address how sponsors can eliminate some of the common deficiencies that the FDA has already seen in 510(k) submissions for such devices.

Dr. Geetha Jayan, U.S. Food and Drug Administration
Dr. Sheila Murphey, U.S. Food and Drug Administration
11:00am- 11:15am Coffee Break
11:15am- 12:30pm Update on IECEE’s CB Scheme - This session will provide background on the organization and concept of the CB Scheme and the change required to incorporate the 3rd Edition of IEC 60601-1 for medical electrical equipment within the IECEE CB Scheme. The speaker will also provide an update on the implementation of ISO 14971: 2007 – Medical Devices -Application of Risk Management to Medical Devices within ANSI/AAMI/IEC 60601-1: Medical Electrical Equipment.
Joseph Murnane, Underwriters Laboratory (Invited)
12:30pm- 1:30pm Networking Luncheon
1:30pm- 3:00pm Medical Device Software – This session will include a discussion of the recently harmonized ANSI/AAMI/IEC 62304: Medical Device Software – Software Life Cycle Processes and a review of the status of IEC 80001: Risk Management of Networks Incorporating Medical Devices standard. Speakers will also discuss the difference between health software and medical “device” software.
Sherman Eagles, SoftwareCPR
Brian Fitzgerald, U.S. Food and Drug Administration
John Murray, U.S. Food and Drug Administration
3:00pm- 3:15pm Coffee Break
3:15pm- 5:00pm ISO/TC 194 – The Series: Biological Evaluation of Medical
Devices - ISO/TC 194 focuses on the biological evaluation standards and test methods applicable to medical and dental materials and devices. Learn the significance of this series of standards and how FDA uses these standards in review of medical device submissions.
Molly Ghosh, U.S. Food and Drug Administration
Jennifer Goode, U.S. Food and Drug Administration
Vicki Hitchins, U.S. Food and Drug Administration
Barry Page, Teleflex Medical
5:00pm- 6:00pm Reception

THURSDAY, MARCH 19, 2008
8:00am- 8:45am Continental Breakfast
8:45am- 9:15am Global Harmonization Task Force Update – A member of the GHTF will provide an update to attendees on the recent activities of the group and what is scheduled for 2009.
Tim Ulatowski, U.S. Food and Drug Administration
9:15am- 10:15am Unique Device Identification (UDI) and GS1 Coding Standards - This session will provide an overview of the issues and activities of the FDA and international organizations in regard to developing and implementing standards regarding the device identification systems.
Terrie Reed, U.S. Food and Drug Administration
John Roberts, GSI US
10:15am- 10:30am Coffee Break
10:30am- Noon The Impact of the Revisions to the Medical Devices Directive (MDD) in Europe – Speakers will provide an overview of the MDD and recent developments and their impact on the medical device industry in Europe.

Roger Gray, Donawa Consulting
David Osborn, Philips Healthcare
Noon- 1:30pm Luncheon Program,
Les Weinstein, Obmudsman, U.S. Food and Drug Administration
* Topics and time may be subject to change.

HOW TO REGISTER
Registration fees are $765 for AAMI members; $995 for nomembers; and $485 for government employees*. (Group discounts are available - please call Chris Dinegar at 703-525-4890 ext. 210.)

There are four easy ways to register:
 Online: Click here to register online.
 Phone - Call 1-800-373-3174, to register with your credit card (VISA, MasterCard, or AMEX only).
 Mail - Click here to download the registration form (PDF). Complete the form and mail it, along with your check or credit card information, to the address on the form.
 Fax - Click here to download the registration form (PDF). Complete the form and fax it to: 301-206-9789.
* Those requesting the government-employee rate must register via mail or fax; this rate is not available online.
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source: AAMI Website