FDA Puts a Stop to Implants: Medical Devices Seized

Everyone values their health. We cannot place a value on our health and safety. When Americans place their health in the hands of a surgeon they expect to receive the best of treatment. A patient sincerely hopes that all factors related to medicine will have the highest of standards. Safety must be first.

To keep with the highest safety requirements, the FDA has seized medical devices due to risk to patients. A Union, New Jersey facility has been found to have medical devices that do not meet medical standards. Concerns are in regards to the sterility of the medical devices.

Shelhigh, Inc. manufactures implants for surgical procedures such as open-heart surgery. Other devices involved in the issue include soft-tissue patches involved in neurosurgery. Implants for abdominal and pelvic surgical procedures are suspect, as well. Their products are available for use for both adults and children. As many as 19 items have been seized and recalled.

Doctors have been warned to use other products to avoid risk to patients. Adults and children who may have received one of the devices manufactured by Shelhigh, Inc. are urged to call their doctor for advice. Patients who have one of the Shelhigh products should be monitored for infection. Also, doctors should be certain to check for effectiveness of the Shelhigh product for the duration of the product's life. More information about the products will be released and available on the FDA website.

On April 17, 2017 officials from the FDA seized the medical devices due to concerns about the manufacturing process of such devices at the Shelhigh, Inc. facility. Based on inspection information discovered in the fall of 2016, the facility was not following the appropriate safety guidelines. Shelhigh, Inc. was not properly monitoring the cleanliness of areas where such items were manufactured. Expiration dates on the products may be inaccurate. Shelhigh, Inc. did not properly back up the expiration dates of such products with scientific data.

Patients with immune deficiencies are at the greatest risk of developing complications from Shelhigh, Inc. products. Pediatric patients are also susceptible to this safety risk.

Shelhigh, Inc. was contacted about concerns related to inspections last fall. The FDA brought to the attention of Shelhigh, Inc. the numerous violations of proper manufacturing procedure for medical devices. Two letters were sent to Shelhigh, Inc. forewarning the facility of the actions to be taken should the proper measures to remedy the violations not be implemented.

http://www.FDA.gov…

Smoky Beef Kabobs: Grilled Peppery Summer Sticks

Summer is the time for grilling and barbequing. If the temperatures have started to rise in your area, take the heat of cooking outside. Is it really hot? Try cooking small pieces of meat for speed. You won't have to leave the air conditioning for long when cooking kabobs.

Marinate your beef in a unique marinade and grill it over charcoal. These kabobs come together very quickly and the end result is strikingly flavorful. Add peppers and onions to the skewers for more color, or serve alongside grilled corn on the cob and a fruit salad for an equally pretty effect.

Smoky Beef Kabobs (Serves 4)

Prep time: 30 min Cook time: 20 min

Ingredients:

  • 2 lb Chuck steak trimmed and cubed (1 inch)
  • 1/4 C BBQ sauce
  • 2 T Worcestershire sauce
  • 2 T yellow mustard
  • 1/4 C sweet white wine
  • 1 T sugar
  • 1 T cooking oil
  • kosher salt
  • assorted peppercorns, ground
  • assorted chunked peppers and onions (optional)

Instructions:

  1. Light charcoals in the grill and allow them to reach medium high heat.
  2. Meanwhile, place cubed meat in a medium, shallow dish.
  3. Add BBQ sauce, Worcestershire sauce, mustard, wine, sugar and oil. Mix marinade and make sure meat is coated. Marinades are used to flavor meats intensely as well as to break down some of the meat structure so that the meat will be more tender. This particular marinade is potent enough to do its work in a relatively short time as compared to overnight or 4 hour marinades.
  4. Let the meat set in marinade at room temperature for twenty minutes.
  5. Skewer meat on wooden or metal skewers. If your grill tends to cook hot, use metal skewers. Wooden ones can catch fire.
  6. Season the meat with salt and ground pepper.
  7. Grill for approximately twenty minutes. Turn the skewers occasionally to ensure even and thorough cooking. Small pieces of meat may cook very quickly if your charcoal temperature is high, so watch carefully.
  8. When the meat pieces have an even dark crust on them, take the kabobs from the grill and serve.

Some guests may appreciate BBQ sauce on the side, but these beef kabobs are very flavorful on their own. The flavor is reminiscent of a smoked jerky, but the meat is tender and moist. If you plan on grilling corn for a side dish, you will need to start a little earlier. Corn on the cob can take up to 45 minutes to cook thoroughly on the grill. Use your waiting time to prepare other side dishes such as baked beans, fruit salad or even a cool creamy dessert.…

LACE: A New Medical Device that Can Help Save Lives

published in factoidz

An amazing new device is on the horizon that will help doctors determine who will be readmitted to the hospital after 30 days of discharge, or who may possibly die. This new devise can potentially save lives by predicting the severity of the illness at the time of discharge. The Canadians doctors who developed the devise with they call LACE maintain that the device will be able to predict which patients are at the highest risks for complications and possible death and that in turn will predict which patients are going to need more support and medical care.

Dr. Carl van Walraven of the Ottawa Hospital Research Institute studied the effectiveness of the device with 5,000 mostly middle-aged patients suffering from acute coronary syndromes, cancer complications, and heart failure. The research was conducted among 11 different Ontario hospitals from 2012 to 2016.

The research showed that 8 percent of the patients had died or were readmitted to the hospital within a month. Of that group of 8 percent, 9.4 percent of them had been unexpectedly readmitted to the hospital within 30 days after their initial discharge. Taking this info into consideration, the researchers were able to come up with a mathematical formula to predict in advance what kind of patients would be the most critical patients upon the initial release.

The acronym LACE: length of stay ("L"), acuity (how severe the symptoms are) of admission ("A"), comorbidities (other health issues)("C") and number of visits to the emergency room ("E"), are the factors which are being measured to determine the risk of re admittance to the hospital or death within one month of the original hospital discharge. Patients will get a score up to 19 and the higher the score the greater the risk.

The details of the full study were published in the Canadian Medical Association Journal.

Doctors, clinicians, and other medical personal can determine the support needed for each patient after being initially discharged from the hospital. How this medical help is determined can be: follow up visits, education and medical post care instruction, networking, home care, follow up phone calls, whatever it takes to give to save lives.

Montrealers can visit: http://www.mghlib.mcgill.ca/

The Montreal General Hospital Medical Library, for books, journals, patient resources, and other library services for information on the latest breaking news.

Sources:

http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20100302/hospital_100301/20100302?hub=Health…

How to Really Lose Weight with Wii Fit!

We live in an age where the tasty foods often win out over our will power. We snack late and we eat dessert early. It’s a terrible trend- even if it feels so good. To combat the rising obesity epidemic Nintendo and Shigeru Miyamoto (the genius behind many of Nintendo’s greatest games: Mario, Link, and so-on), developed a game called Wii Fit along with a peripheral known as the balance board. This is truly one of the greatest achievements of this gaming generation- the likes of which Microsoft and Sony cannot compare to.

However, losing weight with Wii Fit can prove difficult if you don’t know what you’re doing. You may play a couple of the games everyday but barely lose a pound. If this sounds familiar, allow me to give you some advice on how to make your Wii Fit workout more successful.

  1.  Weigh Yourself Everyday

There’s a reason that the balance board doubles as a scale. By weighing yourself everyday, you become more aware of how your lifestyle effects your body. When you think of your ‘number’, you may find yourself passing up that extra slice of cheesecake or skipping desert altogether. It’s a powerful when overeating is no longer a victim-less crime. Suddenly you can see firsthand the damage.

  1.  Stick to the Yoga, Strength Training, and Aerobics.

Avoid the Balance Games. While we know Wii Fit can help you with your posture and center of balance- generally people don’t buy it for that. While the Balance Games may be fun, they’re a waste of time if you’re substituting them for the real exercises.

  1.  Add ‘Short Run’ or ‘Long Run’ to your workout everyday.

The best calorie-burner in Wii Fit is its jogging game. Make sure you select one of its distances at least once a day. You might be tempted to skip it, but make sure you ignore that temptation. Besides, with each day it gets easier to complete the course!

  1.  Combine with proper diet.

Wii Fit can’t cover everything. If you want to lose weight, you’ve got to put in the extra effort outside of the game. Watch what you eat- switch over to some healthy substitutes for your favorite snacks. Your balance board will appreciate it.

  1.  Workout everyday.

Even if you don’t play Wii Fit everyday, workout everyday. Go for a quick jog, do a few push-ups, find some stairs to walk up. You’ll see the results of your hard-work next time you weight yourself in Wii Fit.

  1.  Make your fitness goal public.

This is another psychological tool. If you announce your fitness goal to your family, it suddenly becomes more solid. No longer are you working toward an imaginary goal in your mind. Instead you have people waiting to see you either succeed or fail. If they see you slacking off, their perspective is now supported by the knowledge that you’re supposed to be working out.

  1.  Always play your Wii while standing up. Only use motion controls.

A good way to burn some calories is to get lost in a video game for a few hours while standing up. Stay off that couch! Make sure you don’t cheat by switching over to the GC controller or classic controller. Those arm motions will shave off a few calories too! Do this and Wii Fit won’t be the only game you use for weight-loss.

  1.  Don’t eat before sleep.

This is sort of a dieting law. Don’t consume anything (other than water) at least three hours before you intend to go to sleep. That slice of pizza you just ate will simply turn to fat over night …

Greatest Medical Industry Technological Advancements This Decade

When it comes to the latest in medical technology many would argue that the most interesting or greatest inventions are the ones that keep people alive. I however, would argue that these inventions only prolongs a person's suffering, and for this reason anything that would artificially keep a person alive, will not be on this my list of the five greatest medical industry technological advancements this decade.

Greatest medical industry technological advancements this decade: The bionic arm

If you ever watched 'The Million Dollar Man' (a series from back in the eighties), the fact that efforts are being made in the interest of creating mechanical prosthetic limbs, probably doesn't surprise you much, but the advancements that have been made more recently, may both surprise and interest you. Just have a look at the video attached above.

Greatest medical industry technological advancements this decade: The microscope

Over the years the microscope has advanced so dramatically, that one could be hard pressed to determine it from a modern computer. The photo imaging processes which we use today can magnify an object and display it computer screen more than 1,000 times its original size, allowing microbiologists to get a more complete and informative view ; this in part due to recent advancements in physics and the control of ION particles.

Greatest medical industry technological advancements this decade: The cell phone ultrasound,

This is one of the greatest things to hit the medical industry, ultrasound monitors are traditionally very large heavy devices which are not at all portable, making an in house ultra sound next to impossible and forcing people to conform to hospital demeanor when getting a regular checkup on their baby. When this technology becomes more available a busy house wife with child, may never have to leave the home again for a doctors appointment. Mid wives may even be able to take on the monitoring tasks typically done by doctors.

Greatest medical industry technological advancements this decade: The robotic surgeon

– Warning do not view the above link if you have a weak stomach, as with most surgical procedures the videos provided may be graphic in nature.–

A recent episode of 'House' revealed a device seldom talked about or even heard of. A device capable of doing the many tasks a surgeon with shaky hands could never perform. This device is capable of doing these tasks with a higher level of efficiency then a top surgeon ever could. When people play the board game doctor they often try not to touch the sides as they pull parts out, but with this device you won't have the slightest problem with nervous twitches or anything else.

Greatest medical industry technological advancements this decade: Nanotechnology

Nanotechnology has many implications, and while it is still under development, it's soon to be the next stage in surgical and vaccine technologies. Imagine a world where we can create an autonomous robot so small it's hard for your body to differentiate it from the cells which live within it.

Imagine a world where we control such a small technology, that it can pass through your body and provide support for your white blood cells in effectively destroying bacterial infections from the inside, without causing collateral damage. That is the world we soon will live in.

Nanotechnology is still a ways off and may even be considered by some to be Science Fiction. However, this technology is being very strenuously funded due to the endless possibilities it creates.

Greatest medical industry technological advancements this decade: Closing

What can I say? I have a passion for anything that combines mechanical …

Memorial Day Picnic Basket Staples: Prepare Homemade Fried Chicken and Coleslaw

Whether you're spending Memorial Day weekend on the road or at home, pack your picnic basket with some of these delicious picnic staples: coleslaw, fresh corn and fried chicken.

Homemade Coleslaw Recipe

SERVES 6

Ingredients:

  • 8 ounces (1-1/2 cups) finely grated cabbage
  • 1 cup finely grated carrots
  • 1 cup peeled, cored, and thinly sliced Granny Smith apples
  • 1 cup Coleslaw Dressing (recipe follows)

Directions:

  1. Combine the cabbage, carrots, and apples in a large mixing bowl.
  2. Toss together the vegetables with 1 cup of the Coleslaw Dressing. Chill in the refrigerator overnight or until ready to serve.

Coleslaw Dressing Recipe

MAKES 2-1/2 CUPS

Ingredients:

  • 2 cups mayonnaise
  • 1/2 cup granulated sugar
  • 2 tablespoons white vinegar (or to taste)
  • 2 tablespoons commercially prepared horseradish (or to taste)
  • 1/2 teaspoon kosher salt, plus more to taste
  • 1/2 teaspoon freshly ground black pepper, plus more to taste
  • 2 teaspoons prepared yellow mustard
  • 1/2 teaspoon celery seed
  • 2 teaspoons ground cinnamon

Directions:

In a medium-sized mixing bowl, blend together the mayonnaise, sugar, white vinegar, horseradish, salt, pepper, yellow mustard, celery seed and ground cinnamon. Taste the dressing; adjust seasoning if necessary. Reserve 1 cup of the dressing for the coleslaw (recipe above). Store any remaining dressing (up to 1 week) in the refrigerator.

Boiled Corn Recipe

Boiling corn in milk brings out the corn's naturally sweet flavor. 

SERVES 6

Ingredients:

  • 2 quarts milk
  • 2 quarts water
  • 1/2 cup sugar
  • 6 ears shucked corn

Directions:

In a large stockpot, bring milk, water, and sugar to a boil. Add corn; cook 5 to 10 minutes, or until corn reaches desired doneness.

Fried Chicken Breasts Recipe

The quintessential picnic fare, this chicken is absolutely delicious. 

SERVES 6

Ingredients:

  • 1-1/2 cups whole milk
  • 3/4-pound boneless chicken breasts, cut into 1-inch pieces
  • 1-1/2 cups all-purpose flour
  • 1/2 teaspoon freshly ground black pepper
  • 1 teaspoon paprika
  • 1/2 cup (8 tablespoons) unsalted butter
  • 4 tablespoons bacon drippings (optional)

Directions:

  1. Add milk to a large bowl. Add chicken pieces, turning to coat in the milk. Cover with plastic wrap; refrigerate at least 4 hours.
  2. Combine flour, black pepper and paprika in a shallow dish. One at a time, place chicken pieces in dredging mixture, and press chicken firmly into dredging mixture to coat. Place coated chicken pieces on a parchment-lined baking tray. Heat unsalted butter and bacon drippings, if using, in a cast-iron skillet over medium-low heat until butter begins to bubble in the skillet.
  3. Use tongs to place chicken pieces into skillet. Fry until coating is golden brown on one side, 14 to 17 minutes. Turn the chicken pieces over with the tongs; fry on the other side until coating is golden brown, 14 to 17 minutes. Adjust heat to prevent the chicken from burning.
  4. Transfer the cooked chicken pieces to a serving platter.