Thursday, July 30, 2015

No such thing as an FDA approved SIDS Prevention Baby Product

Baby Safe Sleep
According to the FDA website, Some baby products are being marketed over-the-counter with claims to cure, treat, or prevent a disease or condition. Because of these claims, these baby products are medical devices, subject to FDA regulation.

A common medical claim being made is the prevention of Sudden Infant Death Syndrome (SIDS). The National Institute of Child Health and Human Development defines SIDS as "the sudden death of an infant under one year of age, which remains unexplained after a thorough case investigation, including performance of a complete autopsy, examination of the death scene, and review of the clinical history."

The FDA has never cleared or approved a baby product to prevent or reduce the risk of SIDS. The Agency is not aware of any scientific studies showing that a medical device prevents or reduces the risk of SIDS.
Examples of common over-the-counter baby products with unproven claims to prevent or reduce the risk of SIDS include:
  • baby monitors,
  • mattresses,
  • crib tents,
  • pillows,
  • crib bedding, including bumpers and blankets, and
  • infant positioners.
Current research shows that the best way to reduce the chance of SIDS is to create a safe sleep environment for a baby: alone, in their own sleeping space with no other people in the crib or bassinet; on their backs on a firm sleep surface; and in a crib or bassinet free of pillows, blankets, bumpers, sleep positioners, and other objects.

Michigan Safe Sleep offers these tips:
  1. Baby should sleep alone in a crib, portable crib or bassinet.
  2. Always put baby on back to sleep even when he/she can roll over.
  3. No pillows, blankets, comforters, stuffed animals or other soft things should be in the sleep area.  
  4. Keep baby's face uncovered during sleep for easy breathing. Use a sleeper instead of a blanket.
  5. Don't allow anyone to smoke around the baby.
  6. Don't overheat the baby. Dress the baby in as much or as little clothing as you are wearing.
  7. Use a firm mattress with a tightly fitted sheet.
  8. Place baby in the same sleep position every time.
And Michigan Safe Sleep offers these warnings:
  • Babies are not safe sleeping on a couch, pillow or anything soft. 
  • Babies are not safe sleeping with other children, adults or pets. 
  • Babies are not safe sleeping in adult beds. If you feed your baby in bed, put your baby back into his/her crib to sleep.

Wednesday, April 22, 2015


I live in the fabulous state of Michigan. Our Govenor, Rick Snyder, has declared April 20th as Safe Delivery Day. Please read this important message from the Michigan Department of Health and Human Services and share with others.

Help spread the word!

Often, the message of Safe Delivery does not get shared until it’s too late. Until a baby has been abandoned or murdered.
These stories are newsworthy and need to be covered, but proactive stories are even more important as we work together to prevent these infant abandonments and deaths from occurring.

Please take advantage of any opportunities to educate the public about the safe, legal and anonymous alternative provided by the Safe Delivery Law.
Here are a few resources to help you educate your friends, family, colleagues or clients:
Safe Delivery Communications Toolkit
Safe Delivery Proclamation from Gov. Snyder
Safe Delivery Press Release
Safe Delivery Statistics


Check out our website to learn more

Learn more about Safe Delivery in Michigan and what you can do to save the life of a newborn baby at

Wednesday, September 17, 2014

What is IPFQR?

The acronym IPFQR stands for Inpatient Psychiatric Facilites Quality Reporting program.  According to CMS "The IPFQR program is a pay-for-reporting program intended to provide consumers with quality of care information to make more informed decisions about health care options. To meet the IPFQR program requirements, Inpatient Psychiatric Facilities (IPFs) are required to submit all quality measures to CMS. The IPFQR program measures allow consumers to find and compare the quality of care given at psychiatric facilities where patients are admitted as inpatients. Inpatient psychiatric facilities are required to report data on these measures. Facilities that are eligible for this program may have their Medicare payments reduced if they do not report".

The measures are:

HBIPS-1 Admission Screening for Violence Risk, Substance Use, Psychological Trauma History and Patient Strengths completed  (Patients admitted to a hospital-based inpatient psychiatric setting who are screened within the first three days of admission for all of the following: risk of violence to self or others, substance use, psychological trauma history and patient strengths.)

HBIPS-2 Hours of physical restraint use. The total number of hours that all patients admitted to a hospital-based inpatient psychiatric setting were maintained in physical restraint.

HBIPS-3 Hours of seclusion use. The total number of hours that all patients admitted to a hospital-based inpatient psychiatric setting were held in seclusion.

HBIPS-4 Patients discharged on multiple antipsychotic medications. Patients discharged from a hospital-based inpatient psychiatric setting on two or more antipsychotic medications   

HBIPS-5 Patients discharged on multiple antipsychotic medications with appropriate justification. Patients discharged from a hospital-based inpatient psychiatric setting on two or more antipsychotic medications with appropriate justification  

HBIPS-6 Post discharge continuing care plan created. Patients discharged from a hospital-based inpatient psychiatric setting with a continuing care plan created.

HBIPS-7 Post discharge continuing care plan transmitted to next level of care provider upon discharge.  Patients discharged from a hospital-based inpatient psychiatric setting with a continuing care plan provided to the next level of care clinician or entity          

The measures that will be shown on our website ( include all the measures except the first where the data has not been released.  Age stratification is available on most measures.

Wednesday, August 27, 2014

New Labels Proposed by the FDA

Check out the proposed changes by the FDA to the labels found on most food packages in the U.S.  See below for the highlighted changes. Under the changes, Vitamin A and C would no longer be required to be reported. 
More interesting is the proposed change to what a serving size is-
"Change the serving size requirements to reflect how people eat and drink today, which has changed since serving sizes were first established 20 years ago. By law, the label information on serving sizes must be based on what people actually eat, not on what they “should” be eating."
Serving size changes based on consumer behavior? 
Here are the other proposed changes to the labels:
  • Require information about “added sugars.” Many experts recommend consuming fewer calories from added sugar because they can decrease the intake of nutrient-rich foods while increasing calorie intake.
  • Update daily values for nutrients like sodium, dietary fiber and Vitamin D. Daily values are used to calculate the Percent Daily Value listed on the label, which help consumers understand the nutrition information in the context of a total daily diet.
  • Require manufacturers to declare the amount of potassium and Vitamin D on the label, because they are new “nutrients of public health significance.” Calcium and iron would continue to be required, and Vitamins A and C could be included on a voluntary basis.
  • While continuing to require “Total Fat,” “Saturated Fat,” and “Trans Fat” on the label, “Calories from Fat” would be removed because research shows the type of fat is more important than the amount.
  • Require that packaged foods, including drinks, that are typically eaten in one sitting be labeled as a single serving and that calorie and nutrient information be declared for the entire package. For example, a 20-ounce bottle of soda, typically consumed in a single sitting, would be labeled as one serving rather than as more than one serving.
  • For certain packages that are larger and could be consumed in one sitting or multiple sittings, manufacturers would have to provide “dual column” labels to indicate both “per serving” and “per package” calories and nutrient information. Examples would be a 24-ounce bottle of soda or a pint of ice cream. This way, people would be able to easily understand how many calories and nutrients they are getting if they eat or drink the entire package at one time.
  • Make calories and serving sizes more prominent to emphasize parts of the label that are important in addressing current public health concerns such as obesity, diabetes, and cardiovascular disease.
  • Shift the Percent Daily Value to the left of the label, so it would come first. This is important because the Percent Daily Value tells you how much of certain nutrients you are getting from a particular food in the context of a total daily diet.
  • Change the footnote to more clearly explain the meaning of the Percent Daily Value.
  • What do you think about these changes?

    Tuesday, August 19, 2014

    9 in 10 children don't eat enough vegetables

    healthy eatingAccording to the CDC, the amount of whole fruit (*Includes all forms of fruit (fresh, frozen, canned, and dried) children, 2-18 years old, ate increased by 67% from 2003 to 2010 and replaced fruit juice as the main contributor of fruit to children's diets. However, the amount of vegetables children ate did not change from 2003 to 2010. 

    Although we had this increase, the CDC states that children are still not eating the recommended amount of fruit and vegetables. 9 in 10 children didn't eat enough vegetables in 2007-2010.

    What can parents do? The CDC offers these suggestions.
    • Eat fruit and vegetables with their children.
    • If serving frozen or canned vegetables or fruit, choose those with low or no sodium and no added sugar.
    • Provide fruit and vegetables for snacks instead of less healthy options.
    • Include their children when shopping for, growing, and preparing fruit and vegetables.
    • Encourage children to eat a variety of fruit and vegetables, even if it takes many tries.
    • Learn what counts as a cup of fruit or vegetables, for example:
          • 1 small apple; 8 large strawberries.
          • 12 baby carrots; 1 large ear of corn.

    What are your successful tips for getting children to eat fruits and vegetables?

    Wednesday, July 30, 2014

    Mismatched mechnical lift and sling cause of Darlene's death. Is she the only one?

    With the national average for nursing home falls with major injury at 3.2%, there is a lot of room for improvement. It never occured to me that one of the causes would be from the use of mechanical lift.  Afterall, mechanical lift equipment was created to assist in fall reduction and assist in patient safety.

    Nursing home resident, Darlene Carbaugh, died from a nursing home's decision to mix and match lift equipment- the sling and mechanical lift were from different companies. During a transfer nursing home staff used a Medline mechanical lift with a sling manufactured by Arjo. Medline Lift Manual warns about using non Medline Slings. See picture below.   Darlene, 87, was a former school teacher, mother of two sons, and wife to WWII veteran. You can see her bright smile in this article in the Des Moines Register.


    The MDS coordinator for the nursing home stated there were two Arjo slings in the facility, no Medline slings. State report here.

    Patient families need to start asking questions and be knowledgeable about these types of issues.

    One easy way to prevent this type of issue is to require a product number specific to the mechanical lift prior to an order completion.

    What are your thoughts?

    Is this something you would check for or ask questions before you choose a nursing home for yourself or a loved one if they needed mechanical assistance? What about hospitals or rehab centers?

    Wednesday, July 2, 2014

    CHF(Chronic Heart Failure) Discharge Instructions

    The national average across participating hospitals for heart failure patients receiving discharge instructions (HF-1) is 94%. There is no mystery as to why it is that high, after all this was one of the very first quality measures rolled out to hospitals that accept Medicare over 10 years ago (May 2001).
    Why is it important for a CHF/Heart Failure patient to get discharge instructons? From Medicare’s website: Heart failure is a chronic condition. It results in symptoms such as shortness of breath, dizziness, and fatigue. Before you leave the hospital, the staff at the hospital should provide you with information to help you manage the symptoms after you get home. The information should include your

    ·         Activity level (what you can and can't do);
    ·         Diet (what you should, and shouldn't eat or drink);
    ·         Medications;
    ·         Follow-up appointment;
    ·         Watching your daily weight; and
    ·         What to do if your symptoms get worse.

    Giving discharge instructions to CHF patients is particularly important since 23% of heart failure patients are readmitted to the hospital within 30 days unplanned.

    To see how your hospital performs, look them up by zip code here and click on their quality tab to see what their success rate is in giving discharge instructions to heart failure patients.

    Thursday, June 19, 2014

    E-cigarettes are not regulated by the FDA

    Electronic cigarettes, also known as e-cigarettes, are battery-operated products designed to deliver nicotine, flavor and other chemicals. They turn chemicals, including highly addictive nicotine, into an aerosol that is inhaled by the user. The FDA is not currently regulating e-cigarettes.

    Currently, the FDA Center for Tobacco Products (CTP) regulates
    • cigarettes,
    • cigarette tobacco,
    • roll-your-own tobacco, and
    • smokeless tobacco.
    We regularly receive voluntary reports1 of adverse events involving e-cigarettes from consumers, health professionals and concerned members of the public. The adverse events described in these reports have included hospitalization for illnesses such as
    • pneumonia,
    • congestive heart failure,
    • disorientation,
    • seizure,
    • hypotension, and
    • other health problems.
    Whether e-cigarettes caused these reported adverse events is unknown. Some of the adverse events could be related to a pre-existing medical condition or to other causes that were not reported to FDA. You can review the adverse event reports for e-cigarettes that were voluntarily reported to FDA from 6/22/2009 to 3/12/2014 at the CTP FOIA Electronic Reading Room.

    Sunday, May 25, 2014

    4 Summer Driving Tips We Can All Use

    Even with the increasing gas prices, vacationers are taking to the roads. The National Highway Traffic Safety Administration has released these tips to avoid fatalities on our roadways:

    • Buckle Up. Every Trip. Every Time. – Everybody aboard must agree to wear their seatbelts every time they are riding or driving in your vehicle. Wearing a seatbelt is also the best defense against a drunk-driving related crash. For more information on seatbelt safety please click here.
    • Don't Drive After Drinking – Drunk driving deaths spike during the holidays. Every 51 minutes, someone in the United States dies in an alcohol-impaired-driving crash. Be responsible – don’t drink and drive. If you plan to drink, choose a sober designated driver before going out. For more information on NHTSA Drunk Driving prevention efforts click here.
    • Check your Tire’s Air Pressure, Tread Wear, and Spare – NHTSA recently launched its TireWise campaign to provide consumers and retailers with essential information about choosing and caring for tires. Proper tire maintenance is especially important if traveling by 15-Passenger Van. Please click here for additional information on 15-Passenger Van safety.
    • Keep Children Safe In and Around Your Vehicle – Make sure car seats and booster seats are properly installed and that any children riding with you are in the car seat or booster seat best suited to protect them. There are other dangers to children in and around cars that you should know. One of those dangers is hyperthermia, or heat stroke, from being left unattended in a hot vehicle. to find out more about how to keep children safe while in and around your vehicle.

    Saturday, May 24, 2014

    EMS Week 2014 May 18- May 24

    This year marks the 40th anniversary of EMS (Emergency Medical Service) week.  In 1974, President Gerald Ford made the started the week to recognize the dedication of these medical personnel  who provide the day-to-day lifesaving services of emergency medicine's "front line".

    Last year, President Obama said:

    "When Americans find themselves in times of crisis — from car accidents to national tragedies — our robust network of EMS professionals ensures that quality medical care is only moments away. This week, let us RECOMMIT TO SUPPORTING EMS personnel and thanking them for their heroic contributions to our lives."

    If you know an EMT or Paramedic, be sure to Thank Them for their service this week. A great way to do so is by sharing it on where you can give online recognition at no cost.  Let's show them how much we appreciate their dedication.