Medicine

The Future of Health Insurance

The Patient Protection and Affordable Care Act passed on March 23, 2010. The underlying philosophy was to make coverage available and affordable to all Americans.  At the time, there were approximately 45 million uninsured individuals in the US. Today, that number is about 28 million. The tax credits or subsidies have helped many to afford […]

The Patient Protection and Affordable Care Act passed on March 23, 2010. The underlying philosophy was to make coverage available and affordable to all Americans.  At the time, there were approximately 45 million uninsured individuals in the US. Today, that number is about 28 million. The tax credits or subsidies have helped many to afford health insurance coverage. The expansion of Medicaid in Pennsylvania has also allowed more to find the coverage they need. Yet health insurance rates have been on a steady increase for both employers purchasing health insurance coverage and for individuals. The ACA has imposed a myriad of regulations on health insurance carriers and the Federally Facilitated Marketplace in Pennsylvania; also known as the Exchange.

President Trump campaigned on repeal and replacement of the ACA, but that has not yet come to fruition. The House passed the AHCA, American Health Care Act. The Senate created its own bill, BCRA, the Better Care Reconciliation Act. Versions of each, with necessary updates, continue to be discussed among the Legislators.  There is a bipartisan group of 43 in the House, the Problem Solvers Caucus. They want to discuss the reforms needed within the ACA. Their main concerns are: to continue the Cost Sharing Reduction subsidies for individuals below 250% of the Federal Poverty Limit; a dedicated stability fund to help states to keep costs down (reinsurance); exempt “small” businesses from the employer mandate by raising the definition to those businesses with more than 500 employees; repeal of the medical device tax, a 2.3% tax on items like pacemakers and knee replacements; and the ability to sell insurance across state lines.

There are a few other ideas that have continued to garner support as a way to fix the ACA. One of those is to increase the rating ratio from 3:1 to 5:1. Currently, a 64-year-old cannot be charged more than three times the 21-year-old. Along with this comes the suggestion to give more generous subsidies to older Americans. There are discussions of price controls on prescriptions drugs, allowing Medicare to negotiate pricing, and reviewing how other countries control the prices of pharmaceuticals. The use of bundled payments for care versus episodic payments has helped to reduce costs. A knee replacement, as an example, would be one payment to the Hospital and another to the Doctor for pre-operation, operation, and post-operative care.  Antitrust reform to control the hospital mergers; the consolidation of services can be positive, but the elimination of competition often drives prices higher. Tort reform has always been debated as a way to reduce costs. The abuse of malpractice suits means that hospitals and doctors over-treat and over-test.

The idea of “Medicare for All” was a campaign highlight for the Democrats in the last presidential election process. There has been talk about reducing the eligibility to age 55, instead of 65, to enroll in Medicare. Of course, this would require some changes in the type of plans offered. Those 55 and older and still actively at work have demands for health care that are different from those who are retired.

There is not much language available now to show how we would transition from our current system to a “Medicare for All” system. Private insurance companies have no role in the Sanders version of single-payer, other than providing supplemental insurance. The biggest concern is how to pay for it. Vermont studied the viability of a single-payer Exchange for their state, before scrapping the idea, in part, because of cost. It was on the ballot for Colorado voters, who turned it down. California continues to debate the idea of a state single-payer Marketplace. Financing has been a stumbling block. Rep. Conyers has over 100 backers in the House for his version of a single-payer legislation. It will be a tough road ahead with a Republican-controlled House, Senate, and President.

A recent Pew Research Center poll shows that overall, 33% of Americans believe health care should be a single-payer setup. The poll also found that roughly 60% of Americans believe the government is responsible for making sure all Americans have health insurance. Where do you stand on the issue? Use your vote in the upcoming 2018 elections to make your voice heard.

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Recharge – Reset – Repeat

How many times have you felt the need to get out of town for the weekend to recharge and feel like yourself again? In today’s fast paced society we are stressed more than ever before and often do not do enough to reset and recharge. At some point in our life, we must cope with […]

How many times have you felt the need to get out of town for the weekend to recharge and feel like yourself again? In today’s fast paced society we are stressed more than ever before and often do not do enough to reset and recharge. At some point in our life, we must cope with stress. You cannot always anticipate when something will make you feel overwhelmed. Often, the best you can do is to use the healthy coping skills that you have developed throughout life to help you manage your current stressors.

Managing stress comes in all shapes and sizes. In times of change, you want to realize and understand your perception and interpretation of the situation that determines how change affects us. You want to change toxic and irrational thought patterns, such as “I must be competent at all times!” and replace absolutes with “I am not perfect- I am doing the best I can do.”

Stress does not always have to be negative. Some aspects of stress can be both healthy and rewarding, such as engaging in a sport or recreational activity as well as working hard to complete a project. Work stress can also be seen as positive. Too many times the stress one encounters at work does not stay there which can negatively affect our relationship with others and yourself. Work stress can help one grow and change. Work stress forces one to learn new skills and creative ways to think to solve problems. Practicing self-care techniques improves the body and the mind. Remember how important it is to meet the physical and psychological needs for exercise, rest, good nutrition, and recreation. Disconnect from the screens we are connected to and try new activities!

It is important to remember to focus on what you can control, not what you cannot control. Do not attempt to control the uncontrollable! Change can be overbearing. A way to make change more bearable is to break the change up into smaller steps and short-term goals. Remember to welcome feelings, both good and unpleasant, and learn to cope well with the “bad” ones. When you are stressed and experience unpleasant feelings, the best thing is to recognize and accept them. Unpleasant feelings are unavoidable and normal. They grow and intensify when you push them out of sight. Those who do not judge their feelings and accept their own doubts and limitations will have less stress and enjoy their lives more.

No matter how stressful things can be, do not forget to laugh and use your sense of humor. Reach out and connect with others, so you do not feel alone. When you develop good, supportive relationships change is easier to understand. It is important to not keep your feelings in and isolate yourself. Remember you can seek professional help when you feel over-stressed. It is not a sign of weakness; it shows strength and courage to realize that help is needed.

There are many ways to manage stress. A few good rules include:

  • Do not take responsibility for the things you cannot control
  • Take care of yourself, or you can’t take care of anyone else
  • Rushing can increase stress, remain in the present
  • Be accepting of yourself, don’t ignore feelings and needs; accept limitations
  • Limit the “should’s”
  • Be accepting of others
  • Ask for support when you need it
  • Accept, Alter or Avoid a negative situation
  • If you never make mistakes, you’re not learning anything
  • Life is not fair or a contest, do not compare
  • One has to begin where one is

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Breast Reconstruction

Rebuilding Since 1895 Plastic surgery. Both praised and criticized in the mass media; cosmetic surgical procedures have always been seen as slightly taboo. Shrinking factions of modern-day culture often look down upon the altering of one’s physical features, a criticism admittedly not without merit. While many believe cosmetic surgery is simply a tool used to […]

Rebuilding Since 1895

Plastic surgery. Both praised and criticized in the mass media; cosmetic surgical procedures have always been seen as slightly taboo. Shrinking factions of modern-day culture often look down upon the altering of one’s physical features, a criticism admittedly not without merit. While many believe cosmetic surgery is simply a tool used to enhance one’s existing features and increase body positivity, others attack its artificiality; “natural” beauty is to be embraced without alterations, they argue. But one often overlooked portion of the plastic surgery industry, encompassing over a quarter of all procedures, will rarely draw controversy.

Whether through physical trauma or disease, disfigurements to the body are emotionally devastating. And it’s up to a plastic surgeon to restore a patient’s confidence in their own skin. According to the American Society of Plastic Surgeons, over 5.8 million reconstructive procedures were performed in the United States in 2016. Of those (excluding tumor removals), laceration repairs, maxillofacial surgeries, and scar revisions topped the charts.

But the next most common procedure is fairly unique in origin. While lacerations and maxillofacial injuries and scars are often the results of physically traumatic accidents, the disfigurement caused by breast cancer is incomparable in nature.

The removal of cancerous breast tissue can be devastating both physically and mentally to a breast cancer patient. And considering the fact that breast cancer is the most common cancer among women, amounting to about a quarter of all female cancer cases, extensive research has been done into treatment options for those affected. In fact, the oldest evidence of breast cancer treatment comes from the Edwin Smith Papyrus, estimated to have been written about 3600 years ago in Egypt. It describes eight cases of breast tumors which were treated with cauterization of the breast, noting that “there is no treatment” for this disease.

Between ancient Egypt and the 17th century, little advancement towards treatment was made. Medical practitioners occupied themselves with postulating preventative measures rather than responsive treatments. And the treatments that were proposed were often barbaric; prescriptions of poisonous herbs and chemicals, including arsenic, were common due to the danger associated with surgical removal of the affected tissue. Even when it was discovered that excision of the tumor was often necessary for a positive prognosis, little thought was given to recovery after surgery. Early mastectomies from the 6th century and on were brutal and disfiguring, leaving a woman’s chest looking “like a skeleton” in most cases; as time passed, surgeons began to remove more of the affected area, including lymph nodes and underlying muscles. These procedures were later refined and became known as radical mastectomies, a term popularized by American surgeon William Stewart Halsted, who was aided by modern anesthesia and aseptic technique decreasing the risk of pain, trauma, and infection in the late 1800’s.

Still, little consideration was made towards post-surgical physical rehabilitation in the form of reconstruction. Radical and so-called “super radical” mastectomies left little tissue to work with. The first documented attempt at a breast reconstruction did not occur until 1895 when Vincent Czerny, a surgery professor in Heidelberg, transplanted a lipoma from the patient’s flank to her breast. Over the next few decades, rare attempts at reconstruction were made using various tissues from other locations on the body. Early reconstructive attempts were often risky and laden with complications such as necrosis of the tissue and heavy scarring; reconstruction was rarely recommended.

It wasn’t until 1963 with the introduction of the silicone implant that the modern era of breast reconstruction began. From there, research advanced quickly. Implants were generally inserted with a brief delay following mastectomy, but in 1971 it was reported that immediate silicone implants inserted in place of the removed tissue underneath the breast wall proved to be more effective and less traumatic.

Various types of flaps were also designed, using the patient’s own tissue to reconstruct a breast mound.  Continued refinements were made to improve surgical procedures and appearance of the reconstructed breast.

Significant research in the 1980’s and 1990’s confirmed that breast reconstruction performed immediately after mastectomy, during the same surgical procedure, did not lead to increased recurrence of breast cancer.  This led to the current standard of care of immediate breast reconstruction where an oncologic surgeon performs the mastectomy procedure and a plastic surgeon performs the breast reconstruction immediately afterwards so that when the patient wakes up from anesthesia, she does not have a devastating mastectomy defect, but rather has begun the process of moving forward to become whole again.

Today plastic surgeons work closely with their oncologic surgeons to determine the best surgical plan for treatment of the patient who requires mastectomy for treatment of breast cancer.

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Hair On… Hair Off

It’s a running joke that when men lose the hair on their heads, it inevitably shows up somewhere unwanted. Many will shave or wax during the summer.  Others opt for a more permanent solution. I’ve treated thousands of men and women in the Lehigh Valley who have wanted to discreetly and permanently get rid of […]

It’s a running joke that when men lose the hair on their heads, it inevitably shows up somewhere unwanted. Many will shave or wax during the summer.  Others opt for a more permanent solution.

I’ve treated thousands of men and women in the Lehigh Valley who have wanted to discreetly and permanently get rid of hair in a variety of places (men often ask for back and shoulders.  Women aim for the underarms, legs and bikini line).  I am proud to say I was one of the first physicians in the country to use lasers to remove hair.  Since then, I’ve been active in the development of new treatment parameters to make certain laser hair removal remains safe and effective. Typical treatment to reduce and remove hair involves a series of four to six treatments, spaced six weeks apart.  The hair needs to be treated across the entire growing cycle to make sure you get it all.  So if you want the hair removed before summer, it’s best to start the process in the Fall or Winter.

All that said, one laser is never enough.  Always look for a practice with experience and access to multiple lasers to treat multiple kinds of hair.  Your skin tone and hair color all work into the equation.  A person with light skin and dark hair responds to many systems, but patients with light hair need different wavelengths of light to successfully treat and reduce hair.  I cannot tell you how many blonde or gray haired laser hair removal patients we see after they’ve cashed in a Groupon at a laser clinic with just one laser, only to be disappointed with the results.  Shop around!  Currently, we are using Palomar’s Icon™ system as our primary system at our Bethlehem office. The Icon system utilizes the revolutionary SkinTel system that performs exact pigment typing that allows for optimized and safe laser parameters, while our long pulsed YAG laser is reserved for resistant hair in patients with darker skin types.  Other available lasers for hair removal at Aesthetica include the Spectra Q-switched YAG laser, the Lutronic Advantage, and the Viora V20.

There’s something for even the most stubborn cases.

On the opposite side of the discussion, there are men and women who struggle with hair loss.  There are emerging solutions for that, too.

We always suggest our patients try topical treatments first (things like Rogaine, etc.) or oral medications.  If those fail, surgical hair transplants have been widely used for years.  Now, we have an exciting option that can delay or completely negate the need for surgery, platelet rich plasma (PRP) that can stimulate hair growth at the site.

PRP utilizes the body’s own potent growth factors found in platelets to stimulate natural hair growth. By delivering the platelet-derived growth factors to a patient’s area of thinning hair, PRP treatment is able to promote the growth of healthy hair.

We use the Selphyl® system in our office.  We take a small sample of your own blood and spin it in a centrifuge, separating the platelet rich plasma.  The PRP is injected into the scalp, stimulating each hair shaft.  Most patients come in for a series of three different visits.  While not instant, optimum results are seen in the first 12 months.  Hair gets thicker, more hairs grow, and fewer are lost.  Results are natural and lasting, often improving over time.

Sports medicine has used PRP for years to treat injuries to the Achilles tendon, joints and muscles by stimulating stem cells. In the case of hair loss, the injected platelets prompt inactive or newly implanted hair follicles to enter an active growth phase, causing the hair to start growing again.

While none of the hair reduction or replacement treatments are typically covered by insurance, the cost ranges from hundreds of dollars versus the thousands you can spend on surgical solutions.

Whether it’s hair on…or off.  We’ve got you covered!

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Why the proposed changes to Medicaid are a really bad idea.

Seventy-four million people in the U.S. currently receive their health insurance through Medicaid. When the Affordable Care Act was introduced, almost 20 million of these gained medical insurance through Medicaid expansion*.  As a result, healthcare has become more accessible to millions of people, and the primary point of care has shifted from hospital emergency rooms […]

Seventy-four million people in the U.S. currently receive their health insurance through Medicaid. When the Affordable Care Act was introduced, almost 20 million of these gained medical insurance through Medicaid expansion*.  As a result, healthcare has become more accessible to millions of people, and the primary point of care has shifted from hospital emergency rooms to physician’s offices, as it should be.

The Medicaid program delivers health insurance to poor, working-age people, including children, the disabled, and patients needing long-term care in nursing homes. The individual states administer it within Federal statutes and rules, and the states are reimbursed at least 50% by the federal government. Each state creates their own policies, eligibility and reimbursement rates for doctors, nursing homes, and hospitals.

The proposed cuts to Medicaid now working their way through Congress as the American Health Care Act (AHCA), will shift the financial burden of treatment back to hospital emergency departments, as millions of Americans lose their health insurance. The House’s proposed changes to Medicaid funding will have a significant impact on state spending, vastly reducing enrollment in Medicaid and reducing physician and hospital reimbursement. Governor Wolf has predicted that Pennsylvania would lose $2 Billion in federal funding for Medicaid – an amount which he says, the state couldn’t possibly absorb, since Pennsylvania is already facing a $3 Billion deficit.

How the AHCA will change Medicaid

The proposed changes, if passed, would reduce each state’s flexibility in adapting to the unique changes in the needs of its Medicaid enrollees. The needs of each state differ and are influenced by a number of factors, primarily age and income. The states with the highest poverty rates and an older, working-age population would carry an especially heavy burden.

Under the proposed Medicaid changes,

  • There would be a strict ceiling on federal funding for every Medicaid beneficiary.
  • States would be limited to the benefits they could offer Medicaid enrollees and their reimbursements to physicians.
  • The federal government would continue paying Medicaid reimbursement through 2019. But In 2020, Medicaid expansion would be frozen, and the financial burden for new enrollees would fall on the individual states.

The Congressional Budget Office (CBO) estimates that the AHCA will result in a near-doubling of the U.S.’s uninsured rate to 19% of the poor, working-age population, up from the current 10%. The largest segment of those who lose coverage would be older, low-income Americans, a group which tends to have higher overall health care costs. The burden for covering the health concerns of these patients would fall to the states and local hospitals through charity care funding.

PA Foot and Ankle Associates is one of the largest podiatric practices in the Lehigh Valley, being that we treat a significant number of Medicaid patients. Foot, ankle and lower leg problems which occur as the result of obesity, old age, and diabetes, must be treated in a timely manner – preferably as soon as symptoms are detected. When a patient has no health insurance, they typically delay treatment until a problem becomes severe and sometimes life-threatening. These patients frequently require hospitalization and surgery, when in most cases, in-office treatment and monitoring during the early stages of their condition would have avoided these serious and costly consequences.

Pennsylvania, and indeed every state, has spent 50 years building their Medicaid programs to care for their most vulnerable citizens. These programs have been built according to federal guidelines and federal reimbursements. Dismantling Medicaid to the degree the AHCA proposes would be disastrous for patients, physicians and hospitals alike.
*According to the Henry J. Kaiser family Foundation

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Vaccine Refusal and Delay

MEDICAL AND LEGAL IMPLICATIONS FACTS DO MATTER Should all children be required to have all recommended vaccines/some vaccines for school entry, Day Care, college? Do parents who refuse or delay vaccines for their children have a responsibility to other children and the community? Liability for not doing so? Vaccines have been one of the most […]

MEDICAL AND LEGAL IMPLICATIONS

FACTS DO MATTER

Should all children be required to have all recommended vaccines/some vaccines for school entry, Day Care, college?

Do parents who refuse or delay vaccines for their children have a responsibility to other children and the community? Liability for not doing so?

Vaccines have been one of the most effective preventive health measures in medical history. A study by the CDC(Centers for Disease Control) found that among children born between 1994 and 2013, full vaccination would have prevented 732,000 deaths. Scientific studies have shown that unvaccinated children (primarily for nonmedical reasons) have a 9-fold increased risk of varicella (chickenpox), up to a 35-fold increased risk of measles and a 6-28-fold increase in pertussis (whooping cough) compared to vaccinated peers. Delay in receiving vaccines at the recommended times generally results in more severe disease in infants and younger children who contract vaccine-preventable diseases. In addition, there is a risk of community outbreaks of these diseases.

Vaccine refusal and delay is a complex problem influenced by several factors, including convenience, confidence, and complacency. Convenience relates to availability, affordability, and accessibility of vaccines. Vaccines are widely available and covered by almost all insurers, including Medicaid. In addition, there is a program in our state that provides free vaccines to children without insurance. Health departments also provide free vaccines to those in need.

Confidence in vaccine effectiveness and safety has declined in recent years because of lower trust in our government, vaccine manufacturers, and health professionals. Complacency has occurred because of a widely held belief by parents who have not seen vaccine-preventable diseases that these diseases are not serious and do not pose a risk to their children or other children. Because vaccines have been so effective in nearly eliminating many diseases, many parents have not seen these diseases and don’t know about the potentially serious complications and effects of the diseases covered by the vaccines.

Immunization laws are state-regulated and vary among states. Vaccines are required for all children attending Day Care and school, but states vary as to which vaccines are required. Exemptions are granted for three reasons-medical, religious and philosophical.

Pennsylvania allows all of these exemptions. The most controversial and nonspecific exemption is philosophical, interpreted as personal, moral or philosophical belief against some/all vaccines. States with religious and philosophical exemptions have higher rates of vaccine-preventable diseases. Nonmedical exemptions are the primary reason for vaccine refusal or delay, which occurs in up to 6.2% of children.

Parents primarily refuse vaccines because of safety concerns and studies indicate that 60-70% of all exemptions are due to safety concerns. These concerns vary and include many alleged side effects such as autism(not shown), neurological damage(not shown), overload of the immune system(not shown), autoimmune diseases(not shown), Guillain-Barre syndrome(rare), susceptibility to infection(not shown) and intussusception (coiling of intestine within itself requiring emergency treatment-rare). Some of the concerns relate to rare, but serious or potentially serious side effects. Most vaccine side effects are minor, self-limited and modifiable, consisting of low-grade fever, injection site redness and tenderness.

The Institute of Medicine has systematically reviewed well over 200 studies regarding potential side effects and found a true causal relationship between vaccines and only a small number of significant side effects. They concluded that vaccines do not cause autism, neurological/developmental problems or Diabetes. There has been a great deal of scientifically unfounded public attention regarding thimerosal, used as a preservative in multiple-dose vaccines, and neurological side effects. There are also several misperceived concerns resulting in vaccine delay or refusal, including low-grade fever, minor illnesses, prior mild injection site reactions, antibiotic use at the time of immunizations, recent exposure to infections and penicillin or non-vaccine allergies.

The true medical reasons to withhold or delay vaccines include potential allergic reactions to the vaccines or one of its components. The other main category relates to risk in children who have certain types of deficiencies in their immune systems. The potential allergic reaction of most concern is anaphylaxis, a life-threatening multi-system allergic reaction. The actual incidence of this problem has been shown to be very small, 5 cases/7.5 million doses in one large study. In many cases, the vaccines can be administered as long as the staff can manage a potential allergic reaction. The concerns for children with certain specific immune deficits is primarily with live vaccines, and many of these conditions are temporary (chemotherapy, HIV, certain medications) and vaccines can be resumed when conditions improve.

Regarding religious exemptions for vaccines, there are some specific concerns expressed by certain religions and groups. Some vaccines use cells from aborted fetuses to grow the specific virus and manufacture the vaccine. These fetuses were aborted for other reasons and the Catholic Church has endorsed vaccines because of the overriding public health benefit of vaccines. Jewish and Islamic people do not consume pork and some vaccines use pork-derived gelatin as a stabilizer. However, Jewish and Muslim scholars endorse vaccines because vaccines are not ingested as food.

Vaccine effectiveness varies and no vaccine is 100 percent effective or can be expected to be so. Most are highly effective and protect 95 percent or more of those immunized according to the recommended schedule. They provide a great benefit to individuals as well as the community because of a key public health concept of herd immunity. This relates to the protection of those who cannot safely receive certain vaccines being dependent on the complete vaccination of the rest of the community(90-95% of community needs to be immunized). There have been several outbreaks of highly contagious and potentially dangerous diseases like measles, mumps, and pertussis because of vaccine refusal and delay.

Ethical concerns have been raised and are a consideration in vaccine requirements. The key issues relating to the balance of parental rights and personal liberty and the societal rights to protect children and the community. Most believe that the public health value of vaccines and allowing nonmedical exemptions are not equal alternatives. Nonmedical exemptions have resulted in increased outbreaks of vaccine-preventable infections along with their complications.

In summary, the effectiveness of vaccines balanced against the common minor side effects and rare more serious side effects strongly supports their use in all children other than those who truly cannot receive certain vaccines because of medical reasons. The science and many decades of successful vaccine implementation, as well as the continued improvement in the technology with the development of new vaccines, have a profound benefit for the health of children and communities.

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bridging-gap

Bridging the Gap Through Smiles

Setting the standard for excellence in oral surgery, Dr. Wayne J. Saunders began The Center for Oral and Maxillofacial Surgery over 15 years ago as a solo practice.  Now known as St. Luke’s OMS, the practice has grown to a twelve-doctor practice with four locations throughout the Lehigh Valley, and a new location in Stroudsburg, […]

Setting the standard for excellence in oral surgery, Dr. Wayne J. Saunders began The Center for Oral and Maxillofacial Surgery over 15 years ago as a solo practice.  Now known as St. Luke’s OMS, the practice has grown to a twelve-doctor practice with four locations throughout the Lehigh Valley, and a new location in Stroudsburg, PA.  Still, the largest practice in the area, St. Luke’s OMS continues to be the most innovative.  The practice is proud to announce the addition of not only the area’s first and only female oral surgeon but also the first Latina and Spanish speaking surgeon – Dr. Veronica Barreto!

“I feel honored that I was given the opportunity to be the first female oral surgeon in the area,”  states Dr. Barreto.  “I can understand being a female in a male-dominated specialty can come with its own sets of challenges and preconceived notions, but I embrace those challenges with warmth and laughter.”

Dr. Barreto received her dental degree from the Maurie H. Kornberg school of dentistry in Philadelphia, PA where she graduated magna cum laude, then completing her residency training at Temple University Hospital.  She was the recipient of several awards including American Academy of Pediatric Dentists Predoctoral Student Award,  the American Association of Endodontists Student Achievement Award and the Edward B. and Arnold R. Cook Prize in Children’s Dentistry.  During her dental school training, she also volunteered abroad, providing dental care and oral health awareness to the underserved populations in Costa Rica and Panama.

“Barreto is the perfect addition to the practice,” states Dr. Saunders, founder and managing partner of St. Luke’s OMS.   “Aside from being a clearly skilled surgeon, myself and the other doctors are happy to have not only a skilled female surgeon alongside us but also someone who is able to speak Spanish.  Barreto not only is a great doctor, but she embodies the spirit of the practice with her philanthropic background.  Giving back to the community is a large part of what we do, and I have no doubt she will help us continue that mission.”

Barreto hopes to inspire others with her career choice and new position.  “I hope that being a surgeon and a female will help to break barriers and set an example for other aspiring amazing women to join this highly rewarding profession,” Barreto proudly exclaims.  “I plan to offer patients the utmost care just like any one of our doctors at St. Luke’s OMS would provide, and I know that being a female is just the icing on the cake!”
Dr. Barreto and the other St. Luke’s OMS surgeons offer a full range of oral and facial procedures.   The mission of all surgeons at St. Luke’s OMS is to provide patients with affordable, high-quality, state-of-the-art care in a gentle, safe and secure environment.

For more information on Dr. Veonica Barreto or any of the other St. Luke’s OMS Surgeons, please call 610.865.8077, or visit StLukesOMS.com.

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medical

Quality Management Systems for Medical Device Manufacturing and Supply Companies

In general, manufacturing is manufacturing; just make a thing.  When talking about a medical device, a “thing” that could affect human health, there’s more to think about than your production line, though. Quality management systems…really exciting stuff, I know.  Typically, poorly understood and unpopular subjects with fast-moving entrepreneurs, they are usually thought to be blockades […]

In general, manufacturing is manufacturing; just make a thing.  When talking about a medical device, a “thing” that could affect human health, there’s more to think about than your production line, though.

Quality management systems…really exciting stuff, I know.  Typically, poorly understood and unpopular subjects with fast-moving entrepreneurs, they are usually thought to be blockades to market entry or hoops you need to jump through.   Unfortunately, these systems are also necessary evils in the world of medical device manufacturing and supply, and sometimes just good business practice.

Okay, so what is a quality management system?  According to the definition, “A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction.”  Simplified, it’s making sure what you make meets your client’s needs and keeps them happy.  Seems simple enough, right?  But mention FDA inspections, audits, and potential jail time for the owner or principals of a company, and people get nervous.

I’ve been in the medical device manufacturing and supply industry my entire career and have found that many people really struggle with quality management systems and implementation.  I think it may be out of fear of doing the wrong thing, but this stuff is pretty straightforward and can even be easy. And you should never fear the audit or the inspection…although jail time is a different story!

Really, the key to implementing a QMS is understanding your needs in the scope of your business model and how it’s most easily conveyed to your employees.  If I were manufacturing a pen, for instance, a couple of bins of parts in front of a worker with a diagram of how those parts fit together may be enough.  Machining a small, highly specific part with multiple pieces, like a stent, however, requires a more thorough document describing the nuances of the process; a simple diagram may not be so appropriate.

For medical device manufacturers or supply companies, there are generally two guidelines for your QMS: FDA 21 CFR part 820 and ISO 13485 (google the acronyms for a good time).  Both FDA and ISO 13485 give an outline of what you, as a medical device manufacturer, need in your QMS.  That said, the FDA regulations and ISO standards are open to interpretation as to how they apply to your company and process.

Basically, you need to have control over how you manufacture, starting with raw materials all the way through your product labeling for your customer. You also need to troubleshoot issues and prevent bad products from reaching the market (doesn’t everyone?). Not a wholly unreasonable proposition.

For a raw material supplier, for which I have worked for two (one supplying highly technical raw materials, one supplying a commodity type product), the ISO standard is for you.  Unfortunately, there is another caveat depending on your business model.  Certainly, the FDA regulations are not your concern, but supplying parts is different from manufacturing a final device.

On the one hand, if you specifically want to target device manufacturers, complying with the 13485 standards is a great selling point / marketing tool.  It can make it easier for certain companies to use you as a supplier as well, and any chance to remove a blockade to sales is just good business sense.  It is also expensive to set up and maintain, which can lead to premium pricing for your products.

Conversely, if you are making a more commoditized product, ISO 9001’s general QMS standards for manufacturing (think making refrigerators, paint, HVAC systems, pens, etc.) are enough.  Even a manufacturer of a medical device wants to go to the lowest bidder.  Although your product was never intended for use in a device, the device manufacturer has to control their supply; the onus is on them, not you.   ISO 9001 is also cheaper and easier to maintain, allowing you to stay competitive with price.

In order to manufacture, market, and sell a final medical device, whether a tongue depressor, hip replacement, or blood test, you need to establish a QMS that meets all of the regulations defined in 21 CFR part 820.  There’s no getting around this one; the FDA has to be involved if you want to be a device manufacturer.

To determine your path, just evaluate your overall business model.  Solicit the opinions of your potential customers, but always do what’s best for your company’s particular situation. It’s not one size fits all when it comes to a QMS, and it’s a complicated business.
If you need an outside opinion, shoot me an email. I’d be happy to help.

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A-Little-Heart

A Little Heart Can Make a Big Difference

We all evolve as we go through life, and if we are truly introspective, many of us will find that our life tragedies and everyday experiences shape our future and the causes that call to us.  I know that has been true for me. In 2012, I felt like I was just starting to make […]

We all evolve as we go through life, and if we are truly introspective, many of us will find that our life tragedies and everyday experiences shape our future and the causes that call to us.  I know that has been true for me.

In 2012, I felt like I was just starting to make a name for myself as a young personal injury litigation attorney, despite having just welcomed two babies into the world only 15 months apart.  While I was still figuring out the work-life balance, I did feel like I had my life relatively well under control.

All of this changed, when one day, I had a heart attack completely out of the blue at age 36.  I had decided to train for the SheRox Triathlon and had begun a swim conditioning class.  I had done a few triathlons in the past (albeit at a slow pace), and I thought this would be a great way to reclaim myself and have some “me” time away from work and family.  After a swim conditioning class, when I pulled myself from the pool, I felt a nagging pain in my upper abdomen behind my breastbone.  That feeling lasted about 15 minutes and resolved.  While it caused concern, a heart attack was not on my radar.

Two mornings later, the feeling returned and eventually led to classic heart attack symptoms – pressure across the chest, shortness of breath, nausea, vomiting, and weakness in the arms.  After a trying time in the hospital, with some initial dismissive treatment from an ER doctor, a heart attack was confirmed, but the cause was something I had never heard before – spontaneous coronary artery dissection or SCAD.

I was told that the doctors rarely see this and know little about it.  Essentially, SCAD occurs when a tear forms in the innermost layer of the coronary artery. The dissection can lead to clot formation at the tear site or otherwise obstruct blood flow starving the heart muscle of oxygen, causing a heart attack.  Unlike the typical heart attack involving atherosclerosis, SCAD is relatively uncommon and often strikes people living healthy lifestyles. For that reason, it is often misdiagnosed.  SCAD disproportionately impacts many more women than men, and because research has historically focused on men, it was not hard to believe that my doctors, in 2012, knew little about SCAD.

The fortuity of the timing of my SCAD heart attack was that the condition was just starting to get some media attention.  The Mayo Clinic in Rochester, MN, had just begun studying the condition, and Robert Alico, with the death of his wife as motivation to find answers, had started the non-profit SCAD Research, Inc., to help fund research endeavors into why SCAD occurs.  The weekend of my SCAD marked the very first 5K fundraiser that SCAD Research hosted in the Chicago, IL, area to raise funds.  The media showed SCAD survivors who were walking, running, and most importantly living after this life altering diagnosis.  I knew what I had to do.

I immediately booked a flight to the Mayo Clinic to be seen by the study doctors and to enroll in the study.  I read every article I could get my hands on.  I joined the Board of Directors for SCAD Research.  I learned that Fibromuscular Dysplasia (“FMD”) is an associated vascular condition, which makes people more susceptible to dissections and aneurysms, and that I have that condition.  I became active in FMDSA.

Because SCAD and FMD are diagnoses that are often overlooked by doctors, raising awareness that these vascular conditions exist and funding the research that will help us fully understand their impact is critical.  The Mayo Clinic doctors now believe that SCAD may be the #1 cause of heart attacks in women under 50 and is the #1 cause of heart attacks in Post-Partum women.

The Lehigh Valley has an opportunity to greatly impact this research as it is now the site of the East Coast 5K SCADaddle fundraiser.  In September 2016, the first Lehigh Valley 5K SCADaddle and Gratitude Gala grossed over $20,000 in donations and proceeds, thanks in large part to friends and family of a local woman, Meagan Duarte, who was taken much too soon from her family as result of SCAD.  We are hopeful to make an even bigger impact on this research in 2017. Consider being a Title Sponsor for the second 5K SCADaddle and Gratitude Gala in the Summer of 2017. Contact SCAD Research, Inc., at 5Keastcoast@scadresearch.org for sponsorship information.

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Winter-Wonders

Winter Wonders for your Skin

Winter is often the time to wear layers and cover up. Believe it or not; it’s actually the best time of year to focus on improving your skin. Many cosmetic dermatology treatments take a series of sessions to get the best results, and no one will ever know what you’re doing since you’re dressed for […]

Winter is often the time to wear layers and cover up. Believe it or not; it’s actually the best time of year to focus on improving your skin. Many cosmetic dermatology treatments take a series of sessions to get the best results, and no one will ever know what you’re doing since you’re dressed for winter! Here are four different conditions we commonly treat this time of year:

1 Sun Damage

As we age, our skin ages with us. Irregularities in pigmentation, called liver spots or age spots, can form. Skin loses youthful tension and collagen, creating wrinkles, and exposure to the sun can give us irregularities called sun spots. Laser Skin Rejuvenation is the process of bringing youthful firmness and complexion to skin that has suffered aging, wrinkles, or sun damage, and restoring a young-looking appearance and youthful feel to the skin.

Addressing your skin concerns during a consultation can help us create a customized solution to rejuvenate your skin. A combination of the highly sophisticated skin care products and the latest laser and light sources for rejuvenation of your skin will be recommended and a timeline established.

2 Spider Veins

If you cover up your legs during the summer because of unsightly (and sometimes uncomfortable) spider veins, winter is an excellent time to treat. Spider veins typically appear on the face or legs and inherit their name from the blue or red spider web shape they take. Since it’s good to have options, we have many lasers at Aesthetica for the treatment of leg veins and spider veins including the visible light V-Beam® Perfecta Pulsed dye laser and Palomar’s Icon™ System. A number of long-pulsed YAG lasers, the Cool Touch Varia V3 laser, and Cutera Excel V laser, are also utilized in treating leg veins.

3 Hair Removal

If you’re sick of shaving or waxing, laser hair removal makes good sense for you. It’s fantastic for people with brown hair and can be performed on the legs, underarms, and bikini line. In fact, I was one of the first physicians in the United States to perform laser hair removal and actively participated in the development of effective treatment parameters for this procedure. Currently, we are using Palomar’s Icon™ system as the primary treatment tool at our Bethlehem office. The Icon system utilizes the revolutionary SkinTel system that performs exact pigment typing that allows for optimized and safe laser parameters. We also have solutions reserved for resistant hair in patients with darker skin types. It’s one of the very first treatments we offered at our practice, and we continue to run specials to make it cost effective (look for one in early 2017).

4 Body Contouring

If you enjoyed a little too much holiday cheer, Aesthetica offers excellent solutions for body contouring. While they aren’t for weight loss, our new Exilis Ultra, Cellutone® and the Viora Reaction systems are used to treat stubborn spots that don’t respond to diet and exercise. We can address lax upper arm skin, baby belly ” pooch,” love handles, “bra fat,” waist and belly areas, “saddle bags,” and cellulite!

As always, it’s best to come in so we can customize a solution for your specific treatments. The right time to get started is now to allow yourself ample time to get ready for summer 2017.

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