This video shows how Dr. Kolodenker specializes in limb preservation of diabetic feet and charcot surgical reconstruction. He demonstrate how to use negative pressure wound therapy pump and how to replace the black foam wound dressing.
Equinox Medical manufactures several negative pressure wound therapy and black foam dressing kits for the wound care market in the USA.
UNI NPWT Foam Dressing
UNI Negative Pressure Wound Therapy Foam Dressing Kit
Negative pressure wound therapy is an effective modality in advance wound care. NPWT requires less dressing changes and it’s a less painful treatment. NPWT can be used in multiple setting from acute care, long term acute care, skilled nursing to home-care. NPWT can bring positive clinical results and provide a better quality of life.
The UNI Foam Dressing Kit is design to universally work with any NPWT pump system. Our dressing can easily adapt and fit with any negative pressure wound therapy pump system.
Our foam dressings are made out of high quality reticulated polyurethane/polyethylene foam with an open pore structure (400-600 microns). The use of our hydrophobic, hydrophilic and silver foam dressings were designed with flexible contours for deep or irregularly shaped wounds. UNI foam dressing kits promote cellular activity and formation of granulation tissues in wounds.
The UNI foam dressings helps draw wound edges together, remove wound fluids and infectious materials. Our foam technology works actively and can easily adapt to any NPWT pump systems.
UNI Black Foam Dressing(Hydrophobic)
- Open-pore, reticulated
- High tensile strength eliminates fraying and reduces contamination and infection
UNI White Foam Dressing(Hydrophillic)
- High density
- Ideal for tunneling and undermining wounds
- Flexible wet or dry, minimizing damage to wound bed
Indication for Use:
The UNI NPWT Foam Dressing is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through removal of excess exudate, infectious material and tissue debris.
UNI Silver Dressings
- Silverlon antimicrobial contact layer, non-adherent to the wound bed
- Available for 3 days use with NPWT application
- Accelerate wound healing and helps eliminate infection.
- FDA K023612
The Obama administration went to great lengths last week to inform us that it recovered $3.3 billion in fraudulent payments to Medicare health care providers in fiscal year 2014. Officials even went so far as to give an advance copy of their report to The Wall Street Journal, which, like the Center for Public Integrity, has been investigating Medicare fraud and abuse.
In a story that appeared in the Journal before the official release of the report, WSJ reporter Stephanie Armour wrote that the recovery “was part of an effort by the Obama administration to improve enforcement and prevent abusive billing practices.” That effort is run jointly by the Department of Health and Human Services the Justice Department.
HHS secretary Sylvia Burwell was quoted in the story as saying that “we’ve cracked down on tens of thousands of health care providers suspected of Medicare fraud,” an effort she said is helping to extend the life of the Medicare Trust Fund.
That’s good news, of course. Taxpayers benefit when doctors and other health care providers get caught trying to rip off the government.
But when it comes taking on big and well-connected insurance companies that have been ripping off the Medicare program for years, the administration has been far less aggressive in catching, much less punishing, the abusers.
As the Center for Public Integrity reported last week, officials in the Obama administration were advised as long ago as 2009 that a formula the government uses to pay private insurers that participate in the Medicare Advantage program “triggered widespread billing errors and overcharges” that waste billions of tax dollars every year.
There was no press release issued by the administration about that 2009 report; in fact, the administration buried it. The report probably never would have surfaced at all had the Center for Public Integrity not filed a Freedom of Information request seeking records going back several years regarding payments to Medicare Advantage plans.
The Medicare Advantage program is a privately run alternative to standard Medicare. Close to a third of Medicare-eligible Americans are now enrolled in insurance company-operated Medicare Advantage plans. People enrolled in these plans typically pay less out of pocket for their care–which explains their appeal–but also typically have a smaller network of providers to choose from.
As Center reporter Fred Schulte explained in his March 13 story, the federal government pays these private health plans a set monthly fee for each patient based on a formula known as a risk score. Risk scores were put in place by the government to measure the state of Medicare Advantage enrollees’ health. “Sicker patients merit higher rates than those in good health,” Schulte wrote.
Schulte’s investigation into risk score payments last year uncovered evidence that the government has been overpaying private insurers for years. That’s because the risk scores can be manipulated by insurers to make it appear that enrollees are sicker than they actually are. Just last week, the Government Accountability Office estimated that “improper payments” to Medicare Advantage plans totaled more than $12 billion in 2014 alone.
When Schulte came across the unpublished 2009 report, he asked CMS why it was never made public.
The explanation he got was preposterous. According to a CMS spokesperson, the agency wanted to publish the report but was told it was too long, that to be considered for publication on a government-run research site, it would have to be “substantially shortened.” This despite the fact that some of the reports that have been published on that site are even longer than the one on risk score manipulation.
The story gets even more incredible. The CMS spokesperson said that “given competing workload demands we were not able to revise and resubmit the article.”
I don’t doubt that the folks at CMS were especially busy in 2009. That’s the year debate began on what would eventually become Obamacare.
Equinox Medical is the fastest growing negative pressure wound therapy (NPWT) pump and black foam dressing company in the USA. FDA approved wound dressings are mandatory to use in nursing home and hospitals.
Next Generation Accountable Care Organization: A New Model From CMS
The new model will build on the experience gleaned from the existing Pioneer and Medicare Shared Savings Program models. These models permit ACOs to retain a percentage of the Medicare savings generated through their coordinated care efforts. While the existing ACO models remain available, the Next Generation initiative is based on two central features that will differentiate it from its predecessors:
- The Next Generation model will allow an ACO to reap greater financial rewards, in exchange for assuming a larger share of financial risk, than under the Shared Savings or Pioneer models.
- Participating ACOs will be able to offer beneficiaries significant “benefit enhancements” designed to encourage more active engagement between the ACOs and the patients they serve.
In order to support the heightened risk and reward potential, the new ACOs will feature different financial terms than are available under the previous models. Next Generation ACOs will be able to choose between the following payments models:
- Traditional Fee-for-Service (“FFS”): Next Generation ACO providers can be paid through normal FFS channels at standard reimbursement levels, as in the standard ACO model.
- FFS Plus a Monthly Infrastructure Payment: In addition to receiving normal FFS reimbursements, Next Generation ACOs can receive a per-beneficiary per-month (“PBPM”) payment allowing the ACO to invest in infrastructure to support its coordinated care activities. These payments will be no higher than $6 PBPM and will be recouped by CMS during reconciliation, irrespective of savings or losses realized by the ACO. In order to qualify for this payment model, an ACO will be required to maintain a financial guarantee large enough to ensure the repayment to CMS.
- Population-Based Payments (“PBP”): This payment model provides monthly payments to ACOs to support ongoing activities and allows greater flexibility in the types of arrangements the ACO can enter into with providers. ACOs and providers will agree on a percentage reduction to FFS payments that otherwise would be made. CMS will then pay the ACO the amount by which the full FFS rates have been reduced pursuant, essentially funding ACO capital in real time through reduced FFS payments.
- Full Capitation: Under the capitation model, CMS will estimate the total annual expenditures for the ACO’s beneficiaries and will pay that amount to the ACO in monthly installments. The ACO then assumes the responsibility for paying its providers for the services they have provided to the ACO’s beneficiaries at rates negotiated between the ACO and its providers. CMS will continue to pay normal FFS claims provided by providers and suppliers with whom the ACO does not have a capitation agreement.
The financial benchmark used to evaluate an ACO’s success in reducing health care expenditures will change as well. The Next Generation model will use a more predictable, stable benchmark that is set prospectively by CMS at the start of each performance year, rather than at the end of each year, as with the Pioneer and Shared Savings Program models. The benchmark will also be amended to reflect the concerns of ACOs under the previous models. Under those models, an ACO’s success was measured in relation to its increased efficiency compared with its past performance. ACOs have expressed concerns that this measurement system penalized ACOs that had already achieved high levels of efficiency, as it is difficult to generate significant increases in cost savings year after year. Responding to these concerns, CMS will alter the Next Generation benchmark calculation by taking into account not only an ACO’s historical performance, but also its regional and national efficiency compared to peers. This may allow historically efficient ACOs to continue to hit critical benchmarks despite decreased relative improvement over time. While the benchmark calculation methodology has been set for the first three Performance Years of the Next Generation ACO, CMS has specifically reserved the right to alter the Participation Agreement in Performance Years 4 and 5 to respond to experience acquired in the early stages of the Next Generation model’s existence.
In addition to these new financial features, the Next Generation model includes several “benefit enhancements” intended to mitigate the higher risk inherent in the Next Generation system by encouraging beneficiaries to seek higher rates of care from the ACO with which they are aligned. These “benefit enhancements” include:
- Co-Pay Waivers: A Next Generation ACO will be permitted to reduce or even eliminate co-pays for “high-value” services, such as preventative care, in exchange for a beneficiary’s voluntary alignment with a Next Generation ACO. The reduction of such co-pays is intended to encourage more preventative care visits, which, in turn, could contribute to the reduction of health care expenditures over time.
- Beneficiary Coordinated Care Reward: Under the Next Generation model, beneficiaries retain their freedom of provider choice, allowing them to seek care outside of the ACO network. However, beneficiaries who obtain a high rate of care from providers in the ACO with which they are aligned will become eligible for cash rewards from CMS, thereby incentivizing more active engagement by beneficiaries. These rewards are expected to equal around $50 and will be paid semi-annually.
- Increased Coverage for Skilled Nursing Facility Care: A qualified Next Generation ACO will be exempt from the three-day inpatient stay requirement for admissions to skilled nursing facilities.
- Telehealth Expansion: CMS will reimburse telehealth services for aligned Next Generation ACO beneficiaries regardless of where they live. This contrasts with standard payment rules, under which reimbursement for telehealth services generally is available only for beneficiaries who live in rural areas.
- Post-Discharge Home Visits: Next Generation ACOs will also be able to offer, with “incident to” reimbursement, in-home services to beneficiaries after their discharge from an inpatient facility. Such visits will be limited to no more than one in the first ten days after discharge and one more in the twenty days thereafter.
In addition to benefitting Next Generation-aligned patients, the expansion of telehealth, SNF, and post-discharge visit coverage also provides an incentive for providers to affiliate with a Next Generation ACO in order to take advantage of these new reimbursement opportunities.
In another important shift from the previous Pioneer and Shared Savings Program models, Next Generation ACOs will be required to operate under risk-based contracts with commercial payors, in addition to governmental payors. By instituting this requirement, CMS appears to be attempting to stimulate similar cost-reduction models in the private health care insurance sector as well. This requirement, however, may be an impediment to forming a Next Generation ACO in areas where such risk-based provider contracts are less prevalent.
Due to the specifics of the new model, particularly the heightened risk ACOs will be required to assume, the Next Generation ACO will likely be most attractive to large provider organizations that have experience in delivering advanced coordinated care to specific populations. Provider groups must have a beneficiary population of over 10,000 to be eligible to qualify as a Next Generation ACO. The Shared Savings and Pioneer models require only 5,000 beneficiaries to qualify.
CMS has stated that it expects 15 to 20 providers to participate in the Next Generation model. CMS will accept applications in two rounds, on June 1, 2015 and June 1, 2016. In order to be eligible to submit an application in the first round, interested organizations must submit a Letter of Intent by May 1, 2015. Applicant organizations that are accepted into the program are expected to commence operations on January 1, 2016.
Blue Ocean Medical Products is the fastest growing FDA 510 (k) pre-market, 510 (k) submission, and fda approval consultant and pre-market medical device manufacturer in the US.
Before purchasing or doing any business about Pensar Medical aka Accuro Medical. I suggest asking the following questions. After several searches from the FDA database. Pensar Medical is not showing any 510 (k) number for their wound dressings.
Things to ask Pensar Medical Reps before doing business with them.
Actor Christopher Reeve died of an infection resulting from a pressure ulcer, commonly known as a bedsore, following years of paralysis. While bedsores do not commonly cause death, they affect an estimated 2.5 million Americans each year and often become difficult to treat. Now, engineers at UC Berkeley are developing a new “smart bandage” that uses electrical currents to detect early tissue damage from bedsores before they become visible — and while recovery is still possible.
“We are beginning a small clinical trial at UCSF,” Dr. Michel Maharbiz, associate professor of electrical engineering and computer sciences at UC Berkeley, told Medical Daily. If all goes well, then, smart bandages may soon be available for use.
Bedsores, which are injuries to the skin and underlying tissue, develop most often on skin that covers bony areas of the body, such as the hips and tailbone. People at risk for these pressure ulcers are those who are confined to a bed or, like Reeve, people with medical conditions requiring use of a wheelchair. The increasing prevalence of diabetes and obesity has increased the risk for bedsores, which can develop quickly and cause considerable pain and expense.
The odds of a hospital patient dying are nearly three times higher when they have pressure ulcers, according to some research.
“By the time you see signs of a bedsore on the surface of the skin, it’s usually too late,” Dr. Michael Harrison, a professor of surgery at UCSF and a co-author of the new study, said in a press statement.
Beneath the Surface
“My group had been considering ideas for monitoring the state of wounds (and maybe eventually affect wound healing) using technology for a few years,” Maharbiz told Medical Daily.
As leader of the research project, he envisioned a bandage that could detect bedsores as they are forming below the surface of the skin. To accomplish this, the research team thought about the electrical changes that occur whenever a healthy cell begins to die. Normally, a cell’s membrane is relatively impermeable and acts essentially like an insulator to the cell’s conductive contents. However, as a cell starts to die, the integrity of its walls also begin to break down, allowing electrical signals to leak out as they would from a broken resistor.
Based on this model, the researchers began the creation of a smart bandage by printing an array of electrodes onto a thin, flexible film. They found that a small current discharged between the electrodes would create a spatial map of any underlying tissue based upon electricity flows at different frequencies. (This technique involved impedance spectroscopy.)
To test their new bandage, the researchers needed a test subject, so they gently squeezed the bare skin of rats between two magnets as a way to mimic a pressure wound. After removing the magnets, resumption of normal blood flow caused inflammation and damage that accelerated cell death in the rats. Next, the researchers attached the non-invasive “smart bandage” to the skin of the injured rats. With consistency, the bandage was able to detect varying degrees of tissue damage, invisible to the human eye, across multiple animals and tracked the progress of the wounds.
For more information, watch the UC Berkeley video below:
Source: Swisher SL, Lin MC, Liao A, et al. Impedance sensing device enables early detection of pressure ulcers in vivo. Nature Communications. 2015.
Negative pressure wound therapy is a great alternative accelerated wound healing for diabetic ulcers, bed sores, venous ulcers, and post-op wounds.
Diabetics once facing the prospect of amputation to their lower limbs due to the effects of foot ulcers are now back on their feet thanks to a new technology.
Foot ulcers are common for diabetics as they often suffer from reduced sensation on the skin. Even a slightly high blood sugar level can, over time, damage some nerves – a diabetes-related issue called peripheral neuropathy.
If sensation is lost in parts of the foot, it can be difficult to know if the foot has suffered any damage. This also means it is difficult to protect small wounds by not walking on them – and the wounds can rapidly deteriorate and develop into ulcers. Foot ulcers are prone to infection and can quickly become severe and in some cases lead to amputation.
This was the case for William Hutchinson, 57, from Havant, a Type Two diabetic who has suffered from recurrent foot ulcers on both feet for a number of years and was on the verge of having to have a toe on his left foot amputated.
Mr Hutchinson said:
I have very little feeling in my feet, so any cut or nick I get on my feet can quickly turn in to an ulcer.
I attended clinics for months due to an ulcer which I had on my big toe. I was wearing an air cast walker to try and heal the ulcer, which I’d had for 13 months in total – but this caused an ulcer to develop on my other foot because I was unbalanced. I had the second ulcer for four months.
When Mr Hutchinson was referred to Solent NHS Trust’s specialist Podiatry Team at St James Hospital in Portsmouth, they suggested a very new approach – and the results were quickly evident.
Mr Hutchinson continued:
My podiatrist suggested I try a new type of total contact cast – and that I try it on both feet. I believe I was the first person in the UK to have been treated with the cast on both feet – and it worked brilliantly. I was absolutely amazed. After 12 weeks, I’ve virtually healed.
The technology is called the TCC-EZ – and is a Total Contact Casting system. Total Contact Casting is considered the gold standard of care for off-loading diabetic foot ulcers.
The TCC-EZ, from Dermasciences Europe, is a one-piece, roll-on, woven cast that can be applied in just ten minutes by the podiatrist. It works by promoting healing of the wound by minimising pressure and friction, as the TCC-EZ redistributes the weight away from the wounds, meaning it can heal even while the patient is walking.
Mr Hutchinson attended a specialist podiatry clinic at St James’ Hospital, part of Solent NHS Trust. Portsmouth Clinical Commissioning Group (CCG), which works with Solent NHS Trust as a partner organisation, has one of the highest amputation rates in the country at 4.3 per 1,000 adults with diabetes – with the neighbouring Fareham and Gosport CCG highest at 5.1 per 1,000, compared to the national average of 2.6 per 1,000.
The podiatry clinic, led by Podiatrist Advanced Practitioner Emily Sambrook, was trialling the new technology and asked Mr Hutchinson if he would like to take part – and the results were dramatic.
Emily Sambrook, Podiatrist Advanced Practitioner at Solent NHS Trust, said:
As a clinician, I’m always a little sceptical about new technologies – but the TCC-EZ is the best new technology I’ve experienced. Patients who have been seen for many months with little improvement are now healing, in some cases, within eight weeks, which is absolutely fantastic.
The TCC-EZ is an easy one-stop system– and means I don’t have to refer patients to have a plaster cast technician, at which point I might lose the patient in the system. This means I can progress a programme of care which allows the patient to follow the right routine and heal more quickly.
The system also significantly reduces the chance of amputation. We can use the TCC-EZ to dramatically increase the healing process of foot ulcers by reducing planter pressures – which typically takes many months – and results in less risk of infection. Less risk of infection ultimately means less risk of amputation.
Our patients often suffer from depression as they can’t do what they normally do and can’t see an end-goal. They will often ask how long the healing process will take. Using a traditional method, it’s very difficult to allocate a timeframe – but now I can provide an end-point based on evidence. The patients we’ve been dealing with have been amazed how quickly they are healing – and that has had a dramatic effect on their quality of life.
In just 12 weeks Mr Hutchinson went from having ulcers on both feet, with one wound at a depth of 10mm – to almost fully healed and will soon be back on his feet and out walking his dog.
Mr Hutchings continued:
I’m looking forward to getting out walking again – which is my big love. I’m pretty close to getting to that point now, which is just amazing.
“I’ve now got the correct footwear, which has been specially made, so I can get back to being outdoors – and fingers crossed, everything should be ok now.
Equinox Medical, LLC. The best leading wound care company in the united states. The company manufactures negative pressure wound therapy pumps and black foam dressing kits for diabetic ulcers, venous ulcers, and post-op wounds.
Many of the DME and HME companies in the US are familiar with the Accuro Medical Wound Pro pump. This pump was designed for gauzed dressing only. But lately, the new owner or new company Pensar have been promoting their wound pro pump with black foam dressing. The wound pro pump was off the FDA class II recall list. But their new black foam dressing kits does not have FDA approval or a FDA 510 (k) number. Anyone DME and HME companies using these kits in the wound care market are taking a major safety risk and liability. If your company or nursing facility have been approached by Pensar Medical. Please make sure to ask the following questions.
CAN YOU PROVIDE US YOUR FDA 510 (K) NUMBER FOR STING RAY AND BLACK FOAM DRESSING KITS?