Please join us on March 3rd, 2015 at 10:00 am EST
Hosted by Holly Desimone, RN, BSN, WCC
Location: Online (Webinar)
Subject: Offloading application using the UNI NPWT black foam dressing kit by Equinox Medical
How long is the webinar? Approximately 20 to 30 minutes
How can I join? Please complete the registration form by clicking ont he link below.
Once Registered, you will received an email from EquinoxO2 with all the webinar informations.
I just noticed this website the other day (www.szuomc.com). Its a new distributor that sells the newest Halo MINI Negative Pressure Wound therapy pump system from Equinox Medical. I believe they started carrying this product late last year. They also carry the Halo XT, and Cobaltt NPWT pump system in the US wound care market. Come check this site and see what you think.
FDA’s New Approach to Regulating Medical Device Accessories
The US Food and Drug Administration (FDA) has outlined a new framework for classifying and approving medical device accessories, making clear that device accessories can be brought to market more quickly than their parent devices in certain cases.
“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is –
- recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them;
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”
Medical devices are brought to market, in general, in one of four ways:
- The Premarket Approval (PMA) – This process is intended to evaluate and approve high-risk devices or devices with no known predicate.
- The 510(k)/Premarket Notification – This process expedites the review and approval of devices that are highly similar to an already-marketed predicate device, or that are subject to certain controls on their manufacture.
- The De Novo Process – If a low-risk device is deemed ineligible for the 510(k) process because it lacks a predicate, a manufacturer may petition FDA to review it through the de novo process, which allows FDA to make a risk-based classification of the device.
- 510(k) Exempt — Some low-risk devices, such as bandages, are explicitly exempted from FDA’s premarket review process and can be brought to market almost immediately as long as they conform to established standards (“general controls”).
Medical Device Accessories
That general framework, however, has proven a bit confusing for manufacturers of medical device accessories. Accessories function in tandem with another device, known as a “parent device,” which is often (but not always) cleared or approved as a separate device.
As defined by FDA, a medical device “accessory” is a device “intended to support, supplement, and/or augment the performance of one or more parent devices,” while a parent device is a device “whose performance is supported, supplemented, and/or augmented by one or more accessories.”
At issue is how FDA should evaluate each device accessory. For example, if a parent device was deemed to be “high risk” but a subsequent accessory is inherently low-risk, should the accessory be judged on its own merits, or should it inherit its parent device’s “high-risk” status?
A Nuanced Approach to Risk
FDA’s guidance, Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types, is meant to clarify some of the ambiguity in this space.
As noted by FDA, a key consideration in the agency’s assessment of risk is the accessory’s relationship with its parent device. Some accessories are critical to the proper function of a device, such as a rechargeable battery for an AED. Other accessories allow the parent device to perform new functions, but are not necessary to its core functions. Still other accessories allow a parent device to perform its functions better or more safely.
“FDA intends to determine the risk of accessories and the controls necessary to provide a reasonable assurance of their safety and effectiveness according to their intended use in the same manner that is used to determine such for devices that are not accessories,” the regulator explains in its guidance.
FDA goes on to explain that it plans to access the risk of a device “when used, as intended, with the parent device.” However, it does not plan to simply pass on a parent device’s risk classification to its accessory. “The risk profile of an accessory can differ significantly from that of the parent device, warranting differences in regulatory classification,” FDA wrote.
The regulator also recommended the use of the de novo classification pathway for many device accessories, which it said would help in allowing some manufacturers to get their products to market more quickly.
– See more at: http://www.raps.org/Regulatory-Focus/News/2015/01/19/21106/FDAs-New-Approach-to-Regulating-Medical-Device-Accessories/#sthash.q5WOTR1Q.dpuf
Equinox Medical is offering a free educational training on how to use the black foam dressing for BRIDGING application.
The webinar is hosted by their wound care certified nurse Holly Desimone, RN, BSN, WCC.
When: Tomorrow! January 20,2015
What Time: 10:00 am Eastern Standard Time
How can I join?
Click on the link below and register for free!
Smith & Nephew has slipped back despite analysts continuing to believe there is a chance US rival Stryker could strike.
The medical device company’s shares are down 22p at £11.58 as UBS moved from buy to neutral but raised its target price from £11 to £11.75.
The bank reckoned there could be a takeout bid of £13 or more and said:
As we have argued previously we see a chance that Stryker makes a bid for Smith & Nephew, based on historic multiples including Zimmer Biomet, at a price of £13 or more. We have also examined, in depth, the possibility of a three way deal with Coloplast amongst the bidders for the wound care business.
We have no insight on if or when a deal might be proposed. Our price target is now the midpoint of our upside (a takeout at £13) and downside (standalone valuation of £10.50) scenarios.
At the fourth quarter results on 5 February we expect two areas of focus. (1) Tough fourth quarter Orthopaedic comparisons after a strong final quarter last year, possibly due to patient confusion over the impact of healthcare reform which won’t repeat. (2) Wound care’s continued improvement after a weak first half.
Breaking News: Competitive Bidding Bills Reintroduced in the House and Senate
Hill sources have let AAHomecare know that legislation to reform the Medicare competitive bidding program has been jointly reintroduced in the House and Senate.
AAHomecare applauds Representatives Tiberi (R-Ohio) and Larson (D-Conn.) and Senators Portman (R-Ohio) and Cardin (D-Md.) for their determination to put the patient first by bringing common sense and prudence to this defective program.
These bipartisan, budget-neutral, and common-sense pieces of legislation will require bidders to stand by their bids and deter efforts to unfairly game Medicare contract auctions for home medical equipment. Download the FAQs on binding bids to learn more.
Stay tuned for the official bill numbers and text. When they are released, AAHomecare will provide a link to a new Action Center message you can use to contact your elected officials and urge them to support the bill.
Be sure to download the AAHomecare smartphone app, AAHomecare.org/app and follow @AAHomecare on Twitter for more breaking news announcements.
Vibha Dixit, a 33-year-old expert, lives up to expectations late into the night and awakens. Her work hours are sporadic and there is the consistent race to stay a venture in front of her rivals and climb the expert step. Work is distressing and leaves no time for herself. She hasn’t practiced in months on the grounds that “there is no time for activity,” she says. Episodes of corrosiveness have ended up basic and she is putting on weight. Her specialist has announced she is a potential diabetic and is at danger for coronary illness.
The issue with Dixit is unmistakably her inactive way of life. Physical idleness can have genuine ramifications for individuals’ wellbeing. The World Health Organization (WHO) has on numerous occasions cautioned that an inactive way of life could be among the 10 driving reasons for death and inability. It builds the reasons for mortality, copies the danger of cardiovascular malady, diabetes, and stoutness, and expands the danger of colon growth, hypertension, osteoporosis, lipid issue, despondency and nervousness.
As indicated by WHO, 60 to 85 every penny of individuals on the planet, from both created and creating nations, lead inactive ways of life, making it one of the more genuine, yet inadequately tended to, general wellbeing issues of our time. It is evaluated that about two-thirds of kids are likewise inadequately dynamic, with genuine ramifications for their future wellbeing. Added to Dixit’s inactive way of life is her poor eating methodology and late night dietary patterns. She needs to consolidate moderate physical action for up to 30 minutes consistently, tobacco end, and sound sustenance.
She could likewise check for hereditary danger. Her way of life, coupled with abnormal amounts of anxiety, put her at danger for diabetes. As per the American Diabetes Association, the danger of creating sort 2 diabetes is:
One in seven, if one of your folks was diagnosed with diabetes before the age of 50.
One in 13, if one of your folks was diagnosed after the age of 50.
One in two, if both your folks have diabetes.
She ought to instantly check for measurable markers and get into checking toward oneself mode about her wellbeing. These are body mass record (BMI), hypertension, raised triglycerides and cholesterol levels.
The uplifting news for Dixit is that the Diabetes Prevention Program contemplate, a huge investigation of individuals at high hazard for diabetes, has recommended that weight reduction and expanded physical action can avert or deferral sort 2 diabetes. Blood glucose levels likewise come back to ordinary sometimes.
Consume right and rest soundly: Eat a low-sugar, high-protein adjusted eating regimen. Slumber is a discriminating recuperation period. So you may need to eliminate the late supper post work, however best to not eliminate your slumber.
Rehearse some manifestation of activity: Not having sufficient energy to practice is the most antiquated reason on the planet. A 40-moment walk, continually utilizing the stairs, and getting up from your work area each half hour are all effectively conceivable.
Use breathing procedures: When dashing musings keep you from nodding off or you wake up in the night and can’t return to rest, realize a few routines for breathing from a yoga master. On the off chance that you have time, on your vacation day, try for a yoga class or sign up for some type of gathering revival action.
Plan your day: We believe that on the off chance that we work the full eight to 10 hours, we’ll accomplish more. Rather, benefit goes down and anxiety levels go up. The better approach is to wipe out interferences. Worldwide studies have demonstrated that on the off chance that we have exceptional fixation for around 90 minutes, took after by a concise time of recuperation, we can clear the assemble up of anxiety and restore ourselves.
Screen toward oneself your significant wellbeing markers: This is the most ideal approach to be solid.