FDA’s approach to regulatin medical device and accessories

FDA’s New Approach to Regulating Medical Device Accessories

FDA 510 10 (k)

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.

Background

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 educational webinar training about Bridging two wounds with NPWT Black Foam

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!

How to bridge two wounds together using black foam dressing kits when using negative pressure wound therapy?

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Bridging two wounds using NPWT Black Foam Dressing Kits

Dressing for Success:
9 Principles of Negative Pressure Wound Therapy Dressing Techniques

Dressing application, as noted above, provides an opportunity for us to educate our patients.

 

And just how did you acquire your own knowledge and skills around the application of NPWT dressings? Most of us learned by observing another clinician doing dressing applications, or from a manufacturer’s representative. We likely just imitated what they did, largely improvising. In my work over the past few years, I have been surprised to learn that many excellent clinicians have gaps in technical ability.
The information provided in this section is intended to review principles of NPWT dressing application to increase the accuracy of your techniques. These tips are distilled from principles that are typical of manufacturer guidelines. It is always recommended that you read and follow the manufacturer’s guidelines for the product that you are using. Read More

Join Our Webinar

Wound Bridging Technique Webinar
January 20, 2015 at 10am Eastern Standard Time

Our goal is to teach our clinical and distribution partners on how to bridge a wound using our UNI foam dressing kit.  Learn how to

off-load and bridge a wound.  This webinar will fill up fast, please make sure to sign up early, webinar space will be limited.   Sign up today.

THE MARKETING HELP YOU NEED
Equinox Medical Clinical and Marketing Value Added

Equinox Medical offers all our distributors marketing support.

 

We support all our distributors by providing all our distributors webinar support.  This webinar covers how to set up our UNI foam dressing kit and how to operate our Halo and Cobaltt NPWT pumps.  In addition, we provide all our distributor marketing collateral to show their customers our product brochures, post cards and flyer.

 

Our clinical support is able to all our clinical and distributors. We have a clinical wound care nurse to help answer and assist any customer with a clinical wound care question.  We also have videos available, to help provide a quick reference guide to all our customers.  All our educational videos are on our website at www.equinoxo2.com.

 

Smith and Nephew’s stocks plummet and in trouble

Smith & Nephew slips despite continuing hopes of £13 a share bid

UBS analysts raise price target for company but reduce recommendation from buy to neutral


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 Legislation is reintroduced to the Senate and Congress

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.

HALO MINI negative pressure wound therapy pump

Protect your heart from Workplace stress

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.

Brisk TIPS

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.

Families must be alert to possible problems – Family Healthcare

Pat Mcginnis, official executive of California Advocates for Nursing Home Reform, said its regularly troublesome for families to comprehend what they’re getting when confronted with contracting an in-home guardian.

“No one truly supervises homecare specialists,” Mcginnis said.

It’s not difficult to mistake homecare specialists for home medicinal services laborers. Home medicinal services specialists have the capacity give essential therapeutic observing, for example, checking pulse, and undertakings, for example, wound consideration and infusions. They must be authorized to give such administrations.

Homecare specialists give fundamental backing, for example, aiding to move, bolster or bathe a patient. There are no authorizing and personal investigations needed.

In California, that is starting to change. Prodded by instances of senior misuse and robbery, the state Legislature as of late passed AB 1217. It would oblige the state’s assessed 100,000 homecare suppliers to enroll with the Department of Social Services in their individual regions.

The division is obliged to check all registrants for conceivable criminal foundations and keep up an online rundown of consideration suppliers and their status.

That law gets to be viable in about a year.

Meanwhile, specialists say purchasers need to fill that crevice.

“You generally need to do a criminal historical verification,” Mcginnis said. “Continuously look at to discover where else they’ve met expectations.”

Some homecare offices give that investigation as a feature of their administration.

My Choice in Home Care, with work places in Canyon Lake and Laguna Niguel, serves Orange and Riverside regions. Laurie Zimmerer is CFO for the organization. She said the organization gives a historical verification on every last bit of its representatives. Anyhow that is one and only of the components buyers need to consider when picking a parental figure, she said.

“You need to verify they are authorized (on the off chance that they are giving home human services), fortified, guaranteed and foundation checked,” Zimmerer said.
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A few organizations, for example, hers, she said, give that affirmation. Some don’t. What’s more, she said, its less normal with free suppliers.

“In the event that you got to Craig’s List and contract a guardian, there’s no personal investigation,” she said.

Indeed a personal verification, on the other hand, is no surety. Zimmerer said families need to be on their toes.

“The enormous things are to regularly stroll into the home unannounced and investigate mother and father constantly,” she said.

Things to search for would incorporate weight reduction and wounding.

“You need to listen to mother and father,” Zimmerer said, and listen deliberately. “Guardians can be oppressive to the patient but that patient needs the guardian to stay in light of the fact that they’ve persuaded them nobody else will deal with them.”

Low wage families and veterans may meet all requirements for scope of a percentage of the expenses connected with home mind, she said. For center pay families, its more troublesome. Furthermore it simply got to be harder.

Another law went live Jan. 1 obliging that homecare specialists (NPWT) be paid additional time following nine hours, raising expenses as much as 50 percent or more.

Zimmerer said the expense for somebody requiring a full-time in-home guardian has climbed from around $4,800 to about $7,500 every month.

This is how we take care of wounds in Edwardsville

Charles Lecher dozes in a hyperbaric chamber as he gets treatment for an injury that is having a troublesome time recuperating at the Gateway Regional Medical Center in Edwardsville Monday, Jan. 5, 2015. The hyperbaric chamber Lecher is in works at two times the typical air weight. Photograph By David Carson, dcarson@post-dispatch.com

Living with an unending wound can be difficult and crippling. At the same time going by a propelled wound focus may give trust – and even good faith – for a full recuperation.

At the Gateway Regional Medical Center Wound and Hyperbaric Center in Edwardsville, staff parts strive to mend patients’ perpetual wounds with negative pressure wound therapy totally inside 16 weeks.

Sonja Dulick, program chief, said a number of the patients who visit the focal point are experiencing surgical wounds or diverse sorts of ulcers, for example, diabetic, venous or weight ulcers. Wounds can be dealt with topically or with dressings, yet some require hyperbaric oxygen treatment. This includes the patient lying in a tube loaded with 100 percent oxygen for 90 minutes, five days a week.

Utilizing hyperbaric oxygen help expands oxygen in the blood, aiding to mend the injury quicker.

Charles Lecher, for instance, is accepting the treatment in arrangement for having his teeth extricated.

Obscene person, 68, as of late had radiation and chemotherapy to treat disease, abandoning him more inclined to contamination.

Hymn Lecher, 68, said if the oral surgery causes a contamination in her spouse’s mouth, Charles Lecher may need piece of his jaw evacuated.

To keep this, the Troy, Ill., occupant is experiencing 20 hyperbaric oxygen medicines before his surgery and 10 after.

The middle, which has been open for a long time, sees around 20 patients a day. Dulick said the project serves to avoid drawn out or perpetual inabilities while diminishing doctor’s facility re-confirmations.

“I think we’re truly enhancing the personal satisfaction for individuals,” she said.

One patient even let out a celebratory whoop when staff let him know his injury had totally mended.

Keith Paasch, 51, got a compound blaze on his left foot in October when a hose loaded with sodium hydroxide broke on him at work.

He said he washed his face and arms however didn’t understand the substance had gone’s through his shoe.

“After three days my foot was dark.”

Paasch, of Granite City, went by the Gateway Regional Medical Center crisis room in the place where he grew up, where specialists alluded him to the injury focus in Edwardsville.

He said he went by the focal point once a week for three months. When the staff cut into the injury, he said, the mending process radically accelerated.

Paasch said it was the first run through in his life he heard a specialist joke, “You’re recuperating excessively speedy.”

Despite the fact that the trust is for patients like Paasch to be 100 percent mended inside 16 weeks, certain variables can act as a burden.

Way of life decisions, for instance, can enhance or hinder the methodology.

Dr. Rashmin Adesara, who uses one day a week at the center, said he prescribes dodging liquor and tobacco — particularly for patients with diabetic ulcers — and appropriately overseeing eating regimen and prescription. The injury focus will allude patients to a nutritionist when required.

Also in light of the fact that diabetic ulcers regularly begin in the feet, Adesara suggests wearing a shoe embed or off-stacking shoes on the grounds that the sole just achieves the center of the foot. He said dry skin and splitting is a passage point for microscopic organisms, so he prescribes applying salve two to three times each day and to check feet for tough skin

negative pressure wound therapy pump

How to use the NPWT Black Foam Dressing Kit Webinar

Equinox Medical is offering a online training on January 6, 2015 at 10:00 am.

NPWT Webinar

The webinar will cover the following:

  1. Standard Application of the black foam dressing kit on complicated wound
  2. Step by Step procedure on how to use the npwt black foam kit dressing
  3. When to use the black foam dressing kit
  4. Contraindication and Indication use for the negative pressure wound therapy  black foam dressing kit

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