Free Black Foam Wound Dressing Standard Application by Joey Mallari at Equinox Medical
Clinical Webinar covers the following:
- Kit Content
- How to cut the foam
- How install the dome pad
- How to use drape
Clinical Webinar covers the following:
Ten Questions WIth Wound Nurse Holly Desimone, RN, BSN, WCC
1. Can I use black foam in undermined areas?
2. Do I need to moisten the foam?
3. What comes included in the kits?
4. Will I need any additional supplies for the NPWT dressing change?
5. There is black eschar in the wound, can I still use NPWT?
6. Why do I need to irrigate if the NPWT system is pulling out the exudate?
7. Can you treat 2 wounds with one kit?
8. What does protect the peri-wound mean?
9. How do I use the white foam?
10. I notice a foul odor to the wound, does that mean it is infected?
Video edit by Joey Mallari @ www.equinoxo2.com
Acelity aka KCI is at it again with their negative pressure wound therapy technology. The easy clear purge is supposed to clear the dressing tubing to clear any obstructions preventing any blockage in the tubing. This easy clear purge allows the npwt pump to turn on its positive pressure clearing any blockage every five minutes of therapy. After positive pressure is completed the pump returns to negative pressure therapy. Although I am not sure if saline is use during the purge.
Here is the actual marketing text from the KCI website.
Spencer Jones said he hopes to submit the blood-draw device he developed to the Food & Drug Administration for approval by the end of the year or early 2016.
Jones, through his startup Jones Innovative Medical Solutions Inc. of Little Rock, created the Bifurcated Venous Access Device, which allows medical providers to draw blood from the same tube used for IV fluids.
Jones, 24, said he came up with the idea for the product while he was in nursing school treating hospital patients.
Jones said he had to draw blood on a diabetic patient, who had already had her finger pricked several times. He said he wanted to use the IV site already established, but the device wouldn’t allow him to do it.
“That was not an acceptable answer,” Jones said. “This woman was a pin cushion for no reason other than the devices didn’t allow us to do that.”
So he set out to design a product that would allow blood to be drawn.
Jones entered the product in the ARK Challenge Demo Day in Little Rock in November and won a $150,000 investment.
Jones, who has partnered with med-tech investor David DePoyster, said he is fine tuning the device so it will be perfect when it’s submitted to the FDA, which could take an additional five or six months to give its approval. “The product that you take to market has to be the same product that you submitted to the FDA,” he said. “It’s really paramount that we go to the market, not with just the first product we can, but with the best product that we can offer. ”
Halo MINI NPWT PUMP System is manufactured by Equinox Medical in Smithfield Rhode Island. The company distributes the UNI black foam wound dressing in the US.
Medical-related apps may soon turn your smartphone or tablet into an FDA-regulated medical
device. The FDA released revised guidance in February 2015 on how it will regulate medical
Under the new guidance, the FDA placed mobile apps into three categories: those that do meet
the definition of a medical device under the FD&C Act and whose functionality could risk
patient safety if malfunctioned; those that do not meet the definition of a medical device, but
pose a very low risk to patients; those that do not meet the definition of a medical device.
How will the FDA determine which category the app falls under? That will depend on the app’s
intended use. The FDA will determine the app’s intended use through advertising, labeling and
the manufacturer’s statements.
Although the FDA could regulate all devices that appear to meet the definition of a medical
device, the agency will only draw the line when the app could pose as a risk to the patient if
used incorrectly. Apps that function like a medical device but pose a low risk to patients will not
be scrutinized by the FDA.
If an app does meet the definition of a medical device and does pose a risk to patients if it is not
used properly, the app developers may need to follow regulatory controls. This may include
labeling, registration and premarket notification of approval.
Michigan-based medical device investment firm BioStar Ventures just raised $68 million for its third and largest fund. It plans to focus its investments on devices in cardiovascular and orthopedic medicine.
Its previous two funds collectively raised $65 million – and helped spawn more than 30 companies. BioStar has about 20 active portfolio companies, and 13 that have been acquired by large medical device manufacturers.
In its latest fund, BioStar has five investments made through this third fund, it said in a release – two of which that have received FDA approval and are prepping for commercialization.
It tends to invest in startups at the seed or early stages, making initial investments of up to $1 million and from $2 million to $6 million overall.
MCHENRY, Ill., June 30, 2015/PRNewswire/ – Medela, Inc., has banded together with the Wound Care Education Institute, Inc.® (WCEI), the nation’s driving wound consideration training supplier, to give industry affirmation to Medela’s expert wound consideration staff. The main of its kind, the Certified Wound Care Market Specialist (CWCMS®) system was made to teach proficient groups on proof based current measures of consideration in wound administration. WCEI has effectively prepared and confirmed about 1,000 wound consideration deals and promoting experts in both medicinal services and assembling commercial ventures.
“Medela Healthcare has given Negative Pressure Wound Therapy since 2008 through our accomplished group and PartnerFirst™ Network,” said Alan Cawley, Director of Sales for Medela Healthcare. “This WCEI affirmation backings Medela’s dedication to giving our clients, and at last the patients we accomplice to serve, with unparalleled mastery.”
“This association guarantees Medela deals and advertising faculty keep on having the right stuff and competency in the developing field of wound consideration to bolster clinicians across the nation,” said Nancy Morgan, president and prime supporter of Wound Care Education Institute, Inc. “This sort of exceptionally centered preparing in wound consideration speaks to a developing chance to enhance the general clinical results for wound consideration patients.”
About Medela The Medela family organization, headquartered in the Canton of Zug, Switzerland, was established by Olle Larsson in 1961. Medela focuses on two specialties units: “Breastfeeding,” with essential research that is perceived internationally and driving in the improvement and assembling of breastfeeding items, and “Healthcare,”engineering and assembling very imaginative therapeutic vacuum innovation arrangements. Medela has 18 auxiliaries in Europe, North America and Asia, circulates its items in more than 90 nations, and utilizes more than 1,500 staff around the world. For more data, visit www.medela.com.
About the WCEI Founded in 2003 by Nancy Morgan RN, BSN, MBA, WOC, WCC, CWCMS, DWC, OMS and Donna Sardina RN, MHA, WCC, CWCMS, DWC, OMS, Wound Care Education Institute, Inc. has developed to turn into the main instructive middle of greatness for wound consideration and ostomy instruction in the United States. WCEI’s central goal is to create multi-disciplinary wound consideration experts by offering preparing projects in light of momentum benchmarks of consideration and confirmation based exploration. To date, WCEI has prepared more than 25,000 wound consideration doctors, advisors, medical attendants and deals/advertising experts. For data in regards to WCEI’s instructive projects, visit www.wcei.
The Affordable Care Act may have survived one of its greatest difficulties a week ago with a good controlling from the Supreme Court on King v. Burwell, however one of its less famous procurements may tumble to the administrative process. A bill requiring the cancelation of a questionable 2.3 percent therapeutic gadget assessment has passed a vote in the House and now heads to the Senate, leaving medicinal gadget makers on the edge of their seats as they hold up to perceive how Congress will address the issue.
The extract expense went live toward the start of 2013, squeezing a little more than two percent of the producer’s expressed costs from specific classes of managed therapeutic gadgets, including substitution joints, pacemakers, and other implantable gadgets, some of which are turning out to be progressively essential for remote patient checking and human services’ Internet of Things.
The FDA has attempted to calm the apprehensions of numerous wellbeing IT organizations by saying that it doesn’t expect to place buyer grade mHealth gadgets, quiet engagement applications, or generally safe restorative reconnaissance devices on the rundown of assessable gadgets. Applications and hardware that oversee wellbeing data or medicinal information won’t be entirely controlled either, said FDA authorities recently.
“The FDA tries to propel general wellbeing by advancing advancement and improvement around there by persistently adjusting our administrative way to deal with mechanical advances to address the issues of patients and buyers,” the organization said in a February blog entry. “The restorative gadget information frameworks (MDDS) direction affirms our goal to not implement agreeability with appropriate regulations for innovations that get, transmit, store, or showcase information from therapeutic gadgets. We trust that finish of this strategy will make a force for the advancement of new innovations to better utilize and presentation this information.”
Still, therapeutic gadget producers that are liable to the extract expense have brought up issues of its potential effect on their capacity to develop and flourish in an exceedingly focused commercial center. Elected authorities have anticipated that the duty will bring $29 billion up in income for the administration, a noteworthy aggregate for designers who put in quite a long while toward the start of the decade pondering when the FDA was going to draw up the principles for the mHealth business, which had begun encountering quick development and mind boggling interest.
The medicinal gadget assessment repeal, HR 160, passed a House vote 280 to 140, drawing in “yes” votes from both sides. Notwithstanding the effective edge, it confronts an indeterminate political future in the Senate. Regardless of the possibility that it clears its second Congressional obstacle, President Obama has debilitated to veto the nullification.
Advocates of the assessment say that it will keep on creating quite required income without essentially affecting the exercises of producers. Supporters of cancelation note that the extract has officially gathered far not exactly foreseen, and the lost income is keeping medicinal gadget producers from putting resources into greatly required development, incorporating extending openings for work in their home areas.
A 2014 report from the Congressional Research Service anticipated that the restorative gadget duty would do little to effect makers. “The evaluations in this report propose genuinely minor impacts, with yield and job in the business falling by close to two-tenths of one percent,” the brief expressed. “This restricted impact is because of the little duty rate, the exception of more or less a large portion of yield, and the generally obtuse interest for wellbeing administrations.”
“The investigation recommends that a large portion of the assessment will fall on purchaser costs, and not on benefits of restorative gadget organizations. The impact on the cost of human services, in any case, will no doubt be unimportant in view of the little size of the duty and little share of social insurance spending owing to therapeutic gadgets.”
Be that as it may, therapeutic gadget makers see it in an unexpected way. As indicated by them, the duty is keeping them from putting resources into their own development, which thusly affects the capacity of the social insurance industry everywhere to proceed with its change into an information driven, investigation minded wellbeing IT continuum that can saddle the colossal capability of consistent restorative gadget incorporation and interoperable wellbeing data administration.
“At the point when the duty went into play, my shareholders still anticipate that me will deliver the same returns as we delivered before,” countered Haemonetics Corporation CEO Brian Concannon to journalists from the Boston Globe. The blood handling gadget maker has surrendered give or take $4 million in income to the expense as such. An identical aggregate would permit him to contract 40 extra specialists. “In the event that that expense goes away, I could burn through a great many dollars all the more on innovative work without so much as a second thought,” he included.
Equinox Medical, LLC. Best negative pressure wound therapy pump system manufacturer in the united states of america. Kinetic and Smith and Nephew carries similar products in their portfolio
As the enactment makes headway, spending plan minded Senators will tussle over how to supplant lost income from the duty, if it be canceled. While the therapeutic gadget extract gathered give or take $1 billion not exactly foreseen amid its first year, the dubious effect of cancelation on the social insurance industry and the government spending plan everywhere will remain a divisive issue as the bill advances through the authoritative procedure.
It is a notorious picture imitated amid each and every irresistible ailment flare-up in the most recent century: men and ladies clad head to toe in surgical outfits and surgical covers, keeping an eye on the wiped out or attempting to clean sullied territories. However, notable or not, the US Food and Drug Administration (FDA) has an additionally squeezing concern: Are the outfits successful at shielding their clients from the spread of disease?
The inquiry is the center of another draft direction record issued by FDA, Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.
Under 21 CFR 878.4040, surgical attire is characterized as:
“gadgets that are planned to be worn by working room faculty amid surgical methodology to secure both the surgical patient and the working room staff from exchange of microorganisms, body liquids, and particulate material. Cases incorporate surgical tops, hoods, veils, outfits, working room shoes and shoe spreads, and confinement covers and outfits. Surgical suits and dresses, ordinarily known as scour suits, are prohibited.”
Equinox Medical, LLC. Fastest Growing Negative Pressure Wound Therapy pump system manufacturer in the United States Of America.
As FDA clarifies in its new draft direction record, not all surgical defensive hardware is controlled similarly.
Under 21 CFR 878.4040(b)(1), surgical outfits and surgical covers are Class II medicinal gadgets and require the accommodation of a 510(k) application and agreeability with both general and uncommon controls built up by FDA under 21 CFR 878.4040(b).
Light and portable Halo Mini NPWT Pump system is now available to the united state of america. The wound pump has similar functions of any kci wound pumps, and smith and nephew pump system in the wound care market.
Nonetheless, not all surgical attire is managed as Class II gadgets. Except for surgical outfits and veils, most surgical attire is directed as Class I therapeutic gadgets (21 CFR 878.4040(b)(2)). Class I items are absolved from premarket entries or survey, however must consent to general controls built up by FDA.
As FDA has already noticed, the execution of surgical outfits, and specifically surgical confinement outfits, is basic. In the event that you have motivation to wear a surgical outfit in any case, the exact opposite thing you need to stress over is whether fluid splatter containing an irresistible microorganism will leak through and come into contact with your skin.
The issue, as FDA clarifies in the direction, is that definitional perplexity at present exists in the commercial center. Case in point, a few norms setting bodies utilize the expression “disengagement outfit” to portray what FDA calls “surgical outfits.” That’s conceivably dangerous in light of the fact that FDA considers outfits guaranteeing to give more elevated amounts of hindrance security “to be higher-hazard gadgets than those that claim negligible or low levels of boundary assurance.”
In the event that conflicting definitions are utilized, organizations may accept they are excluded from giving the obliged execution proof, FDA said. “The motivation behind this direction, along these lines, is to elucidate and portray the premarket administrative necessities relating to outfits directed under 21 CFR 878.4040 and the execution testing expected to bolster fluid hindrance claims for outfits proposed for utilization in health awareness settings,” FDA included.
FDA’s direction depends upon a current standard kept up by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) known as ANSI/AAMI PB70. The PB70 standard portrayed four levels of security, with Level 1 insurance offering a “negligible” measure of hindrance assurance, and Level 4 offering “high” obstruction security.
FDA says it considers Levels 1 and 2 to on the whole offer “insignificant or low” obstruction security, and Levels 3 and 4 to offer “moderate or high” boundary insurance.
As FDA’s direction archive goes ahead to clarify, the cases made by a maker about its surgical attire (under 21 CFR 878.4040(b)(2)) will decide how it is controlled by FDA.
An outfit (not a surgical outfit) which is named with articulations that it is expected to give insignificant or low obstruction insurance may be directed as a Class I gadget absolved from premarket survey.
In any case, if that same item is named as a surgical outfit, cases to give “moderate or abnormal state obstruction security,” or is proposed for utilization amid sterile systems, it will be managed as a Class II gadget and be liable to the 510(k) procedure and unique controls set up by FDA.
On the off chance that a 510(k) is needed of a surgical outfit or related gadget, FDA says it must meet the PB70 standard and incorporate execution test information planned to exhibit hindrance adequacy.
Under the new approach, existing items as of now available however obliging a 510(k) will be conceded makeshift mercy, FDA said.
Remarks on the direction record are because of FDA before the end of August 2015.
Pioneers Memorial Healthcare District has partnered with Wound Care Advantage (WCA) joining a growing number of hospitals seeking alternative solutions to wound center management.
Pioneers Memorial Healthcare District in Brawley, CA. recently partnered with Wound Care Advantage (WCA) to utilize the Luvo model of management for their outpatient wound center. The partnership strengthens the hospital’s commitment to the specialty of wound care by joining a network of wound centers across the country working with WCA to manage their outpatient wound center.
The Wound Clinic at Pioneers offers advanced wound care treatments and hyperbaric oxygen therapy to help heal wounds – including diabetic wounds of the lower extremities, pressure ulcers, venous stasis ulcers, ischemic ulcers, traumatic ulcers, radiation wounds, atypical wounds and post-surgical wounds.
Poor circulation, infection, diabetes, obesity and injuries can cause advanced wounds that are difficult to heal without specialty care. The relative 5-year mortality rate for diabetics after limb amputation is 68 percent. Wound healing increases patient quality of life and works toward limb preservation in patients both with and without diabetes.
“Offering hyperbaric oxygen therapy locally provides state-of-the-art advanced medicine to treat chronic, non-healing wounds while reducing amputations,” Art Mejia, MPA, FACHE, Associate Administrator Clinics & Support Services Pioneers Memorial Healthcare District said. “These types of conditions can be common in communities such as ours, which struggles with issues such as uncontrolled diabetes. The expansion of our wound clinic means that patients no longer have to travel outside of Imperial County to receive this necessary treatment.”
The wound center is currently utilizing several Luvo modules including Keystone, Prism, Resume, Pressure, Lighthouse and Chalkboard.
“The biggest benefit to using the Luvo operating system is that the system is 100 percent based in wound care patient management,” Mejia said. “All of the functionality that has been developed across the system, from entry to maintenance to reporting, is intended to support the medical practice of wound care. It should prove to be a great resource with which to continuously improve our performance and achieve our ultimate goal of positive patient healing rates and outcomes.”
WCA is an innovative service-based wound care company, providing the necessary tools for a well-equipped wound care program. Transitioning wound care management providers can be a complex undertaking. WCA provides transition specialists to guide hospital executives through the entire process, making it as smooth as possible.
“We welcome anyone interested in learning more about the program or wound care in general, whether patient or provider, to reach out to our highly trained staff,” Mejia said. “We are available to answer questions and/or schedule appointments Monday through Friday, 8 am to 5 pm.”
About Pioneers Memorial Hospital
Pioneers Memorial Hospital (PMH) is a highly respected 107-bed acute care facility accredited by DNV, whose mission is to provide quality healthcare and compassionate service for families of the Imperial Valley. PMH is committed to providing state-of-the-art healthcare and the highest quality community education. PMH is a level 4 trauma center and offers a modern sixteen-bed emergency facility, staffed with board-certified emergency physicians. Within the Phyllis Dillard Family Medical Center is a dual surgery suite for obstetrical and gynecological surgeries. There are fourteen LDRP (Labor and Delivery, Recovery, Postpartum) suites in our Perinatal Department within the Center and we deliver approximately 1,800 babies per year. Pioneers Memorial Healthcare District is proud to be the only ISO 9000:2008 certified hospital in Imperial Valley. ISO 9000:2008 certification is an international signal of our dedication and commitment to protecting our patients’ health and safety while they are with us. To learn more about The Wound Clinic at Pioneers visit http://www.pmhd.org/WoundCare/index.html or call (760) 351-4848.