FDA Issues Final Guidance on Evaluating Substantial Equivalence in 510(k) Submissions

FDA Issues Final Guidance on Evaluating Substantial Equivalence in 510(k) Submissions

Practices: FDA Regulatory

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On July 28, 2014, the Food and Drug Administration (“FDA”) issued final guidance regarding the agency’s substantive review of Traditional 510(k) premarket notifications. This document, titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications,” marks a key milestone in FDA’s re-evaluation of the 510(k) program, which the agency initiated in 2009 in response to concerns that the program did not sufficiently assure the safety and effectiveness of devices as well as industry concerns that the program had become unpredictable and opaque.

Below we summarize the key points from the guidance, discuss how FDA responded to criticisms of the draft version of this guidance, and describe further actions that remain to be completed as part of FDA’s 510(k) re-evaluation project.

Key Points from the Guidance

The new guidance is FDA’s first update to the 1986 “blue book” document, “Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3.” FDA asserts that it developed the guidance to inform industry and FDA staff about the agency’s “current review practices,” not to “implement significant policy changes.” Key points from the guidance include.

Elimination of split predicates. The guidance states that the use of a “split predicate” is inconsistent with the 510(k) regulatory standard for demonstrating substantial equivalence. A 510(k) uses a “split predicate” when it compares the device that is the subject of the 510(k) (the “new device”) against one predicate device to show sameness of intended use, and a separate predicate device with a different intended use to show similarity of technological characteristics. Although FDA has been taking this position in practice for several years, this is the agency’s first official, final policy statement on this topic.

Designation of a “primary predicate.” Unlike split predicates, FDA will accept multiple predicates in some circumstances. Multiple predicates are commonly relied upon when a 510(k) combines features from two or more previously marketed devices into a single, new device. In the guidance, FDA generally encourages the use of a single predicate to simplify the decision-making process. It also recommends that, when a manufacturer relies upon multiple predicates, the 510(k) identifies the “primary predicate,” which is “the one with indications for use and technological characteristics most similar” to the new device.

Explanation of “reference devices.” The guidance discusses the use of “reference devices,” which, like the term “primary predicate,” does not appear in the statute or FDA regulations. Reference devices are legally marketed devices, other than the predicate device(s), that are referred to in a 510(k) to help support the use of particular scientific methods or reference values. The guidance states that a manufacturer intending to rely upon a reference device should provide a scientific rationale for its use.

Definitions of “intended use” and “indications for use.” FDA has long recognized a distinction between the “intended use” of a new device, which must be the same as the intended use of the predicate device, and the “indications for use” of a device, which may differ to some extent between the new and predicate device. In the guidance, FDA defines “intended use” to mean the “general purpose of the device or its function,” whereas “indications for use” means “the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.” FDA also repeats the point it has made elsewhere that a manufacturer’s intended use for a device can, in some cases, be determined by facts and circumstances outside the 510(k) submission itself. Although these concepts may sound straightforward, identification of the “intended use” of a device can be a matter of negotiation, and in some cases dispute, between manufacturers and FDA.

Determining whether new “indications for use” constitute a different “intended use.” According to the guidance, FDA may find that changes in indications for use constitute a different intended use when they raise a safety or effectiveness issue not raised by the predicate or have the potential to significantly increase a safety or effectiveness concern raised by the predicate. The guidance contains several illustrative examples of how FDA applies this concept. It also asserts that FDA may rely upon publicly available scientific information or FDA knowledge about how a disease progresses to determine whether indications to treat a certain disease or anatomical site constitute a new intended use.

Determining whether differences in technological characteristics raise different questions of safety and effectiveness. Where differences in the technological characteristics of a new device raise different questions of safety and effectiveness, the new device is not substantially equivalent to the predicate. The guidance describes a logic scheme by which FDA identifies the technological characteristics of a device, compares them against those of the predicate device, and then determines whether there are differences in technological characteristics that raise different questions of safety and effectiveness. FDA states that a “different question of safety and effectiveness” is a question “raised by the technological characteristics of the new device that was not applicable to the predicate device, and poses a significant safety or effectiveness concern for the new device.” Similar to the section of the guidance addressing indications for use, this section of the guidance relies largely on illustrative examples.

Performance data requirements. If the new device described in a 510(k) has the same intended use as the predicate and the differences in technological characteristics do not raise new questions of safety and effectiveness, the remaining statutory question is whether the 510(k) contains information deemed necessary by FDA to demonstrate that the new device is “as safe and effective” as the predicate. The guidance does not discuss this statutory standard at this point in the logic scheme, most likely because FDA’s interpretation and application of that standard is discussed in a separate draft guidance issued on July 15, 2014, titled “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics.” Instead, the guidance discusses how FDA applies the statutory “least burdensome” principles by applying a hierarchy of performance data requests starting with descriptive information only, and then proceeding stepwise to include non-clinical bench testing and biocompatibility data, analytical studies using clinical samples (e.g., for in vitro diagnostic devices), and clinical performance data if required.

Encouraging 510(k) “Summaries” rather than 510(k) “Statements.” FDA regulations require a 510(k) submission to include either a “510(k) Summary” or a “510(k) Statement.” A 510(k) Statement is a certification that the manufacturer will make available all safety and effectiveness information in a cleared 510(k) within 30 days of request by any person, other than permitted redactions for patient privacy and trade secret protection. Because FDA can and does proactively post 510(k) Summaries on its website, which facilitates transparency, the guidance “encourages all submitters to utilize the 510(k) Summary option.”

Encouraging greater transparency in 510(k) Summaries. The guidance states that FDA, in an effort to improve the transparency and predictability of the 510(k) program, intends to verify the completeness of the information a manufacturer submits in a 510(k) Summary. The guidance includes appendices describing the content required to be included in such summaries under FDA regulations, provides guidance on what information and data should be included, and includes a sample 510(k) Summary. In particular, the level of detail FDA is requesting be included with respect to clinical studies may be greater than manufacturers have been accustomed to providing in the past.

Responses to Criticisms of the Draft Guidance

On December 27, 2011, FDA announced the availability of a draft version of the 510(k) guidance and invited public comment. FDA received numerous comments, but ultimately made few significant changes to the guidance document. The principal changes were to:

  • Expand the discussion of the use of predicate devices and the reasons for defining a “primary predicate”;
  • Add examples to several sections to clarify FDA’s decision-making process for finding devices substantially equivalent despite differences in indications for use, technological characteristics, or performance characteristics;
  • Add an appendix with a sample 510(k) Summary to demonstrate that level of detail FDA expects; and
  • Remove sections of the draft addressing Special 510(k)s and Abbreviated 510(k)s, due to the relationship between Special 510(k)s and planned FDA guidance on submitting a new 510(k) for a device modification.

What’s Next?

It appears that criticism of the 510(k) program has abated somewhat since FDA launched its re-evaluation initiative in 2009. Nevertheless, there are concerns that the 510(k) guidance reflects narrowed interpretations of the substantial equivalence standard that should have been subject to notice and comment rulemaking under the Administrative Procedure Act. Whether FDA’s 510(k) policies or individual 510(k) decisions will be subject to more frequent appeals within FDA, or legal challenges in court, remains to be seen.

Although it has now finalized the 510(k) guidance, FDA has yet to complete a number of other important actions relating to the 510(k) program. These include:

  • Issuing new draft guidance on when modifications to a device are significant enough to require a new 510(k), after having been required by Congress to withdraw its previous draft guidance from August 2011 on this subject;
  • Issuing new guidance on Special and Abbreviated 510(k)s; and
  • Considering comments received in response to the recent draft guidance, “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics.”

In addition, FDA in the past has stated that it intends to develop new regulations relating to the transfer of ownership of 510(k)s and to develop a public repository of medical device labeling. Ropes & Gray will continue to monitor developments on these proposed initiatives, and other aspects of the 510(k) program.

FDA Releases Guidance On In Vitro Companion Diagnostic Devices

FDA Releases Guidance On In Vitro Companion Diagnostic Devices


By Nick Otto

The FDA recently released guidance in an effort to define in vitro companion diagnostic devices (IVDs), explain the need for FDA oversight of those devices, and clarify that, in general, those devices and their corresponding therapeutic products should be cleared simultaneously.

According to the FDA guidance, companion diagnostics manufacturers should submit applications to the FDA contemporaneously with drug product submissions to improve chances that both the drug and relied-upon device are approved at the same time.

If the agency determines an IVD companion diagnostic to be essential to the safe and effective use or indication of a novel therapeutic product, the FDA will generally not approve the product or indication if the IVD companion device is not approved or cleared for that indication.

The regulation of companion diagnostics will be risk-based, as with all other medical devices, and the guidance advises sponsors to consult early with the FDA on the best approach for approving the companion diagnostic.

The FDA also “strongly encourages” both the drug and device manufacturers to participate in discussions about their respective products as early as possible during the development process.

This will enable “a more focused and in-depth discussion about the validation of the IVD companion diagnostic device and will aid in planning for a device PMA or 510(k) that is complete and timely,” the guidance notes.

The guidance also adds that if an in vitro diagnostic manufacturer wants to use a currently approved test and begin marketing the product for use as a companion diagnostic, a new premarket submission will be needed. New companion diagnostics that are intended for the same use as an approved or cleared companion device will be reviewed via premarket approval or 510(k) clearance, as appropriate, the guidance notes.

Labeling for drugs that use companion diagnostics should identify a type of FDA-approved or cleared test to use with the treatment. And, because federal regulations require labeling for IVDs to specify the intended use, device-makers must specify the drug for which their diagnostic is intended.

The FDA also recently released guidance addressing key issues in the agency’s clearance program, describing in detail the critical decision points in the 510(k) substantial equivalence review process.

Smith & Nephew Warns on Advanced Wound Management Business

Smith & Nephew Warns on Advanced Wound Management Business


By Jana Simmons and Hester Plumridge

LONDON–U.K. medical equipment maker Smith & Nephew PLC (SN.LN) on Friday said it expects its advanced wound management business to grow below the market rate for the full year as it reported a drop in second-quarter profit.

Net profit in the three months ended June 28 fell to $89 million from $129 million in the same period last year. Revenue was slightly higher at $1.2 billion, from $1.1 billion a year earlier.

The company, which specializes in replacement joints, said it remains confident in its overall group outlook for the full year, although advanced wound management is now expected to grow below the market rate.

The group previously said it expects the business to deliver growth above the market rate. It didn’t provide details on the market rate.

Advanced wound management revenue grew to $337 million from $333 million a year earlier, against an estimated global market growth rate of 2%. The unit offers products used to manage wounds such as pressure sores, diabetic foot ulcers and venous leg ulcers.

Smith & Nephew, a relatively small player in the industry, has been the subject of takeover speculation amid increasing consolidation in the health-care sector. In May, acquisitive U.S. company Stryker Corp. ( SYK ) was forced by U.K. takeover rules to say it didn’t intend to make an offer for Smith & Nephew after the company’s shares spiked on takeover rumors.

The “put-up-or-shut-up” rule means that a potential acquirer must state its intentions immediately and act on them within 28 days. In fact, Stryker was still considering its options. It must now wait six months before returning with an offer, unless a rival bidder emerges.

Write to Jana Simmons at jana.simmons@dowjones.com and Hester Plumridge at hjester.plumridge@dowjones.com

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Equinox Medical, LLC. 
Negative Pressure Wound Therapy Pump Company in the USA and Europe. 
American Made NPWT pump dressing kits

Have you tried the best NPWT rental company in the US

After seeing all the big changes going on the durable medical equipment market. The one that always stand out is MedcoAmerica from Louisiana. This company continue to grow even with all the changes on the Medicare/Medicaid changes in our domestic healthcare. The company specialize on Negative pressure wound therapy pumps, NeutroPhase wound cleansing and Black foam dressing. This company controls the wound care market in the south and taking a big chunk of market share from the market leader.

MedcoAmerica is one of the fastest growing npwt pump rental company in the US. They are looking for a distributors and partners across America. If interested, check out their website at www.medcoamerica.com.


MedcoAmerica NPWT Pump Rentals

The lightest and portable Cobaltt NPWT pump is now available in the US

I am happy to report that the most up to date, lightest, and convenient Cobaltt negative weight wound treatment pump is presently accessible in the US. This pump was outlined in Germany and by the searches of its fabricated for a tough utilization. This specific NPWT pump might be use in the Hospital, intense forethought, long haul consideration, aided living and home mind setting. The pump accompanies a simple to peruse LCD screen. Cobaltt npwt pump is composed with two npwt treatment modes, persistent and irregular. Whether the doctor endorsed a consistent weight of 125mmhg or an irregular of -125mmhg of high weight for 5 minutes (flexible) and -80mmhg low weight for 2 minutes. The guardian can alter the pump without any difficulty.

I cherish how the pump really accompanies a compact sack for patient you are walking. I see a considerable measure of dynamic patients that need NPWT treatment and they have to be stuck in their rooms while accepting the treatment. They can go out delight on the planet, run hang out with the family at a recreation center, restaurant or wherever they wish to use their day. The pump respects strive for 24 hours once its completely charge. Envision, you don’t need to stress over charging the npwt pump while you are out doing your errands. Yet you just need to charge this Negative weight wound treatment pump for four hours to be completely charge. Cobaltt likewise accompanies two canister choices, 300cc (for low exudate wounds) and 500cc for substantial exudate. Likewise, Cobaltt additionally accompanies a NPWT dark froth dressing packs, which is an injury forethought market standard. Lion’s share of the parental figures in medicinal services offices are well known withe the dark froth dressing change convention which likens to speedier usage of this new NPWT pump in any office. They know how to utilize and put the dressing even without seeing it.

With the Smith and Nephew Renasys Recall happening as of June 2014, numerous solid restorative supplies merchants and NPWT rental organizations have been hit drastically. They have patients that are right now on Renansys NPWT pump and they need to take them off and utilize an alternate npwt pump. In addition I am not certain if Medicare/Medicaid will keep on reimburing the office if the renasys npwt pump is on review. That would be a decent thing to ask immediately. On the off chance that you are a merchant and searching for another npwt pump and needs it immediately. Give the gentlemen at Equinox Medical a call. They can help you experience this NPWT review at this point or until Smith and Nephew settles their issue. This review and resolutions will normally takes something like 120 to 240 prior days you get a reply from the FDA after Smith and Nephew submits their 510k changes.


Cobaltt NPWT Pump System by Equinox Medical Cobaltt NPWT Pump by Equinox Cobaltt NPWT Pump User Interface Cobaltt NPWT Pump Canisters Cobaltt NPWT PUmp Canister

Former KCI executive now running another NPWT Pump Company

Do you think hiring someone from your competitor’s team is innovative or just trying to keep up with the competition? The company wants to know what this guy learn from the market leader and hopefully he can implement market leader’s tactics and strategy to his new company.

Spiracur Appoints Chris Fashek as Its New President and CEO

SUNNYVALE, CA, Jul 09, 2014 (Marketwired via COMTEX) — Spiracur, the developer of the only mechanically powered advanced wound care solution that delivers the proven efficacy of Negative Pressure Wound Therapy (NPWT), today announced the appointment of Chris Fashek as president and chief executive officer. With two decades of experience leading health care companies, Fashek will oversee execution of Spiracur’s development and growth strategies as it expands its global presence as a preferred provider of innovative wound healing technologies.

Prior to joining Spiracur, Fashek served as president and vice chairman of Kinetic Concepts, Inc. (KCI) USA, which is the leader in NPWT of the wound care industry. Before joining KCI, he managed businesses in the pharmaceutical and consumer product markets for Sterling Drug, a division of Eastman Kodak in the United States and internationally. Mr. Fashek currently serves as chairman of the Board of Directors for Spiracur, and director of the IDN Summit, the World Craniofacial Foundation, and other commercial and charitable boards. Fashek received his Masters in Business Administration from Fairleigh Dickinson University and a Bachelor of Arts from Upsala College.

“I am very excited to assume this new role at Spiracur at this time, as the company has significant elements in place for expanding its commercial success,” said Fashek. “Spiracur has the opportunity for sizeable growth due to a substantial increase in covered lives including Medicare reimbursement and positive coverage decisions from multiple private payors, as well as being added as an approved product in two of the largest U.S. GPOs. Not only is Spiracur extremely well positioned to enhance wound care treatment for patients who can benefit from NPWT, but this patient population is growing even larger as we announce new product offerings later this year, which expand our technology platform for broader usage,” continued Fashek.

Spiracur is credited with creating a new category of chronic and acute wound management solutions that combine the benefits of advanced wound care with non-powered NPWT. The SNaP(R) (Smart Negative Pressure(R)) System provides patients with a sophisticated, non-invasive NPWT system designed to promote wound healing, which weighs only 2.2 ounces and does not require batteries or electricity.

Several clinical studies have been published supporting the SNaP System as an effective alternative to electrically powered NPWT, including a comparative Randomized Controlled Trial (RCT) that also showed the small device makes a positive difference in patients’ quality of life. Recently, promising data from the multicenter RCT comparing the treatment of venous leg ulcers (VLU) using the mechanically powered SNaP System, to an electrically powered NPWT system, was presented at the Symposium on Advanced Wound Care (SAWC) Spring Conference in April.

According to Spiracur’s chief scientific officer, Kenton Fong, M.D., “This recent RCT data shows extremely promising results for the SNaP System when used to treat venous leg ulcers. Specifically, the data revealed that wounds treated with the SNaP System demonstrated greater improvement and a higher likelihood of complete wound closure than those treated with the electrically powered VAC system.”

About Spiracur Inc. Spiracur Inc., headquartered in Sunnyvale, Calif., is a privately held medical device company focused on the development of innovative wound healing technologies. Spiracur was founded out of the Stanford University Biodesign Innovation Program in 2007. Its first product, the SNaP Wound Care System for the treatment of chronic and acute wounds, is the result of patient and clinician feedback that current negative pressure wound therapies were too cumbersome. The company’s ciSNaP(R) Closed Incision System with proprietary controlled tension relief is designed to improve healing of high-risk surgical incisions. Both devices have received 510(k) clearance from the U.S. Food & Drug Administration (FDA) and have received CE Mark approval. Spiracur’s proprietary mechanically powered technology does not require batteries or electricity to operate. For more information, please visit http://spiracur.com .

Spiracur, Spiracur logo, SNaP, Smart Negative Pressure, and ciSNaP are registered trademarks of Spiracur Inc. VAC is a registered trademark of Kinetic Concepts, Inc.

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KCI settles Wake Forest wound care patent spat for $280M

KCI settles Wake Forest wound care patent spat for $280M

July 1, 2014 by Brad Perriello

Kinetic Concepts Inc. agrees to a $280-million settlement of its long-running patent infringement war with Wake Forest University over negative-pressure wound therapy technology.

KCI settles Wake Forest wound care patent spat for $280M

UPDATED July 1, 2014, with comment from KCI.

Kinetic Concepts Inc. said it agreed to pay $280 million to settle a patent infringement lawsuit with Wake Forest University, putting their long-running war over negative-pressure wound therapy to rest.

KCI licensed the NPWT patents from Wake Forest in 1993, but stopped paying royalties in 2011 after a federal judge in 2010 ruled the patents invalid.

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A year later KCI and wound-care rival Smith & Nephew (FTSE:SN, NYSE:SNN), which had been tussling over the technology since Smith & Nephew’s 2007 acquisition of Blue Sky Medical Group, put their legal battle to rest as well.

Yesterday KCI said that it agreed to settle with Wake Forest via a series of payments covering retrospective royalties on the patents.

The deal calls for KCI to pay $80 million this month, another $85 million in June 2015, $85 million in June 2016 and a final $30 million payment in June 2017, according to a regulatory filing.

The Settlement Agreement includes a stipulated dismissal with prejudice of the lawsuits between KCI and Wake Forest, including the lawsuit that was previously scheduled to begin trial on July 28, 2014 in the U.S. District Court for the Western District of Texas, San Antonio Division.

“We are pleased to have resolved all negative pressure wound therapy patent litigation with Wake Forest. KCI pioneered the use of negative pressure wound therapy products when we launched our first V.A.C. Therapy System in 1994 and in so doing, improved the lives of millions of people. Today, KCI’s V.A.C. Therapy has been the treatment of choice for more than 8 million wounds worldwide and is the most effective therapy for accelerating wound healing,” KCI general counsel John Bibb said in prepared remarks.

Proposal to list surgical sutures, wound care products and disposable laparoscopic trocars and associated instruments

Proposal to list surgical sutures, wound care products and disposable laparoscopic trocars and associated instruments

Published By   /   July 9, 2014  /   No Comments

MIL OSI – Source: Pharmac – Press Release/Statement

Headline: Proposal to list surgical sutures, wound care products and disposable laparoscopic trocars and associated instruments

Proposal to list surgical sutures, wound care products and disposable laparoscopic trocars and associated instruments

8 July 2014

PHARMAC is seeking feedback on a proposal to list a range of surgical sutures, wound care products and disposable laparoscopic trocars and associated disposable instruments (“Medical Devices”) in Part III of Section H of the Pharmaceutical Schedule as a result of a provisional agreement (“Agreement”) with Covidien New Zealand Limited (“Covidien”).

In summary, this proposal would result in Covidien’s ranges of Medical Devices being available for DHBs to purchase at PHARMAC negotiated prices from 1 September 2014, subject to consultation and approval.

PHARMAC estimates that the proposal would offer at least $640,000 in savings per annum to those DHBs that currently purchase the Medical Devices, and could offer further significant savings should any other DHBs decide to purchase the Medical Devices.

DHBs may continue to choose to purchase other suppliers brands of medical devices.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 28 July 2014 to:

Maree Hodgson
Procurement Manager
PO Box 10 254
Wellington 6143

Email: devices@pharmac.govt.nz

Fax:     04 460 4995

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal. Please contact us if you would like to discuss the timing of your submission outside this timeframe. Please note that extending the timeframe is likely to delay the potential savings to DHBs.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.

Details of the proposal

Covidien’s range of Medical Devices would be listed in Part III of Section H of the Pharmaceutical Schedule from 1 September 2014.

The product range includes:


  • Biosyn
  • Caprosyn
  • Dermalon
  • Flexon
  • Maxon
  • Maxon CV
  • Monosof
  • Novafil
  • Polysorb
  • Sofisilk
  • Stainless Steel
  • Surgidac
  • Surgilon
  • Surgipro
  • Surgipro II
  • Ticron
  • Velosorb
  • V-Loc
  • Umbilical tape
  • Suture Bolsters
  • Teflon Pledgets
  • Bone Wax

Wound care products

  • Curasorb
  • Curity Multitrauma
  • Excilon
  • Kendal AMD
  • Kendall Copa
  • Kendall Plus
  • Kerlix
  • Mothermates
  • Polyskin
  • Telfa
  • Vaseline dressings
  • Xeroform

Disposable laparoscopic devices

  • Dexide
  • Endo
  • FRED
  • Mini Step
  • Pediport
  • Poly
  • PLDS
  • Premium
  • Roticulator Endo
  • SILS
  • Step
  • Surgineedle
  • Surgisleeve
  • Surgiwand
  • Thoracoport
  • Roticulat
  • Versaport
  • Versaport V2
  • Versastep
  • Visiport

If the Agreement is approved by PHARMAC’s Board or its delegate, Covidien’s range of Medical Devices would be listed in Part III of Section H of the Pharmaceutical Schedule, which contains products with national agreements that DHBs are able to purchase under.

The Agreement includes terms for education services to be provided by Covidien to DHB personnel on appropriate use of its Medical Devices, which is to be provided at times as agreed with individual DHBs.

The exact product list, pricing and specific Agreement arrangements in the proposal have not been included in this consultation for brevity. The surgical suture and disposable laparoscopic medical device ranges both have a tiered pricing arrangement that could offer further savings to the Schedule listed pricing for increased individual DHB commitment. The details of this tiered pricing arrangement and commitment levels would remain confidential and would only be made available to Procurement Departments at DHBs to work through with their clinical teams. Some DHBs already qualify based on current usage of Covidien product for the second tier pricing offered and they will be notified individually.

For the Suture range the Agreement also allows for supplier managed inventory systems to be put in place for those DHBs who wish to utilise this service.

The range of Medical Devices would be listed in Part III of Section H of the Pharmaceutical Schedule. We propose that the Medical Devices would not be individually listed in the printed Section H of the Pharmaceutical Schedule, but rather a reference made in Part III of Section H to an electronic source available on our website in an Excel spreadsheet format, and a PDF document.


In the May 2013 PHARMAC consultation, Surgical Sutures and Wound Care products were identified as 2 of the 11 categories PHARMAC would be working on as part of the phased plan for PHARMAC to progressively take on the management of hospital medical devices.

In August 2013 PHARMAC issued a registration of interest document, seeking proposals from suppliers for non-exclusive national agreements for wound care products. Following the closure of this request, we have been working with a number of suppliers in order to seek to reach an agreement with them, Covidien responded to this request.

In September 2013 a direct approach to the known suppliers in the New Zealand market, with comprehensive surgical suture ranges was made. This approach was in the form of a request for a submission to PHARMAC for a listing on the Pharmaceutical schedule and Covidien responded to this request.

Laparoscopic disposable trocars and associated instruments was not part of PHARMAC’s initial group of categories for medical devices consulted on in May 2013. The opportunity to list these medical devices was presented to PHARMAC following the initial consultation that identified the categories and significant saving opportunities for DHBs was offered. PHARMAC assessed the potential opportunity and determined it was substantial and would be worthwhile pursuing.

Following further consultation with; the sector as a whole, the Royal Australasian College of Surgeons specifically, and DHB Procurement teams, PHARMAC chose to pursue the opportunity offered in the disposable laparoscopic market. In November 2013 a direct approach to the known suppliers with comprehensive disposable laparoscopic device ranges in the New Zealand market was made and Covidien responded to this.

No reusable vs. disposable costing models have been undertaken on this range of medical devices for this process as PHARMAC is looking to obtain improved pricing on disposable products already in use in DHB’s, not advocating a change to disposable products. DHBs role in choosing the mix of disposable and reusable equipment they use would not be altered by this proposal.

The range of products available in all three categories would not be altered by this proposal and DHBs would continue to be able to choose which medical devices they purchase.

PODCAST: Chronic wound care offers insight into battling biofilms

PODCAST: Chronic wound care offers insight into battling biofilms


DANA POINT, CALIF. – “Biofilms are ubiquitous,” said Dr. Robert Galiano, a plastic and reconstructive surgeon at Northwestern Memorial Hospital in Chicago.

“They [bacteria] hijack the body’s healing mechanisms, so instead of healing, … the body’s inflammatory cascade gets amplified to a degree where it actually becomes tissue damaging,” he said at the Summit in Aesthetic Medicine 2014.

Much of what we know about how bacteria communicate with one another to form biofilms comes from research into the prevention and treatment of chronic wounds. More research is needed, but greater understanding of how bacteria communicate with one another to prevent antimicrobial action may lead to new therapeutic targets that could benefit many medical specialties, he added.

Potential therapeutic targets range from coatings for wound dressings to protective barriers on stents and implants of all kinds to extend their durability. In this interview, Dr. Galiano discusses current treatment strategies to manage bacteria, which patients are at greatest risk, and future directions for biofilm prevention.

The summit was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications. Dr. Galiano had no financial conflicts to disclose.

Repost from WS Journal “Renasys NPWT Pump Recal”

Statement regarding RENASYS(TM) NPWT in the United States

LONDON, June 23, 2014 /PRNewswire/ — Smith & Nephew (LSE: SN; NYSE: SNN), the global medical technology business, announces that it has temporarily ceased commercial distribution of the RENASYS Negative Pressure Wound Therapy product line in the United States.

This action follows instruction from the FDA to obtain new regulatory clearances through the premarket notification (510K) process in respect of certain design enhancements made to RENASYS systems. The applications for clearance have now been filed and are awaiting action.

This action only affects RENASYS products in the United States. Other NPWT products, including PICO(TM), Smith & Nephew’s portable, canister-free system, are not affected.

Smith & Nephew is working cooperatively with the FDA to address its concerns in order to resume distribution of RENASYS products in the United States as soon as possible and regrets any disruption caused to customers.

Sales of RENASYS products in the United States accounted for less than 5% of global Advanced Wound Management revenue in 2013.

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 11,000 employees and a presence in more than 90 countries. Annual sales in 2013 were more than $4.3 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).

For more information about Smith & Nephew, please visit our corporate website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

(TM)Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.

SOURCE Smith & Nephew

/CONTACT: Investors, Phil Cowdy, +44 (0) 20 7401 7646, Smith & Nephew, Media, Charles Reynolds, 44 (0) 20 7401 7646, Smith & Nephew, Trade Media, Suzanne Miller, +1 646 405 5992, Magellan Communications

/Web site: http://www.smith-nephew.com