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The Life and Death of the Luer

The Life and Death of the Luer

The luer connector design allows direct or functional connection between unrelated delivery systems, including vascular, enteral, respiratory, epidural, and intrathecal medical devices, as well their components and accessories. And multiple connections between medical devices and tubing are common in patient care.

Despite its modern-day difficulties, the luer has a rich history. Luer connectors got their start in 1896 when Karl Schneider, an instrument maker for the H. Wulfing Luer Company of Paris, France created an all-glass syringe that consisted of a glass cylinder and glass plunger with no additional “packing” material to create the seal between plunger and cylinder. A variety of syringes and related products with Luer-type connectors appeared in the company’s catalogs in the early 1900s for a variety of applications, from hypodermic and intravenous injection to urethral and uterine instillation.

In this original locking form the male and female parts, each featuring a 6% taper, allowed a clean press fit. The simple design created a strong hold that could be accomplished in a variety of materials—glass, metal, and eventually, plastic.

The next major development solved the problem of keeping needles firmly fixed to syringes when pressure was applied during injection. In 1930, a patent for the Luer-Lok connection was granted to Fairleigh S. Dickinson, cofounder of Becton Dickinson. The addition of locking flanges addressed the Luer’s tendency to pop open under pressure and enabled users to connect the needle to the syringe by twisting to engage interlocking cams.

The Luer-Lok connector locks and unlocks with a twist and remains locked. Due to these features, this simple, effective and economical connector gained attention in a wide variety of medical applications. (Roughly 20 years after the Luer-Lok patent was issued, the luer lost its proper-name status. Except for specific references to events after 1950, luer-lock and luer are lowercased.)

Before and after development of the Luer-Lok, various tapered connectors found expanded use in medical applications particularly involving syringes.

  • The 1925 S. Maw, Son, and Sons catalog includes a Rose’s “antrum instrument” for use in nose and throat surgery. A tapered connector is used to attach the cannula.
  • A 1930s Charles Lentz & Sons catalog includes a variety of lachrymal syringes for irrigating the tear ducts and nasal instruments with tapered connections for washing and suction.
  • The Allen & Hansburys Ltd. catalog included a “Record” syringe with needles. Record and Luer connectors coexisted until the 1980s.
  • The 1943 V. Mueller & Company catalog illustrated a variety of connectors for medical applications, including the Luer-slip (trademarked by Becton Dickinson), Luer-Lok, small French slip, large French slip, standard thread, Record slip, 606 hose end, ¼″ tubing.

In 1954 Becton Dickinson introduced a disposable glass syringe for a test of the Salk polio vaccine. Over a period of three weeks the syringes were used to vaccinate more than 1 million children in 44 states. One year later, Roehr Products introduced Monoject, the world’s first disposable plastic syringe. In 1961, Becton Dickinson introduced Plastipak, a disposable plastic syringe. However, because many believed sterilization of reusable syringes was economical and comparably safe, there was little demand for the products.

The fate of the reusable syringe was sealed when Dr. Albert Weiner was convicted on 12 counts of manslaughter in December 1961 after a dozen of his patients died of hepatitis attributed to the reuse of infected syringes. Demand for disposable syringes skyrocketed, and within a year, disposables secured one-third of the U.S. needle market. The mass production of plastic luer-type syringes, in turn, led to the growing use of plastic luer connectors in a variety of applications. That expanded interest and use could now lead to its contraction in the medical marketplace.

Expanding Use of the Luer

Advances in thermoplastic technology allowed manufacturers to mold plastics in precise parts and dimensions, making luer connectors easier to manufacture. They were rapidly adopted in a variety of medical applications. In 1961, for example, a method for percutaneous transvenous catherization was described as using “dialysis tubing fixed to a Luer-lock at the end of the venous catheter.”

During the 1960s industry consolidation survivors Abbott Labs, Baxter, and B Braun dictated fit, form, and function of intravenous (IV) connectors. They settled on the luer and luer-lock connectors and agreed on dimensions and materials as they moved away from metal and glass. Connecting metal and glass together could result in cracks, leakage and/or entrainment of nonsterile air leading to infection.

The luer style was selected because it was reliable, and inexpensive to manufacture, and therefore purchase. It also had a simple design that worked with few complications, and allowed device manufacturers to make items that would easily connect with other products.

http://www.mddionline.com/article/sidebar-air-show-disaster-elevates-luer-connectorSidebar: How did an airshow disaster fix a serious problem in medical luer connectors?

Subsequent Developments

Indwelling catheters, such as the PICC line, drove the development of new luer-type connectors. The female connectors on the indwelling catheter represented an open system that was capped using a closed-end male luer-lock connection—essentially a cork. The cap could be removed to provide access, but it provided an opening for infection. The alternative closed-system connectors were permanently capped with a rubber injection port through which a needle could be inserted to draw blood or introduce medication. The closed injection port used a male luer connector attached to the female luer at the end of the indwelling catheter.

In approximately 1978 the ANSI Luer Taper Standard was issued, the first-ever parenteral device connection standard. (Other standards from the EU and Japan came later.) The nonstandardization of materials and dimensions had resulted in deaths, injuries, misconnections, and taped connections. The new standard allowed an approximately five-year phase-in period to develop new molding machines and use existing inventory.

In the 1980s, rising concern over needle sticks as a cause of hepatitis and HIV transmission led to the development of needle-less technologies. Blunt plastic cannulae replaced metal needles as a means of entering the closed system through the rubber port. Luer-activated devices (LADs) performed a similar function, creating a leakproof seal that opened automatically when a suitable luer-based connector was attached to it.

In complex IV systems, stopcocks allow delivery of various materials to be turned off and on without opening the system, providing individualized control over multiple materials being introduced through the same line. These modular systems, largely created using lures, allowed a level of control over the delivery of drugs, blood, and other materials and reduced the opportunity for infection.

At the same time, luers were being used to connect gas delivery lines for applications such as limb cuff inflation. Patients in operating, recovery, and emergency rooms could have dozens of luer connections delivering a variety of gases and liquids.

By the late 1960s, the luer had largely supplanted the more slender Record connector due to the marketing dominance and technological leadership of U.S. companies' intravenous (parenteral) products. U.S. dominance of the IV market in terms of IV bottles, IV bags, kits and trays and the associated sets and devices, all revolved around the use of the parenteral luer.

The luer connector had become the de facto standard in the U.S. by 1980, however most European users employed the Record (sometimes referred to as Rekord) connector. Interestingly, the luer was not formally defined as a standardized small-bore (inside diameter less than 8.5mm) connector until 1986. (It is defined in ISO594-1 and ISO594-2 and described as a “conical fitting with a 6% taper for syringes, needles, and certain other medical equipment.”)

The luer’s place in medical history was solidified following investigations of an August 1988 midair collision at the U.S. Ramstein Air Base. (See the sidebar "Air Show Disaster Elevates Luer Connector.")

What the Future Holds

Luers have a long, storied history and possibly a replicated future. But there will be changes in form and function, if not fit. National committees and international working groups are driving the changes, as are researchers and users. The question of what the future holds for the simple luer might be answered in the new options manufacturers are offering.
What was once a simple solution in a simple time is now being replaced with a more appropriately straightforward method: matching connectors for each media and purpose. Even where general luers may still be used, they likely will see design changes. Applications in which luers are no longer are allowed will see significant change. And, as medical applications advance so must the connector industry’s progress.
Connector manufacturers are adopting unique closure and fitting applications including color-coding, audible signals (a click when the match is right) and radio frequency identification (RFID). Matching-color sets can reduce the risk of mistaken connections. Textured closures can simplify and ease the mating process. Audible indicators clarify whether the proper closure has been made. RFID signals warn of misconnections, declare good connections, and record the findings. Colors, textures, and connection options are just a few of the possibilities being considered to meet stricter requirements, and also retain the luer’s low-cost appeal.
 

Given safety concerns and new standards that restrict their use, luers will either decline in use or change dramatically from a design that has seen few alterations throughout its lifetime. The popularity of new and different connectors such as quick-disconnect couplings continues to rise, because these advances offer greater protection and confidence in accuracy and closure success.
 

Manufacturing innovations are making these critical safety options more accessible and affordable as luers are phased out of many medical environments, where standards risk mitigation call for safer new approaches. Luers might still be used for vascular access; however, the focus is on new connector designs that specifically address the prevention of misconnections in other applications.
 

Certainly it is the buyers’ and the manufacturers’ responses to the standards committees that spell the fate of the luer. ISO 80369 will test the industry’s willingness to turn from a tested, but now questioned, low-cost technology toward new, potentially more costly, but safer connection options. Likely the widespread use of luers will diminish. No one technology will replace them. The fun part will be to see what comes next.

++++++++++++++

Jim Brown is business unit manager for medical markets at Colder Products Co. He has been customizing fluid connections for more than 20 years. His expertise includes applications for medical devices such as blood pressure monitoring, dialysis, and surgical equipment. He has a B.S. in mechanical engineering from the University of Minnesota, Institute of Technology. Brown is a member of LifeScience Alley and AAMI and currently serves as a US Expert to ISO Technical Committee 210/JWG4 developing standards to prevent misconnections of small-bore connectors.
 

What a Top CDRH Official's Prostitution Arrest and Employee Surveillance Says About FDA

Bill Maisel
William Maisel, who is the deputy director for science at CDRH, has been a proponent of in silico clinical trials.

If they weren’t all potentially related in a serious way to each other, you’d be tempted to throw up your hands in despair.

The first part of the story—nine CDRH scientists’ allegations to Congress and others that managers coerced bad decisions out of them to please industry—has been related numerous times, so I won’t go into details again.

As I see it, the troubling if tortuous and tenuous string unravels this way. In attempting to quell the whistleblowers’ complaints, CDRH initiated FDA chief counsel’s office-approved clandestine electronic monitoring of their government computers, including new spyware.

In the course of this, private emails and home computers were allegedly invaded, including the whistleblowers’ communications with Congress and private parties, including journalists.

On top of that and coincidentally, 510(k) documents that were attached to some of the communications were accidentally released in public cyberspace by an FDA contractor, raising the specter of FDA hypocrisy in accusing its employees of leaking government-protected industry documents when it was in effect doing far worse itself, albeit accidentally.

At this point, you should consider the whistleblowers’ claims that even if they had shared industry 510(k) documents with Congress in order to support their arguments that CDRH managers were directing improper results in their 510(k) reviewers, Congress is part of the government and held to the same confidentiality standards as FDA with respect to those documents. In other words, they say, Congressional receipt of those documents is privileged by law.

This is an old and, to my mind, unsettled issue at law – but for current purposes here, a digression.

The tangled string continues. In the course of all this, it turns out that Dr. Maisel was late in July arrested by county police in Maryland and charged with four counts of soliciting prostitution and one of disorderly conduct, during a police “sting operation” on a public highway. An FDA spokeswoman, Erica Jefferson, publicly dismissed this as a “personal matter that has nothing to do with the work he does at the agency.”

But now enters the National Whistleblowers Center , which in a letter to HHS secretary Kathleen Sebelius asked whether FDA had shown a “double standard” in the Maisel affair vis a vis the whistleblowers case, since Maisel was the official who authorized the termination of one of the whistleblowers, “Dr. Ewa Czerska, a female 23-year veteran civil servant.” Czerska, the letter said, “is a member of the original ‘FDA 9,’ who filed significant health and safety complaints to various appropriate authorities. Prior to her discharge, Dr. Czerska also filed a Title VII sex discrimination complaint.”

The letter asked Sebelius whether FDA will “assist in the criminal prosecution of Dr. Maisel by conducting targeted surveillance of Dr. Maisel and all of his known associates? Will the FDA use targeted surveillance to develop additional evidence of crimes committed by Dr. Maisel or any of his ‘cohorts’?”

NWC told Sebelius that Czerska’s computer systems were extensively monitored and that resulted in the collection of “private and personal information,” including confidential information related to her sex discrimination complaint, as well as her Office of Special Counsel complaint. Questions posed to Sebelius include:

“When FDA managers were looking at Dr. Czerska’s personal communications, what safeguards existed to prevent a person who may be engaging in sex crimes from looking at her most intimate emails?

“What background screening did the FDA require to ensure that persons who had access to highly private and confidential internet/computer information (including access to passwords that could permit persons to access employee bank accounts, transfer money, or access medical records) had the necessary good character to be granted access to such information?

“What background screening was given to every FDA manager who authorized the scope of surveillance on Dr. Czerska (or any of the FDA whistleblowers who were the target of the spying operation) and/or had access to any of the whistleblowers’ private email?

“Did Dr. Maisel have access to Dr. Czerska’s personal emails or the personal emails of the other whistleblowers?”
There is an element of salaciousness here, and also the never-easy issue of when ostensibly “private” behavior by high public officials should lose its privacy.

U.S. Code Title 5, Part 2635--Standards of Ethical Conduct for Employees of the Executive Branch, Subpart A, Section 2635.101 Basic obligation of public service, states: “Employees shall endeavor to avoid any actions creating the appearance that they are violating the law or the ethical standards set forth in this part. Whether particular circumstances create an appearance that the law or these standards have been violated shall be determined from the perspective of a reasonable person with knowledge of the relevant facts.”

An uproar on my Web site among FDA employees occurred after the Maisel arrest was published. One commenter with an apparently legal background wrote: “Solicitation of a prostitute is a crime. This was a police sting, therefore there is likely videotaped evidence of the activity. Such behavior clearly violates the standard of ethical conduct for executive branch employees cited above. Not only is solicitation of a prostitute unethical and illegal, it sets up an opportunity for other criminal behavior such as extortion by the prostitute. While we wait for the legal proceedings to take place, it is hard to believe that Dr. Maisel is innocent of the crimes for which he is charged, since they occurred as part of a police undercover operation. As second in command at CDRH, he can hardly return to his leadership position unstained after this breech of the law and ethics. The questions raised about how FDA responded to Dr. Maisel's arrest are appropriate and valid.”

As has often been observed in other cases, FDA management has a long track record of reflexively protecting its own.
That is precisely why it did not deal adequately with the nine CDRH whistleblowers’ complaints in the first place and now has a much more awful mess on its hands.

Hopes that it will be able to comprehensively and quickly deal with industry’s many issues concerning product reviews and timeliness must be faint until all this is settled.

Medical Device Tax 101

Medical Device Tax 101

Set to take effect January 1, 2013, the 2.3% excise tax on certain medical devices, which was imposed as part of the Affordable Care Act (ACA), will pose significant challenges to the medical device industry. Although the tax will apply primarily to manufacturers and importers of medical devices, it’s safe to assume that the tax will have a far-reaching impact on the entire healthcare industry and consumers who need these devices.
Tax
Before the tax goes into effect, medical device companies need to understand which of their devices will be taxed, get and idea of how much they will owe, and deal with the compliance issues associated with the tax.

Which Devices Will Be Taxed?

The first order of business for medical device companies will be to determine if the manufacture and sale or import of a specific device is subject to this new excise tax. For planning purposes, the mindset should be that, indeed, the device will be subject to the tax. This is an important mindset because it gives companies time to budget and plan for this new cost, which more than likely will impact their pricing, salaries, and, ultimately, their bottom line.

The provisions of the excise tax on medical devices rely almost entirely on the definition of medical devices provided by Section 201(h) of the Federal Food, Drug, & Cosmetic Act to determine which devices are taxable. The tax will apply to devices that are intended for human use and will include dental instruments, dental equipment, and research-use-only devices.

There are three major categories of exemptions available:

  • Devices to be further manufactured.
  • Devices manufactured that are ultimately destined for export outside the United States.
  • Devices intended to be sold at retail for use by the general public (referred to as the “retail exemption”).

The IRS has already provided a great deal of guidance around the retail exemption, including providing specific examples. Items such as eyeglasses and hearing aids would be exempt. It is important to keep in mind that items qualifying under the retail exemption will not necessarily be bound by FDA Class I, Class II, and Class III listings. There are many items qualifying for the retail exemption that could fall under any of the above classes, including certain bandages (Class I), pregnancy test kits (Class II), and denture adhesives (Class III).

How Much Will You Owe?

Aside from determining if a device will be subject to the tax, there are two major issues that will need to be addressed by all companies: pricing models and calculating the amount upon which the tax will be assessed.

Pricing Models. Adapting pricing models for the new tax is a major dilemma for business leaders. Take the example in Table 1, of a medical device manufacturer that produces a device at a cost of $1000 and is able to sell this device today for $1335 to a distributor, realizing a gross profit of $335. Once the medical device tax takes effect, the tax will attach at the point of sale from the manufacturer to the distributor. In this basic model, the manufacturer now has an additional cost of $30.71 ($1335 x 2.3%) per device, regardless of whether the excise tax can be passed on to the distributor.

Table 1. A demonstration of the excise tax's effect on gross profit.
    Pre-Excise Tax   Post-Excise Tax

Sales Price

  $1335.00   $1335.00
Cost of Manufacture $1000.00   $1000.00  
Excise Tax $0.00   $30.71  
Total Cost   $1000.00   $1030.71
Gross Profit   $335.00   $304.29


To further complicate matters, companies will have to pay the tax on inventory on hand on December 31, 2012, that is not sold until January 1, 2013. Many companies have probably not considered this in their current pricing models. The tax will also factor into the sale of a business. Regardless of whether the assets are sold or stock is sold, the tax will attach to all inventory transferred in the sale.

There is a lot of concern that the industry will see a significant drop in mergers-and-acquisitions activity going forward. To the extent a company bears 100% of the burden of this cost, this will reduce the earnings and thus the ultimate value of the company in a merger-and-acquisition transaction.

Companies also will have to factor the liability for the excise tax into sales price negotiations. The seller will have an additional liability at the time of sale for which the buyer may not be willing to adjust the purchase price.

Calculating the Amount Upon Which the Tax Will Be Assessed. The calculation of the sales price on which the tax is computed does not offer much room for pricing adjustment. Allowances for discounts and rebates cannot be factored into the sales price of the device until actually awarded to the purchaser. Additionally, costs of packaging, shipping, and warranties (not provided at the purchaser’s option) are also factored into the sales price for calculating the tax. The IRS will also assume that the sales price is determined at arm’s length, so it will be important to review pricing policies and documentation between related parties.

Compliance Issues

In addition to the myriad pricing issues, companies will also have to deal with compliance issues. Even if a company is exempt from the tax, it will still be required to register with the IRS. The IRS is already prepared to deal with noncompliance.

When the medical device excise tax takes effect,
the IRS will most likely request FDA’s listing of registered companies and match it against its listing.

Companies that produce, manufacture, or import medical devices are currently required to register with FDA and update those registrations on a yearly basis. When the medical device excise tax takes effect, the IRS will most likely request FDA’s listing of registered companies and match it against its listing. As such, companies will not have the ability to fly under the radar.

The penalties for failure to register start at $10,000, with a $1000 penalty per day of noncompliance. Ironically, the IRS has yet to update IRS Form 637—Application for Registration (For Certain Excise Tax Activities) to reflect the new excise tax on medical devices.

Once registered, companies will need to document their various transactions. If a manufacturer or importer is selling for further manufacture or for further sale, it will need to obtain, in writing, a copy of the purchaser’s registration number and certification of the exempt purpose. They also need to receive proof of the resale within six months of the date of sale. Sales to a purchaser for further export will need to be documented with a registration number, proof of the export, and an exemption statement from the purchaser. Finally, companies will need to adapt their accounting systems to track the tax and put controls in place to report and remit the tax.

Conclusion

The excise tax on medical devices is quickly approaching. Despite a House of Representatives vote in favor of repealing the tax, bills to repeal the tax will face stiff opposition in the Democratic-controlled Senate between now and the November election. It is difficult to say if this provision of the ACA will be repealed even if a new president is elected in November.

With the impending onset of the tax, many critics are decrying the hit the medical device industry will take and are concerned about the impact to this industry. There will be many challenges ahead, but there will also be many opportunities. It will be interesting to see how companies respond in this new climate.

With this new tax slated to take effect in just a few months, many medical device companies are already planning and preparing for it. Companies that haven’t begun to prepare for the tax should start.

Mitchell Kopelman is the partner in charge of the technology and biosciences practice at Habif, Arogeti, & Wynne (Atlanta). He focuses on helping medical device companies with R&D tax credit studies, mergers and acquisitions, and proactive tax and accounting planning. He also works with companies as they expand globally or enter the United States. Kopelman graduated from Georgia State University with a bachelor’s degree in accounting. He can be reached at [email protected]

Ori Epstein is a tax manager in Habif, Arogeti, & Wynne’s technology and biosciences practice. He regularly speaks at medical device industry conferences on topics such as the excise tax, business trends within the medical device industry, and tax planning and preparation for medical device companies. Epstein graduated from the University of Georgia with a bachelor’s degree in accounting and a master’s of accounting with a concentration in tax. E-mail him at [email protected]

 

If All Goes Well, Abiomed Will Continue to Fare Well on Wall Street

In order for that to happen, however, the company’s new micro heart pumps must fare well on the market. While most of the company’s revenues now come from its Impella 2.5 cardiac assist device, the Impella cVAD and Symphony cardiac devices will become crucial to its product portfolio going forward. The Impella cVAD has received the CE Mark while the first in man use of the Symphony was announced in December 2011.

Potential hurdles for the firm include the Centers for Medicare and Medicaid Services’ potential to rethink its reimbursement decision for the Impella device or lower the reimbursement amount for the device. Another complication is that Thoratec plans on debuting a percutaneous heart pump that would go head-to-head with the Impella. Another concern, not mentioned in The Motley Fool piece, is the looming medical device tax. Abiomed's chairman, president, and CEO Michael R. Minogue recently spoke out against the tax at the House Committee on Small Business and its effects on small companies. 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz. 

Nanofiber Stent Coating Encourages Arterial Healing

Transmission electron microscopic images show the structure of BioNanomatrix, a natural, peptide-based nanofiber material developed by Endomimetics to inhibit the proliferation of smooth muscle cells and prevent platelets from clotting.

Cardiovascular disease is the leading cause of death in the United States today, resulting in the implantation of more than two million stents each year. Although stents are lifesavers, however, they are far from trouble free. While 15 to 45% of all bare-metal stents result in restenosis, requiring follow-up procedures, 2% of drug-eluting stents clot off over four years. As a result, approximately 45% of stent thrombosis patients die each year. Answering the need to improve stent technologies, Endomimetics LLC (Birmingham, AL) has developed BioNanomatrix, a completely natural, peptide-based nanofiber stent coating material that inhibits blood-clot formation, prevents blood vessels from renarrowing, and encourages the normal arterial lining to heal.

"Although stents save lives, they carry their own risks," remarks Brigitta C. Brott, Endomimetics's chief medical officer and a practicing interventional cardiologist at the University of Alabama at Birmingham. "Although bare-metal stents have been approved by the FDA since the early 1990s, they carry with them the significant risk of arterial renarrowing over the six to nine months after implant." The risk of renarrowing, she adds, particularly affects diabetes patients. In response, drug-eluting stents were introduced in 2003. But while these devices inhibit renarrowing, they also inhibit the normal healing process and are associated with an increased risk of clotting, according to Brott. To avoid clotting, patients must take anticlotting medications--sometimes for years.

Renarrowing occurs when smooth muscle cells grow excessively and scar tissue forms over a stent, whereas clotting develops when there is inadequate healing over the stent, exposing stents struts to the blood flow. To reduce the proliferation of smooth muscle cells, Endomimetic's BioNanomatrix material releases nitric oxide over a two-month period, preventing renarrowing and clotting. The material also encompasses cell-adhesive amino acid sequences known as YIGSR, which attract the normal endothelial cells that line the arteries, further reducing the risk of blood-clot formation by covering over the surface of the stents. Thus, the components of the nanomatrix work together to inhibit clotting, enhance healing by endothelial cells, and inhibit excessive proliferation of smooth muscle cells. "Our approach is to develop a stent material that enables the artery to heal over in an all-natural way, enabling it to create its own lining again," Brott says.

Using a water-evaporation self-assembly process, BioNanomatrix is fabricated from two separate segments that combine to form into hollow nanofibers containing a hydrophobic tail on their inner surface. The fibers' more-hydrophilic surface areas feature either YIGSR--part of the normal basement membrane of a blood vessel--or a polylysine tail, which is used to deliver nitric oxide. Through water evaporation, the material dries progressively onto the surface of the stent. During this process, the hydrophobic portions of the fibers form hollow tubes, creating many fibers several hundreds of layers thick that form a loose coating mesh on the stent surface.

Incorporated into the polylysine tail, nitric oxide enhances endothelial cell growth while significantly inhibiting the proliferation of smooth muscle cells and clotting, Brott explains. However, one of the problems with drug-eluting stents is that they incorporate a polymer for releasing nitric oxide. This polymer contains a solvent that can cause an inflammatory response. "The ability to provide sustained nitric oxide release over a two-month period without the use of solvents is really the core of BioNanomatrix technology," she adds.

To test BioNanomatrix's ability to release nitric oxide over a two- and four-week period, Endomimetics performed a pilot study in order to compare bare-metal with coated stents in rabbit iliac arteries. While the bare-metal stent induced the proliferation of smooth muscle cells, causing stent renarrowing, the BioNanomatrix-coated stent resulted in reduced narrowing with no hint of platelets or inflammatory cells, Brott notes.

"Some of the most significant findings from our in vitro testing resulted from comparing our coating with collagen--a normal component of arteries--and stainless steel--a common stent material," Brott explains. "Compared with collagen, the nitric oxide-releasing nanomatrix led to a 150-fold decrease in platelet adhesion, while compared with stainless steel, it resulted in a 47-fold reduction in platelet adhesion."

Endomimetics's ultimate objective is to make its nanofiber stent-coating material available for both drug-eluting and bare-metal coronary stents, peripheral stents, and other applications, including vascular bypass grafts, heart valves, and in-dwelling catheters. Looking ahead, Brott comments that the coating material could also benefit future biodegradable stents. "If you have a stent that degrades over time but the artery is not completely healed over, there is a risk that little pieces of the stent can float downstream. Thus, because our coating may ensure that the artery over the stent is completely healed, it is attracting the attention of stent manufacturers interested in developing biodegradable technologies." --Bob Michaels

Twin Piston Pumps and Compressors from Thomas Division

A designer and manufacturer of precision engineered compressors and vacuum pumps found in medical systems offers a line of twin piston pumps and compressors designed to withstand the most demanding applications. Comprised of the 2660/2668 Series, these pumps and compressors feature air flows to 5.3 cfm (148.7 l/min), pressures to 160 psi (11 bar) and maximum vacuum to 99% of local barometer (990 mbar).The versatile platform design offers OEMs the ability to add custom options to meet or exceed their specific design criteria. The use of die-cast aluminum parts provides a strong, lightweight and durable component. In addition to low vibration and reduced sound level, Thomas’ oil-less WOB-L¨ technology extends operating life.

Sheboygan, WI

Dymax SG-100 Hand-Held Spray Gun Systems

A developer of adhesive, coating, dispensing, and light-curing systems for applications in the medical industry has released a new line of hand-held spray gun systems. These systems, the SG-100, available in both standard- and high-flow models, provide a solution for manually spraying materials for masking and coating applications. These systems are able to dispense from pressurized cartridges, bottles, and pails, making them compatible with most standard fluid packages and delivery systems. Their lightweight assembly with low trigger resistance allows for hours of effortless spraying, and the easy adjustment of material flow and spray atomization results in greater dispensing accuracy with less material waste. All wetted components of the SG-100 spray guns are stainless steel, Teflon, or Kalrez, making them compatible with a greater number of fluids. The fluid body is sealed, so there is no exposure to ambient conditions enabling easy shutdown and cleanup. The spray guns are also pneumatically operated and require no electrical power.

 
Torrington, CT
 

Rotork Fairchild Launches New High Pressure Regulators

Constructed with 316 stainless steel bodies, the units are available as the HPD diaphragm design for pressures up to 413 Bar (6000 psi) and as the HPP piston design for even higher supply pressures. Both the HPD and HPP designs are available with 6mm (¼”) ports in either 2 or 4 port configurations and in multiple output pressure ranges. The HPD design features high strength Inconel diaphragms as standard and will accurately regulate output pressures down to 1.66 Bar (25 psi). It is available with the standard polymer valve seat for media temperatures up to 80°C and supply pressures up to 241 Bar (3500 psi). Optional higher performance valve seats are fitted for temperatures up to 260°C and a maximum supply pressure of 413 Bar (6000 psi). The all-stainless steel HPP piston design models will also handle temperatures up to 260°C and increase the supply pressure capability to 689 Bar (10,000 psi).
 
Winston Salem, NC
 

This Week in Devices [8/17/2012]: FDA Issues Further Mandates to St. Jude; Smart Medical Devices; UCLA Performs Groundbreaking Heart Surgery; A Brain Implant for Parkinson's

This Week in Devices [8/17/2012]: FDA Issues Further Mandates to St. Jude; Smart Medical Devices; UCLA Performs Groundbreaking Heart Surgery; A Brain Implant for Parkinson's

St. Jude Under FDA Order to Study Heart Devices

  • After its implanted heart device components have led to as many as 20 deaths, FDA has ordered St. Jude to conduct further studies on the health of patients who received these implants.
    Source: The New York Times

The Rise of Smart Medical Devices

  • More and more medical devices are employing technology to put patients' care back into their own hands and reduce the aid for constant attention from healthcare professionals.
    Source: The Wall Street Journal

UCLA Performs first TAVR Using New Device

  • UCLA has performed its first transcatheter aortic valve replacement (TAVR), using a new device approved by FDA.
    Source: News-Medical

Revisiting the Parkinson's Implant

  • Wired revisits the story of a man who received a brain implant to slow the progress of his Parkinson's disease.
    Source: Wired
 
 
 

Medtech Compliance Training: Does Online Education Work?

It wasn’t so long ago that many of us mocked the validity of an online education. Often this form of higher learning was dismissed as merely ‘mail order degrees’ that inferred an almost tabloid inferiority by comparison to real educations earned, of course, by attending college. That stigma is wearing thin now. Just have a look at the market caps of businesses like the University of Phoenix’s at $3.6 billion or Kaplan University’s (a division of the Washington Post) at $2.5 billion. These companies are proving that online education works on a global scale. For educating all ages, see Salmon Kahn’s Khan Academy, which offers more that 3000 free video courses on an overwhelming list of topics. Khan, who left a cushy hedge fund gig to devote himself entirely to this cause, gave this year’s commencement speech at MIT and has now attracted generous support from the Bill & Melinda Gates Foundation.

The medical device industry recognizes that its audience, comprised mostly of physicians (customers) and engineers (employees), also needs educational content. And many business owners are looking to employ the convenience of online delivery. Instead of incurring costly travel expenses for a group to meet in a central location, many companies now opt to conduct product training online. This trend has created a cottage industry of sophisticated learning management systems (LMSs) that are deployed to, among other things, administer training centrally.

What to Look For in a Training Program

Top LMS firms include SABA or SAP’s Success Factors formerly known as Plateau, are popular among larger OEMs who have formalized training within their human resources or corporate training departments. They use course curriculum, known in e-learning as Sharable Content Object Reference (SCORM) compliant. SCORM provides administrators with easy LMS Integration for simple, convenient prescription to students.

Online delivery is also beneficial for OEMs whose managers are required to receive regular compliance training on global regulatory, clinical, reimbursement, and QA topics. As part of compliance audits, FDA regulators can choose to check the training backgrounds of everyone involved with any device under investigation. As a result, OEMs in good standing can retain their culture of compliance by providing their management with online educational courses that are self-paced, and thus conveniently amenable to their busy schedules.

Compliance-related training online has become a sensible outsource solution for many. Unlike an OEM’s product-specific application instruction, it’s cost-effective to utilize packaged compliance courses. Key educators include:

  • World Medical Device Org offers more than 150 online courses on global clinical, QA, regulatory, and other topics throughout the entire life cycle for medical devices. Globally-located subject matter experts provide. All course content is SCORM compliant. WMDO clients without LMSs have access to free cloud-based administration tools. Premium account holders gain access to SME’s for additional course questions.
  • The US Food & Drug Administration (FDA) offers workshops and conferences for medical device education. Online regulatory courses are also available via FDA’s partnership with Eduneering, div of UL.
  • The Regulatory Affairs Professional Society (RAPS) is a global organization specializing in regulatory training. Though their Online University and Certification (regional) events, they offer a comprehensive education in worldwide regulatory affairs. RAPS national conferences are held annually (2012 Seattle and 2013 Boston).
  • Eduneering provides the online regulatory training, documentation, and serves as the virtual university for FDA’s Office of Regulatory Affairs (ORA).
  • For QA topics, see the American Society for Quality. All educators should be accountable for their bodies of knowledge (BOK), so look for high quality instructional design, current regulatory knowledge, independent peer reviews, and accreditation where possible.

Accreditation

Educators meeting ISO 9001 will often seek accreditation according to ISO 17024 (competency validation, typically described as “the demonstrated ability to apply knowledge, skills and attributes). Commercially available course and program accreditations can be investigated through the Institute of Credentialing Excellence (ICE) along with the accreditation body, the National Commission for Certifying Agencies (NCCA). Educators fulfilling the requirements of the NCCA standards can maintain compliance via recertification (due in five years). In Europe, the Swiss Accreditation Service (SAS) examines and accredits conformity in a similar fashion.

Organizations and individuals seeking compliance courses can also follow industry organizations like the LSA (Lifescience Alley) and MDMA (Medical Device Manufacturers Association US) and for physicians, SoPE (for Physician-Surgeon entrepreneurs) via Twitter, Linked In groups, and other medical device online communities. Lastly, check for peer reviews, often available through course publishers, for candid consumer assessments of individual course content.

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Scott Hewett is an account manager at WMDO. Contact him at [email protected]