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Articles from 2012 In August


This Week in Devices [ 8/31/12]: St. Jude to Cut 300 Jobs; ICDs Endangered by Europe's Financial Crisis; Turning Your Body into a Wireless Hotspot; Libel Claim File Against the Lipotron 3000; Virtual Clinical Trials

This Week in Devices [ 8/31/12]: St. Jude to Cut 300 Jobs; ICDs Endangered by Europe's Financial Crisis; Turning Your Body into a Wireless Hotspot; Libel Claim File Against the Lipotron 3000; Virtual Clinical Trials

St. Jude Medical to Cut 300 Jobs

  • St. Jude has announced it will be eliminating 300 jobs as part of a reorganization of its various medical device-making divisions.
    Source: Bloomberg Businessweek

Will Europe's Financial Crisis Endanger Implantable Devices?

  • Admist growing concern that the European financial crisis could lead to further underuse of implantable cardiac devices, the European Heart Rhythm Association (EHRA) has started an initiative, ICD for Life, to raise awareness about the importance of ICDs and sudden cardiac death in countries in Central and Eastern Europe.
    Source: Medical News Today

Turning Your Body into a Wireless Hotspot

  • Researchers say that Body Area Networks (BANs), which will provide wireless connectivity for the human body for potential telehealth applications, may be coming much sooner than we think.
    Source: EE Times

Libel Claim Filed over Lipotron 3000

  • We previously wrote about the Lipotron 3000, an unintrusive liposuction device that has been sold and distributed without FDA clearance. Now a medical device distributor has filed a libel claim against FairWarning, the consumer group Public Citizen, and several other parties, claiming they made false statements about the sales of the Lipotron 3000.
    Source: NBC News

Virtual Clinic Trials

  • Researchers at the University of Tennessee are collecting scores of data from optometry patients with the aim of creating virtual clinical trial simulations that can be accessed and used by manufacturers.
    Source: University of Tennessee
 
 

CDRH Rejects Petition on Stryker's Wingspan, Narrows Indications

Approval of the HDE was based on bench and animal testing and a clinical trial, CDRH says. It goes on to say that the agency has concluded that the results from several clinical trials and other items in the petition do not constitute a basis for withdrawing the HDE.
 
The letter told Public City that its petition “does not contain information for FDA to determine that there is a lack of showing of reasonable assurance that the device is safe under the conditions of use in the revised labeling, that the device is ineffective under the conditions of use in the revised labeling, or that there is no reasonable basis from which to conclude that the probable benefit to health from use of the Wingspan stent system for the specified subpopulation of patients … outweighs the risk of injury or illness, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.”
 
The letter said the indications for use and labeling for Stryker’s Wingspan stent had been changed to limit its use to a narrow, select group of patients and conditions. The changes were based on analysis of the original humanitarian device exemption (HDE) clinical study, data from studies performed after the HDE was approved and data from the Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis study.
 
Earlier this year, the advocacy group Public Citizen and former CDRH science and engineering laboratories director Larry Kessler petitioned the agency to withdraw approval for the stent system that was supposed to prevent strokes in patients who have already had one stroke. They said a study found that the device actually increased the risk of subsequent strokes and death.
 
The FDA announcement said that after reviewing the available safety information, the agency believes that a very specific group of patients with severe intracranial stenosis and recurrent stroke despite continued medical management—who have not had any new stroke symptoms within seven days before planned Wingspan treatment—may benefit from use of the device.

FDA said its assessment of the device’s benefits and risks considered that the patients are at serious risk of life-threatening strokes due to reduced blood flow to the brain from narrowed or blocked arteries. 

Amalgam Causes Genetic Behavior Defects in Boys: Study

Chronic exposure to mercury in dental amalgam causes adverse neurobehavioral effects (e.g., diminished attention, diminished ability to place pegs in holes) among boys with the CPOX4 genetic variant of the heme pathway enzyme coproporphyrinogen oxidase, according to a University of Washington study published in the September-October issue of Neurotoxicology and Teratology.
 
Led by research professor emeritus James S. Woods, the seven-year study among 330 Portuguese children aged 8–12 at baseline is “the first to demonstrate genetic susceptibility to the adverse neurobehavioral effects of Hg exposure in children,” its abstract says.
 
In a controversial HHS decision last December, FDA was prevented from answering a petition seeking reversal of an earlier CDRH finding that dental amalgam is safe in children of that age.
 
The authors say the children in the study were “initially randomized to Hg amalgam (treatment) or composite resin (control) dental treatment groups. Subjects were evaluated at baseline and at seven subsequent annual intervals following initial dental treatment using an extensive battery of neurobehavioral assessments.”

They say that the concentration of adverse effects in boys over girls with the CPOX4 variant “provides evidence of sexual dimorphism in genetic susceptibility to the adverse neurobehavioral effects of Hg in children and adolescents,” and speculate that girls may excrete more mercury than boys and thus have a “lesser likelihood of mercury retention and accumulation.” 

CDRH Revises its 'Refuse to Accept' Policy for 510(k)s

CDRH has revised its procedures and criteria it intends to use in assessing whether a 510(k) submission meets an “acceptability level” for a substantive review. “Focusing FDA’s review resources on complete submissions will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible,” the Center’s Refuse to Accept Policy for 510(k)s draft guidance says.

The guidance revision was mandated by the recent reauthorization of the device user fee program to help improve CDRH’s performance goals based on review timeliness. “Acceptance review therefore takes on additional importance in both encouraging quality submissions from sponsors of 510(k) notifications and allowing FDA to appropriately concentrate resources on complete submissions,” the guidance says. “Therefore, we have modified our 510(k) Refuse to Accept policy to include an early review against specific acceptance criteria and to inform the submitter within the first 15 calendar days after receipt of the submission if the submission is administratively complete, or if not, to identify the missing element(s).”

The guidance includes checklists to help clarify the necessary elements and contents of a complete 510(k) submission. It may be accessed online

FDA Asked for ‘Overhauled, Streamlined’ 510(k) Database

In a letter, the two pointed to reports over the past several years of patients being seriously harmed or even killed by medical devices such as artificial hips and mesh implants indicated for urinary incontinence in women.

“A flaw in the 510(k) process opens the door for defective devices to make their way onto the market and jeopardize patient safety,” Markey and Merkley asserted. “Current law requires FDA to clear a device shown to be substantially equivalent to a predicate, even in cases where the new product contains the same flaws as an earlier model that had to be recalled by the manufacturer due to a fundamental design flaw.”

The lawmakers said they believe the solution requires an expansion of FDA’s authority to enable it to reject clearance if a device repeats design flaws that have led to the voluntary recall of earlier products. That change is embodied in H.R. 3847, the “Safety of Untested and New Devices Act,” they wrote.

Te two believe that providing device manufacturers, the public, and medical professionals with better information about devices recalled for serious design flaws could help avoid future injuries.

Markey and Merkley asked that FDA update its 510(k) database to reflect:

  1. If the device itself was the subject of a recall because of a serious design flaw that negatively affected safety or effectiveness.
  2. Whether the device itself was cleared on the basis of a predicate recalled for a serious design flaw that negatively affected safety or effectiveness.

“In these cases,” they wrote, “the database entry for such a device should provide a link to information about the predicate’s adverse event reports and recall, so that consumers and doctors can determine the nature of the earlier problem.”

The letter included a number of questions for Shuren to answer about whether CDRH will take specific steps the lawmakers are requesting and reasons for not agreeing to them if that is the case.

AdvaMed Pushes 510(k) Guidance Changes

“The current draft guidance document is patently unacceptable,” it says, “and our comments submitted to the public document detail our issues. The draft guidance substantively modifies existing regulations and is inconsistent with other FDA policies.”
AdvaMed also says that the proposed 510(k) Program Guidance could significantly affect the notification process and that many aspects of the draft document introduce new questions and challenges for manufacturers. 

“It needs to address how the agency intends to determine a product’s intended use,” the letter says. “The draft guidance suggests that FDA plans to use information other than the proposed labeling, including ‘agency knowledge’ to determine a product’s intended use — an approach that conflicts with the statute. This issue needs to be addressed as it also further hinders the transparency and predictability of FDA’s decisions.”

Adhesive-Based Technologies Stick to Home Healthcare

Adhesive-Based Technologies Stick to Home Healthcare

As healthcare costs increase, patients are spending fewer days in the hospital; the continuum of care is shifting to the home where patients with chronic conditions receive treatment and therapy as they resume their daily routine. An aging population also contributes to home healthcare’s growth.
 
The Metria patch-based wearable sensor technology platform is designed for consumer and clinical health management applications. It combines the latest advancements in sensors, electronics and software algorithms with skin-friendly adhesive technology. All photos courtesy of Avery Dennison Medical Solutions.
This trend is expected to accelerate and has spurred the development of next-generation medical technologies specifically designed for, or easily adaptable to, the home healthcare setting. These advancements accommodate the lifestyles of home-based patients, who tend to have higher activity levels and fewer restrictions than hospital patients.
 
The new solutions, which often incorporate skin-friendly adhesive technologies, include wearable sensors, wound care dressings, and securement devices. These enable medical device suppliers and medical service companies to enhance their product offerings to more effectively meet the needs of the home healthcare sector.

Remote Patient Monitoring

Wearable sensors are an increasingly important part of the home healthcare sector. As remote patient monitoring technology improves and new applications emerge, the wearable sensor market is expected to grow rapidly. According to ABI Research Inc., about 80 million wearable sensors will be in use for health-related applications by 2017, an eight-fold increase over 2012.
 
A new patch-based wearable sensor technology platform is designed for clinical and health management applications. It combines the latest advances in sensors, electronics, and software algorithms with skin-friendly adhesive technology. Several key objectives drove the new platform’s design and development. The top priority was to demonstrate clinical effectiveness. Additionally, it had to be feasible to manufacture and fit within the existing medical industry reimbursement.
 
The platform is expected to support a family of patch-based wearable sensors for home healthcare applications. The monitors attach comfortably to the user’s skin using advanced adhesives and continuously collect physiological data including heart rate, body temperature, and other vital signs. The stored data is then wirelessly transmitted to computers or mobile devices to provide a snapshot of the user’s health and physical condition.
 
The platform’s first patch-based wearable sensor will enter the market in late 2012. The device is equipped with multiple sensors that collect more than 5,000 data points per minute. Initially, it is intended as an evaluation tool for weight management and will track lifestyle indicators such as steps taken, calorie expenditures, and activity levels.
 
The wearable sensor is the fruit of an extensive design engineering effort. The device’s adhesive presented an especially difficult challenge. There were several exacting requirements. The adhesive had to be gentle yet strong, to minimize the potential for discomfort or irritation upon removal, and to ensure user confidence and quality of life during wear. It had to perform by staying in place during daily activities. To meet these requirements, a custom-designed skin-friendly adhesive formulation was created.
 
A foam substrate carries the adhesive and provides a waterproof enclosure for the device’s electronics—a battery, ASIC and memory, and ECG. In addition to its sophisticated design and functionality, the patch-based wearable sensor has a low profile and can be worn comfortably and inconspicuously.

Wellness Programs

Potential additional applications for the patch-based wearable sensor include wellness programs, which are becoming increasingly popular. Primary care physicians who offer wellness services can have their patients wear the device continuously for a full week and then review the data collected. The data reveals the patient’s activity levels and vital signs at various times and while conducting different activities. It gives the physician an overview of the patient’s overall health and cardiac fitness to inform behavioral modification for patients who are overweight or prediabetic.
The BeneHold tube fixation device effectively secures multiple medical tubes, lines or cords in one device. The hook-and-loop closure system allows temporary or permanent fixation and repositioning of tubes and lines without removal and retaping.

Acute and Chronic Care

Advanced remote monitoring technologies, such as the patch-based wearable sensor could also be used for acute and chronic care applications. In the acute care category, wearable sensors can be used to monitor patients for health problems prior to surgery or to monitor postoperative (post-op) patients during recuperation.  
 
Consider cardiac patients recuperating at home after surgery. Studies show that more than 20% of post-op cardiac patients are readmitted to the hospital within 30 days of release.1 Reasons include excessive anxiety following surgery, and failure to take medications and follow other postsurgical guidelines. Fitting patients with wearable sensors can allow surgeons to monitor vital signs remotely, offering reassurance to patients and their families, while also helping to reduce the likelihood of hospital readmissions.
 
In the chronic care category, patients suffering from diseases such as congestive heart failure could be candidates for remote monitoring. This method could reduce the number of home visits by nurses or other care providers, and contribute to lower costs.
 
Wearable sensors are certain to gain greater functionality in the future. Research efforts are currently focusing on expanding the number of physiological vital signs that can be monitored. One example is blood pressure, which remains difficult to measure without the conventional armband cuff. Research suggests, however, that it may soon be possible to gauge blood pressure directly using wearable sensors or indirectly by measuring a surrogate sign that gives a good indication of blood pressure.2

Advanced Wound Care

New varieties of sterile absorbent wound dressings can benefit patients suffering from chronic wounds including pressure ulcers. One family of dressings that is anticipated to launch in Q3 2012 exhibits superior fluid handling capacity versus comparable commercial dressings. The dressings are constructed of a self-adherent wound contact layer and a water-resistant polyurethane top film. The wound contact layer absorbs wound exudates and transforms into a soft gel that protects against dehydration and facilitates conditions conducive to healing. The high fluid handling capacity of the dressings support moist wound healing, without causing skin maceration.3
 
The dressings’ rounded corners help prevent edge lift, which can compromise a dressing’s protection against bacteria and other contaminants. One of the dressings is transparent and provides easy wound visualization without removing it. The dressings are designed for the management of lightly to moderately exuding wounds. They come in various formulations and thicknesses to suit different wound types and exudate conditions. For example, patients suffering from wounds to the lower back (sacral) area can use one that is specially designed to fit that area’s curvature. Other dressings are specially formulated to capture odor molecules to help increase patient comfort and confidence.     
The high fluid handling capacity of the BeneHold absorbent wound dressings support moist wound healing while minimizing the risk of skin maceration.

Securement Devices

New securement products feature skin-friendly adhesives, which is ideal for home healthcare. They can be used to further secure dressings to the patient, and affix and organize tubes and lines. The product designs support long-term wear and are conformable for enhanced patient comfort and mobility.

Medical Tape Strips

The securement innovations include new patent-pending medical tape strips on a sheet. These are highly breathable strips of paper tape that feature latex-free acrylic adhesive. The strips adhere well to dry or slightly moist skin and are designed to minimize the risk of skin maceration or damage.
 
The tape strips are an alternative to conventional roll tape, which is one of the few medical products commonly reused without sterilization. Roll tape is prone to bacterial contamination and is a possible source of infection.4  It is often left on counters and tables, touched without gloves, and shared between patients and clinicians.
 
In contrast, tape strips allow the care provider to select and handle only the amount of tape needed for the procedure. This practice reduces tape waste and helps address infection concerns. The tape strips are supplied on perforated sheets that can be divided in half or quarters as needed. The tape strips have an adhesive-free tab at both ends to facilitate easy handling and a clean application of tape.
 
The medical tape strips offer a variety of uses in the home healthcare setting, such as securement of tubes, lines, or dressings to the patient, as well as immobilization of fingers or toes.

Universal Tube Fixation Device

Patients receiving treatment at home often have a number of medical tubes, lines, or drains that require securement and organization. During infusion therapy, for example, medication or fluids are administered via needles or catheters. Long-term infusion therapy increasingly takes place in the patient’s home to reduce costs and allow the patient to continue daily activities.
 
The BeneHold medical tape strips allow a care provider to bring into the patient care area only the amount of tape needed for the procedure. This helps reduce tape waste and address infection control concerns.
The same is true of patients receiving negative pressure wound therapy. The therapy is intended to reduce tissue swelling and promote the healing of certain types of chronic wounds. In these and similar applications, tube fixation devices can be helpful to patients and care providers. One such fixation device effectively secures medical tubes, lines, and drains. The device has a special hook-and-loop closure system that allows temporary fixation and repositioning of tubes and lines without removal and retaping. The closure system also features an adhesive zone that offers permanent fixation of tubes or lines to prevent movement. The tube fixation device lifts tubes and lines off of the patient’s skin, reducing the risk of pressure points or skin abrasion. The device has an absorbent hydrocolloid adhesive that is gentle to the skin and can be removed without irritation. It can be used with IV catheter lines, epidural lines, Foley catheter tubes, urinary drainage tubes and surgical drain lines.

Conclusion

The recent advances in adhesive-based medical disposables and wearable sensor technologies are expanding the offerings of medical device suppliers and medical service companies, enabling them to provide more effective solutions for home healthcare applications. The solutions accommodate the active lifestyles of today’s home-based patients, while supporting overall efforts to reduce hospital stays and readmissions, which helps to contain costs. These products facilitate the monitoring of patients preparing for or recuperating from surgery, and help home-based patients and their caregivers successfully manage the treatment of chronic wounds and other long-term conditions.     
 
In the years ahead, with the shift of more medical care and oversight to the home, the pace of change is expected to accelerate. Home healthcare professionals will need disposable medical products that are more effective and easier to use to help manage their care of patients in the home. Wearable sensors are well positioned to help patients at risk for chronic diseases such as obesity, diabetes, and heart disease increase their activity level and become more engaged in their own health and well being as part of preventative care efforts initiated by physicians.

References

  1. W Boulding, et al., “Relationship Between Patient Satisfaction With Inpatient Care and Hospital Readmission Within 30 Days,” The American Journal of Managed Care 17 (2011): 41-48.
  2. DD Baek and L Lading, Cardiovascular Sensing,” Danish Technological Institute, January 2012.
  3. GD Winter, “Formation of the Scab and the Rate of Epithelialisation of Superficial Wounds in the Skin of the Young Domestic Pig,” Nature 193 (1962); 293-294.
  4. DA Redelmeier and NJ  Livesly, “Adhesive Tape and Intravascular-Catheter-Associated Infections.” Journal of General Internal Medicine 14 (1999).
 
Deepak Prakash is global market segment manager of wearable sensors at Avery Dennison Medical Solutions. He can be contacted at Deepak.Prakash@averydennison.com.
 
Emily Berlin is global market segment manager of advanced skin adhesives and antimicrobials at Avery Dennison Medical Solutions. Contact her at Emily.Berlin@averydennison.com.

CathCAD Modeling Software for MicroCatheter Development

A company produces computer aided design software for the design of composite tubing and analyzing and predicting the mechanical performances of microcatheters. CathCADestimates flexibility (EI), pushability (EA), torqueability (GJ), and kink radius (KR) of the design in an unloaded configuration. The software runs under Windows XP and Windows 7 operating systems and also features integration with Microsoft Excel. The software includes an extensive materials database (including extruded and film cast materials) as well as a braid wire database. These managed databases are stored in a MySQL server that is accessed by via Internet. Both databases can be configured and customized at the customer level to meet specific design requirements.

San Antonio, TX
 
 
For more on the engineering fundamentals addressed by CathCAD read the MD+DI article, "Design Considerations in Small-Diameter Medical Tubing" written by the developer of CathCAD. 

 

Intertronics Biocompatible Adhesives

A manufacturer of industrial adhesive products produces a two-component, silver filled, electrically conductive epoxy for chip and substrate bonding. Polytec PT EC101 can be cured below 100°C and still have a volume resistivity of 1-2 x 10^-3 Ω-cm. The special chemistry of this epoxy also allows rapid cure cycles at higher temperatures. EC101 features fast curing (60 min at 95°C to 40 sec at 180°C), a pot life at room temperature of two days, pH value of 8.5 and high temperature stability in service (-55-200°C continuous to 300°C intermittent). It also has USP Class VI biocompatibility certification, making it suitable for use in the manufacturer of disposable medical devices.

Oxfordshire, England
 

Famed VC Vinod Khosla on the Death of Medicine as We Know It

Famed VC Vinod Khosla on the Death of Medicine as We Know It

Khosla knows more than a thing or two about exponential technologies. He was a co-founder of Sun Microsystems, and, through his Khosla Ventures firm, now invests in everything from mHealth products like the iPhone ECG to social media and cloud technologies.

Vinod Khosla (on the right) told Wired's Thomas Goetz that, in contrast to most healthcare VCs, he looks at healthcare from the perspective of the consumer. 

If technology now makes it possible for cars to drive themselves, why can’t technology reboot the way medicine is practiced? In California, legislators have recently sent a bill to the governor’s desk that would green light the development of autonomous automobiles. “Driving a car from San Francisco to L.A. is an order of magnitude more complicated than a doctor diagnosing a disease,” Khosla told Wired executive editor, who interviewed him onstage at the event.

Earlier this year, in a piece titled “Do We Need Doctors Or Algorithms?” Khosla argued for the importance of artificial intelligence in medicine’s future.

At this event, he continued that thesis, stating that machine learning could enable robots to perform a large proportion of doctors’ duties. “Eventually, we won’t need the doctor,” he said. "Machine learning makes a better Dr. House than Dr. House," he later added, referring to the Gregory House, MD, the fictional genius physician of the TV series “House.”

“My willingness to fail is exactly what gives me the ability to succeed.”

Throughout his talk, he minced no words when it came to traditional medical practice, even comparing it to witchcraft. “[Doctors] do things because that is how things have been done,” he said. In the future, medicine will be based on probabilities.

New devices also will be substantially less expensive than legacy technologies, he said, pointing to the AliveCor iPhone ECG, which is “remarkably cheaper” than traditional clinical ECG units.

Khosla, who is an investor in the iPhone ECG, also used the device to illustrate the importance of software and hardware converging. In the future, lifescience companies won’t be able to choose between software and hardware—they’ll have to do both.

Khosla recommended that the entrepreneurs in attendance at the event be skeptical and not fearful of being perceived as wrong. “My willingness to fail is exactly what gives me the ability to succeed,” he said. “I don’t mind investing in something that has a 90% chance of not working but it has to have a real chance at making a big difference.”

He quoted George Bernard Shaw’s statement that: “all human progress depends upon the unreasonable man,” adding that “the reasonable people” do “all of the incremental stuff [in healthcare]. They will never do anything radical so the field is wide open.”

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz. He will be chairing the upcoming MedTech Cardio event held October 30 and 31 in Minneapolis. 

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