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Articles from 2013 In January


The Science and Art of Miniaturizing Diagnostic Medical Devices

Microfluidic CD system developed at the University of California, Irvine, can be used to perform medical diagnostic applications.

On Wednesday, February 13, Marc Madou, Chancellor's Professor of mechanical and aerospace engineering and biomedical engineering at the University of California, Irvine, will hold a keynote presentation at the MD&M West Conference on "The Science (and Art) of Miniaturizing Medical Devices: A Closer Look at CD Technology in Molecular Diagnostics."

A subfield of microfluidics, CD microfluidics concentrates on the behavior, control, and manipulation of fluids in the microdomain. In this technology, fluidic channels and reservoirs are embedded in a CD-like plastic substrate that is spun using a motor. Exploiting centrifugal forces to achieve fluid propulsion, the system can perform a range of fluidic functions, including valving, decanting, calibration, mixing, metering, sample splitting, and separation. These functions are then combined with such analytical measurement techniques as optical imaging, absorbance, fluorescence spectroscopy, and mass spectrometry, enabling the CD platform to perform a host of medical and clinical diagnostics.

In a conversation with MPMN, Madou explains how his CD technology could eventually improve the practice of medical diagnostics and perhaps enable doctors in the future to run medical tests by simply popping a disk into an ordinary CD player.

MPMN: Please describe your CD technology and why you think it can play a role in medical device applications.

Madou: Our CD technology takes advantage of the same rotating platform that is used to play music and movies. However, many people have perhaps not recognized that in this very inexpensive CD player there is a sophisticated optical platform that can do three things for us at a very inexpensive cost. First, it's a microscope. Thus, it can easily be turned into a device for visualizing objects as small as cells. And of course, microscopy is used often in biomedical technology. Second, because the CD spins, it can function as a centrifuge. Third, CD technology is an inexpensive plastic disposable item. Thus, instead of employing glass slides, microtubes, or polymerase chain reaction (PCR) tubes, the CD contains chambers that we carve into the plastic. Lateral, flat structures, these chambers can contain a liquid, just like a PCR sample in a little tube.

For years, people have used silicon technology as an entry into manufacturing inexpensive disposables. Similarly, we are using the CD as a disposable item. However, the CD can also serve as an infrastructure for performing many biomedical applications, including immunoassays and blood gas, blood electrolyte, or DNA analyses. We have been addressing all of these technologies with our CD platform.

MPMN: How can your CD technology serve as an avenue for miniaturizing medical devices?

Madou: In addition to the CD's three primary characteristics, the technology can also act as a pump. In almost all medical diagnostic applications, you need a pump. In addition, the pump requires tubing. In our case, we don't need tubes because the rotating CD, performing as a pump, contains leads in the plastic disk. This feature promotes miniaturization because the disposable CD can serve as a small pump. And because the CD is symmetrical, it can easily be multiplexed. If you think of the CD as a pie, we can divide it into many small segments. Depending on size of the segments, the rim of a single CD can be used to perform 1,056 immunoassays.

MPMN: That explains the science behind your technology, but where does the art come in?

Madou: The art of solving problems that we can't solve simply through engineering comes from people that have worked with many manufacturing techniques and intuitively know if a technology is too complicated. For example, where should your heat source be located? Should it reside on the CD--the disposable part of our technology--or should it reside in the instrument used for running the CD? This is a partitioning question, and answering it helps us to design platforms to meet specific application needs. Thus, there's a huge difference between a CD application that's meant to perform high-throughput screening and one that's meant to perform a biomedical application. High-throughput screening can involve the use of a much more expensive CD, whereas in diagnostic applications, we try to put everything we can into the instrument and as little as possible into the disposable plastic CD.

In short, the element of art in our work comes down to understanding during the manufacturing process how much complexity we want to design into the instrument versus the disk. This requires good intuition.

MPMN: What are you and your colleagues striving for--a more complex CD or a more complex instrument? Or does it depend on the application?

Madou: When the microfluidics arena started, it was unfortunately quite heavily geared toward high-throughput screening for such applications as drugs. This trend misdirected the whole microfluidics field a bit because diagnostic applications are very different from high-throughput screening. For diagnostics--and that's mostly what we do with CDs--the equation is to achieve as little complexity as possible on the CD and shift as much cost and complexity as possible to the instrument. One reason why the cost factor in high-throughput screening differs from that in diagnostics is that in the former, you don't need to store the CD for a period of time. A robot pipettes liquids and a high-level technician operates the robot. Not so in the diagnostics arena.

MPMN: You've mentioned some of the potential applications for your technology, including diagnostics. What other medical device applications do you think your technology might eventually serve?

Madou: In my presentation at the MD&M West conference, I will highlight some of the products that are already on the market. Measuring blood gases and blood electrolytes was one of the easiest entries into the game. The next step up will be to develop DNA and nucleic acid analysis capability. We are working on both of these applications, but they aren't marketable yet. We also have several successful stations that perform very effective lysing and purification of DNA.

Thus, ours is a very generic platform because it is a smart centrifuge, an inexpensive disposable, and an optical system with very accurate positioning capability. It would be hard to develop such a technology from scratch. It has the backing of a huge CD industry behind it that enables us to work with these components at a low cost.

Svelte Medical Launches Drug-Eluting Stent Clinical Trial

Svelte Medical Systems, a healthcare products manufacturer based in New Providence, New Jersey, announced that it had successfully treated the first patient in its Direct II drug-eluting stent clinical trial. According to a press release by the company, Svelte Medical's Direct II Phase II clinical trial was designed to test the efficacy of the Svelte device against Medtronic's Resolute DES. The Svelte device is designed to automatically elute sirolimus, an anti-stenosis drug, through the use of a bioabsorbable carrier made of a special blend of amino acids. In comparison, the Resolute DES uses a polymer-based drug carrier. In its press release, the company stated that it would enroll 159 patients in its Direct II trial at 20 different sites in Brazil and Europe. Primary endpoints of the study include in-stent late loss and target vessel failure. All participants in the study will receive a six-month angiographic and clinical follow-up. Patients will also be monitored for an additional five years. Jack Darby is the CEO and president of Svelte Medical Systems. In prepared remarks, he said, "We believe our drug-eluting IDS, with its proprietary balloon and drug carrier technologies, represents an easy to use, best-in-class offering which will deliver procedural efficiencies and associated cost savings while demonstrating long-term clinical outcomes consistent with market-leading drug-eluting stents." References The Trials, Tribulations, and Future of Stents
www.sveltemedical.com/news.php?pid=39&article=69 www.businesswire.com/news/home/20130130005170/en/Svelte-Medical-Systems-Announces-Treatment-Patient-Direct

Invacare Signs FDA Consent Decree

Under the decree’s terms, FDA said in a news release, Invacare will not be able to resume normal business operations at two of its Elyria, OH, facilities until it corrects all violations listed in the consent decree and the company has been notified by the FDA that it is in compliance with the FD&C Act.

Seven FDA inspections of the Invacare facilities subject to the consent decree since 2002 have documented violations of FDA’s Quality System regulations, along with failures to properly report adverse events to the agency.

FDA’s decree also requires Invacare to retain a third-party expert to help it develop and submit plans to FDA to correct the violations found by the agency. After Invacare receives permission from FDA to resume manufacturing and distributing, it will have to submit audit reports for 5 years to verify continuing compliance. In addition to these audit inspections, the decree notes that FDA plans to monitor the company’s activities through its own inspections.

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CDRH Roars in January

FDA to Require PMA for Two Metal-on-Metal Hip Replacements

The notice said FDA originally classified the metal-on-metal hip systems as Class 3 because insufficient information existed to support a conclusion that performance standards or general controls would provide reasonable assurance of device safety and effectiveness. Further, it said, concerns expressed at a 2001 meeting of the Orthopedic and Rehabilitation Devices Panel are still relevant today.

“Current wear testing methods for metal/metal bearings are limited, and importantly can underestimate bearing wear by an order of magnitude compared to clinical outcomes,” the notice said. “There are also no standardized wear methods or consensus among researchers for investigating joint microseparation, dislocation, cup deformation, demanding gait activities and third-body abrasion. In addition, there is a lack of wear measurements from retrieved metal/metal bearings, so it is a challenge to correlate wear rates from modern devices to adverse events demonstrated clinically like pseudotumors. To complicate matters further, metal/metal bearings have shown unpredictable wear trends in simulator testing, which have not been explained. Therefore, it is a challenge to introduce sufficient special controls to mitigate the risks of modern metal/metal hip devices.”

Meanwhile, the agency also issued a new safety communication on metal-on-metal hip implants with recommendations for surgeons on evaluating patients, soft image testing, and metal ion testing. The new guidelines are based on the agency’s current assessment of metal-on-metal hip implants, including benefits and risks, evaluation of published literature, and the results of an Orthopedic and Rehabilitation Devices Advisory Panel meeting, last summer.

The guidelines advise surgeons to select a metal-on-metal implant for patients only after determining that the benefit/risk profile of using such an implant outweighs that of using an alternative hip system. They also are advised to regularly evaluate symptomatic patients at least every six months and asymptomatic patients every year or two. There also are recommendations on soft tissue imaging and metal ion testing for symptomatic and asymptomatic patients.

Editors note: If you have more questions about building an FDA friendly PMA, consider attending our upcoming conference Success in Pre-clinical studies and Clinical Trials, on Thursday, February 14, at MD&M West, Anaheim.

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CDRH Roars in January

Nonsilicone Adhesives for Low-Trauma Skin Bonding

 Nonsilicone Adhesives for Low-Trauma Skin Bonding

Developing skin adhesives for wound care applications poses a number of challenges for manufacturers. A key challenge is to ensure secure bonding of a dressing to skin of varying health to promote healing and provide pain-free removal without skin damage. Nonsilicone pressure-sensitive adhesive (PSA) technology is customizable and promotes gentle removal. It can enable better moisture management, patient comfort, and extended wear times. This low-trauma technology is designed for advanced wound care dressings where preserving fragile skin is critical, making it well suited for daily dressing changes when a more aggressive adhesive could cause skin damage.  

Nonsilicone pressure-sensitive adhesives offer benefits such as better moisture management, patient comfort, and extended wear times. 

Evaluating wear properties of skin adhesives using a method that mimics end-use conditions is important for determining actual performance. Because it is difficult to correlate peel adhesion measured on a solid substrate to wear performance when bonded to skin, it is important to identify a substrate with similar surface energy, topography, and viscoelastic properties of skin. It is essential to test skin adhesives on human skin in order to derive reliable conclusions about the performance of that adhesive in a particular application. Designing a wear study that reflects the sample preparation, sample application, wear duration, and environmental conditions that take place during the actual application is instrumental to obtaining a consistent wear performance evaluation. 

This article is based on a study conducted to characterize wear properties for a range of skin adhesives. It reviews several methods used to characterize the wear properties of skin adhesives developed for wound-care and long-term wear applications.

Skin Complexity

Human skin varies from person to person and is influenced by age, gender, race, diet, environment, overall health, and perspiration levels, which can range from 100–8000 mL/d. The structure, surface energy (which varies by application site), and viscoelastic properties of the skin influence how an adhesive will bond to skin, as well as how the skin will respond to removal of the adhesive. 

Skin has three layers: stratum corneum, epidermis, and dermis. The outer layer, stratum corneum, is a barrier layer providing hydration and protecting the body from microorganisms and toxic substances. This layer is composed of dead skin cells and sebum at differing amounts and compositions depending on skin type, age, health, and environmental conditions. The stratum corneum layer controls water transport across the skin. If the integrity of this barrier layer is disrupted, transepidermal water loss (TEWL) correlated to the rate of passive diffusion of water from body through the stratum corneum will increase.1 Various health conditions, such as diabetes, and taking certain medications can adversely affect the stratum corneum layer and may cause the skin to be more susceptible to breakdown.2 Moreover, TEWL value changes with skin type and environmental conditions, and it varies when measured at different parts of the body. For example, TEWL measurement from the forearm and palm are 9.7 g/m2h and 101.4 g/m2h, respectively.3  

Figure 1. Shown are the 24-hour peel forces from skin for various adhesive materials.

Researchers have studied peeling medical adhesives from both rigid and flexible substrates. However, because skin is not rigid, flat surface peeling of an adhesive from skin is a unique process. Skin topography, which varies with age and skin type, is also an important factor in adhesion. Different types of skin present varying degrees of roughness, which create voids where the adhesive can flow, creating mechanical anchorages that enhance peel over time. Low surface energy substrates, such as polyethylene panels, have smooth surfaces that lack the complex and rough surface of a skin substrate. 

Skin also has unique physical properties such as elasticity and tensile strength. Moreover, skin’s tension and retraction during movement depends on the direction, age, body posture, and location on the body. There is a direction of maximum tension, stress, and strain along the body, known as Langer’s lines.4 Langer’s lines are topographical lines drawn on a map of the human body that correspond to the natural orientation of collagen fibers in the dermis. Skin extensibility is lowest in the direction of Langer’s lines. Therefore, when a dressing or a skin adhesive patch is placed on skin, the direction of removal influences the peel force experienced and the degree of skin extension. In testing skin adhesives the peel direction should be consistent to ensure peel force data can be compared without introducing additional considerations.  

Customizable, Nonsilicone Adhesive Technology

Silicone gel adhesives commonly used in advanced wound care applications are, in theory, a good material choice for short-term wear transdermal applications. However, they may require a minimum adhesive thickness of 80 µm to successfully bond to skin, causing a thicker edge which can snag on clothing or other materials. In general, silicone gel adhesives are susceptible to damage caused by common sterilization techniques incorporating gamma radiation that negatively impact adhesion bond levels to skin. 

Figure 2. Shown are the results of a 24-hour self assessment of pain.

Hydrogels and hydrocolloids can also be formulated for gentle removal; however, the adhesive properties of these formats change dramatically as they absorb water, often resulting in adhesive-skin bond failure. These formats also may require a thick application of the material in a layer greater than 80 µm to ensure a reliable bond. As mentioned with silicone gel formats, a heightened edge can result in snagging and uplift of a patch. 

Suppliers are addressing the growing need for skin-friendly adhesives and overcoming the thickness issues of gel formats with low-trauma adhesive (LTA) platform technology for gentle removal. This high moisture vapor transmission rate (MVTR), customizable PSA technology maintains reliable, intimate skin contact for up to three days and can be removed and reapplied without the adhesive bonding to itself. The LTA formulation removes cleanly from skin without leaving any residue and is biocompatible, noncytotoxic, and nonirritating or sensitizing to skin. The LTA technology exhibits good to excellent ratings for resistance to gamma sterilization, unlike silicones, which are often unable to withstand these sterilization techniques. This nonsilicone technology can be tailored to match desired wear properties and further customized through the selection of different substrates and release liners to meet the unique design criteria in advanced wound care applications. 

Study

A recent study compared the peel strength and pain levels associated with the removal of adhesive patch samples designed for 24-hour and 3-day wear in three separate studies conducted by a third party clinical lab. Twelve panelists aged 25–55 years were tested with a total of four test sites, two of which were located on each upper volar forearm. The sample adhesive patches (1 × 3 in.) were removed from the panelists’ volar forearms at the end of each wear-duration and properties such as peel force, skin irritation, and TEWL were evaluated. The skin located in the area of the test sites was not pretreated before application of the sample patches.

Figure 3. Shown are the 3-day peel forces from skin for various adhesive materials.

The study is composed of two parts as follows: 

  • Testing 24-hour wear performance of several formulations of LTA-1 technology (LTA-1A through LTA-1D) from Adhesives Research (AR) that is specifically designed for gentle removal in short-term wear applications. This test evaluated the performance of four different adhesion levels of the LTA-1 formulation to skin to demonstrate the technology’s capability for customization.
  • Testing three-day wear performance of AR’s LTA-3 adhesive formulation that features higher adhesion levels to skin to achieve longer wear times with low-trauma removal. The LTA-3 adhesive was compared with samples of two commercially available reference tapes and a formulation of LTA-1 formulated with higher levels of adhesion. 

TEWL. Measurement of TEWL is a nondisruptive method to investigate the changes in the water barrier function of skin due to removal of the outer skin layers.5,6 Changes in the measured TEWL values are commonly used to determine the problems associated with skin irritation. TEWL is the flux density of water diffusing through the skin barrier and is determined by measurement of the water vapor flux density in the air above the skin. In this study, the TEWL method was employed to assess the skin trauma and level of skin stripping upon removal of skin adhesives. TEWL measurements were taken following a 25–30 min acclimation period in a controlled environment with the relative humidity maintained at less than 50% and temperature maintained at 66–72°F. TEWL were measured after 3- or 7-day wear samples were peeled from the skin.7,8

Figure 4. Shown are the results of a three-day self assessment of pain.

Self-Assessment of Pain and Expert Grader Assessments. Preventing pain and skin stripping during removal of the patch is important for patient comfort as well as prevention of further skin damage. Epidermal stripping due to aggressive adhesives can lead to increased infection rates, hospital reportable incidences, and larger wound size. 

In this study, panelists were asked to rate the pain upon removal of each tape using the Wong-Baker FACES pain scale, which ranges from 0 (no hurt) to 5 (hurts worst), and a visual analog scale. In addition, test sites were evaluated for erythema and edema by an expert grader, approximately 30–45 min after each tape was removed using a scale ranging from 0 (none) to 8 (marked erythema, edema, possible erosion).

Product Removal. The sample patches were removed at a 90° angle at a rate of 300 mm/min. The maximum force, mean force over the plateau region, and the area under the curve were measured.

The LTA platform technology enables customization of peel properties and pain during removal depending upon the application. This set of LTA samples was formulated to target gentle removal after 24 hr of wear time through the fine-tuning of peel force. All the samples, LTA1-A through LTA1-D, are based on the same LTA base chemistry but with tailored properties. The peel forces measured upon removal (Figure 1) indicate that the LTA platform can be formulated with tailored adhesion levels of nonwoven sample patches for 24-hour wear. 

Pain scores at removal for all the LTA-1 platform samples during the 24-hr wear time were low despite the high adhesion levels to skin (Figure 2). The pain ratings measured as low as 0 for most panelists. Variations in skin structure, fragility, and differences in each person’s pain threshold make measurement of pain levels upon sample removal challenging. Comparison of pain levels measured for these samples showed that low pain ratings and a targeted gentleness can be achieved for LTA-1 samples for 24-hour wear without compromising skin adhesion. 

Figure 5. Shown are the results of a TEWL assessment.

Longer wear times require higher adhesion levels to prevent minimal edge lift during wear. However, skin adhesion becomes more challenging with extended wear applications due to increased exposure to skin shedding and perspiration. The adhesive samples evaluated in the 3-day wear study include two LTA platform samples (LTA-3 and LTA-1E) designed to present higher adhesion levels with gentle removal and two commercially available reference tapes. 

The study demonstrates that the adhesion levels and peel values of the LTA platform samples are tailorable to be comparable to competitive adhesives for the 3-day wear time (Figure 3). The LTA samples prepared with the nonwoven and polyurethane substrates provided the desired peel value range to show the flexibility of the LTA format not only by customizing the adhesive formulation, but also through the selection of substrate and release liner materials. 

The pain ratings at removal for all the LTA platform samples developed for 3-day wear time were low (Figure 4). The LTA-1E and LTA-3 pain ratings are comparable to the two reference tapes, indicating that the LTA samples are suitable for applications where gentle removal is required.

TEWL measurements did not indicate a significant change following the removal of the LTA sample patches (Figure 5). These results suggest that the low-trauma samples were not disruptive to skin and did not cause significant skin stripping.  

Conclusion

Developing adhesives for wound care applications is difficult in terms of obtaining excellent bonding while balancing other properties such as pain level upon removal, edge lift, and skin irritation. Therefore, it is essential to identify and characterize all these properties during the development of a skin contact adhesive. A customizable PSA platform targets moisture management, patient comfort, and extended wear times. Wear performance of these new adhesive technologies having various adhesion levels were tested on healthy humans to determine the wear performance over 24 hours and three days of wear time. The results showed all samples removed cleanly from skin with a pain index lower than 1.5 on the Wong-Baker FACES pain scale. TEWL measurements taken before and after sample removal indicated no significant difference suggesting that the samples were not disruptive to the stratum corneum layer. The nonsilicone, skin-friendly adhesives presented good to excellent ratings for resistance to gamma sterilization, unlike silicones, which are often unable to withstand these sterilization techniques.  The LTA technologies may be of interest to wound care and device manufacturers seeking high-performance, nonsilicone technologies that are customizable in chemistry, substrates, and release liner selection to meet their unique design criteria. 

References

1. Peter Pugliese, Physiology of the Skin II (Carol Stream, IL: Allured Publishing Company, 2001).

2. CT Hess, Skin and Wound Care, (Philadelphia: Wolters Kluwer, 2008).

3. J Nuutinen et. al., “Water loss through the lip, nail, eyelid skin, scalp skin and axillary skin measured with a closed chamber evaporation principle,” British Journal of Dermatology 148 (2003): 839–841.

4. Glenn Irion, Comprehensive Wound Management, (Thorofare, NJ: Slack Inc., 2010).

5. M Mündlein, et. al., “Comparison of transepidermal water loss (TEWL) measurements with two novel sensors based on different sensing principles” Sensors and Actuators A: Physical 142, no. 1 (2008) 67–72. 

6. JC Cohen,  et. al., “Comparison of closed chamber and open chamber evaporimetry,” Skin Research and Technology 15 (2009) 51–54.

7. GL Grove, et. al., “Comparative metrology of the evaporimeter and the DermaLab TEWL probe,” Skin Research and Technology 5 (1999)1–8. 

8. GL Grove, et. al., “Computerized evaporimetry using the DermaLab TEWL probe,” Skin Research and Technology 5 (1999) 9–13.

Gozde Karabiyik is product development chemist in medical and pharmaceutical R&D at Adhesives Research (Glen Rock, PA). She has been with the company for three years. Karabiyik holds a doctorate  degree in macromolecular science and engineering from Virginia Tech, a master’s degree in materials science and engineering from Sabanci University (Istanbul), and a bachelor’s degree in chemistry from Izmir Institute of Technology. Contact her at gkarabiyik@arglobal.com.

St. Jude Medical Warned About GMPs

The letter said the agency will not grant requests for export certificates to foreign governments or approve premarket approval applications for Class III devices to which the quality system regulation deviations are reasonably related until the violations have been corrected, according to the company.

The FDA-483 cited 11 inspectional observations covering process validation, design verification, design validation, design change, design history file, training, corrective and preventive actions (CAPA) system, CAPA procedures, complaint files, document control, and control of inspection, measuring, and test equipment. The observations are related to the firm’s troubled Durata ICD leads.

The agency also released the company’s November 7 response with binders containing its completed and planned actions for each of the observations. St. Jude reported that in addition to the steps noted in the binders, it was preforming the following actions:

  • Providing additional learning activities to ensure enhancement of its staff’s knowledge regarding the quality system elements.
  • Identifying and implementing improvements to ensure robust processes for the design and development of products and processes.
  • Identifying and implementing improvements to the CAPA and risk management processes to enhance monitoring and control of the overall quality system.

In a statement, St. Jude said the Warning Letter did not “identify any specific concerns regarding the performance of, or indicate the need for any field or other action regarding the Riata ST Optim or Durata leads or any other St. Jude Medical product.” The company said it would continue manufacturing and shipping product from the Sylmar facility and customer orders were not expected to be impacted while they worked to resolve FDA’s concerns.
 

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CDRH Roars in January

Israeli Device Firm Cited for Illegal Marketing

FDA is often cited for being more aggressive with foreign firms than domestic ones because it has the power to block imports. Further, Curatronic’s devices belong to a category that has a long history of promotional abuse and quackery-but Silverman’s speed is still remarkable.

His letter acknowledged Curatronic’s submission of a 510(k) remarket notification for the BioMove 3000 and 5000 devices for use in stroke rehabilitation by muscle reeducation, prevention or retardation of disuse atrophy, and increasing local blood circulation.

However, the letter said, the company’s Web site is promoting the devices for uses for which it does not have clearance and makes claims not covered by the 510(k)s. FDA also determined that the company is marketing four other cited devices without premarket clearance or approval.

The company was told to stop disseminating promotional materials for the BioMove devices that are the same or similar to those described in the Warning Letter and to stop distributing the four other devices until clearance or approval is obtained.
Boilerplate language threatened detention of the devices “without physical examination upon entry into the United States …” and possible alerts to other federal agencies “so that they may take this information into account when considering the award of contracts.”
 

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CDRH Roars in January

CDRH Roars in January

CDRH Roars in January

Lion mid-roar, photo by Jason Hall
A lion, mid-roar. Photo by Jason Hall via Wikimedia Commons. 

Led by former FDA associate commissioner for regulatory affairs Michael Chappell, this $99 report found almost a 40% increase in CDRH inspections since 2008, almost 30% more Warning Letters to medical device companies, and more than a 250% increase in device recalls since 2007.

FDA commissioner, Margaret Hamburg, did not specifically single out the device industry for increased attention, but she did order a more vigorous agency-wide effort on compliance and enforcement, and Greenleaf’s analyses clearly show that on most measures CDRH has more than kept pace - something it was not doing before.

While clear-eyed objectivity is supposed to be the demeanor of a regulatory health and safety agency, since the Reagan administration, signs of increasing politicization have been observed at FDA as well as other agencies. Ideological budgetary measures up or down have been a popular political tool, in addition to the placement of politically correct key managers.

At FDA, decades of budgetary restraints have curbed compliance and enforcement zeal, nowhere more noticeably than at CDRH. The change at CDRH since Obama’s presidency is palpable.
 

HIghlights from CDRH's Action-Packed January

Israeli Device Firm Cited for Illegal Marketing

Invacare Signs FDA Consent Decree 

St. Jude United Warned About GMPs

FDA to Require PMA for 2 Metal-on-metal Hip Replacements

 

Medical Device Labeling: CDRH Plans Drug-like Labels for Devices

FDA says it is concerned that the lack of standard content and format may translate into increased medical device errors. “Also, there is no single available labeling source for people to view, search, and download for devices that are used in clinical and non-clinical environments,” the notice says.

Key findings from a recent research survey helped create the new outline for standard content and format for medical device labeling that identifies the most relevant sections, the agency says. The survey also called for a condensed labeling version to act as a quick reference for safe and effective device use, which will also be discussed at the workshop.

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