Safety & Flexibility: Alcon Intrepid Polymer I/A Tips

Released by Alcon in late 2009, the Alcon Intrepid Polymer I/A tip has brought a sense of increased safety and flexibility into cataract procedures.  Although, not as soft as the Alcon silicone I/A tip, this polycarbonate material still provides the same safety in allowing to polish the capsule and maintaining the integrity of the capsular bag.

In addition to not only providing safety through its design, it is also a “true” single use device that is disposed of after each case thusly reducing potential factors (such as residual, cortical material)  that could attribute to TASS.  The tips come in three configurations, a straight, 20 degree soft curve, and the 35 degree bent tip.  Each of the tip configurations has a .3mm aspiration port and the flange design to allow for proper placement of the sleeve. All of the tips are fully compatible with the threaded Ultraflow handpieces and with all MicroSmooth sleeves.  The Intrepid Polymer I/A tips are unique and quality products to add to any cataract surgeons procedures.

IOL Master 500

What is the fastest and easy way to find the right IOL?  Simply speaking, the IOL Master 500.  The all in one biometer created by Carl Zeiss Meditec (headquartered in Jena, Germany) is the world’s first non contact measuring device that offers the precision measurements surgeons require to give their patients the quality outcomes they deserve.  In 2006, the IOL Master was recognized by ASCRS as a leader in precision biometry.  A 2005 survey conducted by ASCRS showed that 47 percent of cataract surgeons in the United States were using the IOL Master for measuring axial length.  Since 06’, Carl Zeiss Meditec has continued to dominate the area of biometry and the IOL Master 500 is the latest technology leading them into the future.

Using the Zeiss principles of precision, simplicity and outcomes, the IOL Master 500 is again a complete comprehensive workstation designed to aid in the efficiency of a busy clinical atmosphere.  Equipped with a new Twin Technology mode, the IOL Master 500 will allow for multiple axial lengths and keratometry readings to automatically be captured.  The IOL Master 500 has also been integrated to handle any of the aspheric, multi-focal, or toric measurements and their necessary calculations as well.  IOL calculations are simply done and the reports are easily transmitted to the surgeons desired electronic storage locations or can be printed for paper copies.  Equipped with FORUM, Zeiss data management solution, the IOL Master 500 can provide diagnostic data wherever it is needed.  It also integrates with the CALLISTO eye, and electronic medical records as well.

The IOL Master 500 is fundamentally the “Gold Standard” for IOL calculations.  Carl Zeiss Medical has revolutionized the field of ophthalmic biometry and created a diagnostic tool that benefits all of the surgeons that choose to take advantage of this technology.  As IOLs evolve, the IOL Master will continue to provide the quality and reliable data that surgeons expect.  For further detailed online information, please visit www.meditec.zeiss.com/iolmaster and www.iolmaster-online.zeiss.com

Get a Grip: An Overview of Trends in the World of Medical Gloves.

As the increasing concern over infection control continues to dominate discussion among healthcare professionals; many facilities find themselves looking for answers through stringent policy changes dealing with cleaning and sterilization of instrumentation.  A major component of infection control that is often overlooked is the type of gloves that are being used.   Healthcare facilities need to take the time to examine their glove inventory and determine what types of gloves addresses their particular needs and concerns.

When evaluating gloves, one of the most important factors to consider is barrier protection.  It is essential to have a glove that provides excellent barrier protection against blood borne pathogens and infectious diseases.  An inferior quality glove exposes both healthcare workers and the patients they care for to unnecessary risk of infection.  Natural rubber latex gloves have been shown to have the most effective barrier protection, however due to the increased awareness of latex sensitivity/allergies there are a number of other alternatives (such as synthetics and those with a low level of latex proteins) on the market that address those healthcare workers and patients that may have adverse reactions to latex.

According to data reported by the American Latex Allergy Association, somewhere between 3%-22% of healthcare workers are sensitive to natural rubber latex.  Healthcare workers increase their likelihood for latex sensitivity due to the fact that they are more prone to be exposed routinely to latex proteins in their work environment.  A concerning factor in latex sensitivity/allergy to not only healthcare workers but to patients as well is the use of powdered gloves.  The powder allows for the latex to become airborne and inhaled as well.  Latex sensitivity can result in mild skin irritation to as something as serious as anaphylaxis.

Manufacturers have introduced synthetic materials such as nitrile, neoprene, and polyisoprene into the medical glove marketplace that try to mimic the fit, tactile feel, and protection of the traditional latex glove.  Other manufacturers offer low protein latex alternatives as well.  It is estimated that by the year 2015 the global surgical glove market could exceed $1.38 billion in sales, and is also estimated the powder free alternatives will make up a significant portion of those sales.

Other factors that are important when deciding on a glove are tensile strength, durability, comfort, and ease of donning.   Strength of material must be able to stretch and conform to the hands appropriately.  They must have the durability that corresponds to the tasks the staff or surgeon will be completing, be comfortable to wear, and easy to put on as well.

Gloves are a fundamental component in controlling the spread of pathogens, critical in providing the necessary personal protective equipment for facility staff and surgeons, and key to patient safety.  It is important for any healthcare facility to “get a grip” on the glove needs of their staff, surgeons and patients.

Cataract Outsourcing’s Noteworthy Products for 2009

It is always so interesting to focus on new products each month for our posts.  We as bloggers get the unique opportunity to research products that have very widespread application in the medical arena.  Below is a short list of the noteworthy products of 2009.   I hope you enjoy reading them as much as we enjoyed putting these articles together over 2009.  Be sure to visit these articles in their entirety in the “Featured Products” section.  On behalf of myself and Cataract Outsourcing thank you for your dedicated readership, Happy Holiday, and Best Wishes for 2010!!

ILLUMIN-i System

The ILLUMIN-I  System a significant advancement in Ophthalmic illumination.  The patent-pending ILLUMIN-i module is integrated with a new microscope from Endure Medical and is also available as an upgrade to older optics.

The ILLUMIN-I creates a homogeneous, brilliant red reflex and tremendous detail perception.  The ILLUMIN-i offers triaxial, collimated illumination and multiple angles of delivery that enhance the optical view for surgeons.  This new technology results in a constant, “glowing” red reflex while maintaining contrast and depth of field.  The surgeon perceives fine details and clarity like never before.  www.enduremed.com

Acrysof IQ Toric IOL-Aspheric Excellence

Intraocular lens (IOL) technology is constantly evolving and striving for better performance and outcomes for both surgeons and most importantly the patients they serve.  One of the advancement in IOLs has been the introduction of the Toric lens.  The Toric IOL is designed to correct astigmatism and was first brought into the US market by Starr Surgical in 1998.  Alcon, Inc followed up in 2005 and received FDA approval for their version, the Acrysof Toric IOL, which quickly became the leading Toric IOL in the market.  In March of 2009, Alcon launched the recently FDA approved Acrysof Toric IQ IOL at the American Society of Cataract and Refractive Surgeons meeting in San Francisco, California.  This Toric IOL is unique. It offers a special aspheric optic which is a new innovation in the world of Toric IOLs.

The Acrysof IQ Toric IOL offers a precise astigmatism correction. The aspheric design component of the lens improves both image quality and contrast sensitivity.  This combination creates patients the best opportunity for distance vision without the assistance of glasses.  It was shown in studies that the Acrysof IQ Toric IOL improved functional vision significantly.  Alcon tested their IOL versus a control lens in low visibility environments (such as night driving).  They showed that the Acrysof IQ Toric IOL performed better in 34 of the 36 conditions that were tested.  Significant advantages were found in the ability of the patients to identify pedestrians and warning signs under conditions conducive to both fog and glare.

The Alcon Acrysof Toric IQ IOL aspheric characteristics brings new dimension to the Toric IOL marketplace.  The innovation of this lens creates high quality outcomes for the surgeons and patients alike.  Its ease of use and the Acrysof Toric IOL Calculator that was created by Alcon makes the IOL a very desirable and easy choice for many surgeons implanting Toric IOLs.  www.alcon.com

Acrysof IOL injector-Crestpoint Management

The new injector, the DK7797-2, is a front loading injector designed to accommodate the Alcon “D” IOL cartridge as well as the “B” and “C”.  It is a smooth, single handed delivery, ergonomically designed to fit any sized hand.  The injector can be pre-loaded.  It also comes completely apart for proper cleaning.  Surgeons contacted Crestpoint and asked for a different injector with a smooth mechanism.  Crestpoint (then Duckworth and Kent USA) took the design to Alcon.  Surgeons truly enjoy the efficient and smooth one handed delivery. www.crestpointmgt.com

I.V. House

For many years, Lisa Vallino, RN, had observed other pediatric nurses, as well as constructed herself, makeshift IV covers to help protect and provide comfort for the patients they were dedicated to care for.  These IV covers were created from plastic specimen cups cut in half and secured to the patient with tape.  In 1991, Lisa Vallino and Betty Rozier (Lisa’s business partner and mother) took a leap of faith, applied for a patent and approached a plastics manufacturer to help develop the concept and their dreams.  From this brave step, a plastic u-shaped domed cup was created and I.V. House was born.

The benefits of this product in the healthcare industry are plentiful.  First and foremost, I.V. House promotes patient safety.  By simply protecting the IV site, patient safety and comfort levels are secured.  I.V. House also extends dwell times and eliminates exposed looping issues. This is not only a safety benefit but it will also save on medical costs by preventing unnecessary IV restarts that may create complications and extend the amount of time the patient spends in the hospital.  I.V. House is a single use device and free of latex and DEHP; another effort to avoid complications and promote patient safety.  The I.V. House also allows hospital staff easy access and the ability to monitor the IV site by having a vented and transparent design.  The design also allows for minimum use of tape and in some models no tape at all.  Some of the I.V. House products have an ergonomic designed UltraDressing that fits the patient more like a glove instead of appearing as an uncomfortable medical device.

I.V. House has an extensive line of products.  They have developed a full range of sizes that will correspond to the individual needs of the patients.  There are also varying degrees of how the domes are padded and are designed for the area of the body where the IV site will be located. The I.V. House also has the specialized UltraDressing configurations to be completely free of the usage of tape.  I.V. House has a product that will fit and protect, no matter the needs of the patient.  www.ivhouse.com

Vision Blue

Although capsular staining had been being performed worldwide for a number years, it wasn’t until late 2004 before DORC International received FDA approval in the United States for their product Vision Blue.  This approval allowed US surgeons to finally have a resource that could help with performing a capsulorhexis in less than ideal conditions.  Before the use of Vision Blue, a surgeon may have experienced the inability to adequately visualize the anterior capsule which can result in an incomplete capsulorhexis.  With Vision Blue, the risk of radial capsule tears and other complications are greatly diminished.

With the introduction of Vision Blue into the US market, surgeons have gotten to enjoy the ability to get a much needed assist when performing procedures in which the anterior capsule is associated with a mature cataract or small pupil.  Capsular staining makes the capsulorhexis an easier and safer task when dealt   with such situations.  Ultimately, Vision Blue allows for a much safer procedure and high quality outcomes for the patient which is a win-win scenario for all involved. www.dorc.nl/

Steris Responds to FDA’s SS1 Warning

Medical manufacturer Steris says it disagrees with a safety alert the U.S. Food and Drug Administration issued last week, in which the agency urged users of the Steris System 1 to find an alternative method for sterilizing and disinfecting their instruments.

Besides stating that the modified version of the SS1 has not received FDA approval, the safety alert says that the agency has received reports of operational malfunctions in the popular tabletop liquid chemical reprocessor that could cause such “serious injuries” as patient infections. If you have an acceptable alternative to the SS1, the FDA says, you should transition to that alternative.

Steris responded yesterday by saying that the SS1 is safe and effective when used as directed. “We are working to engage in further dialogue with FDA about this matter,” says the company.

Steris notes that there has not been a documented case of infection directly caused by a SS1 when certified health professionals have followed proper guidelines and instructions.

The SS1 was introduced in 1988. More than 23,000 units have been used in more than 5,000 hospitals and clinics in the United States, sterilizing more than 300 million medical devices or about 30,000 per day. Users who have questions or require immediate assistance can contact Steris at (440) 392-7223.

Hoya Surgical Optics Enters US Marketplace

Hoya Surgical Optics based in Chino Hills, California is a global company focused on meeting the needs of surgeons and patients worldwide.  They are the world’s 4^th largest intraocular lens (IOL) manufacturer and distributor. Hoya Surgical Optics leverages more than 65 years of experience in precision optics technology into the design and manufacture of IOL’s.

Hoya Surgical Optics has recently gained FDA clearance for its IOL’s and iSert pre-loaded IOL System and looks to gain market share via a competitive portfolio of lenses and pre-loaded IOL Systems.  The company is offering spherical and aspheric acrylic lenses with a multifocal lens currently being offered outside the United States.

The AF-1 iSymm Acrylic Lens delivers the proprietary Aspheric Balanced Curve Design, advanced blue light absorbing technology, and 360-degree step-edge design.  This lens has a 6.0mm optic and has received New Technology Intraocular (NTIOL) designation from the Centers of Medicare and Medicaid Services .  The AF-1 iSpheric IOL delivers reliable visual outcomes through proven design, materials, and manufacturing. The lens provides a smooth optical surface coupled with design features that minimize optic deformation and provides excellent intracapsular stability.  The iSert preloaded IOL system has been designed to fit through a sub 2.5mm incision.  This pre-loaded system is easy to use and saves time for the surgeon and staff.

Hoya Surgical Optics has also recently announced the introduction of the Smart Automated Inventory Management system, “SAMI” as part of their customer care technologies and services. Using advanced radio frequency identification (RFID) technology, SAMI provides automated lens reordering as well as real-time, automated inventory management designed to reduce costs associated with reordering IOLs along with increased assurance of avoiding stock-outs for ophthalmic practices.

ILLUMIN-i System: A Revolution in Ophthalmic Illumination

Recently, Cataract Outsourcing sat down with Rob and Edie Hewlett of Endure Medical, Inc. to find out more about the ILLUMIN-I  System, a significant advancement in Ophthalmic illumination.  Based in Cumming, Georgia, this small company has been in the business of the refurbishment, sales and service of surgical microscopes for over 20 years.  Although the main focus of this interview deals with the Ophthalmic side, Endure Medical is also involved with ENT, neurosurgery, orthopedic, plastics, OB/GYN, and dentistry to just name a few.  They definitely cover a large spectrum of the surgical market and have a comprehensive knowledge of all of those specialties.

CO: Rob and Edie, please tell us a little about Endure Medical, your position with the company, how long you have been at that position, and how long you have been involved in the ophthalmic industry.

RH & EH: Endure is family owned and operated and we’ve been in business over 20 years.  We provide both new and refurbished microscopes for all specialties.  Our company is ISO 9001:2000; 13485:2003 certified, registered with the FDA and has CE approval on our new products.  All of our equipment comes with a 2 year warranty.   While developing our new ophthalmic scope, the Reflex, we began experimenting with different illumination systems.  After many ideas and prototypes, we finally discovered the technology used in the ILLUMIN-i….tested with several local surgeons….made a few alterations and filed the patent.

CO: What is the ILLUMIN-i system?

RH & EH: The patent-pending ILLUMIN-i module is integrated with our new microscope and is also available as an upgrade to older optics.  The ILLUMIN-I creates a homogeneous, brilliant red reflex and tremendous detail perception.  The ILLUMIN-i offers triaxial, collimated illumination and multiple angles of delivery that enhance the optical view for surgeons.  This new technology results in a constant, “glowing” red reflex while maintaining contrast and depth of field.  The surgeon perceives fine details and clarity like never before.

CO: How does the ILLUMIN-i system benefit surgeons?

RH: Provides an incredible view without having to replace your entire microscope.

EH: They can upgrade their current optical system and save lots of money over a brand new scope.

CO: What type of surgeon feedback (both positive and negative) have you had with those using the ILLUMIN-i system?

RH: By far, the feedback is positive.  The ILLUMIN-i is a cost-effective option to other new microscopes.  The optical view is comparable (if not better), but the price is much less.  For rural hospitals and ASC’s, our system is the perfect fit.  The surgeon gets the view he needs and the facility saves the money they need…especially in today’s economy.

EH: Optically, our system is just as good as or better than any other microscope on the market.  This is based on feedback from many of the top surgeons across the country.  We’ve kept our floorstand simpler with a small profile.  Some hospitals and surgeons prefer the larger floorstands with electromagnetic brakes and we don’t offer this feature.  Our design goals were to provide modern electronics for the footpedal and optics while keeping the floorstand simple.  This gives the surgeons the features they need/want and keeps the price under control!

CO: If you could only make one statement in regards to selling the ILLUMIN-i system to a skeptical surgeon what would that be?

RH: We will bring it to your facility, be in surgery and let you see for yourself.

EH: Take a look at our video of several surgeons using the ILLUMIN-i and then let us bring it to your facility and be in surgery…you don’t buy it unless you like it.

CO: Endure offers a variety of products and services, please tell our readers about all you have to offer your customers.

RH: While the ILLUMIN-i is specific to Ophthalmology, our company provides microscope systems and accessories for every specialty and budget.

EH: Along with our microscopes systems, we offer various new video systems (single, 3-chip and HD), replacement parts (new and refurbished), repair services and disposables.

CO: For those readers who are interested in the ILLUMIN-i or any other of your products and services, how can they find out more and get in contact with you?

RH: Our direct number is 800-736-3873 / 770-888-3755

EH: Our website is:  www.enduremed.com, my email is:  edie@enduremed.com ; rob@enduremed.com

Cataract Outsourcing would like to thank Rob and Edie Hewlett and the staff at Endure Medical, Inc. for meeting with us and providing information in regards to the ILLUMIN-I system.

The Future of Surgery

Today, robotics has pushed on the boundaries of medicine to be accepted as trusted devices in the operating room.  The new “Da Vinci” system has had a high impact into the surgical world allowing surgeons, controlling robotic arms and viewing three-dimensional images, while operating through micro incision entry points.

To see more click here

Microrobots are on the horizon as well.  Miniature robots that are swallowed to gather information and/or images so more accurate and perhaps fewer incisions for the patient.

To see more click here

As new technology evolves, the cataract procedure keeps evolving as well.  Smaller incisions, instruments, intraocular lenses keep pushing forward the newest techniques.  NASA has even provided new technology that can detect the formation of a cataract before it is clinically visible, thus a camera predicting the future arrival of a cataract.

To view the PDF please click here.

As the future of surgery, our greatest challenges will still be, to maintain the highest level of surgical outcomes while justifying the return on investment for hospitals and surgical centers.  As our future looks so ever exciting in the world of surgery we dare to look behind at what cost will be following.

Innovation in IOL Injection-Duckworth and Kent Acrysof IOL Injectors

Cataract Outsourcing recently conducted an interview with Dot Smith, the Director of Customer Service for Crestpoint Management Ltd.  Crestpoint Management Ltd. was previously known as Duckworth and Kent USA Ltd.  They are known for their premium lines of instrumentation for not only ophthalmology, but a number of other fields as well.  Crestpoint Management Ltd. prides themselves in service, customer satisfaction, and quality products.

CO:  Dot, please tell us about your position with Crestpoint Management and how long you’ve been employed with them.

DS:  I have served the last 15 years as the Director of Customer Service.  Over the years I have developed a broad knowledge base of Ophthalmology.  I handle a lot of customer work and personally follow up with each of them.  It is equally important to me, that my staff also follows up with all of their customers as well.  Crestpoint is known for our excellent customer service and dedication to those customers.

CO:  Tell us about your new Acrysof IOL injector.

DS:  Our new injector, the DK7797-2, is a front loading injector designed to accommodate the Alcon “D” IOL cartridge as well as the “B” and “C”.  It is a smooth, single handed delivery, ergonomically designed to fit any sized hand.  The injector can be pre-loaded.  It also comes completely apart for proper cleaning.

CO:  Was Alcon involved in the design and development of these Injectors?

DS:  Surgeons contacted us and asked for a different injector with a smooth mechanism.  Crestpoint (then Duckworth and Kent USA) took the design to Alcon.

CO:  What are some of the positive response you have gotten from surgeons that have used these Injectors?  Have there been any negative or critical responses?  If so, what were they?

DS:  The positive responses we have gotten have been great.  Surgeons truly enjoy the efficient and smooth one handed delivery.  We have not experienced any negative feedback in terms of the injector.

CO:  If you had to make one statement telling a surgeon why he/she should use this injector what would it be?

DS: It works better than any other injector currently on the market!!

CO:  Crestpoint Management will be attending the 2009 AAO meeting in San Francisco.  What other new or exciting products will you have on display?  Where can our readers stop to see you if they are out and about at AAO?

DS:  The items that we are most excited to have available to our customers are the Osher Changeable tips for forceps/scissors, Toric Axis & Reference Markers, Injector for the AMO Technis IOL, and Capsulorhexis forceps for Microincision.  Please stop by and see us at Booth #917.

We would like to thank Dot Smith and Crestpoint Management Ltd. for sharing their products and time with us.  Please visit their website, www.crestpointmgt.com, or stop by and see them at the AAO 2009 in San Francisco.

A Day in the Life of a Repaired Surgical Instrument

When surgical instruments and equipment are sent in for repair at Mobile Instrument Service & Repair, it is received at our national repair center in Bellefontaine, Ohio. All shipments are received in our central receiving area, where each package is logged into our tracking system. Our ISO 9001:2008 certification mandates very specific tracking through our entire system and this begins the moment a package enters our building. As the package is opened, the applicable equipment is assigned a work order number specific to the healthcare facility from which it came. This work order number is essentially the identification of that equipment as it makes its way to the appropriate repair division. At the repair division, that equipment is logged into the repair lab by customer service representatives where it will then proceed to the technical area for inspection. Qualified, well-trained technicians inspect each piece of equipment to check for damages, defects and malfunctions, and a written inspection is completed and passed along to our customer service personnel.

At this point, the customer service representative completes a quotation based on the information provided by the technical staff and makes contact with the healthcare facility. Factors that may come into play during the quotation phase are related to group purchasing organization (GPO) affiliation, applicable individual repair contracts, equipment condition and age, and prior repair history. Once the quotation is complete, the healthcare facility is contacted and the quote is sent via e-mail or fax. Once approved, the repair is noted as such in our system and the individual repair lab is notified of the status change. The repair is then scheduled and prioritized into our repair log, based on its published turnaround time and is managed by team leaders and/or supervisors within the respective repair division.

Once the repair has been completed it must pass through our ISO-certified quality assurance system, where it will be tested by a quality control technician prior to being returned to the healthcare facility. If for any reason the equipment were to fail during the quality control inspection, it is returned to the repair lab where the technician will oversee the entire process. This process may include the identification of a faulty replacement component, the re-training of a technician on a particular repair process, or identifying any other breakdown in the system that lead to the quality control failure.

Once the equipment has been corrected, it will return to the quality control area, and upon passing the quality assurance inspection it will then be packaged for delivery back to the facility. All return packages are again tracked through our system by the individual tracking number assigned by the shipping carriers so we can ensure each piece of equipment returns to its original destination correctly. Our field personnel and/or customer service representative will then follow up to make sure the repaired equipment was received and that there was a high level of satisfaction with the service.

Throughout the process there are many checks and balances that ensure a smooth experience for our customers. All of this is designed to safely prolong the life of the equipment serviced. Without an efficient system in place, it is impossible to effectively service medical equipment and do so while maintaining long-term relationships. It is essential for any repair company to have a process in place such as ours and it has afforded us more than 30 years of longevity in the third-party medical equipment repair business.

Robert Purtell is director of business development for Mobile Instrument Service & Repair.

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