How to Choose a Contract Sterilization Vendor

How to Choose a Contract Sterilization Vendor

By Martell Winters and Paul L. Littley

Ethylene oxide sterilization chambers are commonly used to sterilize medical devices.

In the world of contract sterilization, selecting the most appropriate service provider can be a daunting task. Even for the seasoned expert, determining the right fit for the needs of your medical device business is an intimidating process. With typical validation periods ranging from two to four months, it would be financially detrimental to complete a validation only to find the new relationship isn’t the right fit after the first month of processing.

When choosing a contract sterilization vendor, there are myriad considerations and questions that must be asked to ensure the final selection will not only meet your company’s immediate needs, but also provide scalability for future growth. Although the following priorities are, in our experience, the logical progression for selection, not all medtech manufacturers may share the same priorities for their selection. Nevertheless, the following considerations should provide the necessary guidance for selecting a contract sterilization vendor. (Additional information and guidance for ethylene oxide contract sterilization can be found in AAMI TIR14, “Contract Sterilization Using Ethylene Oxide.”)


One of the first considerations for OEMs should be the proximity of the contract sterilization facility to the manufacturing site. Transport costs of processing multiple sterilization batches per week can add up quickly. When budgeting, remember to consider return shipment charges.

Turnaround Time

Arguably, the main priority for your outsourcing selection is the ability to get a sellable product to market quickly. When analyzing turnaround time, chamber or carrier size, facility capacity, and the sterilization process, logistics all become a careful balancing act. For ethylene oxide sterilization, does a traditional three-phase process (separate phases of preconditioning, sterilization chamber, and aeration) meet the business need with a turnaround time of approximately five days, or is an “all-in-one” process (typically completed in 24 hours) more appropriate? For radiation, does validation of a typical dose, such as 25 kGy, facilitate a faster turnaround time at the selected location? All of these factors should be considered when assessing contract sterilization partners.


In many organizations, cost will be the primary consideration when selecting a contract sterilization provider. Many companies may not have the operating margins or be in a financial position to be able to afford the price of the “perfect” contract sterilization facility. It’s important to strike a balance between the business needs and the “ideal scenario.”

Chamber Equivalency

When it comes to ethylene oxide sterilization—a common technique used on medical devices—chamber equivalency is important not only for overflow purposes (capacity restraints) but additionally as a contingency strategy. Established chamber equivalency reduces the validation scope of an additional chamber and provides back-up in the event of unscheduled maintenance and capacity restraints. Maintaining multiple validated chambers provides a critical insurance policy to ensure an uninterrupted sterilization process.

Process Controls

Several high-level aspects of quality control stand out when selecting a sterilization vendor. High on the list of process controls is product segregation. Segregation of processed and unprocessed product is paramount, as it is impossible to identify if a product has been sterilized by visual inspection. The vendor should be able to physically confirm that its process or product flow provides clear separation of processed and unprocessed product and that the two never cross paths.

Other key quality aspects to consider are the cleanliness of the facility and its pest control practices. Even a single dead (sterilized) bug provided with your medical device reflects poorly on the quality control of your manufacturing process. Facility pest control should not be ignored or overlooked. Effective housekeeping is a sure sign of the quality of a contract sterilization facility.

It is also important to remember that contract sterilization facilities do not ensure the sterility of your product, only that the validated cycle was run to your specification and that any nonconformances were identified. The ultimate responsibility of product sterility rests in your hands.

Supplier Approval

The final consideration for selection of the appropriate vendor should entail a formal review of the vendor’s regulatory compliance history and conformance to good manufacturing practices. The manufacturer should follow standard protocol for supplier approval including a quality system audit of the candidate vendor. It should also be clear that the vendor fully understands and follows the appropriate AAMI and ISO sterilization standards.


Medical device companies continually seek ways to reduce costs and increase efficiency in the manufacture of their products. While the outsourcing of sterilization provides convenience, efficiency, and initial cost savings, it is crucial that companies looking to outsource be well versed in the criteria that should be considered during the selection process. Prioritized business needs and careful, informed selection will provide years of seamless product sterilization for the manufacturer.

Martell Winters is a senior scientist at Nelson Laboratories. Reach him at

Paul L. Littley is a consulting manager at Nelson Laboratories. E-mail him at 

Human Factors and Packaging: Adventures in Medical Device Usability

 Human Factors and Packaging: Adventures in Medical Device Usability

By Stephen B. Wilcox, PhD, FIDSA

There have always been human factors issues associated with medical packaging, particularly packaging designed for use by patients, as opposed to medical professionals. For example, packaging designers have struggled for years with making packaging easy to use for target users while still making it childproof. The catch, of course, is that target users may suffer from disabilities like compromised dexterity or vision problems, or even cognitive deficits, by virtue of the very conditions—such as diabetes, glaucoma, and heart failure—that their medical devices or drugs are designed to address.

Stephen B. Wilcox, Ph.D., FIDSA

Thus, the challenge is how to make a package easy to open for a person with a variety of disabilities, but difficult—or, better, impossible—to open for a child. One approach is to take advantage of the relatively larger hand of the adult rather than assuming more strength or a better ability to follow the proper procedure to get a package open. In other words, the idea is to design a packaging-opening procedure that requires a hand of a certain span.

In fact, making packaging usable involves the same methods required for making devices usable:

  • Acquiring a good understanding of real-world users, use conditions, and procedures
  • Applying technical information about the users, such as strength, expectations, and body sizes
  • Performing cyclical testing of prototypes to empirically “work out the bugs” prior to finalization

These methods are collectively referred to as the “usability engineering process.”

One thing that’s changed recently, though, is human factors-related regulatory requirements, particularly those specific to drug packaging. For devices, perhaps the best way to think of the regulatory requirements for packaging is to consult IEC/ISO 62366:2007, “Application of Usability Engineering to Medical Devices.” In reference to “information for safety,” the standard states: “If information for safety is used as a risk control measure, the manufacturer shall subject this information to the usability engineering process (Section 4.1.3).”

Packaging may contain “information for safety,” specifically. But, regardless, the same principle applies to packaging that applies to information for safety: If packaging is used as part of the methods for achieving safety, then human factors methods are required.

In general, packaging must be subjected to the usability engineering process, which is described in the FDA draft guidance on human factors issued by CDRH, “Applying Human Factors and Usability Engineering to Optimize Medical Device Design,” if the packaging has any safety implications. That is, the usability engineering process must be applied if the packaging is required for safety or if flaws in the packaging can cause a safety, or even an effectiveness, problem. Needless to say, effectiveness is affected, and, possibly, safety as well when the intended user cannot open packaging in the first place.

The recent change, though, isn’t with device packaging, but with drug packaging. FDA’s Center for Drug Evaluation and Research (CDER) has issued two draft guidances within the past year and a half that, in effect, bring drug labeling and packaging into the human factors orbit in the way that devices have been for several years.

“Safety Considerations for Product Design to Minimize Medication Errors” was released in December 2012, while “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors” followed in April 2013.

The 2012 draft guidance provides a blueprint for building in safety—i.e. addressing use error—with drug products:

  1. Consider a series of issues regarding end-users (“What critical tasks must users perform?”) and environments of use (“Is this product atypical for use within this environment?”)
  2. Proactive risk assessments

In the discussion of proactive risk assessments, the guidance provides a series of specific principles to follow for various drugs and suggests two basic methods—failure modes and effects analysis (FMEA) and simulated use testing. The latter represents the usability testing mandated in the aforementioned CDRH draft guidance regarding human factors, to which the CDER Guidance refers. Also, in its discussion of FMEA, the guidance makes reference to ISO 14971:2007. The 2013 guidance discusses risk assessment as well, but it also provides a set of specific rules for labeling.

In sum, just about anything human factors-related that can be said of any other product that humans use can be said of packaging: It needs to be physically usable, it should minimize use errors, the text must be readable and understandable, etc. Thus, basic methods that have been applied for years to human interfaces of all kinds, also apply to medical packaging.

What’s different, though, is that packaging, for both medical devices and drugs is now subject to a series of regulatory requirements that mandate good human factors practices—at least as they relate to safety and effectiveness. In other words, applying human factors principles and methods to medical packaging has always made good sense. Now, it’s also a regulatory requirement. 

Stephen B. Wilcox, is a principal and the founder of Design Science (Philadelphia), a firm that specializes in optimizing the human interface of products—particularly medical devices. 

Interested in medical packaging design? Download the white paper, "Critical Considerations When Designing Medical Packaging."

Edwards Lifesciences CEO: Medtronic Not As Aggressive in Early Launch of CoreValve

Edwards Lifesciences CEO: Medtronic Not As Aggressive in Early Launch of CoreValve

One theme permeated Edward Lifesciences' second-quarter earnings call Tuesday: better-than-expected sales results in the company's Sapien transcatheter heart valve (THV) product line in the U.S.

Globally, the company recorded THV sales of $219.7 million, a 20.6% jump from the same quarter last year. Of that, $86 million was garnered in the U.S. Transcatheter aortic replacement procedures involving Edwards' Sapien THV increased in number both from the second quarter of 2013 and from the first quarter. 

This is all the more interesting given that analysts and even company management had expected some level of share loss as Medtronic launched its competing CoreValve prodcut in the U.S. After all, CoreValve, which was approved in January, has actually proven that TAVR procedure has better outcomes than traditional, invasive, open-heart surgery.

Yet, the second quarter proved to be sweet for Edwards.

Not only did Sapien do well, but also Medtronic agreed to settle its worldwide TAVR litigation with Edwards, which led to a $750 million upfront royalty payment in the quarter along with the promise of quarterly payments through April 2022. The good news didn't stop there. FDA approved the Sapien XT in June - a lower profile product with different sized heart valves allowing patients who did larger heart valves to be also treated with Edwards' product.

Mike Mussallem, Edwards Lifesciences' CEO, repeatedly said that it was difficult to say precisely what fueled the sales growth for the quarter. Yet he noted that he believes the overall market grew with more transcatheter heart valve procedures done in the quarter.

"Although we have always believed that the TAVR opportunity in the U.S. to be large, it appears that there is an increase in the growth that is being fueled by new lower profile systems, increased valve sizes, clinician experience and the growing body of compelling clinical evidence, he noted in his prepared remarks.

Patients who required larger heart valves led physicians to gravitate toward CoreValve and be trained on the Medtronic product but when Sapien XT was approved in June, many came flocking back to treat their patients with the larger valve sizes now available through that next-generation system, Mussallem added. Additionally, for some reason, it also appeared that Medtronic may not have been firing on all cylinders.

"There's been a lot of back and forth in the quarter. I am not sure that you can know exactly know where it is, Mussalem said responding to a question from an analyst asking about competition from Medtronic and the dynamics of the quarter. We feel like we exited strong and we probably didn't see Medtronic sort of be as aggressive as we thought they were going to be during this early launch period." 

In Europe, too competition has been muted from new entrants to the market. Medtronic launched CoreValve there several years ago, and ahead of Edwards, and now there are competing products from both Boston Scientific and St. Jude Medical with their respective TAVR products. 

"Recall that going into the year, we indicated that we were going to have some headwinds and that we were going to see the introductions of two large competitors - Boston Scientific and St. Jude. Although we have seen them on the scene, we haven't seen substantial impact so far this year. We think that might be because their introductions have been somewhat delayed in terms of having full product line. We expect to see more complete product lines from those companies later on in the year."

While competition hasn't been a drag, at the same time European THV sales have seen a lift from the launch of Sapien 3, Edwards' latest THV, the only commercially available THV product that can be delivered through a 14 French expandable sheath. More than half of European THV sales came from the Sapien 3 product and Mussallem noted that the product helped company to gain share in the European market.

Mussallem is confident of Sapien's potential and analysts cheered the strong sales performance in the second quarter, but the question is how long will it last? Glenn Novarro, senior analyst at RBC Capital Markets put it like this in a research note to investors Tuesday:

While Sapien exceeded our expectations in [the second quarter], and estimates will move higher for 2014-2015, we believe that headwinds [in the second half of the year] may limit further sales and [earnings per share] upside. These headwinds include: 1) the completion of enrollment for Sapien 3 in the U.S., leading to lower clinical sales, 2) the continued roll out of CoreValve in the U.S., 3) clinical trials starting up for [St. Jude Medical, Boston Scientific, and Direct Flow in the U.S, taking away potential Sapien cases and 4) incremental competition in Europe.

[Photo Credit: user iodrakon]

-- By Arundhati Parmar, Senior Editor, MD+DI

Medtronic Has an Internal App-etite for Apple Products

Medtech giant Medtronic apparently hasn't slowed down on its appetite for using Apple technology internally--even as the iconic tech company is signaling its interest to compete more actively in the healthcare market. Fridley, MN-based Medtronic "has developed over 175 internal iOS apps for over 16,500 iPhones used by its employees to facilitate sales, improve productivity and ensure that essential marketing materials are up to date," Apple chief financial officer Luca Maestri told analysts during a July 22 conference call transcribed by Seeking Alpha. Maestri cited Medtronic as an example of a company equipping employees with iPhones to boost productivity, employee satisfaction and profitability. Maestri also mentioned Nestle, with 25,000 iPhones, and NASA, with over 26,000 iPhones. Medtronic's internal love of Apple devices has been reported before. Back in 2011, Medtronic made news over the 5,000 iPads it was using internally. There were 28 apps available at that time, according to MedCity News. Medtronic has more than 46,000 employees. Ironically, the maker of the devices that Medtronic's IT department apparently loves so much is setting itself up to potentially become a competitor--though there might also be partnering opportunities as well. Apple this year announced HealthKit, a glorified healthcare and fitness app bundled into iOS8 that can potentially communicate patient health data to hospitals. The company also announced a partnership with the Mayo Clinic, which is exploring the integration of HealthKit, potentially enabling the app to share health information with clinicians. The rumored iWatch increasingly looks as though it will also be a digital health platform.
Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.
Meanwhile, a Medtronic executive earlier this year described Google as the company's greatest competitor, not other medical device companies such as Johnson & Johnson or Boston Scientific. Colin Anawaty, ?CPO and cofounder of Filament Labs (Austin, TX), suggested to Qmed this week that device developers give special consideration to Google's Android mobile operating system platform, which has the advantage over iOS of being Open Source.

Related Article

Why Medtech Needs to Learn about iOS and Android

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.

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Boston Scientific Merger Shy in Busy Period of M&A Deals

Like the kid on the playground who watches others hop on and off the spinning merry-go-round, Boston Scientific says it will sit out the current whirl of medtech mergers.

Following last week's second-quarter earnings report, president and CEO Michael Mahoney told analysts that the Natick, MA-based company would continue to grow its business organically, with the possibility of a few "tuck-in" acquisitions to contribute to that growth.

Michael Mahoney

Boston Sci's Michael Mahoney

The company reported Q2 revenues of $1.87 billion, a 4% increase over the same period of 2013, narrowly beating analysts' estimates. Its quarterly earnings of $4 million, or 21 cents per share (adjusted to exclude one-time items), was up from 18 cents a share a year ago.

Mahoney called other medtech companies' merger activity "interesting news" that does not affect its 2014 outlook or strategic plan. Medtronic's proposed $43-billion acquisition of Covidien has provoked a great deal of interest, including from competitors such as CR Bard and from the federal government, which, unsurprisingly, is not happy about Medtronic's plan to move its headquarters to Ireland.

"I think what's important for investors and employees is that the company is delivering today. We are building momentum and we have a strategic plan that's compelling. It's attainable," Mahoney said in a transcript provided by Seeking Alpha. "We play in very big markets, well in excess of $30 billion, and we have ample opportunity to grow share in those businesses."

To be the clinical leader in treating widespread diseases,"we will continue to provide tuck-in acquisitions and the right innovation bets to be really clinically differentiated and have scale in those specific disease states," Mahoney added.

In November 2013, Boston Scientific acquired the electrophysiology segment of CR Bard for $275 million. Product lines acquired include diagnostic catheters, cardiac catheter ablation technology, cardiac mapping devices, therapeutic catheters and cardiovascular recording equipment. In total, Boston Scientific says the deal will give it access to a market with a total cap of $2.5 billion.

The company also announced plans in May to acquire Bayer AG's Interventional Division for $415 million, but it was hardly the largest medical device acquisition announced so far in 2014.

This follows a bumpy 2013, in which the company announced two rounds of layoffs of about 1000 employees and further federal scrutiny of its defibrillator business.

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

Nancy Crotti a contributor to MPMN and Qmed.

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Global Orthopedics Trauma Fixation Devices Market To Grow To $9.4B In 2020

The global orthopedics trauma fixation devices market will be worth $9.39 billion in 2020, according to a report from Transparency Market Research.

A growing elderly population and increase in number of road accidents and preventive measures are some of the factors contributing to the growth. In fact between 2014 and 2020, the market will grow at the compound annual growth rate of 7.2%.

North America accounts for the lion's share of the market in the period of the forecast with Asia being the fastest-growing region for orthopedics trauma fixation devices. In 2014, the North American market is forecast to garner sales of $3.3 billion out of the overall market, which is estimated to be $6.1 billion.

As for actual device components, internal fixators, which include plates and screws, command the largest share of the market and is forecast to grow at a CAGR of 7.1% in the forecast period. Companies are also investing in new innovation by developing fixators that comprise bioabsorbable material.

DePuy Synthes is the largest player in the orthopedics trauma fixation devices market. It had a marketshare of 47.3% in 2013. Other players are Stryker, Smith & Nephew, Zimmer and Orthofix Holdings.

 -- By Arundhati Parmar, Senior Editor, MD+DI

8 Recent Medical Device Failures

Updated August 21, 2014 There has been plenty of news recently when it comes to serious medical device errors-- from moldy infant head cradlers to GE Healthcare carbon dioxide detectors with potentially incorrect values to Medtronic's recall of a cerebrospinal fluid draining and monitoring device And unfortunately, in the case of General Electric and Medtronic, these were companies that had seen their share of Class I-level recalls in recent years. Read on to find out more:

1. Moldy Infant Head Cradlers

The FDA has issues a Class I designation for Philips Healthcare's voluntary recall of Gel-E Donut and Squishon 2 gel-filled products--used in hospitals to support and cradle an infant's head and/or body.
Gel-E Donut
Gel-E Donut products, as shown in a Philips Healthcare brochure.
Philips' Children's Medical Ventures subsidiary in Monroeville, PA, recalled the products after receiving a number of complaints about visible mold on the outer surface. Further investigation found the mold to be Cladosporium and Penicillium Fungi, commonly found molds that nevertheless could be deadly for infant, causing infections as well as allergic reactions and difficulty breathing. The affected Gel-E Donut and Squishon 2 products were made and distributed from July 1, 2012 to December 31, 2013. Read the FDA's announcement.

2. An Intranasal Splint Gel That May Not Have Correct Acid Concentrations

FDA officials are increasingly raising concerns about Enhancement Medical's Expression, a hyaluronic acid gel that is packaged in a syringe and listed with the FDA as an intranasal splint to minimize bleeding and swelling inside the nasal cavity after trauma or surgery.
Expression syringe
Expression syringe, as shown on Enhancement Medical's website
The agency on August 14 placed a Class I designation on Wauwatosa, WI-based Enhancement Medical's recall of all lots of Expression after it could not ensure that Expression contains the correct concentration of hyaluronic acid. Enhancement Medical last year asked customers to return certain lots of the Expression after receiving multiple complaints documenting adverse events including swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules--all after subcutaneous injection. The company's further investigation found hyper-concentrated lots of the Expression, according to the FDA. The FDA has also received reports of Expression being used as a dermal filler to fill in wrinkles on the face--an unapproved use. For Expression, Enhancement Medical utilizes hyaluronic acid produced by Denmark-based company Novozymes Biopolymer. The Danish company touts its hyaluronic acid as superior because no animal-derived raw materials are used to make it, so there is no risk of viral contamination or of transmittance of animal spongiform encephalopathy. Older methods derive the acid from rooster combs or microbial fermentation of media containing yeast or animal extracts. The Novozymes hyaluronic acid that Enhancement Medical uses is produced through fermentation of a sucrose-based medium by a novel and non-pathogenic strain, Bacillus subtilis. Read the FDA's announcement.

3. A Cutting Tool That Could Leave Sheath Fragments in Blood Vessels

Made by Cardiovascular System, the Diamondback 360 Peripheral Orbital Atherectomy System is a high-speed cutting tool inserted via a catheter through the skin into a patient's blood vessel. It is meant to reestablish blood flow in narrowed arteries or arterio-venous dialysis shunts. However, New Brighton, MN-based Cardiovascular Systems recently announced a recall involving certain lots of the Diamondback because they may contain defective saline sheaths that could fracture during use. The FDA on August 19 designated the recall as Class I because of the danger of blood vessel blockage. To date, there are no reported patient injuries, according to the FDA. Read the FDA's announcement.

4. GE Hit with Another Class I--This Time over Carbon Dioxide Detectors

The FDA on July 25 designated a GE Healthcare voluntary recall of carbon dioxide detectors as Class I. The products--Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC)--may fail or provide incorrect carbon dioxide values for mechanically and spontaneous ventilated patients, the FDA said in its announcement. Such a malfunction could cause physicians to decisions with life-threatening consequences for patients, including hypoventilation. There are no reports of injuries or deaths associated with the malfunctioned devices, according to the FDA. The modules were manufactured between February 10, 2012 and October 2, 2012, and distributed between February 2012 and April 2014. This is General Electric's ninth Class I-level recall since the start of 2012. Only Johnson & Johnson and CareFusion have had more serious recalls. Medtronic is presently tied with GE. Read the FDA's announcement.

5. Another Class I Recall for Medtronic

Medtronic Duet
Medtronic Duet External Drainage and Monitoring System
The FDA recently designated Medtronic's voluntary recall of a cerebrospinal fluid draining and monitoring device as Class I. Officials at the agency think that the recalled Medtronic Duet External Drainage and Monitoring System could cause serious injury or death because the patient line tubing may separate from the patient line connectors during frequent handling. Such a device failure could result in air within the skull (pneumocephalus), infection such as meningitis, ventriculitis, encephalitis, and over and under drainage of the cerebrospinal fluid, according to the FDA. This is also Medtronic's ninth Class I-level recall since the start of 2012. Medtronic says there have been no permanent serious injuries or deaths connected with the Duet recall. Read Qmed's story about the recall.

6. Resuscitator Bag with a Sticking Valve

Ventlab (Grand Rapids, MI) is voluntarily recalling manual resuscitator bags because a duckbill valve may stick and prevent air from getting to the patient, the FDA and the company announced. One injury has been reported due to a stuck valve, which can prevent oxygen from reaching tissues--slowing breathing and even leading to death. The company received 31 reports of a delay in oxygenation. The sticking may be the result of inadequate curing in the manufacturing process. The Class I-level recall affects devices that were manufactured and distributed from January 10, 2013 through July 1, 2013 and are made for medical personnel use only. The trade names for the recalled bags include Airflow Bag, Breath Tech Bag, Provider Bag, STAT-Check Bag, Safe Spot Bag, V-Care Bag, Medline Bag, RescuMed Bag, VT1000 Kit. Read Qmed's story about the recall.

7. A Catheter with Separation Issues

VentLab VN5000
A VentLab VN5000 series resuscitator bag, as shown on the company's website. It's one of the product series involved in the recall. 
The FDA in July also announced a Class I designation for Vascular Solutions' recall of its Langston V2 Dual Lumen Pressure Monitoring Catheter. Health practitioners use the device to deliver dye, or contrast medium, into a patient's blood vessels during medical imaging tests; the device also measures pressure within the blood vessel. FDA officials think the recalled catheters could cause serious injury or death because Vascular Solutions received reports that the inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub while in use. In such cases, a procedure may be needed to retrieve the separated piece from the patient's vascular system. Read Qmed's story about the recall.
Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

8. Labeling Error Sparks Glucose Test Strips Recall

For the second time this year, a recall involving glucose test strips has received a Class I designation from the FDA. The Class I-level incident, which the FDA announced this month, involves Dorado, Puerto Rico-based Diabetic Supply of Suncoast's voluntary recall of Advocate Redi-Code+ BMB-BA006A blood glucose test strips manufactured by BroadMaster Bio-Tech Corp. of Taiwan. The Diabetic Supply of Suncoast recall comes about seven months after the FDA said Abbott Laboratories' FreeStyle and FreeStyle Lite test strips could cause serious injury or death because they were found to provide inaccurate readings of blood glucose when used with the FreeStyle and FreeStyle Flash meters and the Insulet OmniPod. (The FreeStyle and FreeStyle Flash devices have not been produced since 2010.) In the case of the Suncoast recall, the issues involves a labeling error omitting the test strips model number (BMB-BA006A). According to the FDA and Suncoast, this could potentially lead to use of the Advocate Redi-Code+ BMB-BA006A blood glucose test strips with incorrect glucose meters made by Taidoc Technology Corp. Misuse could result in incorrect glucose test results--a life-threatening situation for a diabetic. Read Qmed's story about the recall.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.

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Medtronic Acquires Neurosurgery Firm Visualase

On the heels of announcing its plans to acquire Covidien, Medtronic has expanded its neurosurgery footprint, completing its possibly $105 million acquisition of Visualase Inc. (Houston, TX). Previously a privately held company, Visualase develops and markets an FDA-approved MRI-guided system for minimally invasive neurosurgeries, including surgical thermal ablation for brain tumors and epilepsy. Medtronic said in a press release that it plans to incorporate the technology into its broader neuroscience offerings. Visualase directs light energy through a laser probe to heat and destroy soft tissue such as tumors and brain lesions, some deemed otherwise inoperable. MRI imaging provides precise targeting for the procedures, according to the company's website. Patients can be awake for the procedure, which may cause little or no pain and require only a one-day hospital stay. Medtronic had previously invested in Visualase and held an ownership stake in the company before completing the acquisition. The all-cash transaction includes an initial payment of $70 million plus additional payments of up to $35 million, which are contingent upon the achievement of specific milestones. Medtronic expects no net impact from the transaction to its fiscal year 2015 earnings. It predicted the acquisition would add value, consistent with its focus on long-term returns. Children's Hospitals and Clinics of Minnesota in May performed the first known Visualase surgery on an eight-year-old boy who had a rare, mature, teratoma brain tumor. The peach-sized tumor shank more than 40% following the treatment,said Dr. Joseph Petronio, medical director of pediatric neurosurgery at Children's, who performed the surgery. The treatment appeared to have destroyed the previously active part of the tumor, Petronio said. Doctors are currently using Visualase in the brain, liver, prostate, bone and spine, and are studying other applications in the thyroid and other thermal tumor ablation, according to the Visualase website.
Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

Nancy Crotti is a contributor to Qmed and MPMN.

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5 Humble Medical Devices Get a mHealth Makeover (PanOptic Ophthalmoscope)

 iExaminer PanOptic Ophthalmoscope

The iExaminer Adapter converts Skaneateles Falls, New York-based Welch Allyn's PanOptic Ophthalmoscope into a mobile digital device. The sytem comprises the adapter which can attach the PanOptic Ophthalmoscope to a iPhone 4 or 4S. The related app helps to take, store, retrieve and send images right to the iPhone. 

The device providers five times the manification of regular Welch Allyn ophthalmascopes and because of that dilation of the pupil is not required.

[Photo Credit: Welch Allyn website]

Start From Beginning 

5 Humble Medical Devices Get a mHealth Makeover (CellScope Oto)

 The CellScope Oto Smartphone Otoscope 

San Francisco-based CellScope has created a device that, with a few attachments essentially turns the iPhone into an smart otoscope. The product is currently in limited launch and is only available through pilot programs but the device is ultimately intended to be used in a variety of settings - home, clinic, day care and for educational purposes.

The system comprises a proprietary iPhone case, scope attachment and case as well as five tip case. The hardware works with a companion iPhone app and a website where the eye exams may be reviewed and transmitted. 

[Photo Credit: YouTube video]