Category Archives: Technology

17Oct/06

A Bar-Code In The Hand Is Worth Two RFID Tags In The Bush

On February 26, 2004, the FDA published its final rule onBar Code Label Requirements for Human Drug Products and Biological Products.  According to the Agency, “Bar Codes will allow health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time.  This new system is intended to help reduce the number of medication errors that occur in hospitals and health care settings.” 

The Bar-Code rule requires linear bar codes on most prescription drugs and on over-the-counter drugs commonly used in hospitals and dispensed pursuant to an order. The bar code is required to contain, at minimum, the drug’s National Drug Code (NDC) number, which uniquely identifies the drug. The rule also requires the use of machine-readable information for blood and blood components intended for transfusion. The machine-readable information must include, at a minimum, the facility identifier, the lot number relating to the donor, the product code, and the donor’s ABO and Rh. 

During the same month, February 2004, the FDA’s Counterfeit Drug Task Force issued its report on “Combating Counterfeit Drugs”. This report called for the implementation of Radio Frequency Identification (RFID) technology to allow the tracking of pedigree and mass serialization for all drug products. The Agency set forth a phased approach to the implementation of RFID technology starting at the case and pallet level for products likely to be counterfeited and progressively including all products at the case, pallet, and package level by 2007. 

In February of 2006, the FDA conducted a Counterfeit Workshop in Bethesda, MD to get an update from stakeholders on the status of RFID implementations. Affected stakeholders, including manufacturers, distributors and pharmacists, presented progress made and concerns associated with RFID and e-Pedigree initiatives. During my remarks to the Task Force, I stated that RFID technology should be used as an enabler, not a silver bullet. I conveyed the agency’s role to set regulatory requirements, gathered in cooperation with all affected stakeholders. However, in my opinion, the FDA should not mandate specific technologies to be utilized to achieve compliance.  

In June 2006, the task force issued its update on the FDA Counterfeit Drug Task Force Report. The agency admitted that although in 2004 it was optimistic that widespread implementation of e-pedigree was feasible by 2007, unfortunately, this goal most likely will not be met. The report went on to say:

“…it is clear from our recent fact-finding efforts that the voluntary approach that we advocated in the 2004 Task Force Report did not provide industry with enough incentives to meet FDA’s deadline.
We continue to believe that RFID is the most promising technology for electronic track and trace across the drug supply chain. However, we recognize that the goals can also be achieved by using other technologies.
Based on what we have recently heard, we are optimistic that this hybrid environment of electronic/paper and the use of RFID/bar code is achievable in the very near future. We believe that efforts to ensure that hybrid pedigrees are secure and verifiable should be a priority consideration.” 

Is this a case of one step forward and two steps back? I don’t believe so. I see it as a net gain for all stakeholders, especially patients.  The FDA estimates that the bar code rule, once implemented, will result in more than 500,000 fewer adverse events over the next 20 years.

Hospitals have recently made major investments in Bar-Code systems to comply with these regulations and minimize medication errors. Asking them to now reinvest in RFID technology without realizing the benefit of Bar-Codes would be a mistake. 

As the saying goes, A Bar-code in the hand is worth two RFID tags in the bush.
 

Copyright 2006 Daniel R. Matlis – AXENDIA

06Sep/06

FDA Approves First Implantable Replacement Heart

The U.S. Food and Drug Administration (FDA) yesterday approved the AbioCor®, the world’s first completely self-contained, implantable Replacement Heart. 

This approval provides patients suffering from heart failure on both sides of their heart (bi-ventricular) and who have no other alternative, a viable option for extending the quality of their life.

“This device represents a significant advance in artificial heart technology and holds promise for critically ill heart patients who are not candidates for heart transplants due to age or other medical conditions,” said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA. “We hope today’s approval will encourage the continued development of potentially life-saving technologies for critically ill patients.” 

The quest for an implantable artificial heart began in 1964 at the National Heart Institute (NHI), now the National Heart, Lung and Blood Institute (NHLBI). The goal was to create an Artificial Heart Program aimed at reducing death and disability from heart disease through the development of reliable cardiac assist and total replacement heart systems.

The AbioCor is intended to replace the severely damaged native heart for patients who are not eligible for a transplant and have no other treatment alternative. The AbioCor sustains the body’s circulatory system and is designed to extend the lives of patients who would otherwise die of heart failure, while also offering a probable benefit for a satisfactory quality of life. A post-market study is planned to allow Abiomed to monitor and optimize the introduction of the AbioCor into clinical use.

FDA based approval on the company’s laboratory and animal testing and on a small clinical study of 14 patients conducted by Abiomed. The study showed that the device is safe and has likely benefit for people with severe heart failure whose death is imminent and for whom no alternative treatments are available. In some cases the device extended survival by several months, allowing the patients to spend valuable time with family and friends. In two cases, the device extended survival by 10 and 17 months respectively, and one patient was discharged from the hospital to go home. 

AbioCor will be available under a Humanitarian Use Device (HUD) provisions and will be limited to a patient population in the United States under this approval, with no more than 4,000 patients receiving the technology each year. In order to ensure the highest standards of patient care, Abiomed intends to make the AbioCor available through a controlled roll-out at approximately five to ten heart hospitals in the United States, including qualified clinical trial sites and additional qualified centers once they have completed a comprehensive and rigorous training program which may take six to eight months. Under HDE approval, the FDA may request a panel review of the post-approval study data. 

AbioMed, maker of the Replacement Heart, will reportedly charge $250,000 for the device.

FDA’s approval of the First Implantable Replacement Heart marks the realization of a goal 25 years in the making.

22Aug/06

The impact of IBM’s Acquisition of MRO Software on the Life-Sciences Market

On August 3, 2006 MRO Software announced that it has agreed to be acquired by IBM.

So, what the impact on Life-Sciences Customers? I think this is great news. The combination of MRO’s deep Enterprise and IT Asset Management knowledge and IBM’s strength in integration software and services allows the combined company to provide a complete Asset Management solution to the Life-Science Market. 

The Life-Sciences industry is facing an increased focus on asset utilization stemming from rising healthcare costs and unprecedented economic and socio-political pressures. As a result, companies are seeking ways to consolidate and streamline asset management, both operational and IT-related, to increase asset utilization. The industry is transitioning from a “Maintenance Management” to an “Asset Management” paradigm, including predictive maintenance, increased asset reliability, and condition based monitoring.  

“This is exciting news for MRO Software and for our customers: we can combine expertise, leverage our focus and offer an even more complete and global solution to our customers in the Life Sciences Industry. Technologies as RFID, integration of the different operational systems with an asset-and service management-centric approach fits very well with the Service Oriented Architecture capabilities IBM is offering. Combining industrial, operational and IT assets and related services in a regulated environment will increase efficiency and differentiate the combined offering” commented Eric Luyer, Industry & Solutions Marketing for Life Sciences & Healthcare markets of MRO Software.  

While vendors like ORACLE(IFS), SAP and Infor (DataStream) propose a monolithic approach to Asset Management, MRO Software continues to provide best in class Enterprise Asset Management solutions and leads the Gartner Magic Quadrant.The acquisition by IBM will propel MRO software to fully realize its “Rational Suite” approach the Asset Management while increasing integration capabilities with key Financial and Knowledge Management vendors though IBM’s Software and Services.   

As I mentioned in an earlier article, there is no one size fit’s all when it comes to software. But if you are serious about managing your Industrial and IT assets, Maximo is still your best choice. If you are still unsure, remember the saying, “no one gets fired for hiring IBM”.

02Aug/06

Can I make your pacemaker software run faster?

I recently read an article on the Free Software Foundation’s Website entitled “Regulatory compliance is no reason to lock up users” The author states that “Medical devices are (theoretically) programmed to a high standard of safety, and careless modification could cause great harm. Medical device manufacturers want to Tivo-ize their devices so that only they can upgrade the software on them. They claim that this is necessary for compliance with FDA regulations.”

The FDA gives manufacturers the freedom to choose what software to use in medical devices. But with this freedom comes responsibly. The Agency does not require or favor the use of commercial over free software in medical devices.  However, the Quality System Regulation (21CFR§820) does require that Medical Devices automated with computer software be subject to design controls.

FDA’s Guidance on Software Validation states that “where the software is developed by someone other than the device manufacturer (e.g., off-the-shelf software) …the party with regulatory responsibility (i.e., the device manufacturer) needs to assess the adequacy of the off-the-shelf software developer’s activities and determine what additional efforts are needed to establish that the software is validated for the device manufacturer’s intended use.”

The difficulty with Free Software is that it falls into software quality limbo.  After all there is no vendor to audit, or documented evidence that a quality system exists and was followed in the design and testing of the Free Software.

I know that auditing Off the Shelf Software vendors can be hard enough (I tried to audit Microsoft once), but in general you can perform an audit of your software provider to assess the quality systems they have established and to ensure that they are following their quality system. Whom do you audit for your open source code?

Nevertheless, this does not purge the use of Free Software in devices. It does put the burden for proving and documenting that the software meets the intended squarely on the shoulders of the Device Manufacturer. The level of diligence required for Free Software is not unlike that of Custom Software. The cost of the Open source Software (free) may offset the cost of this additional compliance burden, but that is a business decision each manufacturer must make.

Free Software has a place in our industry. You want to run your HTTP server on Apache, go ahead (after you have assessed the impact on you compliance program), but I would not recommend using open source software in Medical Devices.

Device Software is one area where reliability and safety should always come before speed.

After all making a pacemaker run faster is not always a good thing.

29Jun/06

I Lost the Cure for the Common Cold!

By Daniel R. Matlis 

It’s 3:00 AM and your newborn baby wakes up crying. You want to go back to sleep, but his circadian rhythm is set for Beijing, not Philadelphia, and he is wide awake.So you get a cup of coffee, turn on your laptop and start to do some work. In a moment of inspiration, you discover the cure for the common cold. It’s all there on the screen right in front of your eyes and then your baby kicks, the coffee spills on your laptop and, just like that, the cure is gone. Who do you call?

Monday, at the Corporate Computing Show in NY, I met the people for the job. DriveSavers Data Recovery is a company that recovers data from crashed and damaged media. They have been doing this for over 20 years and when James Bond looses the data in his laptop he doesn’t call Q. Instead he deals with Kelly Chessen, Data Crisis Counselor DriveSavers (Yes, Sean Connery is a client).

With the prospect of irretrievable information loss, many of the callers with whom Chessen deals are as distraught. The emotional trauma associated with the loss of critical data can be disruptive both at work and at home.

Chessen came to DriveSavers with a background in psychology that serves her well in her dealings with often-frantic customers. She worked with a suicide prevention hotline for more than five years, including one year as the manager and trainer. This is exactly the kind of training I want the person on the other end of the line to have under these circumstances.

In addition to the soft skills, DriveSavers has technical skills and facilities to back them up. They have recovered data from drives that have been damaged, dropped, deleted, burnt, crushed and drowned in the Amazon River. The company has a success rate of over 90%, and recovers data in as little as 24 hours from all operating systems and storage media including hard drives, disk arrays, floppies, CD-ROM, DVD, removable cartridges and digital camera media. They have they own calls 100 clean room, and if they work on your drive, the manufacturer’s warranty is still good, although I’m not sure that a drive full of Amazon River water is covered.

So the next time your husband, wife, son, daughter, dog, cat or self spill a cup of coffee on your laptop containing the cure for the common cold, or the therapeutic area you are working on, don’t sweat it, lay on the couch and call the Data Shrink.