What’s More Sterile: the Band-Aid on Your Paper cut or Cardioplegia?

By Daniel R. Matlis

It’s a trick question. Technically both should be sterile. 

But you would think that cardioplegia, the solution used to stop the heart during bypass surgery, would be more stringently tested since it is infused directly into the heart.

According to a recent USA Today article, at least 11 cardiac surgery patients were stricken with an infection during a 10-month period from the end of December 2004 to September 2005, and three of them died at Mary Washington Hospital.  After a thorough investigation, tests confirmed the presence of several types of bacteria in the cardioplegia solution injected into patients’ hearts during surgery. 

I can already hear the cry from the trial lawyers: “Which Pharmaceutical Do We Go After? 

The answer? None, the reason is that the products leaving the Pharmaceutical companies were perfectly safe and sterile, but some drugs, including high-risk sterile preparations, are made in pharmacies under less-restrictive rules than those that drug companies follow.  Almost all hospital pharmacies do some type of drug making, called compounding. Pharmacist duties may range from low-risk procedures, such as grinding tablets to put them into liquid suspension, to high-risk work, such as making sterile treatments from scratch. 

I’m in favor of compounding, and cannot thank Andrew, my local pharmacist, enough for compounding prescriptions when my kids need them. Try to get a 3 year old to swallow an adult size tablet. It goes much smoother when it is ground and suspended in strawberry flavored syrup.

But there is a big difference between grinding tablets and preparing a sterile solution to be injected into the heart.  This is not an issue of qualifications, but one of oversight and facilities. Hospital pharmacies are regulated by each state, and the frequency and thoroughness of state inspections vary widely. The FDA’s role in oversight is hampered by questions of jurisdiction over what’s generally state matter. To make matters worse, in most states hospitals are not required to test the sterility or potency of products made in their own pharmacies or purchased from outside pharmacies.  So while a drug company could not sell saline solution without testing sterility, hospital pharmacies and their suppliers are not required to test for it. 

I am not a big proponent of government regulations, but this is a case of public safety and the proverbial “what’s good for the goose is good for the gander” theory of enforcement.  Having 50 different state statues regulating sterility and potency requirements for drugs is impractical, when the FDA has the mandate, know-how and capabilities to regulate them.  If hospital pharmacies and suppliers want to continue manufacturing sterile solutions, they ought to be held to the same standards as the Sesame Street Band-Aid I put on my kid’s “boo-boo”. 


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”.


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.


Doctors Don’t Treat Populations, They Treat Individual Patients

This week, Scott Gottlieb, MD Deputy Commissioner for Medical and Scientific Affairs at the Food and Drug Administration made an interesting speech before the 2006 Conference on Adaptive Trial Design in Washington, DC.Dr Gotlieb commented how today’s clinical trials are highly empirical. Drugs are tested on general populations for a response and a treatment effect that is statistically not likely to be a chance result. This approach is rigorous and focused, but inflexible. According to Dr. Gotlieb, “another problem with the empirical approach is that it yields statistical information about how large populations with the same or similar conditions are likely to respond to a treatment. But doctors don’t treat populations, they treat individual patients. Doctors need information about the characteristics that predict which patients are more likely to respond well, or suffer certain side effect. The empirical approach doesn’t tell doctors how to personalize their care to their individual patients.” This results in a highly empirical approach to the practice of medicine. Gone are the days of: Take two off these and call me in the morning. Gottlieb comments “Doctors prescribe treatments knowing full well that only a certain percentage of their patients will receive a benefit from any given medicine.” This approach is akin to: Take all of these and call me if you have a side-effect. 

But with the demands for personalized medicine and the advent of Pharmaco-genomics, there are potentially better alternatives. By enabling more trials to be adapted based on knowledge about gene and protein markers or patient characteristics, we can help predict whether patients will respond well to a new medicine. “These new approaches to clinical trials can result in trial designs that tell us more about safety and benefits of drugs, in potentially shorter time frames, exposing fewer people to experimental treatments, and resulting in clinical trials that may not only be more efficient but are more attractive to patients and their physicians to enroll in.” said Gottlieb. This is only a first step in the process to develop more adaptive clinical trials. This process will lead to more targeted therapies and in turn, Ii is my hope, more personal and personalized medicine.


"Medicine is for the People, not for the Profits."

During my senior year, I was lucky to have a few job offers to evaluate. The top two were from Johnson & Johnson and Exxon. As part of my research I looked at how each company handled adversity. For me it was an easy choice when I compared J&J’s handling of the Tylenol situation vs. Exxon’s Valdez.  I was drawn by the impact I could make in people’s lives and by the industry’s reputation in general and J&J’s in particular.

But in recent years, our industry has gone though some tough times. We’ve have seen record FDA fines, product recalls and withdrawals as well as the erosion of consumer confidence.  In my opinion executives at some Life-Science companies lost focus on the patient and began to concentrate on profits for Wall Street.

It is in times like these that we must reach for our roots and reflect on the legacy left by our industry’s founders.

In the August 1952 Time magazine interview, George W. Merck said “Medicine is for people, not for profits.” He went on “…if we remembered that, the profits have never failed to appear. The better we remembered, the larger they have been.”

In 1943 General Robert Wood Johnson wrote: “We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services.” This Credo is still etched in stone at the J&J world Headquarters.
In 1899 Charles Pfizer said, “Our goal, has been and continues to be the same: to find a way to produce the highest-quality products and to perfect the most efficient way to accomplish this, in order to serve our customers. This company has built itself on its reputation and its dedication to these standards, and if we are to celebrate another 50 years, we must always be aware that quality is the keystone.”

In this post Sarbanes-Oxley era, I am heartened to see that our industry is once again putting patients first.

Let us remember to chase after the cures for human ailments, then and only then will fair profits follow.