Archive for the ‘Medical Device Safety’ Category

Robot Anesthesiologists?

Tuesday, April 19th, 2011

robotic intubationFor anyone contemplating serious surgery, it can be a scary endeavor. From going through it myself and talking to others, I know that the main fear we have going into it is that the surgeon will make a mistake during the surgery, or that we will develop serious complications such as a hematoma, infection, etc. that leads to death or paralysis. While these are very real risks of many forms of surgery, there is another aspect of surgical procedures that gets less attention from patients – the anesthesiologist. While it may get little notice from patients, anesthesiology is a highly complex field of medicine in which doctors (and certified nurse anesthetists) train for years to be able to do it well. This post will focus on just one aspect of anesthesiology known as intubation, and a new development in robotics that may improve the procedure.

What is intubation?

At its most basic, intubation is the process by which the anesthesiologist places a thin plastic tube into the patient’s windpipe to maintain an airway or to facilitate mechanical ventilation. While this is done in a variety of serious medical situations, it is almost always done during major surgery when the patient is under general anesthesia. During such surgery, the patient is rendered unconscious and is unable to breathe on his or her own. Therefore, the anesthesiologist has to essentially breathe for the patient during the surgery, either using a ventilator or sometimes compressing a bag that replaces natural breathing. The process of intubation allows this artificial breathing to take place. Because intubation itself is a painful procedure (remember – a tube is being inserted far down your throat), the patient is usually given paralytic drugs (drugs to induce paralysis) before intubation. This is a key point we’ll come back to later.

Risks of Intubation

While it may sound as simple as sliding a tube down the throat, intubation carries its own risks separate and apart from the risks of anesthesia itself (risks from anesthesia can include death, paralysis, brain damage and a whole host of other less serious injuries). With intubation, there are minor risks such as chipped teeth, lacerations in the gums and sore throat. However, there are many more serious risks as well, including perforation of the trachea, mistakenly placing the tube down the esophagus (a more common occurrence than you might think), aspiration of stomach contents, vocal cord injury, decreased oxygen and elevated carbon dioxide, and nerve injury. Intubation is a serious procedure that requires a high degree of skill and training to do it well and safely.

What if the tube does not get placed properly?

Inability to secure the airway is a major problem in intubation. To understand why, you have to remember that before the tube is placed, the anesthesiologist paralyzes you with drugs. Therefore, before the tube is placed, you stop breathing on your own. It is then critical that the tube be placed quickly and accurately to ensure that you don’t suffer from a lack of oxygen (or ventilation – the exchange of oxygen and carbon dioxide). So what happens when the anesthesiologist has trouble getting the tube in? It just so happens that I have some personal familiarity with that scenario.

A few years ago I had back surgery. The surgery itself was not complex as far as spine surgeries go (it always amazes me how surgeons are able to describe cutting open your back and operating on your spine as casually as they might describe changing a light bulb). It essentially consisted of trimming off a small piece of disc that was pressing on my spinal cord and causing pain to radiate down into my leg and foot.  I was in and out of the hospital the same day, but of course I was under general anesthesia so I had to spend a couple of hours in the Post Anesthesia Recovery Room (PACU) to make sure that I was not suffering from any ill effects of the anesthesia. While waking up, and still groggy, the anesthesiologist walked up to me and said, “I just want to let you know – you were really hard to intubate. If you ever have surgery again, be sure to tell your doctor that you’re really hard to intubate.”

I asked the doctor what he meant by that. He told me that because of the anatomy of my mouth and throat, he had had a really difficult time getting the tube into my airway. Keep in mind, the tube was placed down my throat after I was given drugs to paralyze me. Even in my post-anesthesia addled state, I knew enough to ask the obvious question – what would have happened if he couldn’t have gotten the tube down in time? He was casual in his response. “Oh, we would have given you drugs to wake you back up.” How comforting. My next thought was, “Maybe you could have checked my anatomy out before you gave me paralyzing drugs.” I didn’t ask that because I am sure they did check me pre-operatively.  That is standard procedure before giving anesthesia to make sure that the anesthesiologist knows the patient’s anatomy and can anticipate problems. Apparently, my anatomy was a little more vexing than he had bargained for. However, he was finally able to get the tube in and the surgery went well.

The use of robotics

Because of the ever-present risk of serious complications, researchers are always working on improving intubation to minimize risk. It has always been a hands-on procedure that depended on the skill of the individual performing it. Now we may be moving into a whole new world of intubation thanks to advances in robotics.

Medical News Today is reporting that Dr. Thomas Hemmerling of McGill University and his team have developed a robotic system for intubation that can be operated via remote control. According to Dr. Hemmerling:

The [device] allows us to operate a robotically mounted video-laryngoscope using a joystick from a remote workstation. This robotic system enables the anesthesiologist to insert an endotracheal tube safely into the patient’s trachea with precision.

The system is still in development. It has been widely tested with mannequins that mimic human anatomy, and clinical testing on patients has now begun. Dr. Hemmerling hopes that the new device will allow anesthesiologists to intubate patients using less force and higher precision, which should help to improve patient safety. Even with the use of robotics, I would think that intubation, including pre-operative assessment of individual anatomy, is going to require close hands-on involvement in order to ensure that it is done safely and properly, but it is always exciting to see what was once science fiction being used in real-life surgeries.

What you can do

While robotic anesthesiology is still down the road for most of us, there are still things you can do to minimize your risk of injury. Before agreeing to surgery, most of us do a good job of vetting our surgeon – how experienced he or she is, how many similar procedures he or she has performed. How many times have you heard a friend describe his or her surgeon as “the best?” Yet virtually no one who has been a patient – at least in my experience – makes any inquiry into the experience level of the anesthesiologist, even though a mistake by this person can render you paralyzed or brain-dead (or even dead) in a matter of minutes.

If you are planning on undergoing serious surgery, I would encourage you to discuss the anesthesia care with your surgeon. Find out ahead of time who your anesthesiologist is going to be (if that’s possible), and discuss your situation with that person. No doubt you will be evaluated by the anesthesiology team before your surgery, but it may well be the same day as your surgery, and it will feel like just another routine matter like signing a few forms. Keep in mind, however, that anesthesiology is just as important as the surgery itself. Stay informed and ask questions. Treat your pre-operative session with the anesthesiologist as if your life and health were depending on it – it just may!

And as for robotics, I’m curious what your comfort level would be if your doctor suggested using a robot to intubate you? Would you be willing to try the procedure, or would you prefer the traditional hands-on, human approach?

Image from “Today’s Medical Developments”

Medical Technology and Patient Safety – Part II – EMR’s (electronic medical records)

Saturday, April 9th, 2011

Let’s begin the discussion about whether or not medical technology is truly advancing the efficient and safe delivery of patient care with the topic of electronic medical records (EMR’s). Much has already been written on this subject; however, a recap of some of the arguments being made – pro and con – for EMR’s will set the stage for what I believe is the major problem with this technological advance.

If you have ever had to review old-fashioned hand-written records relating to a patient’s care, which I’ve been doing now for almost four decades, you were thrilled – at least initially - when you heard about the advent of this new, eye-strain-saving project. Not only was I counting on cutting down the number of times I would have to increase the strength of my prescription eyeglasses, I figured I might now be able to actually read what the healthcare provider learned by history, found on examination, thought was the more likely diagnoses causing the patient’s presenting complaint and what the doctor’s plans were to address the medical problem confronting that healthcare provider. What a bonus! No more guessing! Too good to be true?

Now with EMR’s, when you request medical records from a healthcare provider, you could expect to receive – presumably with the push of a “print” button, not papyrus-like records filled with hieroglyphics, but a formatted, easily readable comprehensive rendition of what happened in the course of patient care. Well, not so fast, I quickly learned.

With the arrival of EMR’s, I became mired in a world of radio buttons, drop down menus, cryptic narratives that didn’t really match the fill-in-the-blanks charting, and a world of metadata to find out the story-behind-the-story (like who accessed the EMR, what they were looking at and when they saw it).

Now let’s be real – I sincerely doubt that the medical profession and the computer and software vendors had lawyers in mind when they created and rolled-out this new marvel. As the medical profession is so quick to point out to us lawyers, lawyers are not the ones in the trenches trying to make people better and save lives. We’re the bottom feeders (oh yeah – that’s their description so many times), who do nothing but second guess for our personal monetary gain the medical community’s valiant efforts. That discussion is for another day!

Turns out, however, that it is not only my kind screaming about how this modern medical technology has flaw upon flaw associated with it; the medical profession has serious, second thoughts about just how wonderful EMR’s are.

The Concepts Behind EMR’s

Just do a search in your favorite search engine on the topic of EMR’s – add the word “controversy” or get really ingenious and pose the question: “What are the pro’s and con’s of EMR’s?” While you’re combing through page after page of search results, take note of who is writing about why EMR’s are not the next best thing to sliced bread. I’ll save you the task; it’s the medical profession. That’s right, the very people who hailed the advent of EMR’s and extolled the many intended virtues of this technology.

The Pro’s of EMR’s:

Here are some of intended benefits of EMR’s:

  • improve the quality of patient healthcare through instant, universal access to patient data (at the click of a mouse or push of a button)
  • avoid, if not eradicate, the “unreadability” (interpretation: I can’t read your handwriting; what are you telling me?) of hand-written chart entries.
  • improve patient safety through better detection of adverse events. The intended goal is premised on EMR’s having a central database of patient information, decision-making, outcomes (including adverse events) and other key epidemiological data available and accessible for analysis.
  • enhanced quality of care through immediate access of all pertinent patient information (e.g. testing, radiological studies, medications, vital signs, laboratory studies, etc.) so that caregivers can make better, faster and more informed decisions about continuing plans of care.
  • making healthcare more cost efficient by reducing unnecessary redundancy of testing (due to inability to locate prior paper-based information), digital access to key points of patient data rather than the waste incurred through manual search of past records from various healthcare provider sources, copying, faxing, etc.
  • keeping records safe: with proper digital storage measures, there can be avoidance of destruction, misplacement and the like.
  • overcoming inaccurate past medical history (PMH) information since care providers would have access to a patient’s “true and accurate” medical history by accessing stored medical data. Healthcare providers would no longer be relying on ofttimes faulty patient memory of PMH.
  • improved coordination and information exchange between healthcare providers. Studies have shown that the communication and transfer of information between primary care physicians and hospital-based physicians has been less than optimal.
  • improved, accessible and faster surveillance capabilities for wide scale events such as epidemics, catastrophic natural disasters (e.g. Katrina) and even bioterrorism.

I have absolutely no doubt that there are a host of other EMR pro’s. Yet even though the concept of EMR’s has apparently been the topic of discussion for about forty years and there are so many potential benefits inherent in their use, one must wonder – why did it take so long to implement EMR’s and why are they not being fervently embraced throughout the medical profession?

Some Con’s

As with many great modern marvels, once the allure of the new toy wears-off and implementation begins, some of the flaws begin to surface. ERM’s clearly have their share of warts.

  • privacy concerns – do EMR’s have the ability to turn the sacrosanct confidential communications between physician and patient on their ear? Some scream a resounding “yes.” Some have expressed deep-seated concerns that such accessible data will be used against a patient when they apply for jobs, health insurance, or – I’ve seen said – even a college scholarship. The potential inclusion of genetic data in EMR’s and the accessibility by researchers or others who don’t fit the need-to-know category also has privacy advocates screaming “foul.”
  • loss of the benefit of provider narratives (which were the norm in hand-written charts) so as to better appreciate the subtleties and thought processes of medical care. It is often said that medicine is an art, not a science. The ability to appreciate the art of medicine, some fear, has been lost when all that you can glean is pre-formatted information from drop-down menus and radio buttons. There’s no longer an ability to appreciate the true thinking process of the caregiver. Some refer to these problems as blind and meaningless use of short-cuts, templates and pre-fills, which don’t allow subsequent caregivers relying on EMR charts to get a true and accurate picture of a prior caregiver’s true thoughts. Apparently, quicker and easier input does not always translate into better or more accurate information.

Think I’m making this one up? Here’s what one internist at Harvard Medical School had to say about EMR’s:

Harvard Medical School internist and entrepreneur Dr. Rushika Fernandopulle says that many EMRs are designed to improve coding and maximize reimbursements, often at the expense of clinician functionality. “When you’re trying to read the notes of your colleague [in an EMR], it’s almost impossible to figure out what happened to the patient,” Fernandopulle tells the Journal. “You have to read through two pages of all this junk that’s put in to increase billing.”

  • Notwithstanding the claims of EMR advocates, many in healthcare and related fields firmly believe that EMR’s are not safe and secure. They point out that despite encryption and restricted access through log-in’s via usernames and passwords, there are numerous and disturbing instances of hackers gaining access to private patient information.

• November 26, 2007, Canada. Hackers accessed medical information on HIV and hepatitis from a Canadian health agency computer.
• September 22, 2008, UK. The National Health Service (NHS) reported the loss of 4 CDs in the mail containing information on 17,990 employees.
• September 30, 2008, US. The company Blue Cross and Blue Shield of Louisiana confirmed breach of personal data, including Social Security numbers, phone numbers and addresses of about 1,700 brokers. The data was accidentally attached to a general email.

(source: The HWN Team @ HealthWorldNet.com)

  • computer-driven healthcare is potentially hazardous to one’s health. Rather than paraphrase, let me share one comment I found on a blog extolling the virtues of EMR’s:

Try telling that to a computer: I am on medication that I take every three days. So, a normal 30 day supply last[s] me 90 days. However, the computer at my pharmacy automatically renews the prescription and I get a phone call every month asking me to come pick it up. I now have a year’s worth of pills on hand and they’ll expire before I can take them (which means I should not take them as they may not be effective). So, I called on Friday to tell them that I wanted to opt out of the system. The nice person informed me that I had been removed from the system. 9:01 AM Today (Monday) I got a call, telling me that my prescription is ready to be picked up. This is what happens when people cede thinking and into the ‘computer said it so it must be true’ mindset that we’ve all experienced from time to time to maddening effect.

  • way too much information, a lot of which is purely redundant and distracting. From my perspective as a lawyer, this is a major problem with EMR’s. A click of a radio button or a selection from a drop-down menu often generates duplicate entry data in a host of other fields across the system. As you try working your way through the jungle of screens or paper generated by EMR’s, you say to yourself, “Didn’t I just read that same thing somewhere else?” Now put yourself in the shoes of a healthcare provider. You have a number of patients to see, orders to give, reports on patients to share, calls from your pager to answer – and all you want to know when checking a patient’s EMR is some key information so you can do what needs to be done and move on. What do you find? More information than your ever wanted or needed and at times conflicting information. Frustration mounts and you yearn for the days of color-coded, hand-written charts.
  • How fast can you type? Simple but real issue for apparently many in the medical profession. EMR’s are meant to save time – perhaps not!
  • How fast do the records load? Some have become frustrated when using internet portals for records with very slow loading time of EMR’s when using over-utilized internet connections during peak usage hours.
  • those developing the EMR software failed to consult with practitioners before rolling out their product leading to templates, care strategies and selection choices that have no practical use for actual caregivers.

Just as is the case with the pro’s, there are many more con’s being voiced throughout the internet by medical care providers. That being said, I am of the firm belief that one of the biggest flaws is the manner in which EMR’s were and continue to be implemented – rolled out for use – in our medical institutions and physician offices. This can range from lack of training, lack of quality control, lack of system-wide coordination – you name it. In the rush to purchase, upload and put in use EMR’s, too little thought seems to have been given too many times to such projects before implementation. After the implementation, many problems started to rear their ugly heads.

Here are but a few examples of poor implementation voiced by a nurse, Kaye, in a comment she posted to the first installment of this series. Make sure to take particular note of Kaye’s fourth point!

1. Facilities are not getting input from the potential users before purchasing. Cost and JC compliance is more important than usability. “Here is your new system. Make it work.”
2. Seasoned nurses and ancillary staff are not given the considerations derserving of the huge technological changes. It’s a whole other language. A COW (Computer On Wheels) stands in the field.
3. A culture clash has developed between nursing and the IT department who cannot appreciate the urgency of correcting problems.
4. At my facility, there are 3 different systems. They don’t ‘talk’ to each other. Whose idea was that?

I could go on; but you get the point.

In my next installment, I will share with you with more real-life examples of just how misleading, inaccurate and unsafe EMR’s can be. Just to give you a tease – how about the case of a woman who was paralyzed following an epidural for labor and post-childbirth pain relief. Hours after she was diagnosed by a neurologist as having suffered injury to her spinal cord leaving her with significant, devastating motor deficits and sensory loss, she was noted by a nurse in the EMR to be “ambulating [i.e. walking] x 2″? I wonder if that would have happened if the nurse had to hand-write that entry and not just click on a drop down menu choice. There will be plenty more examples of such just how effective and safe EMR’s have turned out to be. Stay tuned and tune in to Part III coming next week.

Related Posts: Medical Technology and Patient Safety: EMR’s, COW’s, iPads, etc. – are they really doing the job? Part I.

 

The Week in Review: did you miss last week’s posts on health, safety, medicine, law and healthcare?

Sunday, April 3rd, 2011

Last week we launched the first in a series called The Week in Review. We hope you enjoy this project as a way to catch-up on what  you may have missed in the world of health, medicine, patient safety, law and healthcare. Now for our second installment.

 

Yesterday is history. Tomorrow is a mystery. And today? Today is a gift. That’s why we call it the present.”

Inspirational  Quote from Babatunde Olatunji


 

We started the week with Part I in a series of posts intending to explore the issue of whether the ever-growing and expanding advances in medical technology are really accomplishing their goal – or what should be their goal: more efficient, effective and safe delivery of medical care.

The author, Brian Nash, poses the question, “What has technology done to improve healthcare?” Answering in part his own question, he states:

The answer, in short, is – some amazing things and some not so amazing things have taken place in terms of technological advances in healthcare. Unfortunately, as we will explore in this series, some of these technological advances have led to some catastrophic results for patients. One need look no further than how the medical institutions rushed to implement the newest, shiniest and “best” radiology machines and through their haste left in their wake scores of maimed and dead patients.

Read more – Medical Technology and Patient Safety: EMR’s, COW’s, iPads, etc – are they really doing the job?

 

Wednesday’s post by Sarah Keogh explored an often discussed but apparently not always heeded message about car seat safety. Sarah offers some “tips” and suggestions on how to implement simple safety steps to decrease the likelihood of injuries to children while in our cars. She reported -

A recent article on healthychildren.org says that deaths in motor vehicle crashes are still the leading cause of death for young children.

Don’t let this message go unheeded. These are not Sarah’s “tips and tricks” but those of experts in the field of child safety.

Read Sarah’s piece – 4 Tips for Car Seat Safety.

 

The end of last week brought an “interesting” piece by Mike Sanders, also a lawyer with our firm, concerning a so-called study suggesting a possible link between religious activity and obesity. This wasn’t – Mike is quick to point out – a “theory” of his. This was a posting he saw and just couldn’t stop himself from writing about.

While I am usually reluctant to belittle medical research, this study really has me scratching my head and asking, “Who cares?” Before anyone decides to skip church this weekend, let’s look at the details of the study.

Makes one wonder what it takes in today’s world of instant news, internet publishing and blog posting (hmmm), to “get published” as a study.

Read Mike’s piece entitled Can Religion Make You Fat?

The Week Ahead

This coming week will have among its postings Part II in the series about Medical Technology and whether it is doing its job of advancing the safe delivery of healthcare to our population. We’ll start with a topic that is near and dear to all in the healthcare industry – EMR’s – better known as Electronic Medical Records. Sounds like a good idea – right? Since we live in a world of computers, radio buttons and drop down boxes and way too many of us in the field of medical malpractice litigation have made too many visits to the eye doctor from having to reading hand-written medical charts – why wouldn’t this be the next best thing to sliced bread? Well – read Part II coming this week.

We also plan on posting some information and analysis of a medical/anesthesia procedure – the epidural – that thousands of women have every day of every week throughout this country and the world. Well, are they really as safe as some would have you believe? Stay tuned and read our upcoming post.

There are likely to be even more goodies on health, law, patient safety and healthcare in next week’s The Eye Opener from Nash & Associates.

 


Medical Technology and Patient Safety: EMR’s, COW’s, iPads, etc. – are they really doing the job? Blog Series – Part I

Monday, March 28th, 2011

Medical Technology - source: Siemens.com

This is the first installment of a series of posts on issues relating to new advances in medical technology and how they may affect patient health and safety – not always for the good. Unless you live in a cave or just don’t care, you must have noticed news reports about how the medical industry is awash in the creation and implementation of new technologies. Presumably these new medical tech toys and gadgets are intended to advance the timely, enhanced, cost-effective delivery of healthcare with the end point being improved patient care and patient safety. The question is – do they always do that or can they, in fact, be tools the lead to patient injuries and – at times -even death?

I recently came across a posting by Dr. William L. Roper, MPH, CEO of the University of North Carolina Health Care System, which was in essence a transcript of a speech he gave at the Agency for Healthcare Research and Quality (AHRQ) in Washington, D.C. on March 23, 2011. Among his other vast accomplishments, in the spring of 1986, he was nominated by President Reagan and confirmed by the Senate for the position of administrator of the federal Health Care Financing Administration, with responsibility for the Medicare and Medicaid programs nationally. For the previous three years, he served on the White House domestic policy staff.

I bring Dr. Roper’s recent remarks to your attention since they are the inspiration for this series of blogs. While Dr. Roper’s address did not specifically address topics such as EMR’s, COW’s (still wondering how a cow fits into this topic? Stay tuned!), and the like, the following selected excerpts are the seeds of thought for the present series:

I have the job of leading an academic medical enterprise, and am challenged by the task of putting lofty ideas into practice at the local level. I remain very committed to the effort, but we are daily challenged to put the best ideas into practice.

The Institute of Medicine, under Sam Their’s and then Ken Shine’s leadership, played a very important role across the decade of the 1990s, defining “quality” in health care, and pointing to problems in quality and patient safety. Bill Richardson led a multi-year IOM initiative that included the groundbreaking report, To Err is Human in 2000, and then Crossing the Quality Chasm in 2001.

These reports were a clarion call for action – especially making the point that a systems approach was required to deal effectively with these issues.

While Dr. Roper’s speech was, in large part, an historical analysis of progress in the Medicare healthcare delivery system, it is also a well-versed commentary on the so-called advances in medicine for patient care and safety. Why else have so many toiled for so long in trying to find system-failures and methodologies for eradicating those failures and thereby improving the delivery of safe, efficient and effective healthcare?

Dr. Roper and so many other dedicated healthcare professionals are faced daily with the same issue – “…challenged by the task of putting lofty ideas into practice at the local level . . . [W]e are daily challenged to put the best ideas into practice.” Put another way – at least for me – taking public healthcare policy and practices and making a better widget.

As these lofty concepts were debated, published and analyzed, technology streaked along with its new bells and whistles at what some might call an amazing – almost mystifying – pace. Did you really envision yourself 25 years ago sitting with your iPhone or iPad and scouring the world’s news, chatting with your friends and followers on the other side of the planet, watching the latest streaming video of March Madness or sharing every random thought you have on Twitter or Facebook?

What has technology done to improve healthcare?

The answer, in short, is – some amazing things and some not so amazing things have taken place in terms of technological advances in healthcare. Unfortunately, as we will explore in this series, some of these technological advances have led to some catastrophic results for patients. One need look no further than how the medical institutions rushed to implement the newest, shiniest and “best” radiology machines and through their haste left in their wake scores of maimed and dead patients. We reported on this investigation by NY Times reporter, Walt Bogdanich  in Eye Opener, over a year ago.

Just over the course of the last year or so, our firm has been involved in case after case in which this issue of medical technology and patient care/safety keeps rearing its ugly and devastating head. We will share with you (leaving identifying information obscured as we are required to do) tales of just how medical technology can impact – positively and (unfortunately) negatively patient health and safety. We’ll analyze and discuss our views on just how well medical technology and its implementation (more the latter) have, in our view, negatively impacted – all too often – patient health and safety. We invite you to follow along as we consider the good, the bad and the ugly of medical technology such as EMR’s, COW’s, iPads and the like. Please join us and share your comments along the way.

Some related posts to get you started:

The Radiation Boom – Radiation Offers New Cures and Ways to Do Harm

FDA Unveils Initiative To Reduce Unnecessary Radiation Exposure from Medical Imaging

At Hearing on Radiation, Calls for Better Oversight

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

The Story of How a New York Times Reporter – Walt Bogdanich – Has Made a Real Difference in Medical Device Radiation Safety

New Microchip Promises to Make Life Much Easier for Paraplegic Patients

Friday, February 11th, 2011

Hope for those with paraplegia?

Researchers in the U.K. have developed a revolutionary microchip muscle stimulator that will enable patients with paraplegia to exercise multiple muscles at the same time. According to the Engineering and Physical Sciences Research Council (EPSRC), the microchip developed by Professor Andreas Demosthenous from University College of London and his team is truly unique.

The microchip chip is small enough (approximately the size of a child’s fingernail) that it can be implanted directly into the spinal canal. Unlike previous models, the new implant incorporates the muscle stimulator and the electrodes into a singular unit.  The unit is properly sealed to protect against moisture, which could lead to corrosion of the electrodes.

The creation of the implant has been made possible by new laser processing technology, which enabled researchers to micro-pack all components into one unit. With this new laser technology, researchers were able to cut much tinier electrodes from platinum. The electrodes are then folded into a 3D shape that resembles pages in a book. Each electrode can be wrapped around a nerve root. The electrode is then welded to the microchip located in the spinal cavity.

Because the implant comes with multiple electrodes, which can be connected to multiple nerve roots, it is capable of controlling entire muscle groups. In patients with paraplegia, the devise can be used to stimulate or trigger multiple paralyzed muscles at the same time. Researchers also claim that the new device will also be used in patients with bladder or bowel incontinence.  Because the device has multiple electrodes, some electrodes can be connected to nerve roots that control bladder muscles or nerves that control bowel capacity.

Although all of this may sound a bit scifi, the implant will be available for pilot studies sometime this year. If you or someone you know is paraplegic, this research is worth following. It clearly promises to offer life-chaining benefits to patients with paraplegia. If you know of other research on similar devices, we’d love for you to share that information with our readers. We’ll try to keep an eye on the progress and implementation of this device from the UK and keep you posted if and when developments occur.

FDA Commissioner Hamburg’s Report Card: NEJM provides a “perspective.”

Friday, October 15th, 2010

On October 6, 2010, The New England Journal of Medicine published a well written “perspective” on FDA Commissioner Dr. Margaret Hamburg’s efforts to “revive the FDA.” Her principal deputy commissioner, Dr. Joshua Sharfstein, echoed the same sentiment: “I keep a list of things I wish were moving faster and  a list of things moving at just the right speed, and these nothing on the second list.” (emphasis added). Dr. Hamburg is just completing her first year as commissioner at the FDA. We can only hope she remains and stays steadfast to the goals and objectives she has set out to achieve.

Since the NEJM is a subscription journal, I’m not sure if you will be able to access the full article, but I certainly hope you can.

Of significance for those of us who deal with FDA’s actions on virtually a daily basis, Commissioner Hamburg’s first quoted comment is of particular interest: ““You feel it differently at the FDA — how long it takes to move things through the system.” Welcome to bureaucracy at its finest, Commissioner.

What Commissioner Hamburg has done, however, deserves a lot of credit – at least in my non-politically based opinion.

Her objectives are listed by the NEJM article as being making “the FDA more nimble and proactive, restoring its credibility and refocusing staff on its public health mission, persuading Congress to boost funding for its expanding portfolio of responsibilities [and] sharpening its ability to deal with new science and globalization.” A very healthy list in all senses of the word.

Here is a list of just some of the actions taken and projects underway:

  • major recalls of over-the-counter pediatric medications
  • major recalls of salmonella-contaminated eggs
  • engaging in major debates over direct-to-consumer genetic testing
  • addressing safety concerns over the “blockbuster” diabetes drug, rosiglitzone
  • implementation of a 2009 law making the FDA responsible for tobacco regulation
  • making food-package labeling more evidence based
  • launching initiatives to “clarify and standardize” processes for evaluation drugs and medical devices
  • making more information public

As far as dealing with the issue of bureaucratic lethargy, Hamburg, Sharfstein and other key people at the FDA have created a new process known as “risk control review.” Under this program, field inspectors, who had previously been required to simply file reports that would eventually wend their way through the bureaucratic maze, when they detect “urgent health threats,” can now initiate direct meetings with key agency personnel to discuss taking emergency action. As a result of another initiative, an agency food-safety registry, in the first seven months of Hamburg’s leadership, more than 100 food-safety reports were submitted.

For those familiar with how the FDA worked, it is common knowledge that regulators of drugs and medical devices have been under pressure to approve them quickly. In response to criticisms of this so-called approval process, Dr. Hamburg and her staff have created an internal task force to review the way such decisions are being made at the Center for Drug Evaluation and Research (CDER). This approval process, called the 510(k) clearance process, was first met with outright dissent. After a “scathing internal FDA review” identified some of the major problems with the former way of doing business, officials at CDER adopted some of the recommended reforms – hopefully leading to “a clearer, fairer decision-making process.” Another IOM panel report is due next year; it is anticipated that further reforms in such process will be recommended.

Dr. Hamburg’s mantra has been – “follow the science.” Her response to the questions from her people at FDA in terms of what they can do about concerns of immediate public health safety is reported as being – “What do you think the right thing to do is from a public health perspective?” Seems like the Commissioner is a good listener and a pro-active responder.

Needless to say, Dr. Hamburg’s activities could well fill pages of text. She faces issues relating to globalization (ensuring products made overseas and entering our marketplace are safe), funding for her agency (a never-ending task seeking dollars for her projects and people in a seemingly pitiful federal budget), improvement of post-marketing safety studies, implementing and overseeing a data-mining system used to analyze electronic safety records (Harvard Pilgrim Health Care’s Sentinel System) to improve numerous aspects of patient safety, and forging key partnerships with private industry and academia scientists to “get it right” – to name just some of the projects for which her agency is responsible.

All one can say – thank goodness the Doctor is in the house! We wish her continued strength, patience, perseverance and success.