HemoDoc, From Doctor to Patient

NxStage Aluminum Contamination: Is Rockwell Medical Inc. at Fault?

By Peter Laird, MD

On May 14, 2014, NxStage Medical Inc. issued a voluntary FDA recall of 140,000 to 150,000 concentrated dialysate SAKs from elevated levels of Aluminum in lots manufactured from April 2013 to February 2014. NxStage produces the only FDA approved portable home dialysis machine and is a popular choice for many patients who wish to maintain an active and independent lifestyle.

To date, NxStage has not revealed details on how this significant failure occurred. I recently discussed the aluminum event with a high ranking NxStage officer who stated that they are constrained by FDA regulatory provisions that prohibit full disclosure until the FDA investigation is complete.

NxStage outsources all of their lactated dialysate products to two companies, PiSA, the largest pharmaceutical group in Mexico and Rockwell Medical Inc. which signed an agreement with NxStage on March 8, 2013 to produce concentrated dialysate. Shortly after this agreement, the first contaminated lots of concentrated dialysate contaminated with high levels of aluminum appeared in April 2013. Many patients allege that Rockwell new to the NxStage lactated dialysate manufacturing process is the likely source of the contaminated concentrates.

Rockwell Medical Inc. produces mainly bicarbonate dialysate in competition with Fresenius dialysis products for the American dialysis market. Incorporated in 1995, my review of  Rockwell public records reveals that this company has limited experience with lactate dialysis products which are produced in a  complex process through fermentation.

The largest producer of lactate products in the world is Purac which has exceptionally low tolerances for aluminum and heavy metals. Purac manufactures pharmaceutical grade lactate with a max tolerance of 0.1 ppm (0.11 mcg/L) and is considered the gold standard producer of lactate products through out the entire world. In an extensive review of NxStage, Rockwell and PiSA public records, none of these documents listed the source of their lactate products, nor could I find direct agreements in public records with Purac. In addition, Rockwell has not responded to date to my queries for comments on this event.

While NxStage will not confirm that Rockwell is the producer of the tainted product, circumstantial evidence points directly to Rockwell as the source. 

Should the FDA investigation conclude that Rockwell Medical is the source of the NxStage Aluminum contamination, investor relations may suffer in light of what many consider a solid future for this company nearing completion of a New Drug Application for their iron dialysate product, Triferic.  It would also mark continued safety and quality concerns that has haunted Rockwell over the last several years.

In 2008,  state inspectors at a South Carolina Rockwell plant found major safety and manufacturing violations in follow up to multiple customer complaints. (here) In 2009, thousands of cases of shipped dialysate was recalled after finding excessive levels of bacterial growth. (here and here)

In 2012, Dr. Richard Yocum,  a former Rockwell senior vice president in charge of Rockwell's Triferic research alleged SEC reporting violations and fraudulant claims for their drug in development in a wrongful termination lawsuit. (here)  Triferic is expected to soon enter an annual 700 million market for iron replacement. Although Rockwell prevailed in this lawsuit, the judge limited his ruling to the narrow question of whether Rockwell had the right to terminate Dr. Yocum's "at will" employment. (here) A private law firm initiated a secondary investigation into these allegations in 2013. (here) 

With the ready availability of high grade, ultra-pure lactate products from Purac with levels at a fraction of those found in the NxStage lactate concentrated dialysate, the ensuing FDA investigation needs to uncover all of the details of this preventable event. However, should Rockwell Medical Inc. become the focus of this active FDA investigation, many will rightly, I believe, question their dedication to quality products.

In light of the impending FDA approval of Triferic after exhuberant results in their recent PRIME study, I myself will take the advice of a trusted colleague who once told me, don't be the first doctor to prescribe a new drug, nor the last. Until we have extensive evidence from Triferic's post marketing results assuming it will soon be approved, I certainly will not be one of the first patients seeking this companies new drugs.

CMS and Home Hemodialysis: The Story of 40 Years of Neglect

By Peter Laird, MD

The 1973 ESRD Program began with an aura of hope and expectation of ending the suffering of countless renal patients ravaged by a disease that had only recently been a certain death sentence by slow and protracted suffering.  The "nobel experiment" which came to life by the serendipitous invention of a simple shunt became a Federally funded entitlement program literally by the stroke of a pen.

End Stage Renal Disease Program

In 1972 the United States Congress passed legislation authorizing the End Stage Renal Disease Program (ESRD) under Medicare. Section 299I of Public Law 92-603, passed on October 30, 1972, extended Medicare coverage to Americans if they had stage five chronic kidney disease (CKD) and were otherwise qualified under Medicare's work history requirements. The program's launch was July 1, 1973. 

At the start of the ESRD Program, the National Dialysis Registry data shows that on January 1, 1972 40.2% (2,001) of 4,981 patients were on home dialysis - HHD + PD - there were only 25 PD patients at home. 

On January 1, 1974 the figure was 33.0% (3,402) of 10,306 patients  were on home dialysis including 59 PD patients at home.

The politics of home hemodialysis then sadly began in earnest. The pioneers of dialysis developed home treatments to augment the few available hospital based dialysis machines to expand the number of patients that they could treat effectively. Home hemodialysis treatments were significantly cheaper than the in-center treatments by nearly a third in the early days of the ESRD program. 

NBC Commentator Dr. Arthur Caplan Calls Dialysis Cruel and Lousy Care

Data supplied by Richard Rettig,(page 3) a Rand Corporation scholar, shows that in 1972, in-center dialysis costs were between $27,600 - $30,500 while at the same time home dialysis costs were only $14,900 for the first year of therapy and only $7000 for each year there after.

The true tipping point between acceptance of home hemodialysis vs. in-center treatments came in the 1978 congressional hearings prompted by escalating costs of the ESRD Program. At that time, Edmund G. Lowrie, Vice President of National Medical Care, Inc., promoted a false understanding of the costs and effectiveness of home hemodialysis that Dr. Chris Blagg was unable to overcome in his testimony which fell on the deaf ears of those who refused to hear the true story.

The politics of health cost containment: end-stage renal disease

R.A. Rettig (pages 132-133)

Dr. Edmund Lowrie of Peter Brent Brigham Hospital attacked the Seattle experience directly on two points: "our analysis indicates that the cost of self-care dialysis is not significatly less than limited care dialysis, and that the the indiscriminate use of home dialysis may lead to unacceptable patient mortality." . . . "After careful analysis," Lowrie claimed, "the only obvious reason for this inferior patient survival that we can think of is the indiscriminate use of home dialysis therapy." Lowrie's testimony created the impression that three-year survival of home patients in Seattle was unacceptably low. But as Blagg later pointed out, the 58% applied to all Seattle patients, center and home, and inclued elderly and diabetics insignificant numbers."When we look at patient survival on home dialysis," Blagg wrote, "and exlude the center dialysis patients, the 3-year survival in our program is 74 percent including diabetics; if we exlude diabetics, the 3-year survival rate in pateints aged 55 of less is 81 percent on home dialysis. . .

But the political damage had been done. 

Today, after nearly forty years of neglect, home hemodialysis is only a shadow of its humble beginnings mainly due to adverse funding ratios from the hands of congress and CMS. Despite an abundance of evidence of its cost effectiveness, despite widespread acceptance in the rest of the developed world, home hemodialysis remains underutilized and underfunded today despite promises to the contrary.

NxStage internal data presented to CMS in recent public comments on the Renal Bundle and the QIP reveals significant discrepencies between reimbursement for peritoneal dialysis vs. home hemodialysis despite significantly longer training requirements for home hemodialysis (HHD) and and higher associated training costs. Total hours training, PD  - 32, HHD - 103. Reimbursement: PD $1,238, HHD - $408. Estimated HHD costs in a 2007 NxStage survey showed the burden of training for one HHD  patient was at least $4000.

The lack of adequate compensation for necessary training presents an undue disincentive to further acceptance of HHD as the modality of choice for selected patients. According to the same NxStage public comments, only 24% of current dialysis centers are certified for HHD and even fewer enroll patients into their programs despite extensive clinical data of improved outcomes with HHD. Adding to the financial disincentives, few nephrologists or units ever counsel patients on the benefits of home hemodialysis with as few as 12% of patients receiving informed consent on this underutilized modality. (here) Further studies reveal increased requests for home hemodialysis when patients are informed of this option showing the effectiveness of patient education on HHD. (here)

Despite substantial benefit, reduced long-term costs, and proven efficacy of informed consent for HHD, CMS continues to neglect this much unfairly maligned therapy. For those fortunate enough to participate in home hemodialysis training and treatment, the benefits are immediate and longstanding as noted by frequent testimonies on various dialysis advocacy web pages. Only congress and CMS fully appreciate their own reasons for why the continue to withhold appropriate funding of HHD after nearly forty years.

This puzzling story continues to defy any reason and logic. Perhaps one day, enough dialysis patients will know and understand why it should often be their first choice and a shout will go forth that no one can ignore any longer at CMS. But until that day, the voice of despair and discontent with conventional in-center hemodialysis will apparently continue to fall on deaf ears. Perhaps one day, we can only hope that someone, somewhere  and at some time one who can make a difference inside our government will.

Home Hemodialysis: Overcoming the Insurance Barrier

By Peter Laird, MD

Rich Berkowitz of Home Dialyzors United posted an important news report on United Healthcare and their policy change in support of home hemodialysis. I concur with Rich Berkowitz that the policy change by United Healthcare is an important milestone for all dialysis patients. This is one of the few insurance groups in America that support and accepts both observational data and the FHN randomized and controlled study. Perhaps the most important phrase in their policy change is the following:

Home Hemodialysis Medical Policy

Home hemodialysis (HHD) is a proven therapy as an alternative to facility-based hemodialysis for patients with end-stage renal disease. 

There remains much work left to overcome the insurance barrier to home hemodialysis such as Aetna and other insurance companies that have yet to embrace this technology. Reading through the policy discussion by United Healthcare brings to mind many well written treatises by home hemodialysis advocates. In light of the success of NxStage bringing portable hemodialysis technology into the home, the market forces may have played a substantial part in the United Healthcare decision since the evidence has been present for decades. 

All too many patients remain in-center when they could instead enjoy the benefits of home therapies. far too many never hear of these options from their health care team. I am pleased the United Healthcare has taken this important step with in offering a proven therapy and declaring it so. Perhaps we have a bit more sanity today in the dialysis industry today. At the least, this is welcome news. I want to thank Rich Berkowitz for bringing us this information and congratulate Rich for his new webpage albeit still in development.

Parade Calls Hemodialysis a Grueling and Painful Procedure

By Peter Laird, MD

While practicing internal medicine, I had the opportunity to treat many hemodialysis patients in the hospital setting and in my office practice. In the days that my own kidneys were healthy, I was blissfully unaware of the rigors of dialysis therapy that these patients endured in the conventional in-center unit. I must state shamefully, that I expected these patients to do poorly and most of us blamed their terrible outcomes on the underlying renal disease itself. 

Once I began my own journey with renal disease, my views slowly changed as I realized that many of the complications we saw in those dialysis patients we admitted to the hospital were actually iatrogenic in nature. The septic dialysis patient maintained by catheter without a fistula, congestive heart failure secondary to LVH from aggressive ultrafiltration rates over several years, syncopal episodes (passing out) following dialysis and chest pain during dialysis were common causes of seeing these patients in the emergency room that are all potentially prevented with longer duration and more frequent hemodialyis. The misperceptions about this lifesaving treatment continue unabated despite the knowledge that there is a better way to do hemodialysis. One of the more recent example is in the Parade magazine:

The Miracle of Life: How One Woman Turned Tragedy into the Ultimate Gift

Kidney failure, which can be caused by conditions ranging from infection to diabetes to injury, affects 485,000 people in this country, killing more than 70,000 every year. The vast majority of those who survive do so by chaining themselves to a grueling, painful treatment known as hemodialysis (or simply dialysis), which requires being hooked up to a machine that filters waste from the blood for hours at a time. Still, thanks to dialysis, the parents, siblings, spouses, and friends of those receiving the treatment can put off grieving, at least for a while. The patient has no choice but to endure it until a flesh-and-blood kidney becomes available for transplant — a wait typically lasting five years, which is also when the odds of survival on dialysis begin to drop dramatically.  

As I write this post, I am undergoing a home hemodialysis treatment. Other than a momentary needle prick when placing my needles, I would not call my treatments painful, nor are they in any sense grueling. While it is true that I do this procedure for hours at a time, I am able to do so in the comfort of my home thanks to a portable dialysis machine called the NxStage System One. Bill Peckham spent a great deal of time dealing with negative perceptions about dialysis on his blog, Dialysis from the Sharp End of the Needle. There is no doubt that dialysis as a medical procedure is associated with preventable complications that add to the burdens of dialysis and renal disease but most can be prevented.

The quest to move forward with renal transplantation is a viable option for many patients, but the demand for available organs reduces the number of beneficiaries to only a fraction of the total transplant waiting list each year. In the zeal to implore people to participate in organ donation, media reports on renal transplants frequently resort to particularly odious descriptions of the hemodialysis procedure but at the same time provide little knowledge of the complications of renal transplant. Nor do these journalists have any information on how optimal dialysis compares to renal transplant outcomes such as the nearly identical survival when comparing nocturnal daily hemodialysis and cadaveric transplant noted by Pauly in 2009.

This is a continuation of the great transplant love affair and the jilted procedure we call hemodialysis that has never been fully appreciated since the days of Dr. Scribner and his shunt. When I first began writing on DSEN, it was quite easy to find articles such as the one above which portrays dialysis in dire terms. Today, with the growing popularity of home hemodialysis options, these types of articles are fewer and far between. It is time that not only journalists but health care practitioners and patients alike not only understand but appreciate the lifesaving qualities of optimal hemodialysis that are not painful or grueling.  

There will always remain those that are simply unaware, but today, there is really no excuse for misinformed portrayals of hemodialysis. There is likewise no excuse for the American nephrologist that prescribes any painful or grueling sessions marked by cramping, nausea, vomiting and severe headaches any longer as well. The days of ingorance of beneficial hemodialysis need to come to an end, and patients should feel no discomfort whatsoever during dialysis sessions. If any of thes symptoms do occur, dialysis patients should address their providers to eliminate this distress. There really remains no excuse any longer.

Guest Commentary: Dialysis Industry Consolidation Stagnates Technological Innovation

By Mel Hodge

Beyond the obvious economic effect of lack of competition in a market, there is an equally pernicious effect on technological progress. The first rule in managing a technology company is, "Always be the first one to obsolete your own product." The corollary to that rule is, "Never show your own hand until a potential competitor first shows his."

I first saw the NxStage System One in operation in a clinic nearly ten years ago. Since then the iPhone has been introduced and is now in its fourth generation! But the System One is basically unchanged in a decade - and quite properly so from a NxStage management perspective as they have watched a series of potential competitors being snatched off the market. Much better to just sit on their next generation technology and continue to reap the unexpectedly prolonged cash flow into the System One's second decade of life.

The losers from all this are the patients - past, present and future - who are denied home dialysis because the old technology is viewed as too expensive by their centers in the absence of cost-lowering competition or forced to accept the operational and clinical limitations of decade-old technology from the single available machine.

If the old AT&T were still the sole developer, manufacturer and telephone service provider, the iPhone would probably lie somewhere in the distant future. Such is the power of monopoly. But the irony here, however, is that monopoly power does not lie with its temporary beneficiary. In an industry where 80 percent of U.S. dialysis centers are for-profit ventures, two-thirds of which are owned by two companies, the larger of which is also the dominant equipment manufacturer and technology acquirer, it appears that careful inquiry into the facts is long overdue. It really is a matter of life and death. . .

NxStage, Bringing Dialysis Home - Thank you

By Peter Laird, MD

In the 1970's prior to the advent of the ESRD program in 1973, the majority of patients on dialysis, dialyzed at home 6-8 hours thrice weekly and enjoyed excellent rehabilitation and better survival than the current morbidity and mortality of conventional in-center dialysis today. Unfortunately, the Congressional mandate adversely impacted reimbursement for home hemodialysis and with other factors, home hemodialysis soon became a forgotten entity that many today now wrongly call experimental and unproven.

Dr. Scribner spent the last three decades of his life working to educate the public and his nephrology colleagues about the virtues of daily, home hemodialysis and went to his grave disgraced by the profession that he himself embraced and freely gave his inventions to save lives. Thankfully, history is kind to such men as Dr. Scribner who out of love for the lives of his fellow men freely gave not only of himself, but sought that others would likewise seek the betterment of those suffering with renal disease. In an industry now dominated by individual and corporate greed, his memory continues to point the way to a better dialysis treatment.

In the 1990's, renewed interest in home hemodialysis came into effect with our neighbor to the north and today, Canada is a leading advocate of more directed home hemodialysis therapy. However, innovations in dialysis machines hampered the growth of the home hemodialysis market, until NxStage entered with little hope of taking on the corporate dialysis giants with their tiny machine in comparison to the huge immovable home devices still promoted today by these companies. Yet, during the last decade, NxStage has bridged the gap that others have attempted and failed to captivate.

For anyone that has had the opportunity to dialyze for any length of time in a conventional dialysis unit and then bring their treatments home with the NxStage machine, I am sure all are grateful for the opportunity to do so provided by this supportive and innovative company. The testimony of so many patients is that NxStage gave them their life back. I second that testimony and only wish to say, thank you.

Patient Demand Leads Boom in Home Hemodialysis

By Peter Laird, MD

Home hemodialysis, the preferred  renal replacement modality prior to the beginning of the ESRD program in 1973 here is re-emerging today by the power of individual patients seeking a viable alternative to conventional in-center hemodialysis. This is evident in a graph (here) provided by Dori Schatell of the Medical Education Institute and Home Dialysis Central that compiled the number of dialysis centers offering home hemdodialysis options over the last eight years. The greatest growth is in those centers offering short daily hemodialysis facilitated by the ease and popularity of the NxStage System One portable hemdialysis machine. Evaluating the reasons behind the renewed interest in home hemodialysis is revealed in an Australian study that asked patients and care partners why they chose home hemodialysis:

Characteristics of dialysis important to patients and family caregivers: a mixed methods approach

Results. Thirty-four participants from two Australian hospitals attended six ‘nominal group’ focus groups between September 2009 and February 2010. Two groups involved pre-dialysis patients (total n = 8), two involved peritoneal and haemodialysis patients, respectively (n = 9) and two involved caregivers of dialysis patients (n = 17). We identified 28 characteristics of dialysis important to patients and caregivers. Patient groups agreed that the most important characteristics were (i) survival, (ii) convenience of dialysis at home and (iii) dialysis-free days. For caregivers, the most important were (i) convenience of dialysis at home, (ii) respite and (iii) the ability to travel.

Conclusions. Patients and family caregivers highly value treatment that enhances survival and can be performed at home. Future planning of dialysis services could better reflect these priorities through provision of increased home dialysis support services and planned respite for caregivers.

Improved survival came highest on the list of variables that attracted patients to home hemodialysis options in Australia. While the pundits of dialysis hierarchy here in America continue to contest the merits of "non-conventional" dialysis, informed patients are not waiting for them to place the imprimatur of America's academic nephrology elite. The market place and patient demand for travel, survival benefit and convenience is bypassing what in my opinion is the stodgy behemoth industry infested academic nephrology community that continues instead to rubber stamp the American dialysis holocaust while waiting for the holy grail RCT that likely will never come.  

As the evidence mounts, the truth that we have abandoned the right path over forty years ago at the hands of the business of dialysis is the inevitable conclusion. The blood of dialysis patients bathes this for-profit dominated industry that continuous it's gluttonous rape of patients trust and hopes for continued life to only instead receive a counterfeit death sentence filled with the pain and anguish of short, rapid and violent sessions while suffering with nausea, vomiting, severe cramps and syncope in inflexible cattle call dialysis units across America. We can do better. We should do better.

 

NxStage Launches Find a Doctor

By Peter Laird, MD

NxStage System One is a portable dialysis machine that is taking patients into a new future on home hemodialysis. Unfortunately, with a little over 5000 current patients, many nephrologists lack experience over seeing patients maintained on this new machine. NxStage is launching a new program to find doctors who are familiar with this machine making the search to find an accepting physician easier for patients interested in NxStage:

Find a Doctor

The NxStage Find a Doctor directory is provided by NxStage for use by the general public to help locate a nephrologist who has experience caring for home hemodialysis patients treated with the NxStage System One™. The Find a Doctor directory is not intended as a tool for verifying the credentials, qualifications, or abilities of any physician contained therein. The use of the Find a Doctor directory by any entity or individual to verify the credentials of listed physicians is prohibited. Inclusion in the Find a Doctor directory does not imply recommendation or endorsement by NxStage nor does omission in the Find a Doctor directory imply NxStage disapproval.

This is a welcome addition not only for patients looking to try this machine, but also for patients traveling to specific areas who already utilize NxStage for their preferred therapy. Simply typing in the desired zip code will give the results of any nephrologist in that immediate area who has clinical experience with this device. As NxStage gains more market share, any information on actively participating nephrologists will bring many more patients into the home hemodialysis experience. NxStage continues to excell not only in an ingenious design, but in continued excellent patient support.

NxStage: Patient's MUST Comply!

By Peter Laird, MD

I was wakened by my wife this morning at about 8:30 am. That may not sound like an early day for most, but I have migrated into a late night bedtime usually between 1 or 2 am and I need the full eight hours of beauty sleep to keep from being ugly the next morning. However, my wife at times tells me it isn't working even with all of my beauty sleep. This morning turned out to be no exception. I found myself wringing the sleep out of my eyes talking to my NxStage service rep's supervisor's supervisor. It would have been nice to hear from my own rep, but usually all I get is a computer recording listed as "5100" reminding me it is time to call with my inventory.

I got this month's reminder on Monday as I was getting ready to return from Las Vegas. Not perhaps for the reason that Las Vegas conjures, my wife's cousin lives there and my mother in law wanted to see her before returning to the Philippines in a couple of weeks. We returned late Monday night and then I had a meeting for lunch with a dear old friend of mine who recently lost his wife to cancer. It was great seeing him again, but I wish it had been under different circumstances. They were a wonderful God fearing couple that I enjoyed spending time but we had lost contact for a few years as can happen unfortunately. I am going to miss her company, but I know where she is in no more pain or suffering. I didn't feel well after two days off but I did get the run off to a successful start about 6 pm. I wasn't ignoring the message from NxStage, I simply couldn't get to it until today.

In any case, I found my morning routine broken by at first a kind hearted voice on the other end of the line discussing the "fact" that I had not contacted NxStage "3 out of the last 6 months." This was news to me since I have only missed one call in nearly 24 months of home dialysis. I received a default shipment that month while waiting for a reminder call that never came and it was actually what I would have ordered anyway. In fact, when I first started on NxStage, I loved my customer service rep named Lauren. She called like clockwork if I failed to get back to her in a couple of days from the phone reminder. In the 12 months that she helped guide my deliveries, there was never a single issue, all the orders were perfect every time.

Things changed dramatically for the worse when I was assigned a new customer service representative nearly a year ago. I had orders shipped to CA when I was in Idaho even though I had already been in Idaho for several months. I had an emergency machine swap out sent likewise to CA while I was in Idaho at about the same time and went 3 days without dialysis until they were able to send a second machine to the correct place. I have had half orders obviously sent for someone else since it was only enough for using 20 liters per session instead of my prescription for 40 liters. Perhaps that is what the supply computer told the rep to send. Yet, through all of this, we were able to come to a meeting of the minds and for the most part, I thought matters had improved and I let bygones be bygone. Then I got the phone call this morning from the supervisors supervisor.

I was a military man for a good portion of this life and believe in following protocols of the chain of command. In other words, if you have an issue, you call that person directly before going to a higher level. I understand that most folks don't adhere to such formalities, but it just makes sense to me after spending 9 years in service.  I prefer to call the on call service reps and then often I will double check just to make sure the order is correct. I have found that at times,they don't document each and every call when I do my call back checks. In addition, everything in medicine is conducted under doctors orders by prescription.  A couple of months ago, I placed an order for drain lines which did not show up. When I called to find out what had happened, I was informed that the prescription had expired and they needed a new one.

Fair enough, but that required sending an order of drain lines by express mail outside of the usual shipment which is an extra charge. Perhaps a simple call from my service rep could have taken care of that issue before it became an issue since no one communicated this to me or to my unit in any manner before the fact, they simply refused to send the requested material without the correct prescription. I was in a situation where I had short supplies of drainage lines even though I had informed NxStage in a timely manner. I have yet to run out since I keep close tabs on all of my supplies and still had enough to keep that from happening. With 23 years of formal education behind my name, the least I can do at this time is to know what is in my supply room or not.

Making a long story short, I remained respectful this morning until the manager who woke me from my beauty sleep, and a difficult sleep it was with the headache of not having dialysis for two days, to inform me half way through our conversation: "patients must COMPLY" with all treatment and patients "cannot direct their own care" after simply telling her what I needed for my next shipment. That snapped my head out of its socket and as in all cases where beauty sleep is interrupted, things can get ugly indeed. The supervisor's supervisor stated I am not allowed to give the amount of supplies that I need, I must COMPLY and give the inventory and the computer will determine what I need. Sorry, but the computer has not been my friend on more than one occasion in this dance with my NxStage medical team. I went ahead and gave the inventory off the top of my head since I had planned on calling NxStage today anyway.  After all, the reminder was only on Monday. I then asked a confirmatory question, now that I have given you my inventory, what are you going to send me? That lead to more discussion that patients do not direct their own care and must COMPLY. I am left wondering what will show up with my next delivery since my rep's supervisor's supervisor would not even confirm the order with me. It was for me to simply COMPLY and not ask questions.

All is well, but if this is going to be a partnership of care, after all, I am unsupervised when placing 15 ga needles into my arm under aseptic conditions with all of my blood whirling through a machine that I set up, start and stop according to my specific needs for the day, yet I am not allowed input on making sure my orders for supplies are correct. Talk about losing beauty sleep over this conversation.  The upshot at the end of the conversation is that they will send me email reminders instead of voice mail which I simply do not use. I will comply in all aspects of my care to include documentation of ALL untoward supply mishaps. I shall be a good little boy and do exactly what I am told to do, it is my hope that all involved in my supply chain shall likewise do the same. Unfortunately, what has started two years ago as a cordial partnership of care with absolutely no hitches whatsoever is now devolved into calls from my service rep's supervisor's supervisor without hardly a call from my rep in the first place. What am I missing in this equation?

Crashing my NxStage Machine: Pilot Error at Fault

By Peter Laird, MD

Today of all days, I woke up early and ready to go with dialysis from the get go. I had set up the machine last night all the way through the complete prime ending on the standard "23." According to Dialysis Dan, you can shut the machine off and restart it several hours later which I have done on more than one occasion. All went well when I awoke and turned the power switch back on getting a"40" alarm for power outage, that quickly resolved with a tap to the yellow alarm button into a repeat two minute priming session, once again returning to my "23" system check.

I went through the remainder of my usual routine eager to be on the road by 3 pm today for a two day weekend to Las Vegas. My wife and I are frequent visitors to Las Vegas, not for it's casinos or gambling mind you, but it is where my wife's cousin lives less than 4 hours from our house. My wife is quite close to her cousin who for years was her only relative with her from the Philippines in the US. I enjoy spending time with her husband who is retired from the Air Force. However, whenever the best laid plans can go wrong, they will go wrong when visited by someone called Murphy.

I utilize a 2.5 liter rinse to remove an unwanted plastic taste unique to the NxStage machine. Many don't consider what a dialysis machine "tastes like" not realizing that they all have their own individual taste based on the type of plastic used.  For myself and a relatively small group of dialysis patients, the NxStage machine has a strong plastic taste at start up. Lately, I discovered that much of the plastic taste I experience is greatly reduced if I don't turn the warmer bag on until I have actually started the blood pump after hooking up. Try drinking bottled water on  a hot day with the plastic water bottle sitting in the sun for quite some time and you get the same concept of  a strong plastic taste worsened by the heat exposure.

However, today, of all days as I was of course up early, well relatively early I would state for my own personal waking up time, I had the machine all set to go, the car was gassed up, my wife has packed our things, the only thing standing before our well set plans was an infernal dialysis machine that today decided to show me who was boss. At first, my rinsing procedure went well until all of a sudden, the dialysate pump turned on all by itself even when I told it to stop several times. I thought I was going to break that blasted red stop button from pressing on it again and again and again. I had an assortment of alarms from 4 to 20 to 35. I looked over the set up and all looked well. I had hooked up yellow to yellow, green to green, and white to white. I had snapped and tapped until all the bubbles disappeared and it looked like all was in order.

Yet, the machine kept turning itself on with no one touching the buttons just like Skynet on the terminator series. I began to call it a "STUPID MACHINE" and becoming quite exasperated with the entire situation. I turned off the machine, counted to three and then restarted the power button with all appearing well again for several minutes until that loud "Chop, Chop" sound with something turned on again all by itself as pumps began to whirl internally. After several attempts to gain control of the machine, I called tech support to seek their advice. I explained as best I could in my exasperated voice the situation, only to hear their answer that the machine had some how entered into a re-prime mode and that is why I had the numbers doing what they were doing as well as the dialysate pumps operating in self control mode with no over ride. Not to disparage the tech trying to deal with an over heated, red faced, doctor/patient quite out of control of his wits, but perhaps I left out come of the important details as I began my heated diatribe against this out of control, self starting machine.

After 20-30 minutes of cursing this "STUPID MACHINE" I turned it off and started to disassemble it for a second setup. Much to my consternation, I discovered the problem when I began to unhook the yellow "pee" line finding one of the yellow clips still CLIPPED. Whoops, I thought to myself, will a machine except my humblest apology for all that I had said against it's loyalty to me.  After all, I had cursed this infernal machine for nearly 30 minutes and even threatened bodily harm against it, yet all along it had tried to tell me several times over what the stupid pilot had done wrong in setting it up for its run by reminding me of that number "35."

I sheepishly informed my now upset wife, well upset really isn't a good word for her state of agitation at this point, what the "STUPID MACHINE" did wrong. Surprisingly, she had all of her sympathy for the machine and none for me this morning. After all, part of our plans had been to get to Las Vegas early enough to go to her favorite Filipino restaurant before it closes at 9 pm today. With a 4 hour drive after completing dialysis, it is not looking good to make it by that time, all because of pilot error, my NxStage machine dutifully as always tried its best to flash "35" telling me exactly what was wrong several times over, but this pilot chose to blame his faithful machine instead of simply stopping and listening to what it tried to tell me several times over.

That same machine is now eagerly purring beside me as it cleanses my blood. It has long since forgotten it's master's quick tempered tantrum wrongfully waged against it and as it always does when the pilot sets it up well, it chugs along day after day after day in perfect unison singing it's joyful songs of work as it saves my life, one day at a time. Too bad the pilot isn't as perfect in all ways as this ingenious little machine that even tells me what I do I wrong, if I would only listen. Perhaps that is a lesson of more things in this life as well.  

Thank you NxStage for this incredible little machine, even when I am not thinking of kind words towards a poor little machine that really instead always says, I think I can, I think I can and it does. Perhaps you can persuade my copilot in our drive to Las Vegas in a few hours that I really am not as stupid as she thinks right now. Somehow, I have a feeling that this drive to Las Vegas will be  a bit longer than usual.