X-Message-Number: 2306 Date: 18 Jun 93 23:32:00 EDT From: Mike Darwin <> Subject: CRYONICS Letter to the Editor of Cryonics Michael Darwin 1220 E. Washington St. #24 Colton, CA 92324 13 June, 1993 Ralph Whelan, Editor Cryonics Magazine Alcor Foundation 12327 Doherty Street Riverside, CA 92503 Dear Editor, The June, 1993 issue of Cryonics contains an article discussing the care of Alcor Suspension Patient A-1399. This article contains the following statements: "One complication which may have affected the perfusion involved was a result of (surprise!) bleach. Bleach has been shown to neutralize the AIDS virus within 30 seconds of undiluted exposure. As a result, we have incorporated it into our AIDS precautions. Chlorine bleach was poured into the ice bath of the MALSS, because many excretions, including blood from the surgery, flow into the bath. Unfortunately, much more bleach was poured into the bath than was necessary to chlorinate 5-10 gallons of water. The ice-water from the MALSS is used in the perfusion circuit to provide cooling, and the massive amount of bleach may have corrode the heat exchanger causing it to rust. Corrosion of the heat exchanger/oxygenator might then have contaminated the patient circuitry with cooling water. We are still awaiting test results which will give us the information necessary to determine the extent of the damage (if any)." The article in which the above is contained then goes on to state how well the suspension went and in particular to note that: "During this suspension, the atmosphere in the field and in the operating room was much less stressful than for any other I've experienced. This doesn't indicate inattentiveness, it indicates a reduction in the performance-limiting pressures....The team is inexperienced, with some exceptions; however, that inexperience is not hindering the process of performing and improving the quality of cryonic suspensions for Alcor members." The statement about corrosion to the heat exchanger prompted me to call Alcor and speak with Hugh Hixon about this matter. The information I was given stands in stark contrast to both the tone and the specific meaning of the above quotes. I was told that a definite leak of wall water (i.e., tap water) from the heat exchanger into the Viaspan solution perfusing the patient was documented. Further, I was told that the fact that this leak occurred was discovered as a result of observation of a color change of the (residual) red cells present in the perfusing Viaspan from a normal red/pink to brown/yellow. This color change is indicative of denaturation of the patient's hemoglobin (probably due to oxidation by hypochlorite) and is, in and of itself, definitive evidence that the patient was perfused with solution containing lithium hypochlorite (bleach). Since over 60 days have elapsed since this suspension was performed I then contacted Alcor's president Steve Bridge to ask if he a) understood the gravity of the situation, b) had undertaken any testing to determine the time course and degree of exposure of the patient to hypochlorite and tap water, c) determine if this very serious incident had been discussed with Alcor's technical advisors, and d) find out if the next of kin had been notified of the problem and/or if there were any plans to notify them. The answers I received were, in my opinion, totally unsatisfactory. No tests have been run to determine the lithium level in the perfusate (a possible marker for the concentration of hypochlorite). My requests to see arterial and venous blood gas data on this patient (which might indicate the degree of compromise of metabolic activity) were brushed off. No one but Hugh Hixon, Steve Bridge, and Suspension Team Leader Tanya Jones had discussed the matter. I also inquired as to whether the oxygenator had been returned to the manufacturer or to any of the private medical device accident investigation services which exist. The answer was no. The oxygenator should have been professionally evaluated as soon after the accident as possible. Furthermore, tests should have been conducted to see if the failure mode can be repeated with another oxygenator to further clarify the etiology of the accident. In my opinion, the tone and much of the content of the A-1399 case report is inappropriate. Contrary to the statement "that inexperience is not hindering the process of performing and improving the quality of cryonic suspensions for Alcor members" I submit that perfusion of a patient with hemoglobin denaturing concentrations of chlorine bleach and contamination of the blood path with dirty tap water does not constitute an acceptable, let alone improved standard of care. As opposed to either a technical or clinical triumph, what is documented is this report is a biomedical disaster that in a normal clinical setting would be a cause, not for rejoicing, but for profound grief and soul searching. I am told that instead of a scant few grams, nearly 8 ounces of lithium hypochlorite were added to the bath. This is enough to yeild a terminal bleach concentration in the range of .5 to 1.5% (depending upon the volume of water present in the bath). That concentration of bleach, leaving aside its effects on the heat exchanger, would be sufficient to cause contact skin burns on extended exposure (even at 2-4*C). Witness the fact that this solution apparently corroded stainless steel at that temperature. An unmentioned fact is that the patient's skin and mucous membranes were also bathed in this solution. At least as serious as the fact that this accident occurred is the way in which it is being handled. My conversations with Steve Bridge and with Hugh Hixon indicate what appears to be a fatalistic attitude regarding this incident and a lack of urgency to see that it is adequately investigated and steps taken to insure that it (or some root-caused variant) never happens again. The attitude seems to be "Well, that's one mistake we'll never make again." The questions left begging are how and why did it occur in the first place, how will this be handled vis a vis next of kin, and what assurances do Alcor members have that a similar error will not occur next time, or the time after? What I found particularly macabre was that elsewhere in the June issue is a "special note of recognition" praising Hugh Hixon and Team Leader Tanya Jones for a job well done. There is a principle in law and medicine known as the "Captain of the Ship" doctrine. Simply put, this doctrine imposes liability, both moral and legal, on the person in charge of an operation for the actions of his/her assistants during the period when those assistants are under the team leader's control. I would suggest that perfusing a patient with bleach as a result of careless addition of a corrosive quantity of pool chlorine to the ice bath does not merit praise. This incident calls out for creation of a quality control mechanism whereby suspension care can be evaluated by qualified individuals and wherein serious breaches in technique can be dissected, objectively evaluated, and recommendations made for preventing a recurrence. Every hospital has internal medical quality assurance mechanisms which begin with grand rounds and go up the ladder to an internal board of inquiry. Alcor has many technically competent members who might be tapped to serve on a such Board, and there are many outside experts available for a fee in specific areas (Alcor's ability to attract such experts during the Jones case and other litigation is proof positive that it can be done). I believe it is urgent that such mechanisms be put in place as soon as possible, and that basic standards for care be drafted to guide such oversight. Sincerely, Mike Darwin Rate This Message: http://www.cryonet.org/cgi-bin/rate.cgi?msg=2306