Trash if you aren't interested in Y2K and Pacemakers...but I think you
should be, but there is a lot of stuff in this email. DO NOT READ PART OF
IT OR YOU MIGHT GET THE WRONG IMPRESSION...IF YOU AREN'T PREPARED TO READ
IT ALL, JUNK IT PLEASE I DON'T WANT ANYONE HERE THINKING THAT THE JURY HAS
RETURNED ON THIS SUBJECT YET.
For anyone who is really interested here is a reply and several emails on
Y2K and pacemakers I made to Scottish Health Service Y2K discussion group
in response to a query.
>At 14:14 10/02/1998 GMT, Chris Sheldon wrote:
>>At the recent y2k meeting in Stirling, it was agreed to include pacemaker=
>>s
>>in the list of high risk medical devices. There are a number of scare
>>stories around suggesting that some pacemakers may stop working on
>>1/1/2000. The only problem I have found reference to relates to incorrect=
>>
>>download of logged information from the pacemaker to an external computer=
>>=2E
>>
>>Does anyone have any other information on potential problems with
>>pacemakers?
>>
>>Chris Sheldon =
>>
>>
>
>Here are some responses I previously picked up off the main year 2000 list
>I'm on, over the last umpty months. Hope it helps.
>
>Graham
>
><QUOTE>
>As far as we can find out, pacemakers (or any medical
> equipment implanted in someone's body) will not have any
> Yr2K problems. They are not date-aware (If any medical
> equipment users or manufacturers can update this info,
> please do). The potential Yr2K problems are when data from
> such equipment is sent to a monitor or recorder. This
> equipment, being essentially PCs, may have either hardware
> or software Yr2K problems. Such problems can be as trival
> as wrong dates on screens/reports/etc., or as serious as
> erroneous calculations in a medical chart.
>
> Calibration of equipment is another area of serious concern
> for Yr2K problems. If a piece of equipment or system is
> date-aware and is calculating its calibration intervals,
> then it could have the same problems with "00" logic as PC
> hardware/software. We have seen x-ray, radiation equipment,
> and other complicated medical equipment have major problems
> from software glitches. I would recommend that every piece
> of digital equipment get checked.
><QUOTE END>
>
><QUOTE>
>I've seen all kinds of speculation on the NG about pacemakers -- second
>only to elevators. I'm getting very uncomfortable with the posts that begin
>"I don't have any direct experience, but I can't see any reason why a(n)
>(insert widget name here) would need to know the date." I have opinions
>about everything, too, and usually they just serve to confuse everyone.
>
>In the NG on September 5, 1997, in a thread entitled "Computerworld
>9/1/1997 "Will Grandpa's pacemaker really stop?", someone who has real
>knowledge, Paul Penrose ([log in to unmask]) said:
>
>"I feel that I should step in here. I am currently contracting for the
>current world leader in pacemakers (by sales). Pacemakers don't need
>to know what the time of day is, let alone the date. Since pacemakers are
>very small, they also have small batteries, however they need to run for 5
>to 7 years, so everything is optimized for low power consumption. This
>means that anything that is not absolutely necessary is not put in the
>device. Also, there's usually no standard chips of any kind in pacemakers
>as "standard" chips are not optimized for low power consumption. Everything
>is custom designed and built, including the processor, RAM, and ROM. So
>don't worry about your pacemaker, they have multiple safeties, watchdog
>timers, etc. so that they never stop basic pacing functions until the battery
>is completely exhausted (the Docs keep a good eye on the battery status
>at each visit and plan replacement ahead of time).
>Now implantable defibulators are a little different - they have much larger
>batteries. They *may* keep track of the date, but I'm 99% sure that their
>life-saving functions are NOT dependent on it."
>
>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
>
>Date: Tue, 14 Oct 1997 14:10:30 -0400 (EDT)
>From: "'Doc' Don Taylor" <[log in to unmask]>
>Subject: Re: question: embedded systems: Pace makers
>
> Medical rule #1: do no harm.
>
> If you don't have experience with every type pacemaker, past and
>present, its always safest to refer the user to someone who is (i.e.,
>their own cardiologist).
>
> Pacemakers record their performance in some way. Periodically this
>performance record is downloaded into a PC and evaluated. The software
>for this is provided by the manufacturer. My cardiologist said "I can't
>imagine these companies..." but the Veterans Administration has found
>differently. Here is an extract from Congressional testimony March 20, 1997
>by Ann K. Coffou, Managing Director, Giga Year 2000 Relevance Service
>(its online around the Subcommittee on Technology and Subcommittee on
>Government Management, Information and Technology testimony site at
><http://www.house.gov/science/hearing.htm>).
>
>(Introductory material provided for those on the list who are not
>familiar with the procedure.)
>
> In a very simplified explanation, every time a heart pacemaker
> detects an irregular heartbeat it sends a shock to the system
> and then records the time the event occurred. This information
> is regularly downloaded to a computer system so it can be
> analyzed by medical personnel. Whenever the information is
> downloaded, the pacemaker resets itself. The downloaded
> information is used by cardiologists to detect patterns and
> irregularities in the patient's heart rhythms. If the software
> in the receiving system starts recording faulty times for the
> shock deliveries, the cardiologist could misinterpret the results
> and administer improper medical care.
>
> The U.S. Veteran's Administration funded a project to interview
> the top five pacemaker manufacturers to see if they were aware
> of this potential problem. One company was aware of the problem
> and said they would have it corrected by the end of 1997. Two
> companies said that the problem would be fixed before the Year
> 2000, one before 1998. Finally, one company flatly refused to
> acknowledge the problem and when pushed declined to discuss the
> topic any further.
>
> A physician in a heart clinic in Spartanburg, South Carolina,
> related that a new shipment of heart defribulators the clinic
> received recently were recalled by the manufacturer. The
> defribulators use an embedded device that calculates the time
> since last maintenance similar to elevators. Like the elevator,
> if the time since the last maintenance check surpasses a certain
> time frame, the defribulator will not operate thereby reducing
> the possibility of malfunctioning on a patient. The manufacturer
> voluntarily recalled their products when they discovered they
> were not designed to handle the change in century.
>
>
>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
>
>From: "Waldrip, Pat" <[log in to unmask]>
>Date: Tue, 14 Oct 1997 14:31:26 -0500
>
>I read an newpaper article a few months back. It is a possible problem,
>the Doctor and the manufacturer both needs to be contacted.
>
>My understanding per the news article is that at the time of
>implantation a Date and Time is programmed into the pacemaker. This Date
>and Time is programmed in for the purpose of setting an notification
>alarm to notify the user that the battery is approaching the end of
>life. The batteries are probably Lithium and has a life span of 10
>years.
>
>I have not verified this with a Doctor and or Pacemaker Company, kind of
>scary as well as possible liability of failure. I hope that they are
>Year 2000 Compliant.
>
>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
>
>Date: Tue, 14 Oct 1997 18:38:28 -0400
>From: "D.LOUGHRAN" <[log in to unmask]>
>
>I believe some pacemakers have a facility that allows them to download
>status information down a modem. This is save remote patients having to
>make a regular and tiresome journey to the hospital.
>
>After downloading the information is date stamped by the PC that receives
>it for later chronological inspection by doctors. This may be where
>problems could occur.
>
>Damian Loughran
>
>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>.
>>From: "Barry Davenport"<[log in to unmask]>
>>To: [log in to unmask]
>>Date: Fri, 10 Oct 1997 09:03:09 +1000
>>Subject: question: embedded systems: Pace makers
>>
>>Just a quick one to add to all this.
>>There was an artical in our weekend paper to the resident doctor who
>>publishes a column. And this guy was worrying about if his pace maker
>>would work after the year 2000. The doctor said there was nothing to worry
>>about, but to go and see his doctor to be sure.
>>Now I'm no expert and I laughed at it when I first read this, but do pace
>>makers need calibrating or have date hitch to be concerned about?
>>
>>Just curious.
>
>
>From: [log in to unmask]
>Date: Tue, 14 Oct 1997 22:30:17 -0400 (EDT)
>To: [log in to unmask]
>Subject: Re: embedded systems: Pace makers - 2 responses
>
>Even if the pacemaker didn't have a date problem, I'd still check out the
>remote system that many pacemaker users call in to in order to have their
>pacemakers checked out and tuned.
>
>>>>>>>>>>>>>>>>>>>>>>>>>
>
>From: "Friedman, Steve" <[log in to unmask]>
>Date: Wed, 15 Oct 1997 09:42:37 -0400
>
>Barry,
>
>My understanding is that pacemakers do require calibration, and that of
>the 5 major brands of pacemakers, only 2 are Y2K ready. Imagine a
>pacemaker and a microwave oven going on the fritz together.
>
> All the above around the 14th October 1997
>
>BUT......This was posted 30 June 1997
>
>>Siobhan Harper-Jones writes:
>>
>>"Some more than others, of course; an air-conditioner system is orders of
>>magnitude easier to replace than an implanted defibrillator or insulin
>>pump."
>>
>>"I'm trying to find out what Y2K issues are involved in implanted and other
>>medical systems; I welcome any information that anyone can share with me,
>>and I'll be happy to share whatever I uncover as well."
>>
>>Here's what I understand to be true:
>>
>> - 5 or 6 top manufacturers of implanted cardiac pacemakers were
interviewed.
>> - these 5 or 6 represent 90% of the market.
>> - all had pretty much the same story.
>>
>> - when a pacemaker is implanted a referential "start date" is recorded
>>within software on a PC that interprets the pacemaker's data.
>> - the pacemaker itself contains only a simple incremental counter which is
>>set to zero at the time of implant.
>>
>> - when the pacemaker performs a function it records 1) what it did and 2)
>>when it did it. This "time" is stored as a number equal to the value of
>>the counter when the event occurred.
>>
>> - at checkup the data is downloaded from the pacemaker to a PC and
>>interpreted by software. (Each pacemaker manufacturer also writes/obtains
>>their own set of software to interpret the pacemakers data.)
>> - this software compares the stored counter value for each event to the
>>referential "start date" to determine at what point in "real time" each
>>event occurred.
>> - the software produces a report containing this data for the cardiologist
>>to assess.
>>
>> - the referential "start date" is updated to current date each time the
>>data is downloaded. It becomes a referential "restart date".
>> - the incremental counter is also reset to zero at the time data is
>>downloaded.
>> - no historical data is stored within the pacemakers, only the
>>interpreting software has that capability.
>>
>> - therefore, a Y2K date processing concern does not lie within the
>>pacemaker itself, but within the software that interprets the pacemaker's
>>data.
>> - all but one manufacturer said that they were aware of the Y2K
>>problem/date interpretation problem within their software and it will be
>>fixed 1) in the next release or 2) in plenty of time.
>> - the one exception said that they were not at liberty to discuss it.
>>(Basically they didn't think there was a problem, and if there was they
>>would address it when it arose.)
>>
>> - again the major concern is that if a referential "start/restart date" is
>>stored as pre-2000 and data is downloaded with an event occurring post-2000
>>according to the counter value, it is NOT KNOWN how the software that
>>interprets the data and produces reports will respond.
>>
>> - some pacemakers have phone cords attached so that data can be downloaded
>>via phone line and a doctor's visit isn't necessary. Convenient maybe,
>>also may present episodal problems.
>>
>>So we basically don't know. Not ALL pacemaker manufacturers were
>>contacted, therefore this statement does NOT apply to ALL pacemakers. If
>>you have one or know someone who has one, and you are concerned, I would
>>first consult your physician and then the manufacturer of the pacemaker. I
>>don't know of anyone whose tested it, so I have no hard evidence. I simply
>>thought this info would give you a good starting point.
>
>
>
>Graham P P Ride
>Cybermetrix Ltd.
>Tel +44 (0)161 439 0480
>Fax +44 (0)161 439 1912
>Providing Year 2000 services to SMEs and GPs
>Maximising the benefits of the Internet
>http://www.cybermetrix.co.uk
>
>
Cybermetrix Ltd.
Pembroke House
25 Moor Lane
Woodford
Cheshire
SK7 1PW
Tel +44 (0)161 439 0480
Fax +44 (0)161 439 1912
www.cybermetrix.co.uk
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