This topic is tough to discuss. The danger is that one may come across as simply a defender of the medical device industry. I'm not.
Another danger is that one may come across as a media-hater. Again, I'm not. I worked at two newspapers and one television station and have great respect for many of the folk with whom I once worked.
Medical devices are often foreign objects surgically implanted into the human body -- a damn hostile environment for many materials. Corrosion is but one of the immediate threats.
Think about the discredited Liberation Therapy treatment proposed as a treatment for MS (multiple sclerosis). Doctors were slow to embrace the untested surgical treatment as it often involved the off-label use of a coronary artery stent being inserted in a vein in a patient's neck.
The media was quick to attack the doctors, government regulators and insurers for their reticence. The Post Media paper in London, Ontario, ran a story about a local woman unable to obtain government health care funding for the treatment.
When I looked into the wisdom of placing a stent in a patient's neck, I was told by the medical professionals questioned that they would not do it. Why? Too dangerous.
Liberation Therapy is no longer bandied about as a miraculous cure for MS. The doctors and clinics that were so quick to provide the treatment should be ashamed. Patients died having this surgery. It was a high-risk-no-reward treatment. And the press should be ashamed of the role it played in advancing this quackery.
So, is there a problem with medical devices? Yes. But it is a complex problem and the breathless reporting of patient-recipient horror stories, as I've encountered on CBC, is not the adult discussion needed.
My heart doesn't beat well. At least, it doesn't beat well on its own. I have a one hundred percent heart block. This a problem with my heart's electrical system and not a problem with my arteries. I'm not concerned about having a heart attack. What threatens me is heart failure. You see, on its own my heart would beat only about 30 times a minute, maybe even less. Without my pacemaker, my ankles would swell, fluid would gather in my gut and surround my heart. My lungs would fill with fluid and I'd have a difficult time breathing. Within days I'd be dead.
My pacemaker is an implanted medical device attempting to partially correct my heart's electrical system failure. It is not a perfect solution and there are problems associated with having one implanted. How anyone could think that having a chunky metal box inserted into one's chest and attached to one's heart by 26-inches of wire could possibly be risk-free puzzles me.
CBC is reporting that tens of thousands of
medical devices distributed worldwide — like pacemakers — were approved for sale with little scientific evidence . . .
CBC claims devices such as pacemakers are suspected of having played a role in more than 14,000 reported injuries and 1,416 deaths. This number is so large because it includes problems associated with a number of devices, of which pacemakers are but one.
Digging deeper I discovered CBC posted an interactive medical device database of associated incidents. I typed pacemaker into the device category field.
I discovered 157 deaths and 1,291 patient injuries are associated with pacemakers. This is not all that surprising when the complexities of the system and the all-too-clear dangers are considered.
Simply making a pocket in a patient's chest and inserting a metal box is fraught with danger: infection, blood clots, stroke and the list just grows. And, if a problem does arise, the solution may well demand another operation. Surgery is never risk free.
What did surprise me were some of the incidents that made the list. I admit to cherry picking but this is my point. Don't just take the numbers and other bits of information at face value.
The CBC encourages us to question the motives of the device makers. The manufacturers may be driven by a need for profit. I suggest the CBC, and all news folk, should face questions as well. Journalists may have their own demons driving them forward. Think viewers, readers, awards and even think profits. I like to think it's the demand to tell a good story that blinds them.
So what were the surprising incidents that made the pacemaker incident list? Here are a few:
patient piloting air ambulance involved in plane crash died. no evidence to support a device-related cause for the event.
generator and associated leads were removed due to infection. source of infection unknown. patient died from liver cirrhosis.
patient died due to acute coronary artery disease. device tested and functioned properly and within specification. patient was 85.
pacemaker implanted for heart block. developed non-ischemic cardiomyopathy with ejection fraction diminishing. root cause was physiological.
Now maybe a good time to read the CBC fine print:
CBC has not verified the accuracy of the data.
Reports might have been filed to Health Canada with inaccurate or incomplete information.
There is no certainty that the medical device caused the reported reaction.
A given reaction may be the result of an underlying disease, process or another coincidental factor. One report may be tied to multiple parts of the same device and multiple reactions may be connected to a single patient.
The data does not reflect any CBC assessment of association between the health product and the reaction(s).
I'm on my second pacemaker. I got seven years out of my first unit before the battery failed. I apparently suffered no infection from the replacement surgery. My luck seems to be holding. But, I cannot be completely certain I escaped the threat of infection until a full year has passed.
My original lead, the 26-inch wire connecting my pacemaker to my heart, was retained and reused. It has now been operating in a very hostile environment, the human body, for eight years. How long that lead will last is anyone's guess. The electricity-conducting wire could corrode or succumb to metal fatigue. Leads do fail and the frequency increases with time. And, of course, there is always the threat of manufacturing defects and recalls.
Just living carries risks. I simply live with a few extra risks. But risks in life are often nicely balanced by rewards. I believe the risk/reward ratio associated with my pacemakers are weighted heavily in favour of my pacemakers.
Thank you Medtronic.
Despite the scary tone of some of the CBC reporting concerning pacemakers, the ICIJ stories, the source for the ongoing CBC reports, is often not as frightening. The ICIJ is actually fairly reasonable. The following is from the ICIJ report titled: Frequently asked questions and resources for readers.
Do all medical devices have problems?
No. For example, pacemakers and implantable cardioverter defibrillators (ICDs) have revitalized and saved millions of lives.
I'm not keen on having man-made stuff implanted into my body. I've had car problems, microwave breakdowns and expensive camera battery failures. Stuff fails. It is a fact of life. Sadly, sometimes stuff fails because of poor design or shoddy workmanship. This is not acceptable in any situation but it is a worst case scenario when it involves the failure of a medical device. The ICIJ is doing us all a service.
The ICIJ asks who is watching the medical device makers? I wonder who is watching the journalists?
This opinion piece contains many questionable numbers. In the old days it would've been spiked.
"Who's really endangered?" My answer may surprise you: Newspaper copy editors.
A quick reading of the opinion piece written by Elizabeth Nickson left me asking, "Where is a copy editors when you need one?" Copy editors are an important and respected part of every newsroom — or, at least, were in the not-so-distant past. These talented, well educated, team players fixed grammar, corrected spelling and checked both usage and style for agreement with the newspaper's in-house style guide. (This post would look quite different if I had a copy editor.)
Copy editors acted as proofreaders, fact checkers and polishers of dull prose. Exceedingly knowledgeable, copy editors had solid backgrounds in journalism. Some of the best were first-rate reporters before moving to the desk.
Sadly, copy editors are a dying breed. Many have been given early retirement, their jobs declared redundant by the giant media conglomerate owners.
The opinion piece written by Elizabeth Nickson, a fellow at the right-wing Frontier Centre for Public Policy, often called a right-wing think tank, is a good example of writing in need of a skilled copy editor.
Nickson immediately stakes out the territory she is attempting to control: The sixth great extinction. "Unlike climate change, the notion of the sixth great extinction is not contested vigorously . . .," she claims, moving quickly to a full frontal attack on Paul Ehrlich, whom she derisively calls "the godfather of extinction science."
Unfortunately, it seems Nickson got her godfathers mixed and predictions as well. She tells us that Ehrlich predicted 27,000 extinction a day by 2000. He didn't. It was Edward Wilson, the father of sociobiology and a champion of biodiversity, who made that prediction, sort of. He predicted 27,000 extinction a year.
That's more than 70 a day, an amazingly high number until you understand the professor is talking about the destruction of the world's rainforests, the most biologically diverse places on Earth. He is not talking about black-tailed prairie dogs in the west or caribou in Canada's distant north. He does not restrict his prediction to large mammals and birds and this should come as no surprise; Wilson is the world’s leading authority on ants.
Ehrlich's and Wilson's ideas have attracted a lot of opposition over the years. It's a rich, complex world and, just as one would expect, not every biologist studying endangered species agrees with either man. Nickson would be in good company if her facts were correct but they aren't.
Nickson does no better reporting on the black-footed prairie dog situation in Colorado. Numbers are again the Frontier Centre writer's downfall. I won't go so far as to say Nickson is wrong but there is no doubt that her writing lacks clarity. People familiar with the situation in Colorado were puzzled by the Nickson numbers.
Nickson claims 12 million acres was demanded to protect to the black-tailed prairie dog. "In court, the state's scientific rigour won, hands down," she says.
Tina Jackson, Species Conservation Coordinator with the Colorado Department of Natural Resources , wrote me, "I am not sure where they got that information about black-tailed prairie dogs in Colorado." Neither Jackson nor James Baker, also with the DNR, was aware of this ever being taken to court.
Elizabeth Nickson was good enough to share some of her research links with me for this article. Reading through the links, and links to links, she sent me I found the following:
The earliest published estimate of prairie dog occupied acreage in the state (Colorado) is from C.P. Gillette in 1919 . . . (Gillette believed) prairie dogs inhabit about 12 million acres in the State . . . [Is this the source of the 12 million number?]
A good editor will tell a newspaper writer to deliver the goods before the turn. Break a newspaper story into two parts and a large number of readers won't make the turn. Editors keep stories short, interesting and accurate.
Today, a great number of people are failing to even pick up the paper, let alone make it past the turn. If newspapers want to bring back the readers, bring back the copy editors.
g
The CBC is making a big deal of its investigation into the need for seat belts in school buses. I can see the argument. I often accompany my oldest granddaughter on school outings. I sit in the school bus with the children and I feel weird not wearing a seat belt. It has never felt right and so I did some research.
Finding the definitive answer is not a quick search. It turns out this is a complex problem and a lot of folk have given it a lot of thought. Heck, even the researcher quoted this morning in the CBC report was once featured in a New York Times piece carrying the headline "Study Rejects Requiring School Bus Seat Belts."
Kathleen Weber, the researcher quoted by the CBC, told the Times that all the members
of the committee examining the question of seat belts use in school buses were in agreement: the benefits of requiring seat belts were sufficiently
small, and the problem itself sufficiently small, that the committee could not justify
the cost.
I don't like that answer. If seat belts work, put them in the school buses. Period. End of discussion. Surely, cost does not enter into the equation. We are talking seat belts. How much can seat belts cost? The present system of making school buses safe, compartmentalization, cannot be cheap.
No, the question is: do seal belts work? Or more accurately, do standard seat belts work with little children? Think carefully before answering. If you do, you'll realize little children do not ride in the backseat of the family car restrained only by the three-point seat belts provided. By law a booster seat is required. Why? For safety.
In Canada, over a two-year period, 28 children were reported to have sustained injuries consistent with seat belt syndrome; seven of these children remained paraplegic. Among the 16 injured children eight years of age and older, four were properly restrained with three-point seat belts.
Booster seats are an attempt at preventing maladjusted seat belts from causing serious injuries and even death to improperly restrained children. Ill-fitting seat belts are a big safety concern. Studies show children are especially vulnerable to suffering a seat belt caused injury. Transport Canada has some well founded concerns.
As I mentioned, I have grandchildren. I own two types of booster seats: one a booster cushion and the other a high-backed booster seat that installs using the Universal Anchorage System (UAS/Latch). Both are legal in Canada but not everyone in the world agrees. The use of booster cushions is restricted to older children in Great Britain and Europe. In those places, my grandchildren would be breaking the law by using booster cushions.
Whenever possible, I use the high-back booster seats which attach firmly to the car's UAS system. I leave the booster cushions at home in the garage. My gut feeling is that the high-backed, anchored boosters deliver improved protection. I think the Europeans are making the right decision. I'd like to see this style of booster seat, paired with properly designed seat belts, used in school buses.
The Fifth Estate did one thing right. They found IMMI in Indiana. This is a company developing innovative seat belts for school buses. One product features a five-point system that appears to deal with the biggest dangers posed by traditional three-point seat belts. Kudos to the Fifth Estate for finding the IMMI company and bringing it to our attention.
An independent study of the IMMI product or products may be necessary but surely it could be done quickly. Let's make school buses, already remarkably safe, safer still.
Lastly, one-sided attacks, like the one launched by the CBC, make for attention-holding television but such attacks don't encourage folk to come to the table for an adult discussion. I'm not surprised the minister refused to meet with the CBC Fifth Estate reporter. It appears on the face of it that the CBC folk had an agenda and it wasn't getting at the whole truth and nothing but the truth. It was attacking a government bureaucracy. It was in telling a good story.
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When writing a post for my blog, an immense amount of information must be found and read. I admit it may overwhelm me. A better system would be for journalists to work together and to work longer, ignoring self-imposed, artificial deadlines, to deliver accurate information. Below, is just a very small sample of the info found and examined.
Sixteen passengers died and 13 were injured in the Humboldt Broncos bus crash. The
charter bus company involved in the crash had already installed
seat belts without a federal rule, but none of the players were wearing
one.
Research link: http://www.who.int/roadsafety/projects/manuals/seatbelt/seat_belt_manual_module_1.pdf
The three-point lap and diagonal seat-belt used by adults is not designed for children’s varying sizes, weights, and the different relative proportions of children’s bodies. For example, a smaller portion of a child’s abdomen is covered by the pelvis and rib cage, while a child’s ribs are more likely than an adult’s to bend rather than break, resulting in energy from a collision being transferred to the heart and lungs.
Consequently three-point lap and diagonal seat-belts may lead to abdominal injuries among children, and will not be optimally effective at preventing ejection and injury among them. Appropriate child restraint systems are specifically designed to protect infants and young children from injury during a collision or a sudden stop by restraining their movement away from the vehicle structure and distributing the forces of a crash over the strongest parts of the body, with minimum damage to the soft tissues.
Child restraints are also effective in reducing injuries that can occur during non-crash events, such as a sudden stop, a swerving evasive manoeuvre or a door opening during vehicle movement.
Seatbelt Syndrome in Children: This is an interesting paper. Seat belts are good but, when it comes to their use with children, proper booster seats are an excellent addition to increase safety. It should be noted that there are a number of opinions on what exactly constitutes a proper booster seat. For instance, look up what is demanded in Great Britain.
http://www.roadsafetyobservatory.com/HowEffective/vehicles/seat-belts
http://www.roadsafetyobservatory.com/HowEffective/vehicles/child-restraints (The researchers found that abdominal injuries mainly occurred in
children using only a seat belt, emphasising the need for
belt-positioning boosters. (Jakobssen, 2005))
(The main system for safely restraining occupants in vehicles is, of
course, seat belts. However, seat belts do not fit children properly,
and do not fit babies at all. This means they are less effective in
protecting children, and in some circumstances, could even cause injury.
Children are not simply smaller adults; they are proportioned
differently, their bones are not fully formed and their skeletal
structure does not cover and protect their internal organs in the way it
does in adults. All of these things change as children grow older,
meaning that the type of restraint system they use also needs to change,
until they reach the point where the seat belts can provide the same
protection as for adults. (Burdi and Huelke, 1969, WHO, 2009))
Child Car Restraints Compared with Seatbelts
A USA study of 2 to 3 year old rear seat child passengers in crashes
that resulted in at least one vehicle being towed away between 1998 and
2004 concluded that the odds of injury were 81.8% lower for toddlers in
child seats than for toddlers wearing seat belts. (Zaloshnja, 2007)
Another American study comparing the use of child restraints with
seat belts by 2 to 6 year old children involved in vehicle crashes
between 1998 and 2003 found that compared with seat belts, child
restraints (when not seriously misused) were associated with a 28%
greater reduction in the risk for death in children of that age group.
When including cases of serious misuse, the effectiveness was slightly
lower, at 21%. (Elliot, 2006)
A study of crashes in 15 states in America between December 1998 and
May 2002 involving 1,207 children aged 12 and 47 months, seated in the
rear of vehicles, found that the risk of serious injury was 78% lower,
and the risk of hospitalisation was 79% lower, for children in forward
facing child restraints than for those in seat belts. (Arbogast, 2004)
A study of 17,980 children under 16 years old involved in crashes in
15 states between December 1998 and November 2002 found that the risk
for inappropriately restrained (defined as using a seat belt rather than
a child safety seat or booster seat) children was almost double that of
appropriately restrained children. (Durbin, 2005)
An analysis of fatal car accidents in the USA between 1982 and 1987
estimated that children in child safety seats were 50% less likely than
unrestrained children to be killed, but those using the car’s adult seat
belts were only 36% less likely to be killed. (NHTSA, 1998)
When these estimates were updated in 1996, the estimates for the
effectiveness of seat belts on their own had increased to 47% in cars
and 48% in light trucks or vans. The effectiveness of child restraints
had also increased from 69% to 71% for under one year olds and from 50%
to 54% for one to four year olds. (NHTSA, 1996)
I was directed to the Globe and Mail opinion piece by a tweet by a journalism professor. The piece? The Crisis of Living Too Long.
He was right. It was a good piece of writing but a bit too maudlin for my liking. The author tells us that she and her husband aim to "stockpile sleeping pills" as they get deeper into their senior years. I suppose today suicide is an option for those finding life too tough. But it wasn't always so.
When my dad died, suicide was not a good way to leave this world of blood, sweat, toil and tears. For one thing, killing oneself left one's life insurance in question. It left one's spouse and children possibly in a tougher-than-need-be financial crisis.
My dad had a poor heart but excellent doctors. He endured coronary after coronary and after a stay in the hospital he was back home, gulping nitroglycerin pills and waiting for the next major heart attack, the next trip to the hospital and the trip home.
After his last attack, life threw him a changup. He suffered a stroke instead of a heart attack. He lost the sight in one eye, all was a blur. He found himself forced to have one lens of his glasses completely frosted. If he wasn't wearing his glasses, he wore an eye patch. He took no pleasure in his new I'm-a-pirate look. I believe he felt humiliated.
He sold his car. His first new car in decades. It was a small, four-door, Vauxhall with leather seats. It broke his heart to part with that car. But the stroke that damaged his vision also left him slightly paralyzed on one side. The car had to go. In one sense, it was not a big loss as he no longer had a job. The car had become just an expense, a drain on the family finances.
One morning my dad appeared at the breakfast table in his best blue suit. He wore a bright, almost jaunty, tie held firmly in place by a fancy, gold clip. His white shirt was pressed with just the right amount of sleeve extending below the cuffs of his suit jacket. His patent leather Oxfords were perfectly polished. Not a scuff to be seen.
His bald head glistened from the Wildroot used to slick back the dozen or so long hairs he carefully tended. Those hairs were all that protected him from facing the fact he was bald. The world saw him as bald; he saw himself as thinning.
Dad had his usual bacon and eggs breakfast with two pieces of well-buttered toast. He mopped up the dark orange-yellow yolk with a scrap of toast, downed the last dregs of his peculator-brewed coffee, kissed both me and my mother good-bye and walked out of our home and out of our lives.
My dad died in the Prince Edward Hotel.
That was the last either of us saw my dad. Apparently, he took the bus downtown, checked into the Prince Edward Hotel and died. His heart pills, mostly nitroglycerin, were found sitting on the dresser on the other side of the room from the bed in which he was found.
It appeared my dad had died shortly after leaving home but we'll never know for sure. His body was found by the hotel cleaning staff. The hotel called the police, the police, using the information on his pill bottles, called his heart doctor and he, in turn, called us. His doctor identified the body, filled out all necessary forms, and contacted the funeral home.
My dad had a closed coffin, as he wished. Neither my mom nor I ever saw my dad's dead body. His death was from natural causes, a major coronary event unmitigated by medication. His doctor claimed that his death had come so suddenly, so quickly, with such power he had been unable to reach his pills left on the side of the room from where he had stretched himself out seeking relief from the pain.
My dad's death is a story that could be told as I've told it and then left, but to do so would be to tell an incomplete story. My dad died the way he had lived. He was born ill. His mother blamed a sick cow used to provide all the milk given the newborn. In his twenties he had three fourths of his stomach removed: ulcers. In his thirties had had hernias: numerous hernias. He had gall bladder, appendix, bowel operations and more. His health issues in old age, if dying in one's early 60s is old age, were a continuation of health problems that plagued him his whole life.
I'm ending this with a wonderful bit of advice from Monty Python's Life of Brian. And yes, I have considered the jarring note added by this song written by Eric Idle. But, please trust me, as a fellow alive only thanks to my second pacemaker I take great pains to smile. I see no hotel room in my future.
As children stopped taking Aspirin, Reye's syndrome almost disappeared.
Reye's syndrome posed a danger to children when I was young. It was rare but lethal. Today? We rarely hear of Reye's. Why? The relationship between Aspirin (ASA), its use in children and Reye's syndrome was recognized.
The orange-flavoured chewable labeled Baby Aspirin disappeared from drugstore shelves. The powerful drug is now known as low-dose Aspirin.
And yet, today, we still encounter folk using the former name. Even doctors are known to fall into the trap, referring to low-dose Aspirin by it now out-dated-for-a-reason moniker. What puzzles and appalls me is that journalists, those purveyors of truth and accuracy constantly get the name wrong. Where are the editors? In forced retirement, I'd guess.
Aspirin is a drug, a powerful drug and, as with all powerful drugs, taking it comes with risks as well as rewards. If one is healthy, taking even a low-dose Aspirin once a day has always been a questionable practice. As they say: "If it isn't broken, don't fix it."
That said, if you get your medical knowledge from the main-stream media, you might be forgiven for thinking otherwise. The media has a history of presently the taking of low-dose Aspirin as relatively innocuous, almost risk free. To underscore this point, the media often refer to low-dose Aspirin as Baby Aspirin. What could be safer?
This is NOT news. The recent report simply confirms common concerns.
The media should not link babies and Aspirin for the same reason that Bayer changed the name: it was found that parents, especially new parents, thought the low-dose product was made for use by children and infants. It's not. Not today.
If taking Aspirin was risk free,
it might make sense for everyone worried
about heart disease to take it. But Aspirin does have risks.
It can potentially lead to hemorrhagic stroke (bleeding inside the
brain). In the stomach, Aspirin can aggravate bleeding ulcers. Severe gastrointestinal bleeding can
be lethal.
Aspirin is NOT for babies nor children no matter how low the dose. Nor is taking Aspirin completely risk free even for healthy, adult folk. It's a powerful drug and deserves to be treated as one.
I knew that. How? Because my doctors made the risks associated with taking a daily low-dose Aspirin very clear to me. Why doesn't my daily newspaper, and the rest of the MSM, get the story right? It's not difficult and it would lessen the danger of children mistakenly being given low-dose Aspirin.
A young Londoner came down with a illness that left his doctors stumped. And according to The London Free Press, this "experience is all too typical in a country in which Lyme
disease has grown to epic proportions, a crisis that neither doctors nor
public health officials have adequately addressed..."
One problem: The young boy did not have Lyme disease. A Maryland specialist discovered the boy had Bartonella, commonly called Cat Scratch Disease. According to the CDC (Centers for Disease Control and Prevention in the States) people get CSD from the scratches of domestic cats,
particularly kittens. The disease occurring most frequently in children
under 15. The boy in the story was 12 when he came down with his illness.
Which bring us to my second problem: The CDC and many other official sources claim ticks may carry some species of Bartonella bacteria, but "there is currently no convincing evidence that ticks can transmit Bartonella infection to humans."
The young man had an illness that went undiagnosed. Why? The story does not give us enough information to understand why this terrible thing happened.
I sense a bias against the Canadian healthcare system in this story. If it was simply the shoddy Canadian system at fault, why did the boy have to travel to Maryland, a nine hundred kilometre trip. If the American system is so great, why didn't the boy simply cross the border and immediately get help? There are a lot of American doctors closer to London, Ontario, than the specialist in Maryland.
I can feel for this young man. I had a somewhat similar experience. I had a V-tach event while vacationing in California. After running up a bill approaching $30,000, the American heart specialists found nothing to explain what had happened. I was released from the hospital to drive to Vancouver and on home to London, Ontario.
Although one should wait six months before getting behind the wheel after such a cardiac event, I drove some fifty six hundred kilometres immediately after having my heart reset by two paddles pressed tightly to my chest to deliver a jolt of 200 joules. Unlike my Canadian doctors, the American ones failed to discuss driving after being released from the hospital.
When it came to finding a cause for my V-tack event, my London doctors didn't fare much better than their American counterparts but the Canadians persevered, discovered I had a relatively rare form of heart disease and installed a pacemaker/ICD in my chest. I'm now on my second pacemaker/ICD. Thanks to the Canadian system, I have a life. (And thanks to my granddaughters, I have a good life.)
Should the American doctors with all their sophisticated testing equipment have been so easily stumped by my heart disease. I don't know. But what I do know is that I owe my life to my Canadian doctors.
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To keep the above post short I did not examine the newspaper's criticism of the Canada's supposedly out-of-date approach to testing for Lyme disease, but, if interested, read the following.
The story informs readers that in Ontario "doctors won't use a test well-established in the United States and Europe, a Western Blot test, unless patients first test positive using a method known to miss many cases, an Elisa (sic) test."
This would be very damning if it were true. But, it isn't. The CDC (Centers for Disease Control and Prevention) in the States recommends performing an ELISA, or similar EIA test, first and a Western Blot test second. If the first test is negative, no further testing of the specimen is recommended. The American CDC approach and the Canadian one are in agreement. (The respected Mayo Clinic also agrees with the Canadians and the CDC.)
Furthermore, the two steps should be done as designed. The CDC does not recommend skipping the first test and just doing the Western blot. The CDC warns, "Doing so will increase the frequency of false positive results and may lead to misdiagnosis and improper treatment."
Since writing this, I've encountered some criticism. I've decided to post some info from the Mayo Clinic in the States.
Lab tests to identify antibodies to the bacteria can help confirm the diagnosis. These tests are most reliable a few weeks after an infection, after your body has had time to develop antibodies. They include:
Enzyme-linked immunosorbent assay (ELISA) test. The test used most often to detect Lyme disease, ELISA detects antibodies to B. burgdorferi. But because it can sometimes provide false-positive results, it's not used as the sole basis for diagnosis. This test might not be positive during the early stage of Lyme disease, but the rash is distinctive enough to make the diagnosis without further testing in people who live in areas infested with ticks that transmit Lyme disease.
Western blot test. If the ELISA test is positive, this test is usually done to confirm the diagnosis. In this two-step approach, the Western blot detects antibodies to several proteins of B. burgdorferi.
The above has a reference date of May 16, 2018. The above is not stale-dated information.
