FATAL PROBE

CHAPTER II

WIDESPREAD USE OF NON-STERILE
MEDICAL INSTRUMENTS IN THE U.S.:

A Critical Situation Perpetuated By The Fear Of
Millions Of Huge Medical Malpractice Lawsuits

Author's note: No apologies are made for the vituperative
tone of this chapter. There is a time and place for anger.
The time has come and the place is here.

Non-sterilization of highly invasive medical appliances is an accepted
‘Standard of Care' by the American Medical Association, a protocol
sanctioned by the FDA and the CDC.

More than 90% of the two to three hundred U.S. residents with whom
this disturbing, secreted issue has been discussed over the last six
years had a difficult time accepting the following hard-to-believe
facts concerning the widespread use of non-sterile, invasive medical
instruments.

In addition, many physicians and nurses interviewed during the
research and writing of this book flatly denied most of the concerns,
dilemmas and conclusions addressed, dismissing them as ‘Cassandraish'
rants. They vehemently insisted there was no need to bring the
public's attention to the subject . Some who took the time to hear the
facts claimed that women informed of these matters would misinterpret
the information and become afraid to submit to Pap exams .

However, those rants may have already influenced a change. Since the
beginning of this worldwide, very public crusade to rid the system of
the use of known non-sterile equipment and practices , there have been
notable and recent changes in Canada, the United Kingdom and other
countries – but not in the U.S.

THE U.S.

"…hospitals and doctors say they need proof that medical scopes pose a
danger. … critics say Lewis doesn't have any documentation to prove
his estimate that up to 275,000 Americans are infected by scope
procedures each year."
Scope-Cleaning Procedures Debated, Julie Appleby, USA TODAY,04/07/02

"… I wish I had a nickel for every (scope) outbreak I heard about
while I was there (the CDC)…"
Walt Bond, retired CDC microbiologist, USA TODAY, 02/18/99

"If it (sterilization of laparoscopes, endoscopes, vaginal specula and
probes, etc.) is neither available nor suitable, HLD (disinfection,
not sterilization) is the acceptable alternative for final
processing."
"These items (laparoscopes, gastrointestinal endoscopes and vaginal
specula) are second in importance and affect mucous membranes and
small areas of nonintact skin … When correctly performed,
sterilization clearly is the safest and most effective method for the
final processing of (these) instruments."
Johns Hopkins University

"…CDC does not have guidelines that address these devices
specifically."
Lynne Schulster, PhD, Healthcare Quality Promotion Div.; CDC / NCID

According to the Institute of Medicine (IOM), U.S. hospitals are
killing about 100,000 patients every year. CDC estimates that more
than 80% of them – 80,000 – die from an infectious disease, which is
about 4% of an estimated 2 million annual infections caused by
physician care and hospital stays , .

The mainstream media has reported this as Medical Errors; however, the
medical profession has made a conscious and calculated choice to use a
wide variety of non-sterile instruments, which are known to be
potential vectors of various deadly pathogens.

Therefore, a significant percentage of these infection ‘incidents'
cannot be attributed to innocent errors… they were wholly, 100%
predictable and, consequently, must be labeled Medical Malpractice.
A realistic fear of massive liability is the only conceivable reason
the AMA and its members continue to use and defend the merits of
non-sterile devices .

The fact is, if only 10% of those 2 million patients infected annually
by physicians ‘connect the dots' and conclude they were cross-infected
with a non-sterile speculum, endoscope, probe or some other medical
device, the resulting legal actions against manufacturers and their
agents (medical providers) would dwarf the multi-billion dollar
tobacco litigation.

OTHER COUNTRIES

Bathgate, Scotland - Financial Times Information Limited, 13 November
2003
GP'S SMEAR BLUNDER PUTS 100 WOMEN AT RISK OF HIV
A family doctor is under investigation after an astonishing blunder
put up to 100 women at risk of contracting HIV and hepatitis.
Dr Carol Stewart mixed up sterilised and unsterilised equipment
(specula) used for carrying out cervical smear tests. The
extraordinary mistake by the GP, who is still working at the Newland
medical practice in Bathgate, West Lothian, meant that for 18 months
100 women were given (Pap) smears with unhygienic instruments.
…officials at the Scottish Executive were alerted.
…the document (issued by the Scottish Executive) recommends 'at risk'
women should be offered screening for HIV, hepatitis B and C and
sexually-transmitted diseases and suggests offering hepatitis B
vaccinations.
It is also feared patients may have been exposed to the human
papilloma virus - the main cause of cervical cancer - and chlamydia,
which can cause infertility.
…Dr Brian Montgomery, medical director at West Lothian Healthcare NHS
Trust, said patients would be offered counselling, advice and
screening. A helpline has also been set up.
…last night patients' groups and experts expressed anger over the
blunder.
…Infections expert Professor Hugh Pennington said: 'This will be very
bad news for the campaign trying to encourage women to have smear
tests because it will decrease public confidence in a very effective
procedure that should be utterly safe.'

Birmingham, England - Public Health Nurse and Consultants for
Communicable Disease Control; Communicable Disease Unit; Birmingham
Health Authority
Infectious Disease Guidelines.
Vaginal Specula Examination: "All reusable items in contact with the
vagina must be decontaminated between use with a heat method of
sterilization, not by disinfectant or boiling water… Use disposable
speculae where possible."

Ontario, Canada - College of Nurses of Ontario
Infection Control Guidelines For Rns And Rpns:
"…vaginal specula must be sterilized to prevent transmission of the
(human) papilloma virus (HPV) ."

DISCUSSION

In the U.S., electric heating pads, hairdryers and numerous other
everyday household appliances must be put through a detailed series of
rigorous, very expensive tests by Underwriter's Laboratory (UL) – or
some other approved testing facility – before they can be brought to
market.

For example: Although heating pads were first introduced over 80 years
ago, U.S. retailers require a certification from UL (or a competing
lab) – which involves several months of rigorous testing – before
allowing a new heating pad design to be placed on their shelves. This
is true even though identical wires, controllers and fabrics are used
that were previously tested by UL and approved in dozens of other
heating pad designs.

These are not requirements of a federal agency and there is no law
forcing retailers or manufacturers to adhere to such rigid, inflexible
standards. They are the strict requirements of private industry, in
their effort to eliminate dangerous appliances from the market.

Certainly, the primary driving force behind this ‘mindset of safety'
is the fear of product liability lawsuits from users injured due to
defects or design flaws in their products.

Manufacturers, purchasers and users (medical providers) of medical
devices do not have this same fear of retribution, because they are
shielded by several layers of protection (i.e. ‘Standard of Care')
from those who are infected with or by medical instruments.

Non-Sterile Scopes

Scopes used to explore the internal organs of tens of millions of
patients every year cannot be sterilized because of known design
flaws. Nevertheless, neither the FDA nor the CDC has a problem with
that, and most manufacturers are given a ‘pass'.

It is shocking that the FDA does not require many highly invasive
medical appliances to pass the same strict, ‘do-no-harm', standards as
a common household-heating pad.

The leading offender in this area is the largest manufacturer of
medical instruments, Olympus of Japan, an off-shore, mega-billion
dollar firm, who admits in several of their applications to the U.S.
Patent & Trademark Office (USPTO) that their scopes cannot be
sterilized because they cannot survive the level of heat needed for
sterilization.

Olympus also states in their patent applications that, because of
design flaws, body material and blood (which can contain deadly
pathogens) may become trapped inside the scope.

So, body material and blood can become entrapped in Olympus scopes,
scopes that cannot be sterilized.

Medicine's Dirty Little Secret, Hard-To-Clean Endoscopes Can Transmit
Infection
by Robert Davis, USA TODAY, 02/18/99.
"Lloyd Shue picks up an internal channel from a medical instrument
called an endoscope and points to, but does not touch, the rusty brown
lining inside. This hospital probably thinks it's doing a good job
cleaning," he says. "That's somebody's blood and guts."
…if this specific tube were not in Shue's hands at FiberTech Medical…
it would be snaking its way inside an unknowing patient.
… FiberTech repairs about 1,500 medical endoscopes a month; about 30%
of them have not been cleaned properly.
… public health experts say only a fraction of infection cases are
reported
…Microbiologists say they hear story after story of infections thought
to have been spread by an endoscope. These stories, they say, indicate
that the infection risk is much higher than the official line.
… because it's nearly impossible to look inside the scopes after
cleaning, nobody knows for certain whether they're free of what one
doctor calls "schmuts," the Yiddish word for filth.
… "I wish I had a nickel for every outbreak I heard about while I was
there (the CDC)," Bond says (Walt Bond, retired CDC microbiologist).
When doctors, nurses and local health officials would tell him about
infections caused by endoscopes, "I'd say, 'Wow, did you report that?'
And they would say, 'No. We were afraid we'd get sued.' "
… As a microbiologist, Bond knows that infections are spread more
often than 1 in every 1.8 million procedures. "That's out of line," he
says.
… a Florida businessman is suing the Mayo Clinic Jacksonville,
claiming that a flexible sigmoidoscopy to check his lower colon gave
him the human papillomavirus (HPV)
…A Los Angeles lawyer, who does not want to be identified publicly,
has filed a similar suit. He also says he contracted HPV from a dirty
endoscope during a routine colon exam.
Neither case appears to have been reported to local health officials.
… There was the hospital that kept using a scope clogged with blood
because officials saw no scientific proof of a risk. And there was the
doctor's office where a high school girl cleaned the scope in the
toilet.

Scope-Cleaning Procedures Debated
by Julie Appleby, USA TODAY, 04/07/02
Two days after Mary Greene went for a routine colonoscopy in September
2000 at her doctor's clinic, she fell ill. After a round of strong
antibiotics, she recovered and didn't think too much of it.
But four months later, Greene picked up the local paper and read that
the clinic was contacting some patients because its machine for
cleaning the medical scopes might have been faulty.
"I'm very upset that such a thing could happen in this day and age,"
says Greene, 72, who has joined a lawsuit against the clinic and is
convinced that her infection with a bacterium after the exam wasn't a
coincidence, although a direct link will likely never be proved.
…hospitals and doctors say they need proof that medical scopes pose a
danger.
"Endoscopy is an extremely safe procedure," says Douglas Nelson, a
gastroenterologist and associate professor of medicine at the
University of Minnesota. …
More than 15 million Americans each year have a medical test involving
an endoscope, a device with a flexible, reusable tube that snakes
inside patients' throats, lungs or intestines, helping physicians find
and treat disease without surgery.
… Problems (infections) can crop up days, weeks or months after the
initial test, and no one links them with the scopes. No large study
has been performed to follow patients after exams to see if they
develop infections.
The devices are considered disinfected, but not sterile.
His critics say Lewis doesn't have any documentation to prove his
estimate that up to 275,000 Americans are infected by scope procedures
each year.
…Even Olympus Optical has explored making disposable scopes. Olympus
holds more than two dozen patents on the technology, issued during the
mid-1990s. Those patents point out that cleaning conventional scopes
is difficult and time consuming and might not be satisfactorily
performed. But the company has not made disposable scopes.
"They received limited interest by physicians, and we have never
commercialized a product," says David Barlow, director of technical
assessment for Olympus, a privately held company based in Japan.

PARTY LINES

You may be asking yourself how the AMA, CDC and FDA – with full
approval, and no apparent objection from the medical community – can
justify the fact that they allow these potentially contaminated,
infectious medical instruments to be used to probe, poke and pry into
the deep, sensitive recesses of our bodies.

The first ‘party line' goes something like this :

"There is no need to sterilize medical instruments used to examine
body cavities, because those areas are already non-sterile."

We do not need a rocket scientist to tell us that our GI tracts, the
female vaginal cavities, our mouths , ears and nasal cavities are
non-sterile. However, they also are not necessarily infected with HIV,
HPV, HCV, CJD or some other deadly pathogen.

On the other hand, there is no way of knowing whether one or more of
the patients who are previously examined with the same instruments
just rammed into my ‘whatever' are infected with one of these
diseases.

If a patient is infected, and the instrument used to examine that
person is not thoroughly cleaned, and then properly sterilized before
being used in your medical exam, there is a good possibility
cross-infection will occur.

Another ‘party line':

"There is no need to sterilize medical instruments used to examine
body cavities, because body cavities are encased in intact, mucous
membranes."

We will allow Dr. Sanford F. Kuvin, Founder of The Kuvin Center for
Infectious & Tropical Disease to address this incredible claim. He
said:

When examining a body cavity "you're going to abrade the mucous
membranes and you're going to get, if not macroscopic, you'll get some
microscopic bleeding for sure, because you're putting a hard
instrument against a mucous membrane."

A third ‘party line':

"There have been only 1 in 1.8 million infections reported as a result
of (scope examinations)."
The operative word used here is "reported". Patients who have been
infected by these medical devices have ‘reported' the incidents to
every agency that would listen – both federal and state; however,
there is not record of their ‘report'. In fact, there appears to be no
place to report such ‘incidents'.

The source of this spurious, purposefully misleading claim of 1:1.8
million can be traced to one single person, Dr. Fred Silverstein, the
inventor/developer of a medical scope and a member of the American
Society of Gastroenterologists (ASGE), which has embraced this
allegation as one of its tenets and drags it out when having to defend
its members' use of non-sterile scopes.

Non-Sterile Gynecological Instruments

Over-the-counter medications come with warning labels. Your annual
trip to the gynecologist does not, though it should.

Read the response from CDC's Dr. Lynne Schulster to a question
concerning the sterilization of the specula and vaginal probe:

12/10/2002 Re: Inquiry About Vaginal Specula and Probes

Your inquiry regarding appropriate reprocessing strategies for devices
such as specula and vaginal (ultrasound) probes has been referred to
me.

At present, CDC does not have guidelines that address these devices
specifically. The current guideline that touches on this indirectly is
the 1985 CDC Guideline for Handwashing and Hospital Environmental
Control.

In this 1985 guideline, there is a statement that discusses general
principles of reprocessing based on the Spauldling classification of
instruments and devices. Items that contact mucous membranes or
non-intact skin (i.e., semi-critical instruments and devices) should
receive High-Level Disinfection at a minimum.

Most specula that I have encountered are metal and reusable. These
should be thoroughly cleaned prior to terminal reprocessing. Many
clinics will subject these to high-level disinfection, but metal
specula could withstand moist heat sterilization using an autoclave.

In general, if a device is heat stable, the most economical and
effective method of terminal reprocessing is moist heat sterilization.
However, many semi-critical instruments and devices are made from heat
sensitive materials, and so these items usually receive high-level
disinfection if the healthcare facility does not have access to any of
the contemporary low-temperature methods of sterilization.
Lynne Schulster, PhD, Healthcare Quality Promotion Div.; CDC / NCID

The "CDC does not have guidelines" for the reprocessing of the vaginal
specula , a device used in over 100 million invasive, gynecological
exams per year in the U.S. alone. However, as Dr. Schulster's message
denotes, the gynecological speculum and probe are "Items that contact
mucous membranes", which the CDC classifies as "semi-critical
instruments and devices" and therefore according to the Spauldling
classification of instruments ", "should receive High-Level
Disinfection".

High-Level Disinfection destroys all microorganisms except some
endospores .

Endospores are made by bacteria that cause tetanus (Clostridium
tetani), gangrene (Clostridium perfringens) and anthrax (Bacillus
anthracis).

Dr. Schulster: "Many clinics will subject these to high-level
disinfection, but metal specula could withstand moist heat
sterilization using an autoclave."

The nonchalant attitude conveyed by the high level CDC representative
is astonishing. Especially in light of the fact that HPV infected
cells are found on instruments used to examine women with HPV
infection and, if the instruments are not cleaned and sterilized
properly, they are a potential source of infection for the next
patients.

As described in detail in a later chapter of this book, HPV (human
Papillomavirus) IS THE CAUSE OF CERVICAL CANCER, and can be
transmitted sexually or via fomite, i.e. medical instruments.
Therefore:
CERVICAL CANCER IS AN INFECTIOUS DISEASE THAT IS TRANSMITTABLE BY
MEDICAL INSTRUMENT!

If the specula can withstand moist heat sterilization, then why does
the CDC not require the sterilization of these devices?

Excerpts concerning Infection Control published by Johns Hopkins
University and supported by the CDC and the FDA:
Semicritical. These items are second in importance (laparoscopes and
gastrointestinal endoscopes and vaginal specula) and affect mucous
membranes and small areas of nonintact skin … When correctly
performed, sterilization clearly is the safest and most effective
method for the final processing of (these) instruments. If it is
neither available nor suitable, however, HLD (disinfection) is the
acceptable alternative for final processing.

Why are there no official reports of specula-related
cross-contamination of any type of microorganism?

An infection contracted from a speculum will not present symptoms for
30, 60, 90 days or longer… and there lies the rub. Primarily because
of this lapse of time, a woman rarely suspects her health care
provider. Her immediate suspicions center on her most recent sex
partner and if she is married, she will suspect that her husband has
been ‘messing around'.

In the extremely rare event she suspects cross-infection from a
gynecological exam, and takes the step of questioning her doctor, she
will be assured beyond any doubt that it would be impossible to
contract a pathogen during an examination.

If a woman happens to be a virgin or because of the death of a spouse,
injury or old age she has been celibate for several years, the doctor
will introduce her to the "Dormancy Theory." [See "Dormancy
Misrepresentation."]

In no case will the physician admit to any remote possibility that the
patient could have received the infection during an exam.

The following story is exemplar of what patients face when they
suspect their medical provider has infected them. Since this scenario
could apply to a number of various pathogens, no reference is made to
a specific microorganism…

Ann, a 22-year old virgin, has never been infected with a pathogen of
any type. Because she was told that cervical cancer is hereditary –
and her grandmother was a victim of the disease – she has kept a
yearly appointment with Dr. Metker, her gynecologist, for the last
three years. She has passed all the exams with flying colors, with
absolutely no problems whatsoever.

When she began to experience symptoms 45 days after her last exam, she
made an appointment with Dr. Metker, who knows Ann is a virgin and
that she has never been infected with any type of gynecological
disease and has had no other disorders.

Metker first pressed Ann with questions regarding "any sexual activity
without penetration," including the possibility that she had ever been
touched in the genital area by another person. Her answer was "No,
never."

When Ann pointed out that Metker was the only person who had ever
‘touched' her, he became immediately defensive and assured her that he
wore sterile gloves and always used sterile devices during all of his
exams.

Ann actually apologized to him and felt guilty for even suggesting the
possibility.

Six months later Ann read a post in a Yahoo Internet chat room, HPV-1,
which suggested non-sterilized vaginal specula can cross-infect women
with various pathogens.

She also learned from the chat room that non-sterile, ‘community glove
boxes' have actually become an accepted Standard of Care by medical
providers, which become a breeding reservoir for deadly viruses and
bacteria. She recalled that Metker and the nurse always reached into
an open box on the counter to grab a pair of gloves.

She also remembered that Metker and his nurse opened cabinet drawers
and doors both before and after slipping on their ‘non-sterile' gloves
. She had learned from the HPV-1 website that several studies had
reported assays of cabinet tops, door knobs and drawer pulls in
medical exam rooms that showed heavy concentrations of contamination
by various pathogens.

In addition, after a bit of research she learned that reusable, metal
specula – the type used by Dr. Metker – must be autoclaved or gas
sterilized in order to be free of all microorganisms.

Some ‘Rockford File' investigating, involving a friendly conversation
with his receptionist, turned up the fact that Metker had chosen not
to pay the $7,000 for an autoclave and that the specula are simply
thrown into a household dishwasher for cleaning.

Confronted with this information, Metker became upset and simply
repeated there was no way she could have become infected during an
exam in his office, that microorganisms could not be transmitted via
the speculum.

Ann sought the advice of a lawyer, Joe Sedasky, who advertised as a
plaintiff's attorney. During the initial visit, Sedasky was very
positive concerning the possibility of winning a medical malpractice
case against Metker. However, during the follow-up phone call, he told
Ann his ‘legal nurse' had assured him there was no possibility a
pathogen could be transferred via a speculum. She said there were no
reported cases of the transfer of pathogens via the speculum. (See
later section
concerning "Medspeak" and "Medical Hearsay", which describes how many
baseless medical theories take on a life of their own and become
"Common Knowledge".)

Sedasky told Ann he would gladly take her case, but would need $20,000
up front for expenses, plus another $10,000 to $15,000 for expert
witnesses, that the case would be in court for at least a couple of
years and that even if she won, Metker – backed by his insurance
company – would appeal the verdict.

Ann did not have that kind of money and knew that even if she did, she
could not win.
Ann's ‘case' was never officially reported. She had reported the
details of the incident to the State of Florida, the CDC and the FDA,
but never heard from them. Her ‘reports' were ignored. (… as are most
all other ‘patient reports' involving infection incidents in private
doctor's offices and clinics.)

Dr. Metker's practice continues to grow, he continues to use
non-sterile gloves, non-sterile instruments, non-sterile techniques
and he continues to knowingly cross-infect other women… without any
fear of sanction.

He knows he is protected by the code of Standard of Practice, which
means that as long as all other doctors in his area continue to use
non-sterile gloves, non-sterile instruments and non-sterile techniques
he has no fear of penalty or punishment.

It is possible that contamination may occur with use of contaminated
speculum and forceps.
Non-Sexual Transmission Of Sexually Trans. Diseases; Broso P, et al;
Minerva Ginecol 1992; Sep; 44

The glaringly obvious truth that contaminated devices can infect
people is common knowledge. Yet, when we put ourselves in the hands of
our healthcare providers, we defer to their knowledge and authority.
We assume they will protect us. They have been educated and trained,
and are bound by oath to do no harm while they attend to our health.

However, that blind faith we naturally invest is no longer deserved.
Women must guard their health, even in the face of modern medicine.

Ask yourself, "Who has more to lose, me or my doctor?"

The evidence is compelling, if not overwhelming and conclusive. Though
the CDC and the FDA will tell you the author's warnings concerning
contaminated specula and other medical devices are surreal and
immanent, do not be misled. The dangers of reusable vaginal specula
are in fact real and imminent.
Even devices that receive the appropriate length of time in a
functional, recently serviced and calibrated autoclave unit could be a
potential vector for deadly microorganisms.

The metal devices have moving, hinged parts that can easily become
impacted with lubricant in which organisms often become imbedded.
Unless devices are taken apart and thoroughly washed prior to being
placed in the autoclave, pathogens hiding within the overlooked gel
can survive the sterilization process. [Note that some specula cannot
be disassembled.]

If reusable specula are indeed safe, and do not need sterilization,
why does every medical supply firm make the following prominent claims
in their advertisements of disposable, vaginal specula?

U. S. Medical Supply: Disposable Vaginal Speculum
"Reduced risk of cross contamination"

Welch Allyn: Disposable Vaginal Specula - 580 series
"Eliminates cross contamination"

Pelican: Disposable Vaginal Speculum
"Provides protection from cross-infection"

Surge Industrial: Disposable Vaginal Speculum
"Reduce possibility of cross-contamination"

Leespec® Speculum: Improved disposable vaginal speculum
"Eliminating the risk of cross infection"

Ask yourself: Why are these medical supply firms so very aware of
cross-infection from reusable speculum?

The proper use of the disposable specula does indeed eliminate the
risk of cross-infection – at least from the vaginal specula itself.
Cross-infection can obviously still occur if other non-sterile
elements are introduced into the exam, such as hands that were not
properly washed immediately prior to putting on sterile gloves.

Bill and Melinda Gates Sponsor Misinformation to Women

Copied from the website EngenderHealth. … which is made possible
through a grant from the Bill & Melinda Gates Foundation:

Case Study #18:

At a community health clinic, the specula used for pelvic examinations
are processed by boiling. Nurse Diop, who has just started working at
the clinic, feels that the specula should be sterilized to reduce the
risk of infection in clients. Nurse Mwari, who is responsible for
processing the instruments and other procedure items, tells Nurse Diop
that the specula are sterile, because the label on the front of the
boiler says "Instrument Sterilizer."

Are instruments and other items sterile after boiling? Is HLD (high
level disinfection) appropriate for processing specula?

Answer(s) to Case Study #18:

Are instruments and other items sterile after boiling?
No. Boiling is a method of HLD, which means that all microorganisms,
except some bacterial endospores, are killed.
Is HLD appropriate for processing specula?
HLD is suitable for processing specula to be used during vaginal
examinations because the specula will come in contact only with intact
mucous membranes. In addition, HLD by boiling may be more
cost-effective than sterilization.

The hidden – and libelous – take-home message of these studies is that
there is no need to sterilize reusable, gynecological instruments.

Notice there is no criticism of the fact that the label on the front
of the boiler reads "Instrument Sterilizer." At the least, the
suggestion should have been made that the label should be changed to
"Instrument Disinfection – NOT STERILE"

More importantly, Engender Health's claim "HLD is suitable for
processing specula to be used during vaginal examinations because the
specula will come in contact only with intact mucous membranes." is
not only irresponsible, it is libelous.

Women who become infected with these devices could very well have a
claim against this organization if there is any possibility that their
medical provider might have read this statement and/or may have been
influenced by this claim.

Although the proper use of the ‘individually wrapped', disposable
plastic specula is the ‘gold standard', many medical providers
continue to use reusable metal specula, which in most cases are not
sterilized between exams.

Sterilization of medical devices is time consuming, which many medical
providers consider costly, non-essential steps in the area of
gynecological exams. They claim the vaginal cavity is already
non-sterile; therefore, there is no reason to use sterile devices.
They also claim the vaginal cavity is lined with intact, mucous
membranes.

Ref.

[1] During the six-year campaign to eliminate the permissive use of
non-sterile medical equipment and procedures, thousands of repeated
emails, letters and phone calls have been directed to television
network and stations, newspapers and magazines, state and federal
agencies, most medical universities, every congressional
representative, every state governor, every Infection Control agency
in every country, etc., etc., etc.

Web sites were set up and posts were made to dozens of
medical/health/illness chat rooms and newsgroups, which gave the facts
concerning the issue. Numerous members of the medical community
located primarily in the U.S always dramatically attacked these
efforts.

Scheduled appointments with government agencies (i.e. the CDC) were
cancelled at the last minute after learning of the author's research
and public profile with regard to concerns with cross-contamination.

[2] The strongest objections came from a few OB/GYNs. However, others
understood the problem and encouraged the completion of the book.

[3] Moreover, probably innocently.

[4] See the Chapter: What Health Care Providers And Others Say In
Private.

[5] Pap exams are certainly an important source of income to GYNs and
the need for Pap exams is the primary logic used to encourage regular
office visits – during which, more often than not, other medical
billings are generated. This is more than likely the true reason the
AMA has so vigorously objected to the simple and easy "Self-Pap Test",
which has been accepted in most other countries.

[6] The author's campaign in the area of non-sterile medical equipment
has received international attention through television news stories
and the print media.

[7] Center for Disease and Control

[8] According to our estimates, the number of patients infected
annually by private physicians alone is greater than 3 million. See a
later chapter that details these numbers.

[9] It is important to remember that these types of broad-based
decisions/changes that affect the entire U.S. medical profession (as
well as the CDC and the FDA) are not made by individual physicians.
Gaggles of $350/hour, silk stocking lawyers map out 10 to 20 year exit
plans, supposedly designed to elicit the minimum amount of liability
exposure, which, sadly and regretfully, has become one of the top – if
not "the" – primary consideration when deciding many important U.S.
public health issues.
In effect, those who give this type of high-level advice to the
medical profession think of themselves as being in a huge poker game:
Winner-take-all. (But playing with someone else's money.) They know
they have a losing hand, they know their client is wrong, and have
pushed all their chips to the center of the table. If they now
recommend elimination of non-sterile practices (after irresponsibly
and knowingly infecting untold numbers of patients), they will have
blinked and admitted they had been wrong. And whether something is
right or wrong is seldom a subject in the legal profession.
It is disturbing that the very patients who are harmed by the use of
these instruments and practices are paying those $350/hour lawyers in
higher medical fees.

[10] Using CDC's smaller number, not our 3 million figure.

[11] HPV is actually "the" cause of cervical cancer.

[12] Again, for emphasis, HPV, a highly infectious virus, is the cause
of cervical cancer (as well as several other cancers)

[13] All of these ‘party lines' are attributable to what the author
refers to as "Medspeak", which quickly becomes "Medical Hearsay",
which turns a theory (an assumption based on incomplete information or
knowledge) into "Common Knowledge" among the medical elitists.
("Medspeak" and "Medical Hearsay" are described in detail in the
Introduction to this book.)

[14] Because of work done by Dr. David Lewis, guidelines have been
established in the U.S. which mandate that all reusable dental
instruments must be sterilized between patients. Dr. Lewis is a
world-renowned microbiologist who was enlisted by the author to assist
in bringing this matter to the light.

[15] Or numerous other invasive surgical devices

[16] Spaulding EH, 1968. Chemical disinfection of medical and surgical
materials. Adopted by the CDC for their infection control guidelines.

[17] Sterilization destroys all microorganisms, including endospores.

[18] DJ McCance, MJ Campion, A Baram, and A Singer. Risk of
transmission of human papillomavirus by vaginal specula. Lancet,
2(8510): 816–7, 1986

[19] Doorknobs: a source of nosocomial infection, Diagnostic Medicine,
Nov/Dec, 1983, Phyllis J. Kuhn, Ph.D, "..stainless steel produced a
heavy growth of all microbes"