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Widespread Use Of Non-Sterile Medical Instruments In The U.S.

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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

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

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

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.

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.)

Ds. 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.

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?

E. 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,
18(1): 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"
post #2 of 6

Re: Widespread Use Of Non-Sterile Medical Instruments In The U.S.

willlocksley@aol.com (yelxol) wrote in message news:<a71be19b.0401271029.3852d129@posting.google.com>...
> FATAL PROBE

> "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

COMMENT:

While all of this sounds rather scary, I wonder why the author isn't out attacking a far more
pervasive problem of just the same kind. To wit, the re-use of flatware at restaurants. The knife,
fork and spoon that goes in your mouth, which is approximately equivalent to a speculum being used
gently, has been in the mouths of a lot of other people, and who knows what kinds of diseases *they*
had? Or whether or not their gums were bleeding then, or yours are now.

And I promise you that between you and the last 100 customers who used that spoon or fork, there was
not only not an autoclave or EO sterilization, but there wasn't even anything nearly so good as a
medical disinfection with Cidex. Rather, it probably got swiped under a tap with a bit of greasy
soap by some guy in the back of the kitchen who is an undocumented laborer at minimum wage, and for
all you know living in the street when not washing dishes.

Old story: two ladies are having breakfast at a restarant and one orders cow tongue. "Yuk!" says the
other. "How can you eat something that has been in cow's *mouth*?? I'll just have the eggs."

SBH
post #3 of 6
Thread Starter 

Re: Widespread Use Of Non-Sterile Medical Instruments In The U.S.

Dr. Harris: BTW, do you mind if I publish this response... with credit to you? Will

sbharris@ix.netcom.com (Steve Harris sbharris@ROMAN9.netcom.com) wrote in message
news:<79cf0a8.0401271739.1a0a3271@posting.google.com>...
> willlocksley@aol.com (yelxol) wrote in message
> news:<a71be19b.0401271029.3852d129@posting.google.com>...
> > FATAL PROBE
>
> > "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
>
>
> COMMENT:
>
> While all of this sounds rather scary, I wonder why the author isn't out attacking a far more
> pervasive problem of just the same kind. To wit, the re-use of flatware at restaurants. The knife,
> fork and spoon that goes in your mouth, which is approximately equivalent to a speculum being used
> gently, has been in the mouths of a lot of other people, and who knows what kinds of diseases
> *they* had? Or whether or not their gums were bleeding then, or yours are now.
>
> And I promise you that between you and the last 100 customers who used that spoon or fork, there
> was not only not an autoclave or EO sterilization, but there wasn't even anything nearly so good
> as a medical disinfection with Cidex. Rather, it probably got swiped under a tap with a bit of
> greasy soap by some guy in the back of the kitchen who is an undocumented laborer at minimum wage,
> and for all you know living in the street when not washing dishes.
>
> Old story: two ladies are having breakfast at a restarant and one orders cow tongue. "Yuk!" says
> the other. "How can you eat something that has been in cow's *mouth*?? I'll just have the eggs."
>
> SBH
post #4 of 6
Thread Starter 

Re: Widespread Use Of Non-Sterile Medical Instruments In The U.S.

Doctor Harris: At first blush, I thought you were writing in jest, but 'twas not the case. No
disrespect meant - really - but I must say that I would have expected a more learned response from
you. Perhaps you were/are simply playing a game of 'bait the nerd'. Nonetheless, I shall not take
that worm and hope you give it another shot. Best regards. Will

Thomas...: Summarized with grace. (re food dishes... salad, etc) <grin> Will

Thomas Anantharaman <tsa@biostat.wisc.edu> wrote in message
news:<NOIRb.77945$_2.1382@fe14.usenetserver.com>...
> Steve Harris sbharris@ROMAN9.netcom.com wrote:
>
> >willlocksley@aol.com (yelxol) wrote in message
> >news:<a71be19b.0401271029.3852d129@posting.google.com>...
> >
> >>FATAL PROBE
> >
> >>"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
> >>

> >COMMENT:
> >
> >While all of this sounds rather scary, I wonder why the author isn't out attacking a far more
> >pervasive problem of just the same kind. To wit, the re-use of flatware at restaurants. The
> >knife, fork and spoon that goes in your mouth, which is approximately equivalent to a speculum
> >being used gently, has been in the mouths of a lot of other people, and who knows what kinds of
> >diseases *they* had? Or whether or not their gums were bleeding then, or yours are now.
> >

> I don't think the restaurant scenariou is very relavant : most people don't abrade their mouth
> with flatware. The risk of infection of microbes transfered to the food from non-sterile flatware
> (or already in the food from non-sterile dishes, eg salad) is quite small since the primary
> function of the stomach acid is to disinfect all food.
post #5 of 6

Re: Widespread Use Of Non-Sterile Medical Instruments In The U.S.

Thomas Anantharaman <tsa@biostat.wisc.edu> wrote in message news:<NOIRb.77945> >>"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."
> >COMMENT:
> >
> >While all of this sounds rather scary, I wonder why the author isn't out attacking a far more
> >pervasive problem of just the same kind. To wit, the re-use of flatware at restaurants. The
> >knife, fork and spoon that goes in your mouth, which is approximately equivalent to a speculum
> >being used gently, has been in the mouths of a lot of other people, and who knows what kinds of
> >diseases *they* had? Or whether or not their gums were bleeding then, or yours are now.

> I don't think the restaurant scenariou is very relavant : most people don't abrade their mouth
> with flatware.

COMMENT: I've got news for you: most doctors don't abrade vaginas with speculums. Now, it is true
that abrasion of the cervix is done routinely with another instrument, but that one IS sterile. In
the same way it's quite common for people to abrade their gums when brushing their teeth. Or to have
gingiva which are being abraded by poorly fitting dentures. Or to have mouth sores for many other
reasons. The spoon, like the speculum, is merely an instrument for transfer of germ-containing
fluids which are there for other reasons.

> The risk of infection of microbes transfered to the food from non-sterile flatware (or already in
> the food from non-sterile dishes, eg salad) is quite small since the primary function of the
> stomach acid is to disinfect all food.

ROFL! And that's why food and water-borne illness are so uncommon in the world-- all those bugs are
sterilized away by stomach acid. Not.

Look, the primary function of stomach acid may be to partly disinfect food, but that doesn't mean
it's very good at it. Add to which the fact that there are a huge number of people not even getting
that mild benefit, due to taking acid-suppressant medications, or being so geriatric that their acid
production is inadequate.

No, sorry, but the poster is being irrational about at least speculums. They are generally plastic,
disposible, single use, and in any case they serve in much the same capacity as flatware.
Endoscopes, however, are a different issue, and she probably has a point there, particularly when it
comes to those used in abdominal surgery and for surgical procedures like polyp removal. To the
extent that these things can't be completely sterilized, I'm amazed that current guidelines allow
them to be used at all, except possibly in procedures where there is no other good choice, and there
is a significant risk of life in not using them.

SBH
post #6 of 6
Thread Starter 

Re: Widespread Use Of Non-Sterile Medical Instruments In The U.S.

sbharris@ix.netcom.com (Steve Harris sbharris@ROMAN9.netcom.com) wrote in message news:<79cf0a8.0401281233.73329467@posting.google.com>...
> Thomas Anantharaman <tsa@biostat.wisc.edu> wrote in message news:<NOIRb.77945> >>"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."
> > >COMMENT:
> > >
> > >While all of this sounds rather scary, I wonder why the author isn't out attacking a far more
> > >pervasive problem of just the same kind. To wit, the re-use of flatware at restaurants. The
> > >knife, fork and spoon that goes in your mouth, which is approximately equivalent to a speculum
> > >being used gently, has been in the mouths of a lot of other people, and who knows what kinds of
> > >diseases *they* had? Or whether or not their gums were bleeding then, or yours are now.
>
>
>
> > I don't think the restaurant scenariou is very relavant : most people don't abrade their mouth
> > with flatware.
>
>
> COMMENT: I've got news for you: most doctors don't abrade vaginas with speculums. Now, it is true
> that abrasion of the cervix is done routinely with another instrument, but that one IS sterile. In
> the same way it's quite common for people to abrade their gums when brushing their teeth. Or to
> have gingiva which are being abraded by poorly fitting dentures. Or to have mouth sores for many
> other reasons. The spoon, like the speculum, is merely an instrument for transfer of germ-
> containing fluids which are there for other reasons.
>
>
> > The risk of infection of microbes transfered to the food from non-sterile flatware (or already
> > in the food from non-sterile dishes, eg salad) is quite small since the primary function of the
> > stomach acid is to disinfect all food.
>
>
> ROFL! And that's why food and water-borne illness are so uncommon in the world-- all those bugs
> are sterilized away by stomach acid. Not.
>
> Look, the primary function of stomach acid may be to partly disinfect food, but that doesn't mean
> it's very good at it. Add to which the fact that there are a huge number of people not even
> getting that mild benefit, due to taking acid-suppressant medications, or being so geriatric that
> their acid production is inadequate.
>
> No, sorry, but the poster is being irrational about at least speculums. They are generally
> plastic, disposible, single use, and in any case they serve in much the same capacity as flatware.
> Endoscopes, however, are a different issue, and she probably has a point there, particularly when
> it comes to those used in abdominal surgery and for surgical procedures like polyp removal. To the
> extent that these things can't be completely sterilized, I'm amazed that current guidelines allow
> them to be used at all, except possibly in procedures where there is no other good choice, and
> there is a significant risk of life in not using them.
>
> SBH

Dr. Harris: You are apparently going to ride this horse (unsterile eating utinsils) to the wire. I
think the debate style is below a man of your caliber. And I mean that w/o any slurs intended
at all. To argue that it is no more important to use sterile instruments/procedures to perform
Gyn exams than it is to use sterile eating utinsils is absurd... don't you think? Re. abrasion
via speculum: What is your point here? I do not recall anything mentioned re. this. Best
regards. Will
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