Are Reusable Vaginal Speculum a Danger to Patients?

Are Reusable Vaginal Speculum a Danger to Patients?

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In Will Locksley‘s book Fatal Probe, Locksley expresses some critical views on the way the healthcare community and governing organizations manage the sterilization of essential and highly invasive medical devices like a vaginal speculum.

It is a fact kept secret from health care consumers, but readily accepted by medical professionals. Not every piece of equipment, even ones that comes in contact with patients, is subject to full sterilization procedures. Non-sterilization is an accepted standard of care in the U.S. and sanctioned by both the Food and Drug Administration and the Centers for Disease Control and Prevention, according to Locksley. Consider all the facts about non-sterilization practices presented in Fatal Probe.

Why the Big Secret?

Locksley interviewed both consumers and healthcare professionals while researching his book. He states that 95 percent of the people he spoke with couldn’t accept the truth about non-sterilization practices in medical facilities.

Most of the physicians and nurses felt attempting to explain the process and reasoning behind current practices would work against the public’s best interest. If women knew that a vaginal speculum was not sterile, they might refuse to get Pap exams. The methodology was too complex for them to fully understand, so it was kept secret. Healthcare professionals also denied this was an existing problem, despite the facts presented to them.

Pushing for Change

What healthcare professionals call rants in Will Locksley’s book is really about pushing for change. There is a public crusade asking for the ban of non-sterile equipment used during invasive procedures. That push has seen results in many countries. Both Canada and the United Kingdom have implemented new guidelines, but the United States is still lagging.

For their part, U.S. medical professionals are requesting evidence that the current cleaning techniques pose a risk to patients, reports USA Today. Locksley feels this typical response highlights the “elitist” attitude often exhibited by the American Medical Association and other governing bodies.

Studies show beyond a doubt of the danger that exists from the use of non-sterile devices. Tools like vaginal specula are known transfer agents for bacteria and viruses. The evidence is there, the medical decision makers just fail to accept it.

The Politics of Medicine

The debate over sterile vs. non-sterile medical equipment is a political standoff when the issue becomes a talking point in campaigns. The politicians skirt around questions by stating they need to assess the advice given by the medical bodies before commenting – further reinforcing the AMA’s claims that they need more proof.

This is despite some impressive data offered in a 2002 USA Today article written by Julie Appleby. She states Dr. David Lewis estimates up to 275,000 Americans get a healthcare associated infection, or HAI, from non-sterile scope procedures. Shouldn’t the attitude be that patients need proof that non-sterile procedures are safe not the other way around?

What Do Scientists Know About This Problem?

Even the CDC acknowledges that HAIs continue to be a pressing concern. Their current estimate shows around 80,000 people die each year from an infectious disease caught while in a hospital. That number doesn’t account for patients seen outside of the hospital, however, where over 15 million invasive scope procedures are done annually. Retired CDC microbiologist Walt Bond claims that regulating bodies like the CDC are fully aware that devices such as vaginal specula and scopes are causing infectious outbreaks.

Johns Hopkins University states that if the sterilization of semi-critical devices such as laparoscopies, endoscopes, vaginal specula and probes is not available, disinfection is an acceptable practice. These items only come in contact with mucous membranes or skin, so the risk is minimal.

This means that a leading educator is teaching future doctors that sterilization of invasive medical devices is not all that important. The term the facility uses is “second in importance,” but the meaning is clear. There is no reason to protect delicate areas like mucous membranes from the transmission of potentially deadly pathogens.

Locksley explains that this is not a credible claim. Microorganisms can transfer using microscopic openings, meaning it doesn’t take much to contaminate a patient. A 1989 study published in Obstetrics and Gynecology states that an infection may transfer via mucosa, during a gynecological examination, for example.

The Uniqueness of HPV

HPV has been found on device surfaces in more than one study. In 1997, researchers detected HPV DNA on medical instruments and gloves even after they were disinfected with ethanol. Cases of genital warts have been reported in children and young women despite no history of sexual activity. The conclusion is that HPV could be transmitted via a hard surface.

HPV is a particular concern because it is resistant to desiccation. Most viruses have a lipid envelope and can be inactivated by desiccation. HPV is also heat resistant. Cleaning procedures that do not exceed 56 degrees Celsius may fail to eradicate the virus.

The HPV risk is especially prevalent in the gynecological community, because of the use of metal vaginal specula and probes. Publicly, the CDC states that you cannot become infected with the human papillomavirus during an examination. HPV transmission only occurs through genital/anal or skin contact with a person who carries the disease.

In 2002, the CDC did admit in response to an inquiry that they had no guidelines for the processing of these devices. Specula should at least be washed and subjected to high-level disinfection, but they can withstand sterilization in an autoclave. The question is: if they can withstand the heat of sterilization, why is that not a requirement? HPV is a leading cause of cervical cancer, making it an infectious disease that could potentially be transmitted through mucosa.

There are no official reports available about cross-contamination from specula, but the symptoms of an infection may not present for weeks. Women fail to realize that their Pap exam was the source. Physicians are certainly not going to admit any wrong doing even if they are challenged. The few patients that have questioned the current practice have hit dead ends in part due to lack of support from the CDC and FDA.

Will Locksley, the author of Fatal Probe, warns specifically about non-sterile vaginal specula, but feels his claims will fall on deaf ears. The truth is the metal devices have intricate designs and many places where biological debris can hide. To think that even sterilization is enough to eradicate all potential pathogens is ignorant.

Medical supply companies use this ongoing concern to promote the safer single-use disposable vaginal speculum. If they understand the risk, why can’t physicians and other medical professionals embrace the concept? Switching to an entirely single-use disposable vaginal speculum eliminate all risk of cross-contamination.

Governing bodies in other countries have changed their guidelines regarding the reprocessing of reusable vaginal specula between uses. Why is it the U.S. is still living in the dark ages regarding this basic concept?







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