always-new ablation catheters, or cleaned/reused?

Does anyone know what Dr. Natale's protocol is, regarding using internal hardware (catheters, etc) on more than one patient (ie, cleaned, then reused)?

So far the only thing I've been able to find online is this 2009 article St. David's Medical Center, interview with Dr. Natale, where he states that he does reuse catheters:

Quote

Spotlight Interview: Texas Cardiac Arrhythmia Institute at St. David’s Medical Center
Volume 9 - Issue 12 - December 2009
...
Does your lab use a third party for reprocessing?

Yes, we use a third party to process our diagnostic catheters and recycle our platinum catheter tips.

However that was 6 years ago.
Does anyone know if he's changed his protocol regarding reusing catheters since then?


---- why this (might) matter ----

I recently came across a number of horror stories where patients caught nasty diseases (HIV, Hep C, etc) due to "less than perfect" disinfection protocols for internal medical hardware used for multiple patients. Unlike metal hardware, which can be autoclaved, hardware such as internal scopes and catheters often contain rubber and/or heat-sensitive electronic components and thus must be "washed" instead of autoclaved. And in a number of cases the protocol itself was rigorous, but due to human error and/or understaffing (read: people rushing), the cleaning protocol was not followed 100% accurately.

In one case, while cleaning the water pumping component of colonoscopy equipment, a 1-way valve (to prevent backwash) was out of stock, so the tech reassembled it and another tech (thinking it was ready to go) put it back in service, resulting in significant co-mingling of fluid between patients undergoing colonoscopies. At one point someone with Hep C came in for a colonoscopy, and many of the subsequent patients who were serviced with the same equipment contracted Hep C.

So far I've consulted two Seattle-area EP's at two different practices, and asked them the following:

Q#1: what, if any, equipment that goes inside the patient (sheaths, catheters, or anything else) is not brand new (ie, has been used on a previous patient)? (I assume it has been "cleaned" in b/n patients, but I don't 100% trust that process, due to stories like those appended below).

Q#2: would it be possible for me to pay extra $ to ensure that only brand new equipment is using during my EP procedure? (Referring to equipment that goes inside the patient, that is).

So far the doctor's answers:

EP#1: the sheaths, etc are new for each patient, but the catheters are used 3 times (for 3 patients). After each patient, the catheter is sent to some external company for cleaning. The reason they replace them after 3 uses is due to RF performance degradation. However the EP said that they could arrange their schedule so that when *I* came in for an ablation, it would be 100% new hardware (ie, I'd be the "4th" person, and thus get all new hw).

EP#2: they use 100% new hw for each patient. When I pressed, he then thought about it a bit more, and conceded that the mapping catheter is not new each time, but is used for multiple patients. However he said that if I wanted, he would make sure to use 100% new hw for me.

---- cut here for examples of why this is a concern ----

Example #1)
Deadly bacteria on medical scopes trigger infections (May 2015, USA Today),

Quote

The deadly pattern of illnesses began to emerge in 2012 at hospitals in Seattle, Pittsburgh, Chicago. In each case, the culprit was a bacteria known as CRE, perhaps the most feared of superbugs, because it resists even "last defense" antibiotics — and kills up to 40% of the people it infects.

And in each case, investigators identified the same source of transmission: a specialized endoscope, threaded down the throat of a half-million patients a year to treat gallstones, cancers and other disorders of the digestive system. They found that the devices, often called duodenoscopes, accumulate bacteria that are not always removed by conventional cleaning, so infections can pass from patient to patient.

Example #2)Hepatitis C virus transmission during colonoscopy evidenced by phylogenetic analysis. (Jul 2013, Journal of Clinical Virology),

Quote

An acute HCV infection was detected in a person that had undergone a colonoscopy after an HCV-infected patient. Serum samples from both persons were subjected to a molecular epidemiology study. The HCV NS5B genetic region was amplified and directly sequenced and the E1-E2 region was amplified, cloned and sequenced (20 clones per specimen). All sequences were subjected to phylogenetic analyses. A conventional epidemiological investigation was performed to determine the most likely cause of HCV transmission.

NS5B sequence analysis revealed that both persons were infected with closely related HCV-1b strains. Furthermore, phylogenetic analysis of E1-E2 sequences evidenced a direct transmission between patients. The epidemiological investigation pointed out to anesthetic procedures as the most likely source of HCV transmission.

Example #3)Hepatitis C outbreaks at three Toronto colonoscopy clinics kept secret (Sept 2014, Liver.ca)

Quote

11 patients contracted the liver-damaging virus during three outbreaks over the last three years: three were infected at the Downsview Endoscopy Clinic on Dec. 7, 2011, three at the North Scarborough Endoscopy Clinic on Oct. 17, 2012, and five at the Finch Ave. W. site of the Ontario Endoscopy Clinic on March 15, 2013.

Example #4)Robert Metzler colonoscopy hepatitis C lawsuit: South Florida veteran awarded $1.25 million (Nov 2012, West Palm Beach TV, WPTV)

Quote

MIAMI -- An Air Force veteran and his wife have won a combined $1.25 million lawsuit against the U.S. government because he likely contracted hepatitis C at the Miami Veterans Administration Medical Center.

U.S. District Judge Adalberto Jordan ruled Wednesday after a nonjury trial that the center's staff didn't properly clean colonoscopy equipment, probably causing 70-year-old Robert Metzler's infection. The Miami Herald reports that Metzler and his wife, Lucy Ann Metzler, had sought $30 million.

.A VA investigation showed that more than 11,000 veterans received colonoscopies with improperly-cleaned equipment between 2004 and 2009 at VA hospitals in Miami, Murfreesboro, Tenn., and Augusta, Ga. ... The hospitals used equipment that had been rinsed after each patient rather than being sterilized by steam and chemicals as called for by the manufacturer. Investigators who took apart water tubes on some of the equipment that was supposed to be clean and ready for use instead found "discolored liquid and debris."

Example #5)10 veterans test positive for hepatitis after colonoscopies (Mar 2009, USA Today)

Quote

The VA has now sent letters advising 3,260 patients who had colonoscopies between May 2004 and March 12 at the Miami Veterans Affairs Healthcare System that they also should get tests for HIV, hepatitis and other infectious diseases.
...
Rupp, a professor of infectious diseases at the University of Nebraska Medical Center, said that "tracking is very difficult" and that hospitals are not required to report mistakes that expose patients to infectious diseases.
...
The VA did say in an March 19 e-mail to AP that at the VA's Murfreesboro colonoscopy facility "one of the tubes used for irrigation during the procedure had an incorrect valve." The statement also said "tubing attached to the scope was processed at the end of each day instead of between each patient as required by the manufacturer's instructions."

The VA letter to Craig said he "could have been exposed to body fluids from a previous patient."

Example #6) Second victim dies from hepatitis C outbreak at Dr. Desai's clinic (Sept 2013)

Quote

Prosecutors contended throughout the trial that unsafe injection practices involving the anesthetic propofol led to the hepatitis C outbreak. The combination of double-dipping syringes into propofol bottles used on multiple patients spread the virus from source patients infected with hepatitis C on the two different dates in 2007, prosecutors contended.

Desai was portrayed as a penny-pincher who ran his clinic like an assembly line, recklessly churning out procedures at the expense of patient care.

Unfortunately there are many more examples, but perhaps the above is enough to convey the sense that this is not a "once in a blue moon" scenario.

I can answer this one and settle your mind at ease Apache.

Dr Natale's group does NOT reuse catheters and sheaths now at all. At one point, many years ago, they used to have a professional sterilization lab re-sterilize the echo camera part of the ICE catheter for reuse elsewhere, but never any other catheters or sheaths and they have not even done that for years now.

Right after Dr Natale came to St. Davids they would cut the platinum tips off ablation catheters after they were used one time only and then resell the precious metal platinum to precious metal processors in order to collect money for training their large staff at St Davids, but they were never ever reused in any one as once cut from the complex catheter tub body you can't just hook it up to another one and make it work. The sold it only for the value of the precious metal and as a good source of income for internal staff training.

Hence all these colonoscopy and other horror stories .. none of which seem to be associated with EPs and AFIB ablation and mostly around some form of 'penny pinching' or unethical docs not following a strict protocol of sterility not surprisingly do not apply to Dr Natales operation in either St Davids, CPMC or La Jolla.

In the fair number of procedures I have witnessed of Dr Natales first hand, overtime the catheters that are used are in sealed sterile packaging right on the sterile table beside the patient and only opened shortly before use within that patient and before hand are bathed in sterile saline also used to clear any micro bubbles as well before insertion into the femoral vein or jugular vein sheaths. They are a strictly professional medical outfit and the one consistent report you hear from other colleagues who have worked for or with Dr Natale over the years is how meticulous and thorough he is with each step of his process. Something I can vouch for as well in what I have personally witnessed.

Shannon

Thanks for the quick reply Shannon, much appreciated! I'm glad to hear that Dr. Natale always uses brand new hw :-)

On a somewhat related note, some surgeons video tape procedures... and give their patient a copy. In fact the orthopedic surgeon I consulted with (non afib issue) said he actually tapes 100% of his procedures (whether or not the patient asks for it), as it serves as an excellent in-depth record of exactly what occurred during the procedure (in more detail than the standard medical report), which can be helpful for those scenarios where a 2nd procedure is needed. And of course it gives a good sense of fulfillment to those patients that want to know all the minutiea about what was found and what the MD did.

Even if the area being modified (cut, ablated, or whatever) is not in view (of the video recording), just hearing the dialog b/n the MD and assistants (on an audio recording) often provides a lot of insight.

Do you know if Dr. Natale will record the ablation procedure (or let the patient do it via a tape recorder)?

(Unfortunately there was a recent court case where some poor schmuck got a colonoscopy, and recorded the audio with his iPhone, and the MD was sued for saying rude things about the patient ... so this may put a big damper on MD's letting patients have recordings of the procedure)

More recent article talks about EP catheter reprocessing. The procedure for dismantling, sterilization and reassembly have to be cleared by the FDA. I don't believe all catheters can be reprocessed, especially ablation catheters. The article talks about ICE and mapping catheters. No mention of sheaths. Duke EP has high reputation and I assume they have done this without issues. There is also a limit as to how many times you can reprocess before the cabling mechanisms wear out. I would like to learn more about how they do this and the QC process.

[www.eplabdigest.com]

Hi Researcher,

Good EPlabsDigest pointer, thanks.

Unfortunately reading the article, I am even more convinced that I want to avoid reprocessed hw if I undergo an ablation. The entire focus of the EPlabs article was on cost savings. No mention of how they verify the effectiveness of the cleaning procedure.

Having "FDA oversight" is not very reassuring, as there are a number of recent accounts of diseases being transmitted via reprocessed hw which has been cleaned by procedures approved by the FDA. Recent example being Virginia Mason.

From the Virgina Mason outbreak article, "The FDA and Olympus have issued new safety warnings and guidelines for cleaning in the wake of the outbreaks."

So, the FDA is not always in front of the curve.

Per Shannon's earlier reply (above), Natale uses zero reprocessed hw, which is excellent news. Other EP's I've consulted said they use reprocessed hw up to 2 times. In other words, every 3rd patient gets new hw. But in my case, because I asked... they would make sure to use new hw for my procedure. Besides the fact that they're not Natale (skill level), I have my doubts about whether that verbal promise will be effectively communicated through the bureaucracy to the person who lays out the hw for the procedure.

Cheers,
-Ted

What Shannon described at St. David's doesn't sound inconsistent with what is being done at Duke. ICE catheter gets sterilized and repackaged in sterile package. Pacing catheters also get the same treatment. Sheaths and ablation catheters do not. The Olympus endoscope are huge things in comparison and with lots of nooks and crannies.