Saturday, July 21, 2012

Am I At Risk ? Exposure To Bloodborne Pathogens During A Medical Procedure

Hello folks,
I knew this was coming, it was only a matter of time, the much dreaded, over fifty - colonoscopy.

As my physician attempted to address the finer points of the necessary procedure, I quietly gave him my undivided attention.

When he finished, he asked me how I felt about it.

I replied with " Look, I have a real concern here, as you know I had HCV, underwent therapy successfully, and its not something I want to repeat - ever." 

He knew what I was getting at, however, he didn't share my concern, he told me that the risk of exposure to bloodborne pathogens during the procedure is extremely rare. Really?

Am I an alarmist? Yes. Do I read far too many medical journals available to me online? Yes. Should I stop reading my own blog? Yes. Am I still concerned about the transmission of HCV or any bloodborne pathogens during the procedure? Yes. I'm just not ready to take the advice of my doctor. Not yet.

I have three reasons for putting off this colonoscopy, all outlined below in this post.

The horrific outbreak of hepatitis C at Exeter Hospital has been difficult to read, it is extremely painful and unsettling.

For all my readers that are living with HCV or have battled this disease, we know the magnitude of what this means for the 30 innocent victims infected with the virus. The deeply-rooted compassion we feel is not easily expressed - we feel each moment, knowing first hand what the families and patients are experiencing.

David Kwiatkowski was arrested this week in connection with the outbreak. Over the last month we watched the numbers rise; 30 patients who underwent procedures at Exeter Hospital's cardiac catheterization lab were infected with hepatitis C. Still, more news, in the article online at the San Francisco Chronicle,  the lab technician was reported to have worked at other healthcare facilities in the past.


An excerpt from the article published today @ San Francisco Chronicle;

CONCORD, N.H. (AP) — A traveling hospital technician accused of causing a hepatitis C outbreak in New Hampshire previously worked in Maryland and Michigan health care facilities, officials said Friday.
A spokesman for The Johns Hopkins Hospital said David Kwiatkowski worked in the cardiac catheterization lab at the Baltimore hospital from July 2009 to January 2010. Spokesman Gary Stephenson said the hospital is contacting all patients who may have come in contact with Kwiatkowski to offer them free testing for hepatitis C, a blood-borne viral infection that can cause liver disease and chronic health issues.
In Michigan, the state Department of Community Health confirmed that Kwiatkowski had worked there, though officials were still figuring out exact locations.

 I begin with my first reason for feeling apprehensive about undergoing a colonoscopy

Reason #1
Narcotic tampering

According to the same article;

" The lab technician is accused of stealing anesthetic drugs from the lab, injecting himself and contaminating syringes that were later used on patients, 30 of whom have been diagnosed with the same strain of hepatitis C Kwiatkowski carries."

Obviously, I won't be undergoing any procedure in my hospitals cardiology unit. My concern lies in the latter, with the transmission of hepatitis C through narcotic tampering by an infected healthcare worker.

In the Exeter Hospital outbreak drug diversion was mentioned as the route of transmission. A drug called Fentanyl - often used in anesthesia  - was named, a drug which has been named in other outbreaks of HCV. At the risk of sounding redundant, only because I have posted this on the blog numerous times, from 2008-2010 we have three case scenarios where hepatitis C was transmitted to patients through an infected healthcare worker. The three outbreaks were caused by drug diversion/narcotic tampering.

At these following medical facilities, Rose Medical Center in Denver, Mayo Clinic in Florida and Riverside Regional in Virginia, patients were infected with hepatitis C by the reuse of contaminated syringes by medical providers. In all three outbreaks employees admitted to stealing syringes filled with Fentanyl and injecting themselves with the drug replacing the syringes with saline to be used on future patients. These employees also traveled around, and most certainly could have been deemed as  "serial infectors". The summary is available, here

In 2011, published online in the medical journal "Annals of Internal Medicine, researchers related five cases of HCV infection to drug tampering by an HCV-infected healthcare worker. The outbreak at Mayo Clinic in Florida is highlighted, download the full text here.

Australian anaesthetist

James Latham Peters an Australian anaesthetist who worked at the Croydon Day Surgery in Melborne, is being sued by 50 former patients he allegedly infected with hepatitis C, between 2008 and 2009.

Excerpt from SkiNews, May 22, 2012:

Nurse Susan Rowe said in her statement she speculated Peters' patients were getting less fentanyl than required, because he used larger amounts of the drug propofol and because his patients did not experience itchy noses upon waking - a common fentanyl side effect. 
The prosecution alleges Peters infected his patients after administering anaesthesia to them using syringes he had already used on himself, in a bid to sneak the drug into himself while under supervision.
Updated July 20, 2012 @ theage.com

Doctor can't afford to fight hepatitis charges
.
James Latham Peters, 62, has pleaded not guilty to more than 160 criminal charges and is accused of spreading the disease via infected needles to women who underwent abortions at a clinic between January 2008 and December 2009.
On top of criminal proceedings against him, 50 women are also suing Dr Peters, seeking unspecified compensation for pain and suffering, medical expenses and any loss of income.
Dr Peters told the Victorian Supreme Court today that he could not afford a lawyer to contest the civil claim because criminal proceedings resulted in his assets being frozen in August last year, and he was also struggling to get legal aid.

Continue reading...
.
Reason # 2
Hepatitis C Transmission at freestanding Endoscopy Clinics - 2007–2008

In 2010, Dipak Desai who ran the Endoscopy Center of Southern Nevada was indicted by a grand jury along with Keith H. Mathahs and Ronald E. Lakeman both nurse anesthetists, for patient-to-patient transmission of hepatitis c resulting from contamination of single-use medication vials of propofol, used for multiple patients during anesthesia administration.

Teva Pharmaceuticals, was later named in 80 lawsuits alleging that the drugmaker sold propofol in larger vials which encouraged doctors to reuse them, rather then to discard the unused portions, read more here.

Update Jul 18, 2012

Patients in Hepatitis C outbreak slowly recovering

LAS VEGAS (FOX5) -
Patients in southern Nevada are still recovering from the Hepatitis C outbreak, known as one of the largest health care scares in U.S. history. It happened four years ago and some of those who were infected are sharing their story.

"My health is restored," said Henry Channin, a patient infected with Hepatitis C. "It's not quite what it was but I'm functional."

It's a battle Channin may never win. Back in 2006, the school headmaster contracted Hepatitis C after a colonoscopy at the Desert Shadow Endoscopy Center. He won part of a $522 million settlement from the pharmaceutical company, for distributing oversized vials of propofol that were mishandled and led to the outbreak.

"There is no cure," said Channin. "I was very fortunate that a regimen of chemotherapy has suppressed the virus, but I still get tested every six months. There is a chance it will come back."
On Wednesday, Channin and other infected patients shared their horrific stories with health care professionals in hopes to prevent other failures of the health care system.

"There was just a report in the paper two days ago of a dentist in Denver, who was re-using needles in his dental clinic," said Dave Woodward, who's the director of infection control for Valley Health Systems. "There were over 3,000 people who may have been exposed to HIV. This is after the outbreak here in Las Vegas. This is a lesson not yet learned by people."

Woodward said it's doctors and companies looking to save a buck that often leads to infection scares.
"You need to be responsible as well to say is that a clean product?," said Woodward. "Is that a single-use vial?"

It's advice Karen Morrow wishes she had taken. She's also trying to move forward after being infected. She knows that's easier said than done.

"Once you have the infection, you always have it in your system for the rest of your life," said Morrow.

As for the doctor who ran the endoscopy clinics., Dr. Dipak Desai has been indicted on criminal charges and is awaiting trial, following several strokes and a number of court delays.

Copyright 2012 KVVU (KVVU Broadcasting Corporation). All rights reserved.


Oxford Journal:
Hepatitis C virus infections from unsafe injection practices at an endoscopy clinic in Las Vegas, Nevada, 2007–2008.

Clin Infect Dis 2010 Aug 1; 51:267.

We report the initial field investigation of HCV infections among persons who had undergone procedures at an ambulatory specialty clinic. The long-standing practice of reusing syringes for single patients in conjunction with using single-use medication vials for multiple patients led to patient-to-patient transmission of HCV. This resulted in a public health notification that advised nearly 50,000 persons of their potential exposure and their need to be screened for HCV and other bloodborne pathogens.

Medline abstract here, full text available here.

Reason #3
Endoscopes improperly sterilized

In an article published in 2012 at iWatchNews, journalists investigated the difficult process of sterilizing intricate medical instruments.

An excerpt:

From hand scalpels to robots, high-tech creates new cleaning challenges
Decades ago, medical instruments were almost exclusively made of steel and glass, and many looked like the tools used by a butcher or an auto mechanic. Cleaning these tools was simple, and sterilization required little more than a heavy shot of steam.
The tremendous growth of minimally invasive surgeries in the 1990s, however, brought flexible endoscopes that are passed through tiny incisions to see inside patients. Instruments became smaller, more specialized and complex, with moving parts, tiny holes, and long narrow channels running the length of the implements. Manufacturers turned to materials like tungsten, plastic and other polymers. Progress continues. As surgeons begin to rely on robotics, devices are becoming even more elaborate.
Intricate modern instruments revolutionized surgery, but they have proven difficult to clean. Those tiny internal channels become clogged with unseen tissue and blood. Steam sterilization melts and destroys some modern devices. Instruments made of materials like rubber may not heat all the way through, as many metals do, creating sterilization challenges.
“Cleaning was once a basic factory job,” said Joe Lewelling, vice-president of standards development at the Association for the Advancement of Medical Instrumentation. “Now it’s very complex. It takes a lot of steps. It’s more like a laboratory process.”
Theoretically, if a device is truly impossible to clean, it should never end up on hospital shelves. The FDA, as part of its medical device clearance process, requires device manufacturers to verify that their cleaning instructions are effective. Few in the industry, however, believe the regulation works. Instead of testing their tools in the real world of hospitals, industry veterans say, manufacturers usually hire independent labs to evaluate their cleaning instructions under perfect conditions.
“If the lab can do the test, the lab has done their job for the manufacturer,” Trabue Bryans, a vice president and general manager of the lab company WuXi App Tec, said at an October meeting of the Association for the Advancement of Medical Instrumentation at the FDA. “We have all the time in the world.” 

Another excerpt:

In 2009, the Department of Veterans Affairs admitted that 10,737 veterans in Florida, Tennessee and Georgia were given endoscopies or colonoscopies between 2002 and 2009 with endoscopes that may have been improperly cleaned. Some of those patients later tested positive for HIV, hepatitis C, or hepatitis B. Several lawsuits filed against the VA by veterans are currently working their way through the courts, and attorneys expect many others to follow.
Investigation of a 2008 hepatitis C outbreak that sickened at least six people in Las Vegas revealed that an outpatient surgery center was improperly cleaning endoscopes and reusing biopsy forceps designed for a single use. Following that outbreak, a Centers for Medicare and Medicaid Services (CMS) pilot program inspected 1500 outpatient surgery centers and cited 28 percent for infection control deficiencies related to equipment cleaning and sterilization.

Read the entire article written by , here.


Patient Notification for Bloodborne Pathogen Testing due to Unsafe Injection Practices in the US Health Care Settings, 2001-2011

Since 2001, at least 130,000 patients had potential exposure to hepatitis and HIV due to unsafe injection practices in U.S. healthcare settings. The study, published in the May edition of Medical Care, details 35 separate patient notification events involving at least 17 states between 2001-2011.

These events were caused by a variety of unsafe injection practices including reuse of syringes, mishandling of medication vials and containers, reuse of single-dose vials, reuse of insulin pens, and narcotics theft.

Medical Care:
POST AUTHOR CORRECTIONS, 19 April 2012
doi: 10.1097/MLR.0b013e31825517d4

Guh, Alice Y. MD, MPH; Thompson, Nicola D. PhD; Schaefer, Melissa K. MD; Patel, Priti R. MD, MPH; Perz, Joseph F. DrPH
Published Ahead-of-Print

Abstract
Background: Syringe reuse and other unsafe injection practices can expose patients to bloodborne pathogens (eg, hepatitis B and C viruses and human immunodeficiency virus). Evidence of such infection control lapses has resulted in patient notifications, but the scope and magnitude of these events have not been well characterized.

Objectives: To summarize patient notification events resulting from unsafe injection practices in the US health care settings.

Methods: We examined records of events that involved communications to groups of patients, conducted during 2001-2011, advising bloodborne pathogen testing stemming from potential exposures to unsafe injection practices.

Results: We identified 35 patient notification events related to unsafe injection practices in at least 17 states, resulting in an estimated total of 130,198 patients notified. Among the identified notification events, 83% involved outpatient settings and 74% occurred since 2007, including the 4 largest events (>5000 patients per event). The primary breach identified (>=16 events; 44%) was syringe reuse to access shared medications (eg, single-dose or multidose vials). Twenty-two (63%) notifications stemmed from the identification of viral hepatitis transmission, whereas 13 (37%) were prompted by the discovery of unsafe injection practices, absent evidence of bloodborne pathogen transmission.

Conclusions: Unsafe injection practices represent a form of medical error that have manifested as large-scale adverse events, affecting thousands of patients in a wide variety of health care settings. Our findings suggest that increased oversight and attention to basic infection control are needed to maintain patient safety, along with research to identify best practices for triggering and managing patient notifications.

(C) 2012 Lippincott Williams & Wilkins, Inc.

In closing, will I undergo my colonoscopy? Probably. I've put it off for over a year, each time I put my neurotic mind at ease, sadly, an outbreak of hepatitis C is reported.

During my third appointment-not last, to discuss the procedure, I asked which anesthetic would be used, the doc said, "It could be  propofol."  My next question?  What about the hospitals sterilization practice, what about the drug testing of hospital employees, what about the 130,000 patients who had a potential exposure to hepatitis and HIV since 2001, what about.....................

I understand that these outbreaks are rare, but having contracted HCV once, for me, its been difficult to put my unrealistic apprehensions at ease.

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