The Blog

Medical Articles & News

Study Shows Bronchoscopes Still Dirty After Reprocessing

June 20, 2018Sri Mandava Hospital Management Infection Control Joint Commission Managing Endoscopes Patient Safety Regulatory Compliance

A new study has shown that flexible bronchoscopes that were reprocessed according to institutional standards at several US hospitals were still found to be dirty in a majority of the cases. The study was presented at the 2018 Association for Professionals in Infection Control (APIC) Conference.

The study on bronchoscopes now joins other recent studies conducted on colonoscopes and duodenoscopes showing the difficulty in performing high-level disinfection on flexible endoscopes. As this article by Nancy Crotti at Medical Design & Outsourcing explains:

“The results are worrisome as patients undergoing bronchoscopy are commonly at high risk for infection due to transplant status, critical illness, or immune-suppression due to malignancy or chronic disease,” said the study, funded by 3M and supported by sterilization product maker Healthmark Industries. It was presented last week at the Association for Professionals in Infection Control’s annual conference APIC 2018, will be published in an upcoming issue of Chest Journal.

Reusable bronchoscopes are commonly used in interventional pulmonology procedures. They and other reusable endoscopes, including duodenoscopes and colonoscopes, and have been cited in superbug outbreaks in the U.S. and Europe.

The researchers conducted the study at three large hospitals in the United States in 2017, including two transplant centers. They examined 24 clinically used flexible bronchoscopes after they were cleaned and disinfected in accordance with their institutional practices. Contamination was detected using microbial cultures and tests for protein, hemoglobin, and adenosine triphosphate. Reprocessing practices were found to be substandard at two of the three hospitals studied.

After manual cleaning, the researchers found that 100% of the bronchoscopes evaluated had residual contamination. Microbial growth was found in 58% of the fully-reprocessed bronchoscopes, including mold, Stenotrophomonas maltophilia, and Escherichia coli/Shigella spp.

All of the bronchoscopes had visible irregularities, including retained fluid; brown, red, or oily residue; scratches; damaged insertion tubes and distal ends; and filamentous debris in channels. Nursing staff at two of the hospitals were observed handling and transporting patient-ready bronchoscopes with bare hands, potentially exposing the bronchoscopes to contaminants.”

Read the entire article here: Bronchoscopes still dirty after cleaning, study says

The infection risk with bronchoscopes and all flexible endoscopes continues to be a major worry for hospitals. Facilities must ensure staff are trained on general infection control principles and must adhere to reprocessing best practices. To ensure that your staff is following reprocessing best practices on every scope they disinfect, install additional checks and balances into your workflow so that you can document that your staff is following the same process each time. Software systems such as iRIScope have been introduced in recent years to help hospitals and surgery centers ensure that each of their flexible endoscopes is reprocessed the proper way each time, and documentation of their reprocessing is kept electronically using advanced RFID technology.

The 4 Steps Of An Endoscope Risk Assessment

June 14, 2018Sri Mandava Hospital Management Infection Control Joint Commission Managing Endoscopes Patient Safety Regulatory Compliance

Flexible endoscopes continue to make headlines due to the risk of infection stemming from their use on patients. Many hospitals find themselves in the unenviable position of determining how they can perform critical endoscope-based procedures while minimizing the risk of infection. There is ample evidence showing that endoscopes can spread life-threatening illnesses when not properly reprocessed, however the benefits of endoscope-based procedures continue to outweigh the risks.

Now would be a great time for hospitals to conduct a risk assessment of their endoscopy practice. Making sure that hospitals are prepared for the adequate reprocessing and maintenance of endoscopes is required to ensure the safety of their patients. This article by hpnonline.com gives solid advice for any hospital conducting a risk assessment: Safer scopes

As the article mentions, hospitals wishing to conduct a risk assessment can follow 4 steps:

Completing a detailed inventory of their scopes
Identifying and recording risks associated with each of their scopes
Conducting a thorough review of literature from various societies concerned with endoscope safety
Determining mitigation strategies for endoscope safety

The infection risk with endoscopes continues to be a major worry for both surgery centers and hospitals. Facilities must ensure staff are trained on general infection control principles and must adhere to reprocessing best practices. To ensure that your staff is following reprocessing best practices on every scope they disinfect, think about installing additional checks and balances into your workflow so that you can document that the staff is following the same process each time. Software systems such as iRIScope have been introduced in recent years to help hospitals and surgery centers ensure that each of their flexible endoscopes is reprocessed the proper way each time, and documentation of their reprocessing is kept electronically using advanced RFID technology.

Infection Rates From Colonoscopies Greatly Exceed Prior Estimates

June 7, 2018Sri Mandava Hospital Management Infection Control Joint Commission Managing Endoscopes Patient Safety Regulatory Compliance

A recent study conducted by Johns Hopkins reveals that colonoscopies performed at ambulatory surgery centers lead to post-procedure infection rates that greatly surpass previous estimates. The study, sponsored by the US Department of Health and Human Services and the Agency for Healthcare Research and Quality, studied the results of colonoscopies and upper-GI endoscopies (EGDs) performed at outpatient centers.

Previous estimates pegged the infection rate from colonoscopies at around one in a million procedures. The research conducted by Johns Hopkins revealed that infection rates are approximately 1,000 times more frequent – about 1 in 1,000 screening colonoscopies and 3 in 1,000 EGDs result in post-endoscopic infections. As this article from Johns Hopkins Hub explains:

“An analysis of data from 2014 shows that patients who had one of the common procedures at facilities known as ambulatory surgery centers, or ASCs, were at greater-than-expected risk of bacterial infections, including E. coli and Klebsiella. Results of the study were published online this month in the journal Gut.

“Though patients are routinely told that common endoscopic procedures are safe, we found that post-endoscopic infections are more common than we thought, and that they vary widely from one ASC facility to another,” says lead researcher Susan Hutfless of Johns Hopkins University.

Colonoscopy is one of six options suggested by the American Cancer Society for colon cancer screening. The traditional recommendation is that patients be regularly screened starting at 50, but the ACS recently reduced its recommended age to 45.

Upper-GI endoscopies, known as EGDs, can be used to diagnose a number of problems in the upper digestive tract, including heartburn, swallowing issues, and abdominal pain.

Each year in the United States, there are more than 15 million colonoscopies and 7 million EGDs. Both procedures are performed with an endoscope, a reusable optical instrument that gives doctors a view of a patient’s gastrointestinal tract. Besides screening and diagnosis, they can be used for procedures such as removing polyps without invasive surgery.

Researchers examined data from six states—California, Florida, Georgia, Nebraska, New York, and Vermont—to track infection-related emergency room visits and unplanned inpatient admissions within seven and 30 days after a colonoscopy or EGD.

Post-endoscopic infection rates were previously believed to be in the neighborhood of one in a million, Hutfless says. The new study found a rate of infection seven or fewer days after a procedure was slightly higher than one in 1,000 for screening colonoscopies and about 1.6 per 1,000 for non-screening colonoscopies. Rates for EGDs within that time were more than three per 1,000.

Patients who had been hospitalized before undergoing one of the procedures were at even greater risk of infection. Since many ASCs lack an electronic medical record system connected to hospital emergency departments, those ASCs are unlikely to learn of their patients’ infections, Hutfless says.

“If they don’t know their patients are developing these serious infections, they’re not motivated to improve their infection control.”

Though the nation’s first ASC was established more than 40 years ago, the facilities gained popularity over the past 20 years as more convenient, less expensive alternatives for outpatient surgeries and other procedures.

The team found evidence that, among the ASC post-procedure infections, the rates were slightly higher for diagnostic procedures than for screening procedures.

ASCs with the highest volume of procedures had the lowest rates of post-endoscopic infection.

According to the Ambulatory Surgery Center Association, in 2017, 64 percent of ASCs were owned by physicians and 28 percent were affiliated with hospitals or health systems.

While the overwhelming majority of ASCs follow strict infection-control guidelines, says Hutfless, she and her team found infection rates at some ASCs more than 100 times higher than expected.”

Read the entire article here: Colonoscopies lead to many more infections than previously thought

How One Health System Negotiated Its Way To $1.5 Million In Annual Savings On Ortho Implants

May 31, 2018Sri Mandava Big Data Cost Reduction Hospital Finance Hospital Management Operating Rooms Operational Efficiency Supply Chain The Business of Surgery

HonorHealth, a Scottsdale, Arizona-based health system with over $1.7 billion in annual revenues, recently undertook a process to identify cost savings opportunities across the system. Early on, the joint-replacement service line jumped out as a prime candidate for cost savings.

An early analysis by the five hospital system and their group purchasing organization pointed out that there was significant variation in prices among their various orthopedic implant vendors. As this article by Maria Castellucci at Modern Healthcare explains:

“If you haven’t been focused on the cost of your implants and the cost of your supplies, you get a natural creep up—we were simply paying too much. The prices we were paying exceeded what we believe is the market price,” said Alice Pope, chief financial officer at HonorHealth, which operates five hospitals in Phoenix and Scottsdale.

The system worked with Premier, the large group purchasing organization and consultancy, to figure out how its approximately 15 implant vendors compared to each other in costs. They found a lot of variability.

Costs were “anywhere from 10% to 20% higher than we should’ve been at price point,” said Timothy Miller, vice president of procurement and supply chain at HonorHealth. He added that eight of the vendors accounted for 80% of total implant costs, which are about $20 million.

Over several months, HonorHealth leaders worked with surgeons and vendors to negotiate better prices on implants. That effort was successful, to the tune of $1.5 million in annual savings.

HonorHealth is typical of providers nationwide that see joint-replacement surgery—usually a secure money-making machine for hospitals—as a prime opportunity to generate savings, especially as they face shrinking margins with declining reimbursement and patient volumes.

Tackling the wide variability in costs for joint-replacement surgery is a way to get ahead financially.

More than 1 million joint replacements are performed every year in the U.S., and by 2030 that number is expected to increase to more than 4 million as the number of senior citizens grows.

“Hospitals are looking for where they can trim. Supply costs are the largest costs, except labor, for a health system. People would much rather cut supply than cut someone’s job, period,” said Rob Austin, a director at Navigant.

And the largest portion of costs for joint-replacement procedures are supplies, specifically implants, according to a recent analysis from Premier. There is also significant variation in the cost of those expensive implants.

Premier found that among 350 hospitals, the average cost of primary knee implants was $4,464. Yet 50% of the hospitals paid between $4,066 and $5,609 on the devices.

The same group of hospitals paid an average of $5,252 for primary hip implants, with 50% paying between $4,759 and $6,463.

According to Premier, the 350 hospitals could save $23.7 million on knee implants and $19.1 million on hip implants if they paid the same amount as the top 25th percentile of hospitals. The cost data came from Premier’s database of 1,100 hospitals.

But convincing surgeons to switch the vendors and devices they are used to isn’t always an easy sell.

HonorHealth’s surgeons were initially skeptical of the data that showed their implant costs were more expensive than others in the market. The surgeons have close relationships with their vendors, and it was hard to come to terms with the fact that they could be getting a bad deal.

“Even if the data shows there is significant variation, they still like the supplier and the representative, so they come up with reasons to explain the (cost) differences. We had to work through that,” Miller said.

HonorHealth leaders spent a lot of time with the surgeons answering all the questions they had about the data until they trusted it.

“As long as your data is good, they come around, and they will understand,” Pope said.

Then, HonorHealth approached the vendors with the data so they could negotiate down prices. All of the suppliers eventually agreed to new contracts with more competitive prices, Miller said.

The easy accessibility of robust data means hospitals can have in-depth cost conversations with their physicians, said Todd Nelson, director of partnership relationships at the Healthcare Financial Management Association.

…As hospitals get better at collecting and analyzing data and, importantly, ensuring that financial executives and doctors are talking the same language, the easier these conversations become, Nelson said.

Still, the conversations are not widespread and tend to happen at hospitals that are strapped financially, in competitive markets or have a healthy penetration of value-based contracts.

“As long as its fee-for-service for a knee surgery, the hospital is going to be more focused on the revenue they get,” Austin said. “Even though it’s an expensive service line, it’s generally a profitable service line—usually the most profitable service line” for a hospital.

On a positive note, the Premier analysis found that median length of stay for joint replacements has fallen, during a five-year period, among 279 facilities from 3.2 days to 2.3 days.

“That is a direct result of the Affordable Care Act and the requirement to publicly report data and holding back payment where you don’t meet certain quality objectives,” Czajka said.”

Read the entire article here: Getting the price right: Hospitals target variation in joint replacement

Having the right data can be a powerful tool in optimizing supply chain strategies. As this article shows, having accurate data and using it in the right way can lead to incredible cost savings opportunities for hospitals and health systems. If your organization lacks the proper tools to provide powerful data around your supply chain spend, consider systems such as iRISupply which can collect real-time data around supply and implant usage using RFID technology and provide actionable insights to help with vendor negotiations, on-hand inventory levels and owned-consigned mix.

Expensive Medical Supplies Stolen From Hospitals

May 23, 2018Sri Mandava Cath Lab Hospital Finance Operating Rooms Radiology Supply Chain The Business of Surgery

A medical supply rep from Maryland was recently charged in the theft of expensive medical kits from area hospitals that he later sold on eBay. Each of the medical kits were sold for approximately $33,000 each, netting the man nearly $200,000.

As this article from The Washington Post explains:

“Burke Slater, 52, of Gaithersburg, was arrested and charged with several felony charges after Fairfax County Police alleged he stole five kits from INOVA Mount Vernon Hospital in Alexandria and two from a hospital in Maryland, which was not named.

Slater worked as a vendor of medical supplies and had access to operating rooms, according to police.

Fairfax County Police said they launched an investigation after a medical supplier in Florida found some kits on eBay and checked the serial numbers. That showed the equipment was registered to Inova in Alexandria.

Police found that seven medical kits, each valued at $33,000, had been stolen. Officials said detectives found six of the kits that had been sold in states including Florida, New Jersey, Pennsylvania and Washington. Police said none of the customers knew the items were stolen when they bought them.

Slater surrendered to police on Wednesday and faced charges of grand larceny, money laundering and other charges, according to police. He was released on bond.”

Read the entire article here: Maryland vendor stole expensive medical kits from hospitals to sell on eBay, police say

The issue, which has been experienced before by many hospitals in the US, continues to highlight the need for hospitals to increase security on their expensive medical supplies and devices. With the possibility of theft very real given the number of individuals with access to medical supplies, hospitals can turn to high-security solutions such as those from Mobile Aspects. These high-security options include locking doors, RFID technology and secure badge access to ensure that only the people that should be touching their expensive supplies are able to.

Medical Device Recalls Reach Historic Highs In 2018

May 15, 2018Sri Mandava Cath Lab Clinical Documentation Hospital Management Infection Control Operating Rooms Operational Efficiency Patient Safety Radiology Regulatory Compliance Supply Chain The Business of Surgery

The first quarter of 2018 included 343 medical device recalls by the US Food and Drug Administration (FDA). This was the highest for a first calendar quarter of any year on record and was up 126% from 2017.

Experts point to the proliferation of software on medical devices as a primary driver for the record number of recalls so far in 2018. With the trend of placing complex software on medical devices only expected to increase in the future, this may become the new normal for FDA medical device recalls. As this article by Evan Sweeney at FierceHealthcare reports:

“Software was the biggest driver of medical device recalls in the first quarter, accounting for 23% of all recalls. Software issues have been the leading factor in device recalls each quarter since the beginning of 2016.

Bethany Hills, an attorney at Mintz Levin in New York who chairs the firm’s FDA practice, says the rapid increase is not totally unexpected. Medical device software is becoming increasingly complex, with analytics that provide a higher level of clinical decision support.

“The more complex the software, the more likely it is that the developers did not account for all variables in the clinical environment, increasing the risk of bugs and errors,” she told FierceHealthcare. “This risk increases further if the device manufacturer outsources software development because integration of outside software and the inability to quickly modify the code can lead to additional errors slipping through the cracks.”

All told, more than 208 million devices were recalled in the beginning of the year, more than the total number of recalled devices in all of 2017. There doesn’t appear to be one singular reason for the startling uptick, making it difficult to pinpoint an underlying trend.

Although it’s possible the first three months of 2018 were an anomaly, and recalls could dip back down to a level more consistent with past quarters, software challenges aren’t likely to recede. Device manufacturers are building more innovative devices with software that requires frequent updates and patches.

“[Manufacturers] don’t have this figured out yet and it’s going to continue to be a driver,” Mike Good, vice president of marketing and sales operations at Stericycle, told FierceHealthcare.

At the same time, medical device cybersecurity has emerged as a growing concern among industry leaders and lawmakers. Legacy devices are particularly susceptible to attacks, and a recent report from analysts at Symantec indicated a hacker group known as Orangeworm has been launching targeted attacks on the healthcare imaging suites where devices run on outdated operating systems.

Although there have been a limited number of cybersecurity recalls—the most notable being a firmware update for Abbott-manufactured cardiac devices last year—regulators appear acutely aware of the issue. Food and Drug Administration Commissioner Scott Gottlieb, M.D., has asked Congress for funding to create a cybersecurity “go-team” that would be housed in a new Center of Excellence on Digital Health.

Hills expects the medical device recall trend to continue, particularly now that the FDA is accepting devices with artificial intelligence and more complex clinical decision support algorithms.

Although the agency is in the process of updating regulatory guidance, the industry is currently relying on software validation requirements from the early 2000s. Gottlieb has signaled that overhauling the approval process for digital health devices and AI software is one of his top priorities, but manufacturers will still have to balance the time it takes to evaluate the potential hazards of complex software with a potential recall.

Minimizing the number of devices recalled from the market requires a joint effort by manufacturers and the FDA to minimize risks prior to approval, but doing so is a “delicate balance,” Hills says. Devices featuring complex algorithms that rely on large data sets may be particularly susceptible to recalls following widespread clinical use.

“Obviously, neither wants to see devices recalled from the market, but there needs to be a balance between constantly testing and validating software and the clinical benefits of using the software,” she said. “FDA’s job is to ensure that the manufacturer has done a reasonable job to identify and address any outstanding safety issues before the device goes on the market, but it would be an impossible task to resolve every possible issue since the testing environments for investigational devices are so limited.”

Read the entire article at: Medical device recalls reach historic levels in 2018 with software as leading cause

With the increase in medical device recalls only expected to continue to increase, we all must be aware of the role we have as caregivers in making sure that patients are quickly tracked down in the event of a recall. Patients themselves have basically no information available to them to know if implants they received are subject to a recall. The hospital must lead the charge by having access to accurate and timely data regarding recalled medical devices. If performing an analysis like this is a challenge at your hospital, consider a system like such as iRISupply, which provides a simple, user-friendly way to immediately find out the recipients of recalled devices, and also gives you a record of all recalled devices you currently have in stock.

ASGE Releases New Infection Control Guidelines For Endoscopy

May 10, 2018Sri Mandava Hospital Management Infection Control Joint Commission Managing Endoscopes Patient Safety Regulatory Compliance

The American Society for Gastrointestinal Endoscopy recently released guidelines for infection control during GI endoscopy and related procedures. The guidelines come at a time when reports of endoscope-related infections are becoming more prevalent in the media. While the overall incidences of such infections are rarely reported, there is a strong possibility of underreporting of adverse events due to subclinical illnesses or instances where infections are incorrectly attributed to other procedures or causes.

The new guidelines point out that many of the issues related to endoscope-related infections can be traced back to avoidable causes such as poorly followed practices or defective equipment. In response, the ASGE Quality Assurance in Endoscopy Committee based the guidelines on the most current studies and well-informed opinions from a broad array of experts. As this article by Alex Young at Healio reports:

“Several recent reports of infections with multi-drug resistant organisms associated with duodenoscope use suggest that prior assumptions regarding endoscopy-related infection rates may be an underestimate, particularly for [endoscopic retrograde cholangiopancreatography],” the guideline authors wrote. “These outbreaks of infection have led to a reassessment of current infection control practices.”

The following is a summary of the ASGE Quality Assurance in Endoscopy Committee’s recommendations:

Follow all federal and professional organization requirements that require high-level disinfection of endoscopes.
Ensure proper disinfection of duodenoscope elevator mechanism and wire channel to prevent the spread of highly resistant organisms.
All staff involved in endoscope reprocessing need extensive training on infection control, and documentation is required for the training.
Staff should be assessed at least annually for reprocessing efficacy.
If there is a reprocessing failure, the patients, infection control personnel and the device manufacturer, as well as any relevant local, state and federal health agencies should be notified immediately.
General infection control principles should be adopted by the endoscopy unit.
Endoscopy units must have a qualified person to direct their infection prevention plans.”

Read the entire article here: ASGE issues new guidelines for infection control in GI endoscopy

The infection risk with endoscopes continues to be a major worry for hospitals and their patients. As the ASGE points out, hospitals must ensure staff are trained on general infection control principles and must adhere to reprocessing best practices. To ensure that your staff is following reprocessing best practices on every scope they disinfect, think about installing additional checks and balances into your workflow so that you can document that the staff is following the same process each time. Software systems such as iRIScope have been introduced in recent years to help hospitals ensure that each of their flexible endoscopes is reprocessed the proper way each time, and documentation of their reprocessing is kept electronically using advanced RFID technology.

FDA Issues Warning On Multi-Patient Endoscope Connectors

May 2, 2018Sri Mandava Infection Control Joint Commission Managing Endoscopes Patient Safety Regulatory Compliance

The U.S. Food and Drug Administration (FDA) recently released a public alert that warned about the risk of cross-contamination from the use of certain endoscope connectors commonly seen in gastrointestinal endoscopy. The alert primarily points out the risks associated with the use of 24-hour multi-patient use endoscope connectors that are labeled for use with multiple patients over the course of 24 hours without reprocessing.

As of the date of the alert, the FDA had not received enough evidence to demonstrate the safe use of these products, and recommends against the use of the connectors. As the release from the FDA continues:

“Endoscope connectors are small accessories used to connect the auxiliary water channel of flexible gastrointestinal endoscopes to a water source and irrigation tubing. To mitigate the risk of cross-contamination and possible infection between patients, the FDA recommends the use of connectors with features that prevent patient fluids from flowing backwards into the endoscope (backflow prevention features). These connectors may be either single-use connectors that are discarded after each patient, or reusable connectors that are reprocessed according to their instructions for use prior to each patient.

One manufacturer, Erbe USA Inc., currently markets a 24-hour multi-patient use endoscope connector, called the ERBEFLO port connector. The ERBEFLO port connector does not include a backflow prevention feature.

The FDA’s assessment has found that the recommended instructions and device design for the ERBEFLO port connector do not adequately mitigate the risks of cross-contamination for endoscopy patients. This is because the connector, tubing, and/or water bottle can become contaminated with blood, stool, or other fluids from previous patients that travel back through the endoscope channels into the connector and tubing.

Alternative endoscope connectors that are designed according to FDA recommendations are widely available on the U.S. market. These alternatives include backflow prevention features, and may be reprocessed and reused between procedures, or they may be single-use devices.

Recommendations For Health Care Providers And Staff At Facilities Performing Endoscopy:

Do not use 24-hour multi-patient use endoscope connectors because they carry a risk of cross-contamination.

The FDA encourages health care providers and facilities to:

use single-use endoscope connectors with backflow prevention features, or

use reusable endoscope connectors with backflow prevention features, and ensure that those reusable connectors are reprocessed according to their instructions for use prior to each patient procedure.

FDA Actions

The FDA previously described the recommended testing for endoscope connectors in its November 2016 guidance document, Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.

The agency continues to work with endoscope connector manufacturers to ensure that their products are designed and tested to prevent cross-contamination. We will continue to actively monitor this situation, and will update this communication if significant new information becomes available.”

Read the entire release here: Risk of Cross-Contamination From 24-Hour Multi-Patient Use Endoscope Connectors – Letter to Health Care Providers and Staff at Health Care Facilities Performing Gastrointestinal Endoscopy Procedures

The infection risk with endoscopes and connectors continues to be an issue for hospitals. Hospitals must continue to be vigilant in their use of endoscopes and must ensure safety protocols are followed strictly to minimize infection risk. Where strong processes are missing, hospitals must work to ensure the proper people and systems are in place to upgrade processes to the highest standards. Software systems such as iRIScope have been introduced in recent years to help hospitals ensure that each of their flexible endoscopes is reprocessed the proper way each time, and documentation of their reprocessing is kept electronically using advanced RFID technology.

Hospitals Still Struggle To Combat Infectious Bacteria In Their Scopes

April 25, 2018Sri Mandava Hospital Management Infection Control Joint Commission Managing Endoscopes Patient Safety

Recent research has once again shined the spotlight on the struggle hospitals face to rid their reusable medical endoscopes of dangerous bacteria. In this particular study, published in the American Journal of Infection Control, 71% of “patient-ready” scopes at 3 major US hospitals tested positive for bacteria.

The study found problems in various types of endoscopes used for colonoscopies, lung procedures, kidney stone removal and other routine operations. As this article by Chad Terhune at Kaiser Health News elaborates:

“Researchers said the findings at the hospitals, which weren’t named, confirm earlier work showing that these issues aren’t simply confined to duodenoscopes, gastrointestinal devices tied to at least 35 deaths in the U.S. since 2013, including three at UCLA’s Ronald Reagan Medical Center. Scope-related infections also were reported in 2015 at Cedars-Sinai Medical Center in Los Angeles and Pasadena’s Huntington Hospital.

The bacteria this latest study found weren’t superbugs, but researchers said there were potential pathogens that would put patients at high risk of infection. The study didn’t track whether the patients became sick from possible exposure.

The study’s authors said the intricate design of many endoscopes continues to hinder effective cleaning and those problems are compounded when healthcare workers skip steps or ignore basic protocols in a rush to get scopes ready for the next patient. The study identified issues with colonoscopes, bronchoscopes, ureteroscopes and gastroscopes, among others.

“Sadly, in the 10 years since we’ve been looking into the quality of endoscope reprocessing, we haven’t seen improvement in the field,” said Cori Ofstead, the study’s lead author and an epidemiologist in St. Paul, Minn., referring to how the devices are prepared for reuse.

“If anything, the situation is worse because more people are having these minimally invasive procedures and physicians are doing more complicated procedures with endoscopes that, frankly, are not even clean,” Ofstead said.

The rise of antibiotic-resistant superbugs such as CRE (carbapenem-resistant Enterobacteriaceae), which can be fatal in up to half of patients, has made addressing these problems more urgent. About 2 million Americans are sickened by drug-resistant bacteria each year and 23,000 die, according to the federal Centers for Disease Control and Prevention.

“We’re not moving fast enough to a safer world of reusable medical devices,” said Michael Drues, an industry consultant in Grafton, Mass., who advises device companies and regulators. “There is plenty of fault to go around on device companies, hospitals, clinicians, on basically everybody.”

Despite the potential risks, medical experts caution patients not to cancel or postpone lifesaving procedures involving endoscopes. These snake-like devices often spare patients from the complications of more invasive surgeries.

“Patients should speak to their provider and think about the risks versus the benefits,” said Haas, who is also director of epidemiology at Lenox Hill Hospital in New York City.

The Food and Drug Administration and Olympus Corp., a leading endoscope manufacturer in the U.S. and worldwide, both said they were reviewing the study.

Last month, the FDA issued warning letters to Olympus and two other scope makers for failing to conduct real-world studies on whether healthcare facilities can effectively clean and disinfect their duodenoscopes. The FDA ordered the manufacturers to conduct those reviews in 2015 after several scope-related outbreaks in Los Angeles, Seattle and Chicago made national headlines.

Olympus spokesman Mark Miller said the Tokyo-based company intends to “meet the milestones set forth by the FDA…Patient safety has always been and remains our highest priority.”

The latest study examined 45 endoscopes, with all but two manufactured by Olympus. The other two were Karl Storz models.

Last year, researchers visited three hospitals and performed visual examinations and tests to detect fluid and contamination on reusable endoscopes marked ready for use on patients. One hospital met the current guidelines for cleaning and disinfecting scopes, while the other two committed numerous breaches in protocol.

Nevertheless, 62% of the disinfected scopes at the top-performing hospital tested positive for bacteria, including potential pathogens. It was even worse at the other two — 85% and 92%.

The study painted a troubling picture at the two lower-performing hospitals, which were well aware researchers were watching.

Among the safety issues: Hospital technicians wore the same gloves for handling soiled scopes fresh after a procedure and later, when they were disinfected and employees wiped down scopes with reused towels. Storage cabinets for scopes were visibly dirty and dripping wet scopes were hung up to dry, which is a known risk because bacteria thrive on the moisture left inside. The two hospitals also turned off a cleaning cycle on a commonly used “washing machine,” known as an automated endoscope reprocessor, to save time.

“It was very disturbing to find such improper practices in big health systems, especially since these institutions were accredited and we assumed that meant everything would have been done properly,” said Ofstead, chief executive of the medical research firm Ofstead & Associates.

Ofstead and her coauthors recommended moving faster toward sterilization of all medical scopes using gas or chemicals. That would be a step above the current requirements for high-level disinfection, which involves manual scrubbing and automated washing. A shift to sterilization would likely require significant changes in equipment design and major investments by hospitals and clinics.

In their current form, many endoscopes aren’t built to withstand repeated sterilization. Some also have long, narrow channels where blood, tissue and other debris can get trapped inside.

In some cases, disposable, single-use scopes are an option, and new products are starting to gain acceptance. In other instances, certain parts of a scope might be disposable or removable to aid cleaning.

The Joint Commission, which accredits many U.S. hospitals and surgery centers, issued a safety alert last year about disinfection and sterilization of medical devices in response to a growing rate of noncompliance. In 2016, the Joint Commission cited 60% of accredited hospitals for noncompliance, and 74% of all “immediate threat to life” citations from surveyors related to improperly sterilized or disinfected equipment.

Michelle Alfa, a professor in the department of medical microbiology at the University of Manitoba, said accreditors may need to conduct more frequent inspections and endoscopy labs should be shut down “if they don’t get their act together. These results are totally unacceptable.””

Read the entire article here: Hospitals and device makers still struggle to rid medical scopes of infectious bacteria

The infection risk with endoscopes across all the major scope manufacturers continues to be an issue for hospitals. Hospitals must continue to be vigilant in their use of endoscopes and must ensure processes are followed strictly to minimize infection risk. Where strong processes are missing, hospitals must work to ensure the proper people and systems are in place to upgrade processes to the highest standards. Software systems such as iRIScope have been introduced in recent years to help hospitals ensure that each of their flexible endoscopes is reprocessed the proper way each time, and documentation of their reprocessing is kept electronically using advanced RFID technology.

How Supply Price Inaccuracies Can Affect The Bottom Line

April 18, 2018Sri Mandava Big Data Cost Reduction Hospital Finance Hospital IT Hospital Management Operational Efficiency Supply Chain The Business of Surgery

Due to the nature of how hospitals and health systems acquire supplies, product prices are constantly changing. Different hospitals in the same health system, and even different departments within the same hospital, may be paying different rates for the same items, and those prices are typically in flux.

With supply chains and individual departments within hospitals tasked with the goal of stripping out waste and inefficiency from their operations, inaccurate product prices can be a thorn in their sides. This article by Peter Nelson at Health Data Management looks deeper into how pricing inaccuracies can negatively affect a hospital’s operations:

“A simple human error such as failing to update a price change on a distributor website can create confusion and errors, and ultimately lead to delays in completing transactions. Price discrepancies are also expensive, costing healthcare providers alone in excess of $92 million annually to process these exceptions.

This price accuracy situation is in diametrical opposition to the supply chain’s opportunity to strip waste and inefficiency out of the system so the industry can remain focused on providing outstanding levels of patient care.

Price accuracy is one of the most labor-intensive and error-prone issues healthcare organizations face. Every player in the healthcare supply chain believes its pricing data represents the truth, but too often, these prices exist in silos. While pricing data from a manufacturer or distributor may reflect a product’s current price, it may not take into consideration a healthcare system’s negotiated contract or specific discounts available.

In fact, contract price misalignment is a root cause of many price discrepancy issues. For instance, the majority of hospitals purchase supplies from a distributor. Distributors, in turn, receive pricing information from manufacturers. If a healthcare organization negotiates a purchasing contract directly with a manufacturer, that pricing information typically takes 45 to 60 days to be updated and reflected in the distributor’s pricing.

Too many organizations have managed this complex pricing process with outdated manual approaches like fax and email—that’s a sure-fire recipe for miscommunication and delays in contract activations. This results in contracting staff spending hours trying to determine contract start dates and whether a specific organization is entitled to a certain price on a certain date.

Multiply that by hundreds of thousands of pages of pricing data, and it’s easy to see the scale of the inefficiencies at the heart of healthcare price accuracy.

While there’s no magic genie coming to the rescue to solve the price discrepancy issue, the power of technology is increasingly driving collaboration among a trusted community of manufacturers, distributors, group purchasing organizations and hospitals to enable these trading partners to spot price discrepancy issues early in the purchase order process.

Even better, an automated supply chain will know how pricing changes impact specific healthcare organizations based on its buying contracts and can alert those providers in advance of any price changes taking effect, so it can make purchase decisions accordingly.”

Read the entire article here: How improved supply price accuracy can save money

Without the right systems and processes for price accuracy in place, hospitals will continue to struggle with the downsides of inaccurate supply prices. Technology and automation may hold the key to better price transparency and accuracy for hospitals looking for a solution for this tricky problem. Best practices to eliminate this issue include implementing software like iRISupply, which can provide a source of truth for all information related to implants and supplies in the procedural areas of a hospital. This system can provide a bridge between materials management, billing and electronic medical record software to coordinate pricing information across disparate systems.