Top 6 FAQs when Choosing Healthcare Power Products

Selecting compliant power products is an essential but often confusing part of a healthcare manager’s job. If you purchase power strips, surge protectors, isolation transformers or uninterruptible power supplies for your facility, the following questions and answers will help you make an informed choice.

Top 6 FAQs

1. How does location affect my choice of power products?
Where you install your power products can determine the type of product you need to purchase. From a regulatory standpoint, there are two distinct areas within healthcare facilities: inside the patient-care room and outside the patient-care room. If a power product is installed inside a patient-care room, it must be “medical-grade” and UL 60601-1 compliant.

2. How is a “patient-care room” defined?
A patient-care room is “any area within a healthcare facility where patients are intended to be examined or treated.” Patient-care rooms include both general- and critical-care areas:

  • General-Care Areas—patient bedrooms, examining rooms, treatment rooms, clinics and similar areas where patients come in contact with “ordinary devices” such as nurse call systems, electrical beds, examining lamps, telephone or entertainment devices and electro-medical equipment.
  • Critical-Care Areas—special care units such as intensive care units, delivery rooms, operating rooms, coronary care units, angiography labs and other areas where patients will be subjected to invasive procedures and connected to on-line electro-medical devices.

3. How is “patient care vicinity” defined?
Patient care vicinity is “a space within a location intended for the examination and treatment of patients (i.e., patient care room) extending 6 ft. beyond the normal location of the bed, chair, table, treadmill, or other device that supports the patient during examination and treatment and extends vertically 7 ft. 6 in. above the floor.”

4. What is the difference between “medical-grade” and “hospital-grade”?
These terms are often used synonymously. “Medical-Grade” power products are UL 60601-1 compliant and designed for use inside the patient care vicinity. They are not to be confused with power products that feature a “Hospital-Grade” plug and/or receptacles.

Many healthcare facilities unknowingly install non-compliant power strips, surge protectors and backup power supplies in patient-care rooms, believing that all models with hospital-grade plugs and receptacles are UL 60601-1 compliant. They are not. The use of non-compliant products can be dangerous and should be immediately replaced by fully-compliant models.

5. What is the difference between “UL-Listed” and “UL-Recognized”?
Two power strips can meet the requirements of the same UL standard (60601-1, for example) but receive two different UL ratings: either “listed” or “recognized.” The difference is simple: UL “lists” a stand-alone product, but “recognizes” a product that is a component of a larger system. In healthcare applications, power strips that stand alone and are not designed as components of a larger system are UL-listed.

6. What standards apply to mobile applications?
Some diagnosis, treatment, or monitoring equipment can be moved in and out of the patient-care vicinity and is therefore subject to the UL 60601-1 standard. Specialty purpose power strips and backup power supplies are available as components of larger medical systems. These products are UL-recognized for 60601-1 and 1363a standards and can be used both inside and outside of patient-care rooms.

  • UL 60601-1: patient shock-prevention measure required for all devices that potentially come in contact with patients and staff.
  • UL 1363a: standard for power strips that are integrated as components of a larger system, where they supply power to equipment in movable assembly that is rack, table or pedestal-mounted.

Source: TRIPP.LITE

AAMI Spotlights Influence of Healthcare Technology on Patient Safety

Posted March 15, 2016

“On April 17, 2003, I died.”

That year, Matt Whitman, a Michigan state trooper, now retired, was hit by a drunk driver and had to undergo neck surgery. The operation went smoothly, but in the recovery room, a new danger emerged. He was placed on a morphine pump for the pain, but without any electronic monitoring. That night, he stopped breathing—a case of respiratory failure induced by the opioids he was taking. Were it not for a nurse passing by his room to look for an item for another patient, Whitman believes he would be dead.

“I heard you take your last breath,” Whitman recalled the nurse telling him. The nurse called a Code Blue, and a team of doctors resuscitated Whitman. When he came to, a priest was holding his hand.

Unfortunately, not everyone is as lucky as Whitman, and experiences like his are all too common.

According to the National Patient Safety Foundation, one in 10 patients will develop a healthcare-acquired condition during hospitalization. Overall, medical error has been estimated to cause 44,000 to 98,000 deaths in hospitals each year, with recent research suggesting the number could be as high as 440,000 deaths.

Patient safety has become a major public health issue, and this week is dedicated to increasing awareness among healthcare professionals and the public. In recognition of Patient Safety Awareness Week, AAMI is shining a light on the crucial and growing role that safe and effective healthcare technology plays in patient outcomes.

“Advances in healthcare technology are helping patients in ways we could not have imagined not too long ago. Many hospitals are saving lives by integrating technologies such as continuous electronic monitoring of patients on opioids and smart infusion pumps as tools to support the work of clinicians,” said Marilyn Neder Flack, senior vice president of patient safety initiatives at AAMI and executive director of the AAMI Foundation. “At the same time, it can be a challenge to ensure that healthcare technology is developed and used in the best way possible—always with an eye on clinical workflow and patient safety. The AAMI Foundation is committed to tackling these complex issues through our patient safety initiatives. Today, under the Foundation umbrella, more than 100 committed individuals are working toward achieving the goal that no patient will be harmed by healthcare technology.”

The AAMI Foundation’s initiatives are focused on infusion systems, clinical alarms, continuous monitoring of patients on opioids, and home health infusions.

All of AAMI functions with an appreciation for the ultimate goal of advancing patient safety, whether in the form of training webinars for industry professionals, certification options for technicians and specialists, or developing standards for medical devices and healthcare technology.

AAMI President Mary Logan stressed that the association’s mission is to provide global leadership to support the healthcare community in the development, management, and use of safe and effective healthcare technology.

“Patient safety is at the heart of everything that we do,” Logan said. “By developing standards, AAMI works to ensure that all medical devices are designed and manufactured with quality, safety, and usability in mind. By educating and certifying the healthcare technology management professionals who implement and service these devices, we help ensure that patients receive the highest quality care. And by bringing all stakeholders to the table when we discuss mutual challenges, we support the goal of finding lasting and comprehensive solutions.”

AAMI has a host of resources focusing on specific aspects of healthcare technology. All of these resources can be found at www.aami.org.

Cover Story: ECRI’s List of Tech Hazards

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Posted By: K. Richard Douglas on: April 10, 2016 In: Cover Story, Feature Slider, Magazine

By K. Richard Douglas

A January 2015 article in USA Today detailed several incidents of fatal illnesses in Seattle, Pittsburgh, and Chicago related to a superbug bacteria known as Carbapenem-resistant Enterobacteriaceae (CRE). The bacteria is of real concern to medical professionals because it resists even “last defense” antibiotics, according to the story. In each case, the investigation of the source of the deadly bacteria turned out to be a specific type of Endoscope used on a half million patients annually.

Conventional cleaning of these endoscopes proved to be insufficient to remove all bacteria. This problem leads ECRI Institute’s list of the “Top 10 Health Technology Hazards for 2016.” ECRI points out that flexible endoscopes, and duodenoscopes in particular, are constructed in such a way that makes thorough cleaning difficult. The proper reprocessing of these scopes is critical to the well-being of patients. Biologic debris must be removed prior to sterilization or disinfection. The need for this pre-cleaning step is just one area of concern identified by ECRI Institute in this year’s list.

ECRI Institute’s Health Devices Groups says that the list “identifies the potential sources of danger that we believe warrant the greatest attention for the coming year.” ECRI points out that the list does not necessarily reflect the most frequently reported problems, or those with the most severe consequences, but instead those issues demanding the most immediate attention.

Besides the concerns about flexible endoscopes, the list also includes:

  • Missed Alarms Can Have Fatal Consequences
  • Failure to Effectively Monitor Postoperative Patients for Opioid-Induced Respiratory Depression Can Lead to Brain Injury or Death
  • Inadequate Surveillance of Monitored Patients in a Telemetry Setting, May Put Patients at Risk
  • Insufficient Training of Clinicians on Operating Room Technologies Puts Patients at Increased Risk of Harm
  • Errors Arise When HIT Configurations and Facility Workflow Do Not Support Each Other
  • Unsafe Injection Practices Expose Patients to Infectious Agents
  • Gamma Camera Mechanical Failures Can Lead to Serious Injury or Death
  • Failure to Appropriately Operate Intensive Care Ventilators Can Result in Preventable Ventilator-Induced Lung Injuries
  • Misuse of USB Ports Can Cause Medical Devices to Malfunction

“Some of the most obvious resources for addressing these concerns are the hospital IT and biomed/clinical engineering departments. If the concerns and steps listed previously are going to be addressed and utilized, these two departments are going to need a good working relationship.”

The ECRI Institute considers several criteria when forming its list. Those criteria include severity, frequency, breadth, insidiousness, profile (is it publicly known) and preventability. Nominations for the list come from ECRI Institute’s own engineers, scientists, clinicians and other patient safety analysts.

These experts base part of their nominations from investigating incidents, testing medical devices, speaking with other health care professionals, observing operations, assessing hospital practices and reviewing the literature, according to ECRI.

There should be a preventable element to any item that makes it on the list. ECRI also says that the absence of a topic from a previous year should not be perceived as any indication that it is a hazard that no longer deserves attention.

Continue reading …

Evidence-Based Maintenance Is CE’s Moonshot

Published on April 8, 2016

Binseng Wang

A little over 50 years ago, reacting to the Soviet lead in the space race, President Kennedy decided to rally the nation with the moonshot. He justified his decision to the American public by stating, “We choose to go to the moon in this decade and do the other things, not because they are easy, but because they are hard, because that goal will serve to organize and measure the best of our energies and skills, because that challenge is one that we are willing to accept, one we are unwilling to postpone, and one which we intend to win, and the others, too.”1

While landing a man on the moon in itself did not yield many tangible benefits aside from a psychological win for the American public, the moonshot brought an unprecedented advance in science and technology, as well as economic growth. Almost everything that we consider indispensable today can be traced back to the moonshot—such as solid-state electronics, satellite communications, and GPS, as well as most medical monitoring, telemedicine, and imaging technologies.

Today, the clinical engineering (CE) community faces a similar challenge. After decades of effort in dispelling the initial false alarm of electric shocks and developing rational methods to improve equipment maintenance at lower costs, CE professionals were able to attain a much lower maintenance-related failure rate than the Six Sigma quality level sought by world-class manufacturing companies.2 Yet, in 2011 the Centers for Medicare & Medicaid Services (CMS) released a new set of maintenance requirements with little, if any, rationale, demanding blind adherence to manufacturers’ recommendations.3

As a token of recognition to the CE community’s achievements and after intense lobbying, CMS agreed in 2013 to allow us to adopt an alternate equipment management (AEM) program for certain equipment (except lasers, imaging, and “new” equipment) if the hospital can provide evidence that it is “safe and effective.”4 Ironically, such a requirement does not exist for equipment manufacturers. While the Food and Drug Administration (FDA) does require manufacturers to prove their products are safe and effective before marketing, it does not require their maintenance recommendations be proven “safe and effective.” FDA only requires that “[w]here servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements.”5

Since the publication of the CMS mandates and subsequent revision of the standards by its accreditation organizations, including The Joint Commission (TJC), many organizations adapted their “risk-based criteria” to fit the new requirements and redefining risk to conform to the terms “critical” (or “high-risk,” per TJC). In doing so, some CE departments even continued to exclude “low-risk” equipment from their maintenance inventory, in spite of the explicit requirement from CMS to include all equipment.4 Few have thought about how to collect evidence to prove that their AEM programs are safe and effective. Two data-based methodologies have been developed that can prove alternative maintenance strategies are as safe and effective as those recommended by manufacturers. They are reviewed below.

 

  • Reliability-Centered Maintenance

  • Introducing EBM

Continue reading. . .

Source: 24×7 Magazine

Can You Still Use the Risk-based Criteria?

Published on December 17, 2015

24x7mag.com

By Binseng Wang

It has been 2 years since we received the “holiday gift” known as S&C 14-07-Hospital from the Centers for Medicare and Medicaid Services (CMS) with revised requirements for the maintenance of medical equipment.1 Much of the confusion and uncertainty has since been clarified by the accreditation organizations, but some seems to linger. One area of ongoing debate is the use of risk to classify and include equipment in the equipment maintenance/management inventory, popularly known as the “risk-based criteria” (even though its originator, my dear friend and former colleague Larry Fennigkoh, PhD, never meant it to be focused solely on risk2).

Prior to the adoption of the Fennigkoh and Smith model for equipment classification3 in the 1990s, The Joint Commission (TJC) required all AC-powered equipment to be inspected for electrical safety semiannually. The “risk-based criteria” allowed hospitals to establish “criteria for identifying, evaluating, and taking inventory of medical equipment to be included in the management program before the equipment [was] used.” The criteria recommended by TJC were: 1) equipment function; 2) physical risks associated with use; 3) maintenance requirements; and 4) equipment incident history.4 These criteria were typically summarized using the following equation, in which EM represents the “equipment management” number:

EM = function + physical risks + maintenance requirements              (1)

continue reading at http://www.24x7mag.com/2015/12/can-still-use-risk-based-criteria/

 

What Biomeds Need to Know About Infection Control

Published on July 24, 2015

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As hospital-acquired infections continue to rise, following proper disinfection procedures is more urgent than ever. But where do biomeds fit into the picture?

At the AAMI Conference & Expo in Denver this past June, infection control made an unexpected, albeit prominent, appearance. During his annual update on The Joint Commission’s activities, George Mills made the issue a key point in his remarks to biomeds, stressing that healthcare technology management (HTM) professionals need to play an active role in preventing infection and increasing patient safety.

Infection control, he noted, is a critical concern: each year, approximately 770,000 patients contract a hospital-acquired infection and as many as 80,000 die. In 2015, inadequate reprocessing of endoscopes and surgical devices again ranked highly on ECRI Institute’s annual list of top 10 health technology hazards. Over the last year, patient infections linked to inadequate reprocessing of duodenoscopes have also affected several major health institutions across the country.

Mills urged HTM professionals to periodically visit central processing and sterilization areas to identify potential problems, such as placing contaminated and sterilized endoscopes too close to one another. They should also be careful to practice good hand hygiene, especially when entering patients’ rooms. With diligence, he said, the problem can be addressed.

Unquestionably, infection control is a top concern for many facilities. But with all the challenges currently facing biomed departments—including strapped budgets, reduced head counts, and increased workloads—the real question may be whether HTM professionals, despite their best intentions, have the bandwidth to follow Mills’ advice.

Measured Optimism

So far, responses to Mills’ rallying cry appear to be mixed. “This has always been an important topic, but more attention has been given to it recently than in past years,” acknowledges J. Michael Shepherd, CBET, biomedical equipment technician II at Grande Ronde Hospital in La Grande, Ore. “More and more antibiotic–resistant bacteria are evolving, and this increases the need for good disinfection technique.”

The problem is worth addressing, agrees Dennis Minsent, CCE, CBET, president, Healthcare Technology Management Solutions LLC, who provides HTM consulting services to small- and mid-sized hospitals. “I think HTM should be more aware, given the number of serious organisms circulating in the country,” he says, although he notes, “I’m not aware of any serious outbreaks that could be attributed to HTM department lack of vigilance.”

But even if biomeds are clear on proper infection control techniques and willing to implement them, moving forward could prove tricky, especially taking into account the many responsibilities HTM departments already shoulder, Minsent says.

“I’m skeptical. The demands on HTM departments are significant and any data to suggest that HTM could help resolve this is lacking. While this additional focus is warranted, cybersecurity and software patching are perceived as more imminent threats. I think it will take some effort to move this up in priority,” he says, although he believes basic procedures like hand washing could be implemented immediately.

However, Chris Lavanchy, engineering director for ECRI Institute’s Accident and Forensic Investigation Group, believes that Mills’ address could prove a needed catalyst for hospitals to step up their efforts. “I think it’s going to ramp up the thought about it,” he says. “And I presume hospitals will have to show what plans they’ve made to address the concern.”

Gauging Risk

For those biomedical departments determined to implement new strategies to address infection control, how they move forward will depend largely on where they currently stand. It’s worth exploring, therefore, what HTM departments are already doing relative to infection control and—more importantly—what steps they should they be taking.

Minsent says the answer varies depending on the specific responsibilities of a given department. “If the HTM department is responsible for the central equipment pool, it would have a huge role,” he says, which might include cleaning select mobile equipment that is centrally managed between uses. “For more traditional HTM departments, the role would be more consultative, identifying approved cleaners and advising on cleaning protocols. The role would also be significant if HTM had technicians who service the sterilization equipment in central sterile supply.”

At Grande Ronde Hospital, the HTM department takes a central role in sterilization procedures, Shepherd says. “Our work maintaining sterilization and disinfection equipment is a key component in reducing patient infection. It is vital that disinfection and sterilization equipment be working properly.”

In his department, that includes practicing good sterile technique in dealing with all equipment. “I can’t speak for all HTM departments out there, but ours is not a sterile environment. It is important to do a topical disinfection of equipment before returning it for patient use. Whether that is done by the technician or in your central processing department, it cannot be overlooked,” he says.

Certain items like laboratory analyzers, ventilators, anesthesia systems, and heart/lung bypass machines are more likely to become contaminated because blood and body fluids can invade the systems’ internal components, Minsent says. While “the user should be responsible for cleaning and disinfecting exterior surfaces,” devices with contaminated internal components should be sent to HTM for cleaning and disinfection by HTM staff, according to the facility’s protocols. Either way, Minsent says, “You should always assume that any equipment you encounter for maintenance could be contaminated.”

This increased risk of infection and growing caution on the part of hospitals are partly why “infection control has become one of the hottest topics in healthcare today,” says Arman Semerjian, vice president of national sales at Advanced Ultrasound Solutions Inc. His company manufactures Sono ultrasound wipes, a disinfectant product made specifically for ultrasound equipment and designed to destroy pathogens such as MRSA, HIV, and staph, and to inhibit the growth of mold and mildew, as well as the odors they cause.

Semerjian says the Centers for Disease Control and Prevention recommends that when cleaning and sanitizing medical equipment in a healthcare setting, facilities follow the Spaulding method.1 This approach to disinfection and sterilization was devised more than 30 years ago and has been retained, refined, and successfully used by infection control professionals and others when planning methods for disinfection or sterilization. It classifies medical equipment into one of three categories—critical, semicritical, and noncritical—according to the degree or risk of infection involved in use of the items, and provides disinfection guidelines for each category.

Critical items, such as surgical instruments, cardiac and urinary catheters, implants, or invasive transvaginal, TEE, or intraoperative ultrasound probes, are devices that pose a high risk of transmitting infection or disease if they become contaminated with a microorganism. Semicritical items are those that come into contact with mucous membranes or nonintact skin, such as respiratory therapy and anesthesia equipment, some endoscopes, and laryngoscope blades. These devices should be free from microorganisms, but will generally not cause infection if contaminated with only small numbers of bacterial spores. Finally, noncritical items are those that only come in contact with intact skin and carry low risk of infection transmission, such as bedpans, blood pressure cuffs, crutches, and computers.

“In contrast to critical and some semicritical items, most noncritical medical devices like ultrasound may be decontaminated where they are used, and do not need to be transported to a central processing area,” Semerjian says. “Virtually no risk has been documented for transmission of infectious agents to patients through noncritical items when they are used as noncritical items and do not contact nonintact skin or mucous membranes.”

In addition to following these guidelines, biomeds’ use of personal protective equipment (PPE)—gloves, masks, eye protection, and gowns—is a must before working with any device. Lavanchy says that, typically, hospital personnel are instructed about PPE. “I would imagine that most hospitals have provided some fundamental training for healthcare professionals, especially the biomeds, to help them understand what they’re handling in the medical devices being used and patient contaminants.”

Left in the Dark

One of the major challenges facing facilities regarding infection control is that no universal cleaning solution exists for all devices and all organisms. Keeping track of which solutions are compatible with which devices can become a constant, time-consuming struggle.

“Depending on the materials used in the device, manufacturers provide a list of approved cleaners for specific levels of disinfection against the organisms you are trying to address. As organisms evolve and mutate, different cleaning solutions may be needed,” Minsent says. However, if those new cleaning solutions are not properly vetted, they may cause damage to the surface of the equipment, particularly cases and display screens. “Close coordination with the hospital infection control department and the device manufacturer is required to ensure the organisms can be killed without harming the device,” he says.

This issue is one Semerjian has encountered many times over. In many cases, he says, “biomeds are being tasked with bringing service costs down, and have been left in the dark when it comes to infection control products being recommended and used on the equipment they manage.”

Semerjian spent two decades working as an ultrasound field service engineer for a large OEM. Over time, he says, customers began reporting damage to their equipment from cleaning solutions the OEM had recommended to them, but which hadn’t been properly tested on specific ultrasound systems. Problems included damage to the lens and plastics from overly harsh chemicals, causing dropout and occasionally patient shock.

“Being on the service side of the business, we saw the large financial impact this was having on our accounts, with very little concern being shown from the OEM side. We quickly found out that there was little knowledge and no focus on compatibility testing with products being recommended,” he says.

Semerijian subsequently left the OEM world to work as a consultant, eventually landing at Advanced Ultrasound Solutions. The company has spent years testing its quaternary ammonium–based wipe on various ultrasound transducers, control panels, monitors, and system covers. The company is in the process of installing an automated spray system in its offices that will allow them to test not only ultrasound equipment, but all noninvasive medical devices with their patented solution. “Some OEMs are looking to us for testing their transducers because of limited resources,” he says. ”It can take them up to 2 years to complete compatibility testing, where our method can test an entire line of equipment in about 1 month.”

Future Steps

Since infection control isn’t going away any time soon, it could end up shifting dynamics in the hospital landscape. Karen Waninger, director of clinical engineering for Community Hospitals Indianapolis, notes that because of the dangers and anxiety associated with the issue, infection control remains a highly visible issue for healthcare teams as well as the general public.

“The infection control team in most hospitals is going to be proactive with trying to share information relevant to any specific media buzz or any local trends being observed, to help make sure the employees are aware of the specific actions to take for different potential situations,” she says. While infection control employees often take the lead, increasing awareness of the problem is also driving involvement from departments across the hospital. “With the current quality indicator measures regarding hospital-acquired infections, it has become more common to seek input from all perspectives to look for ways to help control exposure and prevent the spread of all types of infections,” she explains.

That shift could mean an increased role for HTM departments in areas where they should already be involved, such as the equipment selection process. “I hope this focus on infection control helps drive improvements in the evaluation of technology before it is purchased, for even small items like suction regulators and thermometers,” Waninger says. “In the past, those were not high-dollar items and may not have required the same kind of prepurchase process that was used, for example, when considering upgrades to physiological monitors or the imaging systems.”

Now that high-profile infection cases like those associated with duodenoscopes have become more common, Waninger says, hospitals better understand the downstream consequences of purchasing a device designed in a way that may make it more prone to transmitting infection. “The potential costs are defined differently now, when the loss of revenue or the cost of an organization’s reputation is considered,” she says. “These concerns should also help motivate HTM professionals to consistently adhere to universal precautions when handling any patient care equipment, whether visibly soiled or not.”

In addition, while hospital infection control departments establish the education, guidelines, framework, and expectations for the facility’s infection control protocols, HTM departments should develop their own specific protocols to support hospital policy, Minsent says. Those checklists could be amended as new, significantly threatening organisms emerge or evolve.

Shepherd agrees that building a list of the types of devices that deserve particular concern regarding infection would be helpful. “I think it is vital that [biomeds] be involved in the development of policy within their facilities, for those attached to a healthcare organization,” he says. “For all HTM professionals, however, it remains important that we all do our jobs to the best of our abilities and practice constant vigilance for areas where technique and processes can be improved.”

Infection control awareness should involve a continuing education in new disease and standards in sterile processing and disinfection agents. “Like most aspects of our profession, infection control and sterilization is a dynamic process, and our acquisition of knowledge needs to keep pace,” Shepherd says.

Nina Silberstein is a contributing writer for 24×7. For more information, contact John Bethune at jbethune@allied360.com.