|Posted by Salah Alkhallagi on January 3, 2016 at 1:02 AM||comments ()|
Engineers and technicians are not always known for their ability to write good reports. To help you out with your end-of-year obligations, 24×7 offer some guidelines. Here is what advised.
|Posted by Salah Alkhallagi on September 9, 2015 at 12:57 AM||comments ()|
Published on September 4, 2015
By William Hyman, ScD
Medical devices follow clear paths to market, beginning with design and progressing through regulatory action by the FDA. In most cases, this happens before biomeds become involved with devices, although biomeds may be involved in clinical trials and are involved in postmarket FDA measures, such as Medical Device Reporting (MDR) and recalls. Repair activities may also touch on regulatory issues such as manufacturer assertions, correct or not, that certain things can or can’t be done because of FDA restrictions. Repair parts may also raise regulatory issues, as illustrated recently with respect to an FDA Warning Letter to a replacement battery company and the recall of parts from a non-OEM supplier.
Biomeds should also play a strong role in device selection. In doing so, it can be helpful to understand the two major ways in which devices negotiate the FDA regulatory system, and the implications of those two paths with respect to how much scrutiny a device received from the FDA before it reached the market. It is here that the two important and distinct labels of “cleared” or “approved” come into play. I will argue that this distinction is not one only for an academic (like me), nor one that only a regulatory geek should care about. But first, a brief background.
All medical devices are divided into one of three classes, cleverly called Class I, Class II, and Class III. Class I devices are the simplest, and come to market without any review by the FDA. Most Class II devices are subject to FDA “premarket notification,” which is commonly called a “510(k)” after the section of the applicable law. Devices that go through the 510(k) process have to argue to the FDA that they are substantially equivalent to some other legally marketed Class II device. This process usually does not require a clinical trial. “Substantially equivalent” does not mean identical, and sometimes considerable differences are allowed. When a 510(k) process is successful, the device is properly said to be “cleared” but it is not “approved.” Class III devices are subject to premarket approval, or PMA. A PMA usually requires a full clinical trial to actually prove that the device is safe and effective.
When selecting a medical device, it is good to know what class the device is and what route to market it underwent. It is good practice to ask the sales rep for the product’s class, as well as the applicable 510(k) or PMA number. Even if the rep looks confused, he or she should be willing to find out for you. While you’re at it, ask for the applicable three-letter FDA product code. This information can be helpful when looking up devices on many of the FDA’s databases, including Manufacturer and User Facility Device Experience (MAUDE), Recalls, and Total Product Life Cycle. The latter can be useful because it displays all vendors, recalls, and a table of reported device problems.
In most cases, all devices of a type being considered for purchase will have the same product code, so class and cleared or approved status will not be a decision factor. However, obtaining this information can be helpful with respect to learning how forthcoming the sales reps are, and in communicating accurately with others. Moreover, I assert that biomeds and others should use the proper terminology, because the terminology has real meaning.
Aside from direct equipment selection, the implications of this difference in FDA scrutiny can be used to educate clinical staff about the devices that they use. Then, doctors perhaps won’t be surprised when they learn that devices such as morcellators and duodenoscopes were never subjected to a full clinical trial, and that such devices were not “approved” by the FDA. Similarly, implanted devices such as metal-on-metals hips and surgical meshes were never “approved.” One reason doctors are often surprised by the lack of clinical trials for cleared devices may be that doctors know more about drugs. Since all new drugs are approved, they may assume that this is also true for medical devices.
Most companies use the correct terminology, but the medical device press (although I haven’t caught 24×7 doing it) and lay press are not always as careful. (A New York Times writer once responded to my criticism in this regard by saying that yes, he knew the difference, but his readers would just be confused by it.) Clinical journals also often get it wrong.
In this regard, biomeds can serve in an educational role by always using the correct word, and helping others understand the difference. Biomeds should also understand the potential regulatory issues around non-OEM replacement parts, and at least bring up the issue with their parts suppliers.
Some, and it turns out most, devices are “cleared” and some are “approved,” and there is a difference. You are probably a geek anyway (in the good sense), so add this distinction to your geeky vocabulary and practice.
William A Hyman, ScD, is professor emeritus, Biomedical Engineering, at Texas A&M University, College Station, Tex, and adjunct professor of Biomedical Engineering at The Cooper Union, New York.
|Posted by Salah Alkhallagi on August 11, 2015 at 6:47 AM||comments ()|
Published on November 16, 2014
By David Harrington, PhD
Photo of Dave HarringtonIt’s the fashion nowadays to describe what we biomeds and clinical engineers do as “healthcare technology management.” I know that my opinion may not be very popular, but I think the name does an injustice to us and to what we do best. Let me explain.
I will admit to being old and somewhat stubborn when it comes to our profession. When I entered the healthcare engineering field in 1962 (not 1862, as some may think), our function was to make items that were needed to treat sick patients, but always keeping in mind the admonition to first do no harm to those patients. Over the years, my fellow healthcare engineers developed some great technology that has saved countless lives and made the quality of life for many people so much better. We would go to meetings and freely talk about what we were working on and seek input from others. (Remember, this was before the Internet, fax, cell phones, and a multitude of publications on every specialty in medicine.)
A Series of Setbacks
Many of those designs were passed on to manufacturers. They marketed those devices, and healthcare jumped forward. Then there was a series of setbacks. One of the big ones was an article published in 1971 in that great technical journal, Ladies Home Journal, by Ralph Nader, called “Ralph Nader’s Greatest Exposé.” In it, he claimed that thousands of people were killed in hospitals every year by micro shock. Now, if anyone has any proof that a person was killed by micro shock from a medical device, please publish that information. Forty years with no proof is long enough to hold onto an error in data collection.
This development was a step in the wrong direction, as hospital lawyers—and I intend no comment on their value to healthcare—got involved and pushed hospital administrations to have every device tested on a regular schedule. This reaction led to another jump in health technology management positions—in my opinion, a waste of time and money. Then there was that group out of an Eastern state that was issuing ratings of devices and suggesting potential problems, and that was followed in 1976 by Public Law 94-295, better known as the Medical Device Amendments of 1976.
In its aftermath, where it used to take days to get a device to a patient, it now took months and, in many cases, years. The law added huge costs to the system, and had a significant repercussion on our profession: Healthcare technology management groups now had more perceived need to manage technology, rather than focusing on what was best for the patients and keeping costs down.
Are the Managers Succeeding?
One of the notable features of healthcare technology management is benchmarking. Well, I have yet to see a single publication or presentation showing that benchmarking has improved patient care, cut costs, or done anything else of true value. If the “managers” doing this work found value, you think that it would have been shared. A lot of the blame for not getting good information out to us all lies with the big institutions and service organizations that supposedly gather data but never share it outside of their groups.
It has been close to 25 years since some of the early “technology managers” started pushing the concept that all medical devices would be interconnected. The result of this development would be that data would flow easily and accurately between all devices, medical records, and, of course, the billing databases, reducing costs and improving patient care. They are closer than they once were, but we still have to fill out all sorts of paperwork every time we go to a doctor or get a flu shot. Outstanding HTM on this one! The fact that we still have so far to go after 25 years makes you wonder what these “managers” are doing.
Another pet peeve of mine involves the process for dealing with the Year 2000 (Y2K) problem. We poor, underappreciated biomeds and engineers worked long and hard making sure that the equipment we were responsible for would work, and that patient care would be continuous. We did all of that at a cost of about 10% of what the IT people spent. Plus, they have replaced the equipment they purchased back then at least twice in the last 15 years, while we still keep our technology working and safe for patients. Again, the managers were wrong and we were right. But who gets all the credit? Not us.
Keep Calm and Carry On
But we do have the comfort of knowing that our work helps so many people get better and we are always cost driven. If the OEM is trying to overcharge us for a part, we go to all the second sources that we know of to get that part and install it so patient care can continue.
And now we have had our profession renamed “healthcare technology management” by those who probably could not do any repairs or assist a nurse or help a physician treat a patient. Regardless, we will continue our work, knowing that what we do is very important and that anyone can be a manager or “leader.” Don’t believe that? Just look at Congress!
In closing, my wife and I are getting close to the age when we will need an increasing level of healthcare, which includes technology. So to all you technical people, thank you for your past services. We hope you are still around when we need you in the future (and that you learn how to use those 3D printers, since many of the new devices we will need will be generated on them). To the managers out there, I would just say this: Please stay out of the way of the technical people so they can do their jobs to support and improve healthcare.
Source: 24x7 Magazine
|Posted by Salah Alkhallagi on August 11, 2015 at 1:52 AM||comments ()|
Published on August 6, 2015
BMETs in Low-Resource CountriesA new report proposes that skilled biomedical equipment technicians (BMETs) are crucial to advancing healthcare in low-resource countries around the world. The report, “BMETs in Low-Resource Countries,” which was prepared for the GE Foundation and the AAMI Foundation, calls on a wide variety of stakeholders to come together to support the development of “scalable, replicable, and sustainable” training models for such professionals.
The BMET report is a summary of a 2-day meeting held in June 2015 in Toronto, Canada, at which 55 professionals from various backgrounds and countries engaged in discussions that addressed how best to achieve effective training for BMETs in countries that need their services.
According to the report, “without technology that supports diagnosis and treatment, patients are vulnerable to needless pain and suffering, poor health outcomes, and even death.” The report outlines how better access to emergency care and the use of diagnostic and therapeutic tools would reduce patient mortality in many low-resource countries, yet much of the available equipment in such locations is not functional.
As summarized in the report, the stakeholders at the June 2015 meeting concluded that until there are more skilled BMETs on the ground to keep medical equipment running safely and effectively, developing countries will be stymied in their efforts to improve patient care. Toward that end, the meeting participants identified six crucial next steps, which are:
Create an international advisory body to assure quality of BMET training based on core competencies.
Create a global alliance that focuses on the promotion of the HTM profession in low-resource countries.
Ensure the strict selection of BMET trainees/trainers.
Engage multiple stakeholders and funders to promote BMETs.
Create sustainable, scalable funding strategies for BMET training to improve public health outcomes.
Define metrics for BMET health impact/outcomes.
The report emphasizes that successful training programs must encompass the student life cycle from pre-admission to professional BMET. Further, the report recommends that such programs use local trainers who are “able to converse in the local language, understand local customs, and have a local network on which to rely.”
The report also identifies several other factors that would be crucial to success for training models, including the need for constant evaluation, trainer fluency in both theoretical and practical knowledge, and an understanding of infrastructure challenges.
A final report, which will include specific recommendations for the training models, is due to the GE Foundation in October 2015.
|Posted by Salah Alkhallagi on August 5, 2015 at 2:42 AM||comments ()|
By Associated Press | August 4, 2015
Federal health officials laid out extra safety measures that hospitals can take to clean specialized medical scopes that have been linked to sometimes deadly bacterial outbreaks across the U.S.
However, Food and Drug Administration officials acknowledged on Tuesday that not all hospitals have the staff, expertise and resources to take the steps, including sterilizing scopes with toxic gas to kill bacteria. Even with such steps "the risk of infection transmission cannot be completely eliminated," the FDA said in an online statement
Despite the risks of infection, the FDA says the devices should remain available because they benefit "appropriately selected patients."
Known as duodenoscopes, the scopes consist of a flexible tube and specialized tip that surgeons guide into the digestive tract to diagnose and treat blockages of the bile and pancreatic ducts. They are used in an estimated half-million procedures per year.
The FDA came under heavy criticism earlier this year for its oversight of the hard-to-clean devices after two Los Angeles hospitals reported patients infected with antibiotic-resistant bacteria, or "superbugs," despite following manufacturers' cleaning instructions. According to government figures, there have been eight outbreaks of antibiotic-resistant bacteria linked to the devices at U.S. hospitals since 2013.
Duodenoscopes' complex design—intended to help physicians drain fluids from the body—also makes the instruments extremely difficult to clean. Bodily fluids and other particles can stay in the device's crevices even after cleaning and disinfection.
In May, the agency assembled a panel of outside experts to make recommendations for improving the cleaning and design of the instruments. Tuesday's recommendations reflect the suggestions of those experts and internal FDA staff.
Currently most scopes are cleaned manually by hospital staff or automated machines designed to disinfect the instruments. In addition to these steps, the FDA says hospitals should consider:
— performing bacterial testing on scopes that have been cleaned to make sure they are bacteria-free
— sterilizing scopes with ethylene oxide gas to kill all bacteria
— using additional sterilizing chemicals to kill bacteria
— cleaning scopes multiple times using standard manual or machine-assisted techniques
All of these steps come with additional costs and potential drawbacks. For instance, testing scopes for bacteria requires hospitals to purchase additional scopes that can be cycled in and out of use. One duodenoscope can cost about $40,000.
The agency also notes that ethylene oxide gas can be dangerous for hospital staff and patients, if residue of the toxic gas stays on the scopes after sterilization.
FDA critics, including several members of Congress, have suggested that the instruments should be redesigned to reduce risks of infection. The agency has previously said it cannot require manufacturers to redesign their products. But in its release Tuesday, the agency laid out several design changes that could reduce risks of contamination, including using disposable components for hard-to-clean areas.
"The FDA is currently working with manufacturers as they explore design innovations incorporating these features," the agency said.
Source: Modern Healthcare
|Posted by Salah Alkhallagi on August 4, 2015 at 8:02 AM||comments ()|
By Adam Rubenfire | July 22, 2015
Two hackers recently proved to Wired magazine that they could wirelessly hack into a Jeep and other vehicles and remotely take control of them.Scarier still? Hackers have demonstrated that they can tamper with medical devices that can mean life or death for patients. “It’s not a conspiracy theory. It is absolutely true that our medical devices are one of the most insecure areas in healthcare today,” said Mac McMillan, a healthcare security expert and founder of CynergisTek, an Austin, Texas-based security consultancy.Implanted defibrillators and pacemakers, insulin pumps and just about every wearable or in-hospital medical device connected to the Internet has been hacked or proven insecure, McMillan said.
Recently, a hack called Medjack has been used to compromise multiple devices in an effort to steal data from hospital networks.
Medjack “has been successful at exploiting the weakness in medical devices to allow an attacker to compromise the network,” McMillan said.
The federal government isn’t working fast enough to address the issue, McMillan said, partly because of the hodgepodge of agencies involved, including the Food and Drug Administration, the Federal Communications Commission, the Department of Homeland Security and HHS’ Office for Civil Rights, just to name a few.
The FDA has recommended that medical-device manufacturers submit documentation regarding cybersecurity issues during the pre-approval process, but McMillan said the industry otherwise lacks regulation on this issue.
Despite vulnerabilities in medical devices, patients are overwhelmingly safer using devices than not using them, said Kevin Fu, an associate engineering professor at the University of Michigan and chief scientist at Virta Laboratories, which is developing a malware detection device for hospital equipment.
Fu said the industry has a long way to go, but there are systems in place to ensure patients’ safety. Part of the problem is that most medical-device engineers aren’t taught IT security in school and have been somewhat unaware of the risk in the past, he said.
Though it’s unlikely patients would be harmed through their implantable devices, it wouldn’t be out of the question for a hacker to use garden-variety malware to infiltrate a hospital’s network and coincidentally break into a medical device running old, vulnerable operating systems, Fu said. Such an attack could prevent infusion pumps from working or cause patient monitors to display incorrect information.
Manufacturers need to make devices that are inherently secure and work directly with hospitals to implement their devices in a protected configuration, Fu said. Devicemakers can’t simply require that the device be installed on a “secure network,” because these days that’s much easier said than done.
“I think a manufacturer can no longer just assume that they’ll provide the device to the hospital, and say, ‘We’ve done our job,’ ” Fu said. “It needs to be much more interactive, because every network is different.”
Industrywide “security hygiene” standards are being formulated through groups like the Association for Advancement of Medical Instrumentation, Fu said, but those efforts are still in their early stages.
Some hospitals have found workarounds to protect the connected devices on their internal wired or wireless networks, but they shouldn’t have to accommodate devicemakers’ often-antiquated operating systems, McMillan said. Manufacturers likely aren’t jumping to work on security because it could force them to undergo the costly process of rewriting outdated code.
“Until someone says they need to address this, bottom line is they’re being driven by their bottom line,” McMillan said.
|Posted by Salah Alkhallagi on July 29, 2015 at 1:37 AM||comments ()|
Published on July 24, 2015
As hospital-acquired infections continue to rise, following proper disinfection procedures is more urgent than ever. But where do biomeds fit into the picture?
By Nina Silberstein
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.
|Posted by Salah Alkhallagi on July 22, 2015 at 3:42 AM||comments ()|
In order to provide medical treatment, biomedical equipment management and service is vital. For this reason, medical equipment in hospitals needs to be continuously improved to ensure that hospitals are working with the best technology. Improvements are also necessary for hospital to show that they are bettering their position in a healthcare market that is not only highly competitive, but that is rapidly changing all the time.
Clinical engineering is very important to the healthcare industry when it comes to helping hospitals meet their goals and stay on top of the latest tech. Clinical engineering is a biomedical engineering specialty that is chiefly responsible for the application and implementation of medical technology for the purpose of optimizing the delivery of health care.
One of the ways in which clinical engineering departments are working toward meeting the challenges of the ever-changing healthcare market, is through mobile software applications. Although developing healthcare-related mobile applications for hospitals is not necessarily the same as developing mobile game apps, for instance, this is still a highly competitive industry. Therefore, if you are an app developer, regardless of the mobile application you intend to create, make sure that you implement the best app advertising strategies for your product.
Technological advancements that have been made within the mobile industry could be highly beneficial for several industries in the future, including healthcare. Some believe that mobile software apps and mobile touch screen devices that offer online access to knowledge management systems and enterprise services, could be useful for clinical engineering.
Thus, it’s wise for hospitals and other healthcare environments or service providers set up and manage an effective clinical engineering department, as well as keep up with the latest mobile health tech trends.
|Posted by Salah Alkhallagi on July 9, 2015 at 3:37 AM||comments ()|
Published on July 2, 2015
By Clarice M. Balconi-Lamica
I was in sixth grade when I decided I wanted to be a biomedical engineer. Before then I thought I would pursue medical school, but once I learned about the biomedical engineering profession, how it fuses both modern medicine and modern technology, I was captivated.
The biomedical world I originally envisioned was one of research and development. But once I graduated from university, I realized I wanted a job where my work in the morning would have a direct impact on people in the afternoon. I found it in the best-kept secret in healthcare: the role of the hospital biomedical engineer. Continue reading...
|Posted by Salah Alkhallagi on June 2, 2015 at 3:37 AM||comments ()|
Published on May 20, 2015
By John Bethune
The idea that technical skills define biomed performance is baked into the job title, whether it’s biomedical equipment technician or healthcare technology management professional. But in recent years, as the field has struggled to move out of the basement and gain more influence and respect, the importance of people skills has become increasingly clear. And at the heart of people skills, says Barbara Christe, PhD, of Indiana University-Purdue University Indianapolis (IUPUI), is empathy.
“The Secret Sauce Is Professional Empathy: Measuring and Improving the Vital Workplace Characteristic.” Continue reading..