What failure rate is acceptable? Things that perform brilliantly in laboratory testing have been a disaster once deployed. Effects analysis relates to the consequences of failures on different system levels. failure rate of 35% to 50% in even the best of hands. Required fields are marked *, https://vextec.com/wp-content/uploads/2020/10/VXT-AM-Logo-Option-7.png, Product Reliability in the Medical Device Industry: Lab Testing Is Not Indicative of True Failure. Laboratory testing is rarely indicative of true wear and does not predict actual product reliability in the medical device industry. You should already be well aware that deficiencies in complaint handling and Medical Device Reporting are two of the most common reasons why the FDA issues 483 inspection observations and Warning Letters (http://bit.ly/FY2013-483-Data-Analysis). The Failures In Time (FIT) rate of a device is the number of failures that can be expected in one billion (10 9) device-hours of operation. Failure rates are often expressed in engineering notation as failures per million, or 10 −6, especially for individual components, since their failure rates are often very low. The FDA is also sponsoring the first annual conference on Frontiers in Medical Devices to focus on computational modeling (http://www.asmeconferences.org/FMD2013/). Or even worse, if the 200 parts slipped through quality control, the models are ready to simulate risk and determine if a recall is required. When we account for the rest of the world, include other types of implants and devices (knee, shoulder, pacemaker, etc. Mandatory Device Recalls - 21 CFR 810. This website uses cookies to ensure you get the best experience on our website. It provides a better means for using and assessing the results obtained from relatively few laboratory/animal/human tests which, by themselves, are unable to characterize the randomness that is critical to population-wide damage tolerance and risk assessment. VEXTEC to Present at Inaugural Frontiers in Medical Devices Conference, Vextec Awarded $800,000 Naval Corrosion Analysis Contract, How Additive Manufacturing Can Fuel Product Development, Additive Manufacturing Is Sparking an Aerospace Revolution, How Technology Can Aid the Additive Manufacturing Process, Taking a Critical Look at the Additive Manufacturing Process, VEXTEC’s America Makes TRX Webinar Now Available On-Demand. As a result, the team developed a filter such that the assessment of the rate of development failure would begin once development work is considered complete. For example, if a feedback mechanism in a therapeutic medication delivery system fails, a patient may receive incorrect or even lethal doses. Whilst none of my direct research ever made it to the shelves, my engineer friend who invents relatively simple guide wires has had some products used on tens of thousands of life saving procedures. Why did the weld fail? The patents history, genetics, life style could used to create a model to simulate the risk of “failure” of a procedure or device. A one percent failure rate should be unacceptable in any industry, especially healthcare. testing code-quality. (E.g. And again, the first OEM to significantly extend implant life from what it is today will dominate the industry. This blog,“Complaint Handling and Medical Device Reporting Common Mistakes”reviews complaint investigations, MDR procedures and adverse event reporting. Estimates vary on the cost of a failed clinical trial, but figures range anywhere from $800 million to $1.4 billion. The FDA is warning that a Greatbatch Medical Orthopedic surgical tool could cause serious injury or death because it came with inadequate sterilization recommendations. In the current age of large multidisciplinary virtual simulation, this is useful in determining how to optimize for the best use of computational and testing resources to arrive at most robust predictions of device reliability. So it is not possible to quantify device reliability. More aggressive and smarter testing will, in essence, cut the current failure rate in half. Information Technology Laboratory National Institute of Standards and Technology Gaithersburg, MD 20899 USA. FAILURE MODES IN MEDICAL DEVICE SOFTWARE: AN ANALYSIS OF 15 YEARS OF RECALL DATA DOLORES R. WALLACE 1. and D. RICHARD KUHN . At these rates, failures are driven by tails of the statistical distributions of loads, geometry and material properties. But warranty is not just an engineering problem. For example, anchoring bone screws can break, or become weakened and susceptible to breaking, when they are over-torqued during installation. Imagine you are in line to ride what’s being billed as the world’s newest, highest, fastest, scariest, roller coaster. Why isn’t my cell phone working? After doing the math, you scratch your head and wonder, “Why are they touting a one-percent failure rate?”  Do you stay the course and board the ride, or head for the comparative safety of the bumper cars? The FDA has hosted meetings on computational modeling. There was a feature article in Wired Magazine last November on the issue of product failure entitled “Why Things Fail”. Catheter failure is costly to patients, care-givers, and the health care system. This growth has been enabled by underlying demographics and by the innovation and expansion of medical devices’ clinical applications and effectiveness. Poor reliability and recalls reverberate throughout a company and even industries as discussed in the article. Was there a problem with the coaster car or track? However, testing alone in a laboratory setting is not adequate in guaranteeing the reliability of a device. When something fails there are a number of questions - and failure analysis provides the answers. While a one percent failure rate is virtually unheard of in most industries, it does, in my professional experience, reflect the current state of the medical implant/device market. The assumption is that two independent safety-system failures would not arise within 24 hr of each other. Consequently, the medical implant/device industry accounts for some of the most (if not the most) litigated cases in today’s courtrooms, shelling out hundreds of millions of dollars in settlements each year. Today, implant life expectancy has doubled to 10 million cycles, or about 20 years. 2. 0% for critical defects (totally unacceptable: a user might get harmed, or regulations are not respected). International standards organizations ASTM and ISO have endorsed PMI, and its results are admissible in court. A one percent failure rate should be unacceptable in any industry, especially healthcare. ISBN 0-87389-300-X 3. 0.01%? He attends the annual American Academy of Orthopedic Surgeons meetings and is a voting member on the following ASTM subcommittees: Get the latest articles from Med Device Online delivered to your inbox. Given the current failure rates of medical devices undergoing compliance testing the only way to reverse the current trend is to give priority to the regulatory requirements during the design phase – rather than after design has been finalised. Per the U.S. Centers for Disease Control and Prevention, 326,100 total hip replacements were performed in 2010 (the most recent year for which data is available) in the U.S. alone, and it’s estimated that number grew to more than 332,000 in 2016. Jon Purdy Jon Purdy. This is the most obvious yet, sadly, one of the most frequent mistakes medtech developers make. The lower confidence limit of the failure rate (in the worst case) is the AQL. As a result, failure analysis has a measurable impact on product quality, longevity, and success leading to reduced litigation, lower insurance premiums, and increased market share. It could be that the survey data is heavily based off the Surface Book and Surface Pro 4's failure rates and other factors such as "frozen or unresponsive touch" were misclassified as failures. These empirical scatter factors do not differentiate between the sources of scatter such as patient type, patient activity level, damage type and locations, material lots and production methods. A critical issue in certifying device reliability is the fact that in-patient failures often derive from non-typical damage conditions. Brentwood, TN, August 28, 2013:  A recent TV commercial on medical implants caught my attention. Failure analysis would be used to pinpoint the cause. This assumption has been criticized ... restore the device or its defective parts to an acceptable level. A failure rate as low as 1 in a 1000 can cause the manufacture to recall a device. How did component failure affect the system as a whole? It is usually denoted by the Greek letter λ (lambda) and is often used in reliability engineering.. Although advances have been made, analysis of the mecha-nisms underlying the persistent high rate of peripheral IV failure reveals opportunities for improvement. Your email address will not be published. These tests are useful in identifying gross design flaws, and the results of these tests must be used to calibrate or validate the full scale design models in the context of the actual usage conditions along with identifying important quality control parameters, but they cannot be used to predict reliability. I predict that, by 2027, we will see the introduction of biocompatible, non-metallic implants. The US Air Force, Navy, Army and NASA are taking this concept a step further in developing an airframe “Digital Twin”. While it’s true that no product or industry can boast 100-percent success, it’s safe to say that a 99.5 percent medical implant success rate is well within reach. This is why explant testing is so important. In the majority of patients who required pump exchange in this trial, the cause of exchange was due to … Your email address will not be published. By John McCloy, Engineered Assurance, LLC. Why is this metric important? One just cannot test enough samples to understand what is going to cause failure in the patient population. Figure 1: Time-Dependent Changes in Semiconductor Device Failure Rate. The Leading Cause of High Failure Rates in Drug Development. If a supplier produces a lot of 200 parts that do not meet a material specification, the model is ready to be used to simulate the risk of failure if the parts are accepted and put into production long before tests can be completed. Computer aided design (CAD), finite element analysis (FEA), computational fluid dynamics (CFD), and material and manufacturing specification are combined to create a model that is a digital representation of the device such as the “Virtual Twin®” used in VEXTEC’s Virtual Life Management® (VLM®). While it’s important to note that some information may be rendered moot due to exemptions and variances, MAUDE reports remain a worthwhile starting point. That level of safety is acceptable in many medical systems. Was the patient compliant (weight, health, aftercare followed), or were these conditions waived because a patient had no other option (obesity, etc.)? Although computational simulation is not as wide spread in the medical device industry, the FDA would like to move the community in that direction. 19.6k 6 6 gold badges 59 59 silver badges 92 92 bronze badges. One of the more controversial requirements of IEC 62304 is the probability of failure of medical device software during Risk Analysis.. EN 62304:2006 paragraph 4.3 “Software Safety Classification” states “If the HAZARD could arise from a failure of the SOFTWARE SYSTEM to behave as specified, the probability of such failure shall be assumed to be 100 percent.” A failure rate as low as 1 in a 1000 can cause the manufacture to recall a device. Generally speaking, device failure can be attributed to one or more of the following areas: Regardless of the cause, when a medical implant or device fails to meet lifecycle standards, the results are product recalls, lost market share, a mountain of insurance claims and, of course, litigation - all of which are costly propositions. The computational methods we advocate are for predicting reliability and managing uncertainty. In fact, were I to judge such cases, I would make sure that test labs were accredited to ISO 17025, as this is the highest attainable testing accreditation. It is up to the manufacturer's risk acceptance policy. Manufacturer and User Facility Device Experience (MAUDE) data details specific adverse events associated with medical devices, allowing you to determine where potential problems are likely to be encountered based on similar implants. While it’s true that no product or industry can boast 100-percent success, it’s safe to say that a 99.5 percent medical implant success rate is well within reach. Failed Trials – It’s a Real Problem. Automotive engineers use these models to computationally “drive the fleet” where the variation in manufacturing, usage, maintenance and repair are simulated to predict the incidents of failure of each of thousands of components. COMMON TECHNICAL SPECIFICATIONS (CTS) FOR PRODUCTS DEFINED IN ANNEX II, LIST A OF DIRECTIVE 98/79/EC. In the landmark Heartmate II destination therapy trial, the failure rate for HMII was 0.06 per patient-year compared with 0.51 per patient-year with the Heartmate XVE [62, 125 ]. Explant testing often employs a process known as positive material identification (PMI). EMC failures ‘The most frequent source of problems for electromagnetic compatibility (EMC) is related to the radio frequency emissions being broadcast by the equipment under test. Inadequate Sterilization for an Orthopedic Surgery Tool. Think of it as detective work, finding and following clues while employing proven tools, methods, best practices, and experience to determine exactly what happened and why. Explant testing (ASTM F561) is the process to surgically recover, thoroughly inspect, test, and analyze a failed part. Additionally, a simple web search can reveal a wealth of information about documented issues related to implants, information that can go a long way toward helping you avoid others’ costly mistakes. U.S. Centers for Disease Control and Prevention, billions of dollars in litigation settlements, Manufacturer and User Facility Device Experience, Product, including design, manufacturing, materials, metallurgy and chemistry, Surgical error, including technique, judgment and infection, Hypersensitivity, including rejection of foreign body, pain, and sinus reactions. Testing is a necessary and vital element in the development of emerging device designs. 3. What factors caused or contributed to failure? Key words: bloodstream infection , dislodgment , For example, to what degree might friction between the femoral head and acetabular component (resulting from failure in the plastic liner) shorten the life expectancy of an artificial hip? The improvement in reliability in other industries has been driven by the use of computational models as an additional tool to physical testing and quality control. Once the anchoring bone screw is compromised, the device itself will become unstable, or experience premature wear or breakage. Here are some of the major medical device failure events since January: 1. In our roller coaster example, let’s say that the coaster derailed, resulting in injury and, of course, litigation. Information derived from failure analysis is used in a number of ways, from identifying responsible parties to settling litigation and, most importantly, driving the development of next-gen products. Medical Washer: A medical device intended for general medical purposes to clean and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices. The medical device industry may have some catching up to do with regard to using additional tools to improve reliability and reduce recalls. The vast majority of semiconductor device’s initial defects belong to those built into devices during wafer processing. The operating margin for companies in the medical equipment and supplies industry averages 2.87%, according to data from CSImarket.com. The cost of failed clinical trials is high, and the industry needs to focus on ways to reduce the continuously high failure rate. Medical Devices Sharareh Taghipour, Dragan Banjevic, Andrew K.S. Failure analysis has roots that run deep in mechanical engineering. Join our medical devices group community. VLM is a computational methodology that estimates the sensitivity of uncertainty in input variables and the sensitivity of modeling approximations to the final output. One just cannot test enough samples to understand what is going to cause failure in the patient population. This represents a YoY decrease of over 1 percentage point, when the average operating margin was 3.88%. Worldwide sales of medical devices rose to $380 billion last year from $260 billion in 2006. TYPICAL ALLOWABLE AIR LEAKAGE FOR MEDICAL APPLICATIONS APPLICATION PRESSURE LEAK RATE CYCLE TIME Catheters 30 psig <1 cc/min (1.6 x 10-2 cc/sec) 1 – 2 sec Balloon Catheters 200 psig 0.6 cc/min (1 x 10-2 cc/sec) 10 – 15 sec Blood Bags 2 psig 1 – 4 cc/min (1.6-6.4 x 10-2 cc/sec) 4 – 10 sec Syringes 10 – 150 psig 0.1-5 cc/min (0.2-8 x 10-2 cc/sec) 3-10 sec It is also true that one cannot substitute modeling for testing, quality control or good engineering. Percentage of product in compliance. More aggressive and smarter testing will, in essence, cut the current failure rate in half. This is understandable; one simply cannot test enough samples at enough conditions to cover all possibilities. 1000 devices for 1 million hours, or 1 million devices for 1000 hours each, or some other … Device failure is exceedingly rare with the current generation of continuous flow VADS. As a result the process remains critical to nearly all equipment-reliant industries from automotive, and aerospace to oil and gas among others. Failure Mode and Effect Analysis, FMEA from Theory to Execution D. H. Stamatis, ASQC, 1995. Here are a few to consider: Most early implants were designed to achieve a life expectancy of at least 5 million cycles; that’s roughly 7-10 years. ), and factor in a one-percent failure rate, the price tag is nothing short of jaw-dropping. Recently, I posted a blog about “Where to Focus your Medical Device Complaint Handling Trai… Sample size justifications should be based on statistically valid rational and risk assessments. Worldwide sales of medical devices rose to $380 billion last year from $260 billion in 2006. The FDA is warning that a Greatbatch Medical Orthopedic surgical tool could cause serious injury or death because it came with inadequate sterilization recommendations. Uncertainty and errors associated with the manufacture, assembly, usage, record keeping and the computational models is all considered to “bound the uncertainty” on the health of the airframe. Fortunately, failure analysis has evolved into a formal process supported by sophisticated engineering, scientific principles, advanced tools, and best practices. For our purpose let’s define medical device failure as the inability to meet quality or durability standards. China’s GJB/z 299 Reliability Prediction Standard The approach resembles a detective examining a crime scene: making visual assessments, inspecting for signs of metal fatigue, looking for signs of operator or installation errors, and looking at the overall design of the device. 4). Let’s assume failure analysis determined that a faulty weld compromised a supporting structure, causing a portion of the track to become unstable. medical device can lead to system failure and may result in patient injury or death. So what’s the answer? One cannot test for high reliability. Was the weld damaged in shipping, or while erecting the structure? Developmental testing at a specimen or sub-component level is required. Were the wrong materials used? This includes all of the engineering orders, repairs and missions that make each tail number unique. Image courtesy of Engineered AssuranceAs previously mentioned, implant failure typically can be attributed to one of two areas: product flaws (design, material selection, and manufacturing) or surgical/installation errors. The whole system failure rate is the frequency of failures when the entire process is performed as prescribed by the manufacturer. For many medical device packaging professionals, this is a common question without an easy answer. Products may be labeled as having failed for any number of reasons: failure to meet price or market share goals, failure to deliver a favorable return on investment, you name it. Were proper welding techniques followed? Here Are the Startup Failure Rates by Industry Kristin Pryor January 12th 2016 9:00 am If all startups were successful, everyone would be an entrepreneur. And it’s not just the patient that innovators should bear in mind; they should also consider the needs of doctors, nurses, installation and service technicians, production and validation experts, marketing and b… In the landmark Heartmate II destination therapy trial, the failure rate for HMII was 0.06 per patient-year compared with 0.51 per patient-year with the Heartmate XVE [62, 125]. 3.1. 1.1 Early Failures The failure rate in the early failure period is called the early failure rate (EFR), and exhibits a shape where the failure rate decreases over time. Computational models with probabilistic methods have been used in aerospace, automotive, civil structures and other industry to predict reliability and identify the most probable sets of conditions that will produce unacceptable failure rates. These estimates are shown for three device renewal intervals, two years, eight years and 15 years. true failure. Additionally, he maintains numerous industry and scholastic licenses and certifications including PE, CWI and MBA. Inadequate Sterilization for an Orthopedic Surgery Tool. dwallace@nist.gov, kuhn@nist.gov . While touting the benefits of extensive laboratory testing, the fine print said that “…results of the testing have not been proven to predict clinical wear performance…” How true. By applying this filter, the team recognized that device transfer is the step that occurs after the development work is considered complete. Full wet chemistry (with gasses), to confirm the alloy was to the specification, Fractography, to characterize the fracture surface and/or wear surface, Grain evaluation (up to 600X), to determine the material was thermally processed properly, In some instances, mini tensile bars are fabricated to determine tensile strength, yield strength, % elongation and % yield, F04.22.12 Tibial Tray (Mobile Bearing F2777), Unicondylar KneeTray Fatigue Testing (WK45235), F04.22 .24/12 Finite Element Analysis in Orthopedics (FEA for F1800) and knee Femoral Closing Bench, F04.22 ISO Knee and Hip Standards Ceramic Head Test, ASTM F561 Retrieval and Analysis of Medical Devices. This packaging, often a pouch or blister pack, is then removed from the clean area for loading into protective packaging. 0.0001%? As you’re about to board, you notice a sign boasting a 99percent success rate! As an example, with regards to implantable medical devices, one wants a high statistical confidence that the device is reliable before beginning patient trials. VLM provides a technique for assessing the scatter in the behavior of clinical damage rather than simply relying on purely statistical safety factors for all operations. There could be a corollary to a future “Digital Patient”. Did the operator allow the coaster to exceed safe speeds? share | improve this question | follow | asked Oct 12 '11 at 16:00. This demand means longer testing cycle times, as well as an opportunity for even more thorough testing and more accurate data to drive the development of next-generation products. And the former owner of Accutek Testing Laboratory, a mechanical and metallurgical testing laboratory for clients from the medical, aerospace, and defense industries. Here are the 10 most common compliance failures for medical devices (and Anna Wildner’s thoughts on them): 1. The safety factors today rely solely on the acquisition of great amounts of empirical field data thereby combining all factors in a single, undifferentiated life factor. John McCloy is Founder and President of Engineered Assurance, LLC. Too few samples are tested at a limited number of conditions to identify the subtle design issues that affect the reliability of the device once it is put into the market. Medical Device, Radiological Health Products ITG SUBJECT: RELIABILITY OF MANUFACTURED PRODUCTS During World War II, a Navy survey revealed that its … 5. Finally, it is recommended that product developers join a professional society and participate in ASTM or ISO subcommittees to stay abreast of industry trends. Packaging test methods rarely contain sample size guidance, so it is left to the individual manufacturer to determine and justify an appropriate sample size. Did the brakes fail? Maurizio Colombo Good point. PMI helps to validate the structural integrity of any given implant and consists of the following: Findings from explant testing allow you to issue recalls, make design modifications, and apply lessons learned to next-generation products. Did the surgeon implant the device properly? Here are some of the major medical device failure events since January: 1. Data is fed back to the industry to allow for improvements to design, material choices, manufacturing, or installation procedures. Among other things, CDC's recommendation that health care providers wear medical gloves demonstrates the proposition that devices labeled as medical gloves purport to be and are represented to be effective barriers against the transmission of blood- and fluid-borne pathogens. Did the patient correctly follow aftercare instructions? Sometimes the technology can blind us all but, when it comes down to it, the patient’s need (and whether it really exists) is the most important part of the whole process of developing a new medical device. However there are many other ways to do medical good too where the odds are not so bad, medical devices for example, success rates are at 70% or so I hear. 4.0% for minor defects (there is some departure from specifications, but most users would not mind it). The reports contain information submitted since the early 1990s. 1. In the case of the two circled columns in the second table, the lower confidence limit of the allowable failure rates given are 2.5% (for 10 out of 200) and approximately 4% (for 14 out of 200). 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