19 min reading time

I’ll be honest: I can’t even imagine what it’s like to learn my implant is being recalled.

But that’s what happened to a group member who prefers anonymity for legal reasons. She writes:

“I was appalled to receive a letter that my two-year-old hip replacements were being recalled. They were supposed to last 25-30 years!

They sold me the ‘the newest and greatest innovation’ when I had both hips replaced at the same time. (I was in excruciating pain, could barely walk, and was bone on bone after too many years of ballet.)

I healed well after physical therapy and, when my letter came, convinced myself my devices would be the exception. It didn’t work out that way.

I started having pain in my left hip and a strange metal-on-metal sound when I moved my leg a certain way after 4.5 years. My MRI showed a pseudo-tumor filled with metal shavings surrounding the implant. If these particles break loose into the blood stream, it can be fatal.

I had my left hip replaced in the fall. The right one is next.”

She concluded with a question for the group: “This is deeply unfair to patients. What can we, as an industry, do to prevent recalls of implanted devices from happening again?”

Related reading: “Are Recalls Preventable?” at http://linkd.in/preventable-recalls

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Come meet us in person. It could make a lasting impact on your career, network, and company. See the agenda at http://medgroup.biz/10x-agenda

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Discussions This Week:

When Your Intellectual Property Is Out-Marketed In Another Country
http://linkd.in/outmarketed

After everything you did, how’d you get that CAPA?
http://linkd.in/howd-you-get-capped

What does “enforcement discretion” mean for medical devices?
http://linkd.in/enforcement-discretion

How are you avoiding Counterfeit Components?
http://linkd.in/counterfeit-components

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Make it a great week.

Joe Hage
Medical Devices Group Leader

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Antonin Cuc
Head of Dept. Health and Safety at work at Ministry for Labour and Social Affairs
I have been perfect informed about all harmonised Standards and Design and rules by the Direction 93/42/EEC Medical Devices for usage the implants of Class. II. b, so as processing with Conformity Assessment CE for dangerous products, there are allways list of most serious risk and producer recomendation to prevency repeated serious risk by all users (Physicians and Patients)….. There are many trivial rules in mandatory skeletal preliminary analyses of patients before surgeries THA, includs mandatory preliminary proccesing Plan with defined exact anchoring of implants in bones with ordinates Xi, Yi, Zi on both ends of stem – by the Designers from producers, there are duty to postoperational radiologic control “Health and Safety with guarancy coaxialities stem and femur…etc., etc. The Orthopaeds are full ignorancy and stupidities, when they didn´t respect this forensic engineering principles….they are without responsibility to patient lives and prevency risk of injuries. The Orthopaeds, Radiologists and forensic Physicianc – which I have known by my crippling – there are about 40 person – fully silly, when they could tell lies by Court – there are not able to recognize “punctuare trajectories a spice of stem through femural bone” or ” a postoperational breaking of stem from femural bone” – there are for me, as for my knowledges from forensic crimi tracing, crimi biomechanics, crimi antropology, crimi Radiology a test about Physicians competency for Orthopadic surgeries. There are working in the Orthopady many idiots, they have no immagine about basal knowledges of mechanical engineers, State inspectors in Health and Safety. When I have to explain for the forensic orthopaed my noticed by written to false medical Court messages before Court processing, the expert could repeated all nonsense about “Lege artis m\y injuring”. I have just given a penal announcement on State office for penal claims for the aware false medical testimony after my forensic engineering evidences. The Judge explain in the judgment “It was not able to defined personal mistakes of Physicians by Crash Fausse route regards to medical testimony of team forensic physicians from Central Army Hospital Prague”, but I was all evideced with the compare the radiological etalon of used stem in sagittal standard imaging…with the first postoperational X-Ray immage …there are different Profil and Dimension of stem…so as I sent describing by written to forensic Physicians so as for the Judge so as form my advocate, so as to a Deliver of set THA B. Braun Germany, so as to the culprits from Regional Hospital Mladá Boleslav. There were no doubts about the Ethics of Physicians in this case: ZERO, Summary knowledges about Health and Safety working with garancy legal levels: ZERO, about rectangle projection and the Pythagorian theorem in Radiology ZERO….I recommend for such medical experts to begin a new career as the musicians or Country singers in pubs. I have extremal anxiety about Health and safety of next orthopaedic patients. Thatfor I have patented decision making method S_T_A_R_S to detect mass medical mistakes in contrary forensic engineering evidences acceptable in the whole world. By my expertise there are yearly in the THA needlessly dying or heavy injured about 5% of all orthopaedic patients under the requirements of implantation Law. I am able to safe about 40% Loss of patients. I need have a competnecy to used Health orthopaedic documentation, monitoring the processing in surgery hall. a competency to used records from EHRs and then the computerised managing of Hard deterministic surrveillance system against most repeated frequently mistakes in Orthopaedy, it could be realise with a big project in duration of 2 years – with a team of experts from Physicians, IT experts and expert from Statistics, for many hospitals paralelly. I asked buy my patent a licence as a duty primary condition.

Antonin Cuc
Head of Dept. Health and Safety at work at Ministry for Labour and Social Affairs
Dear friends! I would satisfied, when we, as the forensic engineers analytics could find all medical mistakes against detects of forensic engineering in the samples of 50 surgeries with THA from various producers, which are keep on the market with set of standard orthopaedic implants. I have been realised such modeling legal analyse by my patented method S_T_A_R_S-Statistical Retrieval and Search of information to decision making with computer support on sample with 3 THA surgeries on my private body, and I clamed the physicians for the systematic ignorancy Law fo legal implatnation by Directive 93/42/EEC Medical Devices, there are this tragic mistakes: – none of THA surgeries were a best medical decison about diagnose and treatments, there are allways on both hip a necrose of femural Head, but my Oerthopaeds and Radiologists weren´t abel to diagnostic this fact intime, DESPITE I WAS SUGGEST SUCH A RIGHT DIAGNOSE AS A PATIENT. In first case, I have visited Orthopaedic radiology, but there are not able by the X-Ray Imaging diagnose on beginning, but by my description my Radiolog sent me immediately to the neurologist – but the right decision making should be MRI. The neurolog has first impresson “it could be neurologic ineravtion of skeletal end” it was not such stupid idea, but after 14 days allways worse locomotion, it was sure full bad decision, He didn´t send me on MRI and it was for my hip tragic destruction of surface of joint in 5 weeks. Instead of nonchirurgical treatments by infusions or with revitalised cells – I losted my hip by inforced THA, but this realisation was perfect. The reply of necroses on the right hip, there was no so much dramatic way, but the Orthopaed observed my joint 2 years only passive way with a smiling “You will get a new else THA”, but the second THA was fully tragic: Orthopaed didn´t prepare the mandatory preliminary Plan of implnatation, he didn´t diagnostic my dysplastic declination of femural neck, he was improvising implantation with tragic concatenation many medical mistkes: by formation of proximale femur the concave for stem, he unknouwingly created the false hole with orthopaedic rasp and then by tentative nashing if stem, the spice of stem was going the false trajectory through the false hole with finishing in declination with 13,68 grads out of axis the femur. He never mind on Crash and he assembeld the set THA fully nefunctional. It was not able to full funkctional angle dimension of postions legs and there it was false friction in joint – But he wasn´t able to recognize Crash of set. He di´dn´t a radiologic control on surgery hall and he finished the needlework. The postopertional X-Ray was realised till 3. dy after surgery, but the declination of stem was in the same direction as the X-Ray imaging – so that “by the intuitieve view only – it was not able for Oerthopaed and for Radiologist to diagnostic FAUSSE ROUTE STEM”. I was nearly dying, but I was transported as “Well THA” patient in the else next Hospital, and then the tragedy was diagnostic till 10 days after Crash. I was return back in Orthopaedic Clinic, the reoperation THA was successfull, but I was with full plegic nervus ischiadicus. The prime Orthopaed has no medical information about full plegic nervus, he never sent me on neurochirugical recontruction nervus in time. I stayed full crippled, so as lame and with full destructured musculus of calf, bad thermoregulation, bad blood circulation. I am needlessly slowly dying on casual next Health complication – with many frequency of radiology, often fallen., stresses, today on leukemia – by biostatiastic evidence about 5,5 years earlier. I tried to explain vy the forensic evidences – it was possible to control the coaxiality stem and femur by comparation the Profile and Dimension of radiologic firm etalon…There are fully out of Physicians knowledges!

Michael Fischer
Auditor at BSI
I read the responses; think most make sense.
I cannot talk for the companies where I have worked, but I can tell you the companies and employees wanted these devices to work well and work for decades after implant.
Look at what you are asking for. How do you design, test, build, and deliver to surgeons a product they can implant in a complex of live tissues that includes arteries, veins, bone tendons, cartilidge and nerves all mixed in with blood, lymph, marrow and muscles. Again these are live tissues. You cannot simulate that environment because it is very, very, difficult to determine what the finished product will be subject to – running, jumping, skipping, hopping, falls, and pounding/impacts of various types, yet alone the corrosive environment inside a human. Yet I know lots of tests were done and companies even found some human volunteers. There are a huge number of other tests performed. Animal tests – no because it turns out dogs/cats/chimps feel pain differently than we do. Their anatomy is different so the results of animal tests do not mean anything.
Cadavera tests don’t work either. Yet thousands are done anyway to get the right fit. and test 100’s of different parameters.
How do you train physicians to do these techniques and how do you improve the products? We are not monsters – we do not just try these things on people without informed consent. We also don’t sit around for years while millions suffer because they can’t walk or otherwise move and are in gross pain while we wait for perfect. People talk about some happy medium. I don’t know what that would be. What I can tell you is that great efforts and expense went into, and continues to go into the design and development of these products.
As one author in this line of discussion noted the rules today include design controls. Those requirements have and are being followed. The designers and purveyors alike of various implants are subject to national and international standards and regulations the likes of which the world has never seen before. Then again, how many times did ISO 14971 change from 2000 through 2010? As a Quality and Regulatory Manager but also as a graduate Biologist, an Engineer, and an Educator I have marveled at the training, experience(s), and immense effort of my colleagues and the companies in an all out effort to relieve human suffering. Yes I know money did change hands too.
There is nothing else on the planet like humans, and by the way to show you how different we are, think about a human infant versus any other new borne living creature. Human babies can’t walk or even crawl to mother for months. Human neonates are helpless and will die if you do not bring them food. Even blind puppies (eyes are closed) can crawl to their mother for sustenance. Most animal walk day 1. Not so our progeny!
Bottom line, because we are so different and for many other reasons, I do not believe you will have zero recalls until medical device technology is far more advanced than it is today. Would you really stop because some folks need replacements? Remember, we have gone through several revolutions in light bulb design and light bulbs were designed and have changed for many years before device implants even came along. Medical device implants are a young industry. It is human to keep trying and to suceed at some things, but to err is human too.
I hope everyone will remember that medications are similarly not always perfect yet we have been working on them and changing them for centuries. Do you know that a cure for syphilis 3 centuries ago killed some of the patients while it cured others? It took a couple of hundred years to get antibiotics. These medical implants are in their infancy. Devices in some cases have been around for only a few decades. We will keep trying. Our quality and regulatory methods will improve, the education of doctors and device engineers will improve and so too will our devices and our patient outcomes.

Mark C Adams, MBA
Medical Device Leader/Executive
People develop and engineer products.
People are flawed.
Case closed.

Dave Sheppard, CMAA
Global M&A, OutSourced B,D&L Leader for SME (Small and Medium Enterprises) & Emerging Technology Healthcare Companies
Dave, you are correct. Any design is only as good as it’s weakest link. And for medical products (especially implants), all “Links” need to be thoroughly validated !

Dave Darley
Technical Trainer at GE Healthcare
The article states the patient did have the discussions and verified what she was getting was the latest and greatest, and therein lies the problem. It was supposed to lat 25-30 years. As with new technology it is sometimes tempting to go with the latest and greatest only to find, it has an unseen fatal flaw. It’s not so great. I saw a case where hip implants were being recalled and the problem turned out to be a hitch in the washing/sterilization process. Microscopic film residues (no-toxic) were left behind preventing the bone from bonding with the prosthesis. An older, proven hip had been available. The point is, they didn’t start testing this proshetic joint 25-30 years ago, but validated it in a few short years with some “Accelerated testing” program, which obviously the FDA bought into, and was obviously flawed. The crime is that the companies are so confident in their processes that this risk is not conveyed to the patient. I have seen this over and over in all industries, but it is particularly disturbing in the medical field. I am old but more cautious in that regard. Where time is a luxury I have, I do my homework, get multiple opinions, and read reports. I can still get bitten, but it is less likely. You shouldn’t have to. Even if she had done this, it is not likely she would have been able to discover this, but I contend that the recall is proof that the manufacturer did not properly validate the safety and effectiveness of that product. FDA, Phamapseudicals, Doctors, all should be watching out for the patient. This is the most important part of their job. Beta testing is a science, because it has to perfectly duplicate und use, whithout actually being used. (It is impractical to put hips in 1000 people and watch them for 30 years to see what happens, then go to market).

Dave Sheppard, CMAA
Global M&A, OutSourced B,D&L Leader for SME (Small and Medium Enterprises) & Emerging Technology Healthcare Companies
Adding to the equation is the good news that many of us are living longer and access to healthcare continues to grow globally. Implants originally were placed on people that were more likely to be “recalled” to their maker before any parts inside would ever need to be recalled. Now, there is an entire industry serving healthier patients who will live longer. While implant technology continues to improve, it’s clear it’s difficult to get any of us a guarantee of “lifetime” success. At the end of the day, we need to choose the best surgeon and ask him/her the tough questions to ensure they are using the “latest and greatest” on us.

Lester B.
Co Founder/Board Member at Miavina
Even successful life cycle testing on a design isn’t always going to guarantee reliable performance over the long term. Rarely do manufacturers produce every component that goes into a final product. The supply chain, and managing that supply chain in a diligent way, is critical . A supply chain evolves over time and problems can emerge in a final product when a 2nd, 3rd or even a 4th tier supplier makes a change to a component after the product is in production, but doesn’t communicate that change up the line. Usually this is because the supplier views it as a minor change and frequently isn’t aware of the impact. A lot of companies and their customers learn this lesson in a painful way. Thorough life-cycle testing is a critical part of the development process for a product before it goes to market and a well designed supply chain management and testing process is a critical part of ensuring reliability during the product life cycle.

Edwin Bills, ASQ Fellow, RAC
Consultant
Jeffery,

Glad you found more information on MEOST> Shainin was a master of simple and uncomplicated techniques that were also powerful. The masters from the early days of quality and reliability still have much to teach us.

Richard Brautigam
Business Development
Ian, your comment and it’s length were completely appropriate to the circumstance. Even the best dynamic test methods available to biomechanical science outside the human body will ever provide 100% certainty.

Ian Broverman
Medical Device Reviewer
I agree with many of the posters that failure – particularly with implants – is a tough issue and a terrible experience for the patient. I also agree recalls aren’t 100% preventable yet, that they are a risk of progress, and we do learn from them.

I’m currently a medical device reviewer for the FDA, so I can’t comment about the group member’s MoM hips, other than that I truly hope her health improves. And of course, my opinions here don’t represent the FDA’s opinions. But I wanted to share (and/or drone on about) a prior experience with a recalled implant to give anyone that’s unfamiliar a glimpse of the possible complexity of implant failure. Back in the early ’90s, I was a technician working for Pfizer’s Bjork-Shiley Convexo-Concave Heart Valve recall team. The valve was susceptible to a strut fracture over time. This was reported on approximately 500 valves, 2/3 of which caused fatality. (Many failures happened post-recall. Due to the risk of the operation, many weren’t replaced) The FDA removed the device from the market in 1986.

There was a good deal of controversy when it was pulled from the market, involving both Pfizer and the FDA. I can’t offer any insight on that; I wasn’t there yet. But I can say this: By the time I was hired, there was white-hot pressure to fix the problem. Death was still a risk for thousands, which was a sobering motivator in our labs. Also, litigation had reached the “Worried about your heart valve?” infomercial level, putting everything under scrutiny. Pfizer had to do the right thing, and I believe it did. Top people were recruited and worked at high capacity. A wide variety of bench and animal testing was developed and performed on hundreds of carefully reclaimed valves. This effort was above & beyond what would be expected for a new device. (Minus clinical trials – for obvious reasons) Yet even with everyone taking the right steps, the valve failure mechanism wasn’t categorized until 1999.

Testing a device over its life cycle takes time. Also, tracing implant wear failures can be tough due to the number of variables. A device system may come in many shapes and sizes that add different risks. Patient anatomy, age, gender, behavior, etc. could all affect wear. Surgical installation device manufacturing technique could affect performance. The Bjork-Shiley ‘s fracture was originally hypothesized to be caused by a welding defect, but was later disproven. However, even normal manufacturing for a device has potential to create differences .

The testing isn’t always straightforward. Physiology may not be well enough understood to be accurately modeled. Or an unconsidered subclass of patients might turn out to be at higher risk. Or, as is believed for the Bjork-Shiley valve, the concurrence of several variables lead to the failure. For the valve, contributing factors were geometry (larger, wider opening angle) + type (usually mitral) + physiology (higher ventricular contractility potential) + behavior(enough to trigger the ventricular contractions and cause high changes in pulse).

I hope I haven’t droned on too much. The majority of implantable devices aren’t affected by weird nuances that result in premature failure. But as new, innovative devices are introduced, that possibility is still non-zero. But I believe the industry is constantly improving, and that possibility is shrinking. Once again, I agree with the other posters that there are good techniques to improve reliability & quality, that we learn from mistakes (and successes), and that the regulatory process continues to fine-tune the process.

Edwin Bills, ASQ Fellow, RAC
Consultant
To support Chet’s post, there are many techniques that have been used in the field of reliability and quality successfully, such as MEOST. We seem to have lost some of the history of the field’s great thinkers in favor of more “modern” thinking. Juran’s Quality Handbook had a great deal of useful techniques for Quality, but unfortunately Shainin was not a writer. His techniques were published by one of Motorola’s Six Signma Gurus, the late Keki Bhote. HIs publication, still available on Amazon, of “World Class Reliability, Using Multiple Environmental Overstress Testing to Make it Happen” was one of several books Keki wrote about Shainin and still a valuable reference today.

Antonin Cuc
Head of Dept. Health and Safety at work at Ministry for Labour and Social Affairs
The physicians – obvious Orthopaeds realised implantation with statistic frequences of mistakes 1 : 10, but in forensic engineering we are usual working with garancy mistakes only with frequences 1 . 10x10x10x10x10x10, it means: You could with a well prediction to be Healthy take a participation on rocket orbital trip with risk about 2%, but when do you attend yours physicians probable 6x through the 2 years, you will be sure only about 50% to be Healthy. None of physicians could you crippled, but his style of working and knowledges about management of patient risk It has been acceptable before 80 years, but the medical processing by diagnostic and treatments are very complicated and physicians are not able to safety use mass intervention of milions new Medical Devices. It is reason, I am dying after many concatenation trivial medical mistakes by surgery THR in contrary to evidences legal requirements of safety usage product wtih CE Conformity assessment. The doctors as culprits are ignoring their mistakes, the forensci physicians covered culprits with false medical testimony and Judge covered culprits with regards to false medical testimony – and a plaintiif – as despite a forensic engineer – by judgement patient never has got a word to explain crimi tracing implants by extremal bad instalation of set THR by civic Court. This is constant function of a white maphia against patients and Ethics. Help me! I am able to design the perfect surgery line with safe about less 35% usual victims of all patient who are needleesly dying or they are injured by THR yearly.

Jeffrey Mumford CTAL-TM
Quality Assurance Specialist at Medtronic Diabetes
I think the first takeaway is “don’t use a device that hasn’t been on the market for at least 10 years” same as my advice for prescription drugs (Vioxx anyone?) Of course this begs the question: “Who’re going to be the ‘guinea pigs’?”
I think it’s pretty clear that the manufacturer dropped the ball here on durability testing here, which is really pretty inexcusable. When I worked at JPL (back in the late ’80s) the were working an an instrumented artificial hip joint that could transmit telemetry on the forces and strains applied to the joint in vivo. I don’t know if they ever implanted it in a person and took readings, but certainly they could have experimented in dogs (many of them are born with hip dysplasia and get artificial joints). Extensive testing of metal-on-metal implants in animals (IMHO) would have found this problem before the implants went on the human market. You simply have to test new technologies like this extensively in vivo before you know what’s going to happen.

Mark C Adams, MBA
Medical Device Leader/Executive
Unfortunately, and especially in light of Obozocare, you’re going to see much more of this.
Why? Because the government has decided cheaper is better.
The debacle created when oxygen went out to bid should have stalled the process.
Bid winners were nowhere near ready for the volume of business thrown their way.
Now because of cost constraints I’m seriously concerned about the quality of all Implantables going forward.
We, as industry people, can do our best to ensure that the products we are responsible for will never put anyone through this sort of agony.
But what can the industry do against price vs quality as that is where medicine is headed.

Kenneth Aycock
Staff Fellow Mechanical Engineer at FDA
This is a terrible anecdote, especially considering the potential consequences had they not identified the patient and notified her of the recall.

“There is often no sufficient ex-vivo testing that is rigorous enough to completely model what will take place inside the patient.”

With this in mind, however, I think that *some* failure needs to be accepted to keep innovation moving forward. We can’t demand new and less expensive medical devices without accepting the occasional disaster (now, defining “occasional” is another matter).

@Chet Haibel, would you agree, or do you think accelerated life testing (ALT) procedures are good enough now to catch most everything? Are medical device engineers and FDA specialists in need of more training in this area?

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
@Mike Coon, thanks for that note. I should have mentioned your team’s workshop at 10x, “Extractables and Leachables Testing for Medical Devices.” Will you be able to incorporate thoughts from this discussion there?

http://medicaldeviceevents.com/2014-conference/medical-device-workshops/#extractables-leachables|leo://plh/http%3A*3*3medicaldeviceevents%2Ecom*32014-conference*3medical-device-workshops*3%23extractables-leachables/ddGU?_t=tracking_disc]

Michele DeMeo
Rtr,Healthcare,Legal Subject Matter Expert,Motivational Speaker,Designer,Artist, Author,Consultant,Activist,FDAVolunteer
Tough work, so needed! I wish I could help more…

Michele DeMeo
Rtr,Healthcare,Legal Subject Matter Expert,Motivational Speaker,Designer,Artist, Author,Consultant,Activist,FDAVolunteer
Yes, I was on the highest FDA team as my profile shows. Would still be, but now terminal.

Roberta Goode
Technical Trainer at Altrec, LLC: Highest-ranked customized training exclusively to the medical device industry.
This is precisely the reason the FDA implemented Subpart C, Design Controls, into the QSR. Trending of product safety data indicated that the majority of device recalls were preventable if design controls were implemented prospectively. It’s little comfort for patients such as this one, but we are getting better at proactively identifying design elements that can lead to harms (esp. with correct application of ISO 14971), and preventing them before marketing a new device.

Michele DeMeo
Rtr,Healthcare,Legal Subject Matter Expert,Motivational Speaker,Designer,Artist, Author,Consultant,Activist,FDAVolunteer
Ok, a bit of a twist to this. Food for thought. I agree with many of the comments, great piece too… but there is something many do not think of and I had to put measures in place for companies that either hired me or i managed, etc…what about the facilities that do procedures that use trays with a combo of instruments and screws and plates (the ones where there is no number on the implant…. and are “stocked” by the SPD department and/or, OR, sales rep, etc???? I had means and process to handle, but as a consultant and someone even though I am retired, who gets hundreds of emails a day with questions, i have to say many many many, yes, here in the US, do not have a process in place of know what patient got which tiny screw out of some nameless hand trauma tray or small frag set, or or the companies are irrelevant. My point is education and awareness is actually still needed to even be able to “recall” all the types of implants used in our facilities.

Mike Coon
Associate Director – Lab Sciences at Charles River Laboratories
In my opinion, the only thing the device industry can do is learn from this terrible situation and make adjustments to improve future implants. Agreeing with Jan, the choice of optimal materials for each device is key. I would assume that the manufacturer in this case complied with all known testing requirements prior to agency approval. I also assume this was not a case of the company withholding negative data from their testing. Unfortunately, the botton line is that medical science does not have 100% guaranteed successes.

Richard Brautigam
Business Development
My experience as a business team leader is very similar to Michael Faraino’s. There is never any question of bad intent on the part of the device design teams when trying to choose materials. There is often no sufficient ex-vivo testing that is rigorous enough to completely model what will take place inside the patient. In the particular case of metal on metal implants, I had close connections with companies that made the parts for several of the major companies in this space. Only after ten or more years of exposure in patients are these issues coming to light.

Jan Voskuil
Director at Aeonian Biotech
May be I am too simple for this, but it seems to me the bottom line is the choice of material. Whether it is a hip, a valve or a breast implant, , the material of choice needs to survive the environment it is meant to function in. How difficult can it be to test rigorously any new device under such circumstances? Or is it really about cutting financial corners????

Glenn Tamir
Northeast Area Manager, Intelliguard RFID Intelligent Inventory Solutions
It is my understanding that while there may be a method to do so, many systems do not do this with great accuracy.

There are systems that are designed specifically to capture this information using simple bar code technology that will automatically document with little or no disruption to the procedure.

If anyone is interested, I would be happy to share this info. Just send me your e-mail.

Glenn Tamir
Storemed
http://www.storemed.com/
glenn@storemed.com

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Glenn, is “not having a system to track an implant” a common issue? That would be frightful.

Glenn Tamir
Northeast Area Manager, Intelliguard RFID Intelligent Inventory Solutions
I am sorry to hear about this group member’s experience. At least they were able to trace the specific implant to her. Imagine how scary it is knowing that one may have a problem and the facility did not have a system in place to track & trace the device.

Richard Brautigam
Business Development
I have been in material sciences as a business leader for over thirty years. Implantable devices are always pushing the boundaries of what the material scientist is going to consider comfortable. The only real way to test materials for implantation is to constantly evaluate and update recommendations based on longitudinal data. Metal to metal implants were considered “safe” until enough of them were in human subjects to demonstrate that unanticipated wear took place over time. As Tom points out, you always need to examine any data or assumptions based on data to discover true risk.

Tom KraMer
President & CEO, Speaker
This is a tough issue for developers and manufacturers. As developers we attempt to go through the most rigorous testing and investigation as possible before freezing the design of a device. The best medicine for this problem is prevention, and the best prevention for adverse effects is good, in depth, usability research up front. Investigating what I like to call the “needs surrounding the need” will help uncover potential problems. This is more than just a hazard analysis and a risk assessment. It is a deeper, preliminary dive to discover the “truth” around a medical device need. Perhaps if more time is spent doing this, we can diminish the chances of horrible recalls like the one described above.