A press release notes:
Consumers Union, the policy arm of Consumer Reports, is calling on the top manufacturers of hip and knee implants to provide warranties that would entitle patients to have defective devices replaced at no cost.
Consumers Union is pushing device makers to equip patients with warranties so they will have a better understanding of how long an implant is expected to last and a clear process to follow in the event that it fails prematurely. Ultimately, warranties will encourage companies to make their devices safer and more durable, according to Consumers Union.
“Patients have a right to know how long medical device manufacturers are willing to stand by their products,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project (www.safepatientproject.org). “While patients may be told by their surgeon how long a device can be expected to last, they rarely get a guarantee in writing since most hip and knee implants do not come with a warranty.”
A Consumers Union review of hip and knee implant recalls found that all major manufacturers have recalled a product or line of products for defects over the past decade. These recalls underscore how devices can fail prematurely and harm patients.
In letters sent to Biomet, Inc., DePuy Synthes, Smith & Nephew, Stryker Corporation, Wright Medical Technology, Inc, and Zimmer Holdings Inc., earlier this summer, Consumers Union urged the companies to provide a 20 year warranty and outlined the terms of a model warranty.
What a great idea. Thus far, I have heard of no overwhelming response from manufacturers.
What if we "helped" them along. What if the American Academy of Orthopaedic Surgeons adopted a policy statement saying that its members would not insert any such implants unless the manufacturer provided such warranties? What if the major orthopaedic hospitals announced that they would not purchase or insert any such implants unless the manufacturer provided such warranties? What if CMS announced that it would not pay for any such implants for Medicare patients unless the manufacturer provided such warranties?
Consumers Union, the policy arm of Consumer Reports, is calling on the top manufacturers of hip and knee implants to provide warranties that would entitle patients to have defective devices replaced at no cost.
Consumers Union is pushing device makers to equip patients with warranties so they will have a better understanding of how long an implant is expected to last and a clear process to follow in the event that it fails prematurely. Ultimately, warranties will encourage companies to make their devices safer and more durable, according to Consumers Union.
“Patients have a right to know how long medical device manufacturers are willing to stand by their products,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project (www.safepatientproject.org). “While patients may be told by their surgeon how long a device can be expected to last, they rarely get a guarantee in writing since most hip and knee implants do not come with a warranty.”
A Consumers Union review of hip and knee implant recalls found that all major manufacturers have recalled a product or line of products for defects over the past decade. These recalls underscore how devices can fail prematurely and harm patients.
In letters sent to Biomet, Inc., DePuy Synthes, Smith & Nephew, Stryker Corporation, Wright Medical Technology, Inc, and Zimmer Holdings Inc., earlier this summer, Consumers Union urged the companies to provide a 20 year warranty and outlined the terms of a model warranty.
What a great idea. Thus far, I have heard of no overwhelming response from manufacturers.
What if we "helped" them along. What if the American Academy of Orthopaedic Surgeons adopted a policy statement saying that its members would not insert any such implants unless the manufacturer provided such warranties? What if the major orthopaedic hospitals announced that they would not purchase or insert any such implants unless the manufacturer provided such warranties? What if CMS announced that it would not pay for any such implants for Medicare patients unless the manufacturer provided such warranties?
Good for Consumers Union. The health care establishment will be shocked (again) by the very thought that normal business practices should apply to it, but I think this is an excellent idea.Your 'helper' idea is also excellent, but I fear it will be studiously ignored.....who is paying the orthopedists, after all. How far we have fallen as a profession.
ReplyDeletenonlocal
Bravo for Consumers Union. Imagine if your body was a car and the new part failed....hopefully patients of old and those yet to come when also rally around this - I'm sure the insurance industry would jump to write these policies for MDs and hospitals...and a new business is born...
ReplyDeleteGreat idea-and so obvious-to require a warranty. In addition to CMS insurers should require this as well. Of course the industry will complain, whine and what not. But the smart competitors will take a Toyota-like approach and engineer better quality in up front, providing another front for competition
ReplyDeleteI think you might have given CMS their next great idea!?
ReplyDeleteThis makes so much sense. I am bringing this to our Med Staff and QA this month. Great idea!!
ReplyDeleteIt’s a good idea. My only question is to what extent can the life expectancy of a device be adversely affected by a surgeon’s error during the operation and how easy is it to tell if a subsequent failure is the fault of the device and thus covered by the warranty or a surgeon’s mistake?lshold 911
ReplyDeleteBarry, the implant company representative is often present in the OR during the surgery, and those companies run the courses at which the surgeons learn to do the surgeries. Therefore, in my mind the device company is still responsible - if they do the marketing and training, then they should assume the risk for that too.
ReplyDeletenonlocal
Mr. Levy,
ReplyDeleteSo you think it is a good idea that manufacturers of total joint “guarantee” the longevity of their product?
Do you really?
1. So now we are telling the world that medicine of a prefect science after all and is performed by perfect surgeons? Really?
2. So if the patient abuses the joint, and I have hundreds that have, still it is guaranteed? really?
3. So if the surgeons puts the device in backwards, the manufacturer is to guarantee the device? Really?
4. So if the device is designed for a patient of a certain weight limit, and they all are, then all obese patients may not be granted the opportunity to have a new joint and must suffer? Really?
5. If the hospitals refused to order implants without a warrantee, there would be no implants to implants.
Medicine and physicians are very talented and the manufactures at remarkable, just look at the advances in their devices over the last 25 years, but perfect, I do not think so. nor should we be put in that position.
I would hope and I am pretty sure that the American academy of orthopaedic surgeons will not likely to agree any time soon.
Thanks for your blog, I read it daily, this time it has cause a little distress.
Simple answer: Yes. What you suggest applies to many, many types of manufactured products that are put into service in lots of types of industries and situations. Normal practice is for a manufacturer to provide a warranty, although there can be exclusions for negligent installation and other types of misuse that you outline.
ReplyDeleteYour orthopedic "friend" does have a bit of a point about patient misuse. Patients tend to treat these joints like their own. A friend of mine even jumped up and down for me just to show that he could.
ReplyDeleteHowever, just the way cellphones have sensors that can tell if you dropped them in the toilet, a joint could certainly have similar censors that can tell if, like Bo Jackson, you were playing center field.
Also why shouldn't the surgeons themselves have warranties? Ironically that would protect them from lawsuits too--"liquidated damages."
Excellent idea.
ReplyDeleteThe warranty should cover full replacement costs of implants that fail, including those that break, crack, cease to function as intended or emit toxins into the body. All product warranties have exclusions for factors that are beyond the manufacturer's control and a medical implant warranty would be no different.
ReplyDeleteFor example, Biomet offers a warranty for one of its knee products which is limited to one full replacement. Consumers Union thinks the warranty should cover the medical expenses associated with replacing the knee, just as "labor costs" are typically included in other warranties.
The purpose of a warranty is for the company to determine whether or not their product failed. Did the patient misuse it or is it a fault of the product? We are trying to create a standardized process that the company will use to vet these issues.
As some have commented, the reps are in the room guiding the doctor and if they provide poor guidance or if the tool they use to assist the doctor (for example, software that the company provides to guide the doctor about where to cut the patient's bone) is flawed, then that would be a company's responsibility rather than the surgeon's responsibility. However, an infection caused by an unsanitary operating room would be the kind of thing not covered by the warranty.
The warranty should cover full replacement costs of implants that fail, including those that break, crack, cease to function as intended or emit toxins into the body. All product warranties have exclusions for factors that are beyond the manufacturer's control and a medical implant warranty would be no different.
ReplyDeleteFor example, Biomet offers a warranty for one of its knee products which is limited to one full replacement. Consumers Union thinks the warranty should cover the medical expenses associated with replacing the knee, just as "labor costs" are typically included in other warranties.
The purpose of a warranty is for the company to determine whether or not their product failed. Did the patient misuse it or is it a fault of the product? We are trying to create a standardized process that the company will use to vet these issues.
As some have commented, the reps are in the room guiding the doctor and if they provide poor guidance or if the tool they use to assist the doctor (for example, software that the company provides to guide the doctor about where to cut the patient's bone) is flawed, then that would be a company's responsibility rather than the surgeon's responsibility. However, an infection caused by an unsanitary operating room would be the kind of thing not covered by the warranty.
Guarantees: and all of a sudden reps, companies and surgeons are at odds, casting blame and claiming negligence of others in front of judges and patients. It is going to get interesting
ReplyDelete