The following are comments regarding the FDA Workshop on refurbishing and servicing of medical devices by third-party organizations and OEMs held Oct. 27-28.
A: Two points the OEMs are trying to make in this (FDA) workshop (Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers, October 27-28, 2016) are examples of horror stories of service by ISOs, which is a reporting requirement, and certification, etc. MITA just attempted to offset the silence yesterday when the OEMs were asked if they reported the horror stories. MITA failed in that no matter how (much) it wished the reporting problem away it appears that these horror stories were not reported as required by 21CFR and it turns out to be a reporting deficiency against those OEMs who did not report those horror stories to the FDA. Those deficiencies are part of an FDA inspection with the OEMs. Oops!
Now let’s see what happens on who pays for certification? Expect dead silence.
A: I have a couple of issues with OEMs giving examples of horror stories.
1. Are you telling me that there are not horror stories that we could tell about OEMs? Did they report them on themselves? However, we fall in the same non-reporting category as them if we do not report them.
2. For every horror story that they tell (rightfully so), there are thousands that are not told. I know it only takes one bad repair or infection or whatever horror stories they are telling to cause a major issue. It is like plane crashes. You only hear of the one plane that crashed killing all passengers on board, not the thousands that are safe. I know I am not completely comparing apples to apples here, but I think it is unfair to show non-statistical repairs by ISOs or in-house biomeds, or imaging techs. I would be willing to bet the number of horror stories are a low percentage, but on the other hand, I do understand the possible outcome, especially if not reported.
Let me just add by saying, just because you are certified on something doesn’t mean you can get the job done correctly either, no matter if you are in-house, ISO, or OEM employees.
A: I think after 40 years in this business I could show examples of horror stories that would shock people. I do not see anything wrong with bringing examples to this workshop provided those examples were submitted to the FDA, as required, and examined by the FDA to reach a conclusion before presenting the horror stories.
The recorded horror stories in MAUDE show the OEM’s employees being suffocated to death, another one (a female) being crushed to death while lifting a heavy part by herself in an MRI room. She was found hours later and one can only imagine how long she suffered. Another OEM employee almost lost his life through decapitation because the OEM wanted to protect proprietary documentation from release to ISOs. He will suffer the rest of his life.
These are very dramatic real-life stories and are part of the MAUDE public database.
Certification and OEM required parts are not an answer to patient safety, it’s a means to eliminate competitors and control the service market.
However, the down side, which OEMs have not thought about, is that the law does not permit profiting by OEMs on these issues.
The problem here is we need a fair and transparent trustworthy FDA CDRH and we are not there. There are hundreds of dedicated loyal and hard working FDA and CDRH employees. There are also some very corrupt FDA and CDRH employees that seem to be in control. I hope the end result of the current FDAIG, Congress and White House investigation, oversight and queries will help resolve CDRH corruption problems but that is idealistic at best.
The bottom line is OEMs control CDRH and get almost all of what they want. Why, most of you do not participate in the daily work of CDRH. Most of you do not demand better of CDRH. Most of you do not support CDRH in a way that benefits patient safety and, finally, most of you do not understand or even know what the laws are and how that applies to you.
If the FDA CDRH was more trustworthy I believe compliance would be more generally accepted and common place. The rest of the OEM issues would be a non-issue.
A recording of the FDA Workshop sessions can be found online at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm511411.htm.
Q: Do you have to use the OEM for training? What about using an ISO?
A: Currently there is no law that requires OEM training. If such a law is passed, the FDA’s past communications dictate OEMs will provide that training on a no-profit basis.
A: I would image that it would be the same as any college, technical training institute or university where as if the ISO is certified to teach the course, they can certify others. As far as “for free” I don’t know of any free training in my industry. You either pay tuition or through the equipment purchase, but it would be extremely rare to receive no charge training.
A: From my past experience on training with OEMs, the people getting trained sat in on the same classes of the OEM’s employees. From a practical sense, the training must meet the basic concept outlined in 21CFR, adequate is used in radiographic, 1020.30-33, and service in 1040.10-11 and 1050. One could make a case that any training required by the OEMs to be certified must be at a level adequate to assure the trainee is capable of assuring the device meets all OEM performance specifications for all devices. The OEMs have a legal concern here if they intentionally under train and certify people other than their employees with a lesser degree of training. It’s not all that complicated and the framework in 21CFR could allow for training without generating new regulations.
A: Let’s not confuse “not for profit” with “for free.” Not for profit means, generally, at a cost not exceeding what can be reasonably expected for literature, accommodation of students, teacher salary, materials, etc. I believe Tom is referring to a section of 21 CFR which specifies service information must be provided, and in relation to conversations with the FDA and OEMs where the OEM has claimed a value on the service information, or required training to receive the service information, and the FDA has extended the “at cost” requirement of the service information to the training if it is a requirement.
A: Absolutely correct.
A: I’ve been told that if a (laser) manufacturer wants to allow for third-party service they must provide in-house training. For smaller companies, that alone is enough of a reason to provide service only through them. I get free annual laser training from AMO for certification on the excimer. They used to charge for it many years ago. We don’t pay extra for it through consumables or other means either. I’m also certified on the Ellex yag and only had in-house training for two days many years ago. No annual training needed.
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