True safety concern for the public should be the bottom line for the discussion, notwithstanding the significance of the wasted money. For medical imaging equipment, safety encompasses image quality, because a device that doesn't meet specifications will lead to a misdiagnosis and harm to the patient.
OEMs cannot claim that if they withhold the ability of a hospital to perform safety and efficacy checks on their own equipment is somehow risking the health and safety of patients. Quite the opposite, it sets up a substantial conflict of interest for the OEM to be the maker of the specifications, the exclusive provider of service, and the seller of spare parts. We should not assume that any party, OEM or ISO, is unfailingly honest and competent.
Those of us who have experience in the real world can cite many examples of OEMs who obscured real problems that affected safety, broke clear FDA rules, falsified documents, and lied to customers and government officials. To be clear, I know of many instances where ISOs have done the same. Both are bad for us.
There are plenty of ISOs who have men and women who know just as much, or more, than their OEM counterparts and exceed the professionalism and skill of OEMs.
In general, in the MRI and CT sphere, OEMS illegally and unethically withhold information from equipment owners and ISOs. Even independent physicists who might want to test the device, and are no threat to compete in the repair business, are shut out from access to this. So imaging providers are left to trust that the OEM has followed the rules. I've personally seen hundreds of examples where they didn't.
An instructive example of this is the current litigation over Philips and their defective CPAP machines. People within the company discovered a problem, and their voices were squelched. To their credit, there were a handful who resigned rather than help perpetuate a health hazard. Not until hundreds of patient complaints, aided by independent service providers, came forward, was the problem addressed; only after terrible harm resulted.
The FDA has been deaf to the safety needs of the public in this regard, and it's high time that reforms were made. Openness in service standard, methods, and tools is a practical way to put many eyeballs on this problem, instead of making it the exclusive property of a party who makes money by obscuring problems.

~ Is this really the current status of our Judicial System, how can this be?
FULL DISCLOSURE:
We are currently in Litigation regarding this matter (Case 3:22-cv—-147-G District
Court for the Northern District of Texas Dallas Division)
Under 21CFR820.170 I have an obligation as a manufacturer and installer of Medical
Devices. OEM's have an FDA and FDCA obligation of instruction requirements for
testing, use, installation, and operational instructions. 21CFR matches the Food Drug
Cosmetic Act, and these were written into Federal Law to protect patient's safety.
The OEM appears to be violating the private litigation clauses of the FDCA by claiming
extensive trade secrets for instruction under FDA 21CFR820.170 (plus other sections)
as well as the FDCA, at the same time denying access to instructions the OEM up until
2019
provided.
OEM's are required under 21CFR820 to comply with my requests for adequate
information and I have requested this material over the past 22 years from all the OEM's
and it seem very few fear the FDA, or the Federal Government as they have not
provided anything while the OEM's sue, settle, and seal ligation in direct violation of
their obligations.
Federal Judges do not understand the FDCA or 21CFR820.170 and the OEM has
conditioned the courts, including in my case, to disregard the regulations to build on a
record used in courts that violate the FDCA, LOC Medical Device Exemption as well as
FDA 21CFR820.170
The FDCA was enacted by Congress to Protect Americans from the inherent dangers of
radiation devices including MRI and CT’s. The Library of Congress Medical Device
Exemption also was written to allows owners, and other providers access to circumvent
security to Maintain, Service, and Install Medical devices to include Data Files.
The OEM seems to be attempting to undermine and corrupt the FDCA and the FDA by
claiming trade secrets for instructions that are REQUIRED under the FDCA and 21CFR
and are further excluded by the MEDICAL DEVICE exemption
within the Library of Congress.
The Northern District Federal Courts are ignoring Federal laws, FDA Regulations, and
Federal Library of Congress Exemptions. The facts are being discarded as I am actually
being prosecuted for following FEDERAL FDCA REGULATIONS, FDA REGULATIONS
and FEDERAL Library of Congress Exemptions.
DICE/FDA has responded several times confirming my information is correct and there
is an obligation by the OEM to provide ADEQUATE information, and this is the very
information this case should consider, but again, this
information is not being allowed for some reason.
As a Veteran Employer, as one who has placed much faith in our Country and legal
system, I am simply stunned by what is happening and how total disregard for the
Federal regulation Library of Congress Medical Device Exception and FederalLaws are
not being considered a Legal Defense by my court.
I would like to submit my claims to the Committee in charge of HHS and the FDA to find
out why we have regulations and laws in place yet no enforcement action when and
OEM uses
private litigation to circumvent the law.
The U.S. Supreme Court has held that the Federal Food, Drug Cosmetic Act vests the
FDA with exclusive authority to enforce the FDCA and may bar private litigants from
bringing
claims that require Courts to enforce or interpret the FDCA and its implementing
regulations.
See Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 352 (2001).
Prior to all of this, I contacted my Government to alert them what the OEM was doing
and the plan to circumvent the FDA. LOC and FDCA. I contacted the FDA and
informed them almost yearly of the OEM’s failure to comply.

They will battle ISO’s one at a time, raising private litigation against is one by one.

Patient safety is completely lost over greed and attempts to monopolise our business.

So we have federal courts ruling against federal laws and federal regulations and in my case the judge said if they lock FDA required installation documents behind new passwords they it becomes illegal to access it.

That makes zero sense!

But we are here and with these actions they are saying that even though they provided FDA requirements for 20 years prior, in 2019 they locked it up and now that public information becomes illegal.

So after 26 years i maybe signing off as the OEM has decided i am a criminal.

The FDA did an extensive investigation of ISO’s a few years ago prompted by the OEM’s lobbying group.

The FDA investigation failed to find any serious issues with ISO’s, in-house or resellers. The report is still on the FDA’s web site.

In addition, the FDA’s MAUDE database does not demonstrate any major patient safety issues connected to ISO’s or In-house service groups

The key to patient safety is not more regulatory control of in-house resellers or ISO’s.

The laws are on the books and have been for decades enacted to control patient safety for all manufacturers, which includes in-house and ISO’s and all distributors and sales, resellers, of devices.

Finished device manufacturers are 510k holders.

Any and all persons providing installation and other functions for any device is a manufacturer. all subject to the FDA regulations. All required to have an active compliance program

Manufacturers include 510k holders in-house and ISO’s.

The 510k holders have the mandatory requirement to provide adequate instructions, manuals, software and special tools and test equipment. Those adequate instructions are required to be at a lay person’s level.

The FDA is failing in upholding this requirement. The FDA is the problem not ISO’s.

Hospitals are a problem for not verifying compliance with FDA laws from all providers of sales and service and resellers.
Hospital are required to have and use FDA compliance program.

Litigating 510k holders are equally responsible and again the FDA is failing there as well. 510k holders in litigation present commercial trade secret case and hide their FDA requirements.
the FDA requirements and obeying these requirements reduces liability from litigation from any source.

If you’re looking for answers first get a compliance program and use it. Second use the FDA’s systems to report 510k holder failures to comply. Third, track litigation and don’t stay on the sidelines hoping you’re not next. Fourth do not use anything that doesn’t come from the 510k holder directly.

This problem can be resolved and American lives can be saved, I.e. the sleep apnea deaths were preventable if the FDA reacted or you reacted to the deaths as there were happening. 8 years to discover a problem was 7 year 10 months too late.