Calyx Metrology Laboratory President John A. Walls III posted a suggestion regarding quality on the Biomedtalk listserv, saying: “I suggest departmental accreditation is really the quality benchmark that the world’s professional biomedical community should begin to consider and eventually work toward. From my perspective, ISO 17025 would fit hand-in-glove.”
The testing, repair, and calibration of medical devices is totally fragmented and unregulated. There are manufacturers, independent service organizations, hospital employees, and shared service groups performing the tasks on devices in hospitals, clinics, and physician’s offices. Almost all groups follow their own policies and procedures, which are generally not vetted to be sure that they are the best methods. They are generally not specific to the device but to a category of devices. The closest thing to a regulation in all states are The Joint Commission’s Environment of Care requirements—and they are very unspecific. This has been the case for many years, and it has contributed to the lack of respect with which our profession is viewed.
What most people do not realize is that well over 90% of all diagnostic and treatment procedures involve technology of some sort. How that technology is maintained goes directly to the quality of patient care and the cost. If the technology is not working correctly, there are repeat tests, procedures, and delays in getting the patient healthy. We need to track our technology costs better and report the good, the bad, and the ugly to the administration and medical staff.
So what will ISO 17025 bring to the dance? First and foremost, there will be costs both capital and labor. The capital cost will be for additional test equipment, reference materials, and spare parts. On the labor side, each organization will have to write more specific policies and procedures for its departments or services. Yes, there will be organizations that will be selling the policies and procedures, some might share with others, and the rest will have to write them out. Even those that are bought, swapped, begged, borrowed, or stolen will have to be altered to fit the institution or company.
It will bring standardization to our procedures and allow for a quicker and simpler introduction of new technology, less repeat tests and procedures, and better reporting of results.
It will allow for data mining on various devices so problems can be found and corrected by the manufacturer. The FDA can better monitor what is going on with technology, and it would allow hospitals and clinics to avoid problem devices that have been well hidden in the past.
It should reduce repair costs as the OEM will have to share its information and test procedures with all clients that own that product. The manufacturers will fight this provision as many make more profit from service than they do from the sale of the device.
It should require both the manufacturers to provide classes on servicing the devices and the BMETs to take the classes.
It will push the IT people to make the networks safer and more robust, helping the EMR or EHR to grow more quickly.
It will bring a new set of inspectors into health care, which could be good or could further confuse what is being done.
It could force more BMETs and CCEs to get certified. This could force employers to address the ongoing training or lack thereof.
What won’t ISO 17025 bring to the dance? Peace and harmony as every group jockeys to get onto the gravy train of “new money.” There will be no immediate cost savings, and it will be difficult to judge the cost savings just on the inspection process. It is necessary to factor in all cost savings and expenses before making a judgment.
Will ISO 17025 become the new operating standard for the medical device repair industry? Probably not unless Medicare/Medicaid/VA and insurance companies require it to be implemented, existing biomeds and CCEs push for its incorporation, consumer interest lobbyists push for it, and special interest lobbyists do not push too hard against it.
Over the past 40 years we have heard all sorts of calls for affordable health care here in the United States, and until enough people in Washington act on health care instead of talking about acting on it, this, and all other good things, will not happen.
“ThisisJohnSmithwithGenericBiocorpsixonesixfivefivefivesevenfivefournine.” It is even harder and sometimes impossible to understand that message when it is spoken with a thick accent or over a bad connection. By speaking clearly, support personnel can more easily contact you if they cannot immediately solve the issue.
The second item to have on hand is specific information about the device, software, or usage problem. Have the model numbers, serial numbers, and version numbers of the items in question ready. This will help you navigate voice mail systems and give support personnel information for tracking problems.
Finally, have all the information about the problem that prompted the contact in the first place. Support personnel will want to know what is working incorrectly, what is working correctly, and what is working differently than before. Dreaded voice mail mazes are annoying, but they are not as frustrating as bouncing among a group of incorrect people.
During a support session, the support giver may provide specific instructions and procedures to be followed step by step. Hopefully, you will not be run through procedures that you have already performed independently, but it may be necessary. The technician often needs to get your system into a condition or position that is known and understood. Do not “get ahead” of the technician as they may introduce a subtle change to the procedure. This stepwise operation helps the support technician visualize the problem.
Large companies will often have a tiered support network. The first level of a tiered support network triages the case. Personnel at this level usually uses a support script, a book or program that operates like a flowchart. Support scripts are good for resolving common and well-understood problems. In some cases, the people using a support script have never seen the product in operation. The second level of a tiered support network provides more specific help. Level-two personnel usually have had training on the specific products and can provide more specialized support. The top level is usually a product engineer, who has an equipment setup to try to replicate your problem.
Sadly, not every problem can be solved remotely. When it cannot, either a support representative will come on-site or you will send the equipment out for service. There are a few very important things to do when shipping items. First, confirm the shipping address and return address. Next, include a copy of the Return Material Authorization paperwork in the box, and display the number clearly on the box. Then, record the tracking numbers so you can confirm delivery and receipt of the unit. Remember to buy shipping insurance for your equipment. When shipping equipment back to the manufacturer or service center, always have at least 2 inches (5 cm) of proper filler between the edges of the box and the unit. Having less than this voids most shipping-damage warranties and risks aggravated damage to the unit.
In summary, remember to have pertinent information ready before you call. Also, record all names, numbers, and times of your communications. Speak at a normal pace, enunciate, and be polite. Remember, people who perform customer support rarely, if ever, get called when things are working right.
David Harrington, PhD, is a health care consultant, Medway, Mass, and is a member of 24×7’s editorial advisory board. For more information, contact .
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