Service after the sale can be a bother or a boon to revenue. But if you know what to ask for from the manufacturer before the sale, you can save yourself a lot of trouble, experts say. The keys to a long and happy device life are developing good relationships with manufacturers and learning to negotiate the terms of sale. Below, we examine regulations imposed on manufacturers by the U.S. FDA and discuss purchasing strategies that use those regulations to help ensure minimum service costs and liability after the sale and, ultimately, a safer patient environment.

Roger DeBaise, CBET, a biomedical engineer at Wallingford, Conn.-based Gaylord Hospital, is unhappy with his current options for after-sale equipment service. When DeBaise entered the fi eld 30 years ago, it was a different story
“Manufacturers would provide truly useful and comprehensive service manuals, usually backed up by a strong local fi eld service department and very capable factory phone support,” DeBaise says. He’s come to expect much less than that today, noting that often all that is available when something goes wrong is a telephone tech support line that can help with software issues. If a screw comes loose or a part breaks, you’re often on your own, he says.
But according to FDA regulations, manufacturers are still required to provide comprehensive service manuals, says Tom Quinn, president of Wexford, Pa.-based Medical Resources Alliance, a healthcare facilities consulting fi rm. The problem, Quinn says, is that most people either don’t know that providing this information is required by the FDA, or they don’t know how to ask for it.
Access to this information is benefi cial to everyone – the manufacturer, the facility who purchases the equipment, the biomeds who work on it, the doctors and nurses who use it and, most importantly, the patients who rely on it for diagnosis or treatment.
“If you have more service options, the manufacturer won’t be tied down because anybody can service it,” says Mickey Couvertier, CLRT, senior laser specialist at Palm Bay, Fla.-based Universal Medical Lasers. “The independent service organization (ISO) benefi ts, too, because now he’s an option to service it. And patients benefi t, because everybody who handles the equipment has the correct information, the correct standards, and is following federal standards for output and service intervals.”
Below is a step-by-step purchasing plan that will ensure you have all the information you need to install, service, and repair your equipment – without breaking the bank – before you commit to the purchase.

ENSURE FDA APPROVAL
The fi rst step, Quinn says, in reducing after-sale service costs and liability should be taken before you ever pull out the checkbook. When considering buying a new piece of equipment, fi rst make sure that it’s FDA-approved.
“There are a number of pieces of equipment being sold that are not FDA-approved, and having those at your facility is a liability risk,” Quinn says. Ask if the device has been 501K-approved, and then ask to see the documentation. If the device is FDA-approved, you’re ready to move to step two. But don’t jump the gun – you’re not ready to buy yet.
GET THE INFORMATION YOU NEED
The next step is the most important, Quinn says. When requesting information about the product, tell the salesperson you’d like to review the manual before agreeing to buy. When making this request, wording is important. Quinn says it’s essential to ask for the “compliance manual,” not the “service manual.” If you don’t ask for compliance information, Quinn warns, manufacturers are likely to give you a manual that won’t have all the information you will need to service the product.
Knowing how diffi cult service will be and the level of detail provided for installation, maintenance, and service should be a deciding factor in your purchase. You don’t want to buy a piece of equipment that might cost you more in the long run. Detailed instructions should be clear enough that any trained biomed can service the equipment, according exactly to the manufacturer’s specifi cations. For smaller facilities that don’t have an in-house biomed, this allows the freedom to choose an ISO. But that’s not the only benefi t that requesting this information before the sale can provide.
The ease with which a manufacturer releases this information is a good vetting tool. If they’re hesitant, buyers should beware. Noncompliance with the U.S. Code of Federal Regulations (CFR) could be a sign of more serious problems within the company. If you know how to ask for the information, “The manufacturer doesn’t have any option in this matter,” Quinn says.

KNOW THE LAW AND APPLY IT
As outlined in Title 21, Section 820.170 of the U.S. CFR, manufacturers of installable medical devices are required to provide “adequate installation and inspection instructions, and where appropriate test procedures. Instructions and procedures shall include directions for ensuring proper installation so that the device will perform as intended after installation.” This includes manuals, software, and any special tools and test equipment, Quinn says.
What’s more, the manufacturer cannot make a profi t on any of that information. “The manufacturer shall distribute the instructions and procedures with the device or otherwise make them available to the person(s) installing the device,” the section reads. Deeper into Title 21, that requirement gets more specifi c, stipulating that this information must be made available “at a cost not to exceed publication and distribution,” as specifi ed in Section 1020.30, which applies specifi cally to radiation devices.
However, Quinn says this is true for all installable devices, and manufacturers are aware of it. It’s easy to get bogged down in the wording of offi cial documents, Quinn says, but manufacturers know their responsibilities. Many have a compliance offi cer who works specifi cally to ensure compliance with federal law and the FDA. If you have trouble getting the information you need, ask to speak to the compliance officer.
“The problem here is that most users, ISOs, and others involved in purchasing do not know how to ask for that information or get the correct information,” Quinn says. As soon as you cite 21CFR, he says, manufacturers will realize you know the law and be much more likely to comply. “Once they get the hint, they change their tune, and any other barriers they’ve put in place will then work themselves out.”
Another useful fact: This information must be delivered upon request. If you ask for it, the manufacturer has to process that request in a timely manner. What’s more, no purchase is necessary to obtain this information. Any person on the street can call a manufacturer, ask to speak with the compliance offi cer, and have this information made available to them.
“The more people that know about the equipment and how to operate and service it, the safer it is,” Couvertier says. “If there is any abnormal operation outside of specifi ed parameters and it touched the patient, that can become an injury. You don’t know in the long run how it’s going to affect the patient.”

REPORT PROBLEMS TO THE FDA
So, what do you do if your equipment does malfunction? If you’ve followed the steps above, it shouldn’t be diffi cult to have it serviced by whomever you choose. But the incident still needs to be reported to ensure the continued safety of medical devices and the people who come into contact with them.
Reporting to the FDA is an essential step in ensuring that facilities are safe for patients, and that manufacturing problems are addressed appropriately. Anyone who witnesses a problem or sus-pected problem with a piece of equipment is encouraged to report it at www.fda.gov on the medical device reporting page. Look for a link to fi ll out or download form 3500, which, according to the FDA, “should be used by healthcare professionals and consumers for voluntary reporting of adverse events noted spontaneously in the course of clinical care.”
A related form, 3500a, must be fi lled out to report known or suspected patient death or injury as a result of a medical device. Those forms then become public information, accessible to anyone on the FDA’s website. Quinn says that responsible reporting will lead to better manufacturer practices overall. “The worst thing that could ever happen to a manufacturer is to get on the FDA’s radar,” he says. “The FDA is then forced to do something – and it’s usually not very pretty.”
If enough users report problems with a device, the FDA will be forced to act, and the device will be corrected or replaced on the manufacturer’s dime. Another possibility? The device will be removed from the market altogether. “Form 3500 is like the kiss of death to the manufacturer,” Quinn says.
In fact, he has witnessed a manufacturer’s ruin as a result of Form 3500. Quinn began reporting errors with that company’s equipment, and he encouraged some of his clients, who were being overcharged for replacement parts from the manufacturer, to do the same. The information became public, and people within the medical equipment community started talking. “Their approval dropped off the screen, and they couldn’t get money for equipment from their parent company. That played a large role in their demise,” Quinn says. Today, the company is out of business.
Still, many people don’t report problems as often as they should. Couvertier reveals that he has heard people say they don’t have the time or they don’t believe it will make a difference. But when it comes to patient safety, there are no excuses, he says. Reporting is not only imperative to ensure the safety of patients and users of medical equipment. It’s also an essential tool in helping facilities save money and ensure they have equipment with clear instructions for proper installation, use, and service.
Couvertier’s says one thing is essential: “Have patience. It’s not going to happen overnight, but it will get easier if we all do it.”