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Printing 3D Medical Devices Comes With Substantial Liability Risk

Healthcare Risk Management

Just a few years ago, 3D printing was a futuristic breakthrough that seemed to have endless potential for manufacturing and other industries. The future is here, and healthcare is one of the fields in which professionals are using 3D printing to create models and even surgical devices that are otherwise unavailable.

The medical community is excited about all the ways 3D printing can be incorporated into patient care, but risk managers might need to be the ones who pull back on the reins and consider the potential liability. Creating a device in-house opens up the hospital to an area of potential liability that previously affected only commercial medical device manufacturers. Normally, when a device is blamed for an adverse outcome, the hospital can direct the plaintiff to the manufacturer and escape liability, but not when you made the device yourself.

Healthcare providers use 3D printing in two principle ways: either creating a 3D model that helps physicians plan and practice surgery and other procedures, or making temporary tools. Some of the tools are templates affixed to bone to guide the surgeon in shaping the patient’s bone structure to accommodate an implant of standard size, or drill guides that help the surgeon place screws in the right place based on the patient’s unique dimensions.

Other tools are being made in the hospital, including splints, stents, spinal cages, hip prosthetics, and artificial bone structure for repairing facial injuries or birth defects.

Hospitals that are making their  own surgical devices are assuming the risk of their failure, says Max Gaujean, JD, a malpractice attorney and founding member in the White Plains, NY, office of the Brown, Gruttadaro, Gaujean & Prato law firm. In addition to the possibility of immediate failure, hospitals don’t test their homemade devices for longterm wear and tear, he notes.

“Hospitals are also removing a deep pocket, namely the manufacturers, exposing themselves to enormous economic risk,” Gaujean says. “Hospitals may also be assuming any risk that the doctor may expose them to since the physician may not have been trained to install the custom device.”

Physicians also are exposed to the usual malpractice complaints: that they did the procedure incorrectly, that they were not properly trained to handle the surgery or the device, or that they failed to provide informed consent with regard to risks associated with the device.

Gaujean recommends that risk managers require informed consent for use of any hospital-made device. It also would be a good idea to obtain the opinion of the hospital’s medical ethics board, he says.

The biggest risk from 3D printing, also known as additive manufacturing, is lack of education and unrealistic expectations by healthcare professionals, says Adam Clark, the founder of Tangible Solutions in Matthews, NC, consultancy and provider of 3D printing/additive manufacturing and engineering design services.

“Sticking a printer in a hospital, and letting a doctor or nurse print stuff, is currently very risky because there is a serious knowledge gap in additive manufacturing methods, materials, and finishing processes,” Clark says. “Currently levels of expectations of the technology from the general population are relatively unrealistic. Healthcare professionals are really good at what they do, taking care of people when they are sick or injured. This does not mean they are qualified to print a new device off a [3D printer] the hospital decided to buy because they got pulled into the hype.”

Nevertheless, Clark says 3D printers are in hospitals and will play a bigger role in the future. Hospitals should, at least, consult with a company specializing in 3D printing and possibly partner with one in the same way hospitals outsource diagnostic or scanning services. “Education will enable an understanding of what additive manufacturing is and how it can be implemented, not just from the user perspective, but how additive manufacturing fits into the organization from an enterprise level,” Clark says. “This will help manage risk, and the technology can be exploited for the good of their patients.”

Tort liability in 3D

Tort liability is a primary concern with 3D printing in healthcare, notes Colleen T. Davies, JD, partner with Reed Smith in San Francisco. The firm recently launched the white paper titled 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles. If a 3D printed medical device is at issue in a lawsuit, Davies says, a key question will be who the manufacturer of the device is.

“Is it the 3D printer company? Is it the creator of the software used to make the design? Or it the surgeon? Or the hospital?” she says. “That is as of now an unresolved issue. It’s not clear in the law yet, so it definitely has to be considered when assessing risk.”

That question has not yet been tested in the courts, Davies says. There are many unanswered questions regarding the technology and healthcare, but it is clear that risk managers should be involved in overseeing its use in the hospital, she says. As with other technologies, there must be a process for quality control with the machine, maintenance, and supply chain, she notes.

There is a possibility that hospitals will have some protection from liability related to 3D items. State laws vary, but in general, they do not impose strict liability on hospitals for medical devices, says Paven Malhotra, JD, partner with the law firm of Keker & Van Nest in San Francisco. States are more concerned with commercial sellers of a product and are not likely to see the hospital in that way for 3D printed devices, he says.

“That could change if a hospital were printing these devices in bulk, using them in the hospital, and selling them as well,” Malhotra explains. “That could push them over the line so that the courts see the hospital as a commercial seller. If you stay with printing the item as needed or in small batches to use in the hospital, you’re unlikely to be held strictly liable.”

However, courts would be likely to accept a claim of negligence, he notes. But what is negligence in 3D printing of medical devices? The practice is so new that it would be difficult to prove a standard of care or bring in expert witnesses to testify, he says.

“Hospitals should think of best practices in general and how you can apply that to 3D printing,” Malhotra says. “Explain it all to the patient, everything: the risks, how new this item is, the fact that there is no liability record to draw on, and you explain the benefits as well. If you end up in court, you want to show that the patient was well-informed and you didn’t hide anything about this new device.”

Follow usual safeguards

Risk managers should be very cautious with 3D printing and insist on at least the same safeguards that would be required for any other item used in the hospital, says Amy Alderfer, JD, a products liability attorney with the law firm of Cozen O’Connor in Los Angeles. The FDA has approved about 85 3D printing products for use in healthcare, and confirming that approval for any particular device is a good starting point, she suggests.

The risk manager might have to be the one who says no to a surgeon who has printed a device and is planning to use it on a patient, Alderfer says. Just because it is created through 3D printing doesn’t make it different from any other medical device in regard to ensuring safety and quality. After all, Alderfer says, you wouldn’t let a surgeon use a device that he made in his garage and brought to the hospital, at least not before getting the proper clearances and quality assurances.

“If I have surgeon who announces he has this hot new item that he printed at home or on the hospital’s 3D printer, I’m going to say ‘Whoa!’ and slow this down. There are a lot of things we need to step back and evaluate,” she says. “This is always a challenge in risk management, having to temper the excitement of clinicians who are eager to do something new and innovative.”

When 3D printing is used for modeling rather than with a patient, the risk manager need not apply such strict review, she says. However, the hospital should remind surgeons and others that the same approval process for medical devices still applies to 3D printing. FDA approval is available on an emergency basis for any medical device, she notes.

“Just because you have a new technology doesn’t mean that you don’t have any regulations or we’re going to develop new regulations,” Alderfer says. “The existing framework you have for ensuring that you use approved medical devices still applies here. The danger is that a surgeon will think it doesn’t because this technology is so different and exciting, and not take his or her device through the approval process.”

If that happens, the potential liability is huge, Alderfer says. A plaintiff’s attorney would see many avenues to pursue and many defendants.

“The hospital doesn’t want to be in a position of being sued and asked how you allowed this to happen, how you let somebody make their own medical device and use it on a patient without all the appropriate safeguards,” Alderfer says.