Philips Forte Recall and Stop Use Order: What You Need to KnowPosted on: 12.05.19 by Digirad
If your practice is using the Philips Forte Gamma Camera, then you should have been in receipt of an urgent stop use notice as of September 19, 2019.
Philips’ Senior Manager of Post Market Surveillance issued an urgent field safety notice to all users of the Forte family of cameras to discontinue use until further notice. This applies to all Forte cameras, including the Powerpack, the Jetstream, or systems refurbished by Philips.
This obviously has a major impact across the imaging world – many of these cameras are still in regular use across the U.S., Canada and other countries.
Here’s what you need to know:
What is happening?
Philips issued the stop use order on September 19, following an incident that was reported by a customer in Germany. Philips warns in their stop use notice:
“There is a possibility that a detector may fall unimpeded vertically to the end stops of its travel limit, due to mechanical failure, possibly making contact with a patient that could result in entrapment, serious injury, or death.”
This raises some serious questions for facilities that rely on the Forte family of cameras for nuclear imaging. What is being done about it and how long is it likely to take?
First of all, Philips has been working to offer a field repair, however, at this stage, there is no timeline for this or information on how it will work. One thing to remember is that any field repair they propose will have to be scrutinized and approved by the FDA first. This means it is difficult to put any kind of timeline on repairs prior to approval.
Most sources close to the stop order say “months” if asked to give an estimation. The earliest we’ve heard is March 2020. This has affected hundreds of users across the country and of course, their patients. The talk in forums has included backlogs of patients and potentially lost referrals due to reliance on a Forte camera. A wait of months really won’t work for many facilities.
The bottom line is if you’re relying on a Philips Forte gamma camera, your imaging services could be out of commission for an untold period of time. If it is going to drastically affect your ability to serve patients and continue to receive referrals, then you may need to look at alternative choices.
A note on camera age
One thing that is noteworthy about the Philips Forte series of cameras is that it has been several years since the company declared them “end of life” (EOL). However, facilities that still operate the cameras have been able to do so by getting parts and servicing through third-party providers.
The newest Forte model hasn’t been manufactured since 2004, so all cameras are fifteen years old or more. Generally speaking, when you have a camera that is approaching the ten-year mark (since its manufacture), then it will be almost EOL.
It is risky to continue using a camera beyond this point because the manufacturer has already declared that they can’t support it anymore. This means the manufacturer has made the decision that they can no longer reliably repair and maintain the system. It isn’t necessarily about planned obsolescence – sometimes there are subcomponents that are no longer being made, meaning the manufacturer couldn’t make repairs even if they wanted to.
The risk is highlighted here with this stop use order. If you’ve been relying on third-party suppliers to maintain and repair your camera, they can’t do anything about it once a stop use order has been sent out. You’re left waiting for a field repair that may be difficult to make happen.
What do we recommend? If you have cameras that are approaching ten years old, you should be making plans to replace it. While third-party suppliers might keep you going for a bit longer, you can’t always find reliable repair and maintenance. There’s a real mixture out there in terms of quality and availability. If you’re running a state-of-the-art medical practice with patient care at the center, then taking heed of manufacturer’s EOL for devices is essential.
What are your options?
For most imaging facilities, a wait of months is simply not going to work for their business. It will mean loss of patients and significant backlogs for imaging studies. This means that if you have no other cameras available, you’re going to have to look for alternative options.
There are basically three ways you can go:
Buy a new camera
This is definitely the most costly option upfront. However, if you conduct an analysis of the volume of studies that you need to perform each month, it may make sense to purchase a new camera.
As a general rule, we’ve observed that a facility that conducts more than 100 studies per month tends to have the financial viability for purchasing a camera. Below that, you have to look at temporary staffing, or hybrid approaches to make financial sense.
If you’ve decided that buying a camera is the way to go, then you’ve got another choice to make; buy new or buy refurbished?
A new camera will, of course, cost more, however, you have the advantage that you’re getting it right at the beginning of its service life. You have the choice to get something with the latest technology embedded and you know that the camera is actively being maintained and managed by the manufacturer (hence avoiding a Forte scenario).
A refurbished camera is generally a cheaper option and may make sense for medical facilities that just don’t have the budget for new. You can still get some very high-quality imaging equipment, however, there are a few key things to be aware of:
- The age of the camera. Does it still have a significant amount of time before its end of life?
- The technology and operating systems – how do these compare with the technology in brand new cameras?
- Maintenance and repairs. Are parts readily available and will the manufacturer still service it?
- Image quality. Does the camera still produce images of a quality that is acceptable for the types of studies you usually conduct?
- Connectivity. Many older cameras can’t be upgraded to current software versions or patched securely. This would mean they can’t be connected online due to the risk of data being accessed improperly.
Rent a camera
Gamma camera rentals can be looked at in a similar way to how you’d compare either buying or leasing a new car. Leasing gives you the advantage of access to a new model without the large payments of purchasing. There can also be incentives to buy, just like with a car.
Rental terms can be virtually anything – weeks, months or years. Like most rental agreements, there’s usually incentive to rent for a longer period with cheaper payments.
Another plus on the side of rentals is that they can give you the opportunity to “try before you buy.” You might want to test out a type of camera before committing to purchasing it and rentals give you the opportunity to do so.
Of course, if you’re leasing a camera that is nearing its end of life, you can simply rent a newer camera without the financial commitment of purchasing.
A mobile service (such as that offered by Digirad) offers you flexibility in terms of timing and location for the service. You get to have state-of-the-art equipment available to your patients and you could choose to use this type of service as a stop-gap while you’re waiting on your Forte repair.
Opting for a mobile service also means that you don’t need to reconfigure your imaging suite for a different camera, especially if you’re using the mobile service while you decide on a new purchase or while you wait for repairs.
For some medical facilities, analysis of study numbers might reveal that it’s not worth the cost of buying or renting across fixed periods of time. Perhaps it makes more sense for a mobile service to come in at certain intervals and take care of all of your imaging needs. For example, you might have a mobile gamma camera come out every two weeks.
The Philips Forte stop use order is having a major impact on many imaging facilities. For some, this will lead to backlogs and lost patients. A wait of months for a fix simply isn’t a feasible option.
We see this as a cautionary tale about what can happen when you continue to use cameras past their manufacturer’s end of life. It’s always better to be using equipment that will still be maintained by the manufacturer.
For facilities that can’t wait for a repair, your options are to either buy a camera, rent a camera or hire a mobile imaging service. From the information we have, any of these options will at least have you up and running well before a repair is available.