Innovative Health's Response to Medtronic's Letter

It has come to my attention that Medtronic is advising hospitals that they cannot use reprocessed single-use Medtronic mapping catheters. The rationale provided as a letter from Kristy Simmons, Quality Director, AF Solutions is flawed and misleading and may result in significantly increased price per procedure without added patient safety or quality.

The rationale provided...is flawed and misleading and may result in significantly increased price per procedure without added patient safety or quality.

In the letter, Ms. Simmons warns about the “the reuse and re-sterilization of the Arctic Front™

Cardiac Cryoablation Catheter System”, which includes the single-use Achieve™ mapping catheters. Ms. Simmons’ warning is about all components of the “system”, although the devices are very different from a functionality and cleaning perspective – and were FDA cleared not as a system, but as individual devices.

In the “system”, neither cryo-ablation devices nor cryoballoons have ever been cleared for reprocessing by FDA. However, FDA HAS cleared Innovative Health to reprocess the Achieve™ mapping catheter, which means the following:

1. FDA has determined that Innovative Health has collected sufficient data to demonstrate that the device can be cleaned without any resultant additional risk or harm to the patient. In her letter, in apparent disagreement with FDA, Ms. Simmons postulates that cleaning procedures “risk product damage and patient harm”. We are surprised that as a Quality Director with Medtronic, Ms. Simmons lacks basic knowledge of the FDA clearance process, but we are happy to educate.
2. Reprocessed devices conform to the same industry leading medical device standards for cleaning, functional performance and sterilization
   
   • ISO 13485:2003: Medical Devices – Quality Management Systems
   • FDA 21 CFR Part 820: Quality System Regulation
   • FDA Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)
   • AAMI/TIR 30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
   • ANSI/AAMI/ISO 10993: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
   • ANSI/AAMI/ISO 11135-1: Sterilization of health care products-Ethylene Oxide-Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

    

   Reprocessed Medtronic Mapping Catheters are 510k cleared by FDA using the Original Manufacturer device as the predicate. The 510k clearance demonstrates substantial equivalence to the Medtronic Achieve Mapping catheter. All the Cleaning, Testing, Sterilization data met engineering acceptance criteria and was submitted to FDA as part of the 510k.

   Extensive Mechanical / Electrical / Simulated Use testing is conducted as part of the Product Development Process – Visual Inspection, Electrical testing, Deflection Force, Buckling Force, Tensile Force, Torque testing etc.

3. FDA has determined that the reprocessed devices are functionally equivalent to the new device. In sharp contrast, Ms. Simmons points to a technical manual that claims that reprocessing may “compromise the structural integrity of the device or create a risk of contamination of the device that could result in patient injury, illness, or death”. FDA’s clearance process involves examining data that shows no functional difference between reprocessed and new device. Without this, FDA would not grant its clearance. In addition, data from FDA’s MAUDE database clearly shows reprocessed devices do not fail more frequently than new devices.
   
   

   FDA’s clearance process involves examining data that shows no functional difference between reprocessed and new device.

4. The clearance to reprocess single-use devices is only granted to companies that can safely do so – and can demonstrate this to FDA. The terminology in the “technical manual” of a single-use device instructs the hospital to not reprocess and re-use the devices in the hospital, and I agree they shouldn’t, because it is not safe. This, however, has nothing to do with the FDA cleared process that reprocessors follow. The “single-use device” label is not determined by FDA, but by Medtronic. FDA grants clearances to reprocess single-use devices based on science, and this helps hospitals safely reduce costs in spite of Medtronic’s attempt to reduce re-use and cost savings based on labeling.

Ms. Simmons continues to create confusion about the nature of a reprocessed device by pointing to the fact that Medtronic has not determined that the devices can be re-used: “The Arctic Front™ Cardiac Cryoablation Catheter System has a complex design and is comprised of components that are neither designed nor tested for reuse”. This is incorrect. True, Medtronic has not tested the devices for re-use, but Innovative Health has. Otherwise, there would be no FDA clearance to reprocess. She adds that “[a]dditionally, products may fail to withstand the harsh conditions encountered during re-sterilization”; - reprocessed devices are validated to withstand these conditions.

I understand that Ms. Simmons is concerned about Medtronic devices failing or introducing risk to the patient. She should be, it’s her job. However, devices reprocessed by Innovative Health are Innovative Health devices, the liability is ours, and our methods have been scrutinized and cleared by FDA. It is not helpful to the hospital that Ms. Simmons a) misleads her customers to think that the “technical manual” warns against an FDA sanctioned practice; b) suggests that re-sterilization harms the products in spite of FDA review; c) confuses the discussion about single-use device reprocessing by warning against the cleaning of devices that are NOT reprocessable, like the balloon and the cryo ablation catheter; and d) voices concerns over micro-lumen cleaning, a reprocessing technology that Innovative Health has developed and is using in several different devices across manufacturers: Innovative Health has demonstrated to FDA that micro-lumens can be both cleaned and inspected.

Ms. Simmons makes it clear that her company is committed to patient safety and optimal performance of Medtronic products. However, Medtronic has also made it very clear that, as a company, they are committed to value-based care delivery and reducing the cost of healthcare. In fact, this is how Medtronic has positioned itself. Given that using safe, FDA cleared, reprocessed single-use devices in the EP lab saves US hospitals about $300M per year, Ms. Simmons’ threatens hospitals that reprocessed devices are unsafe and the use of these in procedures voids the warranty on other Medtronic products - seem strangely at odds with a company that prides itself in supporting cost reduction.

...using safe, FDA cleared, reprocessed single-use devices in the EP lab saves US hospitals about $300M per year...

I suggest that you ask your Medtronic rep the following questions:

1. Given that Medtronic questions FDA’s determination about the safety and functionality of FDA cleared reprocessed single-use devices, what data supports the notion that these are NOT safe and have equivalent functionality?
2. How does guidance that prevents reprocessing and effectively increases procedure costs by hundreds of dollars per procedure based on inaccurate information match Medtronic’s position that they are committed to reducing the cost of healthcare?
3. How does the launch of devices that are increasingly labeled as “single-use”, including a mapping cable that used to be reprocessable match Medtronic’s position that they are committed to reducing the cost of healthcare?

Innovative Health partners with many EP labs across the country where reprocessed Achieve mapping catheters and cables are used. And in most of these, Medtronic mappers are supporting the cases. I recommend that you do not allow Medtronic to protect their profitability under the guise of “safety concerns” that can easily be refuted based on data and regulation. Additionally, I am happy to personally meet Medtronic and discuss this matter in front of the hospital staff, so that fact and fiction can be separated and the EP labs can remain in control of their purchasing and utilization decisions.