REACTHEALTH Acquires Invacare Respiratory Product Line Instructions
- June 4, 2024
- REACTHEALTH
Table of Contents
To: All Invacare customers
October 17, 2023
React Health understands the need for a service and repair solution across the nation to support the installed base of Invacare products. We acknowledge the business disruption that the transition from Invacare to React Health may have caused. As such, we wanted to provide an update, and share some of the challenges that have contributed to the timing of this transition.
FDA – Invacare has been in business for many years and produced products according to the FDA requirements at the me of manufacturing. React Health, the new legal manufacturer of the products, is commited to meeng all the applicable FDA and ISO requirements. We have taken the me necessary to assure the highest level of regulatory compliance while transferring the operation from Invacare to React Health.
Supply Chain – It is no secret that the supply chain has been challenged over the last 2-3 years. React Health has been working to stand-up relationships with former Invacare suppliers, which takes me. Additionally, some suppliers discontinued items to focus on larger volume items to minimize financial impact and the disruption seen in the supply chain. Where component manufacturers desired to continue manufacturing the items needed, me to source, schedule, and produce these items has been apparent. In instances where manufacturers discontinued or no longer desired to continue to manufacture items, new vendors needed to be sourced, and their products tested/validated to ensure effectiveness of the products they were going to support.
Manufacturing – Immediately post-acquisition, the transition of inventory and manufacturing equipment was kicked off. The React Health team quickly coordinated this inventory and equipment transfer across the nation to our manufacturing facility. Upon receipt, manufacturing equipment had to be inspected, reinstalled, fixed where necessary, tested/validated, and then the manufacturing process audited by outside agencies to obtain required certifications. As assembly lines are established (both current and future state), the training of manufacturing associates has to take place before manufacturing can begin. This training is customized per manufacturing environment and needed to be created. Upon compleon of the assembly process, the products go through tesng and validaon to ensure the product aligns with the specificaons of that item. In instances of nonconformance, common among the establishment of new assembly lines, problems are invesgated, soluons are developed then implemented, and are finally executed across the next round of items being produced. This process is standard across all manufactured items, and takes me to finalize to ensure the process output is always high quality product.
The three concepts detailed above are the areas which represent the transition me which has been necessary to make products and parts available as soon as possible. React Health continues to quickly address any additional challenges to expedite our return to market with the acquired Invacare parts and products. We fully understand our customer concerns and remain committed to working expeditiously to produce the items sought by our customers.
Update on Repairs and Service Parts
As part of React Health’s management of the repair network, going forward only React Health approved Independent Repair Centers (IRCs) will be authorized to perform repairs and purchase service parts for Invacare respiratory equipment. Customers who are not an approved IRC will only have access to purchase items needed for product use, defined as consumable items.
Frequently Asked Questions
1. Why did React Health change the policy that was in place with Invacare?
Why is React Health only selling parts to and allowing repairs by authorized
IRCs?
• React Health intends to maintain our commitment to regulatory compliance by
proactively managing partnerships with approved IRCs to control the parts and
processes necessary to ensure safety and efficacy of the device. This change
is also driven by React Health’s commitment to compliance with FDA regulations
for timely complaint reporting and investigation.
2. Which IRCs have been approved to perform repairs on Invacare equipment?
• This list is currently being finalized and details will be shared as soon as
possible.
3. Specifically, which parts are deemed “service” vs. “consumable”?
• Please see the attached crossover list of repair parts that React Health
will offer. Each is identified as either service, consumable or discontinued.
Note that most items sold through Invacare’s parts division, The Aftermarket
Group (TAG), have been discontinued. Many of these items have equivalent
Invacare Service Part numbers, which are noted on the list.
• What happens to the repair parts that non-IRCs currently have on order?
Orders for “service only” parts will be canceled. Our team will provide a
notification of any order cancellations. Please refer to the crossover list
for details.
4. When will React Health have parts to support IRC repairs?
• We have some parts available now with more becoming available daily.
5. How will this change impact the recall on Perfecto2 V? Can DMEs still
update their own concentrators?
• React Health is committed to supporting Invacare’s regulatory obligations
and processes surrounding this recall. We are working with Invacare to
determine the best process by which to provide these kits to customers. We
will share details once the plan is finalized.
6. How will warranty repairs be handled?
• Going forward, React Health-approved IRCs will be authorized to process
warranty claims directly with React Health. DME customers should work with the
IRC of their choosing. The IRC will handle the acquisition of parts and
submission of all documentation directly with React Health.
• For repairs in-progress or performed prior to React Health-IRC
authorization, or repairs performed by non-React Health-authorized entities,
warranty claims shall be processed by Invacare.
7. How will non-warranty repairs be handled?
• Non-warranty repairs should be handled the same way as warranty repairs.
Simply put, all repairs on all products need to be performed by a React
Health-authorized IRC.
8. Will IRCs be repairing Platinum Mobile Portable Concentrators (POCs)?
• No, as POC parts become available, POCs will be repaired in-house by React
Health. React Health will provide additional updates as parts become
available. Please request to join the Invacare Update distribution list, if
you haven’t already done so, to receive these updates.
9. How can my business become a React Health-approved IRC?
• React Health is working to establish an initial authorized IRC network.
• At some point in the future, after React Health has had time to assess and
optimize our IRC onboarding and management processes, we may consider
authorizing additional repair centers. However, this will not be near term nor
is it a guarantee.
• Send an email to [email protected] to express your interest in consideration for
becoming an IRC.
React Health is committed to supporting the needs of your business and is looking forward to supporting our customers with the addition of these world class products to our product offering.
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www.reacthealth.com