FDA registered medical instruments

Rehabsurge is now fully registered medical device establishment facility. EISTM tools are now fully registered Class 1 Medical devices. Please check FDA Registration and Device Listing Database with Registration Number: 3032912829

Owner Operator Number: 10091625

Exclusive Availability on Amazon

For those interested in purchasing the manual only, it is exclusively available on Amazon for $99. You can choose between a print edition or a Kindle version to suit your preference. This manual is a valuable resource for professionals seeking detailed guidance and insights. To get your copy, visit Amazon today and select the format that best supports your needs.

 

Evolution of Tools

Advancements led to the development of second-generation tools such as HawkGrips, Graston, Astym, and Smart Tools, which have shown promising results. However, these tools often result in patient discomfort, including pain, petechiae, and bruising.

Sanitization Concerns in the COVID Era

The pandemic underscored the importance of stringent sanitization practices. The prevalent method of using Sani-wipes for cleaning instruments falls short of hospital standards, especially against resilient microorganisms like C-diff, which require prolonged exposure to disinfectants.

Limitations of Cleaning Methods

Ultrasonic cleaners present an alternative, but their standard sizes do not accommodate larger tools such as those from Graston. Moreover, tools made from materials like plastic may not withstand the heat and water in ultrasonic cleaners.

Issues with Emollient Application

The common practice of using emollients, such as cocoa butter or petroleum-based products, involves application methods that may compromise hygiene. Utilizing popsicle sticks for application does not guarantee cleanliness, especially when these sticks are stored improperly, risking contamination each time the container is opened.

Ergonomic Instrument Soft Tissue Mobilization

Need for improved tools, standards and practice

The shift towards third-generation tools in soft tissue mobilization marks a significant advancement in improving therapeutic outcomes, efficiency, and safety. The FDA determined that IASTM products are medical devices because they are intended to temporarily increase blood flow and local circulation at the site of application in healthy individuals. The FDA has determined that IASTM products are medical devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act and are general wellness products (class 1 medical device). The FDA has not approved or designated IASTM products for any purpose and has not made any determination about, or endorsement of, its stated use or benefits.

  • Enhanced Tactile Feedback and Design
    Third-generation tools are crafted to allow practitioners to feel adhesions through the instruments, enhancing diagnostic precision. Their design includes no-slip surfaces and 90-degree treatment edges, optimizing the manipulation of soft tissue decreasing discomfort or injury risk to the patient.

  • Operational Efficiency
    The objective is to notably enhance patient outcomes within a minimal number of visits, promoting a quicker return to normal activities and reducing the treatment burden.

  • Ownership and Cost
    These tools are available for outright purchase, eliminating the need for leasing, contracts, or hidden fees, thus ensuring a straightforward and cost-effective practice model.

Moreover, addressing hygiene concerns, particularly in minimizing cross-contamination, is paramount:

  • Hygienic Emollient Application
    Transitioning to emollients in pump bottles significantly reduces contamination risks associated with traditional jar-based applications. This approach ensures a safer therapeutic environment by minimizing direct contact.

  • Advanced Cleaning Protocols
    The recommended method for cleaning these new tools involves ultrasonic cleaners, which offer a thorough and efficient sanitization process. This method is capable of eliminating microorganisms that conventional cleaning methods may not, aligning with the stringent hygiene standards required in medical settings and ensuring the tools’ longevity and integrity.

This holistic approach combines therapeutic efficacy with the highest standards of hygiene and safety, representing a comprehensive advancement in patient care and practitioner experience in the field of soft tissue mobilization.