Hospitals Can Restore™ ACA Compliance

by HCE Exchange on October 9, 2015

RMS-thumb1The Patient Protection and Affordable Care Act, known as PPACA or ACA for short, is arguably the most influential driver of policy and operational decisions by hospitals across the country. Hospitals are aggressively working to maximize revenues under new regulations and payment methodologies.

In FFY13, Medicare began replacing a small portion of traditional Medicare payments (1 percent growing to 2 percent by FFY17) with the Value Based Purchasing (VBP) model for hospitals based on specific quality and service measures that reflect national best practices and outcomes. Examples include delivery of certain medications within specified time frames, reduction of hospital readmission rates, REDUCTION OF HOSPITAL ACQUIRED CONDITIONS, and more.

Let’s look at reduction of hospital acquired conditions a little more closely. Effective July 1, 2011, ACA required the Secretary to issue Medicaid regulations prohibiting federal payments to states under section 1903 of the Social Security Act for any amounts expended for providing medical assistance for healthcare acquired conditions. These non-payment policies for provider preventable conditions (PPCs) include healthcare acquired conditions (HCACs) and other provider preventable conditions (OPPCs). Some of the minimum set of conditions, including infections and events, that states must identify for non-payment are:

Surgical Site Infection Following:

  1. Coronary Artery Bypass Graft (CABG) – Mediastinitis,
  2. Bariatric Surgery, including Laparoscopic Gastric Restrictive Surgery,
  3. Orthopedic procedures, including Spine, Neck, Shoulder, and Joint Replacements.

Restore Medical Solutions, Inc. recognizes that surgery plays a huge role in the ACA as it pertains to maximized payments vs. non-payment. It is Restore’s mission to focus on products and techniques that will promote a higher level of efficiency and productivity, enabling our nation’s hospitals to deliver quality healthcare to all.

Every second is important when someone’s life is in danger, so the last thing a surgeon needs to worry about is where his or her instruments are or if they were cleaned appropriately. We are proud to bring our system to market knowing that it will help save lives and contribute to lowering the cost of healthcare.”

~ Shawn Flynn, President

The reality is that Hospital Acquired Infections (HAIs) can affect nearly everyone. Chances are you know someone who has contracted one or you know someone currently hospitalized who is fearful of contracting an HAI at that facility. There is no doubt that your local hospital is being affected as well, since they are no longer being reimbursed for patients who have to be readmitted to their care due to contracting one. So who or what is to blame? Dirty surgical instruments are common culprits, and therefore, many hospitals are rightfully implementing process improvement strategies within their Operating Rooms (OR) and Sterile Processing Departments (SPD).

As a hospital administrator, my first concern is the safety and well-being of the patient. The prevalence of surgical site infections (SSIs) is one of grave concern that is being addressed by hospital administrators across the country. The ‘State of the Art’ Modular Sterilization Tray System designed by Restore Medical Solutions will not only make the sterilization process more efficient, but potentially lead to decreasing potential SSIs due to a reduction in debris, biofilm, and bioburden on surgical instruments.”

~ Michael D. Wright, FACHE

How is Restore Medical Solutions helping? If you have ever worked in an OR or SPD, you are already familiar with the jumbled basket of dirty surgical instruments that find their way from the OR to the SPD for decontamination, sterilization, and reprocessing following every surgical procedure. Any SPD Tech can tell you the challenges of sterilizing and reprocessing surgical instruments because there are chronic problems that every SPD faces. Some of these are dealing with broken or missing instruments, needlesticks acquired while separating the basket of dirty instruments, and worst of all, the difficult-to-clean instruments. There are many hardworking and dedicated SPD and OR personnel that live with antiquated equipment, and they recognize the need for a better, safer, and cleaner system. Enter Restore Medical Solutions.

I like them, I think it’s a great idea, perfect for storage purposes and easy to use. I really like the system. The instruments are cleaner and there are time savings associated with it”.

~ Brandi Brooks

Sterile Processing Manager

Baptist Memorial Hospital, Memphis

Restore™ was co-founded by Ryan Ramkhelawan and Shawn Flynn, who both have medical backgrounds, including experience working within the SPD of the largest Level One Trauma Center in the Southeast. Shortly after experiencing these chronic challenges firsthand in their own SPD, Ryan and Shawn developed the Restore Modular Sterilization Tray System, and the solution was born. Co-founder Shawn Flynn received his initial medical training in the military as a Surgical Assistant. There he was cross-trained in SPD as well and realized the value of the OR and SPD functioning as one unit. He was surprised to find that in the civilian world, the units many times function separately. Restore™ endorses the practice of the OR restringing instruments at the point of use in the OR. This solitary action makes it easier to recount instruments on the back table and accurately account for them. It also enables a quicker and safer inspection in the SPD, which in turn delivers cleaner instruments to the OR in a more efficient manner.

While FDA and AAMI standards recommend that instruments go through the sterilizer in an open and upright fashion, prior to Restore™ there was not a product on the market that facilitated this, which is in–situ to the containment device. With the instruments in an open and upright fashion, it is easier for the SPD Tech to inspect and reassemble instruments, thereby lessening the touchpoints within the surgical sterilization continuum. Fewer touchpoints translate into fewer sharps-related accidents for staff, reduced capital budget for repairs and replacements, decreased assembly time, and increased focus on inspection and functionality. The bottom line is: fewer touchpoints translate into more patients being seen and receiving better quality healthcare, as well as increased revenue for the hospital. Now that’s a win-win.

Since receiving its FDA Clearance in August 2013, Restore™ has primarily been marketing its Modular Sterilization Tray System within its local Memphis-based market. In particular, the Restore™ system is currently in the middle of a time-and-motion study in a local SPD setting, which, once complete, will be published as a White Paper that focuses on the efficiencies realized by implementing a system that includes AAMI and FDA-recommended features in modular tray and racking devices like the ones manufactured by Restore™. Additionally, the Restore™ system has already shown a ~99.99 percent reduction of bioburden on surgical ring-handled instruments during third-party cleaning validation studies.

“Our product will allow hospitals to clean and re-sterilize surgical instruments in a more efficient and safer way,” says co-founder Ryan Ramkhelawan, whose background includes developing process improvement strategies that decrease the number of surgical complications.

Significant milestones to date for the company include the successful closing of their $2.5 million Series A financing, international patent portfolio development, ISO 13485 certification with CAMDCAS, independent laboratory validation of marketing claims, company website launch, securing assembly/distribution/office space, successful IQ/OQ/PQ, and FDA clearance of Restore’s Premarket Notification.

Our partnership with INNOVA and MB Venture Partners will propel us to incredible heights. Our experience in healthcare and the financial support from our partners gives us the ability to help fight against raising healthcare costs. Our product will allow hospitals to clean and re-sterilize surgical instruments in a more efficient and safer way.”

~ Ryan Ramkhelawan, CEO

Restore™ will definitely change Sterile Processing forever, and Restore™ is an exciting young company to watch. You can keep up with the latest news on the company website at www.restore-med.com.

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