The iON ESPS™ Ergonomic Surgical Positioning System

david gomez [Date] [Course title]

Evolving Patient Positioning

1

The iON ESPS™: Ergonomic Surgical Positioning System

Device Description: iMT has created the first uniquely designed ergonomic surgical positioning system (ESPS) for the arm adducted surgical position. This position is a necessity for daVinci® robotic surgical cases and many other specialty surgery types such as ENT, neurological (spine and brain), cardiac, vascular, gynecological, and bariatric procedures. Multiple other general surgical case types where the procedure and/or surgeon require maximum access to the surgical field would also benefit from this product.

The iON ESPS™ evolves the current standard of care by offering efficient and consistent arm adduction. It can be implemented almost entirely by a single member of the surgical team with an average time of less than 2 minutes. The iON’s use offers lower levels of positioning variance than was previously possible through standard methods involving a draw sheet and padding. More importantly, anesthesia care and access will be greatly enhanced as its design eliminates circumferential wrapping of IVs and other vital patient monitoring equipment. The iON will accommodate the majority of ideal body weight (IBW) adult patients and those with body mass indexes (BMI’s) up to 55kg.m2. A larger iON for the morbidly obese patient is also an option for patients larger than 55kg/m2. The iON ESPS™ is the culmination of practice experience, creative design, and unsurpassed utility.

iMT’s patented design allows for the visualization of vital of commonly injured radial and ulnar nerve anatomical landmarks. This potentially leads to safer care and diminishes liability and poor patient outcomes related to positioning variance. It is important to note that no product can make a medical claim or fit every circumstance especially across a wide scope of patient body types. The iON ESPS™ is a “One Size Fits Most” medical device and clinical judgment should always prevail.

The intuitive design and utility of this device will help standardize care relating to this surgical position, improving the variability of practice standards currently advocated by professional originations such as The American Society of Anesthesiologists (ASA), Association of peri-Operative Registered Nurses (AORN), and the American Association of Nurse Anesthetists (AANA). The iON ESPS™ is a tool to be used along with institutional process improvements, those of which allow the facilitation of “safe” efficient utilization of surgical staff during surgical positioning and preparation, ultimately improving surgical caseloads and reimbursement potentials.

2

The expanded value of the iON ESPS™ will also help minimize care provider injuries related to repetitive positioning of obese patients by eliminating the two to three providers currently needed to deploy this position. Rising obesity rates in the US increase the physical demands of providers during positioning, contributing to preventable and costly back injuries, those of which currently cost the industry $16 billion annually.

The improved value gained through more efficient positioning methods could save 5-15 minutes on average per case, keeping in mind that the metrics of time and utilization increase with the patient’s BMI, as creativity and variance takes hold. This poor utilization equates to a range of $310-$930 per case. This is a significant cost savings to payers when the average US surgical cost per minute of $62 is factored7. More importantly, this becomes a significant gain for institutions as we begin the transition into bundled payment initiatives. Lastly, these time saving improvements can positively impact utilization of staff and operating room availability, thus allowing the potential for additional surgical cases, furthering the value and ROI for the iON ESPS™. Demonstrated time savings has an impact on maximizing reimbursements under bundled payment initiatives.

An example of the impact of time saved under bundled payment initiatives:

A Level V ENT procedure (APC 0254 @ $1964) that saves 6 min results in a 20% return

investment per procedure. A Laparoscopic cholecystectomy (APC 0131 @ $3709) that

saves 6 min is an 11% return investment per procedure.

Clinical Basis for Design and Utility:

x Perioperative ulnar neuropathy accounts for one third of all nerve injury claims in the American

Society of Anesthesiologists (ASA) Closed Claims Study database according to a 1985 study1.

x Nerve injuries now represent the second largest class (16%) of adverse outcomes in the ASA

Closed Claims Study database1. Just three sites–the ulnar nerve, the brachial plexus, and the

lumbosacral roots–account for most nerve injury claims2.

x The ulnar nerve has been, and continues to be, the mostly commonly cited nerve injury

associated with surgery3.

x These injuries may result in chronic pain or paresthesia, employment disability, catastrophic

economic damages, and malpractice litigation2,3,4.

Perioperative nerve injuries can result from a number of mechanisms including excessive pressure and/or direct compression, stretching, ischemia relating to compression or vascular insufficiencies, metabolic derangement, direct trauma, laceration, and many other potential physiological factors related to obesity, diabetes, and other metabolic disorders.

3

iMT believes positioning standards advocated by such prestigious practice organizations like the ASA, AORN, and the AANA, are becoming increasingly difficult to perform due to our rapidly evolving domestic obese population (35.7%8). The practice of using sheets and pads becomes increasingly difficult to employ safely because of the obese patient’s larger body habitus, especially when compared to the standard operating room surgical table’s width of 20 inches. Few existing products address this issue, but none of those devices offer the ease and utility of use when compared to the iON ESPS™. None of them offer quick and assured access to vital anesthesia landmarks necessary for the delivery of care. The iON ESPS™ is a complete product, offering both security and accessibility for this surgical position. Existing products geared to arm adduction provide inferior performance and are both difficult and time consuming to deploy, and most still rely on the use of draw sheet and pads. The iON ESPS™ is a revolutionary product because of its utility and intuitive design. It is an evolutionary product because of its intrinsic value to patients, providers, and facilities.

AORN’s Standards of Care and Warnings for Arm Adduction

Recommended practices for positioning the patient in the perioperative practice setting states:

1. The patient’s arms should not be tucked at his or her sides when positioned in a supine position unless it is necessary for surgical reasons.

2. There is an increased risk for tissue injury and compartment syndrome in the upper extremity when the patient’s arms are tucked tightly at his or her sides with sheets.

3. There are increased risks for interference with physiologic monitoring (eg, blood pressure monitoring, arterial catheter monitoring) and unrecognized IV infiltration, which may interfere with delivery of intraoperative anesthesia medications and resuscitation efforts during an emergency.

4. If the patient’s arms are not tucked tightly enough, there is a risk for them to become unsecured during the procedure.”

5. Aligning the patient properly, redistributing pressure, protecting the patient from tissue and nerve injuries, preserving IV access and physiological monitoring, and providing appropriate exposure for the procedure are all important considerations for safe and effective patient positioning” AORN JOURNAL APRIL 2009, VOL 89, NO 4

iMT’s founding members have observed many variances in positioning employed by staff in regards to this surgical position. Modern healthcare’s drive for efficiency, especially within the perioperative setting, have placed providers under continuous pressure to accommodate measured performance. Human nature is to subconsciously (or consciously) cut corners, thereby paying less attention to detail for the sake of these efficiency requirements. This increases the potential for unsafe patient outcomes. This is the new “psychology” of the industry and one that

4

must be considered when developing new technologies. The iON ESPS™ requires minimal instruction or guidance for use. Variability of positioning differs from provider to provider, despite recommended practice guidelines. We know from clinical experience that bad techniques or processes can be passed on during staff training, despite a culture of vigilant care. This is not to lay blame or point out specific provider faults, but an opportunity to learn from them. This is where value begins to exceed the iON ESPS’s utility.

Diagram based on AORN standards

Standards of Care and Practice: Unfortunately, despite the recommended standards pictured above, there are many variations of this position deployed in the operating room. Often times it becomes necessary to adjust sheets, sometimes adding even more linens, in order to effectively secure the arms. Obesity complicates this task even more. Improper arm positioning, such as allowing the elbow to rest on the steel frame of the surgical table, can be related to loose securing of the arms. This may create external pressure on the ulnar nerve, trapping it as it courses within the rigid bony canal of the superficial condylar groove at the elbow 4,5,6. Such uninterrupted pressure can ultimately produce nerve ischemia and injury. Clinically these injuries are either transient or permanent, but to the affected patient, they are devastating and can greatly affect their quality of life. From a theoretical standpoint, applying the standard sheet and pad technique introduces the potential for a tourniquet like effect. This assumption utilizes the basic laws of physics. When a patient’s weight is used to secure the blanket, the security of that arm is held by a combination of forces. This effect depends on how tightly secured the arms were initially affixed (with linen) in relation to the patient’s individual weight.

5

For example, if the operating room table was tilted to one side or the other, you could surmise that the shift in the patient’s body habitus would tighten the sheet secured method even more on the affected side, theoretically causing a tourniquet effect. This effect potentially increases the incidence of tissue compression and/or vascular insufficiency, allowing for the development of compartment syndrome in the upper extremities. The addition of pads and gel protection in this finite space further increases the potential for this type of injury. iMT believes existing standards of care become ineffective against injury in the obese patient population. Non circumferential securing of the arms with the iON can help reduce this potential.

Injuries sustained by providers: Variances in positioning practices employed by care providers carry the potential for injuries, for both the patient and themselves. Care provider work place injuries were strongly considered during the development of this product.

x Nurse’s back injuries cost an estimated $16 billion annually in workers compensation

benefits9

x Medical treatment, “light work days,” and turnover cost the industry another $10 billion annually9

x Every single day in the United States, 9000 healthcare workers sustain a disabling injury while performing work-related tasks. Disabling back injury and back pain affect 38% of nursing staff10

x In the 1998 Bureau of Labor Statistics ranking of the professions at the highest risk for back injury, healthcare workers accounted for 6 of the top 10 positions. An obvious conclusion would be that these injuries are contributing, at least in part, to the current nursing shortage10

x The consensus is that nurses are being injured primarily while transferring patients or when lifting patients, either by cumulative injury, by lifting over and over day after day (year after year), or by a direct injury such as lifting or transferring a 135-kg (300 lb) patient alone10

x When a nurse turns a patient side to side the reach is 33 to 35 inches. The nurse must lift 35% of the patient’s body weight (avg: 52.5 lbs.). This is FAR beyond safe lifting limits11

These statistics can affect many other providers within the perioperative environment. Anesthesia, surgeons, surgical techs, and many other ancillary personnel associated within the perioperative setting are also called to facilitate the positioning of patients for surgery.

6

It is not uncommon to utilize two, three, or even four members during the positioning of super morbidly obese patients. This repetitive and unsafe ergonomic activity is a continuous strain on the care provider’s physical health. This unsafe physical process will be minimized, if not eliminated, with use of the iON ESPS™. Resources: [1] Cheney FW. The American Society of Anesthesiologists Closed Claims Project: what have we

learned, how has it affected practice, and how will it affect practice in the future? Anesthesiology 1999;91:552–6.

[2] Cheney FW, Domino KB, Caplan RA, et al. Nerve injury associated with anesthesia: a closed

claims analysis. Anesthesiology 1999;90:1062–9. [3] Kroll DA, Caplan RA, Posner K, et al. Nerve injury associated with anesthesia. Anesthesiology

1990;73:202–7. [4] Stoelting RK. Postoperative ulnar nerve palsy—is it a preventable complication? Anesth Analg

1993;76:7– 9. [5] Dawson DM, Krarup C. Perioperative nerve lesions. Arch Neurol 1989;46:1355–60.

R.C. Prielipp et al. / Anesthesiology Clin N Am 20 (2002) 589–603 601 [6] Swenson JD, Bull DA. Postoperative ulnar neuropathy associated with prolonged ischemia in the

upper extremity during coronary artery bypass surgery. Anesth Analg 1997;85:1275– 7. [7] http://www.cdc.gov/obesity/data/adult.html [8] http://ether.stanford.edu/asc/documents/management2.pdf [9] Eldlich, Richard F., Kathryne L. Winters, Mary Anne Hudson, L.D. Britt, William B. Long,

“Prevention of disabling back injuries in nurses by the use of mechanical patient lift systems,” Journal of Long-Term Effects of Medical Implants, 2004, 14(6)

[10] http://ajcc.aacnjournals.org/content/12/5/400.full [11] http://www.nhnurses.org/Documents/Announcement-Flyers/Alert.aspx

7

Dear David Gomez:

This e-mail provides confirmation that the annual registration for the medical device establishment shown below has been successfully completed for 2015.

If there is no registration number in this email and your establishment previously had one, please send an email to reglist@cdrh.fda.gov and include the registration number you believe is assigned to your establishment. We will review and determine if a duplicate registration has been created for your establishment.

Your registration is valid through December 31, 2015. Registration for 2016 will be conducted between October 1 and December 31, 2015.

Registration Number: 3010396722 Owner Operator Number: 10044733

INFINITUS MEDICAL TECHNOLOGIES LLC 4313 Forest Drive Holly Springs, NC 27540 UNITED STATES

8

9

US PATENT: 8,879,356 B2

10

US PATENT: 8,879,356 B2