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First sterile iPad sleeve for operating room now available, exclusive hands-on review

rkmelton's picture
Fri, 03/30/2012 - 7:00pm -- rkmelton

 

First sterile iPad sleeve for operating room now available, exclusive hands-on review

9 days ago by Felasfa Wodajo, MD

 
EchoMedical has partnered with Protek Medical devices to bring to market a disposable sterile iPad sleeve for use in the operating room.
iMedicalApps was able to get a first-run production unit for quick test.
Read below to see my first impressions as well as what we found about processes used to ensure sterility of the sleeves for operating room use.
I found the sleeve packaging easy to open. It allowed for easy entry of the iPad into the pouch, as well as removal. The fit of the sleeve was good, with just enough gap to not make insertion excessively difficult. Yet, it was snug enough that the iPad did not move around within the sleeve.
The iPad could be inserted into the pouch by the circulating nurse while the sleeve was held by the scrub tech without much difficulty, analogous to inserting an X-ray jacket inside a sterile sleeve.

The sleeve comes inside a small sterile package. Once opened, it is unfolded and the top opened. Once the iPad is inserted, the adhesive strip is exposed by peeling off the paper strip and the top flap is folded over, sealing the device inside the sterile enclosure.
The procedure is self evident but for those who wish to prepare ahead of time, the manufacturer includes a pictorial guide below. Per the manufacturer, the tablet cover is sold in 24 count boxes with the starting price of $125 for a box of 24.
The price per box goes down with higher volume commitments.

EchoMedical also makes a customizable patient education package for peri-operative patients. It allows surgeons and other physicians to easily build customized education modules for their patients with embedded video, images and interactive menus.

Sterility
The main question for a first time user is whether the sleeve is truly sterile and what standards have been applied in its manufacturing. In this case, the sleeves are made by original equipment manufacturer (OEM) Protek Medical, which states on its website:
Protek Medical Products is recognized globally in the development and manufacturing of Probe Covers and Needle Guides for ultrasound, Drapes for instruments in general medical applications and mechanical devices. We are experts in sterile disposable packaging and processing.

Furthermore, the website states:
Protek’s probe covers are a proven shield against cross contamination and protects your equipment from blood and other contaminants from getting into hard to clean areas. Tested to isolate a site of surgical incision from microbial or other contaminantion.

We asked Echo Medical and Protek Medical several questions regarding the type of testing routinely performed to satisfy sterility requirements and about FDA clearance.
Below is a FAQ summary of the information provided after discussion with Echo Medical:
OEM/Distribution
Who is the OEM for this product?
Protek Medical Products Inc, makes this product exclusively for Echo Medical
Is the OEM a US Medical Device Manufacturer?
Protek is an ISO 13485 medical device manufacturer located in the United States. Protek is a medical device company registered with the FDA
Is the Tablet Cover Manufactured in the United States?
Yes, the tablet cover is manufactured and sterilized in the United States.
Where is the tablet cover available for sale?
The tablet cover is available for sale in the United States and Europe.
Where do I get the tablet cover?
Echo Medical is the exclusive distributor for the tablet cover. Send order inquiries to orders@echomedical.com
FDA 
Is the tablet cover a medical device?
The tablet cover is a Class 2 medical device.
What is the product classification for the tablet cover?
The tablet cover is classified as a Cover, Barrier, Protective device
What are the medical applications tablet cover?
Surgery, emergency medicine, pediatrics, ultrasound, endoscopy, mobile cart applications, orthopedics, cardiology, otolaryngology, primary care, to name a few.
What is the applicable regulation number for the tablet cover?
21CFR878.4370 (Sec. 878.4370 Surgical drape and drape accessories)
Material Performance
Does the tablet cover contain latex?
No, the tablet cover is a clear, non-latex material.
What are recognized consensus standards for the tablet cover?
USFDA (tested under 21CFR Part 58) “Bacteriophage Penetration” Test. Viral Penetration Test: ASTM F1671-9 Using Phi-X174 Bacteriophage Penetration as a test system. Note: The x174 Bacteriophage is one of the smallest know viruses. The materials tested are intended to provide protection from blood, body fluids and other potential infectious materials.

Cleaning the iPad
In a typical hospital operating room, non-sterile devices like robotic surgery devices and microscopes are commonly enclosed in plastic drapes and brought into an operative field.
In these cases, the devices are routinely wiped with disinfectant wipes between cases. Below is a commonly used hospital cleanser. I found that it dried quickly when used to wipe the front and back on an iPad without real concern for liquid penetration into the inside of the device.

Conclusion
While no medical device or sterile barrier can guarantee sterility if improperly used, this device appears to satisfy regulatory requirements for sterile barriers and, when used with an iPad that has been appropriately cleansed, should satisfy most hospitals’ requirements for operating room use.