Question 1

What do you mean by SOPs laid down by ASTs and its compliance?

Accepted Answer

The Association of Surgical Technologists (AST) was established in 1969 with the mission of ensuring quality patient care. As the oldest and most widely recognized professional organizations for surgical technologists, AST's primary purpose is to ensure that surgical technologists possess the knowledge and skill sets to administer the highest quality of care for every patient (Association of Surgical Technologists (ast.org))(https://www.ast.org/). Among different responsibilities entrusted to Surgical Technologists, they need to follow Guidelines for Surgical Positioning Microsoft Word - Standard Surgical Positioning (ast.org).(https://www.ast.org/uploadedFiles/Main_Site/Content/About_Us/Standard%20Surgical%20Positioning.pdf) In these guidelines, the SOPs laid down related to Positioning Devices and their requirement are referred as SOPs of AST for Positioning Devices. The compliance herein referred as how Viscoelastic Gel with Anti-Microbial Coating (aka Medigel) fulfil these requirements.

Question 2

What are these Standards of Practice which were  laid down by Association of Surgical Technologists?

Accepted Answer

The Standards of Practice laid down by AST Education and Professional Standards Committee, duly approved by the AST Board of Directors are effective since April, 2011. It includes:
1. The surgical team should be familiar with the goals of achieving safe and effective positioning of the surgical patient.
2. During preoperative planning for a surgical procedure, the surgical technologist and other surgical team members should be informed of specific patient physiological factors that can affect the positioning procedure.
3. Based upon the preoperative patient assessment and surgical procedure, the surgical technologist should anticipate the type of OR table and equipment that is needed.
4. The surgical technologist, in collaboration with the other surgical team members should address the needs of special patient populations and implement the necessary precautions to avoid the patient from acquiring a pressure ulcer due to the surgical position.
5. During preoperative planning for a surgical procedure, the surgical technologist and other surgical team members should be informed if the patient is at particular risk for falling.
6. Surgical team members should follow ergonomic principles for positioning patients.
7. A patient who has been placed on the OR table must never be abandoned.
8. The surgical technologist in the assistant circulating role or prior to performing the surgical scrub should assist in safely positioning the patient under the direct supervision of the surgeon and anesthesia care provider.
9. Once the patient is positioned, the surgical team should assess the position.
10. The assistant circulating surgical technologist should document in the patient OR/ intra-operative record the positioning equipment and the patient position.
11. Surgical personnel should complete continuing education on patient positioning, new positioning equipment, and patient and personnel safety.
12. Healthcare facilities should develop and annually review the policies and procedures for patient positioning.

Detailed Guidelines for Surgical Positioning is attached herewith.

Question 3

SOP III-[c] quotes "consideration when purchasing OR tables is the mattresses and ability to evenly distribute the body pressure to prevent circulatory disturbances and pressure ulcers at the bony prominences" & How Medigel comply with i this requirement?

Accepted Answer

SOP-III [c] quotes" "consideration when purchasing OR tables is the mattresses and ability to evenly distribute the body pressure to prevent circulatory disturbances and pressure ulcers at the bony prominences"

Compliance Statement: Complete pressure distribution being oil based Medigel equalizes pressure in all directions as no coverage or film is required. 40 products are already in the lifestyle care preventing pressure sores in comatose state patients, wheel chaired morbid patients, coccyx seat cushioning etc.

Comparison with other technologies: Air gaps in foam (as it bottoms out with time) and/ or  coverage with nylon lead to uneven distribution; Silicon Rubber or Latex Rubber being robust with no elastomerism;  third category: core foam with silicone jelly are encapsulated in plastic film have no pressure equalization between two phases of different nature.

Question 4

SOP-III [C]-1 quotes "the personnel should be allowed by the manufacturer to use the mattresses on a test basis to determine which performs the best and meets the needs of the facility and patients",  please provides  compliance statement to fulfil this requirement?

Accepted Answer

SOP -III [C]-I  quotes" "the personnel should be allowed by the manufacturer to use the mattresses on a test basis to determine which performs the best and meets the needs of the facility and patients".

Compliance Statement: Medigel - test sample is provided with each lot as well as laid down Acceptance Test Procedures so that material can be tested for fulfilment of quality requirement and patient's safety.

https://static.wixstatic.com/media/b5e0d8_d7ae06c539944942918280c100cb0624~mv2.jpg

User manual instructions for its disinfection and cleaning is also provided.

https://static.wixstatic.com/media/b5e0d8_a2dcb736f3aa41e69e29a1b01dc6a82b~mv2.jpg

Visit Acceptance Test Procedures for further details. ATPs | OT Care by Medigel(https://www.otcare.co.in/services-8)

Question 5

SOP-III C-I: Material should be radiolucent, non-allergenic, fire retardant, shelf life and easy to clean? How technology comply?

Accepted Answer

Medigel is radiolucent, non-allergenic (doesn't support any microbial growth) & even coated with anti-microbial coating; not fire retardant, significant shelf life and easily cleaned by any detergent being hydrophobic in nature.

Question 6

SOP III C-2 quotes "Verification should include the positioning equipment can sustain the weight of the patient" & "Modification should be in consent with manufacturer and should be tested accordingly prior to use", please provide compliance statement to fulfil this requirement?

Accepted Answer

SOP III C-2  quotes" Verification should include the positioning equipment can sustain the weight of the patient" & "Modification should be in consent with manufacturer and should be tested accordingly prior to use".

Compliance Statement: Medigel® can bear pressure upto 1600 psi.

https://static.wixstatic.com/media/b5e0d8_2751dd35f9084fae9dc9669ee8533cf5~mv2.png

Medigel® is an indovation (Indian innovation) developed from compound level to completely elastromeric polymeric structure which can be contoured into any desired shape. User can contact us at +9810717192 if they are looking for any customized shape, we provide exclusive services too.

Question 7

SOP III [4] : Patient position should provide optimal exposure for placement of IV lines and anesthesia monitoring devices.
& How Medigel comply with it?

Accepted Answer

SOP III [4]: Patient position should provide optimal exposure for placement of IV lines and anesthesia monitoring devices.

Compliance Statement: Products are designed to provide  all the OT surgical material to get access while keeping patient's at the appropriate elevation and support. Example: HORSE SHOE RING EYE PRESSURE RELIEF & PRONE HEAD REST TYPE -III

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https://static.wixstatic.com/media/b5e0d8_8f971a0ded69466fb84cd1d86453f76a~mv2.png

Question 8

Define SOP IV & its compliance statement?

Accepted Answer

SOP IV: OT Positioning Device should be able to support all the patients fitting into Braden scale assessment (1-4) based on his/ her sensory perception; skin moisture; physical activity; mobility; nutrition; friction and shear.

Compliance Statement: Equalized pressure distribution aided by Medigel® technology suffice this requirement (see image below). 
https://static.wixstatic.com/media/b5e0d8_5b5fb2b1fd394b3ab5fbba661a8db4cd~mv2.jpg

Question 9

SOP IV (2): OT Positioning Device should be able to prevent pressure ulcer development in all surgeries for 03 or more hours? How it comply?

Accepted Answer

SOP IV : OT Positioning Device should be able to prevent pressure ulcer development in all surgeries for 03 or more hours.

Compliance Statement: Medigel® is able to disperse pressure equally being oil based polymer and hence able to prevent occurrence of bed sores. It is re-usable being hydrophobic thus not even support single Prolonged Surgery while it can support many being not even bottom out. Its elastomeric (elongation ability is > 500%). The product is being used by my hospitals successfully.

Question 10

SOP IV (3): Lower extremity device should be additionally padded/ soft to prevent the risk of developing pressure ulcer, how Medigel comply with it?

Accepted Answer

SOP IV (3): Lower extremity device should be additionally padded/ soft to prevent the risk of developing pressure ulcer.

Compliance Statement: Medigel provide a range of lower body positioning devices starting from Hip to Ankle area. All these are extremely soft (Shore O value limits to zero) and highly elastomeric prevent risk of developing any pressure ulcer.

https://static.wixstatic.com/media/b5e0d8_779e74920ec54006ac2832fa70a48ce2~mv2.png

The products include Hip Pad Position Device, Sacral Protector, Contoured Knee Pad,  Knee Crutch Pad, Crutch Stirrup Pad, Heel Support Pad, Heel Protector, Contoured Leg Rest, Contoured Calf Rest, Boot Stirrup Pad etc (see image below). Please visit: Lower Body Positioners | OT Care by Medigel.(https://www.otcare.co.in/copy-of-ot-positioners-2)

Question 11

SOP IV (4): Device should equally support and universal for all age groups, how technology fits, site examples?

Accepted Answer

SOP IV (4): Device should equally support and universal for all age groups.

Compliance statement: Device technology i.e. Medigel® is hypoallergenic and nontoxic thus neonatal head rings to adult head rings are available. This aspect is applicable to complete range of devices. See Catalogue for details on Footer of www.otcare.co.in (www.otcare.co.in)
Example:

https://static.wixstatic.com/media/b5e0d8_81e76f960645481fb987243636a50802~mv2.png

Question 12

SOP IV (5): Device should be able to take shape according to wrinkles which are not feasible to straighten out, explain how it fits?

Accepted Answer

SOP IV (5): Device should be able to take shape according to wrinkles which are not feasible to straighten out

Compliance Statement: Medigel® is also referred as C3I® in which one aspect is Conforming which means able to take shape of bone prominence or body structure.

https://static.wixstatic.com/media/b5e0d8_d53d50297e0e4c7c9baa8513801f9182~mv2.jpg

Just put your finger on the product, it will appear to be natural skin, it takes cover of your skin till pressure is applied, once removed, it will rebound immediately, an import elastomeric property of Medigel®

Question 13

SOP IV (6): Device should not contribute in enhancing the gravity of previously existing pressure ulcers? How it will comply?

Accepted Answer

SOP IV (6): Device should not contribute in enhancing the gravity of previously existing pressure ulcers.

Compliance Statement: Medigel® being impact resistant elastomeric cushioning device which rebound in less than fraction of second, does not able to cause any further increase in pressure ulcers. For details visit: Medigel | OT Care by Medigel(https://www.otcare.co.in/team-4)

Question 14

SOP V: Device should not aid support to risk of falling patients due to mental confusion as occurred in many disorders. How Medigel OT Positioning Devices fits into this requirement?

Accepted Answer

SOP V: Device should not aid support to risk of falling patients due to mental confusion as occurred in many disorders.

Compliance Statement: All devices are provided with one sided non-woven layer which prevents slipping of medical device while placed on OT table.

https://static.wixstatic.com/media/b5e0d8_ad98e8fcfa3c42dab6c4c917d91e46f4~mv2.png

Further stick on Velcro device is also now provided as an accessory ensuring once positioned even if patient’s reflexes might try to shift the positioning device, will not be able to shift.

Question 15

SOP VI [E] (1):  Pressure points and bony prominences should be identified and properly padded. How information provided from company side ensured that Surgical Technologists are able to use Positioning Devices properly.

Accepted Answer

SOP VI [E] (1):  Pressure points and bony prominences should be identified and properly padded.

Compliance Statement: The catalogue is extensively designed to provide dimensions of each micro part of OT positioning devices thereby aid specialists to select right OT device. Please click on Catalogue on Footer section of www.otcare.co.in (www.otcare.co.in)to download latest catalogue.

Question 16

SOP VI [E] (2): No body part should extend beyond the edge or end of the OR table or positioning devices, such as arm boards to avoid nerve injury. Whether such products are available.

Accepted Answer

SOP VI [E-2]: No body part should extend beyond the edge or end of the OR table or positioning devices, such as arm boards to avoid nerve injury.

Compliance Statement: A number of patient positioning devices are now available suffice this requirement.

Also the Stick on Surface doesn't allow Device to move unnecessarily. 
https://static.wixstatic.com/media/b5e0d8_ad98e8fcfa3c42dab6c4c917d91e46f4~mv2.png

All the product's dimensions are as per well accepted norms. Example: Contoured Calf Rest.

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Question 17

Define SOP VI [E] (3) regarding safety straps? Whether modifications available with  Medigel® to fit in?

Accepted Answer

SOP VI [E] (3): The OR table safety strap must not be secured too tightly across the patient in order to avoid pressure that can compromise circulation and friction. The surgical technologist should be able to comfortably insert two fingers under the mid-section of the safety strap to assure it is safely applied.

Compliance Statement: Safety strap can also be padded using strips of Medigel® to reduce such pressure.

Question 18

SOP VI [E] (4): Direct pressure on the eyes should be avoided to prevent corneal abrasions - The use of a head ring (donut) or horseshoe-shaped headrest should be avoided in order to avoid the risk of pressure on the eyes. The head may move in these devices during a surgical procedure resulting in direct pressure on the eye causing retinal ischemia. Whether such devices are available for fulfilment of such requirements?

Accepted Answer

SOP VI [E]: Direct pressure on the eyes should be avoided to prevent corneal abrasions - The use of a head ring (donut) or horseshoe-shaped headrest should be avoided in order to avoid the risk of  pressure on the eyes. The head may move in these devices during a surgical procedure resulting in direct pressure on the eye causing retinal ischemia.

Compliance Statement: Prone Head Rest Type III (with see through section) is available avoiding risk of pressure on eye.

https://static.wixstatic.com/media/b5e0d8_d27e3811f00744eb94fcd942c7e34a42~mv2.png

New advanced conformation with Eye Pressure Relief region in Horse Shoe Ring is available.

https://static.wixstatic.com/media/b5e0d8_cd2371e242014745b951d29c11172bf0~mv2.png

Question 19

SOP VI [E]-5: A pillow should be placed under the posterior of the patient’s knees to relieve pressure on the lumbar region of the back. Which products can provide such aid?

Accepted Answer

SOP VI [E]-5: A pillow should be placed under the posterior of the patient’s knees to relieve pressure on the lumbar region of the back.

Compliance Statement: Knee Support Pads are available in this technology aided this requirement. The knee support products are given below:

https://static.wixstatic.com/media/b5e0d8_5f7ee5ce79eb4c628570910d5a8a9cbe~mv2.png

Crutch Stirrup Pads.

https://static.wixstatic.com/media/b5e0d8_c3c1a6654fae4e6fae0356f758887160~mv2.png

Knee Crutch Pads

https://static.wixstatic.com/media/b5e0d8_52691ea97d5240f88ab030024514bad7~mv2.png

Contoured Knee Pad.

Question 20

SOP VI [E] (6): The surgical technologist should be aware that nerves are vulnerable to injury by traction and pressure leading to potentially medicolegal action when they do occur. The nerves most commonly injured are the ulnar, common peroneal and brachial plexus (see specific nerve injury precautions and required products).  Which Positioning Device fits into this requirement?

Accepted Answer

SOP VI [E] (6): The surgical technologist should be aware that nerves are vulnerable to injury by traction and pressure leading to potentially medicolegal action when they do occur. The nerves most commonly injured are the ulnar, common peroneal and brachial plexus (see specific nerve injury precautions and required products).

Compliance Statement: In human anatomy, the ulnar nerve is a nerve that runs near the ulna bone. The ulnar collateral ligament of elbow joint is in relation with the ulnar nerve. The nerve is the largest in the human body unprotected by muscle or bone, so injury is common especially during prolonged surgeries.  Medigel- Ulnar Brachial Nerve Protector System is now available in two sizes fulfilling this requirement.

https://static.wixstatic.com/media/b5e0d8_3c2b2e48ce5144f9b500f30b8e05aa9d~mv2.png

Ulnar / Brachial Nerve Protector.

Link for Shop: ulnar - OT Care by Medigel(https://www.otcare.co.in/search-results?q=ulnar)

Question 21

SOP VI [E] (7) defines Safety measures recommended (while utilizing OT positioning devices) for supine position, kindly suggest products available for different recommendations?

Accepted Answer

SOP VI [E] (7) defines Safety measures recommended (while utilising OT positioning devices) for supine position.

(A) : To prevent dyspnea in Cardiovascular disease, raise it temporarily.

Elevation Pillow is available for raising head temporarily as well as other Head Rests.

https://static.wixstatic.com/media/b5e0d8_09d82afd23df4c70a629f83d5786a273~mv2.png

Link for Head Positioners: Head Positoners | OT Care by Medigel(https://www.otcare.co.in/copy-of-ot-positioners)

(B): Pillow should be placed posterior to the knees joints to decrease pressure on the lumbar region of the back.

Compliance Statement: Knee Support Pads are available in this technology aided this requirement. The knee support products are given below:

https://static.wixstatic.com/media/b5e0d8_5f7ee5ce79eb4c628570910d5a8a9cbe~mv2.png

Crutch Stirrup Pads. 
Link: OT Positioners | OT Care by Medigel(https://www.otcare.co.in/projects-3-2)

https://static.wixstatic.com/media/b5e0d8_c3c1a6654fae4e6fae0356f758887160~mv2.png

Knee Crutch Pads
Link: OT Positioners | OT Care by Medigel(https://www.otcare.co.in/projects-3-2)

https://static.wixstatic.com/media/b5e0d8_52691ea97d5240f88ab030024514bad7~mv2.png

Contoured Knee Pad. 
Link: OT Positioners | OT Care by Medigel(https://www.otcare.co.in/projects-3-2)

(C) Well padded armboards with additional padding for elbows.
Medigel® Contoured Armboards and Elbow support devices should be used.

https://static.wixstatic.com/media/b5e0d8_1c94b8849edc417bb7eb90b67710e0b5~mv2.png

Link: OT Positioners | OT Care by Medigel(https://www.otcare.co.in/projects-3-2)

(D) Safety strap should be placed 2” above the knees. It should not be restrictive to avoid compression and friction injuries.
Compliance Statement: Medigel® safety strap with cushioning layer should be used.

(E) Heels must be protected from pressure by placing a pillow, ankle roll or donut.

Heel Protector Device is now available along with Heel Support Pad (Without Strap).

https://static.wixstatic.com/media/b5e0d8_e95fa35503e4469d8188bc2b32ef2ab0~mv2.png

Heel Protectors

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Heel Support Pads.

Look for these products under Lower Body Part Positioners:
Link: Lower Body Positioners | OT Care by Medigel(https://www.otcare.co.in/copy-of-ot-positioners-2)

(F) To avoid aorto-caval compression during Caesarean section or when the obese patient is in the supine position, the patient should be tilted approximately 15 degrees to the left to reduce the uterine pressure on the vena cava. This is accomplished by tilting the OR table slightly to the left and/or placing a wedge under the patients right hip.

Wedge Positioner (15 degree) is available for the same.

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Wedge Positioner (15 degreee)
Link: Wedge Positioner - OT Care by Medigel(https://www.otcare.co.in/search-results?q=Wedge+Positioner)

The above list is not exhaustive and only suggestive, please download catalogue for right selection of OT Positioning Devices.

Question 22

SOP VI [E] (8): Safety measures recommended (while utilising OT positioning devices) for lithotomy position, What are the products suggested for such position?

Accepted Answer

SOP VI [E] (8): Safety measures recommended (while utilising OT positioning devices) for lithotomy position.

(A) The stirrups should be well-padded and positioned equal in height. Two surgical personnel must lift the legs simultaneously and position in the stirrups. One leg at a time MUST never be placed in the stirrups in order to avoid lumbosacral injury and hyperflexion of the hip.
-Calf compression can be reduced (since non-avoidable) by remove the patient’s legs from the stirrups every two hours with continuous invasive compartment measurements.

Crutch Stirrup Pads & Boot Stirrup Pads  are available with adequate gel padding.

https://static.wixstatic.com/media/b5e0d8_5f7ee5ce79eb4c628570910d5a8a9cbe~mv2.png

Crutch Stirrup Pads 
Link: Lower Body Positioners | OT Care by Medigel(https://www.otcare.co.in/copy-of-ot-positioners-2)

https://static.wixstatic.com/media/b5e0d8_dc21ff81487940eeab6ae06d2b3e9800~mv2.png

Boot Stirrup Pads
Link: Lower Body Positioners | OT Care by Medigel(https://www.otcare.co.in/copy-of-ot-positioners-2)

(B) The arms should be placed on the padded armboards that do not extend more than 90° with palms upward. The armboard straps should be placed to secure the arms without causing undue compression.

Medigel® Contoured Armboards, Lateral Positioners, safety belt/straps and Elbow support devices can be used. Please download catalogue to select right product.

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Contoured Arm Board Pad.

https://static.wixstatic.com/media/b5e0d8_b3d104182de94277a6dac55929b928e2~mv2.png

Lateral Positioner.

Question 23

SOP VI [E] (9) :Safety measures recommended (while utilising OT positioning devices) for Trendelburg position, Which products are suggested for such position?

Accepted Answer

SOP VI [E] (9): Safety measures recommended (while utilising OT positioning devices) for Trendelburg position:.

(A) Try to avoid shoulder braces and if unavoidable, place it outer parts of shoulder away from neck.
(B) Saftey strap should be 2" above knees - If it can be avoided, patients who have a history of head trauma or intracranial pathology; Cardiovascular diseases including heart failure or Myocardial infarction should not be placed in Trendelenburg’s position.- Diaphragmatic movement is impaired by the weight of the abdominal viscera.

Medigel® shoulder braces and safety strap can be used with all precautions mentioned.

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Supine / Contoured Head Rest.

https://static.wixstatic.com/media/b5e0d8_45fb48806a0a4a1e9f4ef40d8908e8d4~mv2.png

Universal Positioning Device.

Please select right products for this position by downloading catalogue.

Question 24

SOP VI [E] (10): Safety measures recommended (while utilising OT positioning devices) for Reverse Trendelburg position. Which products can provide aid.

Accepted Answer

SOP VI [E] (10): Safety measures recommended (while utilising OT positioning devices) for Reverse Trendelburg position

-Well padded Foot Board with bottoms of the feet should be flat against the foot board with no inward curling of the toes.
-Safety strap should be2" above the knees.

Compliance Statement: Foot board can be padded by using Medigel®OT sheets as well as Safety strap with gel cushioned material.

Question 25

SOP VI [E] (11): Safety measures recommended (while utilizing OT positioning devices) for Fowler's position, What products can aid this positioning arrangement in Operation Theatre?

Accepted Answer

SOP VI [E] (11): Safety measures recommended (while utilizing OT positioning devices) for Fowler's position.

(A) Pressure points should be well-padded including the occiput, lumbosacral area, and heels.

(B) Arms may be placed on armboards with the palms downward. If not placed on armboards, a pillow should be placed across the abdomen, not the chest, and the arms bent at the elbows resting on the pillow; the arms should not be positioned where one arm is resting on top of another arm or crossed.

Compliance Statement: Arm Board Pads, Bolster device and Elbow resting universal positions are now available along with products given below.

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https://static.wixstatic.com/media/b5e0d8_f139dfe71c7747d2976cf0b414c2fa6c~mv2.png

Flat Arm Board Pads																	Dome Flat Bottom Chest Roll

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C-Shape Head Rest										Boot Stirrup Pad

These are some suggestions however this is very specific position and Surgical Technologists should download our catalogue to use suitable positioner.

Association of Surgical Technologists (SOPs)