This project is part of the Hack Covid 19 effort in Columbia Missouri.
This repository contains the FreeCAD project files and assemblies for the finished device. The assembly file also contains a spreadsheet with a Bill of Materials
Shield:
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.
is below. It provides a description of traditional methods of proning patients, why the Roll-To-Prone was developed, a brief description of how it works and the staff needed. It describes the advantages, disadvantages and anticipated risks. It discusses how to obtain a RTP. It provides our understanding of the current regulatory issues relevant to constructing and using a Roll-To-Prone. Here is a link to it in our google drive: https://drive.google.com/file/d/182th2Dl5fQ3e4c2UXt_SmKHfageZed11/view?usp=sharing
provides more detailed information about how the RTP assists in proning patients, what it can do in addition to proning the patient and what supplies are required It discusses the minimum staff required and staff responsibilities. There are descriptions the components of the RTP and how they function using both pictures and drawings. There are suggestions for training of staff. Here is a link to it in our google drive: https://drive.google.com/file/d/1Ac9cEFHUrvGrhj9ObVe-I6KE-IIqKwqV/view?usp=sharing
provides drawings with parts named, a list of materials required to build an RTP, drawings, construction notes, specifications, and information needed to do build a RTP. Here is a link to it in ouir google drive: https://drive.google.com/file/d/1QrrSeKrRrUjFflSVqfgwapPYGh51_ALp/view?usp=sharing
explains how to determine if the RTP will fit a bed other than the Striker Secure 3 bed. It then discussed factors to consider and evaluate in designing and building a Pronation Assisting Device (PAD) to fit a different bed. Here is a link to itin our google drive: https://drive.google.com/file/d/11D-213pw5O8vaBjpEURfMmcU0bHEXhzP/view?usp=sharing
“Proning” is turning patients from laying on their back, to lying on their belly (laying belly and face down is the prone position). Patients who are intubated or having difficulty breathing sometimes benefit from being in the prone position.
Roll-To-Prone (RTP) is the name given to a device to help hospital staff prone patients in their beds. The Roll-to-Prone is not a commercial product. The design of the device is being made public through a Creative Commons Attribution Share Alike 4.0 International license so that hospitals that choose to can have them made and use them if they desire. The term Roll-To-Prone refers to the specific design we developed. We suggest that the term pronation assisting device or PAD be used as a general term to describe any device being used for that purpose.
The Roll-To-Prone was designed to fit the Stryker Secure 3 bed. Fitting means that the base of the Roll-To-Prone straddles the base of the bed and allows the RTP to be in the proper position. The RTP may fit other beds, but we only have access to the Stryker Secure 3 bed. If you determine that that the Roll-To-Prone does fit other beds please let us know.
The Roll-To-Prone was developed by Columbia Gadget Works a local non- profit “makers” group in Columbia Mo. At the onset of the Covid-19 pandemic personal protective equipment was in short supply. Doctors at the University of Missouri anticipated a surge of patients infected with Covid-19. They were concerned about the number of staff required to prone a patient, their potential virus exposure and the scarcity of the personal protective equipment required. A request for assistance in ways to prone patients was sent to the UMC Department of Engineering “Hack Covid” Task Force. Columbia Gadget works was approached by the Task Force and agreed to develop a device to assist in proning. Several options were presented and the Roll-To-Prone was developed and tested with input from Dr. Salman Ahmad and other staff.
Proning a patient is typically done by having 2 to 3 staff on each side of the patient, and another at the head of the bed. The staff on one side pull the sheet under the patient to move the patient to the side of the bed. They then pull up on the sheet to roll the patient onto their side, and then on over on to their belly. The staff on the other side position the limbs, and control and guide the roll. The staff at the head of the bed guides the head during the pronation. If the patient is intubated they will also monitor the tubing and airway. If the patient has multiple tubes in place, there may be additional staff to monitor these. If the patient is larger than average, there will be additional staff needed on the sides of the bed. After the process is started and the staff are lifting and rolling the patient a pause in the roll leaves staff on one side holding the weight of the patient. To pronate a patient typically takes 5 to 7 staff, in a very “hands on” process. If the patient has COVID-19 each of the staff is at risk of exposure and requires the use of PPE. The Roll-To-Prone was developed to provide a means to pronate patients using fewer staff, thus exposing fewer staff, and using less PPE.
The RTP is a frame holding a roller at the side of the bed. A sheet from under the patient is wrapped around the roller. A crank is used to turn the roller, pulling the sheet up, rolling the patient into the prone position. A ratchet wrench on the roller keeps the roller from reversing direction
With some planning and preparation, it is possible to pronate the patient and at the same time remove the old flat sheet, old fitted sheet, and put on clean fitted and flat sheets under the patient.
Using a crank and roller to pull the sheet uses leverage to reduce the effort needed by staff. The crank requires one person instead of the 2 to 4 needed to prone the patient by staff pulling the sheet up. Having the ratchet wrench means the person cranking can pause if needed, and not have to hold the crank continuously. Because the rate at which the patient is rolled is easily controlled and can be paused, only one person is needed to control and position the limbs instead of 2 or 3 using the traditional means. Using the RTP to pronate a patient can usually be done with 3 staff instead of 5 to 7.
Fewer staff being required to prone each patient means decreased use of scarce personal protective equipment.
Fewer staff being exposed to Covid-19 means fewer staff getting Covid-19 and being unavailable to provide patient care.
Additionally, more staff is available for other patient care.
The mechanical advantage of the roller pulling the sheet and lifting the patient puts fewer nurses at risk of back injuries and other musculoskeletal injuries. In the traditional manual method of proning a patient, the height of the bed means nursing staff must use back, shoulder and arm muscles- and do so continuously until the patient has been turned. Back injuries and musculoskeletal injuries are significant problem for healthcare workers and healthcare facility staffing in “normal” times and are even more of a problem as need for staff increases.
The minimum number is 3, as described below. More should be available when gaining experience with the RTP. More may be needed for larger patients and patients with more complex medical problems and multiple tubes.
One person is at the head of the bed, managing the head and any associated tubing. They will be in verbal communication with the other staff.
The person at the foot end of the bed is responsible for positioning the sheet on the roller, then turning the crank while visually monitoring the patient being pronated. They monitor any tubing routed to the foot of the bed. They will adjust the rate they turn the crank to match the needs of the other staff involved.
The person at the side of the bed is responsible for positioning any clean linen to be placed under the patient after they are turned. They position the patient’s limbs prior to, during, and after the turn. They control the position of the patient’s torso during and after the turn. They monitor any tubing routed to the foot of the bed.
The RTP must be stored someplace when not being used, transported to the bedside for use, then cleaned and returned to where it is kept.
If the bed is not adjusted to the proper height there is a very small chance the patient could be pulled up to and over the roller and out of the bed. This could occur if the center of gravity of the patient is higher than the roller. This is easily avoidable by adjusting the bed height, so the roller is twice the depth of the patient’s chest over the mattress. If it were to start to occur it would occur slowly and would be obvious to any of the staff present. If it started to occur, it would be easily mitigated by reversing the direction of rotation of the roller.
If one of the patients lines were to become entangled in the sheets the line could be pulled out or loose. This risk is also present in the traditional method of proning a patient. This risk can be reduced by making sure the lines are secured to the patient before proning, and carefully routing the lines next to the patent such that they travel with the side of the patient traveling “up and over”, and not the side being pulled by the sheet “down and under”.
If a finger or hand were trapped between the retaining bar and the roller with the roller turning there is a risk of severe injury to the hand and fingers. The risk of this occurring is minimized by having only one staff person put the sheet between the retaining bar and the roller, and that same staff being the only one to use the crank and turn the roller.
The Roll-to-Prone is not a commercially available product. If you want one, you will have to have it built. We are granting permission to build one using our design, and providing the necessary drawings and specifications to have one built. The Columbia Gadget Works Roll-To-Prone is licensed under a Creative Commons Attribution Share Alike 4.0 International license. This license grants the use of our design so long as it is identified as our design, or a modification of it.
This website also provides an opportunity to discuss you experiences with the Roll-To-Prone or other pronation assistance device (PAD). Please let the community know of any suggestions for improvement in design or use.
The Columbia Gadget Works is a 501(C)(3) nonprofit organization with a scientific and educational purpose. Its members are volunteers with a variety of backgrounds. Columbia Gadget Works is not a manufacturer of commercial products. We are not a medical facility, nor do we train medical staff.
The design of the Roll-To-Prone is relatively simple. Please let us know of any improvements you make. The risks we are aware of have been documented in the information on the website above. There may be risks we have not identified.
Every facility is responsible for its policies, procedures, and staff training. These would include proning patients by traditional methods. The facility possessing a Roll-To-Prone device is responsible for developing policy and procedure for its use as well as the of training staff to use it. Presumably this would be a subsection of the policy on proning. Because the RTP is a new device there is no standardized or accepted training in its use. As the designers of the RTP the Columbia Gadget works has identified areas of competence unique to the use of the RTP device. There may be others we have not identified. The ones identified are found in **Roll-To-Prone FAQ, Component Information and Suggested Staff Training
We at the Columbia Gadget Works have no experience or expertise in the classification or approval process of medical devices. The following is based on our understanding of the approval process and may be incomplete or incorrect.
The RTP is considered a medical device because it is used with patients. Medical devices are considered as Class 1, Class 2, or Class 3 based on the risks of the device., with Class 1 devices having the lowest risk. The FDA has multiple regulations related to medical devices. Part of the classification system is based on the similarity of the new device to devices previously classified.
The link below provides information about the medical device premarket notification process and regulations.
https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k
It has a subsection on when devices do not require a 510(k) with seven situations specified. https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification- 510k#whennot
It is our understanding that the Roll-To-Prone would fall under #2, and possibly #7 as in the link above, and reproduced below with 2 and 7 in bold.
#2 would appear to apply to a hospital having an RTP or PAD built.
#7 indicates that devices may be exempt because of their similarity to devices already approved. One such device may be https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=890.5180 https://ecfr.io/Title-21/Section-890.5180
Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9).
When not required
The following are examples of when a 510(k) is not required.
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You sell unfinished devices to another firm for further processing or sell components to be used in the assembling of devices by other firms. However, if your components are to be sold directly to end users as replacement parts, a 510(k) is required.
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Your device is not being marketed or commercially distributed. You do not need a 510(k) to develop, evaluate, or test a device. This includes clinical evaluation. Please note that if you perform clinical trials with your device, you are subject to the Investigational Device Exemption (IDE) regulation (21 CFR 812).
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You distribute another firm’s domestically manufactured device. You may place a label on the device, “Distributed by ABC Firm” or “Manufactured for ABC Firm,” (21 CFR 801.1) and sell it to end users without submission of a 510(k).
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In most cases, if you are a repackager or a relabeler and the existing labeling or condition of the device is not significantly changed. The labeling should be consistent with the labeling submitted in the 510(k) with the same indications for use and warnings and contraindications.
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Your device was legally in commercial distribution before May 28, 1976 and has not been significantly changed or modified in design, components, method of manufacture, or intended use. These devices are “grandfathered” and you have Preamendment Status documentation to prove this.
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The device is made outside the U.S. and you are an importer of the foreign made medical device. A 510(k) is not required if a 510(k) has been submitted by the foreign manufacturer and received marketing clearance. Once the foreign manufacturer has received 510(k) clearance for the device, the foreign manufacturer may export his device to any U.S. importer.
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Your device is exempted from 510(k) by regulation (21 CFR 862-892). That is, certain Class I or II devices can be marketed for the first time without having to submit a 510(k). A list of the Class I and II exempted devices can be found on Medical Device Exemptions 510(k) and GMP Requirements. However, if the device exceeds the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9), such as the device has a different intended use or operates using a different fundamental scientific technology than a legally marketed device in that generic type of device, or the device is a reprocessed single-use device, then a 510(k) must be submitted to market the new device.
The link below has information on devices with exemptions.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
The FDA Emergency Use Approval Process Due to Covoid-19
Because of the Covid 19 epidemic is a national emergency the FDA has granted emergency use authorizations for medical devices.
https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices
This link has Frequently asked questions. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-emergency-use-authorizations-euas-medical-devices-during-covid-19-pandemic
The RTP does not appear to fit into any of the presently established categories for Emergency Use Authorization (EUA). There is a category for Other Medical Device EUSs, but nothing there resembles the RTP. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/other-medical-device-euas
There is a template to apply for an EAU authorization. https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwjSpqXnzK3rAhWBBs0KHfV4B8kQFjAAegQIBBAB&url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F137965%2Fdownload&usg=AOvVaw0OLWgN-KP0O21g8dMJHIDo