A How-to Guide for moderately experienced fabricators:_________________

Producing a medium-sized production run of Disposable Protective Gowns for the COVID PPE Effort

For questions, contact: Sarah Miller sarahlouisamiller@gmail.com

I Research

II Gown Standards

III Gown Patterns

IV Testing, Materials, and Sourcing

V Packaging Standards

VI Working with Volunteers

VII Production Line

To disseminate gown design options, material needs, sourcing information, standards research and tooling data to groups of makers with moderately-sized machinery to produce a truckload of basic, disposable protective gowns for use by healthcare workers in the face of an acute supply shortage caused by the COVID-19 global pandemic.

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Goal:

Contents:

I RESEARCH

Product

We procured 6 gown samples from Boston area hospitals to study. Mass General, Tufts Medical, Brigham and Women’s, etc. to study materials, uses and design features.

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Survey

We interviewed 20 ER nurses and other health care professionals from over 15 hospitals for hospital buying patterns, donning and doffing procedures, case studies and general user knowledge and terminology.

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Below are links to the resources we found most useful in our early days of research:

FDA.gov: Medical Gowns

FDA.gov: Personal Protective Equipment for Infection Control

FDA.gov: Premarket Notification Requirements Concerning Gowns

FDA.gov: Surgical Mask and Gown Conservation Strategies

CDC.gov: Personal Protective Equipment: Q&A

CDC.gov:Considerations for Selecting Protective Clothing used in Healthcare for Protection

AAMI.org: ANSI/AAMI PB70:2012, Liquid barrier performance of protective apparel and drapes

NIH.gov: A Review of Isolation Gowns in Healthcare: Fabric and Gown Properties

JTATM.com: SURGICAL GOWN REQUIREMENTS CAPTURE: A Design Analysis Case Study

Cardinal Health: Infection Control Apparel

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Materials�ASTM (American Society of Testing and Materials) is a voluntary standards developing organization. The most relevant standard for gown production is ANSI/AAMI PB70, which establishes standardized testing and a system of classification gowns based on their liquid barrier performance. Based on the results of these tests, four levels of barrier performance are assigned to the gowns, Levels 1-4 (1 low; 4 high) for their performance in areas of use life, spray rating, suter hydrostatic rating, durability and water-resistance.

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II GOWNS BASICS

Each of the gown companies has attempted to simplify the hundreds of pages of documentation released by the FDA, AAMI, ASTM, AORN into easy to digest infographics. This one is pretty good. There's a lot of info that would otherwise take me many slides to present.

II GOWNS STANDARDS

AAMI has made their standards free for COVID

Association for the Advancement of Medical Instrumentation® (AAMI)

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1. Cardinal Health Gowns Brochure
2. Halyard Gowns Brochure
3. Kimberly Clark Gowns Brochure

The FDA recommends each medical device should

• state its intended use.
• have consistent labeling on package consistent with sales sheet

1)

2)

3)

Materials�ASTM (American Society of Testing and Materials) is a voluntary standards developing organization. The most relevant standard for gown production is ANSI/AAMI PB70, which establishes standardized testing and a system of classification gowns based on their liquid barrier performance. Based on the results of these tests, four levels of barrier performance are assigned to the gowns, Levels 1-4 (1 low; 4 high) for their performance in areas of use life, spray rating, suter hydrostatic rating, durability and water-resistance.

Standards and Requirements

There are industry standards for gown materials, and individual hospital requirements for gown type, construction, features and sterilization.

PROTOTYPING

On April 3.

-Mass General Hospital

-TuftsMedical Center

-Boston Medical Group ,

-Beth Israel Hospital

Mount Auburn Hospital

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WE WERE SELLING

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LEVEL 1 Isolation/ Doctors/ Protection Gowns

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WE WERE NOT SELLING:

Patient Gowns LEVEL 2

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NOT SELLING:

Surgical Gowns LEVEL 3-4

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We created a sale sheet for hospitals and provided prototypes.

GOWN STYLE OPTIONS _

Brochures from Industry leaders:

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Halyard https://products.halyardhealth.com/infection-prevention/protective-apparel/protective-gowns.html

Cardinal Health: https://www.cardinalhealth.com/en/search.html?q=gowns%20brochure

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There are 3 major sellers of PPE in US.

All brands offer VERY similar options and differences between brands are nominal.

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ELASTIC-

• Often found in in disposable gowns
• Provides less coverage
• hard to source non-latex elastic
• Separate machine needed

HYBRIC ELASTIC AND HOOK-

• Most preferred for disposable gowns
• Good coverage
• Elastic keeps hook in place
• Hard to source elastic
• Seperate machine needed, add one entire step to process

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THUMBHOOK

• Easy to make
• Common for disposable gowns
• Good coverage
• Not nurses favorite
• Rips out if fabric is too thin
• Gloves go on top of hook

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KNIT CUFF

• Found in surgical, both disposable and reusable surgical gowns
• Seperate 2” tube jersey cuff material needed
• Seperate machine needed

TAPE TAB

• Not common
• Not seen
• Fine to do in a pinch

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TIE NECK

• Very common in both disposable and reusable

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OVER THE HEAD

• Very common for both disposable isolation gowns and procedural gowns
• Disposable only

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HOOK AND LOOK

• Not common
• Not seen
• Fine to do in a pinch

OPEN BACK

• Very common
• Disposable only

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TIE NECK

• Very Common in both disposable and reusable,
• Very common Level one and Surgical Level 4
• Requires additional manufacturing steps

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OVER THE HEAD

• Very common for both disposable isolation gowns and procedural gowns

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We choose these options based on ease of manufacturability and # of times these options were found at local hospitals

PROTOTYPING

See Slide 11 for fabrication details

Made from Poly-backed paper painters drop cloth from Home Depot SKU #1003804381

Made from 100% Spunbond Polypropylene Landscape Fabric from Home Depot SKU #1002696711

Notice one of the rotary cutting wheels has TAPE on it. These are the areas we filed flat so we could run along break-away backing to create a PERFORATED LINE!

An 24” impulse sealer bonds this plasticbased landscape material with an electicfied wire in under 7 seconds. Very strong!

The 2nd set of prototypes were inside ULINE bags and sealed on one side with an impulse sealer. All bags rom this point forward were sealed with impulse sealers. 4 seconds each.

Made from a Tyvek Suit. See last slide for Instructables and slide 16 for newly released Tyvek 1222A.

Bag made from plastic painters dropcloth and sealed with impulse sealer.

TOOLING

CNC?

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LASER

CUTTING

OVERALL PLAN ORGANIZATION

Here was the first draft of this doc.

III GOWN PATTERNS

II Gown Patterns

OR

HeLa Gown DISPOSABLE Patterns and Tooling Options https://docs.google.com/drawings/d/1wQigqaUywnTXg62eFRUVNCysCy9JsMeyxY-lpR8TW80

*Blue italics indicates this is the path we are using, we used polypropolene 100% spunbond

OR

IV TESTING, MATERIALS, & SOURCING

An amount of water is dropped at a 45 degree angle at 30cm above target. Blotter paper underneath testing material is weighed before and after drop to determine Impact Penetration result.

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Test material is placed over 3 large drops of water and pressurized from below until water is pushed through material. When 3rd drop comes through, that’s the Hydrostatic head measurement.

While AAMI standards don't dictate what material to use, it must pass performance tests.

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Interesting and Basic Summary of which fabrics to try:

Can you tell by looking at similar thickness, similar looking/feeling fabric if it’s hydrophobic or hydrophilic? No but, boiled down, the question is: When you spray water across it, does it bead? If it soaks in, like nylon does naturally cause it’s like a diaper, it’s a fail and you shouldn’t endanger people's lives by offering protective gear that soaks up liquid. If it beads, even if it lets in a substantial amount of water under pressure, but very little under light squirts, then you quite possibly have a fabric that can offer a basic level of protection from sneezes and coughs. Make few prototypes and get them into hospitals hands.

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35gsm Spunbond, uncoated: FAIL

35gsm Spunbond Poly with even a 1% hydrophobic coating: PASS

35gsm SMS (trilayer) uncoated: often Passes

50gsm Spunbond Poly uncoated: often Passes

50gsm SMS (trilayer) uncoated: often Passes

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Try this:

Find a 100% polypropylene fabric, weigh a square yard, if it beads when you spray water on it, and weighs 1.5 oz/sq/yrd, you are on to something. Anything less is a fail and FYI, fabrics above 90gsm start to get to be too stiff to wear. We have narrowed it down to a sweet spot.

3RD PARTY TESTING SUMMARY_______________________

TESTING____________________________________

Picture Taken by Sarah Miller 4/17/2020 to demonstrate the water penetration of a a level 2 gown from a Cardinal Health Level 2 Isolation gown from Mass General Hospital. Water indeed passes through material, but a spray of water certainly beads.

MATERIAL SPECIFICATIONS____________

It’s a good to track down the Material Safety Data sheet or specifications sheet from the provider of the material you decide to use and then provide a distilled version of the pertinent information to the hospitals or organizations you are working with. Here are examples of the materials we used.

As with normal AAMI requirements on water permeability, tear resistance, flammability, etc, SOME of the information typically used to describe gown material is also found on data sheets like this. This material was approved by hospitals in our area but may or may not be approved where you are.

AAMI are recommendations hospitals use as guidance but are not requirements. That decision rests in the hands of each hospital system.

In our case, landscape fabric has some hydrophobic properties and beads when a light spray is applied but commonly fails Level 1 testing. For this reason, we choose not to use the term Isolation gown.

Full MSDS here:

http://www.alphafoam.co.in/downloads/nonwoven/nonwoven.pdf

SOURCING________________________________

Existing companies with established relationships with vendors will have an easier time gaining access to material than you and will likely be a priority over a customer with no previous buying experience or orders. Consider reaching out to professional sourcers or thinking of *other* industries in your area that have established relationships that can call around for you.

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Your material might be: plastic sheeting, or treated washable fabric. Do research on industrial names.

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COATING REQUIRED TO PASS SIMPLE HOSPITAL SPRAY BOTTLE TEST. .

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ROLLS LESS THAN 60 inches require

Additional seam.

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USE DOLLYS OR FLOOR JACK TO TRANSPORT.

Order as much fabric on a roll as you and one other person can lift together safely.

Our fabric is about 100lbs/roll.

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This has to do with your buying power. The manufacturer with the best prices might commonly be filling order sizes of 100-500K yards so consider contacting other maker spaces and pooling funds or be realistic that you won’t be able to access best prices if you're ordering small batches

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Most of our focus/excitement was based around price per yard. Make sure you are clear to your accounting folks that price per yard does not equal price/gown. For us: 2.0 yards/gown.

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Line up your orders by lead times.

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Most likely, unless you have EXISTING RELATIONSHIPS WITH VENDORS, you won’t be allowed to pay 30 days after you order.

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This price highly affects your bottom line, and should be calculated into your PRICE/GOWN. Our shipping costs were $1000 per $6000 worth of material.

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SOURCING___More Info to come…

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I have a lot to say about sourcing.

Things we tried:

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IN PROGRESS

V PACKAGING STANDARDS

Label information research:

Each package is labeled according to FDA requirements for medical devices. See slide 21-22.

Commercial gowns are packaged 10 per pack, 100 per case. No need to bag each gown individually. Note the variety of names used for different gowns. Each gown clearly states its “intended uses” using icons seen on slide 5. Also , see slide 21-22 for labeling. The term “isolation gown” carries with it a common perception that it has been deemed a LEVEL 1 or LEVEL 2 gown by a 3rd party testing facility. See Testing slide 14-15 for more details. Unless you have had your gowns tested, it is my strong recommendation *not* to label them isolation gowns (except in conversation since that is a common name). We officially call ours NON-STERILE PROTECTIVE GOWN and indicate they are 100% SPUNBOND POLYPROPYLENE, not SMS, which is harder material to come by and by its very nature as a 3-ply poly, much better water resistance, tear ability and water impact index.

LABELING: SUPPORTING DOCUMENTATION FROM FDA

• Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff (March 2020, 11 pages) https://www.fda.gov/media/136540/download

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• Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings: Guidance for Industry and Food and Drug Administration Staff (Dec 2015, 9 pages) https://www.fda.gov/media/92146/download

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• FDA Recalled Cardinal Health Surgical Gowns and Procedure Packs https://www.fda.gov/medical-devices/medical-gowns
• Labeling Regulatory Requirements for Medical Devices (Aug 1989, 52 pages) https://www.fda.gov/media/74034/download

• 4B. Label whether or not intended for medical purpose, incl. health care professionals, or general public

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• State intended use, i.e. “minimal fluid setting”
• Determine intended use through labeling: i.e. basic care, hospital medical unit,

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• 4C. State ‘minimal fluid setting”

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• 4B3. Drawings, schematics of gowns including dimensions and locations of critical and non-critical zones

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• 4C. “The product includes labeling that makes recommendations that would reduce sufficiently the risk of use, ie., in the presence of high intensity heat or flammable gas

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• 4C. If it is not a surgical gown, say that “FDA will not object to distribution of gowns non intended for use as “surgical gowns”

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• Non surgical gowns are exempt from premarket review
• ASTM F2407 describes tear resistance, seam strength, lint generation, evaporative resistance, water vapor transmission

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• 4A. Label as “gown”, not surgical gown include statements of barrier protection, i.e. only for minimal low barrier protections�
• 4C. Label as “gown” not “surgical gown”
• 4D.The label accurately describes products sterility level

• 2. Common names include “surgical gowns, isolation gowns, surgical isolation gowns, cover gowns, comfort gowns, procedural gowns and operating room gowns, not patient gowns

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• 2. Include statements of barrier protection, i.e. only for minimal low barrier

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• 4B2. Performance test data to demonstrate gown is effective barrier AAMI PB70, Both for single-use and reusable gowns

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• 4B4. Sample labeling clearly identifies level of liquid barrier protection ANSI/AAMI PB70

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• Section 201- ALL Labels needs to be comprehensive and consistent, including sales sheets, inside labels, box labels.

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• Section 502 (a)- “Misleading Labeling” is not limited to false, untrue, fraudulent but open to incomplete data, inadequate, ambiguity, and half truths.

• Misbranding is constituted as: labels that fails to contain name and place of manufacture, accurate statement of contents in terms of weight, measure and/or numerical count�-any wording that doesn't bear adequate directions of duration of use�-If device is subject to performance standard and does not bear labeling prescribed in standard

• If there is space on the product and on the packaging, labeling is required

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• If it is not going to a hospital setting, no requirement is enforced by FDA.

SALES PAGE AND LABELING

• SALES ONE-SHEET TO INCLUDE:
• PPE -14 HOSPITAL WAIVER: prevented hospitals and their employees from seeking financial retribution for medical devices such as gowns.
• PRICE
• QUANITY
• SHIPPING INFO
• SIZING
• MATERIAL TYPE (PPE MA TEMP LAW stipulates also material ORIGIN.
• Required to say: NON-STERILE- UNTESTED
• Required to state: INTENDED USES
• Include pricing, visual representations,material type, origin of material, sizing, units per box, address of your business, and details like: NON -SURGICAL, NON STERILE, UNTESTED, and intended uses.

PLEASE SEE SLIDE 20 FOR INFORMATION ABOUT WHAT THE FDA WANTS TO SEE ON ALL DOCUMENTATION:

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• Section 201- ALL Labels needs to be comprehensive and consistent, including sales sheets, inside labels, box labels.

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• Section 502 (a)- “Misleading Labeling” is not limited to false, untrue, fraudulent but open to incomplete data, inadequate, ambiguity, and half truths.

• Misbranding is constituted as: labels that fails to contain name and place of manufacture, accurate statement of contents in terms of weight, measure and/or numerical count�-any wording that doesn't bear adequate directions of duration of use�-If device is subject to performance standard and does not bear labeling prescribed in standard

LABELING

• The entire category of gowns: isolation gowns, surgical gowns, protective gowns, procedure gowns (all different uses and standards) is categorized as a Medical Device. Of all the 150 pages of reading I needed to sift through, one of my biggest takeaways was how important labeling is. NOT labeling is a higher offence than getting it wrong by accident. On the following page, see how each bullet point led to a specific bit of information being included o the label.
• Under Covid-19, ceratin states have realeased umbrella legislation that temporarily protects you from liability.
• Legal DISCLAIMER offer up by OSCMS Group: https://legalbizglobal.com/free-legal-disclaimer-for-covid19-open-source-creators-and-makers/
• This label available here: https://docs.google.com/drawings/d/14m88r0c_f0jSarDmjAIkSzUiMS9q_-zHNLmjZ9x1Xck/edit?usp=sharing

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UNTESTED / UNRATED

(For Single Use Only)

All gowns have been produced to the best of adherence to strict standards set in place by the FDA and CDC, though they have been slightly modified to address specific needs of the COVID-19 response effort.

NON-STERILE PROTECTIVE GOWN

Infection Control- DISPOSABLE

Lightweight Non-Woven Spunbond

Provides comfort and protection in minimal fluid setting

UNIVERSAL

Latex- Free

Non-Surgical

Over-the-head design

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Thumb hooks

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Front/back ties

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Material Composition

Non-woven Spunbond, 100% Polypropylene

Total Weight 50gsm

MD Grab Tensile 31.5lbs/in

MD Grab Elongation 57%

Air Permeability 114/M3/M2/MIN

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Black White Charcoal

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DISCLAIMER, BUYER’S RISK, PLEASE READ

The product noted above has been produced by Artisan’s Asylum using commercially reasonable efforts to source materials and provide finished

product that complies with standards acceptable to the Buyer. The Buyer acknowledges that they have reviewed the product offering from Artisan’s Asylum and that no guarantees are provided to the Buyer for the specific quality, size, consistency, material, availability, delivery or efficacy of the product. The Buyer is purchasing the product at their own risk

Packing Details

Product: Non-Sterile Protective Gown

Quantity/Unit: 10 units/pack

Packs/case: 10 packs/box

Size: Universal

Weight: 13.3lbs

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AAMI PB70 Test Method: Requirement

Level 1 AATCC 42 Water Resistance: Water Impact

Impact Penetration ≤4.5g

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Nursing Food Service Visitors

Contact Precautions Laundry

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Topics for you to decide:

VI WORKING WITH VOLUNTEERS

1. Google Intake Form

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3. SignUpGenius for volunteer time slots.

• Sign Waiver: Read Policies and Procedures for Cleanliness
• Outline of Volunteer Guidelines https://docs.google.com/document/d/1ppomkGr8gsEVnO_vp1l0LbwF_sOo9PLIlC_lZAUXldQ

• Skills needed/not needed

(i.e We found that saying “No sewing!” was helpful)

• Sample schedule

(i.e. See #1, we asked people in a google intake form to tell us which part of day was best)

• Protocol on site

(i.e. See #3 for the info on procedures for entering building)

• Demeanor and speed of work requested

(i.e. I made sure to say “Fast is better than perfect. This is not about your afternoon of zen, this is triage, people!”

• Gratitude and comradery

(i.e. We ordered lunch every day, $60-100/day adds up!!!)

• Sense of ownership and teaching others

SCALE OF MAN-HOURS and BREAKDOWN OF TIME PER PROCESS

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1 person

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3 people,

8 hours a day

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75 people,

8 hrs each

Gowns/Day

Man hours/day

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Number of Processes

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Name of Processes

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See Inventory tracking page. We hit 400 a day and it stayed that way. We had spaces open in on the online sign up sheet for 8 people per shift, 3 shifts a day.

On average, this is what we saw each day in terms of actual turnout:

3-4 volunteers 10am-1,

2-3 volunteers 1-5p and

6-8 Volunteers 6p-9pm.

Breakdown of Average Time for each Process using volunteer labor

INVENTORY TRACKING

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We track:

• Deliveries
• Yardage
• Expected yield

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See bottom of spreadsheet for info on how to calculate cost of gown per width of fabric roll and including delivery charges. But not including start up costs.

• Fabric dimensions
• Yards per gown by fabric
• Projections
• Most importantly: Daily Finished Totals.

See our spreadsheet here:

https://docs.google.com/spreadsheets/d/1vqVJPgUsJnERzUWe2tZUiW271nk7bpPPA0hVdNZVbbk/edit?usp=sharing

FINANCIAL TRACKING

Consider how you will track finances per PPE initiative. This is how we tracked ours.

I don’t own this doc so I can’t share but you could make your own.

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VII PRODUCTION LINE

Good: folding instructions

Better: folding boards

(folding board pattern)

1. Lay Out Fabric

Roll fabric flat. (Works best with at least 2 people team)

2. Cut

One person uses a fabric saw, one helper holds down fabric and template.

3. Fold

Fold gowns so that bottom of sleeves are aligned, then fold in half lengthwise.

This makes it easier for the person working the impulse sealer.

Standardize how you fold gowns.

We use folding boards (pattern) – they make it  easy to teach new volunteers.

We use a custom-made “scoop” to neatly stack gowns for bagging (STL, .skp).

5. Fold

4. Bond

One volunteer runs the impulse sealer, running sleeves through one at a time.

6. Box

10 gowns per bag.

Press to squeeze the air out of the bags to fit more per box. (We use a custom-made press, foot-pedal operated). Seal the bag while the gowns are compressed.

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6

2

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CAPS INSTRUCTIONS

https://docs.google.com/presentation/d/1DL20sDObnsEWI9JD36ayss8n8ZpAzAnhBqAQuYAxiG0/edit?usp=sharing

TYVEK SUIT TO GOWN INSTRUCTIONS

https://docs.google.com/document/d/1db0e-3pBW5MdLnaIFM_h6dus2joLvHGWXU8dRft37VM/edit?usp=sharing

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