How to use ISO 14971 to improve a Risky Business

/in /by
This is under revision… please don’t forward this version. For a current version, please see my iteration on Linkedin.
Early in 2018 I underwent surgery surrounded by medical devices that were made by companies for which I had consulted. As the staff connected to a device that would keep me breathing during surgery, I thought about my experiences helping companies become more innovative while reducing risk to patients. I wrote this article while recovering. To keep it fun I use 1980’s pop-culture to illustrate the most important points.
Background
Reducing medical device risk is a law in the United States and a standard internationally. The regulations define risk as the severity of harm and how likely it is to happen.
Risk = Severity X Probability
This is more than just a definition, it’s a systematic method of reducing risk that provides repeatable, inspectable methods known to reduce harm to patients and create new products. Unfortunately, this method is underutilized or misunderstood, which harms people and adds costs to companies. For example, 44% of medical device recalls could have been prevented by design-controls that included risk-reduction, and up to 250,000 people die each year from accidental deaths in the American healthcare system. But, when used properly, risk management creates safer products, opens new markets, and makes quality control more efficient.
Regulatory requirements
Medical device manufacturing is regulated in United States by 21 CFR 820, and internationally by ISO 13485. Both require risk analysis, but neither describes how to do it, so we use methods from from the International Standards Organization, ISO, which describes Risk Management in ISO 14971:2007. Additionally, selling medical devices in the European Union requires a supplemental standard, EN 2012 : ISO 14971. which requires, among other things, that risk be reduced “As Far As Possible” (AFAP), which is a stronger statement than ISO’s, “As Low As Reasonably Practicable” (ALARP), and implies that cost can not be an obstacle to reducing risk to people, property, or the environment. Including property and the environments in risk is unique to ISO; the Food and Drug Administration limits risk to patients and users.
EN 2012 : ISO 14971 satisfies risk requirements for all countries, and using it allows a abbreviated regulatory process in the United States. A FDA 510(k) submission can refer to EN 2012 rather than explain internal processes that may be questioned by the FDA.
Medical device companies must pass country-specific audits before they can sell products in that country. An exception is the Medical Device Single Audit Program, MDSAP, which is currently accepted by five countries, including the United States. The image below, from Australia’s MDSAP policy, illustrates that risk management should be fundamental to all areas of a company’s quality-control system, especially purchasing from suppliers, and that risk management begins with a company’s management team.
Hazardous situations
A key aspect of ISO 14971 is identifying potential hazardous situations that could lead to harm. Hazardous situations are often unforeseen, especially by a small group of people who are likely biased by their experiences, therefore identifying hazardous situations requires diverse team input and constant re-evaluation. A classic example is the 1986 Space Shuttle Challenger explosion, which stemmed from a small O-ring allowing gas to leak in a rare, but catastrophic series of events that led to a hazardous situation of a postponed launch, a cold launch day, and fuel leaking around the O-ring that was not rated to such a cold temperature. Some people knew of the risk, but, in 1986, systems weren’t in place to ensure risk was analyzed for all hazardous situations.

Risk analysis methods
After identifying potential hazardous situations and harms, risk analysis is conducted to quantify the severity and probability of each harm. Risk analysis must be documented in a systematic way so that your work can continue with a product’s life-cycle, and that assumptions can continuously be monitored and updated. The two most common methods for medical devices risk analysis are:
Failure Modes and Effects Analysis (FMEA)

, which can include a dFMEA for design, a pFMEA for manufacturing processes, a system-level FMEA, a supplier FMEA, etc.

Fault Tree Analysis (FTA)
Other risk-analysis methods are less common to medical devices, but all should lead to similar results. Most use a table, or matrix, to illustrate Risk = Severity X Probability for different scenarios.

Probability is initially assumed based on similar products or scientific literature, and should be continuously updated with data from real-world use. For the matrix example shown, “catastrophic” and “high” risks would be unacceptable, and “moderate” risks would need to be reduced As Low as Reasonably Practicable or As Far As Possible. In the case of the space shuttle, an unlikely probability of a sequence of events leading to a hazardous situation would be balanced by the severity of failure.
To apply a risk analysis matrix for medical devices, each harm must be unambiguous. Harm is defined by ISO 14971, section 2.1, as “physical injury or damage to the health of people, or damage to property or the environment,” and must be unambiguous so that a “severity” number can be applied, monitored, and continuously re-evaluated.
Companies are required to maintain their risk analysis in a risk management file so that auditing organizations can see evidence of continuous improvement by constantly re-evaluating risk, which includes re-evaluating potential hazardous situations and harm that could result from those situations.
Risk Control
Both ISO 14971 and the EN 2012 supplement describe systematic methods of risk management. For example, they standardize how risk is solved by providing three priorities:
Improve the design to be risk-tolerantAdd safeguards to reduce exposure to riskLabels or instructions to educate or warn of risk
Most of us don’t read or follow instructions, so ISO doesn’t consider written warnings to be effective risk control. This partially explains the European Union’s supplement that cost can not be an obstacle to reducing risk, i.e. companies can not apply a warning label to justify not improving their product’s design. This concept is summarized by an image used for training companies, provided by Oriel STAT-A-MATRIX, a training and consulting organization:

Other forms of risk control can be included in manufacturing processes, inspections before shipping products, etc., but it’s important to emphasize that ISO standards clearly state that prioritization should be placed on design and safeguards, whichever is the current “state of the art.” State of the art means that if a solution is known, it should be implemented; if not, extensive justification should be documented for audits. And, per the European Union definition of reducing risk “As Far As Possible,” cost can not be justification for not implementing state of the art risk control.
Post-market surveillance
Risk analysis uses assumptions that must be constantly re-evaluated using real-world data. Your company’s post-market surveillance processes must be linked to your risk-management processes, ensuring real-world data is used to adjust assumptions in a closed-loop system of continuous improvement.
Definitions
The following definitions can help you search risk management regulations:
HARM – injury to people or property
HAZARD – something that can cause harm
HAZARDOUS SITUATION – a situation in which a hazard could cause harm
HAZARD ANALYSIS – a process for identifying hazards and hazardous situations
RISK – the severity of harm and the likelihood it will happen
RISK ANALYSIS – a process for estimating risks from hazard analysis
RISK CONTROL – actions taken to reduce risk for a product
RISK MANAGEMENT – a company’s official, systematic process for reducing risk
RISK MANAGEMENT PLAN – a plan before risk activities, required by law and standards
RISK MANAGEMENT FILE – a document tracing the location of all risk documents
RISK MANAGEMENT REPORT – a report summarizing all risk management activities for a product, and how it will be continuously improved.
Safer Products
Needle sticks:

Hospital caregivers were often exposed to used needles, increasing their risk of a skin puncture and exposure to diseases such as HIV and Hepatitis C. The first company to innovate a way to reduce this risk quickly dominated the market, and other companies scrambled to create their own designs. Now, patients all over the world benefit from multiple forms of risk reduction, ranging from different needle designs to user-friendly disposal containers.

New Markets
Automatic Electronic Defibrillators (AED’s):

In the past, a patient with a heart attack had to wait for trained paramedics to arrive with a cardiac defibrillator. Paramedics were trained to ensure a patient had a heart attack, as opposed to an illness with similar effects, because using a defibrillator on someone without a heart attack could harm them. Companies innovated defibrillators that reduced this risk by detecting a patient’s condition before allowing defibrillation, which allowed public defibrillators all over the world. This expanded market size, and improved public safety.
Improved Quality Control
Manufacturing processes:

The Sulzer orthopedic company recalled one of their hip implants because a manufacturing change introduced risks into their product. Their quality system did not have modern risk management methods, resulting in thousands of patients with failed hips, secondary surgeries, and permanent damage to their livelihood. A billion dollars went towards lawsuits, putting the world’s 4th largest implant manufacturer out of business. Modern risk management methods ensure that changes are reviewed by a risk management team, reducing errors before they become harmful and costly problems.
Resources
CONSULTING & TRAINING
AUDITING ORGANIZATIONS
Summary
Risk = Severity X Probability

Risk management is required by:

FDA ISO
Risk management standards are:ISO

Common risk-analysis methods are: requires a company’s quality system to be a risk-driven process.

Risky Business
I’m having fun with 80’s pop culture while sharing my belief in ; there’s no new information here.

was a 1983 film that springboarded into fame after he danced in his underwear, just like how my career began. (Just kidding.) In the film, a teenage Tom took risks, resulting in harm to his father’s Porsche sports car and their home. Like most movies in the 80’s, their problems were quickly solved with money and quirky but reliable friends.
Healthcare is Risky Business. In the real-world of medical devices, risk affects people’s lives and well-being, and can rarely be fixed with money. If you if they would rather have insurance money or be able to walk normally the rest of their lives, they would have prefered a less-risky hip replacement. Any heart-attack patient saved by a public defibrillator would be grateful for risk-reduction, and hospital workers all over the world are safer each day thanks to reduced risk of needle-sticks.
Our work can be more fulfilling knowing it makes the world a safer, healthier place. We can do our work more effectively by understanding Risk Management regulations that focus on patient safety.
Take a break from saving lives to watch Tom Cruise dance in his underwear, a risk that paid off.

How to pass a quality-system audit using Brown M&M’s

/in /by
6 minute read.
In the 1980’s, the rock-band Van Halen caused $85,000 damage to their dressing room because they found brown M&M’s in their bowl of “munchies.”
Van Halen’s story can help medical-device companies pass an FDA or ISO Quality-System audit. This article shows you how, but the conclusion may not be what you think.
The 80’s

Van Halen, circa 1985
In the 1980’s, Van Halen was one of the most successful bands in history. According to Wikipedia,
[Van Halen’s] lead single, “Jump”, became an international hit and their only single to reach number one on the Billboard Hot 100. The following singles, “Panama” and “I’ll Wait”, both hit number 13 on the U.S. charts. The album went on to sell over 12 million copies in the U.S. alone.
Van Halen toured nationally; concert venues prepared weeks in advance. Their contract required providing “munchies,” including a bowl of M&M’s with the brown ones removed. In 1982, the band destroyed their dressing room after finding brown M&M’s.

35 years later, I use lessons from Van Halen, and brown M&M’s, to help medical-device companies comply with FDA and ISO requirements.
Jump In
Why would Van Halen’s contract require having brown M&M’s removed? That answer will help explain how to pass quality-system audits. My answer is after this video of “Jump. Feel free to sing along while you think about possible reasons one of the world’s most successful bands would add a clause in their contract about brown M&M’s.

“Jump!” by Van Halen, 1984

The answer is that Van Halen used brown M&M’s to guage attention to detail in their contracts. They toured globally, performing several times a week, and were one of the first rock bands using 3rd-party contractors to prepare concert venues according to their specifications. Stages had to withstand the weight of their show, and electrical circuits had to handle requirements for amplifiers, stage effects, and VERY LOUD SPEAKERS. Van Halen used the contract clause about brown M&M’s to quickly guage if complex safety requirements would be met.

Van Halen stage show in the 80’s
Here’s what the lead singer of Van Halen, David Lee Roth, said about brown M&M’s:
Van Halen was the first band to take huge productions into tertiary, third-level markets. We’d pull up with nine eighteen-wheeler trucks, full of gear, where the standard was three trucks, max. And there were many, many technical errors — whether it was the girders couldn’t support the weight, or the flooring would sink in, or the doors weren’t big enough to move the gear through.
The contract rider read like a version of the Chinese Yellow Pages because there was so much equipment, and so many human beings to make it function. So just as a little test, in the technical aspect of the rider, it would say “Article 148: There will be fifteen amperage voltage sockets at twenty-foot spaces, evenly, providing nineteen amperes …” This kind of thing. And article number 126, in the middle of nowhere, was: “There will be no brown M&M’s in the backstage area, upon pain of forfeiture of the show, with full compensation.”
So, when I would walk backstage, if I saw a brown M&M in that bowl … well, line-check the entire production. Guaranteed you’re going to arrive at a technical error. They didn’t read the contract. Guaranteed you’d run into a problem. Sometimes it would threaten to just destroy the whole show. Something like, literally, life-threatening.
You can read an NPR article about David Lee Roth’s views on brown M&M’s, or listen to Dave explain it himself in

Phrasing
Look at Van Halen’s phrasing in their contract:

They clearly indicated NO BROWN ONES, and asked for twelve (12) Reeses’s peanut butter cups. The other phrasing, such as “assorted” dips, or the open-ended “nuts,” allows freedom for these choices. This is similar how ISO defines their phrasing in ISO 13485:2016 section 0.2:
“shall” indicates a requirement”should” indicates a suggestion”may” indicates a permission”can” indicates a possibility or capability
You can use these phrases to prioritize improvements to your Quality System, or to be more efficient when evaluating your suppliers.
FDA audits
I’ll paraphrase David Lee Roth, imagining him as your guide to the FDA:

Medical Device regulations are to protect public safety. Some requirements seem simple. Other requirements are more complex, and have direct impact on patients.
So, if I walk into an audit and I see simple requirements aren’t met… well, line-check their entire process. They didn’t understand the requirements. Guaranteed you’d run into a problem. Sometimes it would threaten to just destroy the entire process. Something like, literally, life-threatening.
Brown M&M’s for FDA and ISO
The FDA maintains a database of FDA warning letters they sent to companies, which are often commonly found among thousands of companies and can be used as Brown M&M’s. Here are examples of some of the most common warning letters:

Expired calibration of manufacturing equipment
Companies must keep calibration records of equipment used to manufacture medical devices. This is clearly stated in FDA 21 CFR 820.72 and ISO 13485:2016 clause 7.6, so an expired calibration probably means that more complex requirements weren’t followed.

Products or parts of products on employees’ desks without a label identifying the parts as “not for human use”
Companies must identify and control products that are non-conforming so that they are not accidentally delivered to patients. This is clearly stated in FDA 21 CFR 820.90 and ISO 13485:2016 clause 8.3.2, so uncontrolled products probably mean that more complex requirements weren’t followed.

A Design History File with any of the following:
* Design-changes without test data or rationale
* Design-reviews without an independent reviewer
* Long time-periods without updates
FDA 21 CFR 820.30 (j)requires companies to maintain a Design History File for each product, ensuring that decisions follow a plan, changes to plans are team-decisions based on data, and that design reviews have an independent person to reduce bias. Failing any one of these, or going for long time-periods without updates, are all brown M&Ms.
How to Pass any Audit

Brown M&M’s are not the problem, they are a symptom. Use the concept of Brown M&M’s to evaluate the effectiveness of your quality system, then make gradual improvements to your quality system, training, and culture before audits are scheduled. Use these steps:

Make improving your quality system a core responsibility of senior management. Ensure your company’s Quality System complies with FDA Quality Requirements and ISO 13485 Standards.
Continuously improve your quality system by making it a closed-loop process.

Create a culture where everyone understands their role in patient safety; be authentic, transparent, and positive.Perform internal audits, use independent auditors, or hire consultants.Use the concept of brown M&M’s to help you audit your suppliers and subcontractors. If you find Brown M&M’s for a critical supplier, that’s an indication that they may not follow more complex processes, therefore are a risk to your supply-chain and, ultimately, to your customers.

Resources
OFFICIAL DOCUMENTS
The FDA Quality System Requirements (QSR) for medical devices, 21 CFR 820
The International Standards Organization (ISO) quality system standard, ISO 13485:2016

MDSAP audit model

CONSULTING OR TRAINING
AUDITING ORGANIZATIONS
BLOGS WITH 1980’s THEMES
Summary

Brown M&M’s are quick ways to gage compliance with other, more complex requirements

Common Brown M&M’s in FDA warning letters include:
expired calibration on manufacturing or test equipmentmedical device parts outside of a manufacturing area that are not labeled “not for human use”missing signatures or dates in a Design History File
Brown M&M’s can help you quickly gage supplier quality control, which is critical to ISO 13485:2016 and MDSAP.
When using ISO 13485to gage your Quality System or audit a supplier, prioritize requirements with the word “shall,” followed by “should,” “may,” and “can.”
Please Share
If you feel people in the medical device industry would enjoy this article, or benefit from it, please share it.
Parting Thoughts
The 1980’s were fun, and I’m definitely a “child of the 80’s,” as my high-school homecoming photo shows:

Hopefully, I make wiser choices today than I did in the 80’s, especially with haircuts. I help companies make wise choices to become more effective, and I use blogs like this to illustrate concepts in FDA and ISO requirements.

Take this quiz to see if you’re ready for MDSAP

/in /by
3 minute read, or a 12 minute quiz, if you’re ready.
By January 2019, the Canadian government will require all companies selling medical devices in Canada to be certified under the Medical Device Single Audit Program (MDSAP). There are only a few circumstances in which this deadline can be extended.
If you’re familiar with MDSAP, this article quizzes your knowledge of key concepts. If it’s new to you, read how to prepare for MDSAP.
Background
MDSAP allows medical device companies to sell products in multiple countries with one audit. To help you prepare, I created a guide to MDSAP and this quiz.
If you can answer all questions in this quiz, you should be able to discuss three questions with anyone, at any level, in your company:
Is MDSAP right for your company?If so, are you ready for a MDSAP audit?If you’re not ready, what steps can you take to prepare?
QUIZ
MDSAP overview
How many countries are participating in MDSAP? List them.Is MDSAP mandatory for all participating countries?Does MDSAP add regulatory requirements beyond existing ISO 13485 and country-specific requirements?If your company doesn’t plan to sell products in one of the MDSAP countries, do you still have to comply with that country’s unique requirements to pass a MDSAP audit?
Canada
When will Canada require MDSAP for most companies?

Under what conditions will Canada accept alternative MDSAP routes or deadlines?

Which classes of medical devices apply to Canada’s MDSAP requirements? Check all that apply:

Class IClass IIClass IIIClass IV
Auditing Organizations and audit reports
What is an “Auditing Organization (AO)?”List two, fully-recognized AO’sIf an AO finds a score of 5, how long do they have to report that score to regulatory authorities?If your company receives a MDSAP score of 5, how long do you have to submit a corrective-action plan?How many tasks with scores of 4 result in the same action as one score of 5?If your company has no scores of 4 or 5, how long does an AO have to submit a report to participating countries?
Audit model
How many quality-system “processes” are identified by MDSAP? List them.

What is task 7 for the process “Production & Service Controls?”

Which ISO 113485 clause(s) are used for task 7?If your company sells a product in Japan, list additional requirements for task 7, if any.

The image below is used by some regulatory agencies to summarize MDSAP processes and links. In your own words, explain the concepts this image is trying to convey.

Image thanks to Australia’s TGA
MDSAP grading
Use the MDSAP two-step grading system to answer the following questions.

Scoring matrix via Australia’s TGA
An AO discovers that a company has a procedure addressing ISO 13585:2016, clause 5.5, but did not follow it. This was the first finding, and it did not result in shipping a nonconforming product.

What is the Step 1 grade?What is the Step 2 grade?What is the final grade?Would the AO report this grade to regulatory agencies within five days, or simply include it in their final audit report?
Repeat question #1, but as a second audit, with the previous finding documented and uncorrected.

What is the Step 1 grade?What is the Step 2 grade?What is the final grade?Would an AO report this grade to regulatory agencies or simply include it in their final audit report?

Repeat questions #1 and #2, replacing clause 5.5 with clause 7.3.Repeat question #3, this time as if a nonconforming product had shipped.

Are you ready?
Would MDSAP be useful for your company? Why or why not? (Hint: use the “readiness” questions in how to prepare for MDSAP)

Do you believe your company is ready to pass a MDSAP audit?If your company isn’t ready, what are two things you could do to start getting ready?List three consultants or consulting companies that provide MDSAP training or consulting.

Conclusion
MDSAP is straight-forward and transparent. To paraphrase The Buddha, there are no secrets “hidden in the closed fist of the teacher.” If you weren’t sure about portions of the quiz, see these key resources, which include links to consultants and trainers to help larger groups gain understanding of medical device quality systems and regulations.
Resources
OFFICIAL DOCUMENTS
Canada’s MDSAP updatesSearch “MDSAP” in the
CONSULTING OR TRAINING
AUDITING ORGANIZATIONS (AO’s)
Good Luck!
Please share this blog if you think other people could benefit from it.

Medical Device Design Controls

/in /by
5 minute read.
This article provides an overview of FDA design controls and lists resources to help understand and apply them.
BACKGROUND
Researchers in the 1980’s discovered that 44% of medical device recalls in the United States could have been prevented through design controls.
Almost half of medical device recalls were preventable before a product was manufactured.
The risk to patients and cost to American medical device companies was addressed by the United States Food and Drug Administration. The FDA worked with industry experts to understand best-practices for effective and efficient design, adding Design Controls to recommended guidelines. In 1997, these guidelines became the FDA Quality System Regulation (QSR), a law under theCode of Federal Regulations, Title 21, part 820 (21 CFR 820).
OVERVIEW
FDA laws apply to any manufacturer of medical devices or pharmaceuticals selling products in the United States. Design Controls are one subsystem of a required Quality System.

Design Controls are not required when researching new ideas. Design Controls begin, and must be documented, when a company commits to developing a product. The distinction between research and development should be defined in each company’s Quality System.
Design Controls have ten components listed in 21 CFR 820.30, paraphrased below:
General Requirements 21CFR820.30 (a)

Use design controls. It’s required for all manufacturers of class Class II and Class III medical devices and a few Class I devices.
Design & Development Planning 21CFR820.30 (b)

Create and follow a development plan.List who’s responsible for all aspects of development and how teams interface.Update plans when necessary using a team-driven process.
Design Input 21CFR820.30 (c)

Inputs are what needs to be accomplished by a design, including regulatory requirements and business needs.
Inputs are not “designs,” inputs are what should be accomplished by a design to ensure user needs are met.
Inputs are agreed upon, in writing, by people listed in your plan.
Design Output 21CFR820.30 (d)

Outputs are design features that satisfy inputs.

Outputs are typically in the form of drawings, software, procedures, labels, and inspection criteria of features critical to satisfying Inputs.Outputs are reviewed and agree upon, in writing, by people listed in your plan.

Design Review 21CFR820.30 (e)

Reviews ensure plans are followed and updated using a team-driven process.Reviews shall have at least one person attending who does not have responsibility for the stage of your plan being reviewed.Reviews are approved, in writing, by people listed in your plan.
Design Verification 21CFR820.30 (f)

Verification compares outputs to Input requirements.

Verification must be measurable.For example, for an Input of “weighs less than 2.0 kilograms” the output could be verified by measuring weight on a scale.

Verification is reviewed and approved, in writing, by people listed in your plan.

Design Validation 21CFR820.30 (g)

Validation ensures Inputs are met for output that can not be measured.For example, measuring a mass-produced chemical wouldn’t be practical, output can tested using samples and validating consistency through statistics
Validation also ensures user needs are met from the user’s perspective.For example, if an Input is that a package “must be opened within 30 seconds” the final design couldn’t be measured directly, it must rely on real-world people in a controlled test.

Validation must use production-units in actual or simulated conditions.Validation is reviewed and approved, in writing, by people listed in your plan.

Design Transfer 21CFR820.30 (h)

Ensure that you can transfer a design to manufacturing without losing control of outputs that were verified and validatedTransfer is reviewed and agreed upon, in writing, by people listed in your plan.
Design Changes 21CFR820.30 (i)

Changes to inputs, outputs, and verification or validation methods must be controlled ensure there aren’t unforeseen consequences, including for other products that may share design componentsChanges are reviewed and agreed upon, in writing, by people listed in your plan.
Design History File 21CFR820.30 (j)A Design History File (DHF) is evidence that a product was developed according to a Plan, including references to the locations of all plans, inputs, outputs, verification, validation, and transfer procedures.
I emphasize that a DHF is also a history of “why” changes are made so that future teams learn from current teams. This has been critical in addressing device recalls and designing improvements.
Design Controls assume that teams document risk-assessments throughout development to minimize risk in designs and manufacturing processes.
Historically, a waterfall-diagram has been used to illustrate Design Controls.

Most companies don’t follow a waterfall-method for development. Design activities occur simultaneously, often across different teams that may reside in multiple states or countries. Modern companies also strive for concurrent-design between teams, such as development and manufacturing.
Design Controls may be simplified to documenting a process of creating and following a plan, focusing user needs and regulatory requirements to create inputs, facilitating communication between teams using change procedures & reviews, ensuring outputs satisfy Inputs through verification and validation prior to transfer, and documenting your process in a Design History File that includes assessments of risks and mitigations in both design and manufacturing.
Design Controls extend into manufacturing and throughout the life of a product. Feedback from manufacturing and post-market surveillance becomes input for design changes.
RESOURCES & NEXT STEPS
The FDA is a transparent organization. To paraphrase The Buddha, there isn’t a secret “hidden in the closed fist of the teacher.” The FDA tells you exactly what they require and tries to help you accomplish it. The resources below are focused on medical devices and Design Controls.
FDA OFFICIAL INFORMATION
FDA Quality System (QS) Regulation / Medical Device Good Manufacturing Practices21 CFR 820, printed version21 CFR 820, electronic version (e-CFR)FDA “Device Advice”

FDA Division of Industry & Consumer Education (DICE)

Includes phone numbers for conversations with real peopleGo ahead, roll the “dice” (I couldn’t resist)
FREE TRAINING
FDA Design Control Guidance for Medical Device ManufacturersFDA guidance on Design Controls (.pdf version)FDA presentation on Design Controls

FDA online training and continuing educationalmost overwhelming with the amount of information ranging from foods to drugs to devices – search for keywords
TRAINING & CONSULTING COMPANIES
SUMMARY
Design controls are laws to protect patient safety and facilitate efficient companies.Design Controls are a part of the FDA Quality System Regulations.Design Controls can be summarized as: Focus on solving user needs, follow a plan, ensure communication via design reviews, verify and validate that designs meet user needs, oversee successful transfer to manufacturing, and document all designs and changes in a Design History File.
FDA design controls are one part of selling medical devices in the United States. To sell in other countries requires additional requirements, including a comprehensive quality control system that meets FDA Quality System Regulations and the International Standards Organization standards in ISO 13485, plus each country’s specific requirements including the new

.

Good luck!

MDSAP: The Medical Device Single Audit Program

/in /by
6 minute read.
The Medical Device Single Audit Program (MDSAP) allows medical device companies to sell products in multiple countries with one audit. This article summarizes the MDSAP and helps your company prepare for it.
If you’re confident in your knowledge of MDSAP, consider taking a quiz to see if you’re prepared for MDSAP.
After you understand MDSAP, if you’d like to have fun learning how to improve your Quality System, consider reading “Van Halen, brown M&M’s, & the quality system audits”
BACKGROUND
Medical devices are regulated by governments in order to protect patient safety. For example, when the United States discovered that 44% of medical device recalls could be attributed to design flaws, the FDA began enforcing design controls.
Companies must comply with the regulatory requirements of each country in which they sell medical devices. Participating countries will accept MDSAP in lieu of individual audits. These countries, and their regulatory agencies, are:
MDSAP is a standardized way of auditing, ensuring repeatable audits regardless of the auditor. It doesn’t add any new regulations; it standardizes the audit process to emphasize risk-driven processes, which was already required by ISO 13485.
Currently, MDSAP is voluntary. Beginning in January 2019, Canada will require MDSAP. There are only a few circumstances in which this deadline can be extended.
Before continuing, it’s important to emphasize that MDSAP was driven by industry input, and is considered both practical and beneficial by the International Medical Device Regulators Forum, which archives the respected work of the Global Harmonization Task Force.
Most participants believe that MDSAP audits represent an improvement over previous audits. More importantly, MDSAP can increase patient safety while improving company efficiency.
Does MDSAP add requirements to existing quality systems? Why or why not?
MDSAP VS. PREVIOUS AUDITS
Previously, each country required an audit.
MDSAP allows one audit to be used for all participating countries. A company only needs to comply with countries in which they intend to sell products.
Previously, auditors were encouraged to review a company’s quality system as process but were allowed to audit components independently.
MDSAP audits are conducted as a “process,” ensuring each part of a quality system links to other parts for a seamless flow of information. This must be a close-loop process; the outputs of each process become the inputs of another process, with information cycling through a review by senior management to ensure continuous improvement of the entire system.
The most common links are Risk Management and Purchasing procedures; all decisions must be based on reducing Risk to a patient, and documented to provide evidence for auditors and metrics for management review.
Image thanks to Australia’s TGA
Previously, noncompliances were graded as “minor” or “major.”
MDSAP noncompliances are graded from 1 to 5 based on the potential impact to a patient, frequency of occurrences, and whether or not products were shipped with the noncompliance.
What is a “closed-loop process,” and how does it apply to a quality system for continuous improvement?
How do you make, and document, risk-driven decisions about suppliers?
Consider checking your understanding in these fun, but informative, articles:
PROCEDURE
MDSAP auditors grade companies using a list of approximately 92 “tasks,” provided in seven chapters of the MDSAP audit model. The tasks capture all clauses of ISO 13485:2016, plus country-specific requirements.
Audits are conducted through Auditing Organizations (AO) that are approved by Regulatory Authorities (RA) of participating countries. I list some AO’s at the end of this article.
An AO will conduct an initial audit, perform surveillance audits, then re-certify a company every three years. An initial audit begins with a review of documents before an on-site visit; subsequent audits are document reviews unless there’s a reason to conduct a special audit.
What are MDSAP “tasks?”
GRADING
Noncompliance for each MDSAP task is graded from 1 to 5, with 5 being the most adverse. Grading has two steps.
STEP 1: start with a score based on two factors:
Potential impact to a patient, either indirect or direct, which corresponds with clauses in ISO 13485
Clauses 4.1 through 6.3 are indirect, = 1 point
Clauses 6.4 through 8.5.3 are direct, = 3 points
Frequency of occurrence, increasing a score +1 if the noncompliance was reported in any two previous MDSAP audits. (A “repeat” is defined between different audits, not within the same audit.)

Scoring matrix via Australia’s TGA
STEP 2: apply an escalation score, if applicable.
+1 if a process isn’t documented (vs. being inaccurate or incomplete)+1 if the company shipped a non-conforming product
The final MDSAP score for each task is the combination of Step 1 and Step 2 scores, but with a maximum score of “5.” Audit results will include the following information:
Step 1 scoreFinal scoreThe ISO clause, or country-specific addition, out of complianceExamples of company documents out of compliance
Audit reporting formats, plus a standard grading system, allow regulatory agencies to know exactly what happened during the audit. This also allows companies a clear, unambiguous path to correct non-compliances.
Auditing Organizations report a score of “5” or three scores of “4” to Regulatory Authorities within five business days. Otherwise, AO’s have 90 days to submit their report to all participating countries.
Look at Step 1 scoring. If you were preparing for an audit, which ISO 13485 clauses would you focus on, initially, if you did not have a lot of time? In other words, which clauses are “bang for your buck?”
STEPS TO PREPARE
Determine if MDSAP matches your company’s business needs

Do you sell, or plan to sell, in participating countries?Canada will require MDSAP in January 2019; how does this affect your business?Does your company still use ISO 13485:2003? If so, this may be a good time to transition to the 2016 version and incorporate MDSAP.
Determine your MDSAP readiness

Understand MDSAP audit “tasks” and “grading.”

Follow the MDSAP audit modeltasks; begin by looking for obvious grades of “5” or “4” by focusing on ISO 13485:2016 clauses 6.4 – 8.5.3, which have “direct” impact and higher grade penalties.

Complete an assessment of all tasks, ensuring your procedures for risk management and purchasing are linked between parts of your quality system.

Consider if consultants could help you train your company or assist preparing for MDSAPSchedule an audit with an Auditing Organization soon; there are only a few AO’s, so their schedules may be busy.

MORE TO MDSAP
An overview of the MDSAP won’t answer every question. Examples include how companies respond to noncompliances, how internal audits are utilized, etc.
But there are no surprises with the MDSAP. To paraphrase The Buddha, there are no secrets “hidden in the closed fist of a regulatory agency.” All documents used by Auditing Organizations are available, for free, online.
If you have the MDSAP audit model, are you fully prepared for what an auditor will ask? Why or why not?
RESOURCES
OFFICIAL DOCUMENTS
CONSULTING OR TRAINING
AUDITING ORGANIZATIONS (AO’s)
SUMMARY
Five countries are participating: USA, Japan, Australia, Brazil, CanadaCanada will require MDSAP by January 2019

Uses existing requirements. Differences from previous audits include:

One audit recognized by participating countries rather than individual auditsRequires links between parts of a quality system, emphasizing risk and purchasing procedures, rather than focusing on specific partsNoncompliances are graded 1-5 rather than “major” or “minor”
Test your understanding by taking this MDSAP quiz.
Please Forward
If you think others would benefit, please “like” or forward this article.

Backpacking in Buddha’s Birthplace

/in /by
5 minute read.
The Buddha was born in Lumbini, Nepal, 2,600 years ago. Today, Buddhism is the world’s 4th largest religion. I traveled to Lumbini to see what the Buddha’s life would have been like when he was known as Prince Siddhartha Gautama.
Lumbini
I arrived in Lumbini by bus after hiking over the Himalaya Mountains and completing a walking safari in the jungle. I had lost 15 pounds, and was enjoying as much street food as possible. My favorite samosas from Nepal and India came from a street-side restaurant in Lumbini. It was operated by a friendly family that taught me their recipes, which included loving what you do.

Their restaurant had rustic infrastructure, like most of Nepal. They used a hand-pump for water, which is where they washed dishes throughout the day.
For breakfast, I’d have coffee with milk, made by hand with an ancient espresso machine, and two samosas stuffed with curried vegetables, for 30 Rupees (30 cents U.S.).
I’d take a bag of samosas to share as I walked to a park dedicated to the birth of the Buddha. It’s almost two miles across, with hiking trails and dozens of monasteries, built by Asian countries to support their citizens in pilgrimages to Lumbini. Meditation centers are available for drop-in sessions or 10-day retreats, all for free.

The Buddha was born as Prince Siddhartha Gautama. His birthsite is enclosed in a modern building to protect the 3,000+ year old temple and rock carvings inside. His mother bathed in the nearby pond, and in the background you can see a Pillar of Asoka from 283 B.C. Asoka was an Indian emperor who embraced Buddha’s teachings of nonviolence, placing stone edicts at sites of the Buddha’s life and throughout his kingdom.
The park is centered around a man-made river and reflecting pond. On one side was an eternal-flame, dedicated by dozens of countries as a symbol of peace and unity. On the other end was a peace-pagoda built by Japan for the benefit of all.

Most Asian countries have built monasteries or pilgrim rest-houses throughout the park, which is a fun way to see different styles of architecture side-by-side. China and Japan have simple structures, Thailand and Korea have elaborate temples.

I walked around the park each day, enjoying the simple signs along the path, which is a metaphor for what the Buddha taught.

I spoke with many monks, most of whom were pilgrims to the site from other countries. It’s rare to see a caucasian tourist (that’s a euphemism for “white guy”) so I stood out. They were anxious to learn from me, share their knowledge, and take “selfies” with me. But, I told them, the Buddha taught there’s “no self-ie,” so we took photos of each other.

Monks are funny. By that I mean they have good humor. Generally speaking, monks are joyful, without ego or “self.” That helped me make friends, because it would take a joyful monk to laugh at my puns:

Siddhartha

I hired a motorcycle driver to explore the surrounding area, including lesser-known archeology sites. I was interested in how Siddhartha lived before he became known as the Buddha. The walled city and his childhood palace were 30 miles away, almost unvisited today. Another site marks where, at age 37, he returned to his family as the Buddha. The ruins included Hindu symbology; Buddha was born Hindu, similar to how Jesus was born Jewish.
If you think the rock figure looks familiar, you’re probably right. The Hindu god Shiva is represented by one of the world’s oldest symbols, a phallus. It’s inside of the feminine equivalent, meant to show unity.
Over time, the meaning behind symbols was lost. Religious doctrine focused on a caste-system based on hope for happiness in a future life rather than the unity of all humans in the present. The Buddha renounced the caste system, leaving his palace to understand how to use intellect to obtain peace on earth rather than hoping for happiness in an afterlife. He walked out of his kingdom’s eastern gate, which is still there, marked by the foundations of his city and prayer-flags from Buddhist pilgrims. It was unsurprisingly unremarkable.

Surrounding villages
I imagine that life in the villages around these historic sites hasn’t changed much. There were no cars, commerce and social life centered around markets, women dug through mud to find fish and crustaceans for protein, and families maintained the same line of work for generations.

Life in poverty
People were smiling, kind, and generous with what little they had. For example, the family that made samosas had been feeding a homeless youth who had nowhere to go because Nepal doesn’t have social services. The kid was always smiling, happily wandering in the dirt street with an old soda bottle he used for drinking water and as a toy. He was approximately 11 years old. No one knew for sure, and no one knew his name, because he couldn’t speak. He was mentally delayed at the level of a 4 year old, and probably had been abandoned by his family when they realized he wouldn’t contribute to household income. Nepal is poor; if a child can’t work, the entire family goes hungry supporting him.
People shared what they could with the boy, but did not show affection. This was mostly for his benefit: if they can’t sustain affection, it’s false-hope and cruel to inflict on the kid. This was also for their benefit: by not becoming attached, they minimize their guilt of not doing more.
Over the next week, the kid would rush to me for a hug and we’d go walking to buy fresh fruit. He was dirty from sleeping in the street, but well-fed by the family restaurants. Eating fried samosas every day is unhealthy, so I bought fresh fruit for us, hoping he’d learn to enjoy it. Fresh fruit is more expensive than samosas, so I gave the restaurant money to add fruit to the kid’s diet after I was left.
I had avoided saying goodbye before leaving, but the kid saw me and came running down the street. My bus drove off before he reached us, and I could see him standing in the dirt road, waving his soda-bottle. I had only known him for a week, but I cried during the twenty minute ride to India’s border, and am crying as I type this. My tears are for the millions like him that go unloved because we’re too busy with things that aren’t important. I include myself in that; I could have changed that kid’s life, but chose not to.
Food cost ~ 50 cents per day, less than $200 per year. Money isn’t the biggest challenge, it’s the infrastructure to administer it, checks and balances against exploitation, and daily love that stems from compassion.
When we hear about people suffering we become upset or worry, but do not do anything. We do not even wish them happiness. We may say the words, but we do not feel compassion, or that compassion is temporary without becoming part of our lives. We experience suffering without ending the suffering of others.
The Buddha taught that selfless compassion leads to our happiness; that’s a start to providing sustainable futures for everyone on Earth, and follows the teachings of every world religion. The first words of the Old Testament taught the importance of social justice for the poor, which is emphasized by every book of the Old Testament used by Muslims, Jews, and Christians. Six hundred years later, Jesus said to serve the poor because it is better to give than to receive. One day we’ll listen, regardless of which religion we claim to follow. At the very least, we can strive to feel compassion for the suffering of others, which leads to our own happiness, and provides the mental clarity to make decisions beneficial to everyone.
(This blog is a work-in-progress; check back or subscribe for bundles of updates a few times per year. Or, subscribe on LinkedIn for more traditional blogs on international regulations in healthcare applied to corporations selling medical devices internationally, equitable education, and my goal to provide more opportunities for Corporate Social Responsibility)
Be well, and live peacefully.

A walking safari in Nepal’s jungle

/in /by
6 minute read.
When you walk through a jungle, remember four things:
If you’re charged by a rhino, climb the nearest tree. If there are no trees, run in a zig-zag pattern and drop your backpack or a piece of clothing; rhinos have poor eyesight and use their sense of smell when charging.If you encounter a sloth-bear, stay still and don’t startle it. Gather in a group and bang sticks on the ground.If you cross paths with a tiger, maintain eye contact and back away, slowly.If charged by a wild elephant, run and pray.
That’s the training we received before hiking into the jungle for three days, where we stayed in villages surrounded by fences to keep out wildlife. Nepal’s national parks are some of the few places in the world where you can go on a walking safari. It’s a rare opportunity to get up-close with endangered species in their natural environment.
During Nepal’s civil war, their army, which guards national parks, was pulled away to fight for ten years, allowing poachers to decimate already-endangered animals. National parks are vital to the future of endangered species; approximately 300 of the world’s remaining 3,000 one-horned rhinoceroses are protected in Nepal’s Chitwan National Park.
Getting there
This was part of a multi-month backpacking trip through Nepal and India, where I arrived in Kathmandu without plans, hiked across the Himalaya Mountains and explored the kingdom of Mustang. After resting a few days, I took a bus from the foothills of the Himalayas to the jungles of Nepal.
To be affordable, public buses in Nepal allow people to sit on each others’ laps, stand, or cram several people into seats designed for two people. Buses are small; I’m taller than average Nepali people, and I had to pull my knees towards my chest to fit into the seat. It’s uncomfortable, especially for a six-hour ride across bumpy mountain roads. To have fun, I let kids play with my camera. In poor areas of the world, people in tourists’ photos have rarely seen a photo of themselves or used a camera; many of the photos in my blog were taken by kids I met while backpacking.
Welcome to the jungle
The town near Chitwan National Park, Sauraha, is separated from the park by a river. The people of Sauraha use Elephants like people in the rural United States use tractors, working in fields and riding into town.

Shop owners share old produce with the elephants: their trunks can lift 750 lbs using 150,000 muscles, yet tickle your hand when they’re sniffing for an apple.

There are few roads or infrastructure in this part of Nepal, and villages inside the national park are isolated and rustic. There are few roads, and during the rainy season roads become impassable even to jeeps, but elephants live here naturally and can cross rivers that jeeps can not. They carry wood to cook food, and products to trade in town. And, they’re safer than walking: each year, people are killed by bears, tigers, rhinos, and wild-elephants.

The villages were sheltered from development because, until recently, there was malaria in the area. Then, the civil war kept development away. Now, the lack of roads, schools, and hospitals keeps the area isolated, except for tourists coming through with much-needed money. A popular activity is touring the jungle on the backs of elephants. They’re intelligent, social animals, known to show compassion and mourn their dead. They resist being chained and made to carry people, and the methods used to keep them domesticated is inhumane. So, as much as I enjoy them, we could not justify supporting a decadent use of elephants. We hiked into the jungle, enjoying elephants in a more natural setting.
Canoe & hike

We left town in a canoe, early in the morning when a thick fog blocked view of shore. We could hear monkeys howling in trees, birds singing from shore, and crocodiles splashing in the water. Over the next three days, we alternated between wading through rivers and hiring dugout canoes for deep sections where crocodiles may be unseen; the week before we arrived, a soldier disappeared while on patrol, presumably killed by a crocodile.

At night, we’d sleep in villages that were surrounded by rustic fences to keep out wildlife. Both guides were born in the area, became trained in conservation, and now earn their living preserving wildlife and wilderness. To make this a sustainable social business requires tourists willing to make the journey.

Most of our time was spent hiking to and from villages, observing wildlife along the way. We saw seven one-horned rhinos, which is a treat because there are only 3,000 remaining in the world today. They’re known to “Charge!” when startled, especially when protecting young rhinos. The rest of the time, they’re content sitting in water, eating and farting between naps.
To me, this sounds like a wonderful world: everyone eats, swims, farts, and naps; don’t be aggressive, except to protect your children from harm.

We had a scary experience with one rhino, after we startled one while hiking through high grass. This one photo was taken just before we all ran, including our guides, after ensuring we were safe.
Nepal requires two guides for walking safaris, one in the front and one in the read, watching all directions and keeping count of tourists. One of our guides had scars on his arm from a sloth bear attack.
Guides are usually from local villages, and are well-educated about animal conservation. They are there to help tourists have authentic experiences; we protect what we cherish, and we cherish what we experience positively.

Seeing tigers require being still. Each morning, we’d sit silently for four hours, observing trails that led to watering holes. Mostly, we only saw wild hogs, which are intelligent enough to realize that they’re cute and we’re mostly harmless.

Back in town
Over the three days, I had become friends with our guide. Back in town, I stayed with his family, in a hut overlooking the river. He insisted on buying beers: a Nepali beer is 350 Rupees ($3.50 U.S.), he earned $15/day as a tour guide, which required a year of school. His family and I grilled food, played music, and discussed what to do about balancing nature conservation with infrastructure development and people’s need for employment. He chooses to not take tourists on elephants, even though that’s more lucrative. He also knows that every road helps villages have access to modern health and education, but takes away land from wildlife; all threats to humans stem from us encroaching on land used by these animals for thousands of years before we started building roads there.
Ultimately, animals will be saved when humans preserve their land; we can’t expect rural people to preserve land at the expense of their own well-being, especially when faced by decadence in other areas of the world. The future of conservation may require sustainable tourism based on socially-responsible businesses, and democracies where people choose where tax funding goes.
Nepal is new to democracy. The civil war ended recently, and they had their second elections, which I witnessed when backpacking in the Himalayas. Everyone hopes for the same, and when we help them have equitable health and education they can help preserve nature for all of us.
We didn’t solve the world’s problems, but had fun and enjoyed cold beers while playing music and grilling food over an open fire. Alcohol is detrimental to inflammation in our bodies (I have chronic inflammation), and can become a problem for many people, but at that moment, sharing a beer was the best choice I could have made. The day before, I had been charged by a one-horned rhinoceros and saved by the guy buying me a beer.

I travel by backpack to get to know people who live drastically different lives than we do. I believe this allows me to better appreciate my home in San Diego, California, which makes me happy. When you’re happy, you want to share, which is I work towards equitable education and healthcare for others.
The future
Preserving these beautiful animals requires people like you and me making it financially feasible for villagers to earn a living sustaining their wilderness. We can do this through responsible tourism, supporting animal-welfare organizations, and encouraging global programs that assist local entrepreneurs in creating sustainable businesses.
Learn more:
Continue to:

I entered the kingdom of Mustang illegally

/in /by
6 minute read.
After hiking across the Himalaya Mountains, I entered the kingdom of Mustang. I had learned a few Nepali phrases; how to meditate effectively; and how to be mindful in each moment. I would spend the next two weeks hiking through Mustang and down another side of the Himalayas.

The previous blog ended on a sunset; this blog begins a few days later.
The sunset had lenticular clouds, so knew they’re be rain/sleet/snow soon. I chose to continue hiking because I felt strong after summiting Throlong La Pass, and my mind was clear after the helicopter rescue and experiencing a higher level of mindfulness. For the next day, rain and hail pummeled me as I walked the high-plains leading towards China.
The first town I came upon was Kagbeni, on a river that flowed from China and through the kingdom of Mustang. It had been trading center for centuries, and it’s 1,200 residents seemed more Tibetan than Nepali.

Kagbeni was built as a medieval city; I felt like a kid exploring the maze of streets that were barely wide enough for two people, and was shared by livestock kept inside city walls.
A 600 year-old statue at one of the gates to warn-off invaders let me know that 600 years ago the people of Kagbeni had a sense of humor. (Zoom in if you don’t see why.)

Young monks at the Kago Chode Monastery huddled around fires to stay warm during the sleet and rain. They were learning Buddhism, but also digital awareness, environmental sustainability, and social-entrepreneurship. Modern science was becoming common in Tibetan monasteries, probably influenced by the Dalai Lama’s 50+ year message of peace through compassion and wisdom, and wisdom includes embracing the fact of global warming and risks of population growth.
60-million year old fossils

The river brought fossils from the tops of Himalayan Mountains. I searched through the riverbed for fossils, only finding ones too big and heavy to justify carrying in my backpack. A monk realized what I was doing, gave me a small seashell he had found, and told me it was “good luck.”

People in this region considered fossils to be bones of deities, or gifts from gods. It’s easy to understand why, and that’s almost more believable than the truth: the highest mountain on earth was previously the bottom of an ocean floor, pushed up by giant plates floating on molten iron, carrying seashells 5 miles above earth, and preserving them for 60 million years until rains wash them down a river.
I’m OK simply saying they’re good luck.

Across the river from Kagbeni was a small village, part of the kingdom of Mustang and off-limits to tourists without special permits and licensed guides. I thought I had the special permit; when I realized otherwise, I was already a few days into Mustang and decided to keep going. When life provides an opportunity to enter a forbidden kingdom, take it.

Mustang
The trail hugged cliffs of a massive valley, and was swept with strong winds from the mountains. You could see for dozens of miles. The mountains were so massive that views wouldn’t change. After hours of hiking into the wind I’d see the same view, and for a moment believe I hadn’t moved.

Villages in Mustang blended into the cliffs and were almost invisible. Inside each village was like stepping back in time: farming done by hand or by animals, no electricity, wood or dung stoves, villagers butchering yaks and sharing the meat immediately. Houses stored wood for long winters on their roofs, and decorated homes with animal skulls for good-luck.

Like most people in Nepal, the people of Mustang were kind and seemed genuinely happy. Tourism is rare here, and guest houses rustic. Part of the reason tourism is restricted is the lack of services and supplies; tourism can destroy a local ecosystem by using more firewood than is sustainable and or using electricity for non-essential purposes. And, we’re accustomed to frequent hot showers, which is difficult to sustain based on heating from firewood. Government agencies had been trying to make Mustang “tourist friendly,” including adding wood-stoves that simultaneously provided warmth, cooked food, and heated water.
As I got closer to China, I discovered a road being built with modern equipment. China was financing a road connecting it to India, going through the Himalayas of Nepal. I saw the road being built through a region of ancient cave monasteries, damaging some and sending debris into the river. That loss is saddening, but the road will allow the people of this region to experience trade, tourism, electricity, healthcare, and education.

Snow blocked my path at higher elevations, so I turned around and retraced my steps until I returned to Kagbeni. I learned that the road I saw was also being built from the other direction, connecting India to Mustang, and had almost reached Kagbeni. The road will eventually connect India to China; combined, their populations are 1 out of 3 people on Earth. In addition to bringing modern life to millions of people in poverty, an overland trade route between the world’s two most populous countries will have global impact.
Yak Hamburgers
Tourism has quickly adapted to the new roads. Back in Kagbeni, I met tourists who had flown to a nearby airport and hired a driver for a day to see the views. These types of tourists are called “flashpackers,” typically former backpackers but with more money than time. I met them at a “Yak Donalds.”

Nepal honors Hindu traditions of not harming cows, so hamburgers were made from local yaks. Their “Happy Meal” included locally grown potatoes and wild sea buckthorn juice.
I’m mostly vegetarian, eating meat only 1-2 times a month because it causes inflammation, harms our environment, and is usually cruel to animals. But, it builds tissue and a strong immune system with amino acids unavailable in most vegetarian proteins. I had been hiking for almost a month and my muscles screamed for rest and rebuilding. Besides, I couldn’t resist trying a yak burger at YakDonald’s.

I continued hiking down the Himalaya Mountains. Towns along the way felt isolated; they were rarely visited by backpackers now that a road and airport was available on this side of the mountains. I followed a route documented 160 years ago by a Japanese traveler who had also crossed through Mustang illegally, at a time when there weren’t YakDonalds and smart-phone translator apps.
Hot springs

As I dropped elevation, trees and forests opened up. It was the opposite of my experience starting at lower elevations, so I knew what to expect. I looked forward to fresh produce and warm days, discovering both at a town called Tatopani, which means “hot water” (Tato = hot, pani = water). Tatopani has natural hot springs and fields of fresh fruits for home-squeezed juice when you take breaks from soaking in outdoor hot springs, surrounded by snow-capped mountains and adjacent to roaring waterfalls.
I do not have the words to describe how AMAZING it feels to soak in hot springs and eat fresh fruit after hiking through snow and sleet for weeks. Even better was feeling I had nowhere to be and a long time to get there.

The most common local food was lentils and rice with curried vegetables, called “dal bhat.” Dal bhat usually comes with something pickled and crispy bread adds texture. Mountain guides swear by the energy, saying, “Dhal Bat power lasts 24 hour!”
Dal bhat is healthy, filling, and locally-sourced for only 150 Rupees ($1.50 U.S.). Here’s a good Dhal Bat recipe from a Tibetan food-blogger.
Pokhara

The last stop on this trek was Nepal’s second-largest city, Pokhara, which is becoming an international destination for outdoor adventures. The roads and airport are changing the types of tourists from backpackers to flash-packers, people who have more money than time and would like to go somewhere remote, quickly. Pokhara has families exposing their kids to other cultures, kayaking on the lake, and paragliding in the surrounding mountains.

Pokhara’s economy is geared towards tourists, and many businesses try to support the underserved classes through sustainable social entrepreneurship. I received massages by Seeing Hands, staffed and managed by blind massage therapists who live communally. I took a few days to get massages, read books, and relax while consuming calories to regain the weight I had lost.
I boarded a bus to the Nepal lowlands, to begin hiking in jungles.
Continue to:

I hiked across the Himalaya Mountains

/in /by
11 minute read.
It took 28-days to hike over the Himalaya Mountains. This blog describes people I met, life in the Himalayas, altitude sickness (and rescues), and methods I used to develop mindfulness. It began in the town of Besisahar and ended in Beni Bazar.

Background
This was part of a longer backpacking trip through Nepal and India, where I arrived in Kathmandu, learned basic Nepali phrases, then traveled through both countries without plans, adapting each day based on people I met and lessons I learned.
PLEASE NOTE: this is an older post, written immediately after arriving home. I’m keeping it here because of links to it, but I’ve rewritten it in another article it to be more genuine. Not that this one isnt’ genuine, it’s just more “factual” rather than personal – I was new to blogging, especially about personal topics. I don’t fully understand what happened to my mind in the briefest of moments after crossing the Himalayas; it was positive, but complex and due to changes in neural connections and consequently my perspective. I suggest using the “search” feature or seeing highlighted blogs to understand that better, for example the article “You get what you give in Varanasis India” that I wrote after a few months of practicing writing more genuine, personallized articles. I’ll probably keep working on more and hope you check back or subscribe for updates every 6-12 months.
Also, a lot happened on this hiking that I can’t begin to summarize in one, two, or a dozen articles – these 28 days of hiking could be a book separate from the 2.5 month trip through Nepal and India.
Added August 2018
I’ve traveled this way for 30 years, flying into one country and out of another, and this trip was a milestone of having visited 1 out of 4 countries in the world. This trip was different because I had a goal to hike without pain medications, developing mindfulness instead. Doctors at the Veterans Health Administration had prescribed pain medications to me for over nine years to postpone surgeries that have low probabilities of relieving pain. The pain meds treated symptoms, but my mind was sluggish and it was difficult to make wise choices for long-term health. In this blog, I share a few techniques I used to develop mindfulness, hopefully helping someone else find alternatives to opioid pain medications or surgery.
The trail

I flew into Kathmandu, learned basic Nepali phrases, and decided to hike across the Himalaya Mountains as part of a longer trip through Nepal and India.
I took a bus from Kathmandu to the village of Besisahar, being dropped where the dirt road ended and a hiking trail began. I had a backpack with two months worth of clothes. I carried a day’s worth of food and water, a few books, a camera, and a Frisbee.

This was the foothills of the Himalayas, an area with thick forests and steep canyons carved by rivers. The trail cut into the sides of mountains, crossing rivers with suspension bridges swinging hundreds of feet in the air. Two people could not pass on the narrow bridges, so we’d coordinate who went first. Goats, cows, and buffalo used the bridges; I gave right-of-way to anything with horns, and played with anything that was cute.

Sleeping & eating
I carried a day’s worth of food an water, knowing I’d find more on the trail. The trail goes through villages, passing people’s front doors. Most families offer simple beds and dinners to travelers. Their ancestors had done the same thing to Tibetan traders for generations.

Clean water was available at filter-stations, installed by the government of New Zealand, which trained villagers to maintain them. This type of investment is called a “sustainable social business,” providing the infrastructure for local entrepreneurs to earn a profit while benefiting people and the planet. Sustainability is the triple bottom line: People, Planet, Profit.

Most villages don’t have schools. Some do, and nearby villagers walk the trail for hours to reach them. There are not medical services. Poverty is common, and the area was recovering from a recent civil war that killed 19,000 people and displaced 200,000. Foreign aid doesn’t reach them. Despite these challenges, the Himalayan people are kind, industrious, hard-working, and peaceful. Himalayan people say, “what is there to do?” as a way to be present in the moment and only worry about what is within their control.

Part of what’s in everyone’s control is our kindness towards others. Nepali culture encourages compassion, shown by how kids would run into the street to greet me when I approached a village. They’d clasp their hands, bow, and say “Namaste,” the Hindu word for “I see the divine in you.” I’d clasp my hands, bow, and wait to feel the sentiment before returning the word, “Namaste.”
Feeling compassion and speaking truthfully makes everyone happier. Imagine if our culture encouraged pausing to seek compassion for a person before saying, truthfully, “I hope you’re well.”
The poorest backpacker is wealthier than these kids can imagine, and many share treats. A consequence is a that kids start seeing backpackers, most of whom are caucasian (white), as sources of things rather than as people. They don’t say Namaste, they shout, “Money! Chocolate! Sweet!” You can’t see the divine in each other with a hierarchical relationship, so I gave the most valuable thing I have, time.

Many Himalayan families had been in travelers’ photos, but had never used a camera or seen their own picture. I lent my camera to kids, letting them learn by playing with it. They’d take photos of their parents, show them, and try again with new button combinations. In return, they’d teach me Nepali words for what they saw. This is co-learning, a powerful tool for connecting with students.
Kids took many of these photos, letting us see the world through their eyes.

People

I was hiking uphill each day, gaining 400-500 meters of elevation. Each night got colder; before going to bed, I’d huddle around kitchen fires, learning to cook Himalayan food while talking with families.

Most guest houses were people’s homes, and they juggled family duties while preparing our dinners. One host, Narme Llama, was a third-generation Tibetan with newborn twins. He had a warm smile, had learned four languages, and helped take care of his new daughters while running his business.
I arrived at the end of season without tourists, so a bed was free. A meal cooked over their wood stove was 200 Rupees ($2 U.S.). Ginger tea was 60 Rupees. They saved money to send their older daughter to boarding school in the nearest city, two-days away, for $15/month. They were lucky to save $2 per month, which would have to support them in old age. There were no schools nearby, and all jobs were physical labor that didn’t need an education, but Narme-Llama valued education. He realized their government wouldn’t build roads, schools, or hospitals in rural areas, but was grateful for his family and the values installed by his grandfather that helped make their exile from Tibet and independence in the Himalayas peaceful, despite being viewed as unwelcome refugees. Images of Buddha were on the walls; the Buddha taught how to seek your own happiness, because no one else can do that for you.

Sometimes a guesthouse would have other backpackers, or travelers with a guide, and we’d share time around a fire learning different perspectives on the world.
Some travelers had smart-phones with translation apps and solar-chargers, allowing us to communicate with almost anyone. Even tiny villages had WiFi; people couldn’t get toilet paper, but could browse the internet. Our world could be moving towards a global democracy, where people solve problems rather than politicians, or we could could be moving towards replacing democracy with “dataism.” (Read “Homo Deus.”) Wherever we’re going, 7.6 billion people using smart-phones will get us there faster.

Elevation
I hiked uphill 4 to 8 hours per day. Trees became rare, and snow-capped mountains became common. Tibetan prayer-flags highlighted mountains I’d eventually cross.

At higher elevations, people from poor castes walk downhill to collect firewood each day, walking back uphill to sell it. Tourists use more firewood than the local ecosystem can resupply; to balance this, the government agency overseeing this area has encouraged gas stoves. The alternative was burning yak-dung, which isn’t as smelly as you’d imagine, but I wouldn’t try it at home.
Mules resupply villages with gas tanks and food that can’t be grown in high elevations.

Democracy
Every few days I’d walk into a town, which is larger than a village and serves as a trading center. Towns had comfortable guest houses and supplies for backpackers, such as Snickers candy bars.
In the town of Manang, we had to wait four days because all guest-houses in the region were full of people from Kathmandu, who had traveled to vote in the national election. In Nepal, people must vote in the town they’re registered, usually where their ancestors were born. This was Nepal’s second election; their democracy was new, and followed a ten-year civil war that had divided the people between the poor and wealthy.

Nepali soldiers patrolled the streets of Manang, enforcing a curfew with guns rather than logic. Nepal uses their soldiers as defense, police, and national park protection. Until the civil war, they were the only people with guns, and without checks-and-balances they abuse their power in rural areas. I believe this will change now that Nepal has a democracy; I’ve never had a gun pointed at me in a country with a functional democracy.

The curfew didn’t affect our stay in Manang because there was nothing to do at night, especially when temperatures were below freezing. We’d walk up and down the street then return to our guesthouse to get warm around a yak-dung fire.
The guesthouse where we stayed was decorated for what the owners imagined a typical traveler would enjoy. Their home look like a rustic version of a 1970’s television sitcom; for some reason, they assumed that a typical traveler expected a Tiki bar.
The family had locally-made rice wine, which is served warm. We’d place cups of wine on the stove to keep both us and the wine warm.

We spoke with local families about the election. Most people didn’t understand the differences between political ideologies, they simply hoped for a better life. The communist party overwhelmingly won elections in rural areas. In cities, the status-quo remained. Their new democracy would share government decisions between parties. Regardless of this year’s outcome, it’s a step towards more people having a voice in their future. They celebrated with parties in the street.

Silence
After the elections, I started hiking through remote areas. My head hurt from spinal injuries, my hips hurt from arthritis and inflammation, and the screws in my ankle caused the bones to throb with pain. But I did not experience worry, anxiety, stress, or suffering. I walked silently, concentrating on being mindful.

You see more wildlife when walking silently. Some, like this yak, are not subtle. Others are easily missed; there are at least four mountain goats in this photo:

And at least two in this photo:

Mindfulness is being an observer of your mind and body’s interactions. Mindfulness begins with an intention to be more aware of each moment and how we choose our thoughts and actions. For many people, that’s enough to change their lives. But, people with chronic pain are constantly distracted by signals between their body and mind, so mindfulness requires concentration and practice, like a sport or academic subject that seems difficult at first.
To practice mindful meditation while walking:
Be aware of each moment, but do not become attached to it.Be aware of discomfort, but become detached from it.Be aware of pain, but do not suffer.
Mindfulness is difficult while hiking, especially at high altitudes and with a heavy backpack. Many people practice with 10-minute sessions of meditation, observing thoughts and feelings come and go, then apply the same concentration while walking.
Altitude
Many people do not get altitude sickness. I’m not one of them.
This photo was taken from the window of a shelter, where I stayed for three nights to recover.

For almost a week, I had been hiking at over 3,400 meters (~11,000 feet), gaining 300-500 meters each day. I had a headache and craved oxygen. My body fought two needs: deep breaths to get oxygen vs. tightening my windpipe to keep out the cold, dry air. I have asthma, and my breath “wheezed” on steep sections of the trail.
When you’re emotionally detached from discomfort, you’re able to differentiate between transient discomfort and symptoms of altitude sickness. At 4,880 metres (16,010 ft, ~ 3 miles) I realized that my headaches and dizziness were signs of trouble, so I descended to a shelter at 4,540 meters.

I stayed in a small room with one window that allowed cold wind into the room. I laid awake for hours, trying to stay warm as ice formed in my water bottle. It was -17 degrees by 2am. My heart was pounding at 124 beats per minute, more than twice my normal resting rate. Every muscle in my body was tense, sending blood to vital organs. I couldn’t descend; in daylight, it was six hours down a narrow and dangerous trail to the next shelter. I concentrated on relaxing until my jaw unclenched, which led to my teeth chattering at 124 beats per minute. I had prefered a clenched jaw.
By sunrise, my pulse was down to 80 beats per minute. I didn’t move that day, and by that evening my pulse was ~ 60 beats per minute, still more than my normal resting rate, but reasonable considering I was 3 miles high.

I acclimated by hiking to higher elevations during the day, descending to sleep at night. On one of these hikes, I found an emergency satellite phone. Three years prior, almost 400 people were trapped at this location by a surprise snowstorm; 42 died, and 175 suffered frostbite. I was not reassured by the satellite phone, which was made from a coffee can and something that looked like the dish-drying rack by my sink at home.
Hiking at high altitude requires focus for each step. Your body is tired from lack of oxygen, and your mind wants to be somewhere else. Hiking above 17,000 feet can require 10 to 15 seconds of focus per step.

I had been focused on each step for six hours when I saw a tea shop.
Seriously.
A cheerful entrepreneur had brought gas stoves and tea to a shelter at 17,900 feet. I paid $1.50 for a cup of hot tea; I would have paid a hundred.
Over the next few hours, his hut saved someone’s life.

I reached the summit, sat down, then got up as I realized something was wrong with one of the four other people. She was suffering severe altitude sickness. Her eyes were rolled back into her head, her breathing was in brief gasps, and her pulse was more than 150 beats per minute. She was in shock, and it was likely that pressure was building insider her brain.
None of us spoke the same language; we carried her into the tea hut while her guide was trying a satellite phone to call help. Over the next few hours, we kept her warm in the tea shop while preparing a helicopter landing zone. We carried her and her bags onto the helicopter, which would prioritize getting her to a lower elevation, and then to a hospital.

The helicopter cost $10,000. It was a private service, and the patient’s guide received a commission for calling it. The tea shop entrepreneur made $1.50. Three years ago, when the storm trapped 500 people here, local people dug through snow without concern for how they would get paid. There’s no right or wrong, just facts. Mindfulness is being aware of facts, but differing judgement until those facts are necessary to make a decision.
When the helicopter left, I was alone again. I started walking down the other side of the pass.
Mindfulness
I had been so focused on the rescue that I hadn’t felt pain or symptoms of altitude sickness. I started to notice the pain again. Descending steep trails is harder on your joints than hiking uphill, and my head and joints screamed with pain. People become addicted to temporary relief from pain, either from medications or work, so more doctors are recommending mindfulness to reduce suffering.
I practiced mindful meditation with each step. When I had descended enough to reduce the effects of altitude sickness, I stopped to eat a Snickers candy bar. It was the first food I could hold down in 24 hours; at that moment was the most delicious thing I had ever eaten. In the time it took for my teeth to break through a peanut, all discomfort faded. I had no thoughts, just awareness. The sky was brighter, the air cleaner, rocks more beautiful than before I began taking that bite. All that needed to be done was done. I was seeing things how they really are. This experience lasted for a month, and, to a lesser extent, remains now that I’m home.
Pairs of neurons in my brain had become detached, separating physical pain from mental suffering, allowing me to see more clearly. A month later, I’d learn more about this phenomenon from experts on meditation and neuroscience at a conference on “Mind and Modern Science.” At the conference, the Dalai Lama emphasized that understanding how our minds work allows us to make wiser choices that benefit ourselves and others. I had read research about this, and had heard testimonials from other people, but to experience it for oneself removes all doubt.
I walked downhill for a few more hours, found a guest house, and enjoyed the sunset. Two days later, I started hiking off-the-beaten-path.

Continue to:
Or, jump forward two weeks:

I arrived in Kathmandu without plans

/in /by
4 minute read.
Two hours before arriving in Kathmandu, I opened a guidebook for the first time. I was flying into Nepal and would depart from India. My plan was to not have plans, adapting each day based on people I met and lessons I learned.
I’ve traveled this way for 30 years: fly into one country, out of another, hiking across borders and meeting people along the way. This trip marked my having traveled through 1 out of 4 countries on Earth. Most have been what we call “third world” countries, providing insights into healthcare, education, and sustainability on our shared planet.
Introduction to Kathmandu
I learned that Nepal was recovering from an earthquake. 9,000 people had died; this was after a ten-year civil war killed 19,000 and displaced 200,000. That explained my cheap plane ticket.
In Kathmandu, workers repaired buildings while people enjoyed their city’s safe-zones. Only some of Kathmandu’s earthquake repair work was in”child-labor free zones.” That’s as bad as it sounds, is a problem in developing countries, and part of why I’m expanding my work in healthcare and education to include global equity. This blog is a step towards that direction.

Sleeping in a monastery

Monks at Benchen Monastery operate a guesthouse, using revenue to fund a free health-clinic that treats 60 to 80 people per day. My room was more comfortable than many hotels in Kathmandu, and cost 600 Rupees ($6 U.S.) I’d explore the city each day, and read or chat with monks at night.
Benchen functions like a sustainable social business, benefiting society by being profitable enough to sustain themselves. Sustainable businesses are vital to the people of Nepal, who lack social services and equitable education because of a poor government. Benchen Monastery is one of the few places in Kathmandu with trash and recycling bins, and they operate a small vegetarian cafe to provide healthy food at a price most people can afford; breakfast cost 80 Rupees.

I could walk from the monastery to explore the old city, where workers pushed supplies through narrow streets that weaved between temples. People rotated prayer-wheels as they walked around the temples, an ancient ritual that helps be mindful of the moment.

The caste system

People dedicated to spirituality sat near temples while street-workers sewed strands of flowers all day. People on their way to or from work purchased strands of flowers to leave as temple offerings. All three groups were doing their duty, which had been dictated by their social caste.

In the caste system, you do the work your father did, who did the work of his father. Your children will do your work.
You can not marry outside of your caste. Your name includes the work you can do; I’d be Jason Ian Partin-Engineer. (Not really; if I did my family’s work, I’d be Jason Ian Partin-Prisoner.)
The caste system has been Hindu doctrine for almost 4,000 years, and was Nepali law until recently. Millions of people are hoping to change the lingering effects of a caste system. This isn’t unique to Hinduism; in the United States, we’re hoping to overcome the lingering effects of slavery.
Many Nepali workers wore hats with the “OBEY” logo, which led me to thinking about Hope, Happiness, & Socio-Economics. A change for global equity must go beyond “giving jobs” and provide long-term sustainability, especially in a world where almost all jobs will soon be obsolete. The future of education will have to evolve from job training to innovation and personal happiness.
Education
Helping kids overcome the effects of unjust socio-economics requires equitable education. “Equitable” means to give a bit more to people who start with less, and to ensure that education techniques are personalized for the unique needs of each student.
Today, success requires skills in communication and innovation; in the near-future, success will require skills entrepreneurship. In Kathmandu, I helped students develop communication skills and techniques for entrepreneurship using collaborative-learning and design-thinking.

Guidelines for co-learning are:
Be their equalCreate a culture where everyone helps each otherMonitor and guide everyone’s progress
Guidelines for design thinking are:
Empathize with your customerPrototype an ideaTest your idea with customersImprove your ideaRepeat
The kids taught me Nepali phrases; I helped them develop public-speaking skills through sleight-of-hand magic. Seriously! Learning magic helps overcome fear of failure; you have fun, practice in front of people, and improve based on what you learn. Designing new magic tricks uses design-thinking, which is a step towards innovation and entrepreneurship. Looking up new techniques uses internet search skills, and performing increases communication skills. Plus, it’s fun.
Graffiti

Street-artists practiced their craft on modern buildings in the newer parts of Kathmandu. Art was painted; political graffiti was stenciled; messages were hashtags.
GKC is a Nepali orthopedic surgeon who advocates equitable healthcare and education. He provides free healthcare to rural villages and has become a symbol for the people in Nepal who believe that inequity must stop. When GKC was asked his top three priorities, he only gave two: service to patients, and service to students.

Last day

I chatted with monks or read books from the monastery’s library every night. On my last day, I hiked to The Monkey Temple, which had overlooked the city of Kathmandu for thousands of years, to relax by reading.
I had decided to leave Kathmandu the next morning; I’d attempt to hike over the Himalaya Mountains. My doctors have prescribed pain medications to postpone surgery. I decided to stop taking them, feeling they numbed my mind without solving the cause of suffering, and had been practicing using mindfulness instead of medication.
Continue to:
Post-Script
I posted this blog in February, 2018, a week before my friend and rock-climbing partner, John Seroki, died in an airplane crash. He was an engineer and orthopedic surgeon who worked with Doctors Without Borders to provide free healthcare in developing countries, including Nepal. We miss you, John.

John, ahead of me on the trail to Bear Creek Spire, Eastern Sierra Mountains.