Unwritten Rules of ISO 11607
June 13, 2022
Many industry veterans know that parts of ISO 11607 are up for interpretation. There are portions you shall (must) follow, and there are areas that are left up to you and your organization to determine how they relate to your products. This is our quick, expert guide to the areas of ISO 11607 that are more open to interpretation than others.
Packaging 101: ISO 11607
March 21, 2022
When you first enter the medical packaging industry, you’ll frequently hear about ISO 11607. But what does it mean, and why do you need to know about it? Here, we share the top six things you need to know about ISO 11607.
Healthcare Packaging: Change is the New Normal
February 7, 2022
It’s no secret that one of the biggest challenges faced by today’s healthcare packaging engineers is change management. The industry is moving faster than ever. Both external and internal forces are requiring packaging engineers to be much more proactive as they consider changes that may impact the packaging system; and all of this comes as international regulatory bodies heighten their expectations of healthcare organizations.
Unique Device Identification System for Medical Devices – Part 1
November 29, 2021
Under various medical device regulatory jurisdictions worldwide, the Unique Device Identification (UDI) System is being developed to facilitate adequate medical device identification through distribution and use. Healthcare providers, distributors, group purchasing organizations, payors, researchers, and others are using UDI for supply chain efficiency, tracking medical devices in the electronic health record including track and trace, comparative effectiveness research, electronic procurement, and a multitude of other information. This article, the first in a 2-part series, will give you a quick overview of the basics of UDI and its importance in the track and trace process at medical device companies. In this part, let’s talk through the basics–including what it is and why it matters.
Updates on China’s New Regulations for Medical Devices
June 15, 2021
In late March 2021, China’s National Medical Products Administration (NMPA, formerly CFDA) published the revised Regulations on the Supervision and Administration of Medical Devices. This version of regulations was postponed until March 2021 due to re-prioritization of tasks of NMPA in response to the COVID-19 pandemic. The updated regulatory framework was slated to take effect on June 1, 2021.
Country-by-Country: Asia’s Regulations on Medical Packaging
June 1, 2021
Asia is emerging as one of the fastest-growing regional markets in the East. A number of dynamics are driving growth, including expansive government expenditure, increasing healthcare needs of aging populations, and greater accessibility to healthcare overall. As Asia opens these new dimensions, it is bringing economies, commerce, marketing and social issues such as healthcare, to the fore. The double-digit growth has highlighted the need for more standardized, precise medical device regulations, which have varied widely across APAC countries, until now.
MDR Starts on May 26; Read This to Get Ready
May 25, 2021
MDR has been a part of our vocabulary since 2017. It was postponed last year, but the time is finally here. On May 26, 2021, the European Union Medical Device Regulation (or, EU MDR) will finally be implemented. Since the announcement of this new regulation, all notified bodies and medical device manufacturers across Europe have been actively preparing. By now, stakeholders are aware of what must be done. But with that said, it is an extensive regulation, so we also know companies who are wondering if they’ve interpreted MDR correctly, and more importantly, if they comply or not.
From Machine Operator to Head of Quality
March 30, 2021
I raise up my voice—not so I can shout, but so that those without a voice can be heard. We cannot succeed if half of us are held back.
- Malala Yousafzai, recipient of the Nobel Peace Prize
ISO 11040-7: Packaging In-Process Pharma and Prefilled Syringe Tubs
January 13, 2021
For those in the medical device and healthcare packaging industries, whether you are just starting out or have been in the field for 30 years like me, we understand ISO 11607. We live and breathe it every day. Whether we are considering the device itself, the package design, making a material selection, or considering sterilization and transportation, ISO 11607 is our guide.
MD&DI Interviews FDA Commissioner
November 3, 2020
How the FDA continues to generate the science and data of a pandemic, keep the public health on active duty, and serve innovation, in the year that upended the world.
Out with the old? Changes to EO sterilization may help meet new challenges.
August 12, 2020
Ethylene oxide (EO) sterilization has remained largely unchanged for decades, but recent changes have shaken up the industry. Concerns with the carcinogenic nature of EO and the alleged levels of emissions from sterilization facilities led to subsequent closures of some contract sterilization facilities. EO is a highly effective sterilant with many advantages, but it is also toxic and classified by the U.S. Environmental Protection Agency (EPA) as a known carcinogen.
FDA Pilots Programs to Enhance Traceability
July 30, 2020
What is happening with FDA Title II Drug Supply Chain Security Act (DSCSA)?
July 7, 2020
An entity all its own:
“Why did THEY make it this way?”
“What were THEY thinking?”
How many times have I uttered those or similar phrases about “they” in my career?
Who are “they” anyway?
In my case, my “they” has often been the people who wrote the ISO 11607 or ASTM standards that we use to test our packages.
Global Medical Device Regulations & Harmonization Efforts of Sterile Medical ...
May 26, 2020
We are going through a global health crisis which is unprecedented in our lifetime. This is a global pandemic which requires an international response. As such, it becomes even more important to understand global harmonization of best practices in the healthcare industry.
ISO 11607 & EU MDR: Getting Clarity on Risk Management
April 29, 2020
A year after the publication of ISO 11607-1/2 revisions, seeking further harmony with 2020’s EU MDR, new changes are in the works.
Seal Strength Testing: Is 1 lb. Still the Go-To Metric? ASTM WK57656 Update
March 13, 2020
A few years ago, I started a journey on behalf of packaging professionals everywhere—to validate or debunk the 1 lb. standard for seal strength testing. For as long as I can remember, it has been a popular topic of conversation and debate in every gathering or get-together with veteran and beginning packaging engineers alike. We discuss where the 1 lb. standard came from, why 1 lb. became the go-to metric, and if 1 lb. is right for every package out there.
Med Tech Regulatory Bosses Around the World
November 14, 2019
There is no dispute about why the med-tech industry is highly regulated. No matter how robust the sterilization or disinfection process, if the packaging and seal closures of a medical pouch are compromised, there is a significant risk of product contamination during shipping and storage that could pose a danger to the end-user. Moreover, we all know that “end-user” ultimately means you, me or someone we love.
Sterilization and the FDA Innovation Challenge
November 7, 2019
By now, we are all familiar with the recent discussion around sterilization in the medical device industry. Ethylene oxide or EtO is the most popular sterilization modality in the industry accounting for approximately half of the market. EtO is a colorless gas, and long-term exposure can pose serious health risks. Some US communities located in and around EtO sterilization facilities have become increasingly concerned, ultimately forcing the FDA to take action.