The Gray Sheet publishes article about MedAccred

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The Gray Sheet publishes article about MedAccred

25 September 2015

The Sept. 7, 2015, issue of “The Gray Sheet” featured a “Medtech Talk” guest column on MedAccred, the Medical Device Industry supply chain oversight program created to reduce risk to patient safety, assure quality products and compliance with requirements as they apply to critical processes used in the production of medical devices. The article, written by PRI staffers, is republished below with kind permission of “The Gray Sheet.”

Manufacturers, Suppliers Offer Perspectives On Supplier Quality Program


MedAccred, the new collaborative supplier quality initiative developed by the medical device industry, is rapidly gaining momentum. The first accreditation for the program has been awarded, and with more suppliers scheduled to undergo audits over the next several months, we look at what is making these companies step forward and become part of the process.

The list of companies actively participating in the MedAccred program is growing. High-profile firms involved now number more than 30, including Abbott, Applied Thermal Technologies, Baxter, BD, Boston Scientific, Celestica HealthTech, Covidien, DePuySynthes (Johnson & Johnson), DSM Biomedical, Flextronics, GE Healthcare, Global Technologies, GW Plastics, Harterei Gerster, Industrial Metal Finishing, Jabil Nypro Healthcare, Kimball Electronics, Lake City Heat Treating, Medtronic, Merz Aesthetics, Paragon Medical, Paulo Products, Philips HealthTech, Plastikos, Sanmina SCI, Solar Atmospheres, Stryker, Synergy Health, Techmetals, Tecomet and Terumo Cardioascular Systems.

MedAccred is an industry-managed supply chain oversight program governed by industry representatives that reduces risk to patient safety, helps build quality products, and aids firms as they strive to comply with requirements as they apply to critical processes used in the production of medical devices. (Related: “Nonprofit Groups Work To Bring Device Companies Together For Supplier Accreditation” — “The Silver Sheet,” July 2013.)

Currently focused on cable and wire harness, heat treating, plastics, printed circuit board assembly, sterilization and welding, MedAccred audits are conducted using collaboratively created audit criteria; accreditation is granted and accepted by the program’s subscribing members.

The audit criteria incorporate industry-accepted performance standards and manufacturer specifications that meet the requirements of the regulator. Process-focused product audits are conducted by industry-approved and industry-trained subject matter expert auditors who have extensive experience and knowledge of their process. (Related: “GUEST COLUMN: The Latest On Medical Device Supply Chain Accreditation” — “The Silver Sheet,” September 2014.)

FDA Interest

FDA is also aware of MedAccred. Since the program was established, the MedAccred Management Council (the program’s governing body) has proactively sought to keep FDA updated on the program’s development.

Briefings have been held with the Center for Devices and Radiological Health’s Office of Compliance and the Office of Global Operations within the Office of the Commissioner. The program’s purpose and scope was discussed, along with the results of proof-of-concept audits conducted to demonstrate the program’s viability.

FDA provided positive feedback and strong encouragement to pursue the development of the program. Further synergies were established between FDA’s Case for Quality initiative – specifically, the “critical-to-quality ” methodology – and MedAccred, with MedAccred recognized as an important
tool in assuring critical manufacturing process quality by ensuring flow-down of critical-to-quality specifications through the sub-tier supply chain.

The Manufacturer’s Perspective

Through consensus of participating medical device original equipment manufacturers (OEMs), the MedAccred program establishes a consistent practice and organization for special process assessment. “That’s what the industry is missing right now,” said Bruce Dall, a senior staff quality engineer at Stryker who also serves as chair of the MedAccred Heat Treatment Task Group.

“Ultimately, the goal is to achieve a consistently high level of product quality from our special process vendors,” he said. “Presently, every OEM has nuances in their specific expectations that lead to differences in process validation and pyrometry control requirements. This places a burden on the supply chain, as they must meet all customer requirements. There are limited common requirements. MedAccred establishes a common expectation,” Dall noted.

He continued: “From a personal standpoint, I spend a lot of my day helping suppliers with compliance questions – hopefully MedAccred will save a lot of my time dealing with these issues and free up our supplier resources from a quality auditing perspective as well. In addition, it will give greater clarity to our suppliers, and save them time too. I would hope that MedAccred results in improved process control and product quality, as well as reduced effort by everyone.”

The Supplier Perspective

In May, Solar Atmospheres became the first company to receive MedAccred heat treatment accreditation.

On receipt of the certificate, Mike Moyer, director of sales at the Souderton, Pa., firm pointed out that “many companies only enter these programs when their customers mandate compliance. At Solar Atmospheres we embrace these programs as opportunities. It is a good thing when industry original
equipment manufacturers and final device-makers recognize the benefits that accrue when suppliers become involved in the global management of activities surrounding their special process.

“After all, who knows a special process better than the companies that perform it every day?”

Moyer noted that “the programs inevitably bring the OEMs and suppliers together at the same table where pertinent discussions lead to achieving the following goals: first, improvements in the substance and flow-down of the requirements from the OEMs; second, improvements in the performance of the supplier base; and third, improved products to doctors and patients resulting in better quality medical care with fewer complications.”

Further, Stryker’s Dall noted that “from a heat treatment perspective, the requirements don’t change much between aerospace and medical device manufacturing. We had already recognized that AMS2750 was the ‘gold standard’ of pyrometry control for managing heat treatment processes. It is widely used in aerospace and we had already been trying to introduce our supply chain partners to the standard. But as a single OEM, gaining traction was difficult.”

Stryker viewed MedAccred as an opportunity to build those key requirements into a broadly supported accreditation program.

“Consequently, the basis of the MedAccred heat treatment audit criteria is AMS2750,” Dall said. Naturally, we also had to look at some of the particular nuances of the medical device industry, such as rework control, process validation and documentation. These are areas that the FDA pays particular attention to, so we made sure that they were addressed appropriately.”

Participation Wanted At All Levels

The key to MedAccred is the collaborative approach to program development and, unlike other audit programs where auditees have little involvement in the audit criteria they must adhere to, MedAccred is different.

Suppliers, as well as OEMs and contract manufacturers, are strongly encouraged to participate at all levels of the program management structure, from the task groups where they can influence audit criteria to the management council, which shapes the overall program strategy.

Solar Atmospheres’ Engelhard talked openly about the benefit of active participation for his company. “By actively participating, we get to put across our perspective and have input into a program that will touch a very important part of our business. Participation also supports our company positioning in the marketplace as a company committed to being at the cutting-edge of heat treating.

“The other thing that is very important is that through active participation, a supplier gains exposure to quality personnel that they would never get to see otherwise,” he continued. “The networking benefits and the exposure of your company to the top decision-makers in the field are unparalleled.”


View the article on The Gray Sheet website

[Editor’s note: Views expressed by guest columnists do not necessarily reflect those of “The Gray Sheet.”]