What ending the ASR program means for medical device manufacturers

Web content editor Ian Bolland spoke to Morgan Palmer, chief technology officer and Kim Wakeman, solutions engineer at ETQ about the FDA’s decision to formally end the Alternative Summary Reporting (ASR) Program. The discussion covered what it means for quality management at manufacturing companies, the medical device industry, regulators and regulation going forward.

The move by the FDA to make medical device reports public is designed to allow more informed decision making. The ASR Program was in effect from 1997 until June this year, allowing manufacturers to request exemptions, variances, or alternatives to reporting requirement – which meant ASRs were allowed ‘for specific well-known and well-characterised’ events associated with specific devices.

Kim Wakeman, solutions engineer of ETQ – a quality management solutions provider – explains the benefits it could have for manufacturers, though admits there are both pros and cons.

She said: “There’s millions of documents and records.

“With more information [manufacturers] can help determine what the risk would be to themselves. I think it’s good for manufacturers to see this information to understand what the possible risk is to their product, as well as other manufacturers.

“There’s pros and cons as far as releasing this information to the manufacturers that were producing these products. There is more concern, but it does provide them the information that they can put in place to help prevent those same issues happening. It could damage these manufacturers as far as the information being released but it also could prevent those same type of issues happening.”

Morgan Palmer, ETQ’s chief technology officer feels the reaction from the industry is key in order for confidence in the sector to be maintained. From ETQ’s own research of the ASR data, there had been 176 deaths associated with issues considered ‘low risk’.

He said: “I think it’s going to come down to how well the industry deals with this data and how forthcoming they are about communicating how they are going to handle this data.

“It’s pretty phenomenal, we’re actually getting deaths from what we consider low risk issues. If the industry doesn’t react appropriately, I think it will further diminish the view of quality in the industry.

“If it can shake itself up a little bit and say ‘this is an opportunity to put our best foot forward and explain how they’re going to improve quality’, I think, maybe, it could have a positive end.”

So, do the new developments mean changes to regulation? And is there enough resource at regulators for this to be effectively remedied?

Wakeman said: “I definitely think there’s going to be some changes in looking at the way things are reported across both the US and other countries.

“That affected individuals worldwide not having this data available to them so I think there will be some regulatory changes.”

Palmer suggested that along with the need for more resources at the FDA, the reliance on manufacturers to report issues has its flaws to it.

He said: “The people that come in don’t have the necessary time or resources to do a good job, they don’t come in often enough. When they do find an issue, what I’ve heard is overkill on the individual cases – they’re not spreading themselves enough across the whole industry.

“I think there’s definitely a regulatory issue there and they’re counting on the fact that manufacturers are going to be good citizens, they’re going to do the right thing, report it in the right way and make the right change themselves.”

One of the overarching objectives of this exercise is to allow manufacturers to learn lessons from past mistakes – whether it’s their own or of others – but Palmer feels that analytics is going to be a driver of change following the disclosure of ASRs as companies revisit events and processes gone before. While analytics may be a big deliver, there is the question of how that change is implemented.

“One of the things that will entail is the need to have pool systems to support that. They’re going to need to, certainly from a purely data analytics perspective, they’re going to need business intelligence tools to be able to process that data.

“That truly is at the heart of quality management which is once we’ve identified an issue, all of the follow-up that happens is making sure you have an action plan, that you’re verifying its effectiveness, you’re making the documentation and procedural changes, training – anything that has to do with effecting change improving quality in an organisation.”