On 18 October 2017, a group of people experienced a RAPS chapter event of epic proportions. Attendees and chapter organizers alike struggled through extreme winds and rain, finding unlikely refuge and uplifted spirits in an event guiding them through the Medical Device Single Audit Program (MDSAP).
RAPS Vancouver Chapter leaders, Jennifer Cabralda, Karen Long and Dinar Suleman, had begun the day excited about an event that was hard to pull off successfully. The three planned to work in concert to have dinner and information ready for attendees. Suleman was on site ensuring everything was set up, Cabralda would drive in and bring the drinks, Long would take the train and bring the cutlery and dinner would be delivered. The speaker, Alexander Crosby of Intertek’s Business Assurance Americas Group, was prepped and ready to share his expertise on MDSAP.
Then, the intense rain began.
“It was pouring with rain, and I mean monsoon-like. I was watching out the window as crews were placing sandbags around the facilities, to no avail.” explains Suleman. “The streets around LifeScan were flooded, cars abandoned, detours in place.”
An abandoned car in front of the LifeScan building where a RAPS Vancouver Chapter program was successfully held, despite unusual flash flooding event.
“Jen was stuck in traffic, since the roads were completely flooded. Her trip to the venue should have taken just 15 minutes, but instead she was in the car for over an hour!” Karen remembered. “I stepped out of the train station and realized my seven-minute walk would be much more difficult than I realized.”
Walking from the station, Long bravely fought rising waters. “I found a path where the first puddle was only a few inches deep, but the second part of the water was much worse. I found myself in water up to my knees!” On her journey through the water, Long saw cars swept into the road at odd angles and abandoned by drivers. “They were just stalled out and left there.”
Part of a large flash flood RAPS Vancouver Chapter volunteer Karen Long navigated to help put on the popular October MDSAP event.
This rain-caused chaos had gridlocked much of the traffic around the venue, yet attendees kept streaming in. “We had several people drive to this event from as far as Seattle, and they showed up at LifeScan with smiles on their faces and ready to learn, despite the weather challenges.” Suleman continues, “They knew the MDSAP program was not getting enough attention, and they had to make the training happen.”
Crosby made the program worth the struggles. “He went on for a long time, almost 2 hours of constant presentation. Best of all, he was so engaging and funny. He made the program enjoyable,” said Long. “He kept telling us, ‘You can do this! You can start tackling it now and be ready.’ I think we needed to hear that.”
In his talks, Crosby focused on empowering the event attendees to take charge of their preparation. “Most people tell you you’re already behind. They’ll say ‘the train has left the station and you’re already too late!’” explained Suleman. “But this guy gave me so much confidence. It was as if he was saying ‘Hop on board! There’s room and we can all get there!’ I enjoyed his take on things.”
One part of Crosby’s talk both Long and Suleman found enlightening was his explanation of MDSAP changes. He discussed how Canadian regulations had been held out of date for a long time. Long remembers, “He said MDSAP incorporates all the changes we should have seen over the last 10 years. When he explained that, a lightbulb went off for me. Suddenly the reason behind things made a lot more sense.”
“While he mentioned we might have more close investigations with MDSAP, he reminded us that the regulators will mostly be looking for us to show our process.” explained Long. She continued, “Everything should be in place if you’re following the guidelines. He reminded us that we should only have to change how we document.”
Both chapter volunteers were happy with how much guidance Crosby offered, suggesting his presentation should help attendees get a jump start on their documentation updates. “His companion documents were great, too!” exclaimed Suleman. “I think people will find they will make the basis for SOPs, and I loved that they included several links directly to documentation.”
Crosby had titled his presentation “What does MDSAP Mean for Device Manufacturers?”, and both Long and Suleman thought this appealed to attendees. “Most people want to know ‘How does this affect me?’, and he came right out and answered that question.” The large crowd, enthusiasm undimmed by the extreme weather event, seemed to agree.
“We don’t want people to think this sort of weather is normal for Vancouver! This was definitely an unusual day, but the amount of enthusiasm for learning was exactly what RAPS events in Vancouver are working to foster,” explained Suleman. The October meeting drew one of the largest crowds for a Vancouver program, with active questions and participation throughout.
The success of the RAPS event even seemed to tame the weather. When participants left after the event, the wild street flooding had completely receded and the sky was calm.