An MD&DI April 1997 Column
Safety programs in the medical device industry maintain a relatively low profile compared to those established for quality, largely because manufacturers are primarily concerned about meeting FDA regulations--particularly in recent years. Even so, safety is an enormous consideration that can affect productivity and product quality.
"When you're looking at how to set up and run equipment safely, you're addressing quality," says Stephen Sheng, regulatory compliance manager for International Medication Systems, Ltd. (South El Monte, CA), a maker of pharmaceuticals and plastic injection moldings used in medical devices. "If a person is injured, you've lost production time and you're affecting quality," he adds.
However, compliance with FDA quality requirements--particularly good manufacturing practices--does not satisfy safety and health requirements laid down by OSHA. While FDA regulations focus on products as the means to ensure public safety, OSHA regulations seek to ensure the safety of the people making those products. As a result, companies often assign specific staff to develop and operate in-house safety programs aimed at ensuring compliance with state and federal regulations and identifying ways to keep workers on the job.
At Advanced Technology Laboratories (ATL; Bothell, WA), Cathy McCaffrey works with a full-time nurse and risk manager to establish and maintain a safe workplace environment. As the company's environmental and safety manager, McCaffrey focuses on regulations set by the Washington State Industrial Safety and Health Act. These regulations, which are implemented by the Washington State Department of Labor and Industries, are much more stringent than those of the federal government, she says.
States often use federal regulations as the core of their own safety and health programs. "The states usually add on what they think are appropriate requirements," says Robert James, now a consultant in Hempstead, MD, who served 26 years with Becton Dickinson (Cockeysville, MD), most recently as director of regulatory affairs and quality systems. Doing so allows compliance staff to focus on requirements specific to their company and locality.
But developing an effective safety program can be challenging, and no single safety program can fit all medical companies because work processes vary depending on the products and the approaches to manufacturing. Requirements for the storage of flammable and combustible liquids and the use of personal protective equipment, for example, may not apply if such chemicals or noise levels are not encountered by workers.
And there may be other concerns unique to a company, even concerns specific to medical device companies. ATL workers service used diagnostic ultrasound scanners. These scanners often include probes designed for use intraoperatively and in body cavities. "Although the risk of infection is not great, we have a strong infectious pathogen program that includes decontaminating scan heads sent back for service, before they are handled by our employees," McCaffrey explains.
Because of such special circumstances, companies must first examine their operations, processes, and work environments in the context of safety regulations. A formal audit of worker practices is the first step in establishing a compliance program, a step taken by Sheng when he set up such a program several years ago at International Medication Systems. After the operations analysis, he says, management must be informed of the results and enlisted to implement a program aimed at resolving any problems.
Workers must then be trained in how to perform their work safely. OSHA requires that educational materials, including labels and data sheets, be prepared and distributed to workers to warn of occupational hazards.
Records of safety information and instructions, worker training, and audits are essential to achieve government compliance, as inspectors inevitably request such documentation. When establishing and administrating safety programs, manufacturers must ensure that efforts meant to satisfy certain government regulations do not violate others. "Sometimes, when you change a process, you want to make sure the quality of the product has not been affected," Sheng says. Companies can do that by integrating safety and quality teams. McCaffrey at ATL works closely with specialists focused on FDA concerns, as well as concerns dictated by other federal and state agencies.
Done well, safety programs can generate benefits other than just meeting the letter of the law. They can increase morale among the workforce and create the opportunity to improve the lives of employees. "We have a very good 'return to work' program," McCaffrey says. "If employees are injured, we modify their duty so they can return sooner. The nurse works with them during this phase, while keeping in contact with the doctors." One reason for the program is productivity, she says, but more important is the mental health of the employee. "Statistics show that the longer someone is sitting at home, the more likely they are to get depressed," McCaffrey says. "We want them back here."--Greg Freiherr