Within the last couple of years, 24×7 has addressed some of the “standardization” issues the profession faces. We covered META’s survey to find a standard word that would define a BMET, the educational challenges because there is not a set curriculum, and the barriers to expansion the profession faces because jobs are posted under multiple titles and many people do not even know the field exists.
On the Biomedtalk Listserv I saw recent postings asking what the PM procedures were on a specific device. In the same vein, at an upcoming PAMIA meeting, Tim Ritter of ECRI Institute will give a presentation on assessing scheduled support of medical equipment. Questions such as “To PM or not to PM?” and “How safe is safe?” will be discussed, which acknowledge that this area is open to revision and there is not a fixed rule.
Standards, it would seem, represent a challenge. Yet, in an industry where life-saving devices are the focus, standards are essential to maintaining patient safety. Not all of the criteria in question—such as what to technically call a BMET—represent safety issues, but the design, function, and maintenance of medical equipment are of vital importance. The fact that some maintenance procedures can be modified by a facility leads to the question, what is “safe”? Who can actually determine that, and who should have the final say?
The FDA has decided what constitutes “safe,” and long before a medical device reaches patients, it ensures those standards are met through its approval process, but as globalization continues and more equipment is manufactured outside of the United States, how can we be certain new devices meet stringent standards? In a recent interview, G.S.K. Velu, PhD, managing director, Trivitron Group of Companies, Chennai, India, who has 18 years of experience in the diagnostics and health care industries, stated that the global medical devices market was estimated to be $197 billion in 2006, with the United States capturing about $70 billion, the Chinese industry $12 billion—with more than $6 billion in exports—and the Indian market capturing $2.17 billion, expected to reach $4.97 billion by 2012 if it continues at the current growth rate of 15% per year.
To keep a watchful eye on the manufacturing stage, the FDA is requesting nearly $2.4 billion as part of the President’s fiscal year (FY) 2009 budget. According to the agency, this will help ensure the safety of the food supply and accelerate the availability of new, safe, and innovative medical products, including FDA-regulated imports. In the May 13 issue of the Weekly Jolt, we reported on the FDA’s hiring campaign, which it says will help it devote more workforce to food production and handling sites, both at home and abroad, but will this budget allow the FDA to truly monitor devices manufactured outside of the United States? Will it have access to manufacturing plants and records? Does it need that access? What do you think? E-mail me and let me know your thoughts.