The Association for the Advancement of Medical Instrumentation is calling on government entities to become more involved in standards development of medical devices, according to an AAMI news release.
More government participation in standards could help prevent two different agencies from adopting different and conflicting standards, AAMI says.
An example of a lack of consensus surrounds IEC 60601-1, the electrical equipment standard. Last year, the U.S. Food and Drug Administration's Center for Devices and Radiological Health recognized the third and latest edition of the standard.
The Occupational Safety and Health Administration uses the previous edition of 60601-1 for a different purpose than FDA, and is "now indicating it will not recognize the third edition," AAMI says. "This presents some serious difficulties for industry."
Read the AAMI news release urging more government involvement.
Read more coverage about AAMI:
- 4 Key Considerations for Efficient and Effective Sterilization of Surgical Instruments
- Biomedical Departments, Anesthesia Staff Can Maintain Anesthesia Machines, Equipment
- Study Lists Concerns, Suggestions for Borrowing Surgical Equipment
More government participation in standards could help prevent two different agencies from adopting different and conflicting standards, AAMI says.
An example of a lack of consensus surrounds IEC 60601-1, the electrical equipment standard. Last year, the U.S. Food and Drug Administration's Center for Devices and Radiological Health recognized the third and latest edition of the standard.
The Occupational Safety and Health Administration uses the previous edition of 60601-1 for a different purpose than FDA, and is "now indicating it will not recognize the third edition," AAMI says. "This presents some serious difficulties for industry."
Read the AAMI news release urging more government involvement.
Read more coverage about AAMI:
- 4 Key Considerations for Efficient and Effective Sterilization of Surgical Instruments
- Biomedical Departments, Anesthesia Staff Can Maintain Anesthesia Machines, Equipment
- Study Lists Concerns, Suggestions for Borrowing Surgical Equipment