There’s a growing trend towards providing more health care outside of medical facilities. There are many potential benefits in doing this, including:
- Reducing the number of hospital visits
- Reducing the length and cost of hospital stays
- Reducing readmissions through long-term monitoring of patients at home to catch issues before they become big problems
However moving medicine from medical facilities with medical professionals, to homes with patients and caregivers who have less training and possibly significant impairments (vision, hearing, cognition, etc), is challenging. I reviewed some of these issues a while back in my MEDS article, The New World of Home Health Telemonitoring.
In order to better address these challenges, last month the FDA released a new draft guidance Design Considerations for Devices Intended for Home Use. The guidance is similar to the IEC 60601-1-11:2010 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, but with some differences. There’s a nice writeup on the draft guidance at Eisner Safety Consultants that discusses the draft, and points out some of the specific differences.
Since it’s a draft guidance, it has less standing than a final guidance, but it’s very useful to see where the FDA’s thinking is at in this area. The FDA will be accepting comments on the draft for 90 days from the date of issuance (12/12/2012).