2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC56
Submitter : Ms. Beryl Goldman Date & Time: 12/15/2004 11:12:23
Organization : Kendal Outreach, LLC
Health Professional
Category :
Issue Areas/Comments
The accuracy of reporting from hospitals, long term care facilities and home health agencies is cause for concern. Many are unaware that they are obligated to report injuries and deaths to the FDA so it's reasonable to believe that the numbers of reported cases is grossly understated.

Articulation of bed needs further work, Note: all but zone 1 may change with articulation.

Framed flotation therapy beds -- needs clarification of first sentence. Perhaps an example would help clarify. Need to remember that patients in these bed systems (overlays) are obviously already compromised so their safety should be of major concern.

Comments #1. Exclusions
Yes, reconsider. Exclusions (water down) the document. Even though manufacturers "recommend" (side rail) use, it boils down to "critical thinking" by the clinician and the decision may still result in using the device.

The neck test -- the question is whether testers will actually be consistent. Not able to test for reliability and validity. The difficulty with the above test is that it requires the measuring of an angle, i.e., 60 degrees or less, and requiring this angle measurement adds a level of sophistication that may be prohibitive and warrant the test too difficult.

Comment #2 - More stringent dimensional limit on Zone 2. Err on the side of using the smaller number. Whole numbers will work better for staff measuring beds rather than the fractions.

Comment #3 - More stringent dimensional limit at Zone 3. Remove fractions.

Comment #4 - Recommendation for a dimensional limit for Zone 5. Needs to remain. Based on the three bullets, there's no way to ignore this important zone. According to a study by Steven Miles, split rails create high potential for injuries and death.

Comment #5 - Recommendation for a dimensional limit for Zone 6. Yes, it should be included. Low profile siderails can be misleading and organizations need to make certain that zones are being measured appropriately.

Suggestion: Because measuring bed frames in articulated positions may prove problematic, consider suggesting that the tester carefully observe all potential entrapment zones as the head and foot of the bed are raised, respectively. IF any zone becomes larger in size, the tester should re-test the particular zone under study at its largest size.?

Comment #7 - This paragraph and background should be at beginning of document, highlighting flat and articulated. The first bullet under background is inaccurate, the size "may" change during articulation.

Comment #8 - Device could create risks, evaluate bed environment for risks.

Charts will need to be changed...testers/clinicians will be more compliant if (1)fractions are removed from the measurement and (2)inches are used rather than millimeters.

Would strongly advise that all zones other than zones 3 and 7 be tested without the mattresses on the frame. This is the only way to ensure a reliable and valid test. For zones 1, 2, 4, 5, and 6, the size of a particular zone may change significantly when a mattress slides partially off or fully off the frame.