Intra-NICU Patient Transfers: A Study of Frequency and Family and Staff Perceptions.

AIMS: (a) Quantify frequency of patient moves within a NICU with single patient and semi-private rooms (SPR). (b) Compare staff and parent perceptions of these moves. METHODS: A hospital administrative database was evaluated to quantify the frequency of moves. A Room Change Questionnaire was devised to evaluate perceptions from NICU families and staff. RESULTS: Most families reported experiencing at least 1 patient move (92 percent), with the majority reporting at least 3 moves (58 percent). Staff perceived moves as negative significantly more than parents (p < .01), and overreported negative family perceptions (p < .01). Overall, moves did not bother families (52 percent); however, most families who moved 3 or more times reported at least 1 negative perception (63 percent). CONCLUSION: SFRs increase the number of patient moves. NICU staff's perception is significantly more negative than family's perception; however, most families who were moved frequently reported at least 1 negative perception.

Science-based assessment of source materials for cell-based medicines: report of a stakeholders workshop.

Human pluripotent stem cells (hPSCs) have the potential to transform medicine. However, hurdles remain to ensure safety for such cellular products. Science-based understanding of the requirements for source materials is required as are appropriate materials. Leaders in hPSC biology, clinical translation, biomanufacturing and regulatory issues were brought together to define requirements for source materials for the production of hPSC-derived therapies and to identify other key issues for the safety of cell therapy products. While the focus of this meeting was on hPSC-derived cell therapies, many of the issues are generic to all cell-based medicines. The intent of this report is to summarize the key issues discussed and record the consensus reached on each of these by the expert delegates.

Surface roughness of ceramic femoral heads after in vivo transfer of metal: correlation to polyethylene wear.

BACKGROUND: A dark metallic-appearing smear, resembling a lead pencil mark, may be seen on a ceramic femoral head component at revision total hip arthroplasty. The purpose of this study was to investigate the hypothesis that such a mark on a retrieved ceramic femoral head is associated with increased surface roughness of the head and increased polyethylene liner wear in total hip replacement. METHODS: Fifteen ceramic prosthetic femoral heads retrieved from fifteen patients at revision arthroplasty were examined in this study. Thirteen heads had been in vivo for an average of 10.8 years (range, 7.8 to 14.2 years). The remaining two heads had been in vivo for less than one month. The surface roughness characteristics of the explanted ceramic heads, the linear wear of the polyethylene liner, and the patient activity levels after the primary replacement and before the revision were determined. RESULTS: Four of the thirteen ceramic heads that had been in vivo for >/=7.8 years had severe smears (>6% of the surface area), and the remaining nine heads had slight smears (<6% of the surface area). The two heads that had been in vivo less than one month had severe smears. The mean Ra and Rpm, the values for surface roughness, were 44.95 nm and 571.15 nm, respectively, in the hips with slightly smeared regions and 180.77 nm and 1245.88 nm, respectively, in the hips with severely smeared regions (p = 0.002). The mean linear liner wear rate was 0.10 mm/yr in the hips with slightly smeared heads and 0.19 mm/yr in the hips with severely smeared heads (p = 0.002). The activity score for all patients was 5 or 6 points on a 6-point scale. CONCLUSIONS: The results of this study confirm the hypothesis that a visual dark metallic-appearing smear on a ceramic femoral head correlates with increased surface roughness of the head and increased polyethylene wear. These findings imply that contact of a ceramic femoral head with a metallic material, such as may occur with femoral head reduction or dislocation of a total hip replacement, is best avoided to prevent this metallic smear phenomenon.