Technical Documentation Required for CE-marking to Hygiene, Rescue and Antidecubitus Mattresses

Työn tarkoituksena on laatia tekniset asiakirjat hygienia-, pelastus- ja painehaava- eli antidecubituspatjoille. Tekniset asiakirjat liittyvät CE-merkinnän tuomiin vaatimuksiin. Patjat ovat lääkinnällisiä laitteita, joita koskee direktiivi lääkinnällisistä laitteista, eli MD-direktiivi. Direktiivissä on oleelliset vaatimukset lääkinnällisille laitteille, joiden toteutuminen on osoitettu teknisissä asiakirjoissa. Kun oleelliset vaatimukset on täytetty, laite voidaan varustaa CE-merkinnällä. CE-merkintä on valmistajan vakuutus siitä, että tuote täyttää direktiivin vaatimukset ja on turvallinen käyttää. Oleellisten vaatimusten täyttämiseen voidaan käyttää apuna standardeja ja muita dokumentteja. Standardi, SFS-EN ISO 10993-1: Terveydenhuollon laitteiden ja tarvikkeiden biologinen arviointi, on apuna lääkinnällisten laitteiden biologisessa arvioinnissa. Euroopan komissio on antanut ohjeen lääkinnällisten laitteiden kliinisen arvioinnin toteuttamiseen. Ohjeessa on käsitelty kliinisen tiedon arviointia ja analyysiä, jolla varmistetaan laitteen kliininen turvallisuus. Sosiaali- ja terveysalan lupa- ja valvontavirasto, Valvira, on antanut CE-merkintään liittyviä määräyksiä, jotka tulee myös huomioida teknisten asiakirjojen laadinnassa ja varustettaessa tuotetta CE-merkinnällä. Hygienia-, pelastus, ja antidecubituspatjat ovat luokan Ι laitteita, eli matalimman riskin laitteita. Tällöin mikään ulkopuolinen taho ei osallista tuotteen CE-merkitsemiseen tai teknisten asiakirjojen laatimiseen. Valmistajan on itse määriteltävä, mitä oleelliset vaatimukset koskevat tuotetta. Jokaiselle patjalle on laadittu omat tekniset asiakirjat, kuitenkin niin, että pelastus- ja antidecubituspatjojen asiakirjoja tulee lukea yhdessä hygieniapatjan asiakirjojen kanssa. Opinnäytetyöhön ei sisältynyt riskien arviointi. Asiakirjoissa todetaan patjojen täyttävän oleelliset vaatimukset ja olevan turvallisia käyttää

The impact of nutritional status on the process of formation of pressure ulcers in a patient in intensive care after injury cerebro-cranial

Introduction: Pressure ulcers are chronic wounds of very serious social and economic problem. With advances in medicine and the extension of human life, every day they involve ever growing group of patients. Despite much progress in medicine and the progress in the techniques of cultivating chronic wounds, pressure sores are a problem, which for many years is a blemish on for many doctors and nurses. Material and Methods: A 46 year old male, professional driver status. From the interview with the family that the patient smoked about 15 cigarettes a day, no alcohol, he ate irregularly, fed on due to the nature of the work. Height 183 cm, weight 87 kg at the hospitalization day. Patient underwent surgery, the right parietal craniotomy. Intracerebral hematoma has been removed, breaking raised removed invaginated compromise bone. At the time of adoption in the branch, he was unconscious, intubated connected to a ventilator to breath surrogate mode IPPV, under the influence of anesthetics. Sedation infusion of 2% Propofol, Nalpain. Aim: The impact of the nutritional status of a patient with craniocerebral trauma wounds to the formation of bedsore. Results: Taking into account the results of the questionnaire NRS-2002, the scale Norton, Braden, interview, physical examination, symptoms, anthropometric measurements, biochemical and immunological in the initial period and 30 days of hospitalization can be estimated that the nutritional status of the patient is abnormal, which significantly influences the risk bedsore wounds uprising. Conclusions: The risk of complications such as chronic wounds-pressure ulcers in the patient have beenvery large. This is related to the general state of the patient's diabetes type II, with baseline nutritional status, infections, hypercatabolism resulting from craniocerebral trauma. Back to the patient's health requires large amounts of protein and energy. The patient's condition at the time of adoption in the branch was very heavy, unconscious patient, the surrogate breath, undernourished. Key words: chronic wound, bedsore, nutritional status, preventio

An eHealth System for Pressure Ulcer Risk Assessment Based on Accelerometer and Pressure Data

Pressure ulcers are a common skin disease which is associated with pain, reduced autonomy, social isolation, and reduced quality of life. There are several systems for monitoring of pressure ulcer-related risk factors on the market, but up to now no satisfactory solution is available, especially for people with medium pressure ulcer risk. We present a novel pressure ulcer risk assessment and prevention system, which combines the advantages of accelerometer and pressure sensors for monitoring pressure ulcer risk factors. Sensors are used for detection of repositionings of the person lying on the mattress. Sensor data are sent to a tablet where they are analysed and presented graphically. The system was evaluated in a long-term test at the homes of people of the target group. Results indicate that the system is able to detect movements of persons while lying in bed. Weak correlation in between mobility and Braden pressure ulcer risk was found (correlation factor = 0.31). From our data, long-term trends could be visualized as well as 24 h mobility profiles. Such graphical illustrations might be helpful for caregivers in order to optimize care of people with medium to high pressure ulcer risk

Alternative reactive support surfaces (non-foam and non-air-filled) for preventing pressure ulcers

Background Pressure ulcers (also known as injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Reactive surfaces that are not made of foam or air cells can be used for preventing pressure ulcers. Objectives To assess the effects of non‐foam and non‐air‐filled reactive beds, mattresses or overlays compared with any other support surface on the incidence of pressure ulcers in any population in any setting. Search methods In November 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In‐Process & Other Non‐Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta‐analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. Selection criteria We included randomised controlled trials that allocated participants of any age to non‐foam or non‐air‐filled reactive beds, overlays or mattresses. Comparators were any beds, overlays or mattresses used. Data collection and analysis At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. If a non‐foam or non‐air‐filled surface was compared with surfaces that were not clearly specified, then the included study was recorded and described but not considered further in any data analyses. Main results We included 20 studies (4653 participants) in this review. Most studies were small (median study sample size: 198 participants). The average participant age ranged from 37.2 to 85.4 years (median: 72.5 years). Participants were recruited from a wide range of care settings but were mainly from acute care settings. Almost all studies were conducted in Europe and America. Of the 20 studies, 11 (2826 participants) included surfaces that were not well described and therefore could not be fully classified. We synthesised data for the following 12 comparisons: (1) reactive water surfaces versus alternating pressure (active) air surfaces (three studies with 414 participants), (2) reactive water surfaces versus foam surfaces (one study with 117 participants), (3) reactive water surfaces versus reactive air surfaces (one study with 37 participants), (4) reactive water surfaces versus reactive fibre surfaces (one study with 87 participants), (5) reactive fibre surfaces versus alternating pressure (active) air surfaces (four studies with 384 participants), (6) reactive fibre surfaces versus foam surfaces (two studies with 228 participants), (7) reactive gel surfaces on operating tables followed by foam surfaces on ward beds versus alternating pressure (active) air surfaces on operating tables and subsequently on ward beds (two studies with 415 participants), (8) reactive gel surfaces versus reactive air surfaces (one study with 74 participants), (9) reactive gel surfaces versus foam surfaces (one study with 135 participants), (10) reactive gel surfaces versus reactive gel surfaces (one study with 113 participants), (11) reactive foam and gel surfaces versus reactive gel surfaces (one study with 166 participants) and (12) reactive foam and gel surfaces versus foam surfaces (one study with 91 participants). Of the 20 studies, 16 (80%) presented findings which were considered to be at high overall risk of bias. Primary outcome: Pressure ulcer incidence We did not find analysable data for two comparisons: reactive water surfaces versus foam surfaces, and reactive water surfaces versus reactive fibre surfaces. Reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds (14/205 (6.8%)) may increase the proportion of people developing a new pressure ulcer compared with alternating pressure (active) air surfaces applied on both operating tables and hospital beds (3/210 (1.4%) (risk ratio 4.53, 95% confidence interval 1.31 to 15.65; 2 studies, 415 participants; I2 = 0%; low‐certainty evidence). For all other comparisons, it is uncertain whether there is a difference in the proportion of participants developing new pressure ulcers as all data were of very low certainty. Included studies did not report time to pressure ulcer incidence for any comparison in this review. Secondary outcomes Support‐surface‐associated patient comfort: the included studies provide data on this outcome for one comparison. It is uncertain if there is a difference in patient comfort between alternating pressure (active) air surfaces and reactive fibre surfaces (one study with 187 participants; very low‐certainty evidence). All reported adverse events: there is evidence on this outcome for one comparison. It is uncertain if there is a difference in adverse events between reactive gel surfaces followed by foam surfaces and alternating pressure (active) air surfaces applied on both operating tables and hospital beds (one study with 198 participants; very low‐certainty evidence). We did not find any health‐related quality of life or cost‐effectiveness evidence for any comparison in this review. Authors' conclusions Current evidence is generally uncertain about the differences between non‐foam and non‐air‐filled reactive surfaces and other surfaces in terms of pressure ulcer incidence, patient comfort, adverse effects, health‐related quality of life and cost‐effectiveness. Reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds may increase the risk of having new pressure ulcers compared with alternating pressure (active) air surfaces applied on both operating tables and hospital beds. Future research in this area should consider evaluation of the most important support surfaces from the perspective of decision‐makers. Time‐to‐event outcomes, careful assessment of adverse events and trial‐level cost‐effectiveness evaluation should be considered in future studies. Trials should be designed to minimise the risk of detection bias; for example, by using digital photography and adjudicators of the photographs being blinded to group allocation. Further review using network meta‐analysis will add to the findings reported here

Foam surfaces for preventing pressure ulcers

Background Pressure ulcers (also known as pressure injuries) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Foam surfaces (beds, mattresses or overlays) are widely used with the aim of preventing pressure ulcers. Objectives To assess the effects of foam beds, mattresses or overlays compared with any support surface on the incidence of pressure ulcers in any population in any setting. Search methods In November 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In‐Process & Other Non‐Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta‐analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. Selection criteria We included randomised controlled trials that allocated participants of any age to foam beds, mattresses or overlays. Comparators were any beds, mattresses or overlays. Data collection and analysis At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. If a foam surface was compared with surfaces that were not clearly specified, then the included study was recorded and described but not considered further in any data analyses. Main results We included 29 studies (9566 participants) in the review. Most studies were small (median study sample size: 101 participants). The average age of participants ranged from 47.0 to 85.3 years (median: 76.0 years). Participants were mainly from acute care settings. We analysed data for seven comparisons in the review: foam surfaces compared with: (1) alternating pressure air surfaces, (2) reactive air surfaces, (3) reactive fibre surfaces, (4) reactive gel surfaces, (5) reactive foam and gel surfaces, (6) reactive water surfaces, and (7) another type of foam surface. Of the 29 included studies, 17 (58.6%) presented findings which were considered at high overall risk of bias. Primary outcome: pressure ulcer incidence Low‐certainty evidence suggests that foam surfaces may increase the risk of developing new pressure ulcers compared with (1) alternating pressure (active) air surfaces (risk ratio (RR) 1.59, 95% confidence interval (CI) 0.86 to 2.95; I2 = 63%; 4 studies, 2247 participants), and (2) reactive air surfaces (RR 2.40, 95% CI 1.04 to 5.54; I2 = 25%; 4 studies, 229 participants). We are uncertain regarding the difference in pressure ulcer incidence in people treated with foam surfaces and the following surfaces: (1) reactive fibre surfaces (1 study, 68 participants); (2) reactive gel surfaces (1 study, 135 participants); (3) reactive gel and foam surfaces (1 study, 91 participants); and (4) another type of foam surface (6 studies, 733 participants). These had very low‐certainty evidence. Included studies have data on time to pressure ulcer development for two comparisons. When time to ulcer development is considered using hazard ratios, the difference in the risk of having new pressure ulcers, over 90 days' follow‐up, between foam surfaces and alternating pressure air surfaces is uncertain (2 studies, 2105 participants; very low‐certainty evidence). Two further studies comparing different types of foam surfaces also reported time‐to‐event data, suggesting that viscoelastic foam surfaces with a density of 40 to 60 kg/m3 may decrease the risk of having new pressure ulcers over 11.5 days' follow‐up compared with foam surfaces with a density of 33 kg/m3 (1 study, 62 participants); and solid foam surfaces may decrease the risk of having new pressure ulcers over one month's follow‐up compared with convoluted foam surfaces (1 study, 84 participants). Both had low‐certainty evidence. There was no analysable data for the comparison of foam surfaces with reactive water surfaces (one study with 117 participants). Secondary outcomes Support‐surface‐associated patient comfort: the review contains data for three comparisons for this outcome. It is uncertain if there is a difference in patient comfort measure between foam surfaces and alternating pressure air surfaces (1 study, 76 participants; very low‐certainty evidence); foam surfaces and reactive air surfaces (1 study, 72 participants; very low‐certainty evidence); and different types of foam surfaces (4 studies, 669 participants; very low‐certainty evidence). All reported adverse events: the review contains data for two comparisons for this outcome. We are uncertain about differences in adverse effects between foam surfaces and alternating pressure (active) air surfaces (3 studies, 2181 participants; very low‐certainty evidence), and between foam surfaces and reactive air surfaces (1 study, 72 participants; very low‐certainty evidence). Health‐related quality of life: only one study reported data on this outcome. It is uncertain if there is a difference (low‐certainty evidence) between foam surfaces and alternating pressure (active) air surfaces in health‐related quality of life measured with two different questionnaires, the EQ‐5D‐5L (267 participants) and the PU‐QoL‐UI (233 participants). Cost‐effectiveness: one study reported trial‐based cost‐effectiveness evaluations. Alternating pressure (active) air surfaces are probably more cost‐effective than foam surfaces in preventing pressure ulcer incidence (2029 participants; moderate‐certainty evidence). Authors' conclusions Current evidence suggests uncertainty about the differences in pressure ulcer incidence, patient comfort, adverse events and health‐related quality of life between using foam surfaces and other surfaces (reactive fibre surfaces, reactive gel surfaces, reactive foam and gel surfaces, or reactive water surfaces). Foam surfaces may increase pressure ulcer incidence compared with alternating pressure (active) air surfaces and reactive air surfaces. Alternating pressure (active) air surfaces are probably more cost‐effective than foam surfaces in preventing new pressure ulcers. Future research in this area should consider evaluation of the most important support surfaces from the perspective of decision‐makers. Time‐to‐event outcomes, careful assessment of adverse events and trial‐level cost‐effectiveness evaluation should be considered in future studies. Trials should be designed to minimise the risk of detection bias; for example, by using digital photography and by blinding adjudicators of the photographs to group allocation. Further review using network meta‐analysis adds to the findings reported here

Alternating pressure (active) air surfaces for preventing pressure ulcers

Background Pressure ulcers (also known as pressure injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Alternating pressure (active) air surfaces are widely used with the aim of preventing pressure ulcers. Objectives To assess the effects of alternating pressure (active) air surfaces (beds, mattresses or overlays) compared with any support surface on the incidence of pressure ulcers in any population in any setting. Search methods In November 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In‐Process & Other Non‐Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta‐analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. Selection criteria We included randomised controlled trials that allocated participants of any age to alternating pressure (active) air beds, overlays or mattresses. Comparators were any beds, overlays or mattresses. Data collection and analysis At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. Main results We included 32 studies (9058 participants) in the review. Most studies were small (median study sample size: 83 participants). The average age of participants ranged from 37.2 to 87.0 years (median: 69.1 years). Participants were largely from acute care settings (including accident and emergency departments). We synthesised data for six comparisons in the review: alternating pressure (active) air surfaces versus: foam surfaces, reactive air surfaces, reactive water surfaces, reactive fibre surfaces, reactive gel surfaces used in the operating room followed by foam surfaces used on the ward bed, and another type of alternating pressure air surface. Of the 32 included studies, 25 (78.1%) presented findings which were considered at high overall risk of bias. Primary outcome: pressure ulcer incidence Alternating pressure (active) air surfaces may reduce the proportion of participants developing a new pressure ulcer compared with foam surfaces (risk ratio (RR) 0.63, 95% confidence interval (CI) 0.34 to 1.17; I2 = 63%; 4 studies, 2247 participants; low‐certainty evidence). Alternating pressure (active) air surfaces applied on both operating tables and hospital beds may reduce the proportion of people developing a new pressure ulcer compared with reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds (RR 0.22, 95% CI 0.06 to 0.76; I2 = 0%; 2 studies, 415 participants; low‐certainty evidence). It is uncertain whether there is a difference in the proportion of people developing new pressure ulcers between alternating pressure (active) air surfaces and the following surfaces, as all these comparisons have very low‐certainty evidence: (1) reactive water surfaces; (2) reactive fibre surfaces; and (3) reactive air surfaces. The comparisons between different types of alternating pressure air surfaces are presented narratively. Overall, all comparisons suggest little to no difference between these surfaces in pressure ulcer incidence (7 studies, 2833 participants; low‐certainty evidence). Included studies have data on time to pressure ulcer incidence for three comparisons. When time to pressure ulcer development is considered using a hazard ratio (HR), it is uncertain whether there is a difference in the risk of developing new pressure ulcers, over 90 days' follow‐up, between alternating pressure (active) air surfaces and foam surfaces (HR 0.41, 95% CI 0.10 to 1.64; I2 = 86%; 2 studies, 2105 participants; very low‐certainty evidence). For the comparison with reactive air surfaces, there is low‐certainty evidence that people treated with alternating pressure (active) air surfaces may have a higher risk of developing an incident pressure ulcer than those treated with reactive air surfaces over 14 days' follow‐up (HR 2.25, 95% CI 1.05 to 4.83; 1 study, 308 participants). Neither of the two studies with time to ulcer incidence data suggested a difference in the risk of developing an incident pressure ulcer over 60 days' follow‐up between different types of alternating pressure air surfaces. Secondary outcomes The included studies have data on (1) support‐surface‐associated patient comfort for comparisons involving foam surfaces, reactive air surfaces, reactive fibre surfaces and alternating pressure (active) air surfaces; (2) adverse events for comparisons involving foam surfaces, reactive gel surfaces and alternating pressure (active) air surfaces; and (3) health‐related quality of life outcomes for the comparison involving foam surfaces. However, all these outcomes and comparisons have low or very low‐certainty evidence and it is uncertain whether there are any differences in these outcomes. Included studies have data on cost effectiveness for two comparisons. Moderate‐certainty evidence suggests that alternating pressure (active) air surfaces are probably more cost‐effective than foam surfaces (1 study, 2029 participants) and that alternating pressure (active) air mattresses are probably more cost‐effective than overlay versions of this technology for people in acute care settings (1 study, 1971 participants). Authors' conclusions Current evidence is uncertain about the difference in pressure ulcer incidence between using alternating pressure (active) air surfaces and other surfaces (reactive water surfaces, reactive fibre surfaces and reactive air surfaces). Alternating pressure (active) air surfaces may reduce pressure ulcer risk compared with foam surfaces and reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds. People using alternating pressure (active) air surfaces may be more likely to develop new pressure ulcers over 14 days' follow‐up than those treated with reactive air surfaces in the nursing home setting; but as the result is sensitive to the choice of outcome measure it should be interpreted cautiously. Alternating pressure (active) air surfaces are probably more cost‐effective than reactive foam surfaces in preventing new pressure ulcers. Future studies should include time‐to‐event outcomes and assessment of adverse events and trial‐level cost‐effectiveness. Further review using network meta‐analysis adds to the findings reported here

Whole body hyperthermia : the development of and experience with a clinical method

Whole body hyperthermia is one of the methods available for the treatment of malignant turrours with heat. At the Rotterdam Radio-Therapeutic Institute this method was investigated in 27 patients in a period of 3 1/2 years. This thesis describes the results of this investigation. The final conclusions from this study are: the technique used for induction of WBHT is clinically useful and its efficiency is comparable to the efficiencies mentioned by other authors Who use a technique of transcutaneous energy input; - WBHT at 41.8°C for 2 hours is effective, but has to be canbined with either radiotherapy or cherrotherapy to obtain a valuable effect for the patient; In sane cases the treatment may unexpectedly induce severe toxicity. Therefore research should continue with regard to better alternatives such as local hyperthennia and/or a safer method of WBHI'-induction

Pressure sore etiology - highlighted with optical measurements of the blood flow

In line with the quality awareness of good prevention of pressure sores and in treatment of those sores already developed, evaluation of antidecubitus mattresses plays an important role. However, there are shortages in the evaluations performed today, since often interface pressure is the only parameter regarded. Since ischaemia in the tissue is the primary cause of pressure sore, the focus in this thesis is on blood flow measurements in tissue exposed external loading. To study the tissue blood flow would give a better and more direct indication on the mattress effectiveness in minimizing the negative effects on the tissue viability. The results presented in this thesis reveal that the superficial blood flow in areas prone to pressure sore development, is affected by increased skin temperature and external loading of the tissue. Both the effects from pressure and shear stress have been studied. Measurements of the tissue blood flow is interesting to relate to the two theories about at which tissue layer the pressure sores start to develop. To achieved more knowledge about the pressure sore etiology and also be able to non-invasively measure the tissue blood flow for evaluations of antidecubitus mattresses an optical sensor has been developed. The sensor combines the two optical methods, laser Doppler flowmetry and photoplethysmography. With the design of the sensor, measurements of the superficial skin blood flow and the deeper blood flow, even the muscle blood flow, can be performed. Measurement depths of 2 mm, 8 mm, and 20 mm into the tissue is assumed. Preliminary result from measurements performed with the optical sensor in four test subjects, revealed great individual differences in blood flow, but also different response to the same external loading at different measurement depths, in the same individual. This new optical sensor is likely to be of great value in future studies of pressure sore etiology and in future evaluations of antidecubitus mattresses